Cruciani Mario, Pati Ilaria, Masiello Francesca, Malena Marina, Pupella Simonetta, De Angelis Vincenzo
Italian National Blood Centre, National Institute of Health, 37100 Rome, Italy.
Infectious Diseases Unit, AULSS9 Scaligera, 37100 Verona, Italy.
Diagnostics (Basel). 2021 Sep 8;11(9):1645. doi: 10.3390/diagnostics11091645.
Ivermectin has received particular attention as a potential treatment for COVID-19. However, the evidence to support its clinical efficacy is controversial.
We undertook a new systematic review of ivermectin for the treatment and prophylaxis of COVID-19, including new primary studies, outcomes other than mortality, and grading the quality of the available evidence following the Cochrane guidance for methodology.
We searched electronic databases, repository databases, and clinical trial registries (up to June 2021). The measure of treatment effect was risk difference (RD) with 95% confidence intervals (CIs). The GRADE system was used to assess the certainty of the evidence.
The review includes 11 RCTs (2436 participants). The certainty of the available evidence was quite low or very low due to risk of bias, inconsistency, and imprecision. When the analysis was limited to patients with baseline mild or moderate disease (8 reports, 1283 patients), there were no differences in mortality between ivermectin and control groups (low level of certainty); in patients with baseline severe diseases (3 reports, 304 patients), the use of ivermectin significantly decreased mortality compared to the controls (RD -0.17; 95% CIs, -0.24/-0.10; = 0.00001; low level of certainty). In terms of disease progression (to severe pneumonia, admission to intensive care unit, and/or mechanical ventilation), the results were much the same. At day 14, the rate of patients with a negative RT-PCR test was 21% higher (from 5 to 36% higher) for ivermectin recipients than it was for the controls (low quality of evidence). Three studies (736 subjects) indicated that prophylaxis with ivermectin increased the likelihood of preventing COVID-19 compared to controls (low quality of evidence). Serious adverse events were rarely reported.
There is limited evidence for the benefit of ivermectin for COVID-19 treatment and prophylaxis, and most of this evidence is of low quality. Further evidence is needed to fine-tune potential indications and optimal treatment protocols for ivermectin as a treatment for COVID-19.
伊维菌素作为一种潜在的新冠治疗药物受到了特别关注。然而，支持其临床疗效的证据存在争议。
我们对伊维菌素治疗和预防新冠进行了一项新的系统评价，纳入了新的原始研究、死亡率以外的结局，并按照Cochrane方法学指南对现有证据的质量进行分级。
我们检索了电子数据库、仓储数据库和临床试验注册库（截至2021年6月）。治疗效果的衡量指标是风险差值（RD）及95%置信区间（CI）。采用GRADE系统评估证据的确定性。
该评价纳入了11项随机对照试验（2436名参与者）。由于存在偏倚风险、不一致性和不精确性，现有证据的确定性相当低或非常低。当分析仅限于基线为轻度或中度疾病的患者（8项报告，1283名患者）时，伊维菌素组和对照组的死亡率无差异（确定性低）；在基线为重度疾病的患者中（3项报告，304名患者），与对照组相比，使用伊维菌素显著降低了死亡率（RD -0.17；95% CI，-0.24/-0.10；P = 0.00001；确定性低）。在疾病进展方面（发展为重症肺炎、入住重症监护病房和/或机械通气），结果大致相同。在第14天，接受伊维菌素治疗的患者RT-PCR检测呈阴性的比例比对照组高21%（从高5%到36%）（证据质量低）。三项研究（736名受试者）表明，与对照组相比，伊维菌素预防可增加预防新冠的可能性（证据质量低）。严重不良事件报告很少。
伊维菌素用于新冠治疗和预防的获益证据有限，且大多数证据质量较低。需要进一步的证据来微调伊维菌素作为新冠治疗药物的潜在适应证和最佳治疗方案。
Zotero 插件