[爆卦] 瑞德西韋小樣數據出來了

看板Gossiping作者 (Little Y)時間4年前 (2020/04/11 06:09), 4年前編輯推噓27(27推 0噓 41→)
留言68則, 32人參與, 4年前最新討論串1/2 (看更多)
※註:有電視或媒體有報導者，請勿使用爆卦! 無重大八卦請勿使用此分類，否則視同濫用爆卦鬧板(文章退回、水桶6個月) ※政治類爆卦改為政治分類標題 理解無誤的話是指53例的小樣數據顯示對68%的患者臨床有效 April 10, 2020 Data on 53 Patients Treated With Investigational Antiviral Remdesivir Through the Compassionate Use Program Published in New England Journal of Medicine -- Remdesivir treatment resulted in clinical improvement in 68 percent of pati ents in this limited data set -- FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 10, 2020-- Gilead Sciences, Inc. (N asdaq: GILD) today announced results from a cohort analysis of 53 patients hos pitalized with severe complications of COVID-19 who were treated with the inve stigational antiviral remdesivir on an individual compassionate use basis. The majority of patients in this international cohort demonstrated clinical impro vement and no new safety signals were identified with remdesivir treatment. Co mpassionate use data have limitations and multiple Phase 3 studies are ongoing to determine the safety and efficacy of remdesivir for the treatment of COVID -19. The detailed results of this analysis were published today in The New Eng land Journal of Medicine. Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for the treatment of COVID-19. Nearly two thirds of patients (64 percent, n=34/53) in this cohort were on mec hanical ventilation at baseline, including four patients also on extracorporea l membrane oxygenation (ECMO). Treatment with remdesivir resulted in an improv ement in oxygen support class for 68 percent of patients (n=36/53) over a medi an follow-up of 18 days from the first dose of remdesivir. More than half of p atients on mechanical ventilation were extubated (57 percent, n=17/30) and nea rly half of all patients (47 percent, n=25/53) were discharged from the hospit al following treatment with remdesivir. After 28 days of follow-up, the cumula tive incidence of clinical improvement, defined as discharge from the hospital and/or at least a two-point improvement from baseline on a predefined six-poi nt scale, was 84 percent according to Kaplan-Meier analysis. Clinical improvem ent was less frequent among patients on invasive ventilation versus noninvasiv e ventilation (HR: 0.33 [95 percent CI 0.16, 0.68]) and among patients at leas t 70 years of age (HR vs < 50 years: 0.29 [95 percent CI 0.11, 0.74]). Compass ionate use data have limitations due to the small size of the cohort, the rela tively short duration of follow-up, potential missing data due to the nature o f the program and lack of a randomized control group. “Currently there is no proven treatment for COVID-19. We cannot draw definiti ve conclusions from these data, but the observations from this group of hospit alized patients who received remdesivir are hopeful," said Jonathan D. Grein, MD, Director of Hospital Epidemiology, Cedars-Sinai Medical Center, Los Angele s, and lead author of the journal article. “We look forward to the results of controlled clinical trials to potentially validate these findings.” The overall mortality rate in this cohort was 13 percent (n=7/53). The mortali ty rate was higher in the subgroup of patients on invasive ventilation (18 per cent, n=6/34), compared with patients on noninvasive oxygen support (5 percent , n=1/19). Factors associated with an increased risk of mortality included age greater than 70 years (HR vs < 70 years: 11.34 [95% CI 1.36, 94.17]) and high er baseline serum creatinine levels (HR per mg/dL: 1.91 [95% CI 1.22, 2.99]), indicating reduced kidney function. Mild to moderate liver enzyme (ALT and/or AST) elevations (23 percent, n=12/53 ) were observed in this cohort. No new safety signals were detected during sho rt-term remdesivir therapy. Given the limitations of this data set and analysis, data from ongoing, random ized clinical studies of remdesivir are needed to provide a scientifically rob ust understanding of the clinical impact of remdesivir treatment. “While the outcomes observed in this compassionate use analysis are encouragi ng, the data are limited,” said Merdad Parsey, MD, PhD, Chief Medical Officer , Gilead Sciences. “Gilead has multiple clinical trials underway for remdesiv ir with initial data expected in the coming weeks. Our goal is to add to the g rowing body of evidence as quickly as possible to more fully evaluate the pote ntial of remdesivir and, if appropriate, support broader use of this investiga tional drug.” Gilead is conducting two Phase 3 clinical trials of remdesivir, the SIMPLE stu dies, in countries with high prevalence of COVID-19. Data from the SIMPLE stud y in patients with severe disease are expected this month, followed by data fr om the SIMPLE study in patients with moderate disease in May. In addition, Gil ead is supporting multiple clinical trials led by other organizations, includi ng two studies conducted in Hubei Province, China. Gilead has been informed th at the study in China in patients with severe disease was terminated early due to low enrollment; the company awaits the publication of these data to enable an in-depth review of the results. The study in China in patients with mild-t o-moderate disease is ongoing. A global study of remdesivir led by NIAID conti nues to enroll patients and data from this study are anticipated in May. Final ly, additional studies of remdesivir and other investigational treatments for COVID-19, based on a master protocol by the World Health Organization, have al so begun to enroll patients in countries around the world. About the Compassionate Use Cohort Analysis Since January 25, 2020, Gilead has been providing emergency access to remdesiv ir for qualifying patients with severe complications of COVID-19 who are unabl e to enroll in ongoing clinical trials. More than 1,800 patients have been tre ated with remdesivir through individual compassionate use protocols. This cohort evaluated data from 53 patients in the United States, Europe, Cana da and Japan who received at least one dose of remdesivir on or before March 7 , 2020, through Gilead’s compassionate use program. All patients were hospita lized with severe acute respiratory coronavirus 2 (SARS-CoV-2) infection and e ither an oxygen saturation of 94 percent or less, or a need for oxygen. The me dian duration of symptoms before initiation of remdesivir was 12 days. The maj ority of patients (75 percent) were men over the age of 60 years with comorbid conditions, including hypertension, diabetes, hyperlipidemia and asthma. Comb ined, all three of these factors have been associated with adverse outcomes of COVID-19. The planned treatment was a 10-day course of remdesivir, consisting of a 200 m g loading dose administered intravenously on day 1, followed by 100 mg daily f or the remaining nine treatment days. Of the 53 patients included in the analy sis, 75 percent received the full 10-day course of remdesivir, 19 percent rece ived 5-9 days of treatment, and 6 percent received fewer than 5 days of treatm ent. Follow-up continued through 28 days after initiation of remdesivir treatm ent. Four patients discontinued remdesivir prematurely, one due to worsening o f pre-existing renal failure, one due to multiple organ failure and two due to elevated liver enzymes, including one patient with a maculopapular rash. There were no prespecified endpoints for this program. As part of the analysis , rates of key clinical events were quantified, including change in oxygen sup port requirements, hospital discharge, reported adverse events leading to disc ontinuation of remdesivir treatment and mortality. In addition, the analysis e valuated the proportion of patients with clinical improvement, defined as live discharge from the hospital and/or a clinical improvement of at least two poi nts from baseline on a six-point scale reflecting hospitalization and oxygen s upport status, as recommended by the World Health Organization R&D Blueprint G roup. https://reurl.cc/b5E05E -- ※ 發信站: 批踢踢實業坊(ptt.cc), 來自: 39.10.126.111 (臺灣) ※ 文章網址: https://www.ptt.cc/bbs/Gossiping/M.1586556560.A.013.html
推
04/11 06:09, 4年前 , 1F
....你全部上紫色，不如不上色？
04/11 06:09, 1F
→
04/11 06:10, 4年前 , 2F
師爺翻譯翻譯
04/11 06:10, 2F
推
04/11 06:11, 4年前 , 3F
等翻譯
04/11 06:11, 3F
推
04/11 06:11, 4年前 , 4F
我早上看的結論 感覺有效 但因為非隨機非雙盲 所以不肯定
04/11 06:11, 4F
→
04/11 06:11, 4年前 , 5F
幹 專業畫重點欸 meeting都這樣搞得好像自己很認真讀一樣
04/11 06:11, 5F
→
04/11 06:11, 4年前 , 6F
........
04/11 06:11, 6F
推
04/11 06:12, 4年前 , 7F
你好棒喔 都是紫色
04/11 06:12, 7F
推
04/11 06:12, 4年前 , 8F
眼睛痛QQ
04/11 06:12, 8F
→
04/11 06:12, 4年前 , 9F
你乾脆截圖
04/11 06:12, 9F
→
04/11 06:12, 4年前 , 10F
如果要有更詳細的數據 請等之後的隨機雙盲結論
04/11 06:12, 10F
→
04/11 06:12, 4年前 , 11F
我是看得懂 但這排版...根本不想看
04/11 06:12, 11F
推
04/11 06:13, 4年前 , 12F
有啦白字部分是重點
04/11 06:13, 12F
→
04/11 06:13, 4年前 , 13F
這顏色很傷眼
04/11 06:13, 13F
→
04/11 06:13, 4年前 , 14F
wwe大身體好一點嗎？英國災情慘重
04/11 06:13, 14F
推
04/11 06:14, 4年前 , 15F
全部上色不如不上色
04/11 06:14, 15F
推
04/11 06:14, 4年前 , 16F
04/11 06:14, 16F
→
04/11 06:15, 4年前 , 17F
如果有人想看期刊的話可以看一下 總之還是要等解盲
04/11 06:15, 17F
→
04/11 06:15, 4年前 , 18F
馬的都是丁丁色,你是丁丁？
04/11 06:15, 18F
※ 編輯: j5163124 (39.10.126.111 臺灣), 04/11/2020 06:21:41
→
04/11 06:17, 4年前 , 19F
這3天又開始好天氣 我改吃中藥了 有取得對岸小道配方
04/11 06:17, 19F
→
04/11 06:18, 4年前 , 20F
眼睛好痛 給箭頭
04/11 06:18, 20F
→
04/11 06:18, 4年前 , 21F
啊...我的眼睛....我的眼睛
04/11 06:18, 21F
抱歉改了
→
04/11 06:18, 4年前 , 22F
天氣越好 救護車越忙ㄏㄏㄏ
04/11 06:18, 22F
→
04/11 06:18, 4年前 , 23F
現在對岸大使館都發一堆藥和口罩給沒回國的留學生
04/11 06:18, 23F
推
04/11 06:20, 4年前 , 24F
小道配方？希望你一切平安啊
04/11 06:20, 24F
→
04/11 06:20, 4年前 , 25F
剛好認識一個常被台灣室友洗腦的留學生 昨天給我消息
04/11 06:20, 25F
→
04/11 06:21, 4年前 , 26F
對岸3/23 有出一種可緩解症狀的藥 我剛好一年前有帶來
04/11 06:21, 26F
→
04/11 06:23, 4年前 , 27F
之前半信半疑消息 所以之前沒吃 看了配方 開始固定吃
04/11 06:23, 27F
→
04/11 06:24, 4年前 , 28F
其中一種成分拉 反正吃心安的
04/11 06:24, 28F
→
04/11 06:24, 4年前 , 29F
症狀有獲得緩解嗎
04/11 06:24, 29F
推
04/11 06:24, 4年前 , 30F
小樣是什麼? 你哪裡人
04/11 06:24, 30F
在下金城武 ※ 編輯: j5163124 (39.10.126.111 臺灣), 04/11/2020 06:25:46
→
04/11 06:26, 4年前 , 31F
不知道 只感覺 有曬太陽 身體就會比較好
04/11 06:26, 31F
推
04/11 06:26, 4年前 , 32F
這個初步結果算是非常好 這是用在compassionate use 的病人
04/11 06:26, 32F
→
04/11 06:26, 4年前 , 33F
這結果很不錯
04/11 06:26, 33F
→
04/11 06:27, 4年前 , 34F
對岸政府給的官方用藥 自己去買要40鎊
04/11 06:27, 34F
推
04/11 06:27, 4年前 , 35F
簡單說就是對重症有明顯效果
04/11 06:27, 35F
→
04/11 06:28, 4年前 , 36F
這周1發了2盒給留學生 下周還下下周會再發一次
04/11 06:28, 36F
推
04/11 06:28, 4年前 , 37F
對重症病患真的好消息
04/11 06:28, 37F
→
04/11 06:29, 4年前 , 38F
這是前天打聽的 而台灣學生只獲得台灣私人協會3片口罩
04/11 06:29, 38F
→
04/11 06:30, 4年前 , 39F
這台灣私人協會 上週給一堆物資給當地醫院
04/11 06:30, 39F
→
04/11 06:30, 4年前 , 40F
下禮拜股市繼續漲吧
04/11 06:30, 40F
→
04/11 06:31, 4年前 , 41F
而我們外交部駐外單位... 算了 不想講了
04/11 06:31, 41F
推
04/11 06:32, 4年前 , 42F
一般而言 抗病毒藥是越早給越好 拖到重症效果會很差 在這種
04/11 06:32, 42F
→
04/11 06:32, 4年前 , 43F
情況下有這個結果令人振奮
04/11 06:32, 43F
推
04/11 06:37, 4年前 , 44F
可惜這個要是注射不是口服 無法像克流感一樣快篩就給藥吃
04/11 06:37, 44F
→
04/11 06:40, 4年前 , 45F
算了我要刪文了 我看完內文沒這麼樂觀
04/11 06:40, 45F
推
04/11 06:40, 4年前 , 46F
我有打電話回台灣奎寧怎麼買 說這是處方藥 沒得買...
04/11 06:40, 46F
推
04/11 06:41, 4年前 , 47F
這組病人是症狀後12天才給藥 超過一半插管接呼吸器 條件非常
04/11 06:41, 47F
Y大要不要幫大家翻譯一下呀？感覺專業 ※ 編輯: j5163124 (39.10.126.111 臺灣), 04/11/2020 06:42:05
→
04/11 06:41, 4年前 , 48F
差 這種結果算不錯
04/11 06:41, 48F
推
04/11 06:42, 4年前 , 49F
令人驚艷的比例
04/11 06:42, 49F
→
04/11 06:46, 4年前 , 50F
建議你砍文 重發拉... 用word排版吧
04/11 06:46, 50F
手機po文，將就一下吧，文章有連結可以點進去看 ※ 編輯: j5163124 (39.10.126.111 臺灣), 04/11/2020 06:47:09 ※ 編輯: j5163124 (39.10.126.111 臺灣), 04/11/2020 06:47:53
推
04/11 06:54, 4年前 , 51F
重症反映率三分之二 第三期即使掉也是目前實驗藥中最
04/11 06:54, 51F
→
04/11 06:54, 4年前 , 52F
最傑出
04/11 06:54, 52F
推
04/11 07:09, 4年前 , 53F
支那政府在爆發前就已經註冊瑞得西韋治療武漢病毒專利..
04/11 07:09, 53F
→
04/11 07:09, 4年前 , 54F
.越來越像生化恐攻...支那賤畜...
04/11 07:09, 54F
推
04/11 07:11, 4年前 , 55F
有效有推
04/11 07:11, 55F
→
04/11 07:14, 4年前 , 56F
沒有對照組很難說，一樣有效但不知道多有效啊
04/11 07:14, 56F
推
04/11 07:20, 4年前 , 57F
有57%的插管病患投藥後拔管，對比之前金銀潭院長該院插管
04/11 07:20, 57F
→
04/11 07:22, 4年前 , 58F
病患幾乎零拔管，看起來還是好很多，當然還是要等解盲才能
04/11 07:22, 58F
→
04/11 07:22, 4年前 , 59F
確定多有效。
04/11 07:22, 59F
→
04/11 08:10, 4年前 , 60F
零拔管是死光了喔？還是掛在那邊當活屍？
04/11 08:10, 60F
→
04/11 08:32, 4年前 , 61F
60歲憨粉青年繼續感恩中國防疫貢獻
04/11 08:32, 61F
推
04/11 09:24, 4年前 , 62F
五毛一直自言自語像個白癡
04/11 09:24, 62F
推
04/11 09:37, 4年前 , 63F
哈哈樓上
04/11 09:37, 63F
推
04/11 09:48, 4年前 , 64F
to;dr
04/11 09:48, 64F
→
04/11 09:48, 4年前 , 65F
tl
04/11 09:48, 65F
推
04/11 09:49, 4年前 , 66F
幾乎沒效吧
04/11 09:49, 66F
→
04/11 09:57, 4年前 , 67F
勤洗手 戴口罩 別恐慌 小心五毛
04/11 09:57, 67F
推
04/11 10:10, 4年前 , 68F
這效果作為解藥其實不高，只能說比沒有好
04/11 10:10, 68F
‣ 更多 j5163124 的文章
文章代碼(AID): #1UaEwG0J (Gossiping)
‣ 更多 j5163124 的文章
文章代碼(AID): #1UaEwG0J (Gossiping)