Thursday, July 11, 2019

美國總統川普 擬推行目標: 80%腎臟病患接受腎臟移植OR居家洗腎


美股:傳美國擬推動在家洗腎,相關類股週二齊跌,德維特挫跌逾5% 2019/07/10財訊快報 李鎮如 【財訊快報/李鎮如】腎臟透析服務商週二股價集體走跌,此前有報導稱,美國政府將宣布對美國腎臟疾病治療市場近行大幅改造。根據美國政治新聞網站《Politico》報導,川普政府將宣布一系列的舉措,以推動在家進行腎臟治療,接受獨立診所治療的腎臟病患或將因此減少。受此消息影響,洗腎業者股價週二紛紛下跌。德維特(DVA US)下滑2.96美元或5.33%52.55美元;費森尤斯(FME GR)下跌3.50歐元或4.98%66.80歐元;American Renal Associates Holdings(ARA US)下滑0.72美元或9.64%6.75美元。Bloomberg Intelligence分析師Jason McGorman在報告中提到預計對德維特造成的影響。McGorman表示,病患數量流失,將有損近期EBITDA(稅息前折舊攤銷前利潤),儘管還未有正式的提案。Raymond James分析師Chris Meekins預計,美國總統川普可能將宣布在2025年前達到一項目標,讓80%的腎臟病患接受腎臟移植手術或是在家接受洗腎服務。

A new Trump executive order on kidneys could save thousands of lives

It's one of the biggest government actions on kidneys in decades.

By Dylan Matthews@dylanmattdylan@vox.com Jul 10, 2019, This kidney transplant took place in Nice, France, but the ones encouraged by this action will take place in the United States. It's just a visual to put here. BSIP/Universal President Trump on Wednesday announced an executive order on a topic rather far afield from his usual concerns: improving care for patients with kidney disease. That might seem like an obscure topic, but it's a crucial one. A shortage of kidneys for transplant kills about 43,000 people every year. (Compare that to car accidents, which kill 40,000 people a year, or homicide, which kills fewer than 20,000.) Instead of getting replacement organs for everyone whose kidneys have failed, the current US system relies heavily on dialysis, where machines replace kidney function. Dialysis is usually offered three times a week, for four hours at a time. That means no traveling of any real length, since you have to be close to the machine, and holding down a job is extremely difficult due to the time commitment of dialysis and the exhaustion it causes. It's an untenable system, and to the administration's considerable credit, the new executive order appears to go a long way toward fixing it. It would make it easier for living donors to give kidneys and other organs, promote the donation of organs from deceased people, and restructure payment for health care providers to reduce the rate of kidney failure in the first place."There hasn't been presidential action [on kidneys] in 46 years," a senior administration official involved in the executive order told me. "It's time to take a comprehensive approach." It's also a change that, as Politico's Dan Diamond and Rachel Roubein note, reflects the personal histories of key policymakers. Melania Trump was hospitalized for kidney issues last year; Health and Human Services Secretary Alex Azar's father received a kidney transplant last year; Adam Boehler, the director of the Center for Medicare and Medicaid Innovation, has talked about his aunt's death from kidney disease. The result is an under-the-radar policy change that could amount to one of the most significant things the Trump administration does, in terms of total years of life saved. As someone who rarely agrees with the administration and finds most of its conduct actively abhorrent, I am genuinely surprised and impressed at how worthwhile this measure is.

The three components of the executive order The order has three major parts: one on living kidney donors, one on deceased donors, and one on alternatives to center-based dialysis.

Living donors The executive order attempts to reform the system for living kidney donors (like me), as well as living liver, lung, and intestine donors, by making sure donors are held financially harmless for donating. While donors don't have to pay for their medical procedures, they do typically have to cover other expenses like travel to and from the hospital, child and elder care they can't perform while they're recovering, lost wages while they're off from work, and so on. Donors to low-income patients can get travel expenses paid for now, but the executive order would allow people with higher incomes to benefit, and enable reimbursement of more significant costs like lost wages and child care. That could dramatically increase living donations. Since Israel passed a law in 2008 reimbursing donor expenses and providing other benefits, live donation rates have quadrupled. Josh Morrison, an altruistic kidney donor who runs the advocacy group Waitlist Zero, conservatively estimates that the regulatory change might boost donations in the US by 25 percent. That would mean 1,600 or so additional donors every year, each of whom would enable their recipient to live, on average, nine to 10 years longer.

Deceased donation The second aspect of the executive order targets deceased donation. In the US, there are 58 agencies with local monopolies over the provision of dead people's organs, known as organ procurement organizations (OPOs). For some time now, independent analysts and investigative reporters have argued that OPOs are underusing deceased donor organs by the tens of thousands. One report estimated that 28,000 usable organs are abandoned; another put the number at 75,000. The basic argument is that OPOs face perverse incentives: For instance, they're often evaluated on the basis of how many organs are recovered per "eligible death," but "eligible death" is a determination made by the OPOs themselves, making it easy to juke the stats without actually getting more people organs. The result is that tens of thousands of organs go unused. The executive order scraps the existing evaluation system in favor of two simple, harder-to-game criteria: the number of deceased donors as a share of the total number of deceased people 75 and younger with causes of death compatible with donation (an objective standard determined ahead of time); and the number of organs recovered as a share of that group of deceased people."This is a chance for HHS to ensure that OPOs are honoring organ donor wishes," Jennifer Erickson, an Obama White House staffer who worked on organ donation, says. "This is life or death for tens of thousands of people."

Better provider care In an ideal world, everyone in need of a kidney transplant would get one. But even aggressive moves to boost donations like the ones the Trump administration is taking won't be enough to reach that target. So the administration is also pursuing a series of reforms (including changes to Medicare provider payments, instructions to the Food and Drug Administration, and more) to try to offer alternatives to center-based dialysis. Currently, the dialysis industry is heavily consolidated, with two providers (DaVita and Fresenius) accounting for 83 percent of the market. Medicare has covered all end-stage kidney disease treatment since 1973, and a huge share of its spending on the disease goes to those two companies, ensuring them an easy profit stream without much competition. That hasn't been great for dialysis patients. DaVita and Fresenius are paid per treatment, which deters them from preparing patients for transplant and (to some extent) from offering home-based dialysis, which is easier for patients and cheaper in the long run but has higher upfront costs. More than 80 percent of patients in Hong Kong get home-based care, but only 12 percent of American patients do, suggesting there's a lot of room to make the treatment more convenient for people. An antitrust perspective might place the blame here on the lack of competition among dialysis providers. But the Trump administration, perhaps unsurprisingly, argues that "the reason we have seen so little innovation and so little take-up is the government has distorted the space" through Medicare's dominance, the aforementioned administration official told me. However, the Affordable Care Act, in one of its lesser-known, cost-focused provisions, set up the Center for Medicare and Medicaid Innovation, which has the authority to pursue cost-saving treatments that improve quality of care. The executive order instructs the centers to experiment with new approaches to provider payment — like rewarding nephrologists for directing their patients toward transplants, and for preventing patients from progressing to kidney failure for as long as possible. It also instructs the Food and Drug Administration to consider early approval of new technologies and treatment methods that allow patients to avoid exhausting center-based care. These are big enough changes that share prices for DaVita and Fresenius plummeted when Politico broke the news of the administration's new kidney policy.

(7000種罕病/ 400種 可治療) 罕見疾病 檢出率: 63.3%


全基因體定序技術 提高罕病檢出率 優活健康網 201979日(優活健康網記者張桂榕/綜合報導)目前罕見疾病之認定,除以疾病盛行率萬分之一以下為參考基準外,並經「罕見疾病及藥物審議委員會」審議認定,其考量原則包含:「是否需要遺傳諮詢或有利於疾病防治、診斷治療困難及疾病嚴重度」、「如現行健保制度已給付之疾病,則不再考量列入罕見疾病」等認定原則。較為人熟知的罕見疾病包括:苯酮尿症、重型海洋性貧血、成骨不全症(玻璃娃娃)、黏多醣症(黏寶寶)、脊髓性小腦萎縮症(企鵝家族)……等,這些疾病在國內已知的病患人數從數百人到千餘人不等,更有一些罕見疾病,在全世界僅有數個病例,鮮少聽聞。隨著精準醫療的發展日新月異,可望為罕病患者及家屬帶來希望的曙光。國家衛生研究院「亞太生醫矽谷精準醫療旗艦計畫」團隊以全基因體定序(whole genome sequencing, WGS)技術,提供罕病患者更為全面的基因分析資料,做為臨床診治的基準。

罕病多為家族遺傳 全基因體定序技術可提高檢出率 目前已知近7,000種罕見疾病,約80%罕病為家族遺傳,僅約400種罕病可以透過藥物治療。國衛院蔡世峰博士指出,目前已完成139個家族之病人及其家屬之全基因體定序,透過全基因體定序技術,補足現階段檢測方式未能找出的疾病位點,提高檢出率。目前罕見疾病的檢出率為63.3%,可有效降低患者的等待時間及無效治療的機率,是罕病患者的一大福音。

政府已推動四年計畫 針對罕病提供基因體分析服務 國衛院「亞太生醫矽谷精準醫療旗艦計畫」為政府大力推動的四年期旗艦計畫,採用最新之高通量全基因體定序設備(NovaSeq 6000),針對罕見疾病、癌症等特定疾病提供基因體分析服務,透過嚴謹的樣本收集、核酸萃取、全基因體定序、序列分析比對作業,找出導致疾病之基因變異位點,並交由臨床醫師作為診斷的參考依據,透過基因科技的進步,將能有效縮短罕病患者的確診時程。國衛院團隊主要針對免疫缺乏、癲癇、脊髓性小腦萎縮症、聽覺障礙、雷特氏症、自體發炎疾病、以及其他無法確診的罕病類型進行分析。為提供罕病患者更多的資源與協助,國家衛生研究院與財團法人罕見疾病基金會共同成立台灣罕病研究網絡(Taiwan Rare Disease Network, TRDN,進一步確立檢測流程,並且擴大服務範圍,預期將可發揮四大功能:1)了解家族遺傳疾病,提前妥善規劃生活2)協助患者確診,尋求最佳治療方式3)提供患者遺傳諮詢服務,事先加以預防4)以罕病基金會為窗口,協助整合相關資源,提供患者全面的資訊與服務。目前,國衛院精準醫療旗艦計畫以罕病研究為起點,積極進行台灣在亞洲地區幾項特有且重要的癌症之不同族群比較基因體學研究,並已找出重要致病變異。同時,該旗艦計畫亦同步整合族群基因體、生物資料庫與醫療資訊,以及發展新興癌症免疫治療、細胞療法、基因療法等未來方向,加上與美國、日本之間的國際性生物醫學合作計畫,擔任串聯整合的重要角色。相信在不遠的將來,國衛院將能發揮精準醫療的研究能量,結合台灣生技與資訊產業的堅實基礎,創造基因科技價值,進一步嘉惠更多需要幫助的人。

長庚: 15~20%台灣人有HLA-B*13:01基因型 (過敏風險40倍: 磺胺類藥)


磺胺類藥物恐嚴重過敏 特定基因 風險增40 列印2019-07-10 記者吳亮儀/台北報導一名女大生因全身紅疹、發燒多日沒改善,甚至出現少尿、黃疸,就診檢查後才知道是因頑固型痤瘡,服用磺胺類藥物而引起嚴重的藥物過敏。長庚醫院皮膚科團隊最新研究證實,如果帶有特定基因型「HLA-B*1301」,在使用磺胺類藥物時,會更容易發生嚴重的藥物過敏,風險是一般人的40倍以上。

國人20%屬危險群 磺胺類藥物是一種老藥,用途為殺菌、消炎,是治療泌尿道感染、青春痘和皮膚發炎的常用藥物,使用機率很高、難以完全被取代;不過大約有3%6%的人對磺胺類藥物過敏。長庚研究團隊指出,約有15%20%國人帶有「HLA-B*1301」基因型,這些人若使用到磺胺類藥物會比一般人更容易發生藥物過敏,當中更有1%2%會發展成嚴重藥物過敏,例如史帝芬強生症候群(SJS)、毒性表皮溶解症(TEN)等,也可能因嚴重藥物過敏導致肝、腎衰竭而喪命。

恐導致肝、腎衰竭 林口長庚醫院皮膚部與藥物過敏中心主任鍾文宏指出,若早期診斷和停止使用磺胺類藥物,一般輕微的藥物過敏患者就可達到症狀改善。但若是嚴重皮膚藥物過敏反應的病患一旦症狀出現後,即使停止使用磺胺類藥物,但藥物已引起全身性的免疫反應,仍會使病程持續進展、惡化,甚至造成死亡,死亡率甚至高達30%40%。林口長庚醫院皮膚部醫師陳偉迪指出,若能提早基因檢測和疾病早篩,利用藥物基因篩檢出易發生嚴重藥物過敏反應的高危險族群,可免除嚴重型皮膚藥物過敏反應常耗費龐大的醫療支出。陳偉迪說,目前可利用貼膚測試、藥物淋巴球活化試驗等方式,讓民眾在使用磺胺類藥物前先檢查是否有藥物過敏,降低嚴重過敏發生機率。他也提醒,服藥後,若出現皮膚紅疹、起水泡或嘴唇、口腔黏膜潰爛、發燒、喉嚨痛等症狀,應立即停藥並就醫,避免嚴重藥物不良反應等併發症發生。這項研究結果去年7月已發表在國際知名研究期刊《皮膚病學研究雜誌》(Journal of Investigative Dermatology)。

中研院 楊秋忠院士 成立 地天泰 農技: 客製化肥料 農業家庭醫生


3小時將有機廢棄物轉為有機肥技術,地天泰農生科技今年商轉量產 作者 Emma stein | 發布日期 2019  07  09 日土壤的營養平衡一旦被化肥破壞,一來得加倍時間回復地力,二來種不出好作物,得不償失。有感於全球農業過度使用化肥與農藥,中研院院士楊秋忠花費十多年時間研發獨門酵素,能快速將有機廢棄物無臭轉為有機肥料,鼓勵農民回歸天然,讓土地生生不息。目前肥料製造廠房已在建設當中,預計2019年會建成,正式投產。

24 年實驗證明化肥對土壤的破壞,致力於傳授知識給農民 熱愛土地的楊秋忠院士已然將研究與生命結合在一起,從40幾歲起至今,他走透全台偏鄉,巡迴演講超過600場,對象都是最需要新知識的農民,課後還會大方留下家裡電話,歡迎農民有問題直接致電詢問。楊秋忠說,最常遇到農民的疑惑是:為什麼肥料效力越來越差了?對此,楊秋忠坦白告訴農民,不是肥料變差,而是土壤已經退化了。楊秋忠在農試所有一塊地,共分成7區,進行了長達24年的實驗,其中一區連續灑24年化學肥料,另一區連續灑24年有機肥料,還有一區有機肥、化肥混合施灑,以此比較地力的衰退程度。實驗研究表明,化肥田的pH值在短短20年內就從5跌到4,此時作物已經處於「要死不活」的狀態,但土地還有救,只是得等待更長時間回復地力;然而一旦pH值繼續跌至3,則一切大勢已去,屆時這片田地將再也長不出作物,地力也難以復原。但多數農民都誤以為是肥料效力變差,於是加重下藥量,最終形成惡性循環:土壤退化→植物種不好→肥料多灑點→土壤越變越糟。隨著土壤劣化,下一代的農業經營將變得非常辛苦,楊秋忠深入鄉下便是努力宣揚有機質才是土壤救星,提醒農民不應該過度依賴化肥。

獨門酵素法3小時快速將有機廢棄物製成有機肥 有機廢棄物的傳統堆肥法耗時、又臭又髒,直接購買有機肥的話價格又比較高昂,但楊秋忠想打破有機肥形成過程帶給人的糟糕印象,於是花費 30年時間鑽研,終於成功以獨門酵素取代微生物發酵法,開發出快速、乾淨無臭、又不流失有機肥營養成分的設備,能在3小時內就將有機廢棄物製成有機肥,取代傳統3個月又臭又髒的堆肥法。現在楊秋忠院士團隊成立地天泰農業生技公司,具有上、中、下游一條龍的農業服務能力,首先會告訴農民他們土地的營養是否平衡、哪些有機物質已經流失,接著告訴農民各種作物想要長得好可以多補充哪些營養,最後客製化肥料,有如農業家庭醫生「因地治病」,從快速製造有機肥、客製化配方到客製化施肥技術,地天泰都能一手全部包辦。除了有各種獨門酵素能轉化各種有機物(比如動物糞便、廚餘、木屑、中藥渣、蔗渣等)外,該公司也結合專利微生物及設備OEM生產廠商另行販售設備,操作就跟買電鍋回家煮飯一樣簡單,且設廠及機具購買成本低,採取「快速處理有機廢棄物技術的整體解決(total solution)方案」行銷到國內外客戶之商業模式,以確保酵素核心技術之生產效率。目前,該公司位於台中工業區、占地 1,000 坪的廠房已開始建設,預計2019年就會建成,屆時一天可以處理全台 3,000 噸有機廢棄物。

拓展海外市場,未來將研發濃縮酵素 依據統計,全球 2016 年整體肥料市場規模達 1,673 億美元,2016~2020 年複合成長率(compound annual growth rateCAGR)約為 2.9%,預估全球肥料市場在2021年將超過1,929億美元,亞洲市場需求最大,約占全球使用量的 60%,其次為美洲,達全球使用量的25%。而有機肥市場銷售每年 250~300萬噸,約300億多美元,市場甚大。不過楊秋忠坦言,生產量很大也要有銷路才有價值,今年的擴展計畫主要有擴增團隊人數、擴張海外市場、尋找大型客戶三項,團隊人員以行銷企劃及業務經理人員為主,海外市場以東南亞、中國、歐洲為目標,商業合作則會尋找大養殖場、市場、民生廢棄物及事業有機廢棄物。更久遠的目標則是研發「濃縮酵素」,假如進軍美國,由於當地土地遼闊,需求量將大上許多,屆時光是出口酵素的貨櫃成本就是一筆龐大開銷,因此楊秋忠正在研究先將酵素濃縮,去到美國當地後再透過在地工廠還原酵素。

(特管辦法) 細胞治療癌症 三總&中醫大 現階段核准


自體細胞治療 可用在退化性關節炎 20190710日【記者賴玟茹 /綜合報導】每年超過30萬人次跨海來台求醫,細胞治療《特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法》在去年9月開放,優先鄰近國家開放,將有益於台灣作出市場區隔。衛福部醫事司長石崇良表示,「特管辦法」開放到現在,國內已有26家醫療機構,超過50個申請案正在審查階段,其中以自體免疫細胞治療最大宗,其次為自體脂肪幹細胞移植,用在退化性關節炎及膝關節軟骨缺損。目前有兩家醫學中心得到許可,能夠以自體免疫細胞治療癌症。分別為三軍總醫院、中國醫藥大學附設醫院。石崇良說,預計7月底前,能夠再通過2件,預期還會出現首件非癌症類細胞治療。他補充,細胞治療的法規鬆綁,主要還是希望解決病患的醫療需求,同時保護病患的權益,像是收案患者條件及收費要合理,同時針對不符合規定或地下細胞治療的亂象進行管理、確保安全及避免被濫用。另外,細胞製備場所在流程上也需要有一定標準,避免出現混淆意外發生。目前新光醫院與生技公司合作,共同申請「自體脂肪幹細胞移植退化性關節炎及膝關節軟骨缺損」細胞治療計畫,後續還會有免疫細胞療法及皮膚微創技術合併療法送件計畫。對此,新光醫院再生醫學中心暨骨科主任釋高上表示,以退化性關節炎來說,目前只能藉由開刀、PRP自體血小板及玻尿酸等傳統治療方法來解決,未來,如果新光與生技公司合作的脂肪間質幹細胞計畫,經衛福部核准後允許使用,相信對患者在治療上也會有所幫助。

國泰醫院 成立 台灣術後加速康復學會 (減緩術後不適)


台灣術後加速康復學會成立 造福大手術病患 台灣新生報【記者李叔霖/台北報導】國泰醫院昨(七)日宣布,院方怡樂適團隊及各大醫院醫療團隊積極籌辦「台灣術後加速康復學會」已於昨日正式成立,同時舉辦「台灣術後加速康復療程國際專家論壇-從實踐到卓越」。簡單來說,學會推廣術後加速康復療程(ERAS)可以幫助病人接受大手術時,整個過程充分準備,如此可望造福大手術病患。國泰醫院麻醉科醫師郭書麟昨表示,學會成立目的,醫院端就是提供所有醫護人員標準化介入平台,如果每個醫院自行研發一套準則,就會重複浪費太多時間與資源,利用學會平台可讓醫院一致化進展裡面更有效推廣。郭書麟醫師指出,大眾端就是讓民眾知道這是實證醫學支持的療程,有助病人接受大手術過程之中擁有充分準備,術中積極治療,術後正向加速復原,讓民眾有這樣的選擇,民眾可以影響醫院、政府、健保署,讓好的療程真正落實在台灣健保制度之下。目前國泰醫院是第一家實施術後加速康復療程的醫院,台中榮總、高醫附醫將會跟進實施,未來希望推廣至全台各地醫院。不過,這項療程可能產生額外負擔費用,有一些儀器、藥品,目前健保不給付,但是因為這些自費項目在各縣市政府衛生局登記過,可以合法合理收取自費,利用自費醫療項目,加上原本健保提供部分,讓病人可以有更好的選擇。術後加速康復療程是一個以實證醫學為基礎,手術麻醉照護整合性全人醫療,這個療程的目的是讓接受大手術病患,在整個手術醫療過程當中,可以減緩術後不適情形,加速恢復身體機能,進一步降低手術併發症。國泰醫院指出,值得關注的是,論壇邀請亞洲術後加速康復卓越中心新加坡陳篤生醫院、香港瑪麗皇后醫院及國泰醫院專業醫師群,一齊經驗分享國際術後加速康復療程新趨勢,同時針對手術期間止痛控制、營養補充、手術新知、病人參與及清腸新思考等提出最新報告。目前推崇最優良手術後止痛方式為多重模式疼痛控制,除了提供良好止痛效果之外,還減少嗎啡類止痛藥使用及其所帶來副作用,大幅提升病患術後康復品質。另外,手術期間免疫營養補充及改變手術前清腸習慣,有助改善病患在手術的免疫狀況,以及維持身體電解質平衡,降低術前過度脫水引起暈眩、焦躁及術後感染併發症發生率。

大江生醫&印尼工業部 交流 功能食品/護膚產品


大江布局新南向 雅加達設立分公司 2019-07中央社 台北10日電大江生醫在站穩大陸市場後,積極擴大海外布局,除了瞄準美國及歐美市場外,也布局新南向,看好印尼積極發展工業4.0,已於雅加達設立東南亞唯一分公司。大江生醫今天發布新聞稿表示,公司受邀會見印尼工業部長艾朗嘉(Airlangga Hartarto),與談人員包括印尼工業部國貿、醫藥與交通主管官員,及台灣駐印尼代表陳忠。雙方就印尼功能食品工業如何邁向現代化,以及拓展印尼功能食品商機等議題廣泛交流。大江學院營運長陳彥任指出,印尼幅員廣大,人口年輕商機龐大,進口台灣研發製造產品能有效活絡市場,能從需求端刺激製造端提升水準,大江生醫目前已於雅加達設立東南亞唯一分公司,依據過往經驗,將視印尼市場對功能食品的成長幅度,著手進一步在地布局。艾朗嘉指出,將加速各部門效率,加快進口通關速度,以更優質的環境迎接像大江生醫這種國際領導企業進駐,以有效提升印尼在功能食品及護膚產品的科研製造實力,未來更期待能借重大江生醫銷售54國的豐富經驗,帶領印尼品牌邁向國際。大江生醫主力產品為保健食品及飲品代工,近年重心轉移至面膜與生技保養品。客戶遍及54國,包括法國萊雅(L'Oreal),2014年起,大江生醫打入LV集團旗下美妝通路Sephora(絲芙蘭),代工10多款面膜,年出貨上千萬片。大江生醫在出席2019亞太再生能源與市場高峰會時,由永續長李東維宣告將於2020年成為台灣第一家完成轉供綠電企業。李東維表示,為實現愛護地球精進再生能源使用減少二氧化碳,因此成為台灣第一間加入「RE100」會員,承諾於2030年達到百分之百使用再生能源。未來將透過自發自用、再生能源購電協議及綠電憑證(T-REC/I-REC)等三種路徑達到百分百使用再生能源。

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