英国伦敦热带医学和全球卫生中心Martin J. Landray团队研究了羟氯喹治疗Covid-19住院患者的疗效。2020年10月8日，该研究发表在《新英格兰医学杂志》上。

根据体外活性以及来自非对照研究和小型随机试验的数据，羟氯喹和氯喹被建议用于治疗Covid-19。

在一项随机、对照、开放标签的平台试验中，研究组招募Covid-19住院患者，将其随机分组，其中1561例接受羟氯喹治疗，3155例接受常规治疗。主要结局为28天死亡率。

羟氯喹组有421例患者（28％）在28天之内死亡，常规治疗组有790例（25.0％），风险比为1.09。在所有预先指定的患者亚组中均观察到一致结果。羟氯喹组的患者在28天之内存活出院的概率为59.6%，低于常规治疗组（62.9％）。

羟氯喹组中在基线时未进行机械通气的患者最终接受有创机械通气或死亡的概率为30.7%，显著高于常规治疗组（26.9％），风险比为1.14。羟氯喹组与常规治疗组相比，心脏原因死亡人数略有增加（0.4个百分点），但新发重大心律失常率无显著差异。

总之，采用羟氯喹治疗Covid-19住院患者，与常规治疗相比，并不能降低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