Sunday, July 8, 2012

孕婦如何預防未來寶貝過敏 ??!!


醫師:照顧過敏兒 需長期抗戰 ‧聯合新聞網 2012/07/05 醫生表示,不少保健食品標榜提升免疫力,但過敏並非免疫力低落所致,而是免疫失調,即免疫系統對過敏原產生過度反應。因此,過敏兒童身上,可能合併多種過敏病症... 【聯合報╱記者劉惠敏專題報導】 過敏兒愈來愈多,許多家長花大錢,凡宣稱能改善過敏的方法,不論是保健食品還是坊間偏方,都願意一試。專家提醒,照顧過敏兒需要正確的認知與照護,這些比花錢有用。  過敏兒愈來愈多,許多家長花大錢,凡宣稱能改善過敏的方法,不論是保健食品還是坊間偏方,都願意一試。專家提醒,照顧過敏兒需要正確的認知與照護,這些比花錢有用。 專業插畫家吳怡蒨的兩個孩子,分別為過敏性鼻炎、氣喘所困擾。她為了解決孩子的過敏,就像神農嘗百草,尋求中草藥、保健食品不說,甚至還將蔥塞進兒子鼻子裡,希望孩子別再噴嚏打不停、鼻水流不完。「結果都失敗了。」她說,尤其是蔥塞鼻子,孩子連一秒鐘都受不了。 吳怡蒨說,以前不願意讓孩子用藥,怕從此離不開藥物,但偏方屢試屢敗後,還是乖乖依照醫師指示,適當用藥、留心環境過敏原,家裡終於不再噴嚏聲此起彼落。 台大小兒科兼任主治醫師周正成說,不少保健食品標榜提升免疫力,但過敏並非免疫力低落所致,而是免疫失調,即免疫系統對過敏原產生過度反應。因此,過敏兒童身上,可能合併多種過敏病症。 周正成說,面對過敏,必須有長期抗戰的打算,但不少家長缺乏耐心,比起醫師的治療建議,更相信特殊療法或保健食品。他提醒,坊間許多宣稱有效的方法,並沒有經過研究證實,也許對部分對象或病症有效,不能一體適用。 以益生菌為例,周正成說,芬蘭學者曾針對一親等內有過敏疾病的孕婦進行研究,孕婦生產前24周服用益生菌,嬰兒出生後,母乳媽媽續服;餵配方奶者,則由新生兒服用益生菌至6個月大。結果發現,降低嬰兒罹患異位性皮膚炎機率50%,但持續追蹤至7歲,其過敏性鼻炎發生率增加23倍,氣喘增加3.5倍。 因此,臨床醫師不建議無過敏症狀孕婦、新生兒服用益生菌預防過敏。林口長庚醫院兒童過敏氣喘中心主任歐良修說,益生菌預防過敏不一定有用,對已有過敏病症的兒童,也無法證實有效。周正成說,冷飲、二手菸是引發氣喘、鼻炎的過敏原,但許多家長輕忽。 至於用藥,局部類固醇是目前治療及預防氣喘最常見的藥物,吸入型類固醇劑量低,可長期使用,全身性副作用少。若平日好好照護,減少氣喘發作,也可避免服用較高劑量的口服類固醇。 周正成提醒,氣喘擴張劑用於緊急狀況,短時間可舒緩不適,但不能改善呼吸道發炎反應;非類固醇鼻噴劑長期使用有依賴性,停藥後鼻塞更嚴重,兒童不宜使用。



懷孕 放輕鬆 好運(孕)來 !! Maternal anxiety during pregnancy associated with atopic eczema !!!

孕婦吃Lactobacillus rhamnosus(鼠李糖乳酸桿菌)降低新生兒異位性皮膚炎與過敏性鼻炎風險; 雷特氏B菌Bifidobacterium則無!!





中國市占率No 1 隱形眼鏡: 金可(海昌)!!!


金可一條鞭 拚亞洲眼鏡龍頭 【經濟日報╱記者黃文奇/台北報導】 2012.07.09 02:47 am 金可國際董事長蔡國洲表示,金可進軍歐美日隱形眼鏡市場,Made In Taiwan(台灣製造)的號召力勝過中國製造。 金可國際集團董事長蔡國洲表示,金可在兩岸擁有隱形眼鏡、傳統眼鏡及眼鏡連鎖通路3大事業版塊,面對不同的競爭對手,金可透過垂直整合,3年內要由中國第1大隱形眼鏡品牌晉身為亞洲第1大,5年內要打造亞洲最大眼鏡集團地位。蔡國洲表示,金可在大陸的「海昌」隱形眼鏡市占率,已打敗國際大廠,高居第1名,未來3年兩岸將以每年新增5條產線的速度擴產,2014年隱形眼鏡產能將到年4.2億片;此外,也將透過彈性結盟與併購等多角化策略,擴大歐美市場影響力。 金可今年第1季營收8.84億元,稅後純益2.43億元,每股稅後純益3.05元,上周五股價收310元,下跌1.5元,目前是生技類股股后,僅次於精華光學。7月下旬將有生技展等一系列活動,讓投資人對生技類股多所期待,以下是蔡國洲專訪紀要:
問:金可集團事業區塊與未來營運目標? 答:金可目前擁有隱形眼鏡、傳統光學眼鏡及眼鏡連鎖通路3大區塊,去年金可集團合併營收約200億元。尤其重要的是隱形眼鏡,透過「海昌」品牌,目為已是大陸市占率最高的品牌,我們目標是,3年內成為亞洲最大隱形眼鏡品牌,5年內要成為亞洲最大眼鏡集團。 金可是亞洲極少數同時掌握製造、品牌及通路的眼鏡集團,也是極少數兼具隱形眼鏡、傳統光學眼鏡生產能力的集團,這一路走來有太多機緣巧合,因此我們要做亞洲最大眼鏡集團,除了因緣際會,垂直整合的效益也成為最大的優勢。
問:其他隱形眼鏡大廠,若想跨入更多元的眼鏡市場,有何障礙? 答:眼鏡是一項百年產業,過去做光學鏡片的公司如蔡斯、Nikon等,沒預料到隱形眼鏡會崛起,喪失了先機,現在要搶進隱形眼鏡市場,只能找其他小廠代工。 另一方面,現有的隱形眼鏡國際4大廠嬌生、視康、博士倫及酷柏,背後都有大型醫藥集團為後盾,嬌生本身就是醫材保健集團,視康的母集團就是世界前3大的諾華藥廠,博士倫背後為愛爾康藥廠,只有酷柏是專業醫材廠。
問:金可的優勢和隱形眼鏡決勝的關鍵點是什麼? 答:傳統眼鏡方面,每一副眼鏡都有一百多個製程,技術、模具的精密度都很重要,對金可來說,要把成品交到消費者手上不知要失敗多少次,近年雖然大陸近勞力成本提昇,競爭力下滑,但我們強調的是品質和價格之間的性價比,只要品質夠好不怕消費者不買單。 此外,隱形眼鏡製程已經不再神祕,前4大品牌能做的我們也行,只要買到設備、找到人、買到配方就可製造,但其中關鍵點在行銷、品牌的建構。講到舒適度,金可品牌「海昌」及「海儷恩」,都是針對東方人眼球曲率設計,其他4大國際品牌是配合西方人的眼球弧度。
大商機 歐美日偏愛MIT
問:金可近3年的生產布局規劃為何? 答:大陸丹陽廠目前4條產線,台灣中科廠2條產線,年底前台灣擴3條、大陸擴2條,未來3年比照這樣的速度擴線,依每年新增5條產線的速度擴產,2014年將擴充到21條產線約4.2億片產能。大陸未來生產的產品,就是供大陸市場所需,而台灣廠則除了供台灣本地外,也供全球市場。 以「海昌」為品牌的隱形眼鏡,7月下旬要在台灣上架,目前中科廠24小時加班趕工;此外,近期我們正規劃在台灣中科建一個隱形眼鏡藥水廠,預計投資5億元,月產能約120萬瓶,以供應台灣市場所需,明年年中以前即可投產。
問:在台建廠最主要的考量為何? 答:金可著眼的是全球布局,歐美日客人不要MIC(中國製造)、只要MIT(台灣製造),譬如隱形眼鏡要進日本,如果沒有美國FDA的認證,一切免談。海昌大陸丹陽廠生產的產品,在幾年前已經取得歐盟的CE認證,但美國FDA(食品藥物管理局)認證就是拿不到。國際市場對台灣品質的肯定,是金可回台設廠的關鍵。 其次,大陸現在招工不易,加上現在製程幾乎完全自動化,隱形眼鏡已經不需要那麼多勞力,且兩岸簽署經濟協議(ECFA),台灣產品銷往大陸更加便利。最重要的是,台灣產品回銷大陸,價差甚至提高到20%,這是MIT的魅力。未來,台灣中科廠將是金可進軍全球的基地,是全球市場的堡壘。
問:金可為何積極切入日拋產品? 答:日韓隱形眼鏡市場已經飽和,但大陸市場還有很大成長空間;大陸以前是瞇著眼睛灰灰的過日子,但現在經濟條件好了,可能先配副眼鏡,再來才因為實際需要,開始戴起長周期的隱形眼鏡,再進一步換用日拋、彩妝片。 隨著經濟發展,現在大陸隱形眼鏡市場,已經到了要起飛階段,每年有超過20%的成長率。 過去大陸長戴型市場大,因此我必須固守,現在環境轉變,當然也決定了我的產品型態;因此,當初海昌在大陸主打2線以下城市,專攻長周期產品。 未來市場逐漸轉型後,原來長戴型的消費者1年用兩片,現在是1年用500片,因此海昌的轉型是必然的。
問:隱形眼鏡4大國際品牌全球市佔率近90%,金可如何從國際布局突圍? 答:海昌(Hydron )這品牌原屬於西方公司所創立,金可過去僅買下兩岸市場權,其餘歐美地區品牌所有權還掌握在其他公司,金可將與對方談判,拿下Hydron 國際使用權。 其次,金可也要和歐美大型連鎖通路結盟,以貼牌(代工)方式搶進當地市場,取得消費者信任後,即可望順利拿下市佔率。由於海昌當年屬隱形眼鏡代名詞,雖然歐美已經不使用該品牌,但未來只要重新包裝很快就會被消費者認識。 事實上,國際4大品牌已有弱化的趨勢,而且會愈來愈明顯;20054大品牌市占率約93%,但到2010年僅剩下88%,此外,外商大公司動作緩慢,決策效率低,CEO換人可能政策就改了,我們決策靈活,因此具有更大的優勢。 2012/07/09 經濟日報】

杏輝(杏國; SynCore) 加入抗癌微脂體戰局 ! 目標乳癌 (ENDOTAG-1®, A CATIONIC LIPOSOME CONTAINING PACLITAXEL)


Medigene and SynCore enter into Co-Development and Commercialization Agreement for EndoTAG®-1  July 6, 2012, 11:00 a.m. EDT (Thomson Reuters ONE via COMTEX) -- MediGene AG / Medigene and SynCore enter into Co-Development and Commercialization Agreement for EndoTAG®-1 . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement. - SynCore receives exclusive rights to co-develop and commercialize EndoTAG®-1 in Asia, Australia and New Zealand - Medigene retains all US, European and remaining RoW rights - Medigene will receive an upfront, milestone payments and royalties - Medigene plans global pivotal phase III trial in triple-negative breast cancer (TNBC) - SynCore will assume costs for the Asian part of the global pivotal phase III trial Martinsried/Munich, July 6, 2012. Medigene AG (frankfurt:MDG)(frankfurt:Prime Standard) announced that it has granted exclusive rights for co-development and commercialization of EndoTAG®-1 in Asia, Australia and New Zealand to SynCore Biotechnology Co., Ltd. ("SynCore"), a subsidiary of the Sinphar Pharmaceutical Group (Taiwan Stock Exchange, Symbol: 1734). Medigene plans a pivotal global phase III trial of EndoTAG®-1 in triple-negative breast cancer (TNBC) with the aim of achieving worldwide market approval. Under the terms of the agreement, SynCore will fund the Asian part of the clinical trial, representing about 50% of the total number of patients to be included. Subject to clinical trial approval, approximately 400 patients are expected to be enrolled in the global pivotal phase III trial in TNBC. Furthermore, Medigene receives an upfront payment from SynCore and is eligible to payments upon certain development and approval milestones as well as royalties. Medigene retains all US, European and remaining rest-of-the-world (RoW) rights to EndoTAG®-1 with the ability to grant further licenses. Medigene anticipates submission for market approval for EndoTAG®-1 in 2018. The agreement does not impact Medigene's financial guidance for 2012 and the management confirms that the company's funding is expected to be secured beyond 2013. Dr. Frank Mathias, CEO of Medigene AG stated, "EndoTAG®-1 has shown promising overall survival data in patients with TNBC, a type of breast cancer for which only limited treatment options are available. We are excited to continue with the development of EndoTAG®-1 and look forward to working with our partner, SynCore, to advance the product through a pivotal study and to seek worldwide marketing approval for the benefit of breast cancer patients. Medigene is now very well positioned with the ongoing development of two advanced clinical drug candidates and a solid financial profile supporting the company's growth strategy." Dr. Frank Why-Ju Chu, CEO of SynCore commented: "We are pleased to expand our partnership with Medigene, which started in 2011 with Veregen®. With EndoTAG®-1, we seek to provide another innovative product to our Asian patients. The co-development of EndoTAG®-1 fits very well with our strategy to build an innovative late-stage pipeline." The Sinphar Group specializes in the sales and marketing of pharmaceutical products as well as in manufacturing for several global pharmaceutical companies like Johnson & Johnson, Takeda, Shionogi and Astellas. Additionally, Sinphar is one of the largest producers of paclitaxel (Phyxol®) in Asia. Rationale for EndoTAG®-1 in TNBC: EndoTAG®-1 has demonstrated encouraging efficacy in a Phase II trial in combination with paclitaxel in patients with TNBC. In a sub-group of patients with first line treatment for metastatic/relapsed TNBC and ECOG performance 0/1 in this study (total of 119 out of 133 patients), EndoTAG®-1 plus paclitaxel resulted in a median overall survival of 17.8 months (10.1 months for the paclitaxel alone group)1. Subject to clinical trial approval, about 400 patients will have to be enrolled to demonstrate clinical benefit in terms of overall survival, as previously discussed with the European Medicines Agency (EMA). This is a significantly smaller number of patients needed compared to trials in other indications, e.g. pancreatic cancer. Patients will be randomized 1:1 to receive EndoTAG®-1 plus paclitaxel weekly or paclitaxel weekly alone (same total dose of paclitaxel in both arms).
About EndoTAG®-1: EndoTAG®-1 is a novel composition of the established cytostatic drug paclitaxel combined with neutral and positive lipids. The positively charged lipids imply that EndoTAG®-1 interacts with newly developed, negatively charged endothelial cells, which are primarily required for the growth of tumor blood vessels. The EndoTAG®-1 paclitaxel component attacks the endothelial cells as they divide, thus targeting the blood supply to tumors without affecting the supply to healthy tissue. By doing this, EndoTAG®-1 is expected to prevent the formation of new tumor blood vessels and to inhibit tumor growth. Medigene has successfully completed two clinical phase II trials of EndoTAG®-1 in the indications pancreatic cancer and triple-negative breast cancer (TNBC). EndoTAG®-1 is protected by a number of patent families. In TNBC, EndoTAG®-1 is protected by granted patents with terms up to 2029 (USA). In Europe and other countries, patent applications in TNBC with a term until 2027 are pending. Additional patent applications covering the product with terms up to 2031 (USA, Europe, Asia and other countries) are pending.
About Triple-negative breast cancer (TNBC): Triple-negative breast tumors are malignant and do not show any HER2 receptors or hormone receptors for estrogen or progesterone. About 15% of all breast cancer cases rank among this group. There are very few treatment options available, since conventional anti-hormonal treatments or treatments targeting HER2 are not appropriate. In case of relapse following initial surgery, the only remaining treatment option is chemotherapy.
About SynCore Bio: SynCore Biotechnology Co., Ltd, a joint venture between the publicly listed pharmaceutical company Sinphar Pharmaceutical Co., Ltd and the National Health Research Institute of Taiwan, is focused on the development of new drugs. Currently, it is conducting a phase I first-in-man trial on an anti-cancer new chemical entity. Another anti-cancer NCE project is in the pre-IND stage. In addition, SynCore Biotechnology Co. also obtained an exclusive development and commercialization right of an anti-dry AMD new drug, MC 1101, in Asia at 2011 from a US Biotech company, MacuCLEAR. MC 1101 is currently undergoing a US FDA phase II/III trial.
About Sinphar Pharmaceutical: Sinphar Pharmaceutical Co, Ltd (Taiwan Stock Exchange, Symbol: 1734), with subsidiaries in China and Canada, specializes in the sales and marketing of pharmaceutical products and dietary supplements as well as in manufacturing for several global pharma companies like Johnson & Johnson, Takeda, Shionogi and Astellas. Additionally, Sinphar is one of the largest producers of paclitaxel (Phyxol®) in Asia. It is also involved in the research and development of botanical new drugs. Two projects are currently undergoing US FDA phase II trials. Its manufacturing facilities are approved by the Taiwanese FDA and Japan PMDA according to PIC/s GMP guidelines. Further information can be obtained at: www.sinphar.com . 

ENDOTAG-1®, A CATIONIC LIPOSOME CONTAINING PACLITAXEL, DEMONSTRATES ANTI-ANGIOGENIC AND ANTI-INFLAMMATORY ACTIVITY IN RHEUMATOID ARTHRITIS IN VIVO
M. Schmitt-Sody, P. Metz, O. Gottschalk, B. Schulze, H. Bohnenkamp, U. Michaelis, E. Guenzi, M. Funk and V. Jansson
Abstract Introduction: Inflammation and angiogenesis are hallmarks of rheumatoid arthritis (RA) that contribute largely to the formation of pannus tissue and joint destruction in patients suffering from RA. We have recently shown that intravenously applied cationic liposomes target efficiently angiogenic endothelial cells in the synovial vasculature of rheumatoid joints and therefore may also serve as potent vehicles for systemic drug delivery and therapy in RA. Therefore the aim of our study was to quantify the antiangiogenic and antiinflammatory properties of EndoTAG-1® (paclitaxel formulated in cationic liposomes) in the inflamed joints of murine models of RA and to compare the therapeutical efficacy of EndoTAG-1® to Taxol® (paclitaxel in Cremophor EL).
Materials and Methods: Targeting of fluorescently labelled cationic liposomes to the synovial vasculature in mice with antigen-induced arthritis (AIA) was analysed by intravital microscopy. Density of functional vessels and adhesion of fluorescently labelled platelets or leukocytes were determined after treatment with EndoTAG-1®. Knees were subjected to clinical scoring and histopathological analysis. Results: EndoTAG-1® treatment of AIA mice with developing or in established disease showed a strong attenuation of the course of the disease as well as a potent anti-inflammatory effect. Histological analysis of knee sections demonstrated a dramatic reduction of the pannus and infiltration of inflammatory cells. Enrichment of EndoTAG at the synovial vasculature of AIA mice was observed when compared with healthy mice. Treatment of AIA mice with EndoTAG-1® concomitant to disease induction showed a complete remission of the course of the disease as shown by a significant decrease of clinical scores compared to both control and Taxol® treated groups. A complete inhibition (98%) of neo-vascularisation was observed in the synovial vasculature of mice with AIA that were treated with EndoTAG-1® whereas Taxol® alone showed only 50% inhibitory effect. Rolling and adhesion of platelets were reduced to 53% (paclitaxel 5%) and 98% (paclitaxel 57%), respectively. Discussion: Our in vivo data clearly demonstrates that anti-angiogenic and anti-inflammatory activity of Endo-TAG-1® contribute to the therapeutical efficacy of this drug in RA. Notably, therapeutic efficacy with Endo-TAG-1® was superior to Taxol®. This strongly suggests that systemic delivery of cationic liposomes is very well suited to enrich compounds to rheumatoid joints for therapy and could be a promising treatment option for RA.

Academia Sinica elects mostly local academics


 Sat, Jul 07, 2012 - Staff writer, with CNA Twelve of 20 newly elected academicians at Academia Sinica, the nations top research institute, are locally based, including its first surgeon, Academia Sinica president Wong Chi-huey (翁啟惠) said. The position is one of the most prestigious in Taiwanese academia. The academicians, divided into three groups based on their expertise, make policies on academic research at a biennial convocation. Wong said on Thursday that he welcomed the fact that more local academics were elected. Two years ago, nine of 18 academicians elected worked in Taiwan. Wei Fu-chan (魏福全), a surgeon and professor at Chang Gung University College of Medicine, became the first surgeon to be elected. This is the biggest possible encouragement” for local surgeons, whose morale has been low for a long time, he said. Weis election also countered the misconception that surgeons cannot conduct research, said academics Michael Lai (賴明詔) and Chen Pei-jer (陳培哲), who are also doctors. In the life sciences division, Hsieh Tao-shih (謝道時), director of the Institute of Cellular and Organismic Biology at Academia Sinica, and his student, Cheng -Soo-cheng (鄭淑珍), a research fellow at the Institute of Molecular Biology, were both elected. Among the physical sciences, Ma Tso-ping (馬佐平), co-director of the Yale Center for Microelectronic Materials and Structures, and Alice Chang (張聖容), chair of the Department of Mathematics at Princeton University, were elected. Four other academicians elected from the humanities and social sciences were Hsieh Chang-Tai (謝長泰), an economics professor at Booth School of Business, University of Chicago; Fan Jian-qing (范劍青), a professor of finance at Prince-ton; and Academia Sinica research fellows Shih Shou-chien (石守謙) and Chu Yun-han (朱雲漢).  

Beauty treatment centers to face tougher rules: DOH


Sun, Jul 08, 2012 By Lee I-chia / Staff reporter The medical cosmetology market in Taiwan is becoming chaotic and confusing to the public, the Department of Health (DOH) said yesterday, adding that it would soon establish an ad-hoc committee to control the situation. Holding newspapers that showed advertisements for medical cosmetology clinics and pointing out the problematic messages they contained, DOH Deputy Minister Lin Tzou-yien (林奏延) said there were too many deceptive or exaggerated accounts in the advertisements adding “if we don’t control it now, it will be even more unmanageable in future.” The quality of the clinics is inconsistent, with an increasing number of practitioners from various branches of medical care pouring into the booming medical cosmetology market, Lin said. Lin added that aside from conventional plastic surgeons, doctors specializing in ophthalmology, urology, obstetrics and gynecologyare also performing medical cosmetology procedures — a confusing situation for the public which sometimes leads to medical disputes. In addition, Lin said other problems included the fees charged for the same medical services often differ greatly among clinics, the unknown quality of medical instruments, the failure to explain possible risks to consumers, exaggerated advertising seen in text messages and the Internet and an unfit strategic alliance between different business sectors, such as promoting trial coupons and discounts. The department said it has asked Chen Yu-ray (陳昱瑞), a senior doctor at the Department of Plastic and Reconstructive Surgery at Chang Gung Memorial Hospital, to play the leading role in establishing the ad-hoc committee to address the problems. Seeing that the market has become so chaotic, the first thing the department will do is to release an authorized certificate for qualified medical cosmetology practitioners and the education credits will be decided by the department,” Lin said, adding that the department is also to clamp down on exaggerated advertisements. Although we are unable to guarantee a beautiful result, we at least want to guarantee safety,” Lin said, adding the certification mark will make it easier for consumers to choose quality clinics. Moreover, there are currently many medical cosmetology academies with their own certification system, Lin said, adding that actually medical cosmetology is not a branch of medicine which is misleading to the public.

专利到期有机遇 2020中国医药总产值将达十万亿


 发布时间:2012-7-6 来源:药品资讯网信息中心 随着全球大批“重磅药物”的专利集中到期,我国制药企业将迎来巨大的发展机遇。在日前于武汉举行的国际生物医药与医疗器械论坛上,专家预测,到2020年,我国医药行业总产值将达到十万亿,位居全球第二。 会上,200多位来自北美洲、澳洲、欧洲等海外地区及国内的嘉宾围绕我国医药产业动向与趋势、新药研发的政策法规与现状、生物产业转移与资本运作等生物医药领域热点问题进行了探讨。 曾任国家食品药品监督管理局药品审评中心部长、现任北京大学资深研究员的邵颖在论坛上介绍,近十年来,中国医药产业平均增速为16.4%.未来十年,平均增速将达到23.6%.他预计,在国家大力推进健康发展计划的背景下,生物医药领域存在着巨大的市场需求。未来几年内,中国有望成为继美国和日本之后的全球第三大药品市场。 正是看到巨大的市场潜力,包括葛兰素史克、辉瑞、诺华等在内的跨国制药企业纷纷在中国设立研发中心。同时,为了进一步推动产业发展,我国已将生物医药列为战略性新兴产业,先后制定了《促进生物产业加快发展若干政策》、《“重大新药创制”科技重大专项计划》等政策,力争在“十二五”期间发展成为生物技术强国和生物产业大国。

醫美認證: 不保證做得美,但保證安全 !!!


醫美亂象 衛生署要管了 20:43:32 (中央社記者陳清芳台北6日電)醫病不如醫醜的現象下,醫美診所充斥,廣告浮濫,但連醫界人士都說:「根本沒有醫美科」。衛生署今天決定請長庚整形外科教授陳昱瑞出馬,採取3大措施整頓醫美亂象。 前美容醫學會理事長、開業醫師呂旭彥表示,許多診所招牌寫著「醫美專家」,被誤導的患者到了他的診間說,「你不是醫美科,是整形外科嘛」;其實,衛生署的醫學專科名單根本沒有醫美科。 「醫美亂象,再不管就管不了了」,衛生署副署長林奏延、衛生署醫事處長石崇良指著今天報紙的廣告說,廣告出現衛生署核准有效植髮、搶救禿頭等字眼,相關診所及報告可能違規不實廣告。另外某電台週末上午、某些電視談話節目、部分診所臉書粉絲團,都有置入醫美廣告問題。 林奏延指出,衛生署將採取評鑑認證、回收學分、取締廣告等3大措施,請財團法人醫院評鑑暨醫療品質策進會負責認證,通過認證的醫美診所可掛上標章,「不保證做得美,但保證安全」 衛生署將請前整形外科與前美容醫學會理事長、長庚外科教授陳昱瑞,主持醫美專案管理工作小組召集人,對於醫美醫師之間自訂進修學分、教育訓練,給予監督評估,浮濫膨風的學分要回收。 呂旭彥指出,早就該這麼做了,建議衛生署要釐清何謂醫美才能展開評鑑認證。他說,衛生署核准專科中,整形外科和皮膚科有美容訓練,所謂的醫美醫師至少要有這兩科的訓練,不是所有醫師穿上白袍,擺個姿勢,上了招牌,就能醫美。1010706  

Abraxane 对于晚期胰腺癌!!


蛋白结合型紫杉醇治疗多种肿瘤显优势 发布时间:2012-7-6 来源:药品资讯网信息中心 与其他剂型紫杉醇相比,新型靶向化疗药物白蛋白结合型紫杉醇(nab-PAbraxane)可在肿瘤局部产生更高的紫杉醇浓度,且注射时间短。Nab-P可通过gp60穿胞途径及结合于肿瘤细胞外间质的富含半胱氨酸的酸性分泌蛋白(SPARC)途径来提高肿瘤外药物浓度。目前,该药已获美国食品与药物管理局(FDA)批准用于辅助化疗6个月内转移或复发,经联合化疗无效的乳腺癌。今年美国临床肿瘤学会(ASCO)年会上公布的数项研究显示,在肺癌、胰腺癌等肿瘤中,nab-P联合其他治疗亦显示出良好的安全性和有效性。
 Nab-P为晚期乳腺癌治疗注入新活力 复旦大学附属肿瘤医院 胡夕春 紫杉类药物是治疗转移性乳腺癌的主要用药。自上世纪九十年代中期以来,多项Ⅱ、Ⅲ期研究均肯定了紫杉类药物对转移性乳腺癌的疗效,并与多柔比星进行比较,其至疾病进展时间(TTP)与生存期较多柔比星略优或相似。nab-P以纳米微粒白蛋白为载体,改变了助溶剂,提高疗效的同时亦减轻了毒性。今年ASCO年会的两项研究显示nab-P联合铂类药物治疗高危或晚期乳腺癌安全有效。 研究1 英国布朗大学肿瘤组(BrUOG)的研究证实,对于高危乳腺癌患者,卡铂(Cb+贝伐珠单抗联合每周nab-P方案耐受性良好,临床完全缓解率(cCR)和临床部分缓解率(cPR)达84%。研究者纳入60例临床分期为ⅡA~C期的乳腺癌患者(中位年龄47岁),其中31例激素受体(HR)阳性,29例为三阴性乳腺癌(TN),随机予以每周nab-P100 mg/m2)联合Cb[曲线下面积(AUC)为6]+贝伐珠单抗(15 mg/kg),每31次,共12周(队列1),或接着加入剂量密集多柔比星+环磷酰胺(ddAC)联合贝伐珠单抗(队列2)新辅助治疗,术后继续贝伐珠单抗或其他全身药物治疗。 结果显示55例患者缓解(见表),每周nab-P组严重不良事件包括3例恶心或脱水(N/D)、3例伴或不伴中性粒细胞减少性发热(FN)的感染、2例胃肠道(GI)出血;ddAC组尽管应用了粒细胞集落刺激因子(G-CSF),仍有6例(21%FN 3N/D。结果提示,每周nab-P联合治疗持续时间长或联合基于蒽环类药物的化疗可改善缓解率(pCR率由11%升至54%)。该结果与之前其他研究结果一致。(摘要号1045 研究2 复旦大学肿瘤医院一项前瞻性Ⅱ期研究探索了每周nab-P联合顺铂化疗治疗晚期乳腺癌的疗效和安全性。研究共入组了73例复发或转移性的乳腺癌患者,予以nab-P125 mg/m2,每周1次)联合顺铂(75 mg/m2)治疗,每4周重复直至疾病进展,主要观察终点是总有效率(ORR)。 结果显示,所有患者ORR67.1%;中位随访12.8个月后,中位无进展生存(PFS)期为10.5个月,对于接受一、二、三线或更多治疗的患者,中位PFS期分别为12.3个月、9.0个月、7.7个月(P=0.006)。亚组分析显示,最高ORR出现在人表皮生长因子受体2HER2)阳性患者中(P=0.584),继之是TN患者和管腔型患者。46例(63.0%)患者发生4级中性粒细胞减少,但仅有9例(12.3%)出现发热性粒细胞减少,13例患者由于3级外周神经病变不得不中止化疗。(摘要号e11568 截止2011101 27例患者出现皮疹(37.0%),最常见的部位为面部(14例)、颈部(14例)、肢体(18例)和身体摩擦部分(10例)。化疗第一日后2天(1~7天)常出现黄斑和伴瘙痒的丘疹。仅1例患者发生3级皮肤毒性反应伴广泛的红皮和面部损伤,须减小剂量。使用抗组胺药后2天(1~10天)皮疹逐渐消退,13例患者色素沉着。中国患者的皮肤毒性发生率显著高于西方患者(P0.0001),而传统紫杉醇化疗时却未发现显著差异。研究者认为,nab-P中的白蛋白组分可能是引起皮肤病变的原因。(摘要号e11567
Nab-P治疗NSCLC优于溶剂型紫杉醇 广东省人民医院 吴一龙 美国一项Ⅲ期研究表明,对于老年晚期或鳞状非小细胞肺癌(NSCLC)患者,nab-P+Cbnab-PC)方案较溶剂型紫杉醇+Cbsb-PC)方案有生存获益。该研究纳入1052例未治疗的ⅢB或Ⅳ期、美国东部肿瘤协作组(ECOG)评分01NSCLC患者,随机予以Cb联合nab-P100 mg/m2)或sb-P200 mg/m2)。 结果显示,在<70岁的患者中,nab-PCORR显著优于sb-PC组(32%25%P=0.013),在≥70岁患者中,nab-PCORR亦有获益(34%24%P=0.196),且PFS有获益趋势(中位8.0个月对6.8个月,P=0.134),总生存(OS)显著改善(中位19.9个月对10.4个月,P=0.009);且3~4级中性粒细胞减少症、神经病变发生率显著低于sb-PC组(P值均<0.05)。在<70岁患者中,两组PFS期(P=0.256)和OS期(P=0.988)相似。(摘要号7590 组织学亚组分析显示,在450例鳞状细胞癌患者中,nab-PC组(229例)ORR显著优于sb-PC组(41%24%P0.001),OS亦有1个月的改善(10.7个月对9.5个月,HR=0.890),PFSHR=0.865)相似。非鳞状细胞癌患者两组ORRP=0.808)、PFSHR=0.933)和OSHR=0.950)均无差异。不论组织学类型,nab-PC3~4级神经病变、中性粒细胞减少症的发生率均较sb-PC组低。(摘要号7592 生活质量方面,在患者报告的神经病变(P0.001)、手脚神经性疼痛(P0.001)和听力丧失(P=0.002)方面,nab-PC组均有显著改善,nab-PC组医生评估的神经病变率显著低于sb-PC组(47%63%P0.001)。nab-PC组无神经病变患者较sb-PC组多(53%47%P0.001)。(摘要号TPS7618
 联合nab-P成胰腺癌治疗新希望 北京大学肿瘤医院 沈琳 胰腺癌早诊率低,发现时常属晚期,80%以上的患者在诊断时已无法通过手术切除治愈。对于晚期胰腺癌,化疗仍是主要治疗手段;然而胰腺癌对化疗并不敏感,目前仍缺乏满意的治疗方法。 Nab-P利用白蛋白作为紫杉醇的载体,去除了有毒溶剂,在提高用药剂量的同时降低毒性。已有研究发现,大多数胰腺癌组织SPARC蛋白高表达,而SPARC蛋白能够特异地与nab-P结合,提示nab-P或许能够成为胰腺癌治疗的新选择。临床前动物试验结果提示疗效除了来自nab-P本身的抗肿瘤活性外,还可能与肿瘤基质消除作用有关。由于胰腺癌是一种低血管增生而成纤维基质丰富的肿瘤,致密的间质可能是阻碍化疗药物发挥细胞毒作用的关键因素。动物试验中肿瘤组织切片显示联合用药组的肿瘤细胞间纤维条索大幅减少,呈“背靠背”图像,且相比吉西他滨单药试验组,联合用药组肿瘤细胞内吉西他滨浓度提高了2.8倍,提示可能是nab-P通过消除肿瘤基质,继而使得吉西他滨能够更多进入肿瘤细胞内部发挥作用。 今年在ASCO年会上有几篇小样本研究报告也提示,在胰腺癌治疗的多种领域中nab-P都有一定的研究前景。其中一项研究显示,nab-P联合吉西他滨新辅助治疗可达到50%的局部缓解,中位最大标准化摄取值(SUVmax)从治疗前的7.1下降至治疗后的4.6P=0.004)。(摘要号4040)。另一项对nab-P联合吉西他滨和放疗治疗局部晚期胰腺癌的研究报告,疾病控制率91%6个月和12个月的PFS率分别为92%65%OS率分别为85%77%。(摘要号e14714 此外,澳大利亚一项回顾性研究分析了63例接受nab-P联合吉西他滨或Cb治疗的胰腺癌患者资料。结果表明,39例(70%)患者生化缓解,30例(94%)患者肿瘤标志物水平下降超过70%48例(86%)存在生化意义上的疾病控制。影像学疾病控制率为76.79%43例),其中10CR22PR11例疾病稳定(SD)。36例患者死亡,中位OS12.9个月。(摘要号e14718 另一项美国研究表明,小剂量连续细胞毒性药物(节拍治疗)联合抗血管生成药物治疗晚期胰腺癌的缓解率和生存获益优于基于吉西他滨的治疗。该项开放标签Ⅱ期研究纳入40例Ⅳ期胰腺癌患者,中位年龄58岁。予以5-氟尿嘧啶+亚叶酸钙+nab-P100 mg/m2)联合贝伐珠单抗治疗。结果显示,患者中位OS期超过17个月,50%的患者PR22例患者既往接受过治疗,其中11例缓解。34例患者开始治疗时CA199水平超过40 U/ml,其中26CA199水平下降超过50%17例患者CT扫描缓解。19例患者由于疾病进展停止治疗,18例患者由于毒性反应停止治疗,无化疗相关的死亡事件。(摘要号e14582 随着多项nab-P联合吉西他滨应用于胰腺癌的早期研究结果的报道,nap-P有望成为很有前景的治疗胰腺癌候选新药,但有待大样本的随机Ⅲ期临床研究进行确认,我们期待今年底将会揭晓的吉西他滨联合nab-P对比吉西他滨单药一线治疗晚期胰腺癌的Ⅲ期研究CA046的结果,希望能够给处于困境中的胰腺癌患者带来新曙光。  
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