羥氯喹治療Covid-19住院患者的療效分析
作者：
小柯機器人發布時間：2020/10/12 16:54:57
英國倫敦熱帶醫學和全球衛生中心Martin J. Landray團隊研究了羥氯喹治療Covid-19住院患者的療效。2020年10月8日，該研究發表在《新英格蘭醫學雜誌》上。
根據體外活性以及來自非對照研究和小型隨機試驗的數據，羥氯喹和氯喹被建議用於治療Covid-19。
在一項隨機、對照、開放標籤的平臺試驗中，研究組招募Covid-19住院患者，將其隨機分組，其中1561例接受羥氯喹治療，3155例接受常規治療。主要結局為28天死亡率。
羥氯喹組有421例患者（28％）在28天之內死亡，常規治療組有790例（25.0％），風險比為1.09。在所有預先指定的患者亞組中均觀察到一致結果。羥氯喹組的患者在28天之內存活出院的概率為59.6%，低於常規治療組（62.9％）。
羥氯喹組中在基線時未進行機械通氣的患者最終接受有創機械通氣或死亡的概率為30.7%，顯著高於常規治療組（26.9％），風險比為1.14。羥氯喹組與常規治療組相比，心臟原因死亡人數略有增加（0.4個百分點），但新發重大心律失常率無顯著差異。
總之，採用羥氯喹治療Covid-19住院患者，與常規治療相比，並不能降低28天死亡率。
附：英文原文
Title: Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19
Author: The RECOVERY Collaborative Group
Issue&Volume: 2020-10-08
Abstract:
BACKGROUND
Hydroxychloroquine and chloroquine have been proposed as treatments for coronavirus disease 2019 (Covid-19) on the basis of in vitro activity and data from uncontrolled studies and small, randomized trials.
METHODS
In this randomized, controlled, open-label platform trial comparing a range of possible treatments with usual care in patients hospitalized with Covid-19, we randomly assigned 1561 patients to receive hydroxychloroquine and 3155 to receive usual care. The primary outcome was 28-day mortality.
RESULTS
The enrollment of patients in the hydroxychloroquine group was closed on June 5, 2020, after an interim analysis determined that there was a lack of efficacy. Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P=0.15). Consistent results were seen in all prespecified subgroups of patients. The results suggest that patients in the hydroxychloroquine group were less likely to be discharged from the hospital alive within 28 days than those in the usual-care group (59.6% vs. 62.9%; rate ratio, 0.90; 95% CI, 0.83 to 0.98). Among the patients who were not undergoing mechanical ventilation at baseline, those in the hydroxychloroquine group had a higher frequency of invasive mechanical ventilation or death (30.7% vs. 26.9%; risk ratio, 1.14; 95% CI, 1.03 to 1.27). There was a small numerical excess of cardiac deaths (0.4 percentage points) but no difference in the incidence of new major cardiac arrhythmia among the patients who received hydroxychloroquine.
CONCLUSIONS
Among patients hospitalized with Covid-19, those who received hydroxychloroquine did not have a lower incidence of death at 28 days than those who received usual care.
DOI: 10.1056/NEJMoa2022926
Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2022926