Hospital Alemão Oswaldo Cruz, São Paulo, SP - Brasil.
Instituto Dante Pazzanese de Cardiologia, São Paulo, SP - Brasil.
Arq Bras Cardiol. 2023 Apr 7;120(4):e20220380. doi: 10.36660/abc.20220380. eCollection 2023.
Previous systematic reviews have identified no benefit of hydroxychloroquine and chloroquine in non-hospitalized COVID-19 patients. After publication of these reviews, the results of COPE, the largest randomized trial conducted to date, became available.
To conduct a systematic review and meta-analyses of randomized clinical trials (RCTs) to synthesize the evidence on the efficacy and safety of hydroxychloroquine and chloroquine for non-hospitalized COVID-19 patients compared to placebo or standard of care.
Searches were conducted in PubMed, Embase, The Cochrane Library, and ClinicalTrials.gov complemented by manual search. Pairwise meta-analyses, risk of bias, and evidence certainty assessments were conducted, including optimal information size analysis (OIS). A level of significance of 0.05 was adopted in the meta-analysis. PROSPERO: CRD42021265427.
Eight RCTs with 3,219 participants were included. COVID-19 hospitalization and any adverse events rates were not significantly different between hydroxychloroquine (5.6% and 35.1%) and control (7.4% and 20.4%) (risk ratio, RR, 0.77, 95% confidence interval, CI, 0.57-1.04, I2: 0%; RR 1.78, 95%-CI 0.90; 3.52, I2: 93%, respectively). The OIS (7,880) was not reached for COVID-19 hospitalization, independently of the simulation for anticipated event rate and RR reduction estimate.
Evidence of very low certainty showed lack of benefit with hydroxychloroquine in preventing COVID-19 hospitalizations. Despite being the systematic review with the largest number of participants included, the OIS, considering pre-vaccination response to infection, has not yet been reached.
先前的系统评价已经确定羟氯喹和氯喹对非住院 COVID-19 患者没有益处。这些综述发表后，COPE 试验的结果公布，这是迄今为止进行的最大规模的随机试验。
对随机临床试验 (RCT) 进行系统评价和荟萃分析，综合评估羟氯喹和氯喹治疗非住院 COVID-19 患者与安慰剂或标准治疗相比的疗效和安全性证据。
在 PubMed、Embase、The Cochrane Library 和 ClinicalTrials.gov 进行检索，并辅以手动检索。进行了两两荟萃分析、偏倚风险评估和证据确定性评估，包括最佳信息量分析 (OIS)。荟萃分析采用 0.05 的显著性水平。PROSPERO：CRD42021265427。
纳入 8 项 RCT，共计 3219 名参与者。羟氯喹组（5.6%和 35.1%）和对照组（7.4%和 20.4%）的 COVID-19 住院率和任何不良事件发生率无显著差异（风险比，RR，0.77，95%置信区间，CI，0.57-1.04，I2：0%；RR 1.78，95%-CI 0.90；3.52，I2：93%）。COVID-19 住院率的最佳信息量（7,880）尚未达到，无论对预期事件发生率和 RR 降低估计值进行模拟。
极低确定性的证据表明羟氯喹预防 COVID-19 住院的益处有限。尽管是纳入参与者最多的系统评价，但考虑到感染前的疫苗反应，最佳信息量仍未达到。
