華碩VivoWatch鎖定健身市場 續航力高達10天 2015-04-30 15:23:44日前宣佈推出的華碩新款智慧表VivoWatch，基本上沿用ZenWatch外型設計，但主要針對運動與長時間配戴使用需求推出，作業系統也並非採用Android Wear，強調電池續航力約可對應長達10天左右。建議售價部分，VivoWatch預計將以新台幣4588元推出，並且預計5月8日在台開放銷售。華碩今日 (4/30)宣布在台推出日前揭曉的新款智慧表VivoWatch，並且確定將以新台幣4588元價格於5月8日在台開放銷售。相較旗下首款智慧手錶ZenWatch，此次推出的VivoWatch主要聚焦在運動與長時間配戴使用需求，因此保留心律感應、睡眠品質追蹤且對應IP67防塵防水設計，但由於此次採用作業系統並非Android Wear，同時配合低耗電的灰階螢幕，讓電池續航力最高可達10天左右。內建功能部分，VivoWatch可配合華碩VivoPulse量測心律、追總消耗卡路里，同時也加入久坐提醒、紫外線檢測等功能，並且可在配合HiVivo服務讓手錶自動進入睡眠模式，透過感應元件晃動幅度與次數確認使用者舒眠指數。錶帶部分則對應運動使用需求，採用橡膠材質設計，使用者亦可自行更換22mm錶帶。
Sunday, May 3, 2015
日本郵政上市前造勢: 老年健康照護(Apple + IBM) & 國際物流併購 (澳洲TOLL)
蘋果IBM攜手進軍日本老年人健康醫療領域 北京時間: 2015-05-01 14:04:52【希望之聲5月1日訊】蘋果、IBM和日本郵政集團今天正式達成合作協議，為日本的老年人提供健康醫療服務。 日本是全球老齡化最嚴重的國家之一，日本目前有3300萬老年人（年齡超過65歲），約佔日本人口約25%。這次的合作以日本郵政集團為主導，將預裝有IBM應用程序的ipad提供給老年人，這款ipad可以提醒老人按時用藥，飲食和鍛煉，進行突發情況的報警；還可以將老年人連接到自己生活的社區，如展示社區活動，豐富老年人的社區生活；同時這一健康應用程序還可以將收集到的用戶健康醫療數據上傳至雲存儲空間，分享給醫生和保險公司。iPad作為本次合作中的重要角色，其界面非常直觀，方便老年人使用。根據計劃，首期6個月的實驗將在下半年進行，首批1000名使用者可獲得一部免費iPad。預計在2016年該項目可覆蓋400萬至500萬老年人，蘋果CEO庫克表示，這一計劃在日本試運營之後，將會逐步在其他國家推出。責編：李東航
國際產經：日本郵政集團上市計畫曝光，日本郵政等三家機構預定2015年申請上市 財訊新聞 2014/12/23 15:06 【財訊快報／劉敏夫】日本經濟新聞社報導指出，日本郵政集團的上市計劃方案日前曝光，持股公司日本郵政和旗下的郵儲銀行、簡易生命保險兩家金融機構，將於2015年9月同時上市，計劃於2015年3月向東京證券交易所提出上市申請。這可望成為與1998年NTT DoCoMo上市時總市值超過7兆日圓相匹敵的大規模首次公開募股(IPO)。在前日本首相小泉純一郎推出郵政民營化改革的10年之後，郵政的股票終於朝上市邁進。根據了解，日本郵政集團計劃在年底前公佈上市計劃，目前正在與日本財務省和總務省進行最後調整。預定在2015年6月向東證提出正式申請，目標9月同時上市。日本政府目前持有郵政集團全部股份。而日本郵政則持有旗下兩家金融公司和日本郵便的全部股份。日本郵政股份的上市收入將被用作東日本大地震的災後重建財源。
日本邮政拟收购澳大利亚物流巨头 文章来源：日经中文网 2015-02-26 10:43 日本邮政集团2月18日公布了业务战略，提出将收购澳大利亚物流巨头，力争今年秋季上市。将进军海外，力争在国际物流领域跻身全球五强。由于被批评压迫民营企业，日本邮政一直在削减业务，推进民营化路线，此次希望以上市为契机转为成长路线，但也面临着人才短缺等众多课题。日本邮政将投资64.86亿澳元（约合人民币320亿元），最早于6月份将澳大利亚物流巨头拓领控股公司(TOLL)收购为日本邮便的全资子公司。这将是日本邮政集团迄今为止最大手笔的海外收购。该集团社长西室泰三在同日接受记者采访时强调，"在企业间物流领域实力雄厚的拓领是最合适的收购对象"。日本邮政的子公司、日本邮便的高桥亨社长则表示，两家公司"将成为全球前5大国际物流企业"，计划追赶全球最大的物流企业德国邮政(Deutsche Post)等物流巨头。对于日本邮政来说，进军国际物流是长久以来的夙愿。虽然子公司日本邮便的销售额约为2.7万亿日元，但是几乎没有涉足海外业务。由于电子邮件的迅速发展，邮政业务表现低迷，在不断成长的海外宅急便业务方面，日本邮便被雅玛多控股(Yamato Holdings)等企业拉开差距。对于在海外寻求活路的日本邮政来说，在亚洲等55个国家拥有超过1200个网点的澳大利亚拓领是理想的收购对象。但是与国际物流巨头的差距依然巨大。日本邮便与拓领的合计销售额约为3.5万亿日元。德国邮政的年销售额约为7.4万亿日元，息税前利润也接近4千亿日元。美国物流巨头UPS的销售额也高达约6.9万亿日元，包括航空和海上网络，国际物流巨头在全球扎根。日本邮便预计本财年将陷入最终亏损，拓领的纯利润也仅为270亿日元。今后必须进一步扩大规模、提高收益性。
核能所 李德偉 開發 蛋白核醫藥物188Re-HSAM (human serum albumin microsphere)
以輻射為藥，給予癌細胞精準有效的近身打擊!! 文／廖英凱「放射線治療」是個在今日醫學界被廣泛使用的醫療技術。從最常見用於診斷用的X光、核磁共振，到利用游離輻射體外照射或是體內植入核種暴露。特別是在今日癌症的治療上，放射線治療已能有效縮小癌細胞，提升外科手術的成功率。我們可以很輕易地想像，大部分的癌症腫瘤都在身體內部，因此透過體外照射的方式，接收到最多游離輻射的往往是表面的組織，而非真正需要消滅的癌細胞。因此，如何讓能放出游離輻射的「藥物」能精確地放在體內癌細胞的附近，如何讓這些藥物能傳達適當劑量的輻射，以及確保這些藥物不會有過多的副作用，就是放射線治療當前的研究重點。今日，核能研究所的李德偉博士及其團隊，目前正陸續成功開發出用於治療腫瘤的放射性藥物。核能研究所位於桃園龍潭，是隸屬於行政院原子能委員會，專責各項與核能、能源和輻射應用、放射治療有關的研究機構。李博士目前針對癌症中排名第二高的肝癌，開發出188Re-HSAM，做為治療肝癌的藥物。188Re-HSAM分由三個部分組成，分別為能放出游離輻射的「核種188Re」、利用配位共價鍵與核種結合的「人類血清白蛋白微球體」(human serum albumin microsphere, HSAM)，以及能將兩者順利結合的「配方緩衝劑」。在核種的部分，188Re有一些很適當的特性能作為放射線來源。它的半衰期為17小時，因此在體內衰減的時間快。且188Re能放出兩種游離輻射，分別是能量為155KeV的γ射線和能量是2.1MeV的β粒子。γ射線的能量低，且能夠穿透人體，因此醫生可以藉由從體內射出的γ射線來分析腫瘤的所在位置與狀況，也由於放射線同時對所有細胞都有影響，因此先透過低劑量低能量的投藥來觀察，依據病患腫瘤與正常組織比例、肺分流百分比、肝功能及腫瘤大小來訂定最佳劑量，以確保對癌細胞的劑量是對正常細胞劑量的一倍以上，是作為治療前期的精確診斷。而藉由γ射線的前期分析結果，接下來就能提高劑量利用能量較高的β粒子來消滅癌細胞。與γ射線能穿越人體不同，β粒子是高速運動的電子，僅能穿透人體組織平均0.25公分，因此β粒子所攜帶的能量，就會完全被人體組織所吸收，達到消滅癌細胞的功效。再考量到原料的來源，188Re的半衰期短，自然無法從國外進口，需要有相關核能工業的配合。而李博士所採用的188Re，可利用「發生器」內的188Wu（半衰期69天）衰變而來，為核研所能自行製造量產。相較其類似的核種，如半衰期90小時的186Re，就需要從核反應爐中取得，除須配合反應爐的安全管制，製造步驟也較為繁瑣。雖然母核種188Wu也必須取自核反應爐，但由於半衰期長，所以可以減少反應爐內作業的頻率。在核種確定後，李博士選定了HSAM作為攜帶核種的藥劑。早年的體內放射線治療，多是利用植入膠束、導管或金屬片在患部。這樣的缺點是植入取出過程的手術會對身體有害，且當癌症腫瘤過於分散的時候，會大幅提高植入難度，而異物在身體內也會對病患造成不適。而HSAM是一種胜肽化合物，他能在人體內被自然降解而不留下殘留物。再搭配「肝動脈栓塞手術」，讓188Re-HSAM能被聚集在動脈與微血管的交界處。這是利用HSAM的直徑約20μm大於微血管的直徑6~9μm的特性。因此利用肝動脈導管，將藥劑注入供應肝臟癌症腫瘤養分的血管中，並因無法通過微血管而被截留，就能以近距離由內而外給予有效的高輻射劑量殺死腫瘤。 總括今日對於癌症治療的方式，體外放射治療受限於腫瘤數量、體積與腫瘤深度。體內放射物植入有異物不適感且無法應付過於分散的癌症腫瘤。而以肝癌來說，傳統化學治療在目前約可使10~30%晚期肝癌病患的腫瘤明顯縮小，但卻無法使病人在化療後得到存活的優勢。這是因為肝癌細胞本身的抗藥性，加上患者肝功能低落時更難承受化療藥物的副作用。而核研所李博士所開發的188Re-HSAM，結合既有低風險的手術技術又能避免化療副作用，並對腫瘤細胞做精確診斷與治療。在近年來，也開始有越來越多醫生採用核醫藥物作為診治的方式。李博士表示，近期核研所自行研發的核醫藥物，在腫瘤抑制上已取得非凡的成果，未來搭配既有的外科技術與化療，希望能對癌症的治療上，能有更多的突破與助益。從核反應爐的產物，到注射物身體內的藥物。李博士的團隊也匯集了原子科學、分子生物、動物與生命科學等人才，並與醫學界和藥廠合作，從核種的試驗到藥物的合成，從動物試驗到人類臨床。對於生技醫藥產業尖端研發並不蓬勃的我國來說，李博士仍滿懷使命感地說：「事在人為，不做一定失敗，做了還會有成功機會」，相信在不久的將來，這項成功的技術，將成為人類維繫健康減少病痛的新希望。
汎瑪+朝陽 合作LED植物工廠
產學聯手精緻農業 植物工廠拼多角化經營投入「植物工廠」多年的汎瑪國際公司，30日與朝陽科大理工學院簽署「產學合作」，締結教育夥伴關係。（黃玉燕/大紀元） 更新: 2015-04-30 09:27:29 AM 標籤: 產學合作 , 精緻農業 , 植物工廠 【大紀元2015年04月30日訊】（大紀元記者黃玉燕台灣台中報導）以LED光源技術結合「植物工廠」的精緻農業，在台灣興起一股風潮。投入「植物工廠」多年的汎瑪國際公司，30日與朝陽科大理工學院簽署「產學合作」，締結教育夥伴關係，董事長曾士祈表示，在業界繞了一圈才知道母校朝陽具備完善技術與設備，希望能從這裡再出發，訓練農業科技人才、發展「高階作物」，期望如同工業工廠一般控制產量，有計畫地生產各式蔬菜及藥用植物。理工學院院長潘吉齡表示，朝陽科大雖是私校，卻擁有多項國立大學沒有的先進設備，加上完善的師資、技術，經過多年累積的應用化學、生化科技研究能量，在校內已建立包括「費洛蒙中心」、「亞洲穀物檢驗中心」、「植物病毒檢測中心」，及「植物組織培養技術研發中心」等尖端農業技術，可提供業界許多協助，達到農業升級、國際化，以及經濟發展的目標。 應化系「植物組織培養技術研發中心」像一座寶山，「金線蓮、天山雪蓮、捕蠅草」等各式奇珍異草，在培養瓶中待價而沽。應化系講座教授蔡新聲說，從研發中心慎選「高階植物」、培訓農技人才，對「擁抱風險」的「植物工廠」，會有實質的幫助。 所謂「植物工廠」，是指在高技術光源調整，不受外在氣候環境影響，以設施控制光線、濕度、二氧化碳濃度、養分等生長環境，全年無休、可有計畫地生產各式蔬菜及藥用植物，就如同工業工廠一般控制生產數量。 面對現階段「植物工廠」尚屬高成本作物，如何多角化培植「高階作物」， 經營精緻農業多年的汎瑪董事長曾士祈表示，日前才從產業界得知，母校擁有國寶級的師資與技術，在簽訂產學合作人才培育模式後，期望透過學生實習就業、建立獎助機制，加速農業的精緻化、科技化；對「擁抱風險」的精緻農業，他充滿期待。 責任編輯：羅令尹
太景 10日內股價急落34~28 (太景聲明一切正常)
F*太景：針對近日本公司股價異常波動，本公司聲明營運一切正常 鉅亨網新聞中心2015-04-30 15:37:35第二條 第51款1.事實發生日:104/04/302.公司名稱:太景醫藥研發控股股份有限公司3.與公司關係[請輸入本公司或子公司]:本公司4.相互持股比例:不適用5.傳播媒體名稱:不適用6.報導內容:不適用7.發生緣由:(1)近日來因本公司股價波動劇烈，本公司在此聲明，公司財務與營運面一切正常，特此聲明。(2)有關本公司新藥研發進展將依相關規定於公司網站及公開資訊觀測站揭露，有關本公司相關資訊一切以本公司網站及公開資訊觀測發佈之訊息為準。8.因應措施:本公司再次重申，有關本公司資訊來源，請以「公開資訊觀測站」為準。目前本公司營運狀況一切正常，對於市場不實傳言，請投資大眾審慎判斷。9.其他應敘明事項:新藥開發時程長、投入經費高且並未保證一定能成功，此等可能使投資面臨風險，投資人應審慎判斷謹慎投資。
太景 策略委外生產Burixafor-布利沙福 (江蘇常熟神隆&台灣神隆) 與適應症多元布局!!
F*太景 新藥核准試驗 2015-04-30 14:29:35 聯合晚報 記者徐睦鈞／台北報導上櫃生技股F*太景（4157）今宣布，自主研發之幹細胞驅動劑布利沙福，將在自體與異體幹細胞移植之外，再開發化療增敏之新適應症（chemosentization）。太景將與位於大陸天津的中國醫學科學院血液病醫院合作，招募罹患難治或復發急性骨髓性白血病的病患，測試布利沙福是否能增進化療效果。該院人體試驗委員會已核准此試驗，即將開始收案。太景與天津血液病醫院合作的臨床試驗，將在既有的化療之上加上布利沙福進行治療，測試其安全性以及能否達到「化療增敏」的效果。
台灣藥業攜手合作開發幹細胞新藥 台灣神隆與F*太景簽訂臨床原料藥委託生產合約 (中央社訊息服務20140606 14:41:21)專精於原料藥開發製造的台灣神隆(股票代號1789)與新藥開發公司太景醫藥研發(股票代號4157，簡稱F*太景)今日共同宣佈，雙方簽署新藥布利沙福( Burixafor)之臨床原料藥委託生產合約，將在神隆江蘇常熟廠進行委託生產計劃。這項合作除了展現我國新藥及原料藥廠通力合作的國際競爭實力外，更活絡國內藥業專業分工、共同合作的機制，成功地為台灣生技新藥發展建立突破性的里程碑。台灣神隆總經理馬海怡博士表示：「本次與太景合作，不僅創下國內生技製藥公司上下游合作自行開發新穎藥物的指標性意義，也顯示台灣製藥產業累積的研發能量已逐步走出自己的道路。」馬海怡強調：「神隆江蘇常熟廠以快速、彈性、可靠的競爭優勢，提供高品質的原料藥研發製造服務，有效地協助新藥客戶進軍中國及歐美等國際市場，該項幹細胞新藥應用領域非常廣，一旦成功上市後，將可為公司業務注入明顯的成長動力。」太景生物科技董事長暨執行長許明珠博士表示： 「新藥研發是醫藥產業的上游，一旦研發成功，將可為下游的產業創造價值鍊。布利沙福為100%由國人研發的新藥，能應用於多種難治之症。太景與神隆的合作，除了可以為雙方帶來雙贏，更可為全球的病患提供高品質，可治療數種不治之症的全新藥物。」根據醫藥市場顧問公司JSP估計，若僅以幹細胞移植與化療促敏為適應症，布利沙福最高年銷售額估計可達11億美元。台灣神隆憑藉著多年原料藥開發實力及豐富的全球法規註冊經驗，廣獲國內外新藥公司及國際大藥廠青睞，目前接受委託進行新藥的原料藥製程研究開發計劃已超過八十項，其中已有五項新藥上市，另有六項產品進入臨床試驗第三期。透過該公司在常熟的營運，以符合國際最新cGMP的廠房設備及品質管理標準，為客戶提供專業研發與製造外包的一站式整體服務，縮短客戶產品的發展週期，加速新產品上市。常熟廠是神隆拓展新興市場、加深全球佈局策略的重要一環。台灣生技醫藥產業在政府政策積極推動下，國內生技廠商已逐步邁成長階段，出現開花結果的態勢。神隆及太景之合作，可望為台灣製藥產業創造群聚效應，提升我國製藥產業於國際的能見度，未來發展樂觀可期。訊息來源：台灣神隆股份有限公司
太景 Burixafor (布利沙福) 合併化療 (cytarabine/ fludarabine for AML, relapsed or refractory acute myeloid leukemia
F*太景布利沙福再添新適應症，化療增敏臨床將收案 MoneyDJ新聞 2015-04-30 10:22:45 記者 新聞中心 報導 F*太景(4157)今(30)日表示，公司自主研發之幹細胞驅動劑布利沙福，將在自體與異體幹細胞移植之外，再開發化療增敏之新適應症(chemosentization)；將與位於大陸天津的中國醫學科學院血液病醫院合作，招募罹患難治或復發急性骨髓性白血病的病患，測試布利沙福是否能增進化療效果。F*太景表示，該院人體試驗委員會已核准此試驗，即將開始收案。F*太景指出，目前對罹患急性骨髓性白血病病患的治療是以化療藥物為主，但若是「復發或難治型」，目前仍無真正有效的治療，原因在於化療藥物對於躲藏在骨髓中的血液腫瘤細胞的毒殺效果有限，這是導致疾病復發或難治的重要原因，也是醫界急需突破的課題。因此，與天津血液病醫院合作的臨床試驗，將針對罹患「復發或難治型急性骨髓性白血病」之病患，在既有的化療之上加上布利沙福進行治療，測試其安全性以及能否達到「化療增敏」的效果。F*太景表示，布利沙福能與CXCR4結合，阻斷SDF-1/CXCR4軸參與的生理和病理過程。據研究，CXCR4/SDF-1軸可促進白血病細胞存活、增殖、轉移及耐藥，也與白血病骨髓內外復發關係密切。且布利沙福在急性骨髓性白血病的小鼠模型，已證實能將躲藏在骨髓中的白血病細胞動員到周邊血而增加化療藥物的毒殺效果，進而顯著延長小鼠的存活時間，因此布利沙福能開發白血病的化療增敏作用。此一化療增敏之臨床試驗將評估布利沙福合併化療藥物「cytarabine」及「fludarabine」，治療「復發或難治型急性骨髓性白血病」的安全性及療效。F*太景說明，首先將評估化療藥物合併布利沙福治療此類病人的最大耐受劑量 (MTD)，接著，將以此最大耐受劑量，進行第二期臨床試驗，以進一步評估布利沙福合併cytarabine及fludarabine，治療這類病人所能達到的緩解率、無疾病存活期及整體存活期，以及安全性；若試驗效果良好，太景將進行後期臨床試驗，以取得此適應症的上市許可。F*太景指出，布利沙福為具有多種潛在適應症的小分子化合物，除了化療增敏以外，布利沙福開發中的適應症包括自體幹細胞植與異體幹細胞移植，仍待開發的則有治療組織缺血性相關疾病（例如心肌梗塞）之潛力。在自體幹細胞移植部分，布利沙福的安全性與幹細胞驅動效果相當突出。根據太景美國血液醫學年會(ASH)發表的Phase I針對健康受試者與Phase IIa臨床試驗針對多發性骨髓瘤、霍奇金病及非霍奇金淋巴瘤病人的病患的臨床數據顯示其安全性與幹細胞動員效果優異。此外，在異體幹細胞移植上，F*太景表示，與德國Cellex簽署協議，將在德國德勒斯登大學附屬醫院，最多招募37位無法以G-CSF成功驅動出足夠幹細胞的捐贈者，測試布利沙福是否可以從異體造血幹細胞自願捐贈者身上驅動出足以進行移植的幹細胞。另與台大醫學院合作的迷你豬動物模型研究也發現，布利沙福具有治療組織缺血性相關疾病（例如心肌梗塞）之潛力，這也是未來太景考慮拓展之適應症。
TaiGen begins Phase I/II trial of burixafor in China to treat acute myeloid leukemia PBR Staff Writer Published 01 May 2015 TaiGen Biotechnology Company has started a Phase I/II trial of burixafor in combination with two chemotherapeutic agents fludarabine and cytarabine in adults with relapsed or refractory acute myeloid leukemia (AML) in China. Burixafor (TG-0054) is a new, potent and selective chemokine receptor antagonist discovered by TaiGen. Around 15 patients will be enrolled in this open-label trial, which is designed to determine the safety and efficacy of burixafor plus fludarabine and cytarabine. The trial will evaluate maximum tolerated dose of burixafor, as well as other efficacy endpoints such as complete response, disease free survival and overall survival. Institute of Hematology and Blood Diseases Hospital hematologist/oncologist professor Wang JianXiang will lead the trial under a clinical trial authorization for Class 1.1 new drug from China FDA. TaiGen chairman and CEO Dr Ming-Chu Hsu said: "Chemotherapy and stem cell transplantation are the mainstay of leukemia treatment. We know from our clinical study to date, burixafor can mobilized sufficient stem cells necessary for hematopoietic stem cell transplantation. "This study will give us the additional information on the utility of burixafor as a chemosensitizer in combination with chemotherapy and could greatly expand the indications and increase the market potential in hematology/oncology." The company said that burixafor have already completed one Phase I and one Phase II trial in the US, with another Phase II trial in autologous stem cell transplantation is ongoing in the country.
ScinoPharm to Provide Active Pharmaceutical Ingredient to TaiGen for Novel Stem Cell Drug ScinoPharm Taiwan, Ltd. (TWSE: 1789) specializing in the development and manufacture of active pharmaceutical ingredients, and TaiGen Biotechnology (4157.TW; F*TaiGen) jointly announced today the signing of a manufacturing contract for the clinical supply of the API of Burixafor, a new chemical entity discovered and developed by TaiGen. The API will be manufactured in ScinoPharm's plant in Changshu, China. This cooperation not only demonstrates Taiwan's international competitive strength in new drug development, but also sees the beginning of a domestic pharmaceutical specialization and cooperation mechanisms, thus establishing a groundbreaking milestone for Taiwan's pharmaceutical industry. Dr. Jo Shen, President and CEO of ScinoPharm said, "This cooperation with TaiGen is of representative significance in the domestic pharmaceutical companies' upstream and downstream cooperation and self-development of new drugs, and indicates the Taiwanese pharmaceutical industry's cumulative research and development momentum is paving the way forward". Dr. Jo Shen emphasized, "ScinoPharm's Changshu Plant provides high-quality API R&D and manufacturing services through its fast, flexible, reliable competitive advantages, effectively assisting clients of new drugs in gaining entry into China, Europe, the United States, and other international markets." According to Dr. Ming-Chu Hsu, Chairman and CEO of TaiGen, "R&D is the foundation of the pharmaceutical industry. Once a drug is successfully developed, players at all levels of the value chain could reap the benefit. Burixafor is a 100% in-house developed product that can be used in the treatment of various intractable diseases. The cooperation between TaiGen and ScinoPharm will not only be a win-win for both sides, but will also provide high-quality novel dug for patients from around the world."
3D列印airway splint 治療 支氣管軟化症
3D列印支架 治癒兒童呼吸道疾病 2015-04-30 04:43:03 聯合晚報 記者黃秀媛╱即時報導美國密西根大學專家利用3D列印技術，為罹患致命呼吸道疾病的兒童打造能讓他們的身體吸收的個人化植體，藉此保全了三個幼兒的性命，也使3D列印技術的醫學用途獲得新的突破。這三個幼兒罹患會導致氣管塌陷，無法有效治療的氣管支氣管軟化症。研究人員說，患者原已瀕臨死亡，可是在植入呼吸道支架後，能夠自由呼吸並逐漸康復。這種用3D列印技術打造的個人化裝置，尚未通過聯邦當局審核，只得到緊急醫療豁免，仍被視為高風險做法。對大約30名兒童進行的臨床試驗即將展開。研究人員說，第一個接受這種療法的男童，動手術時才三個月大，現已是健康的三歲幼兒。另外兩個男童分別在3個月和16個月大時動手術，現在情況良好，沒有出現任何併發症。研究報告主要作者葛林 (Glenn Green)說，全球大約每2000個兒童，就有一個患氣管支氣管軟化症。由於無法充分吐氣，他們的氣管很容易塌陷。研究人員對兒童病患的呼吸道做電腦斷層掃描，用生醫材料印製能夠隨著患者成長而擴展的個人化支架植體。研究報告說，印製的支架呈中空和多孔管狀能夠縫到受影響的呼吸道，而且用以製作支架的聚己內酯材料，能夠無害的在體內溶解。設計和印製一個植體需要一至三天時間。研究人員說，這種技術最後可能用於治療由於投資成本太高，遭到醫療裝置公司漠視的一些罕見疾病。這種做法還有另一個優點：醫生能夠預先印製氣管和支氣管，在實際開刀前做練習。3D列印技術也正用於製作助聽器、牙齒植體、醫療支架和義肢。
NEJM：3D 打印拯救患病婴儿 来源：ifanr / 作者：王超文 / 2013-06-06 3D 打印可以制作枪支，也可以拯救生命。美国密歇根州有一个两个月大的婴儿，因为患有气管支气管软化，导致气管坍塌，氧气无法顺畅的进入肺部，随时面临窒息的危险。在手术之前，只能依靠插入气管维持通气。在征得婴儿父母以及密歇根大学相关机构的允许后，密歇根大学的研究人员利用 3D 打印机，根据患者胸部的 CT 影像，打印出了气管的形状以及一块夹板。然后将夹板放入患者胸部，支撑起坍塌的气管，从而让气流畅通。手术完成后婴儿使用了 21 天的呼吸机，随后便痊愈出院。如今一年时间过去了，夹板未出现任何异样。这块 3D 打印的夹板只耗时一天制作完毕，相比以往手工制作快速的多，成本只有三分之一。而且它是采用的聚乙内酯材料，属于可降解塑料，也被用来制作手术缝合线。这块夹板大约会在 3 年后降解，但那时患者的呼吸道机能已经完全成熟，可以脱离夹板。这位婴儿很幸运，它是首批 3D 打印机应用临床的案例。这一医学成就发表在新英格兰医学杂志上，作者认为"高清影像、计算机和生物材料的 3D 打印三者结合，可以针对指定的病人，促进创造出可植入的器件。"而在去年，首例利用 3D 打印的下颌移植手术在荷兰完成。这就是 3D 打印带给医疗的福音，在人类与病患作斗争时，技术往往能创造出意想不到的结果。这次案例只是小试牛刀，3D 打印机的可定制化、可降解材料、更高效的生产让其在医疗的未来拥有巨大的想象空间。与之类似，利用 3D 打印机生产骨骼、牙齿，已经被认为是可以实现的方向。而更远的未来，具备生命力的器官也是可以打印出来的。加利福尼亚州的生物打印先驱 Organovo 公司已经成功打印迷你肝脏，并且可以存活 5 天以上。美国康奈尔大学借助老鼠尾巴和牛耳，打印出人耳。也许以后癌症可以利用 3D 打印机来康复。然而 3D 打印仍然面临一些争议，比如打印枪支。我想，这正是技术的魅力所在，技术赋予人无穷的能量，是祸害还是造福，就看人如何使用它。
原文检索：David A. Zopf, Scott J. Hollister, Glenn E. Green et al. Bioresorbable Airway Splint Created with a Three-Dimensional Printer. N Engl J Med. May 23, 2013; DOI: 10.1056/NEJMc1206319
金衛: 擬每股6.40美元收購 紐約上市中國臍帶血!
金衛擬收購中國臍帶血庫企業股權；TDR今恢復交易 MoneyDJ新聞 2015-04-30 10:45:16 記者 新聞中心 報導 大陸綜合性醫療集團金衛(910801)昨(29)日表示，向合資格股東建議，以公開發售形式，按每持有兩股股份可獲認購一股發售股份之基準，以每股1.40港元之認購價公開發售股份。合資格股東有權申請認購額外發售股份。 金衛說明，今(2015)年4月27日，金衛向其非全資子公司及紐約證交所上市公司中國臍帶血庫企業集團(「CO」)董事會提交了一份初步、不具有拘束力的建議書，擬以每股6.40美元的現金收購金衛尚未直接或間接擁有之CO的全部普通股。與該收購相關，金衛也擬根據有關可轉換票據的條款和條件收購CO的全部7%優先可換票據。 台灣證交所指出，由於金衛醫療集團已於4月29日完成股價敏感資料之公布，其參與發行之臺灣存託憑證(證券代號：910801)自4月30日起恢復交易，以其為標的之上市認購(售)權證亦同時恢復交易。
刮痧出痧 加强局部代谢 消炎!!
为何刮痧刮不出痧？刮痧的6大养生作用2015年04月30日为什么刮痧有时会刮不出痧来呢？现如今，刮痧养生已经成为了一种流行。不过，有些人只是盲目跟随，并不了解刮痧的养生作用究竟有哪些。今天，小编就来为大家介绍一下刮痧的6大养生作用都有哪些，一起来看看吧。 刮痧的6大养生作用
能合理调整阴阳。刮痧对内脏功能有明显的调整阴阳平衡的作用，如有肠蠕动亢进患者，在腹部和背部等处进行刮痧后，可使蠕动亢进的肠道受到抑制而恢复正常；反之，肠蠕动功能减退者，则可促进其蠕动恢复正常，说明刮痧可以改善和调整脏腑功能，使脏腑阴阳得到平衡。 活血祛瘀。刮痧可调节肌肉的收缩和舒张，使机体组织间的压力得到调节，以促进刮拭组织周围的血液循环，增加组织血流量，从而起到活血化瘀、祛瘀生新的作用。
舒筋通络。人体的肌肉、韧带、关节囊等受损伤的软组织，会发出疼痛信号，通过神经的反射作用而减少肢体活动的保护性反应，减轻疼痛。损伤部位若不及时治疗或治疗不彻底，会形成不同程度的粘连、纤维化或疤痕化，以致不断地发出有害的冲动，加重疼痛、压痛和肌肉收缩紧张，刮痧治疗能增强局部血液循环，使局部组织温度升高，在刮痧板的直接刺激下，可提高局部组织的痛觉阈，并可使紧张或痉挛的肌肉得以舒展从而缓解或消除疼痛，促进病灶修复。
调整生理功能。人体的各个脏器都有其特定的作用，当脏器发生病变时有关的有关生理功能会发生改变，从而影响整个系统乃至全身的机能平衡。通过刺激等方式作用于体表的特定部位，产生一定的生物学信息，通过传递系统输入到有关脏器，对失常的生理功能加以调整，从而起到对病变脏器的调整作用。刮痧过程中如用刮法、点法、按法刺激内关穴，可调整冠状动脉血液循环，延长左心室射血时间，心输出量增加，增加冠脉流量的血氧供给等。如用刮法、点法、按法刺激足三里穴，可对垂体、肾上腺髓功能有良性调节作用，提高免疫能力和调整肠运动等作用。
促进对机体有毒素的排除。刮痧治疗过程（用刮法使皮肤出痧）可使局部组织形成高度充血，血管神经受到刺激使血管扩张，血液及淋巴液流动明显增快，呑噬有害物作用及运输排泄能力加强，促使体内废物、毒素加速排除，组织细胞得到营养，从而使血液得到净化，增加了全身抵抗力，可以减轻病势，促进康复。 促进机体血液循环。营养物质和氧气血液循环系统的传输对人体健康起重要作用。刮痧作用于肌表，可使局部皮肤充血，毛细血管扩张，血液循环回快；另外刮痧的刺激可通过神经内分泌调节血管舒、缩功能和血管壁的通透性，增强局部血液供应而改善全身血液循，刮痧出痧的过程是一处血管扩张渐至毛细血管破裂，血流外溢，皮肤局部形成瘀血斑的现象，此等血凝块（出痧）不久即能溃散，而起自体溶血作用，形成一种新的刺激素，能加强局部的新陈代谢，有消炎的作用。
那么，刮不出痧又是为什么呢？ 刮痧刮不出痧的原因 刮痧、放血都比较适于治疗实性体质的人和实性的疾病，比如嗓子疼、扁桃体发炎化脓，在后背的"大椎"穴刮刮痧，或者在手指的"少商"、"商阳"穴放放血，之后多喝点水，睡上一觉就轻松很多。刮出的痧、放出的血，其实是你自己的气血宣透了出来，随着宣透把病邪带了出来。 但有些人发现刮痧后不出痧。不出痧不是因为刮的力量不够，而是体质偏虚，气血不够充盛，顶不出痧来。这种人如果采取能去邪的"拔罐儿"疗法，很可能也吸不住那个火罐。此时如果遇到一个正规的中医，他肯定要让你回去吃药，或者通过艾灸先把气血补足了再来刮痧或拔罐儿。 刮痧虽然可以养生，但是也要讲究方法哦。
為何 忍氣吞聲/ 咬牙切齒 易生病 !!
傾聽身體的聲音 專家教你排除一肚子鳥氣 健康醫療網／記者關嘉慶報導-2015年04月30日 上午08:01 （健康醫療網／記者關嘉慶報導）你有多久不曾傾聽身體的聲音？根據美兆首創的「身體小毛病關鍵字」調查，超過13％參與者選擇「脹」字，其解為「腹部脹氣、打嗝」，這些不明不白的鳥氣，到底是怎麼出現的呢？美兆集團研究發展處研發長劉婷婷博士表示，肚子裡的氣體，包括嘴巴吞進的空氣、胃液與胰液中和產生的氣體、以及腸道細菌產出的氣體。一般來說，腸胃狀況不良、蠕動微弱、長時間坐姿、缺乏運動、吞氣症等狀況容易腹脹，也較易出現打嗝與放屁頻率過高，且火燒心及上腹部疼痛等現象也會常發生。值得特別注意的是「咬牙吞氣症」！劉婷婷博士表示，「咬牙吞氣症」不只是引起打嗝及放屁，也是頭痛、肩頸僵硬、眼睛痠痛的原因；甚至造成牙齒耗損、龜裂、牙齦發炎或下巴疼痛等問題。針對「吞氣症」所引起的腹脹，她強調，必須從元兇「長期壓力」中鬆綁，並應改善「咬牙切齒」習慣，透過深呼吸，由嘴巴吐氣可自然將牙齒鬆開，深呼吸同時也可幫助精神紓緩、減輕壓力；此外，還必須注意飲食方式，進食速度太快、發出大聲響，容易將空氣搭配食物一併吞下肚，切記吃飯時要「好好咬、慢慢吃、喝湯要安靜！」原則。另外，劉婷婷博士指出，容易脹氣就是產氣與排氣之間失去了平衡；腸道中的壞菌如葡萄球菌、綠膿菌、大腸菌以及產氣夾膜桿菌等壞菌一旦位居優勢，腸子裡面進行的不是「發酵」，而是「腐敗」的過程。通常屁臭的程度可以是一種指標，用來顯示腸道的狀態。劉婷婷博士進一步解釋，脹氣除了肚子膨脹不舒服，壞菌所產生的臭氣會麻痺腸管細胞，導致便秘。糞便囤積於腸道時間過久，毒素被身體吸收，經由尿液、呼氣、皮膚等管道排出，就容易發生口臭、體臭以及皮膚問題；而且臭氣也會經由血液遊走全身，頭痛、容易感冒、免疫力低下等狀況會隨之而來。可見「一肚子鳥氣」顯示出腸道環境以及對健康所可能造成的影響！劉婷婷博士建議，可以將「一肚子鳥氣」視為一個健康指標，只要留意以下5項飲食與生活習慣，就可很快大幅改善脹氣問題，不需使用消脹氣藥物。1.攝取蔬菜、水果、海藻等富含水溶性纖維食物。2.澱粉類的碳水化合物攝取要適量。麵包、穀類等許多小麥製品與含糖食物，以及薯類跟豆類裡的碳水化合物也容易產氣，雖然沒有氣味，但也會造成脹氣的不適感。3.持續補充益生菌，改變腸道菌相，驅逐壞菌，如攝取發酵食品，優酪乳、泡菜、納豆等，或直接補充優良的益生菌產品。4.適度輕量運動（由於重度運動會興奮交感神經，反而會使腸子不動），充足的睡眠時間，讓腸子有足夠的時間蠕動。5.飲酒要適量，啤酒需要特別小心，因為啤酒通常會喝得太多，對於腸道像是一股大洪水，容易將輕輕附著在腸壁上的好菌沖刷殆盡。
臨床試驗基因分析需求驅動WuXi NextCODE/ DNAnexus結合
WuXi NextCODE, DNAnexus Launch End-to-End Sequencing in China and Beyond By Bio-IT World Staff April 30, 2015 | Last week during the Bio-IT World Conference & Expo, WuXi NextCODE and DNAnexus announced a strategic alliance to accelerate genomics worldwide."Bringing together the sophisticated cloud solution that DNAnexus has built together with the downstream informatics that WuXi NextCODE has created, and layering on top of that the extensive network that WuXi AppTech brings to the table, we now have a seamless and fully integrated platform to really bring precision medicine to the next level," explained Hannes Smarason, Chief Operating Officer of WuXi NextCODE.
See, Chinese Services Group WuXi Buys NextCODE Health for $65m.Integration is the theme Smarason and Richard Daly, CEO of DNAnexus, emphasized in talking about the arrangement. Within WuXi's offerings are CLIA-certified sequencing, drug discovery and contract research services, and clinical genomics analysis and database capabilities. Connecting all of those pieces on the DNAnexus cloud will enable customers to generate, store, and interpret their sequence data and collaborate with colleagues around the world through one platform.Using the integrated offering isn't mandatory, of course. Both companies will keep their own independent offerings. But Smarason believes it will be a huge boon to customers. "We take the complexity out and enable the customer to have a single point of contact, and really not have to discover all of the different pieces," he said. "The client can now expect to get a fully-populated and fully-minable data warehouse on their desktop, as opposed to having to piece all of these components together." For DNAnexus, the alliance was driven by customers' needs, said Daly. "Our initial motivation was just following our existing customers, either pharma companies doing research that used genomics, or clinical diagnostic companies that are providing actual clinical reports that are useful in patient treatment. Their interest and their requirement has just grown remarkably in the last year to be able to operate in China. We needed a strong Chinese partners to enable global customers who are now participating in the very rapidly-growing, very important in-China market ."The companies will provide and host the same platform and capabilities inside and outside of China, in full compliance with local regulations. Under the agreement, WuXi will license the DNAnexus platform and "launch a China cloud," Smarason said.Smarason and Daly believe the alliance will enable unprecedented flexibility, and will open the door to virtual research."Up to now, you had to have somebody in a white coat with lab techs. You had to have the physical instruments to do the test development. And you had to have the bioinformatics," said Daly. "Now you'll be able to pull all that apart, farm out those activities, and do virtual test development. That means the number of people who will be able to do test development in a major medical center, or a small startup, or large pharma will now grow rapidly.""This is going to be pretty revolutionary," he continued. "Genomics is growing very rapidly as a global business."
避免兒童氣喘三害: 塵蟎(46.3％)/ 氣溫急變 (37.7％)/病毒感染 (36.8％)
逾16萬氣喘童調查誘發主因是塵蟎 2015-05-02 16:10:24 國健署表示，12歲以下氣喘童逾16萬人，調查誘發氣喘因素前3名是塵蟎(佔46.3％)、其次是氣溫急遽變化，以及病毒感染。國健署表示，12歲以下兒童經醫師診斷患有氣喘的比率為6.7%，而男童氣喘比率是7.8%，高於女童的5.4%，以103年12歲以下人口數推估，國內目前有16萬5000多名兒童患有氣喘。中央社台北2日報導，國健署調查2088名照顧12歲以下患氣喘的孩子的主要照顧者發現，誘發兒童氣喘的前名是塵蟎(佔46.3％)、氣溫急遽變化 (37.7％)，以及病毒感染(36.8％)。國健署表示，氣喘是一種呼吸道慢性發炎的疾病，主要會反覆咳嗽，呼吸時會發出「咻咻」喘鳴聲。氣喘平時無症狀，不代表已經痊癒，一旦接觸到可能誘發因素，氣喘便會發作。響應5月5日是世界氣喘日，國健署呼籲民眾遠離氣喘引發因素、遵醫囑回診，並配合醫師指示服藥，「積極控制氣喘，別讓氣喘控制你的生活」。（陳恆光編）【中央網路報】
(NEJM發表 CheckMate -069結果) Opdivo (nivolumab)+Yervoy (ipilimumab) 合併試用於 特殊基因表型 ( BRAF wild-type mutation)
First Randomized Study Evaluating Opdivo (nivolumab)+Yervoy (ipilimumab) Regimen Demonstrates Superior Efficacy Versus Yervoy Alone in Patients with Previously Untreated Advanced Melanoma April 20, 2015 08:30 AM Eastern Daylight Time PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced positive results from a Phase II trial (CheckMate -069), evaluating the Opdivo (nivolumab)+Yervoy (ipilimumab) regimen versus Yervoy alone in patients with previously untreated advanced melanoma. Patients with BRAF wild-type mutation status treated with the Opdivo+Yervoy regimen experienced a higher objective response rate (ORR) of 61% (n=44/72) – the primary study endpoint – compared to 11% (n=4/37) for patients administered Yervoy monotherapy (P<0.001). Complete responses were also reported in 22% (n=16) of patients with BRAF wild-type mutation status administered the Opdivo+Yervoy regimen and in no patients who received Yervoy monotherapy. Similar results were also observed in BRAF mutation-positive patients. The safety profile was consistent with previously-reported studies evaluating the Opdivo+Yervoy regimen and included grade 3-4 colitis (17%), diarrhea (11%), and increased alanine aminotransferase (11%)."With the Opdivo+Yervoy regimen, we observed much higher response rates which were sustained, as well as significant reduction in tumor burden than with Yervoy. These responses seen in CheckMate -069 demonstrate the potential of this regimen in patients with metastatic melanoma."These data will be presented today at the American Association for Cancer Research (AACR) Annual Meeting and featured during a press briefing at 8:30 AM EDT [Abstract 2860]. The results will also be published in The New England Journal of Medicine (NEJM)."These data are unprecedented in advanced melanoma, showing efficacy results that have not previously been observed with Immuno-Oncology agents," said F. Stephen Hodi, M.D., Associate Professor of Medicine, Dana-Farber Cancer Institute and an author of the NEJM manuscript. "With the Opdivo+Yervoy regimen, we observed much higher response rates which were sustained, as well as significant reduction in tumor burden than with Yervoy. These responses seen in CheckMate -069 demonstrate the potential of this regimen in patients with metastatic melanoma."Melanoma is the most serious form of skin cancer and strikes adults of all ages. While melanoma represents less than 5% of skin cancers, it results in most deaths. The CheckMate -069 trial is the first randomized study reporting outcomes in the first-line setting for advanced melanoma patients treated with a regimen of immune checkpoint inhibitors compared to Yervoy. The efficacy and safety results of CheckMate -069 are consistent with the Phase Ib dose-ranging trial (CheckMate -004), which evaluated the safety and activity of the regimen in patients with advanced melanoma."The CheckMate -069 results reinforce our belief that the future lies in the combination of Immuno-Oncology agents, including Opdivo and Yervoy, that can leverage the immune system in order to offer cancer patients options with greater efficacy beyond current treatment approaches," said Michael Giordano, senior vice president, Head of Development, Oncology. "Our strategy has always been to build upon the success achieved with Yervoy. In 2011, long-term survival for metastatic melanoma patients was unheard of, but the introduction of Yervoy has helped to make this a reality for some patients. Now we are building on this success with Opdivo, which was the first PD-1 inhibitor to demonstrate an improved survival benefit."
About CheckMate -069 CheckMate -069 is a Phase II double-blind, randomized study that evaluated the Opdivo+Yervoy regimen in patients with previously untreated unresectable Stage 3 and 4 melanoma. The study included patients with both BRAF wild-type and BRAF mutation-positive melanoma. The trial enrolled 142 patients who were randomized to receive either the Opdivo+Yervoy (n=95) regimen or Yervoy (n=47) monotherapy. Randomization was stratified by BRAF mutation status (V600 wild-type tumors versus BRAF mutation-positive tumors as assessed by an FDA-approved test). Patients in the Opdivo+Yervoy regimen group received 1 mg/kg of Opdivo plus 3 mg/kg of Yervoy every 3 weeks for 4 doses followed by 3 mg/kg of Opdivo per every 2 weeks until progression or unacceptable toxic effects. In the Yervoy monotherapy group, patients were treated with the same dosing schedule plus matching placebo.The primary endpoint was ORR in patients with BRAF wild-type tumors. Secondary endpoints included progression-free survival (PFS) in BRAF wild type patients and ORR and PFS in BRAF V600 mutation-positive patients, along with safety. Along with higher ORR and more complete responses, the regimen decreased risk of progression for BRAF mutant and wild-type patients (hazard ratios = 0.4 [95% CI: 0.23, 0.68; P<0.001] and 0.38 [95% CI: 0.15, 1.00], respectively), representing a 60-62% reduction of risk of progression or death. In BRAF wild-type patients, median PFS was not reached. In BRAF mutation-positive patients, median PFS was 8.5 months for the regimen and 2.7 months for Yervoy alone. In addition, ORR was independent of PD-L1 status: 58% among patients with PD-L1 positive tumors and 55% among those with and PD-L1 negative tumors. The minimum follow-up period after randomization was 11 months. CheckMate -069 is the first randomized study to characterize the safety profile of the Opdivo+Yervoy regimen versus Yervoy monotherapy. The safety profile was consistent with that previously reported for the Opdivo+Yervoy regimen. The treatment-related adverse event rate was similar (91% for the Opdivo+Yervoy regimen versus 93% for Yervoy monotherapy). The incidence of grade 3/4 adverse events (drug-related AEs) was higher with the Opdivo+Yervoy regimen (54%) compared to 24% of patients who received Yervoy monotherapy and managed using established safety guidelines and the majority (approximately 80%) improved or resolved with appropriate monitoring and use of corticosteroids. The most common grade 3/4 AEs with the Opdivo+Yervoy regimen were colitis (17%), diarrhea (11%), and increased alanine aminotransferase (11%). The Opdivo+Yervoy regimen was discontinued due to adverse events in 47% of patients versus 17% for Yervoy monotherapy. Of those patients who discontinued due to adverse events, 68% continued to experience a complete or partial response. There were three drug-related deaths associated with the Opdivo+Yervoy regimen.
About Opdivo and Yervoy Cancer cells may exploit "regulatory" pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. Opdivo and Yervoy are both monoclonal antibodies and immune checkpoint inhibitors that target separate, distinct checkpoint pathways. Inhibition of these immune checkpoint pathways results in enhanced T cell function greater than the effects of either antibody alone. Opdivo became the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world on July 4, 2014 when Ono Pharmaceutical Co. announced that it received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma. In the U.S., the U.S. Food and Drug Administration (FDA) granted its first approval for Opdivo for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. Recently, on March 5, 2015, Opdivo received its second FDA approval for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.In the European Union, the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application for Opdivo in advanced melanoma. The application has also been granted accelerated assessment by the EMA's Committee for Medicinal Products for Human Use (CHMP). The EMA also validated for review the MAA for Opdivo in NSCLC.On March 25, 2011, the FDA approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is now approved in more than 40 countries. Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials – as monotherapy or in combination with other therapies – in which more than 7,000 patients have been enrolled worldwide.
OPDIVO (nivolumab) IMPORTANT SAFETY INFORMATION
Immune-Mediated Pneumonitis Severe pneumonitis or interstitial lung disease, including fatal cases, occurred with OPDIVO treatment. Across the clinical trial experience in 691 patients with solid tumors, fatal immune-mediated pneumonitis occurred in 0.7% (5/691) of patients receiving OPDIVO; no cases occurred in Trial 3. In Trial 3, immune-mediated pneumonitis occurred in 6% (7/117) of patients receiving OPDIVO including five Grade 3 and two Grade 2 cases. Monitor patients for signs and symptoms of pneumonitis. Administer corticosteroids for Grade 2 or greater pneumonitis. Permanently discontinue OPDIVO for Grade 3 or 4 and withhold OPDIVO until resolution for Grade 2. Immune-Mediated ColitisIn Trial 3, diarrhea occurred in 21% (24/117) of patients receiving OPDIVO. Grade 3 immune-mediated colitis occurred in 0.9% (1/117) of patients. Monitor patients for immune-mediated colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO for Grade 2 or 3. Permanently discontinue OPDIVO for Grade 4 colitis or recurrent colitis upon restarting OPDIVO. Immune-Mediated HepatitisIn Trial 3, the incidences of increased liver test values were AST (16%), alkaline phosphatase (14%), ALT (12%), and total bilirubin (2.7%). Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for Grade 3 or 4 immune-mediated hepatitis. Immune-Mediated Nephritis and Renal DysfunctionIn Trial 3, the incidence of elevated creatinine was 22%. Immune-mediated renal dysfunction (Grade 2) occurred in 0.9% (1/117) of patients. Monitor patients for elevated serum creatinine prior to and periodically during treatment. For Grade 2 or 3 serum creatinine elevation, withhold OPDIVO and administer corticosteroids; if worsening or no improvement occurs, permanently discontinue OPDIVO. Administer corticosteroids for Grade 4 serum creatinine elevation and permanently discontinue OPDIVO.
Immune-Mediated Hypothyroidism and Hyperthyroidism In Trial 3, hypothyroidism occurred in 4.3% (5/117) of patients receiving OPDIVO. Hyperthyroidism occurred in 1.7% (2/117) of patients including one Grade 2 case. Monitor thyroid function prior to and periodically during treatment. Administer hormone replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism.
Other Immune-Mediated Adverse Reactions The following clinically significant immune-mediated adverse reactions occurred in <2% of OPDIVO-treated patients: adrenal insufficiency, uveitis, pancreatitis, facial and abducens nerve paresis, demyeliniation, autoimmune neuropathy, motor dysfunction and vasculitis. Across clinical trials of OPDIVO administered at doses 3 mg/kg and 10 mg/kg, additional clinically significant, immune-mediated adverse reactions were identified: hypophysitis, diabetic ketoacidosis, hypopituitarism, Guillain-Barré syndrome, and myasthenic syndrome. Based on the severity of adverse reaction, withhold OPDIVO, administer high-dose corticosteroids, and, if appropriate, initiate hormone- replacement therapy.
Embryofetal Toxicity Based on its mechanism of action, OPDIVO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and for at least 5 months after the last dose of OPDIVO. LactationIt is not known whether OPDIVO is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from OPDIVO, advise women to discontinue breastfeeding during treatment.
Serious Adverse Reactions In Trial 3, serious adverse reactions occurred in 59% of patients receiving OPDIVO. The most frequent serious adverse drug reactions reported in ≥2% of patients were dyspnea, pneumonia, chronic obstructive pulmonary disease exacerbation, pneumonitis, hypercalcemia, pleural effusion, hemoptysis, and pain. Common Adverse ReactionsThe most common adverse reactions (≥20%) reported with OPDIVO in Trial 3 were fatigue (50%), dyspnea (38%), musculoskeletal pain (36%), decreased appetite (35%), cough (32%), nausea (29%), and constipation (24%). Please see U.S. Full Prescribing Information for OPDIVO here.
YERVOY® (ipilimumab) INDICATION & IMPORTANT SAFETY INFORMATION
YERVOY (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma.
Important Safety InformationWARNING: IMMUNE-MEDIATED ADVERSE REACTIONS YERVOY can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs) and thyroid function tests at baseline and before each dose.Permanently discontinue YERVOY and initiate systemic high-dose corticosteroids for severe immune-mediated reactions.
Recommended Dose Modifications Withhold dose for any moderate immune-mediated adverse reactions or for symptomatic endocrinopathy until return to baseline, improvement to mild severity, or complete resolution, and patient is receiving <7.5 mg prednisone or equivalent per day.
Permanently discontinue YERVOY for any of the following: Persistent moderate adverse reactions or inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day Failure to complete full treatment course within 16 weeks from administration of first dose Severe or life-threatening adverse reactions, including any of the following: Colitis with abdominal pain, fever, ileus, or peritoneal signs; increase in stool frequency (≥7 over baseline), stool incontinence, need for intravenous hydration for >24 hours, gastrointestinal hemorrhage, and gastrointestinal perforation AST or ALT >5 × the upper limit of normal (ULN) or total bilirubin >3 × the ULN Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full-thickness dermal ulceration or necrotic, bullous, or hemorrhagic manifestations Severe motor or sensory neuropathy, Guillain-Barré syndrome, or myasthenia gravis Severe immune-mediated reactions involving any organ system Immune-mediated ocular disease which is unresponsive to topical immunosuppressive therapy
Immune-mediated Enterocolitis: In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) and moderate (diarrhea with up to 6 stools above baseline, abdominal pain, mucus or blood in stool; Grade 2) enterocolitis occurred in 28 (5%) patients Across all YERVOY-treated patients (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis Infliximab was administered to 5 of 62 (8%) patients with moderate, severe, or life-threatening immune-mediated enterocolitis following inadequate response to corticosteroids Monitor patients for signs and symptoms of enterocolitis (such as diarrhea, abdominal pain, mucus or blood in stool, with or without fever) and of bowel perforation (such as peritoneal signs and ileus). In symptomatic patients, rule out infectious etiologies and consider endoscopic evaluation for persistent or severe symptoms Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). Upon improvement to ≤Grade 1, initiate corticosteroid taper and continue over at least 1 month. In clinical trials, rapid corticosteroid tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients Withhold YERVOY for moderate enterocolitis; administer anti-diarrheal treatment and, if persistent for >1 week, initiate systemic corticosteroids (0.5 mg/kg/day prednisone or equivalent)
Immune-mediated Hepatitis: In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3–5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4% 13 (2.5%) additional YERVOY-treated patients experienced moderate hepatotoxicity manifested by LFT abnormalities (AST or ALT elevations >2.5x but ≤5x the ULN or total bilirubin elevation >1.5x but ≤3x the ULN; Grade 2) Monitor LFTs (hepatic transaminase and bilirubin levels) and assess patients for signs and symptoms of hepatotoxicity before each dose of YERVOY. In patients with hepatotoxicity, rule out infectious or malignant causes and increase frequency of LFT monitoring until resolution Permanently discontinue YERVOY in patients with Grade 3-5 hepatotoxicity and administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When LFTs show sustained improvement or return to baseline, initiate corticosteroid tapering and continue over 1 month. Across the clinical development program for YERVOY, mycophenolate treatment has been administered in patients with persistent severe hepatitis despite high-dose corticosteroids Withhold YERVOY in patients with Grade 2 hepatotoxicity In a dose-finding trial, Grade 3 increases in transaminases with or without concomitant increases in total bilirubin occurred in 6 of 10 patients who received concurrent YERVOY (3 mg/kg) and vemurafenib (960 mg BID or 720 mg BID) Immune-mediated Dermatitis:In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening, or fatal immune-mediated dermatitis (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3–5) occurred in 13 (2.5%) patients 1 (0.2%) patient died as a result of toxic epidermal necrolysis 1 additional patient required hospitalization for severe dermatitis There were 63 (12%) YERVOY-treated patients with moderate (Grade 2) dermatitis Monitor patients for signs and symptoms of dermatitis such as rash and pruritus. Unless an alternate etiology has been identified, signs or symptoms of dermatitis should be considered immune-mediated Permanently discontinue YERVOY in patients with severe, life-threatening, or fatal immune-mediated dermatitis (Grade 3-5). Administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month. Withhold YERVOY in patients with moderate to severe signs and symptoms Treat mild to moderate dermatitis (e.g., localized rash and pruritus) symptomatically. Administer topical or systemic corticosteroids if there is no improvement within 1 week
Immune-mediated Neuropathies: In the pivotal Phase 3 study in YERVOY-treated patients, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported Across the clinical development program of YERVOY, myasthenia gravis and additional cases of Guillain-Barré syndrome have been reported Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities) such as Guillain-Barré–like syndromes Institute medical intervention as appropriate for management of severe neuropathy. Consider initiation of systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe neuropathies. Withhold YERVOY in patients with moderate neuropathy (not interfering with daily activities) Immune-mediated Endocrinopathies:In the pivotal Phase 3 study in YERVOY- treated patients, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism 6 of the 9 patients were hospitalized for severe endocrinopathies Moderate endocrinopathy (requiring hormone replacement or medical intervention; Grade 2) occurred in 12 (2.3%) YERVOY-treated patients and consisted of hypothyroidism, adrenal insufficiency, hypopituitarism, and 1 case each of hyperthyroidism and Cushing's syndrome Median time to onset of moderate to severe immune-mediated endocrinopathy was 11 weeks and ranged up to 19.3 weeks after the initiation of YERVOY Monitor patients for clinical signs and symptoms of hypophysitis, adrenal insufficiency (including adrenal crisis), and hyper- or hypothyroidism Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease. Unless an alternate etiology has been identified, signs or symptoms should be considered immune-mediated Monitor thyroid function tests and clinical chemistries at the start of treatment, before each dose, and as clinically indicated based on symptoms. In a limited number of patients, hypophysitis was diagnosed by imaging studies through enlargement of the pituitary gland Withhold YERVOY in symptomatic patients. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) and initiate appropriate hormone replacement therapy. Long-term hormone replacement therapy may be necessary Other Immune-mediated Adverse Reactions, Including Ocular Manifestations:In the pivotal Phase 3 study in YERVOY-treated patients, clinically significant immune-mediated adverse reactions seen in <1% were: nephritis, pneumonitis, meningitis, pericarditis, uveitis, iritis, and hemolytic anemia Across the clinical development program for YERVOY, likely immune-mediated adverse reactions also reported with <1% incidence were: myocarditis, angiopathy, temporal arteritis, vasculitis, polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis, leukocytoclastic vasculitis, erythema multiforme, psoriasis, pancreatitis, arthritis, autoimmune thyroiditis, sarcoidosis, neurosensory hypoacusis, autoimmune central neuropathy (encephalitis), myositis, polymyositis, and ocular myositis Permanently discontinue YERVOY for clinically significant or severe immune-mediated adverse reactions. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe immune-mediated adverse reactions Administer corticosteroid eye drops for uveitis, iritis, or episcleritis. Permanently discontinue YERVOY for immune-mediated ocular disease unresponsive to local immunosuppressive therapy
Pregnancy & Nursing: YERVOY is classified as pregnancy category C. There are no adequate and well-controlled studies of YERVOY in pregnant women. Use YERVOY during pregnancy only if the potential benefit justifies the potential risk to the fetus Human IgG1 is known to cross the placental barrier and YERVOY is an IgG1; therefore, YERVOY has the potential to be transmitted from the mother to the developing fetus It is not known whether YERVOY is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions in nursing infants from YERVOY, a decision should be made whether to discontinue nursing or to discontinue YERVOY
Common Adverse Reactions: The most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%) Please see Full Prescribing Information, including Boxed WARNING regarding immune-mediated adverse reactions, available at www.bms.com.Yervoy is a registered trademark of Bristol-Myers Squibb Company.
中國康養產業標竿: 台灣敏盛長輩照護中心
兩岸醫療合作台灣敏盛長輩照護中心成立 台灣好新聞-2015年05月02日 下午19:00記者陳華興／桃園報導敏盛醫療體系為因應中國社會廣大的需求，在中國四川的「台灣敏盛日間照護中心」今年增設20張長照床位，改名為「台灣敏盛長輩照護中心」，2日舉行盛大的「定點支持養老中心」簽約儀式，攀枝花市副市長劉建明、康和敏盛服務有限公司董事長劉軍、中心醫院副院長田巨龍以及台灣敏盛集團長照事業部執行長邱獻章皆出席，共同見證台灣敏盛長輩照護中心成為當地首家建立「醫養融合」新平台的機構。敏盛集團總裁楊敏盛2日表示，甫於去年十二月開幕的四川省攀枝花市「台灣敏盛日間照護中心」，投資者為四川省陽城金海公司，是中國境內第一家委由台灣敏盛集團長照事業部輔導建置的日照中心，成為康養產業競相參觀學習的標竿機構。該中心的照護者「年紀大毛病多」是長者身體普遍的狀況，成立50年的攀枝花市立中心醫院，每年的門診量高達100萬人次，住院量6萬人次，住院床位有1500張，是國家等級最高的三級甲等綜合醫院。代表中心醫院與台灣敏盛長輩照護中心簽立「定點支持養老中心」合約的田巨龍副院長表示，未來將提供多項醫療服務，包括：醫師巡診、復健指導、諮詢服務、遠距醫療、雙向轉診和就醫綠色通道等，延伸醫院服務到社區健康管理層面，實踐為人健康服務一生的理念。為攀枝花市導入「醫養融合」理念的推手，正是台灣敏盛醫療體系長照事業部執行長邱獻章，他曾任衛福部嘉南療養院和玉里醫院的院長，現任桃園龍潭敏盛醫院的院長，去年受邀在首屆中國陽光康養產業發展論壇演講，分享台灣敏盛集團醫養融合的成功經驗，促成這次設立「定點支持養老中心」的構想，未來可望透過養老照顧和醫療照護的相互支援，打造整合性健康照護網絡。位於四川的台灣敏盛長輩照護中心，中心的16位工作人員都受過長照專業的教育訓練，設置50床（日照30長照20），室內外面積加起來880坪，平均每位長者可享有近18坪的生活空間，在優質環境和照護口碑的效益下，目前收住率已達八成。楊敏盛表示，「醫養融合」將醫院和機構兩端的服務連結起來，這只是一個例子，展望未來的長照市場，健康照護產業需要互相結盟擴展服務版圖，以合作的方式發揮彼此優勢，才能造福廣大的銀髮族群達到綜效！
正揚生醫(國維) 保留牙醫連鎖 獨立出 艾瑞生醫(生醫&保養品)
正揚擬切割生醫部門成立艾瑞生醫 今富族網記者吳泓駿／報導2015-04-30正揚生醫（4734）發布重大訊息，擬以分割新設方式，將原有的生醫事業部切割成立「艾瑞生醫」，將發行350萬股作為對價，並概括承受該部門過去的資產、負債及營業，分割決算日暫定於7月20日。為因應企業專業分工，強化企業核心競爭力，並促使生醫事業部利於對外擴展業務，正揚生醫於昨（29）日宣布，將依據我國企業併購法及公司法等相關法令規定，將原有的生醫事業部移轉分割新設「艾瑞生醫」，並按分割讓與的營業價值3,500萬元，換取艾瑞生醫普通股350萬股，作為對價。分割完成後，艾瑞生醫仍為正揚旗下100%子公司。正揚生醫的前身為「國維牙醫診所」，1992年以天母為中心開始對外發展，營業項目以診療服務為主，陸續設置雷射診療、電腦鑲瓷、斷層掃描、數位X光及線上約診等系統，逐步發展至聯盟階段，國瑞、瑞星、維美等聯盟診所相繼成立，營運規模持續萌芽茁壯。為因應聯盟的成長，國維聯合科技自2004年成立，力拼成為口腔醫療服務的領導品牌。看好生技醫療產業前景，國維聯合科技跨足生醫科技領域，結合國內外醫療研究機構、學校研究、生醫製造等團隊資源，投入再生醫學的研發及應用，包括醫療、醫藥、保養品等相關產品，2014年更名為正揚生醫，目前營運事業體分成兩大塊，分別為「生醫科技」與「牙醫連鎖診所群」，本次切割出生醫科技部門後，正揚生醫將全力拓展牙醫連鎖診所的事業版圖。