藥華 口服轉塗抹藥 KX01 (KX2-391) (Src & tubulin inhibition) 直接拼TFDA Pivotal Trial (牛皮癬psoriasis) !!!!

藥華醫藥：公告本公司KX01用於治療牛皮癬之臨床試驗，已獲台灣衛福部食品藥物管理署(TFDA)同意執行(更新) 鉅亨網新聞中心2015-05-28 09:12:50　 第三十四條　第42款1.事實發生日:104/05/27 2.公司名稱:藥華醫藥股份有限公司3.與公司關係(請輸入本公司或聯屬公司):本公司4.相互持股比例(若前項為本公司，請填不適用):不適用5.發生緣由:本公司自美國Kinex Pharmaceuticals公司取得大中華及部分東南亞地區授權之新藥KX01，前於西元(下同)2014年12月向台灣衛福部食品藥物管理署(TFDA)遞交臨床試驗用新藥(IND)申請，已於5月27日接獲TFDA函覆同意執行。6.因應措施:發布本重大訊息。7.其他應敘明事項:(1)研發新藥代號或名稱：KX01(2)用途：KX01係本公司自美國Kinex公司取得授權後，投入研發將原本口服劑型開發為可針對皮膚局部治療(topical medication)之創新軟膏劑型，KX01係一輔(酉每)抑制劑(kinase inhibitor)，In-vitro Studies顯著具有抗增殖性(antiproliferative) 、抑制人角質細胞(keratinocyte)的形成與生長、抗新血管形成(neovascularization)等作用，緣此，預估可用於牛皮癬的治療。(3)預計進行之所有研發階段：第一期/第二期/第三期臨床試驗(Pivotal Trial)、新藥查驗登記(NDA)(Pivotal Trial)、新藥查驗登記(4)目前進行中之研發階段：(一)提出申請/通過核准/不通過核准：本公司檢送臺大醫院蔡呈芳醫師主持之KX01臨床試驗，獲TFDA同意試驗執行。(二)未通過目的事業主管機關許可者，公司所面臨之風險及因應措施：不適用(三)已通過目的事業主管許可者，未來經營方向：不適用(四)已投入之累積研發費用：約11,307千元(不含簽約金及授權金)(5)將再進行之下一研發階段：A.預計完成時間：IND申請通過後，在台灣進行第一期人體臨床試驗，按規劃預計於2015年底完成B.預計應負擔之義務：第一/二期人體臨床試驗完成且達到試驗設計之主要療效指標時，本公司將再支付Kinex公司里程碑授權金。(6)新藥開發時程長、投入經費高且並未保證能一定成功，此等可能使投資面臨風險，投資人應審慎判斷謹慎投資。

 KX01 (KX2-391) is a synthetic, orally active and highly selective inhibitor of Src tyrosine kinase signaling and tubulin polymerization. KX01 promotes the induction of p53, G2/M arrest of proliferating cell populations and subsequent apoptosis via the stimulation of Caspase-3 and PARP cleavage. Kinex is developing KX01 as an oral agent for oncology indications and has been tested in four clinical studies, thus far. In defining its pharmacological activity in tumor cells, both in vitro and in vivo, KX2-391 has been shown to have potent activity against a wide range of solid tumors as well as leukemia cell lines, including cell lines that are resistant to commonly used cancer drugs. Kinex has partnered with Hanmi Pharmaceuticals (Seoul, Korea) to develop the oral formulation of KX2-391 for oncology indications in the Korea and greater China Territory. In partnership with Hanmi, the safety, tolerability and pharmacokinetics of KX2-391 have been studied in more than 120 patients in both solid and liquid tumors. Three of these studies ere carried out in the U.S.; a study of KX2-391 in combination with paclitaxel is currently being conducted in South Korea and sponsored through the collaboration with Hanmi Pharmaceuticals. Potent inhibition of the growth of human keratinocytes and several melanoma cell lines in vitro suggests that KX2-391 will have potential clinical activity for actinic keratosis and other dermatologic malignancies. Kinex will initiate a clinical study for actinic keratosis with KX2-391 Ointment later in 2014. KX2-391 has been observed to inhibit T cell migration and endothelial tubule formation in vitro, suggesting additional potential therapeutic benefits for skin conditions like psoriasis where pathology is supported by lymphocyte infiltration, inflammation, and/or angiogenesis. In partnership with PharmaEssentia (Taipei, Taiwan), KX2-391 Ointment is being developed for 

psoriasis

永昕4.9億銀彈買回2200張給員工!! (35~61元/ 104/05/29~104/07/28)

永昕生物：公告本公司董事會決議第一次買回本公司股份事宜 鉅亨網新聞中心2015-05-28 19:52:19　第二條　第35款1.董事會決議日期:104/05/28 2.買回股份目的:轉讓股份予員工3.買回股份種類:普通股4.買回股份總金額上限(元):490,368,9855.預定買回之期間:104/05/29~104/07/28 6.預定買回之數量(股):2,200,000 7.買回區間價格(元):35.00~61.008.買回方式:自集中交易市場買回9.預定買回股份占公司已發行股份總數之比率(%):1.9810.申報時已持有本公司股份之累積股數(股):011.申報前三年內買回公司股份之情形:無12.已申報買回但未執行完畢之情形:無13.董事會決議買回股份之會議紀錄:第一案、本公司第一次執行買回本公司股份案，提請 討論。說 明：1.依據證券交易法第28條之2第1項第1款及「上市上櫃公司買回本公司股份辦法」之規定辦理。2.擬自證券商營業處所買回本公司股份轉讓予員工，相關事項如下：(1)買回股份目的：轉讓予員工。(2)買回股份種類：普通股。(3)買回股份總金額上限：新台幣490,369仟元。(4)預定買回之期間：自民國104年5月29日至104年7月28日止。(5)預定買回之數量：2,200,000股。(6)買回區間價格：每股新台幣35元至65元，當本公司股價低於所定買回區間價格下限時，將繼續執行買回股份。(7)買回方式：自櫃檯買賣市場買回。(8)預定買回股份占公司已發行股份總數之比率：1.98%。(9)已持有本公司股份之數量及金額：0股；新台幣0元。(10)申報前三年內買回公司股份之情形：無。(11)已申報買回但未執行完畢之情形：無。(12)董事會已考慮公司財務狀況，不影響公司資本維持之聲明：請參閱附件二。(13)依據「上市上櫃公司買回本公司股份辦法」第十條規定，訂本公司第一次買回股份轉讓員工辦法：請參閱附件三。(14)依證券交易法第二十八條之二第五項規定：公司於有價證券集中交易市場或證券商營業處所買回其股份者，公司其依公司法第三百六十九條之一規定之關係企業或董事、監察人、經理人之本人及其配偶、未成年子女或利用他人名義所持有之股份，於公司買回之期間內不得賣出。決議：本案經財會主管陳炯祥及林董事長說明後，董事會討論決議買回區間價格依主管機關規定修改為：「每股新台幣35元至61元，當本公司股價低於所定買回區間價格下限時，將繼續執行買回股份。」，其餘照原議案內容通過。14.「上市上櫃公司買回本公司股份辦法」第十條規定之轉讓辦法:一、本公司為激勵員工及提昇員工向心力，依據證券交易法第28條之2第1項第1款及金融監督管理委員會發布之「上市上櫃公司買回本公司股份辦法」等相關規定，訂定本公司買回股份轉讓員工辦法。本公司買回股份轉讓予員工，除依有關法令規定外，悉依本辦法規定辦理。二、本次轉讓予員工之股份為普通股，其權利義務除有關法令及本辦法另有規定者外， 與其他流通在外普通股相同。三、本次買回之股份，得依本辦法之規定，自買回股份之日起三年內，一次或分次轉讓予員工，逾期未轉讓部分視為未發行股份，應依法辦理註銷股份變更登記。四、凡於認股基準日前到職之本公司及直接或間接持有同一被投資公司表決權股份超過百分之五十之子公司(包含海外子公司)員工經董事會同意後，得依本辦法第五條所定認購數額，享有認購資格。五、員工得認購股數將參酌員工職等、服務年資、工作績效及對公司之特殊貢獻等標準，訂定員工得受讓股份之權數，並須兼顧認股基準日時公司持有之買回股份總額及單一員工認購股數之上限等因素，由董事會另訂員工認購股數。惟經理人得認購股數應先經薪資報酬委員會同意後，提請董事會決議之。六、本次買回股份轉讓予員工之作業程序：一、依董事會之決議，公告、申報並於執行期限內買回本公司股份。二、董事會依本辦法訂定及公布員工認股基準日、得認購股數標準、認購繳款期間、權利內容及限制條件等作業事項。三、統計實際認購繳款股數，辦理股票轉讓過戶登記。七、本次買回股份轉讓予員工，以不低於實際買回之平均價格為轉讓價格。惟在轉讓前，如遇有公司已發行之普通股股份增加，得按發行股份增加比率調整之〔四捨五入計算至小數點後第二位止〕。八、本次買回股份轉讓予員工並辦理過戶登記後，除另有規定者外，餘權利義務與原有股份相同。九、依本辦法轉讓之股份，其所發生之稅捐及費用依轉讓當時之法令規定及公司相關作業辦理。十、本辦法經董事會決議通過後生效，日後如因法令變更或主管機關核定變更或基於客觀環境變動時，得報經董事會決議修訂或得由董事長先行核決或執行相關修訂事宜後提報董事會，並應於最近一次股東會報告，修正時亦同。十一、本辦法訂定於中華民國一○四年五月二十八日。15.「上市上櫃公司買回本公司股份辦法」第十一條規定之轉換或認股辦法:不適用16.董事會已考慮公司財務狀況，不影響公司資本維持之聲明:一、本公司經民國一○四年五月二十八日第七屆第七次董事會三分之二以上董事出席及出席董事超過二分之一同意通過，自申報日起二個月內於櫃檯買賣市場(證券商營業處所)買回本公司股份2,200,000股。二、上述買回股份總數，僅佔本公司已發行股份之1.98%，且買回股份所需金額上限僅佔本公司流動資產之9.72%，茲聲明本公司董事會已考慮公司財務狀況，上述股份之買回並不影響本公司資本之維持。三、本聲明書業經本公司上述同次董事會議通過，出席董事8人(含委託出席2人)均同意本聲明書之內容，併此聲明。17.會計師或證券承銷商對買回股份價格之合理性評估意見:永昕生物醫藥股份有限公司本次預計買回公司股份對該公司之股東權益、每股淨值、負債比率、速動比率、流動比率未有重大影響，且預定買回股份、價格均依法規辦理，尚屬合理。18.其他證期局所規定之事項:無

 

 

中化50億的佈局: 王勳聖(新豐二廠/ 台南三廠/ 台中廠)、王勳煇(蘇州滸關)

兄弟各自努力 兩岸分合進擊 2015年05月29日 04:10 杜蕙蓉 以鴨子划水方式低調布局的中化集團，今年火力全開，近年來斥資逾50億在兩岸興建符合國際和中國CGMP法規藥廠，將開始收割，也讓王勳聖、王勳煇兄弟掌舵中化、蘇州中化將各有一片天。王勳聖領軍的中化有完整的產品線，目前在台灣共有6座生產基地，其中新豐一廠為最大生產基地，新豐二廠以高致敏產品為主；另台南三個廠分別負責生產動物藥品、外銷固體劑型及頭孢類產品；台中廠區主要產品則為盤尼西林（青黴素）。由於有符合美國和日本法規的藥廠，中化未來最大動能為海外市場的開拓，和承接日本等國際大廠的代工訂單；另外，長照法三讀通過，中化轉投資的中化生醫，在長期鎖定居家照顧領域下，也被視為金雞母。而王勳煇主導的蘇州中化，配合蘇州政府經濟區的開發，去年順利搬遷至滸關後，蘇州中化目前不僅產能是原來的三倍，也因廠房的規畫設計是符合中國CGMP法規，且今年也積極申請日本厚生省查廠，更讓蘇州中化未來在爭取與外資藥廠的聯盟或代工訂單，將更具力度。最受矚目的是蘇州中化已取得中國商業公司執照，可進行藥品物流配送和藥件申請。雖然是兄弟爬山各自努力，不過王勳聖、王勳煇兄弟則因交情好，彼此交換心得並引薦雙方人脈，也讓中化集團穩健成長。

(免驚) TFDA…. 有機砷快速排出體外

維生素C+蝦併用會產生砒霜？ 【TFDA發布日期：2015-05-28】 ：企劃及科技管理組 解答： (1)衛福部就本謠言曾洽請台北榮民總醫院毒藥物諮詢中心查詢相關文獻，結果顯示並無發現任何有關維生素C引起蝦類中毒的醫學報告。此外，該中心亦表示，甲殼類如蝦、蟹、龍蝦及貝類(如蛤、牡蠣)中雖含有砷，但9成以上以有機砷的形式存在，且有機砷可以很快排出體外，幾乎沒有毒性。另至於無機砷（包括三價砷及五價砷）則確實有毒，若保守估計無機砷含量為海鮮含砷量的十分之一，而蝦含量以4 ppm來計算，則達到最低可能致死劑量20毫克，必須吃下50公斤的蝦。(2)在學理上，純化的維生素C與五價砷，如在實驗室環境加以化學催化作用，或有可能使原來無毒的五價砷轉變為三價砷（俗稱的砒霜）。然而餐點中所食用之檸檬及蝦，其分別所含之維生素C與五價砷含量甚低，且又無化學催化劑及適當之反應條件，實際並沒有產生砒霜的疑慮，請民眾不要擔心

Metformin 有機會用於非糖尿病人青光眼 治療/預防?!!

Diabetes Drug Metformin May Lower Glaucoma Risk Study found people with highest dose were 25 percent less likely to develop eye conditionWebMD News from HealthDay By Steven Reinberg THURSDAY, May 28, 2015 (HealthDay News) -- The diabetes drug metformin was linked to a lower risk of developing the eye condition glaucoma in a new study. People who took the most metformin during the 10-year study period had a 25 percent reduced risk of glaucoma compared with people not taking the drug, researchers found.  "Glaucoma is a leading cause of blindness worldwide and classic open-angle glaucoma develops in late middle age or late age. So we hypothesized that a drug that mimics caloric restriction, such as metformin, might reduce the risk of glaucoma," said lead researcher Julia Richards, a professor of ophthalmology and visual sciences at the University of Michigan in Ann Arbor. Exactly how metformin might reduce the risk of glaucoma isn't known, the researchers said. And, while this study found an association between metformin use and lower glaucoma risk, it wasn't designed to prove a cause-and-effect relationship. Dr. Mark Fromer, an ophthalmologist at Lenox Hill Hospital in New York City, explained that glaucoma is caused by too much fluid in the eye, when fluid doesn't drain adequately, or when the blood vessels in the optic nerve are damaged. "Somehow metformin is affecting one of those conditions," he said. Fromer pointed out that although the results of this study are impressive, using metformin to prevent or treat glaucoma in non-diabetic patients is problematic. Metformin could drop blood sugar too low in people without diabetes, he said. "People without diabetes should not be taking metformin," he said. "If not monitored carefully by a doctor, it can have significant consequences," said Fromer, who was not involved with the study. Richards, however, said that it might be possible to use metformin as a treatment for glaucoma even in people without diabetes. "But since this study was done in a diabetic population, the conclusions are currently limited to this population," she said. "Further work, such as a clinical trial, would be needed to tell if this could be extended to non-diabetic populations or used to prevent progression of glaucoma in those who already have the disease," Richards said. The study was published online May 28 in JAMA Ophthalmology.For the study, Richards and colleagues collected 10 years of data on more than 150,000 people with diabetes. All were 40 or older at the start of the study. The investigators found that 4 percent of the participants developed glaucoma.The researchers said that people taking the highest amount of metformin (more than 1,110 grams in two years) had a 25 percent reduced risk of developing glaucoma compared with those not taking the drug.For every 1-gram increase in metformin taken, the risk was reduced by 0.16 percent. The researchers estimated that taking a standard dose of metformin (2 grams per day) for two years would reduce the risk for glaucoma by 21 percent.This risk reduction was seen even after accounting for lower blood sugar levels, the study authors said. Other diabetes drugs were not associated with reduced risk of glaucoma, they added.

 

Nakagami: 利用疫苗控制血壓 半年免吃藥 (anti-angiotensin II)

Blood Pressure Vaccine Shows Promise in Rats TUESDAY, May 26, 2015 (HealthDay News) -- Remembering to take your high blood pressure pills every day can be a burden, especially if you're juggling a list of other prescriptions. So what if, instead, you could receive a vaccination that would lower your blood pressure for months on end? Such a vaccine has proven effective in controlling high blood pressure in lab rats for up to six months, according to new research published May 26 in the journal Hypertension. The experimental DNA vaccine creates antibodies that target angiotensin II, a hormone that raises blood pressure by causing blood vessels to constrict, said co-author Dr. Hironori Nakagami, a professor at Osaka University in Japan. In that regard, the vaccine is similar to common ACE inhibitor blood pressure medications, which work by helping blood vessels relax and open up, the researchers said. Nakagami said the vaccine could benefit people who don't take their high blood pressure medication as prescribed."The potential of a vaccine for hypertension offers an innovative treatment that could be very effective for the control of noncompliance, which is one of the major problems in the management of hypertensive patients," he said. About 70 million Americans have high blood pressure, which amounts to one in every three adults, according to the U.S. Centers for Disease Control and Prevention. And only about half of them have their condition under control. In the new study, researchers gave the vaccine three times at two-week intervals to rats with high blood pressure.The vaccine not only lowered blood pressure for up to six months, but also reduced tissue damage to the heart and blood vessels associated with high blood pressure, the study reports. There were no signs of damage to other organs such as the kidney or liver."Systolic blood pressure was consistently lower in the DNA vaccine group after immunization, while blood pressure reduction was continued for at least six months," Nakagami said. (Systolic is the top number in a blood pressure reading.)While studies involving animals often fail to produce similar results in humans, the research group hopes to have a version of the vaccine ready for human clinical trials within two or three years, Nakagami said.Researchers suspect that humans likely would need booster shots once or twice a year to maintain the vaccine's effect, he said.Whether the vaccine would be a better option than existing medications remains to be seen.About 85 percent of high blood pressure patients now can be treated using available medications, which leaves a significant minority that could be helped with this vaccine, said Dr. Ernesto Schiffrin, vice chair of research at McGill University's department of medicine in Montreal, Canada. "There remains always a group of patients where you use three, four agents or more and you still don't have blood pressure at goal," he said. "There will always be opportunity for the development and application of new medications, and we should strive to develop new ones because there is a need." However, how long the vaccine can control high blood pressure between shots will be key in determining whether it's more worthwhile than the cheap, safe and effective pills now available, Schiffrin added."High blood pressure pills are not that expensive," Schiffrin said. "They're all generic now, and they are being used quite extensively around the world. The question is, how long will the vaccine last? How effective will it be? And will there be any adverse effects?"SOURCES: Hironori Nakagami, M.D., Ph.D., professor, Osaka University, Japan; Ernesto Schiffrin, M.D., Ph.D., physician-in-chief, Jewish General Hospital, and vice chair, research, department of medicine, McGill University, Montreal, Canada; May 26, 2015, Hypertension

產檢超音波診斷 遙控機器人 代勞!!!

A diagnostic robot for remote prenatal ultrasound exams   A diagnostic robot for remote prenatal ultrasound exams World's first demonstration of the ultrasonic diagnostic robot in January 2014. Credit: Waseda Universiy A Japanese researcher is developing a robot that can conduct prenatal ultrasound exams on pregnant women in remote locations. Although previously considered, the medical examination of pregnant women from a remote location had never been attempted due to safety concerns, such as those relating to the weight of the diagnostic equipment. To address this, Professor Hiroyasu Iwata of Waseda University has designed a structure that supports the weight of the machine, thus reducing the potential burden on a patient's body. "This research was motivated by my desire to shorten the response time for emergency prenatal care in the Tokyo metropolitan area," says Dr Iwata. "Eventually, I want to use this technology for at-home and remote area medical examinations." "Our central challenge is to prove its applicability to a real pregnant woman whose stomach is growing larger and larger," he adds. Last November, in an experiment involving two expecting mothers, "we confirmed the robot's ability to follow the shape of their abdomens and obtain ultrasound echo images. The head, hands and feet of each foetus were clearly visible, which increases our motivation to make this technology a practical reality." Dr Iwata says the next step is to have a practicing physician conduct a trial on the robotic device in an obstetrics clinic and obtain feedback from patients over a one to two month period.

紐約Dr. Sejal Shah 創造肌膚16基因評斷美學!!!

SmarterSkin Dermatology is Now Offering Skin DNA Analysis The unique skin DNA analysis for customized skin care is now available in NYC.(PRWEB) May 27, 2015SmarterSkin, http://www.smarterskindermatology.com, is taking skin care customization to a new level with a cutting-edge test that makes it easier for patients to find skin care products that work specifically for their skin type. Dr. Sejal Shah is a cosmetic dermatologist based in New York and is the first person in NYC to offer the test. This revolutionary DNA test uses 16 genetic markers to evaluate the following 5 categories associated with skin aging: 1. Firmness and elasticity 2. Glycation 3. Sun damage and pigmentation 4. Free Radical Damage 5. Sensitivity and inflammation The results are used to create a personalized skin care regimen based on the patient's skin's needs and takes the guesswork out of selecting skin care products. This takes skin care customization to a new level and the test takes a few minutes to perform using a simple swab inside the cheek. "Customized skin care is the future and Skin DNA analysis takes customized skin care to the next level by using your own genes to determine the best ingredients for your skin," says Dr. Shah.

About SmarterSkin  Sejal K. Shah, M.D. is a board certified dermatologist in private practice in Manhattan. She practices all aspects of dermatology with an expertise in cosmetic dermatology. Dr. Shah utilizes the latest anti-aging treatments and technologies to enhance her patient's natural beauty. Dr. Shah graduated summa cum laude from the University of South Alabama. She continued her postgraduate studies at the prestigious Mount Sinai School of Medicine in New York where she earned her medical degree. Dr. Shah has published numerous articles and book chapters and presented at several national and international meetings. She is also frequently featured in mainstream media. Dr. Shah is a member of several professional societies including the American Academy of Dermatology, American Society for Dermatologic Surgery, American Society for Laser Medicine and Surgery, Women's Dermatologic Society, and the Dermatologic Society of Greater New York.

 

 

台灣健保制度2014推動My Health Bank!!!

Taiwan health care's success story 3:58 a.m. ChST May 16, 2015 Taiwan's National Health Insurance system is globally renowned for providing citizens with easy access to high-quality medical services. Over 99 percent of the population is enrolled in the single-payer NHI, while around 93 percent of the country's health care providers participate. Basic premiums, which are shared among the insured, employer and government, are calculated on the basis of monthly salary and a set premium scale. Those qualifying as disadvantaged can have their premiums and copayments subsidized or waived if necessary. As the NHI has achieved universal coverage at an affordable cost, health care is not a financial burden for the public. These factors contribute to a system satisfaction rate of about 80 percent. But this healthy state of affairs was not achieved overnight. Since its launch in 1995, the NHI has faced funding challenges. Although the system was in the black for the first four years, rising user demand led to budgetary shortfalls, spurring the ROC government to set about implementing system wide fiscal and structural reforms. By 2013, the second-generation NHI was in place and oversight of the system tasked to the newly formed NHI Administration under the Ministry of Health and Welfare. A key component of this change was the levying of a 2 percent supplementary premium on capital gains and unearned income -- a measure contributing to the NHI's newfound financial strength.Another step contributing to the success of the NHI was the adoption of the latest information technologies. These initiatives streamlined procedures and improved services, paving the way toward greater organizational efficiency and reduced administrative costs. The integrated circuit card is one of the most visible signs of IT innovation employed by the NHI. Issued to all system users, it functions as a link between patients and health care providers, enabling the latter to quickly and securely access the former's recent medical records. The smartcard is also an invaluable tool in managing the spread of highly communicable diseases such as SARS. It allows monitoring of the infected, as well as accurate modeling of the dynamics and control of such outbreaks. As time is of the essence when it comes to dealing with medical issues and prescribing the correct medicines in a cost-effective manner, the NHI established in 2013 PharmaCloud -- a cloud-based database of patient pharmaceutical records accessible by health care providers. This undertaking has minimized the incidence of script duplication and over-prescription, as well as the risk of harmful drug interactions. Buoyed by the cost and efficiency benefits of PharmaCloud, the NHI launched My Health Bank in 2014. The database allows users to access in less than 10 minutes their full medical data from the past year. These include records like hospital admissions, medical costs, outpatient visits and prescriptions. By easing access to personal records, it is hoped users will become more aware of their health and develop an appreciation of the need to lead healthier lifestyles. Equally significant is the use of an automated system for processing hospital claims and reimbursements. This contributes to the NHI's administration costs of 1.07 percent of medical expenditures, the lowest in the world. The sizeable database of claims, which boasts leading-edge, internationally certified information security, also allows the NHIA to analyze trends and generate statistics. Going forward, decreasing birth rates and rapidly aging populations are the order of the day. Taiwan is no exception to these global trends and its shrinking youth demographic will have to shoulder a greater financial burden. In estimating future demand for health care, the factor of aging must be taken into account. In 2014, the senior population in Taiwan stood at 11.95 percent, and it is estimated it will exceed 20 percent in 2025 and 40 percent in 2060.Because Taiwan has a low birth rate and extended life expectancy, it will soon have the fastest aging population in the world. This is to result in a shrinking income tax base, placing even greater pressure on NHI funding to meet outlays associated with caring for the rising number of elderly. Looking at ways of improving public health and slowing the rate of aging are two of the most important challenges facing the NHI in the 21st century and beyond.

 

 

強生 laparoscopic power morcellator (LPM) 被FBI調查是否隱匿 癌細胞轉移風險!!!!

子宮切除設備致癌 聯調局調查強生 [2015-05-28] 消息人士透露，針對強生公司在去年被揭發，其生產的一項子宮切除設備令接受手術的婦女患上子宮癌，聯調局（FBI）正在調查公司在去年推出有關產品前，是否已知悉其危害。現時尚不清楚當局的調查進展情況。 據《華爾街日報》報道，FBI在過去數月訊問了多名相關人士，包括早在2006年向強生知會了「腹腔鏡高能粉碎器」（LPM）潛在問題的一名退休病理學家、2013年因LPM導致自身癌症惡化的一名女醫生；以及一名加州女子，據稱她成功向400名可能受到LPM傷害的病人和家屬收集簽名。 LPM主要利用微創手術來切除子宮肌瘤。食品及藥物管理局（FDA）在去年4月警告說，接受LPM手術的女性有1/350的機會無法檢測到危險的子宮肉瘤，並在進行手術後令其惡化。隨FDA在11月對LPM發出最強烈的「黑盒警告」，FBI便展開調查，全國多家醫院也陸續減少或考慮限制使用這項設備。強生公司在去年7月將LPM下架。去年5月接受FBI訊問的賓州前病理學家林柏特表示，他在2006年2月注意到LPM可能檢測不到惡性腫瘤的潛在問題後，曾經聯絡強生公司負責售賣有關儀器的子公司Ethicon。強生發言人約翰遜證實有關說法，並聲稱當時公司因此而修訂了設備使用說明。 新修訂的使用說明指出，如果醫生懷疑或知道患者出現惡性組織，在使同LPM時應配合使用「組織抽取袋」。 42歲的賓州麻醉師里德在2013年於波士頓一家醫院接受LPM手術而導致癌症惡化。她在過去數月也接受了FBI的訊問。該波士頓醫院證實了LPM令里德癌症惡化，並透露這項設備在2012年也令另一位患者的惡性腫瘤擴散。 在2個月前獲FBI接強的加州醫師助理羅賓遜，曾經在FDA的LPM聽證會上出示她收集的LPM受害者簽名。她把該386人的名單交給FBI人員，當中也包括她自己。江蘭心編譯

FBI investigating laparoscopic power morcellator, Johnson & Johnson  (Ref: CNBC, The Wall Street Journal) May 27th, 2015  By: Katie Bell  The FBI is investigating the laparoscopic power morcellator (LPM) and is looking into what Johnson & Johnson knew about the risk of the device before pulling its LPM off the market last year, The Wall Street Journal reported Wednesday, citing three people who have been interviewed. A Johnson & Johnson spokesman said the company is not aware of an investigation into the device. In July 2014, Johnson & Johnson asked customers to return already purchased LPMs as part of a worldwide withdrawal, having previously suspended global sales of the devices amid concerns they can potentially spread cancer in women being treated for fibroids. According to The Wall Street Journal. Robert Lamparter, a former pathologist at Evangelical Community Hospital, Lewisburg, Pennsylvania said the FBI interviewed him on May 12 about his 2006 correspondence with Johnson & Johnson's Ethicon division that sold morcellators. Lamparter had reportedly contacted the company after he began noticing more morcellated specimens in his laboratory, stating that he was concerned about several issues, including the potential for an undetected cancer to be inadvertently spread by the device. Specifically he said he wrote to David Robinson, an Ethicon medical director at the time, that at his small hospital, gynecologists were surprised by an unexpected malignancy at least once a year, for a "1/150 to 1/300 chance that a uterus will have an unexpected malignancy." Lamparter noted at the time "if a morcellation is done, the patient's survival is jeopardised." Johnson & Johnson spokesman Matthew Johnson confirmed the 2006 correspondence with Lamparter, adding that the doctor's concerns led the company to revise the instructions for use of LPMs. Robinson wrote to Lamparter in April 2006 stating that the revision included wording stating use of the morcellator "may lead to dissemination of malignant tissue," while Johnson & Johnson's instructions already recommended that doctors who suspected malignant tissue should use a tissue extraction bag with the device. Ethicon morcellators "have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue," Johnson remarked. Meanwhile, other people said their conversations with the FBI did not center on Johnson & Johnson or other manufacturers. Anesthesiologist Amy Reed noted the FBI has interviewed her several times over the past few months about her case, which involved worsening cancer after she underwent a hysterectomy with a morcellator at a Boston hospital in 2013. In April 2014, the FDA warned against using LPMs during hysterectomy or myomectomy in women with uterine fibroids due to the risk of spreading undiagnosed gynaecologic malignancies within the abdominal cavity, and later recommended that manufacturers update product labelling to include a boxed warning to that effect. In July last year, an FDA advisory panel failed to agree on whether the use of LPMs for gynaecologic indications should be banned. Many health insurance companies, and most recently Aetna, have since stopped covering routine use of LPMs.

FDA: 皮下填補注射物 可能得中風/失明 風險!!

 

Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication Date Issued: May 28, 2015 Health care providers who inject patients with facial soft tissue fillers Health care providers who treat patients following unintentional injection of soft tissue fillers into blood vessels People considering, or who have had, procedures that use soft tissue fillers Specialties: Dermatologists, plastic surgeons, cosmetic surgeons, dentists, and other medical providers who treat patients using soft tissue fillers; other health care providers who may treat patients following unintentional injection of soft tissue filler into blood vessels, such as ophthalmologists, neurologists, and neurosurgeons. Product: Soft tissue fillers, also called dermal fillers, injectable facial implants, or wrinkle fillers, can create a smoother or fuller appearance of the face. They are FDA-approved to reduce the appearance of wrinkles or to augment lips or cheeks. Soft tissue fillers are injected directly into a treatment area. Successful results will depend on the patient's overall health and skin condition, the skill of the health care provider, the location of injection and the type of filler used. Patients may need more than one injection to get the desirable smoothing/filling effect. Soft tissue fillers should be injected only by health care providers who have appropriate training and experience and who are knowledgeable about the anatomy at and around the injection site. The FDA is alerting health care providers and consumers about the possibility of rare, but serious, injuries that may occur due to unintentional injection of soft tissue filler into blood vessels in the face. The FDA has reviewed information that suggests unintentional injection of soft tissue fillers into blood vessels in the face can result in rare, but serious side effects. Unintentional injection can block blood vessels and restrict blood supply to tissues. Sometimes this can result in embolization. This means the filler material has traveled to other parts of the body. This can cause vision impairment, blindness, stroke and damage and/or death of the skin (necrosis) and underlying facial structures. While unintentional injections into blood vessels may occur with injection sites anywhere on the face, the FDA's review of literature disclaimer icon and adverse event reports submitted to the FDA identifies certain injection locations where blood vessel blockage have been reported more often. These sites include the skin between the eyebrows and nose (glabella), in and around the nose, forehead, and around the eyes (periorbital region). For Health Care Providers: Do not inject soft tissue fillers if you do not have the appropriate training or experience. Make sure that you are familiar with the anatomy at and around the site of injection, keeping in mind that blood vessel anatomy disclaimer icon can vary among patients. Before injection, thoroughly inform the patient of all risks of the procedure and the specific product you intend to use. Note that the approved indications for use of soft tissue fillers vary depending on the product. The FDA may not have reviewed use of soft tissue fillers in some locations in the body. Take extra care when injecting soft tissue fillers, for example inject the product slowly and apply the least amount of pressure necessary. Know the signs and symptoms disclaimer icon associated with injection into blood vessels, and have an updated plan detailing how you plan to treat the patient if this should this occur. This may include on-site treatment and/or immediate referral to another health care provider for treatment. Immediately stop the injection if a patient exhibits any signs or symptoms associated with injection into a blood vessel, such as changes in vision, signs of a stroke, white appearance (or blanching) of the skin, or unusual pain during or shortly after the procedure. Tell patients that they should seek immediate medical attention after the procedure if they experience signs and symptoms associated with injection into a blood vessel. Educate health care facility employees on how to quickly assist patients that report signs and symptoms of filler complications. They must understand how to instruct the patient to receive appropriate medical care. Report to the FDA and the manufacturer if you become aware of a patient experiencing an adverse event associated with unintentional injection of soft tissue filler into a blood vessel. Before deciding to have soft tissue filler injections, talk with your health care provider about appropriate treatment injection sites and the risks associated with the procedure. Be aware that FDA reviewed and approved different products for use in certain areas of the face. The FDA may not have reviewed the use of certain soft tissue fillers for all locations in the body. Ask your health care provider about their training and experience injecting soft tissue fillers in the face. Read and discuss the patient labeling for the specific filler you are receiving. Your doctor can provide this information, or you can find it on the FDA's website. Seek immediate medical attention if you develop symptoms such as unusual pain, vision changes, a white appearance of skin near the injection site, or any signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion) during or shortly after the procedure. After reviewing additional information on this subject, the FDA is working with manufacturers to update their labeling. The requests asks that the labeling include additional warnings, precautions, and other statements about the risk of unintentional injection into blood vessels, consistent with the recommendations in this communication, so that both health care providers and patients would have a better understanding of the risks. The FDA continuously monitors reports of injuries caused by soft tissue fillers. With the increased popularity of soft tissue fillers, more information is available about unintentional injection into blood vessels. While current labeling includes some information about this risk, the FDA believes that additional information can be included in the labeling to better inform health care providers and patients.

Reporting Problems to the FDA:Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with these products.If you suspect or experience a problem with soft tissue fillers, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Additional Resources  Soft Tissue Fillers (Dermal Fillers) Soft Tissue Fillers Labeling Request Letter to Industry Carruthers, J., Fagien, S., Rohrich, R., Weinkle, S., & Carruthers, A. (2014). Blindness caused by cosmetic filler injection: a review of cause and therapy disclaimer icon. Plastic & Reconstructive Surgery. Ozturk, C. N., Li, Y., Tung, R., Parker, L., Piliang, M. P., & Zins, J. E. (2013). Complications Following Injection of Soft Tissue Fillers disclaimer icon. Aesthetic Surgery Journal, 862-877. Carruthers, J. (2014). Discussion: New Anatomical Insights on the Course and Branching Patterns of the Facial Artery: Clinical Implications of Injectable Treatments to the Nasolabial Fold and Nasojugal Groove disclaimer icon. Plastic & Reconstructive Surgery, 1083-1084. Contact Information: If you have questions about this communication, please contact CDRH's Division of Industry Communication and Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041, or 301-796-7100.

 

衛福部 推動 Specialty Medicine(特色醫療): 林口長庚/婦產科微創, 北榮/骨科關節鏡微創!!!

 

台灣醫療國際化 急重症、健檢占多數 2015-05-29 02:34:48 聯合報 記者陳雨鑫／台北報導台灣醫療品質優異，衛生福利部持續推動台灣醫療走向國際，提供醫療服務國際化的醫療院所從民國101年的33家至今已有57家，預計下個月還會再增加6家，並以急重症以及健康檢查的服務最多，創造的產值也高達141億元。「國力的大小是指國家對國際的影響力」，新光健康管理公司總經理洪子仁引用新加坡前任總理李光耀的話，他說，台灣醫療能提升能見度，國際醫療是最好的選擇，不僅能幫助更多有需要的人，也能留住台灣醫師。林口長庚醫院國際醫療中心副執行長賴旗俊表示，台灣因醫療技術發達，許多病症在台灣幾乎愈來愈少見，像是小耳症，台灣一年不到10個病例，但大陸的患者卻很多，若能發展國際醫療，台灣治療小耳症的人才既可幫助患者，也能精進技術。賴旗俊以該院為例，去年服務國際病患多達兩萬多人次，以大陸病患最大宗，其次是東南亞、美國、日本。根據衛福部國際醫療管理工作小組會員機構的統計，台灣的國際醫療以治療急重症病患為主，其次為健康檢查、醫療美容，若以大陸申請健檢醫美簽證的人數來看，去年服務就多達5萬4426人次。衛福部技監周淑婉表示，衛福部將推出「特色醫療」，目前已在申請有十家中心，如彰化基督教醫院的「跌倒防治中心」、林口長庚的「婦產科微創中心」、台北榮總「骨科關節鏡微創中心」等。

 

 

無賴公權力 vs 自助餐吃到飽無賴

健保事後核刪制應該廢除政府透過事後核刪，限縮醫療給付等方式，壓榨醫護人員。 2015年05月29日01:21 作者：黃峻偉（診所醫師）花蓮門諾醫院的吳靜芬醫師，最近有篇臉書上的貼文引起醫護人員討論。吳醫師在去年使用困難的心導管技術，將病人從鬼門關前救回來。這種高超的技術，理應受到鼓勵才對。結果過了幾個月，一萬多元的處置費用被核刪，醫院和醫事人員白做工一場。思考這件事情，有個必須注意的地方。從醫學生時代，老師就會教導，醫療行為本身就是種傷害行為，一般人不會容許另一個人在他身上畫刀穿孔，因為這是一種傷害身體的行為，但是我們會允許醫護人員這麼做，是因為當醫護人員在身上畫刀時，是為了治療身上的病灶，是種利大於弊的行為。但是，如果這個醫師做出了畫刀的處置，卻完全對病人沒幫忙，這樣的醫療行為，就是種傷害行為。來看吳醫師的案例，吳醫師做的醫療處置，如果健保署認為對病人沒有幫忙，甚至是不應該做，所以不給予錢，那麼，健保署就是認定吳醫師的醫療行為對病人是有傷害的，應該對吳醫師提起業務過失傷害罪。但是健保署認定吳醫師的醫療行為對病人有傷害，卻放任吳醫師繼續行醫。這樣的作為，很明顯是健保署瀆職，放任吳醫師傷害病人。健保署的官員，就犯下了公務人員的瀆職罪，應判三年以上的有期徒刑（刑法第130條，公務員廢弛職務，釀成災害者，處三年以上十年以下有期徒刑）。如果健保署沒有瀆職，那麼，這種核刪醫師的費用，又該如何解釋呢？試想一種情境，如果今天身上只有600元，但是想吃晶華飯店晚餐一餐要1090元的自助餐，那要怎麼辦嗎？很簡單，吃吃喝喝飽餐一頓後，跟櫃台抱怨濃湯不夠濃，天花板的燈光開太亮了讓眼睛不舒服，生菜太軟不好吃，然後說這一餐不值1090元，只值600元，然後給600元現金後就走掉。更惡劣的話，還可以跟櫃台說，你讓我吃太飽了不舒服，要罰你2000元，下次我來吃不能算錢。這時候讀者應該會驚呼，這種行為不是跟無賴沒兩樣嘛？健保署這種事後無端找理由扣款的行為，的確跟無賴沒兩樣，只是健保署是有公權力的無賴。醫療資源是有限的資源，政府利用健保制度將大部份的醫療體系納入其中，由公部門介入管理。理應教導或政策導引民眾，醫療資源有限制使用。但是政府不思改進，反而將大小疾病通通納入健保，然後透過事後核刪，限縮醫療給付等方式，壓榨醫護人員，讓自己獲得高滿意度，後果就讓醫療體系接近崩壞，醫糾頻繁。如果衛福部真正有心改善醫療環境，應該廢止惡劣的事後核刪制度，重新思考醫療體系的未來走向，並建立慢性照護機構與前端預防保健的措施，才能保住民眾長遠的健康，也才能使醫療體系永續發展。

抗早洩刺激醫材 FDA 等級調降 Ergon Medical's Prolong premature ejaculation treatment (Class III to Class II)

FDA down-classifies Ergon Medical's Prolong PE device May 28, 2015 by Fink Densford The FDA down-classifies Ergon Medical's Prolong premature ejaculation treatment from Class III to Class II.FDA Reclassifies Prolong premature ejaculation vibrator The FDA said it down-classified the Prolong device, a vibrator used to treat premature ejaculation, from Class III to Class II after a request from Ergon Medical Ltd., creator of the device. That means Prolong has the same classification as general-use devices such as condoms, according to the FDA. The reclassification was posted March 20 and goes into effect today, the safety watchdog said. The Prolong device won de novo clearance from the FDA in March, according to FDA's website. Prolong is designed to use repeated subthreshold stimulation of the penis to produce a long-term reduction of sensitivity, through an effect called habituation which is thought to be permanent, West Sussex, U.K.-based Ergon Medical said in a press release. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=2009

 

 

Medtronic (全球總裁Omar Ishrak) 看醫材市場

不只賣醫材　更發掘照護新利基2015-05-27 天下雜誌 573期 作者：黃惠鈴 人口老化、醫療保健支出日益龐大，已成為各國政府的心頭大患。當台灣政府與企業看好生技產業，要逐鹿全球市場，面對的是不一樣的挑戰。特別要有前瞻的眼光，即使國際大廠也省思轉型的必要。「朝以價值為基礎的醫療照護模式發展，是醫材公司必須思考的方向，」全球數一數二的醫材製造商美敦力（Medtronic）全球總裁伊什萊克（Omar Ishrak），接受《天下》獨家專訪時特別提醒，醫材公司不能只想賣設備材料，而是要幫助病人獲得有效治療，配套發展出商業模式。這家美國企業是心臟節律器的發明者，主要業務涵蓋心血管疾病、糖尿病、神經醫學、脊椎手術等領域。

 

聲博 袁炎偉 搶食…超音波儀替代性探頭 (老機新用)

聲博科技　精準眼光　逐鹿全球市場 2015-05 暨二次世界大戰後，1970年醫用超音波掃描儀成熟問世以來，席捲整個醫療影像市場，超音波掃描儀不僅成為一種獨特的成像技術，超音波市場也蔚為一個明日之星，百家爭鳴。其中，以相容替代性超音波探頭深掘出藍海利基，是全球唯一取得美國FDA相容替代性探頭認證之廠商，更以長遠的策略佈局眼光，在全球市場打出自己的一片天。超音波技術在醫學上的應用非常廣泛，影像診斷方面涵蓋腦部、腹部、神經系統等，加上無放射性、快速成像等優勢，使得超音波設備使用普及，技術發展也相當成熟，目前市場仍以歐美為主，每年穩定成長。

毅力堅持 收穫纍纍果實雖然在專業精密技術與大型醫療電子產品的發展，台灣不如世界級大廠，但不少廠商早就投入相關醫學影像關鍵零組件的發展，以相容替代性超音波探頭，找到藍海市場的聲博科技就是一例，日漸高築的進入障礙，更讓其他想進入超音波市場的廠商望塵莫及。成立7年才進入市場，聲博科技在董事長袁炎偉一步一腳印的帶領下，深耕超音波20餘年，終於在超音波替代性探頭市場闖出龍頭地位。看似冗長的過程，袁炎偉帶著驕傲的笑容說，「聲博可說是產業的模範生，7年看似很長，事實上，時間遠比一般創業的平均值快了。」他進一步解釋，醫療用品與消費品、科技產品講求快速不同，醫療用品玆事體大、牽涉的法規繁複，導致研發期及產品生命週期皆長，「因此，想要在產業裡紮穩馬步，第一點，氣一定要長！」除了有過人的毅力堅持，袁炎偉對超音波的專業，也構成了聲博的利基優勢。

專業投入 深崛藍海利基中原醫工系畢業後，袁炎偉便到美國賓州大學攻讀研究所，在這所專攻水下聲納，也就是衍生超音波技術源頭的聖域，他師從國際超音波權威的熊克平教授，習得一身好本領。畢業後，與猶太人合作，成功開發了「Site Rite」超音波影像系統，協助醫護人員找到正確的頸靜脈血管打針。Site Rite問世一炮而紅，成功的經驗也催生了他創業的開端，於是，他與昔日在賓州大學的好友、在工研院生醫中心主持超音波研發計劃的鄭建華，與工研院團隊成員共同創業，而有了聲博科技的誕生。有了對的人，還要切入對的市場。眼光一向精準的袁炎偉，大膽提出要發展相容替代性超音波探頭。他發現常常接觸人體的超音波儀器探頭是半消耗品，會隨著使用的時間及頻率而逐漸耗損，平均二年就得汰換，而原廠探頭價格居高不下，便有了進入利基。

市場制度形成 未來成長不可限量為了搶進這個利基市場，聲博在2007年初，在當時連法規都沒有的情況下，向美國FDA率先提出申請。為了通過認證，聲博全體動員，前後花了半年時間，準備多達兩千頁的資料，送交美國FDA，同年十月，聲博拿到FDA的查驗登記認證。而在聲博拿到認證的將近一年後，FDA發布新政策，允許非原廠製造或供應的相容替代性探頭，通過法規測試後上市，聲博終於攻下灘頭堡，也催生制度的形成。而聲博引起的效應不僅如此。除了持續開發相容替代性探頭，聲博也以ODM(設計製造代工)、客製化的型態，為超音波系統商設計開發超過五十型探頭，客戶遍布台、英、法、俄、以色列等十幾國。此外，另外，聲博還搶先進軍售後市場，做起維修的生意，並推出超音波探頭自動檢測系統，從2011年起，也開始發展系統，甚至做出超音波整機。種種的積極佈局，讓醫療器材大老—奇異，在2013年，也宣布跨足售後市場，併購Unisyn，推出超音波探頭檢測及維修服務。

延攬格局人才 成就隱形冠軍榮耀面對這樣的競爭，袁炎偉反而更加看好整個產業未來的成長發展，特別是聲博將以前瞻的技術、精研世界各廠探頭的專業出發，以「Everything Check」一條龍的服務方式，築起競爭高牆，這也使得袁炎偉更加積極延攬具格局眼光的人才，加入聲博的行列。「但是我們寧缺勿濫。」對於人才培育相當重視的他，除了提供完整的教育訓練外，獨樹一幟的文化哲學，也成了聲博獨特的企業文化。「聲博的市場是全球市場，目標成為全球最大的替代性醫療診斷用超音波探頭供應商，了解當地文化還不夠，要深入當地的宗教、歷史，惟有如此，才更能貼近當地，做好當地的生意。」袁炎偉分享，聲博提供的舞台，是全世界的舞台，氣夠長且願意紮穩馬步的人，自然能夠擁有無邊的國際舞台。在闖出藍海後，不免有許多人好奇，聲博究竟做對了什麼？袁炎偉卻嚴謹地指出，「不是做對了什麼，而是不能做錯任何一件事，才會成功！」他表示，就如同德國的隱形冠軍，在聲名上也許不是大鳴大放，然而在各行各業都獨佔驁頭，佔有舉足輕重之地位，因此，他殷切期許在醫材產業發光的聲博波，能夠成為標竿，引領台灣更多隱形冠軍的誕生。

PENTAXライフケア: 微創手術軟體到硬體整合 (i-SCAN Virtual chromoendoscopy & マルチファンクション Splash M-Knife)

HOYA株式会社PENTAXライフケア事業部 新製品『PENTAX Medical 高周波ナイフ DN-Dシリーズ （愛称Splash M-Knife）』を販売開始May 25, 2015 01:07 AM Eastern Daylight Time 東京--(BUSINESS WIRE)--（ビジネスワイヤ） -- HOYA株式会社PENTAXライフケア事業部は、2015年5月29日―31日に名古屋で開催される第89回日本消化器内視鏡学会総会において、新製品『PENTAX Medical 高周波ナイフ DN-Dシリーズ （愛称Splash M-Knife）』を発表し、日本国内で販売開始いたします。「日本をはじめ世界でのESD普及の促進が、癌の早期治療や医療費の課題解決に貢献すると考え、革新的なデザインのマルチファンクションデバイス、Splash M-Knifeを上市します。ESDをより安全、確実に、かつ効率よく行えることが、低侵襲医療のさらなる普及と発展につながることを期待します。」軟性内視鏡は処置具と組み合わせることで、病変部分の粘膜組織を採取したり、その場で治療を施すなど、「見る」だけでなく低侵襲医療に不可欠な医療機器として発展を遂げています。例えば内視鏡的粘膜下層剥離術（Endoscopic Submucosal Dissection、以下ESD）は、内視鏡先端から出したナイフを使い、消化管にある病変を取り除く技法です。この技法は日本では10年以上前から行われてきましたが、術後の回復が早く、合併症を引き起こすおそれが低減されるなど、患者様への便益が大きく、また医療費の抑制にもつながるため、世界中の医療現場に採用されつつあります。プロダクトマネジメント統括部ヴァイス・プレジデント、ラミ・リーベンザルは、「日本をはじめ世界でのESD普及の促進が、癌の早期治療や医療費の課題解決に貢献すると考え、革新的なデザインのマルチファンクションデバイス、Splash M-Knifeを上市します。ESDをより安全、確実に、かつ効率よく行えることが、低侵襲医療のさらなる普及と発展につながることを期待します。」と述べています。

特徴１：マルチファンクション Splash M-KnifeはESDにおけるさまざまなシチュエーションに対応可能なマルチファンクショナルデバイスで、マーキングからプレカット、粘膜切開・剥離、止血に至るまで、ESDで求められる手技を一本で行うことができます。

特徴２：独自の先端形状 ナイフ部に採用したディスクチップ（突起部）により、スムーズな切開・剥離をサポートします。電極の接触面が広いため速やかな止血対応が可能となり、止血デバイスへの入れ替え頻度を低減します。

特徴３：送水機能 ナイフ先端からの送水により、視野の確保や出血点の確認が可能です。ナイフ先端に付着する組織などを適宜洗浄することにより、ナイフ切開能の低下を抑えます。

HOYA株式会社PENTAXライフケア事業部について PENTAXライフケア事業部は、HOYA株式会社の医療用内視鏡を扱う事業部です。高い品質、医療ニーズに応えるイノベーション、そしてシンプルさを追求した最良の内視鏡製品群とサービスを提供することで、患者さまのケアと医療の生産性向上に寄与することをミッションとしています。 最先端の研究開発と生産技術を通じ、当事業部はPENTAX Medical のブランド名で内視鏡システムとソリューションを世界の医療産業に提供しています。日本国内にある生産設備およびグローバル本部に加え、世界各地に研究開発、販売、サービスの拠点を擁しています。詳しくはウェブサイトをご覧ください。www.pentaxmedical.com

Contacts お問い合わせ先: HOYA株式会社 PENTAX ライフケア事業部　医用機器SBU グローバルマーケティング統括部 マーケティングコミュニケーション部長 川島　香織 Email: kaori.kawashima@pentaxmedical.com 携帯： 080-4794-5842 〒196-0012 東京都昭島市つつじが丘1-1-110

豪雅集團旗下 PENTAX Medical上市用於胃癌早期治療的新款多功能內視鏡黏膜下剝離器材Splash M-Knife(中央社訊息服務20150527 15:17:32)東京--(美國商業資訊)--豪雅集團旗下PENTAX Medical上市新款多功能內視鏡黏膜下剝離器材Splash M-Knife，以實現透過單件器材完成完全性內視鏡黏膜下剝離術（以下簡稱ESD）。該新款器材將在日本消化器內視鏡學會(JGES) 第89屆年會上展示，該年會將於2015年5月29至31日在日本名古屋召開。開發可彎曲內視鏡旨在與其他治療器材一起用於各類微創治療手術。ESD是十多年前日本發明的一種手術，由於其具有臨床和經濟效益，有助於早期恢復、降低複雜性和成本，因而已在世界各地普及。全球產品管理副總裁Rami Liebenthal做出如下評論：「我們正在上市Splash M-Knife，這是一種創新的多功能ESD器材，它有助於ESD的全球普及，加快胃癌的早期治療。我們相信，用於精確、高效率、更安全ESD的創新器材為展開完全性ESD治療設立了一個新標準。我們致力於推廣該手術及其進一步的開發。」

Splash M-Knife具有下列特點。1.多功能 它可實現清晰的標記、更好的止血、更順利更輕鬆的手術，手術過程中無需替換刀具。2.獨特的機制 刀具中的碟片可幫助鉤起組織，從而提高安全性、便於切割，而貼近刀具的金屬板可實現清晰的標記和更好的止血3.噴水功能 它無需改變器材即可實現額外的注射

關於PENTAX Medical PENTAX Medical隸屬於豪雅集團 (HOYA Group) 。我們的使命是透過提供注重品質、貼合臨床的創新和簡單易用的最佳內視鏡產品和服務來改進患者治療和醫療衛生服務品質的標準。PENTAX Medical透過領先地位的研發和製造，為全球醫療界提供內視鏡成像設備和解決方案。總部位於日本的PENTAX Medical服務於全球，其研發、地區銷售、服務和駐在國設施遍及全球。欲瞭解更多資訊，請造訪www.pentaxmedical.com。

Splash M-Knife

 

i-SCAN Virtual chromoendoscopy

    

Reference: Diagnostic and Therapeutic Endoscopy, Volume 2012 (2012), Article ID 193570, Use of i-scan Endoscopic Image Enhancement Technology in Clinical Practice to Assist in Diagnostic and Therapeutic Endoscopy: A Case Series and Review of the Literature

Duodenoscope (十二指腸內視鏡) 成為超級細菌媒介 (Carbapenem-resistant Enterobacteriaceae, CRE)??

FDA reveals 142 cases of tainted scopes Scopes Deadly bacteria can become trapped at the tip of duodenoscopes. (LIZ MARTIN / The Gazette) By CHAD TERHUNE AND MELODY PETERSEN   Business Medical Research Hospitals and Clinics Food and Drug Administration CRE Infections UCLA Medical System The number of patients involved could be far higher than 142 Officials said 669,000 medical scope procedures were performed last year on patients Both the FDA and Olympus Corp., the leading maker of duodenoscopes, have come under fire. Federal regulators shed more light on the potential harm to patients from a controversial medical scope, disclosing 142 reports of contaminated devices and possible patient infections since 2010. The Food and Drug Administration had previously said it received about half that many reports, 75, on duodenoscopes that caused patient infections in 2013 and 2014. The number of patients involved could be far higher than 142 because one adverse event report may include numerous people. The new details emerged this week in advance of an advisory panel the FDA is convening next week to examine recent scope-related superbug outbreaks at several U.S. hospitals, including ones at UCLA and Cedars-Sinai medical centers. That FDA panel of medical experts is expected to recommend further steps that regulators, device manufacturers and hospitals should take to protect patients undergoing a procedure known as endoscopic retrograde cholangiopancreatography, or ERCP. Officials said 669,000 ERCP procedures were performed last year on patients battling cancer, gallstones and other digestive issues. Both the FDA and Olympus Corp., the leading maker of duodenoscopes, have come under fire from federal lawmakers, doctors and patient advocates for not responding sooner and more forcefully to reports of hospital outbreaks. Patients were infected even though hospitals were following the manufacturers' recommended cleaning instructions. Health officials have found that deadly bacteria can become trapped at the tip of these duodenoscopes. "The transmission of infectious material from patient to patient during ERCP, although uncommon, represents a serious public health concern," the FDA said in its latest report. Federal officials acknowledged that their surveillance system for medical devices has limitations and that incidents can be underreported by manufacturers. Some medical experts agree, and they say the number of scope-related infections may be much higher. "These reports can come in 18 months to two years later," said Lawrence Muscarella, a hospital-safety consultant in Montgomeryville, Pa. The FDA's new figures "could significantly underestimate the risk." After a superbug outbreak became public in February at UCLA's Ronald Reagan Medical Center, the FDA issued a nationwide alert to hospitals and Olympus published revised cleaning instructions. At UCLA, contaminated Olympus scopes infected seven patients with the CRE superbug and two of them died. Cedars-Sinai reported a similar outbreak in March that sickened four patients treated with an Olympus scope. Carbapenem-resistant Enterobacteriaceae, or the superbug CRE, is highly resistant to antibiotics, and it can kill up to half of those infected. A spokesman for Olympus couldn't be reached for comment Wednesday. In preparation for the advisory panel debate, the FDA searched its database of adverse event reports filed by scope manufacturers as well as from the makers of equipment that hospitals use to disinfect endoscopes. Regulators said they found 142 reports related to duodenoscopes from 2010 to Feb. 17, 2015. There were four additional reports going back to 1997. Among that total of 146 incidents, 13 involved patient deaths and 121 dealt with injuries, according to the FDA. The other reports involved equipment malfunction or other unspecified outcomes. An FDA spokeswoman said she didn't have a figure for the total number of patients involved in the ERCP reports. She said the agency didn't want to comment further in advance of the advisory panel meeting May 14 and 15 Olympus holds an 85% share of the U.S. market for duodenoscopes and other specialty endoscopes, according to the FDA. The FDA said six of the nine outbreaks recently investigated by health officials involved Olympus duodenoscopes. Scopes from Pentax Medical were involved in two outbreaks, and those from Fujifilm were involved in one, according to the FDA. "There is a systemic risk from this instrument. The problem of underreporting is probably high," said Dr. James McKinnell, an expert on hospital epidemiology at the L.A. Biomedical Research Institute at Harbor-UCLA Medical Center. The FDA continued to stand by its decision to not recall the duodenoscopes. "The agency believes that removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States," the agency said in its report. "FDA believes the benefits of the ERCP procedure outweigh the risks in appropriately selected patients." The FDA also disclosed for the first time the number of reports it had received on patient infections and device contamination related to automated endoscope reprocessors, the machines many hospitals use to disinfect these reusable devices. The agency said it had 152 adverse event reports related to reprocessing equipment from 1992 to March 2015. Custom Ultrasonics, a leading manufacturer of reprocessing machines, has previously said it's monitoring the scope infections closely, but it has "no concerns regarding the safety and efficacy of our devices." Overall, the number of ERCP procedures in the U.S. has grown 15% since 2010 to 668,800 last year, according to industry research cited by regulators.

ERCP (Endoscopic Retrograde Cholangio-Pancreatography) Patient Information from SAGES

What Is ERCP (Endoscopic Retrograde Cholangio-Pancreatography)? ERCP is a procedure that enables your surgeon to examine the pancreatic and bile ducts. A bendable, lighted tube (endoscope) about the thickness of your index finger is placed through your mouth and into your stomach and top part of the small intestine (duodenum). In the duodenum a small opening is identified (ampulla) and a small plastic tube (cannula) is passed through the endoscope and into this opening. Dye (contrast material) is injected and X-rays are taken to study the ducts of the pancreas and liver.

Why Is An ERCP Performed? ERCP is most commonly performed to diagnose conditions of the pancreas or bile ducts, and is also used to treat those conditions. It is used to evaluate symptoms suggestive of disease in these organs, or to further clarify abnormal results from blood tests or imaging tests such as ultrasound or CT scan. The most common reasons to do ERCP include abdominal pain, weight loss, jaundice, or an ultrasound or CT scan that shows stones or a mass in these organs. ERCP may be used before or after gallbladder surgery to assist in the performance of that operation. Bile duct stones can be diagnosed and removed with an ERCP. Tumors, both cancerous and noncancerous, can be diagnosed and then treated with indwelling plastic tubes that are used to bypass a blockage of the bile duct. Complications from gallbladder surgery can also sometimes be diagnosed and treated with ERCP. In patients with suspected or known pancreatic disease, ERCP will help determine the need for surgery or the best type of surgical procedure to be performed. Occasionally, pancreatic stones can be removed by ERCP.

CRE抗藥性檢測 (衛生福利部 疾病管制署)

一、 檢測目的 carbapenem類抗生素屬於強力的廣效性β-lactam類藥物，通常被視為治療多重抗藥性細菌的最後防線；但近年來革蘭氏陰性菌，尤其是腸道菌(Enterobacteriaceae)，對carbapenem類抗生素產生抗藥性(carbapenem-resistant Enterobacteriaceae, CRE)的比例日增，因此受到國際間的高度關注。為協助醫療機構確認藥敏試驗結果及檢測是否帶有NDM-1基因等，並收集國內菌株了解相關抗藥性機制，故提供此通報項目。二、通報方式（一）採志願通報。（二）倘醫療院所於病患臨床檢體分離出CRE，需協助鑑定或進行抗藥性基因檢測者，可經由傳染病通報系統之「其他傳染病」項下「CRE抗藥性檢測」辦理通報及送驗。三、送驗條件（一）對carbapenem類抗生素(doripenem、imipenem、meropenem或ertapenem等)任一種不具感受性(nonsusceptible)之腸道菌(Enterobacteriaceae)。因某些細菌本身即對imipenem不具感受性(nonsusceptible)，則需以其他carbapenem類(如：doripenem、meropenem或ertapenem)進行藥敏試驗。且（二）對以下任一第三代頭孢子菌素類 (third-generation cephalosporins)具有抗藥性: ceftriaxone, cefotaxime, and ceftazidime。四、檢體採集運送（一）醫療院所應將臨床檢體所分離出具carbapenem抗藥性之腸道菌純化菌株，以cary-blair拭子沾滿一圈後，置入cary-blair保持輸送培養基，以採檢箱立即送至疾病管制局昆陽實驗室。（二）運送檢體應於常溫（22℃-35℃）儘速送驗。（三）本菌抗藥性高，採檢時應謹慎操作，避免污染環境。（四）菌株驗出NDM-1基因等陽性約須5-7天。

 

GeneWEAVE 開發快速超級細菌檢測 MDROs / MRSA, CRE, and FRE (Fluoroquinolone-Resistant Enterobacteriaceae)

GeneWEAVE Presents Data for Smarticles™ Assay Targeted Towards Carbapenem-Resistant Enterobacteriaceae (CRE)  Abstract Presented at SHEA 2015 Demonstrates Direct-from-Sample Detection of CRE Utilizing New Molecular Assay  (PRWEB) May 15, 2015  GeneWEAVE, Inc., a clinical diagnostics company addressing multi-drug-resistant organisms (MDRO), announced that initial data presented at the SHEA Spring 2015 Conference demonstrates the ability for its Smarticles™ technology to detect CRE directly from rectal swab samples regardless of the resistance mechanism and without the need for sample preparation or previous culture. This abstract was one of twenty-four outstanding abstracts selected for the SHEA Abstract Award poster presentation. The Company's Smarticles™ technology is a new class of molecular diagnostics that can quickly detect MDROs and assess antibiotic susceptibility directly from clinical samples. An abstract presenting analytical performance for a prototype Methicillin-Resistant Staphylococcus aureus (MRSA) assay tested directly from nasal swabs was previously presented at the AMP Annual Meeting in November, 2014."We are excited by this data that supports the application of Smarticles™ technology to Gram-negative bacteria. The logarithmic increase in resistance mechanisms and global rise in related infections speaks to the need for better surveillance and diagnostic tools," said Steve Tablak, CEO at GeneWEAVE. "In addition to ease of use, this poster indicates how our detection of molecular 'systems' can deliver fast and reliable susceptibility measurements regardless of the underlying resistance mechanism. These results suggest that even as bacteria develop novel resistance mechanisms, our tests will continue to provide reliable susceptibility data to enable successful infection prevention programs and personalized antibiotic selection." The emergence and spread of bacteria such as CRE and MRSA that are resistant to currently available antibiotics is a worldwide threat recently highlighted in the World Health Organization's (WHO) report, Antimicrobial Resistance Global Report on Surveillance 2014. As noted in a recent Centers for Disease Control and Prevention (CDC) publication, infections with CRE are particularly alarming as these have been associated with mortality rates up to 50%. Infections due to CRE are increasing at a rapid rate and have now spread to all but 2 states in the USA. Surveillance programs to identify patients that are asymptomatic carriers of drug-resistant bacteria are a key factor for controlling the spread of these organisms. Quick access to test results in the same shift is needed to ensure that infection prevention measures may be enacted promptly. With Smarticles™ technology, GeneWEAVE is developing fast, direct-from-patient-sample tests for critical MDROs such as MRSA, CRE, and FRE (Fluoroquinolone-Resistant Enterobacteriaceae) to allow healthcare providers to make time-critical decisions.

GeneWEAVE, Inc., based in Los Gatos, Calif., is a privately-held in vitro diagnostics company that is advancing clinical microbiology with diagnostic solutions to aid healthcare providers in the fight against drug-resistant bacteria by enabling impactful surveillance programs, early therapy guidance and successful antibiotic stewardship. The company's innovative and proprietary Smarticles™ technology harnesses the power of biology to rapidly detect drug resistance and measure susceptibility information without the need for enrichment, culture, or sample preparation. We call this new paradigm, "Sample-In/Susceptibility-Out".

 

Source: www.geneweave.com

狗狗DogTelligent 延伸: 開發夫妻忠貞戒指+APP 隨時監控!!

狗狗專用智慧型穿戴裝置！DogTelligent 推出萬能寵物項圈 作者 Jin Lin | 發布日期 2015 年 05 月 27 日DogTelligent 幫助飼主實踐諾言，讓項圈不只是一個象徵物件，更能協助你隨時隨地掌握到愛犬的行蹤、安全和健康，甚至整合犬隻教育訓練，可以透過 App 遠距離對毛小孩發號司令。DogTelligent 是由一群愛狗人士組成的寵物科技產品研發團隊，致力於協助飼主為狗狗打造更好的生活，他們發揮創意將「寵物項圈」打造成一個多功能整合平台，與行動裝置和其他寵物產品結合。 DogTelligent 認為，安全是保護毛小孩的首要條件，他們獨創「虛擬圍欄牽繩科技」，讓項圈可以發出超聲波頻率和震動，好似一條在狗狗身上隱形卻可以無限伸長的牽繩，就算在遠距離也能做到拉繩效果，警告狗兒不該超出不安全的活動範圍；藉由 App 和項圈上的 GPS 定位系統，飼主不僅能掌握狗小孩的健康資訊、活動狀況和行動位置，在寵物失蹤的時候也能發揮最大功效！特別的是，項圈上設有 LED 燈增加我們在夜間搜尋寵物的能見度，更裝有揚聲器，讓緊張的飼主可以從手機的另一頭跟迷路的毛小孩說：「乖乖！坐下！我馬上就來找你！」。DogTelligent 的另一個亮點在於與專業犬隻訓練整合， DogTelligent 項圈除了震動功能外，還有超音波哨，在 App 上用戶可以自行設定不同的指令音哨（像是坐下、不要動、趴下等等），讓飼主直接使用行動裝置下達指令，在教育狗小孩的過程中配合使用；此外， DogTelligent 項圈還能偵測狗兒的激烈咆哮，代替飼主自動下達命令喝止。相較於前一陣子推出的LED燈光寵物背心 Disco Dog 著重於主人與寵物間的娛樂價值， DogTelligent 的產品更精准掌握住飼主的需求、簡化沒有必要的設計。目前線上也推出各種寵物科技，似乎間接證明智慧型穿戴裝置已經開始在寵物市場打出另一片天。而 DogTelligent 項圈不免讓人聯想到武打巨星李連杰在 2005 年推出的電影《鬥犬》，講述一個智商只有十歲的男人從小佩戴狗項圈，被黑社會訓練成殺人機器，片中項圈的意象備受爭議，對於寵物來說，控制性更強的項圈究竟是不是一件好事？如果這項科技應用在結婚戒指上，讓夫妻可以透過 App 監視彼此的忠貞度，聽起來的確令人毛骨悚然。類似 DogTelligent 這種寵物產品的推出，會不會降低我們對寵物的信任感？或是無意間讓主人減少與寵物之間最珍貴的互動？但正如智慧型手機的發明，人們可以更便捷掌握人際關係，科技使人們疏離、亦能讓人更親密，不論如何，最終的決定權還是在人類自己的身上。

Source: http://www.dogtelligent.com/