用于预防婴幼儿和儿童呼吸道合胞病毒的单克隆抗体：一项更新的系统评价和网络荟萃分析。
完整摘要 · 中文译文
背景与目的：鉴于长效单克隆抗体（clesrovimab）的出现、MELODY 试验完整队列数据的可获得性以及一项大型随机试验（HARMONIE）的结果，我们更新了此前的网络荟萃分析，以评估单克隆抗体预防婴儿重度呼吸道合胞病毒（RSV）感染的疗效和安全性。 方法：我们检索了随机对照试验，这些试验考察了 clesrovimab、motavizumab、nirsevimab、palivizumab 和 suptavumab 彼此之间或与安慰剂或不进行预防相比，预防 RSV 感染的疗效和安全性。我们采用频率学框架下的随机效应网络荟萃分析，并使用推荐分级的评估、制定与评价（GRADE）方法评估证据质量。 结果：共纳入 18 项试验，涉及 33,283 名婴儿。Clesrovimab（比值比 [OR] 0.08，95% 置信区间 [CI] 0.02–0.37，中等质量）、motavizumab（OR 0.12；95% CI 0.07–0.19，中等质量）和 nirsevimab（OR 0.20，95% CI 0.11–0.34；中等质量）与重度呼吸道合胞病毒感染率降低相关。Nirsevimab、motavizumab、clesrovimab 和肌肉注射 palivizumab 与 RSV 感染减少相关，且有数种药物还与住院减少相关。Motavizumab、nirsevimab 和 clesrovimab 与更广泛的下呼吸道感染相关结局减少相关。Motavizumab 可同时减少 mec 机械通气使用和重症监护病房入住率。在全因死亡率以及药物相关或严重不良事件方面未发现显著差异。 结论：这项更新的网络荟萃分析证实，clesrovimab的有效性和安全性与已确立的单克隆抗体相当。莫他珠单抗、尼塞维单抗和clesrovimab在更广泛的下呼吸道感染相关结局方面显示出获益。
完整摘要 · 英文原文
BACKGROUND AND OBJECTIVE: Motivated by the emergence of a long-acting monoclonal antibody (clesrovimab), the availability of data from the complete MELODY trial cohort, and results from a large randomized trial (HARMONIE), we updated our prior network meta-analysis to evaluate the efficacy and safety of monoclonal antibodies for preventing severe respiratory syncytial virus (RSV) infection in infants. METHODS: We searched for randomized controlled trials that examined the efficacy and safety of RSV infection prophylaxis with clesrovimab, motavizumab, nirsevimab, palivizumab, and suptavumab versus one another or placebo or no prophylaxis in infants. We performed a frequentist framework random-effects network meta-analysis and used the Grading of Recommendations, Assessments, Developments and Evaluation (GRADE) approach to assess the certainty of evidence. RESULTS: Eighteen trials enrolling 33,283 infants were included. Clesrovimab (odds ratio [OR] 0.08, 95% confidence interval [CI] 0.02-0.37, moderate certainty), motavizumab (OR 0.12; 95% CI 0.07-0.19, moderate certainty), and nirsevimab (OR 0.20, 95% CI 0.11-0.34; moderate certainty) were associated with reductions in the rate of severe respiratory syncytial virus infection. Nirsevimab, motavizumab, clesrovimab, and intramuscular palivizumab were associated with reductions in RSV infection, and several agents were also associated with reduced hospitalization. Motavizumab and nirsevimab, and clesrovimab were associated with reductions in broader lower respiratory tract infection-related outcomes. Motavizumab reduced both mechanical ventilation use and intensive care unit admission. No significant differences were found in all-cause mortality and drug-related or serious adverse events. CONCLUSIONS: This updated network meta-analysis confirmed that the effectiveness and safety of clesrovimab were comparable to those of established monoclonal antibodies. Motavizumab, nirsevimab, and clesrovimab showed benefits for broader lower respiratory tract infection-related outcomes.