兩岸藥廠合作 建立中藥材通路【聯合報╱記者董俞佳／屏東報導】 2013.03.31 04:58 am台灣天明製藥集團與大陸湖北九州通醫藥簽署合作協議。 記者董俞佳／攝影 台灣天明製藥集團與大陸湖北九州通醫藥集團合作，昨天下午雙方在屏東農業科技園區內的天明製藥廠簽訂合作協議，未來透過廈門的通路平台中心，台灣中藥產品將銷往大陸，大陸的中藥材也能藉此平台進入台灣，有助抑制偽藥來台。 天明集團是台灣知名中藥製藥廠，九州通則是大陸規模龐大的醫藥集團，昨天簽署典禮受到台灣中藥業者、學者高度重視，中藥公會以及以藥學系聞名的大仁科技大學都派代表與會。天明集團表示，這是2010年第二次江陳會通過兩岸醫藥合作協議以來，兩岸第一個完成簽署的合作協議；九州通集團項目總經理田春林昨天表示，這是兩岸中醫藥合作的新紀元，期待雙方都能夠越來越好。天明集團董事長王伯綸表示，台灣中藥材有90%以上來自大陸，但過去材透過貿易商進口來台或非法走私，難免會夾帶偽藥進口；現在，雙方成立認證機制，可防制避免偽藥來台，為中醫藥產品源頭把關。【2013/03/31 聯合報】
天明 分階段布局大陸【經濟日報╱記者吳秉鍇／高雄報導】 2013.04.01 05:25 am 圖／經濟日報提供中藥大廠天明製藥董事長王伯綸表示，公司已與大陸最大的民營醫藥集團、九州通簽訂戰略合作協議；藉由此次結盟，天明將大舉揮軍對岸市場，分階段上架銷售保養品、保健食品。 王伯綸說，天明製藥集團全省中醫診所通路覆蓋率高達60%以上，合作藥局通路也超過1,700家，產品除行銷國內外，並外銷美國及東南亞，品項涵蓋藥品、外用藥布、保健食品、保健飲品、美妝品等。天明的生產基地分布在桃園、台南、高雄及屏東，像位於屏東農科分廠斥資10億元打造，為全台灣最大的中藥GMP製藥廠，占地萬坪，具備GMP中藥製藥廠、HACCP食品廠、藥物食品化妝品標準檢驗實驗室、觀光藥廠等。而此次藉由九州通醫藥集團由總經理田春林率團來台參訪，雙方30日在屏東分廠簽訂戰略合作協議。雙方的合作項目，包括天明協助九州通所生產的中藥材及中藥飲片在台灣代理銷售。九州通也協助天明產品在大陸廈門乃至全國代理銷售；另雙方將合資在廈門等地成立中藥材集散中心。【2013/04/01 經濟日報】
H7N9禽流感毒性更強更致命[2013-04-01]香港文匯報訊（記者 劉雅艷）上海出現全球首宗人類確診感染H7N9禽流感死亡個案，敲響各界防疫警鐘。本港多位傳染病及微生物專家均認為病例不尋常，根據觀察，病毒致病性很強，不排除病毒已出現基因洗牌。世界衛生組織昨日認為，現時未有證據顯示病毒會人傳人，傳播效率亦似乎不高，正密切監察有關情況。香港衛生防護中心昨日指，會按事態發展，保持嚴謹港口衛生措施，籲市民避免直接接觸禽鳥或其糞便，若出現流感病徵，應立即求醫。H7N9屬甲型流感之一。中大防治傳染病研究中心主任許樹昌指出，當中的「H」是指血凝素蛋白，有1至16種類型；「N」則指神經氨酸，有1至9種類型。他表示，以往亦曾出現人類感染H7N2、H7N3及H7N7禽流病毒病例，病源均來自家禽，患者多出現上呼吸道或眼角膜感染等病徵，致命率及毒性不算高，「反觀今次H7N9的致命率較一般禽流感病毒高，可能病毒已出現基因改變或洗牌。但綜合過往禽流感病例，病毒人傳人的機率仍然有限」。 何良：內地無針對H7疫苗禽流感H5、H7、H9分支的病毒均可以傳人。港大感染及傳染病中心總監何良表示，以往以H5型較多，而H7N9在亞洲罕見，昨日首現死亡個案，情況特殊，在禽流感病學中屬重要轉變。「短期內最少兩個地方出現3宗人類感染並有死亡個案，相信病毒變種機會很高，但仍要詳細了解病毒基因。」由於內地沒有針對H7病毒的疫苗，何良擔心存在一定風險，又強調現階段最重要追查病源是否來自禽鳥或其他動物，以及傳播途徑，若在動物身上廣泛流行，可能會引致嚴重影響。
袁國勇：測H7N9需48小時 港大微生物學系講座教授袁國勇亦同意病毒可能已出現基因改變，變成高致病性禽流感，「H7N9原本屬於低致病性感冒病毒，死亡率低，但此3宗病例卻顯示病毒的致病性及致命性很強；至於傳播途徑及基因排序有否改變，則需進一步核實確定。」袁國勇續指，本港有甲型流感的快速測試，在2小時內可有結果，而H7N9測試動輒需48小時。H7N9可以透過服用特敏福或樂感清治療，若及早治療病情或可受控。 須查與黃浦江死豬有否關係早前，上海黃浦江發現大量死豬，而其中1宗感染個案、27歲來自上海的男死者又恰巧是豬肉檔販，許樹昌、何良及袁國勇一致認為，難確定禽流感是否與死豬事件有關，而內地當局需要查清兩者關係。何良另建議，對從安徽上海入境、曾接觸過禽鳥動物的人士，港府應加強檢測，若旅客出現嚴重肺炎症狀，便盡快安排快速測試。
世衛：病毒傳播效率不高 世界衛生組織認為，未有證據顯示病毒會人傳人，傳播效率似乎亦不高，對公眾健康構成風險的機會低，現正密切監察有關情況。甲型流感（H7）是本港的法定須呈報傳染病，衛生防護中心發言人強調，會繼續與內地保持密切聯繫，了解個案詳情，提高警覺，視事態發展保持嚴謹港口衛生措施。中心提醒市民時刻保持個人衛生，避免直接接觸禽鳥或其糞便，若曾有接觸，須盡快徹底洗手。禽鳥及雞蛋也應徹底煮熟方進食；外遊市民若有發燒等流感病徵，應即求診及告知醫生曾前赴何地。
EU medicines agency to restrict use of Otsuka drug LONDON | Fri Mar 22, 2013 6:56am EDT (Reuters) - The European Medicines Agency said on Friday it was recommending restricting the use of medicines containing cilostazol, sold by Otsuka under the brand name Pletal, following concerns over side effects. A review of evidence found the drug's modest benefit was only greater than its risk of damaging the heart or causing serious bleeding in a limited number of patients. Cilostazol, also sold as Ekistol, is used for treatment of intermittent claudication, or limping, usually as a result of arterial disease. The agency said cilostazol should only be used in patients whose symptoms had not improved despite lifestyle changes. It should also not be used in patients who have fast, abnormal heartbeats, or those with recent unstable angina, heart attack or bypass surgery, or who take two or more blood-thinning drugs. (Reporting by Ben Hirschler; Editing by Helen Massy-Beresford)
EMA Recommends Restricting Cilostazol Use for PAD Mar 22, 2013 The European Medicines Agency has recommended restricting the use of cilostazol-containing medicines in the treatment of intermittent claudication to a narrower patient population in which there are clear signs of clinical benefits with minimal risks. Cilostazol-containing medicines are available in the European Union under the names Pletal and Ekistol. Intermittent claudication is a symptomatic form of peripheral arterial disease, where poor blood supply to the leg muscles causes pain and limits exercise. The recommendation follows a review of current evidence, which indicates that the modest benefits of these cilostazol-containing medicines — ie, their ability to increase the distance patients are able to walk — are only greater than their risks of certain cardiovascular side effects or serious bleeding in a limited subgroup of patients. The Spanish Agency for Medicines and Health Products (AEMPS) asked EMA's Committee on Medicinal Products for Human Use (CHMP) to carry out a review of these medicines following a number of reports of such suspected side effects, the agency says. These included fatal heart attacks, angina, and arrhythmias as well as cases of serious bleeding, including bleeding in the brain. The CHMP recommendation will now be sent to the European Commission for the adoption of a legally binding decision throughout the European Union. In the US, cilostazol is approved for intermittent claudication but is used less than it is in Europe. In Asia, the drug is more widely used — for example, in stroke patients or added to aspirin and clopidogrel as triple therapy after stent implantation for coronary heart disease.
Review Cilostazol Use at Next Routine Appointment EMA says cilostazol should now only be used for intermittent claudication when lifestyle changes (including smoking cessation and exercise programs) and other appropriate interventions alone have not produced adequate benefit. Treatment should only be started by physicians experienced in the management of intermittent claudication and should be reviewed after three months, at which point therapy should be stopped in those who have not shown clinically relevant benefit. Cilostazol should not be given to patients who have unstable angina or who have had a myocardial infarction (MI) or percutaneous coronary intervention (PCI) within the past six months or to those with a history of severe tachyarrhythmia. The product should not be given to patients receiving both aspirin and clopidogrel or any other combination of 2 or more additional antiplatelet or anticoagulant medicines. Prescribers also need to be aware of the risk of interactions with cilostazol; its dose should be reduced in patients concurrently taking strong inhibitors of CYP3A4 or CYP2C19 enzymes. Doctors should review their patients at their next routine appointment and assess the continued suitability of cilostazol treatment, the EMA notes, and other healthcare professionals should refer patients to the prescribing physician as appropriate. For patients, EMA has this advice: "If you are taking cilostazol-containing medicines, you should make a nonurgent appointment with your doctor to review your treatment. Your doctor will advise you whether you should continue taking cilostazol, stop taking cilostazol, or change the dose that you are taking. The advice will vary for each patient depending on factors such as lifestyle options that could improve your condition, whether your walking symptoms have improved since you started cilostazol, whether you have had recent heart problems, and which other medicines you are taking."
Current Evidence Reassuring on CV Side Effects The CHMP review of cilostazol examined safety data from nearly 14,000 suspected adverse-drug-reaction reports (in the context of over 6 million patient-years of exposure worldwide) and 4000 events in noninterventional studies and confirmed the known adverse-effect profile of cilostazol from clinical trials. Cases of hemorrhage represented about 8% of the spontaneous reports. The most common cardiovascular events reported were palpitations and tachycardia (each about 5% of total spontaneous reports). Analysis of available data suggests an increased risk of hemorrhage when cilostazol is given to patients also taking both aspirin and clopidogrel. However, the evidence suggests that cilostazol alone or in combination with 1 other antiplatelet drug does not increase the risk of bleeding, says the CHMP. There is some comfort, however, on long-term cardiovascular safety of cilostazol from the CASTLE postmarketing study, it adds. Testing cilostazol against placebo, the trial was terminated early because of a high dropout rate in both groups and a much lower mortality rate than expected. There were 49 deaths in the cilostazol group, of which 12 were due to cardiac disorders, and 52 in the placebo group (13 cardiac). When a composite end point of cardiac morbidity (coronary and cerebrovascular events) and mortality was considered, there were 135 events with cilostazol and 153 with placebo. "Although the design and early termination of the study limit the conclusions that can be drawn, these results provide some reassurance with regard to cardiovascular safety of cilostazol," the EMA notes. "In conclusion, the CHMP considered that although on average the efficacy of cilostazol is modest, there is a small group of patients in whom it is of clinical relevance, not least in helping them to begin exercise programs. Although suspected adverse-drug-reaction reports have raised some safety concerns, these have not been substantiated in the clinical-trial data (including the CASTLE study), and it remains possible to exclude high-risk patients in clinical practice."
EMA限制含西洛他唑治疗间歇性跛行 发布时间：2013-3-28 来源：药品资讯网信息中心根据外媒3月22日报道，欧洲药品管理局(EMA)已限制含有西洛他唑的(cilostazol)药物用于治疗间歇性跛行患者。EMA建议，西洛他唑现在只限于间歇性跛行患者在生活方式改善后(包括戒烟和运动锻炼)以及其他适当措施干预后获益不明显时方可应用。医生应在启动该药治疗间歇性跛行3个月后进行评估，如果患者无临床相关获益则应停止该药的治疗。该推荐是根据目前证据审查得到的，审查结果显示，含有西洛他唑的药物可使患者适度获益，比如可增加患者步行距离，但只有很少的亚组患者分析显示该获益大于某些心血管不良风险或严重出血。西班牙相关部门在收到一些有关上述不良反应报告后已要求EMA人用药委员会(CHMP)对这些药物进行审查。相关的不良反应包括致命的心脏病发作、心绞痛、心律失常和严重出血事件(包括颅内出血)。西洛他唑禁用于不稳定心绞痛患者、有心肌梗死病史患者、在过去6个月行经皮冠状动脉介入治疗(PCI)患者以及有严重快速心律失常病史患者；还禁用于接受阿司匹林+氯吡格雷或其他双联及更多附加药物抗血小板或抗凝治疗的患者。目前接受CYP3A4或CYP2C19酶抑制剂治疗的患者应用西洛他唑时应减量。医生应在患者再次就诊时进行审查和评估继续西洛他唑治疗的必要性。EMA相关负责人还表示，虽然上述怀疑药物不良反应报告增加了一些安全性的担忧，但还没有临床试验数据证明，因此有可能在临床实践中排除高危患者。在美国，西洛他唑已获准用于治疗间歇性跛行，但该药在欧洲用的较少；该药在亚洲更为广泛应用。
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