伊维菌素治疗新冠住院重症与非重症患者的REMAP-CAP随机试验
该研究为国际多因素适应性平台随机对照试验，在巴基斯坦、印度和爱尔兰的医院纳入新冠住院重症与非重症患者，比较伊维菌素与不用伊维菌素。主要结局为无呼吸与心血管器官支持天数；因外部证据提示无效及操作层面无效而提前终止入组，结果显示伊维菌素不太可能改善该复合结局与住院生存。
要点
- 重症患者伊维菌素组无器官支持天数中位数为-1，提示死亡为主要结局。
- 非重症患者两组无器官支持天数中位数均为22天，未见优势。
- 研究因操作层面无效提前终止入组，伊维菌素不太可能改善主要复合结局。
核心结论
- 对新冠住院重症与非重症患者，伊维菌素不太可能改善无器官支持天数与住院生存的复合结局。
研究设计与样本
- 国际、多因素、适应性平台、随机对照试验，设置于巴基斯坦、印度和爱尔兰的医院，时间为2021年6月11日至2022年9月9日。
- 纳入重症与非重症住院患者，随机分为伊维菌素组或不使用伊维菌素对照组。
- 主要结局为呼吸与心血管无器官支持天数，按有序量表评估，院内死亡赋值为-1，幸存者计算至第21天无器官支持天数，分析采用贝叶斯累积logistic模型。
- 因操作层面无效而关闭入组，依据为外部证据提示伊维菌素对非住院新冠患者无效。
主要发现
- 重症患者61例：伊维菌素组无器官支持天数中位数-1（IQR -1至17），对照组-1（IQR -1至17.25），校正比例OR 0.94（95%CrI 0.40-2.07），优于对照的后验概率44.2%。
- 非重症患者89例：伊维菌素组无器官支持天数中位数22（IQR 18.5-22），对照组22（IQR 16-22），校正比例OR 1.04（95%CrI 0.48-2.34），优于对照的后验概率53.7%。
- 重症患者住院生存率：伊维菌素组35.1%（13/37），对照组37.5%（9/24），校正OR 1.00（95%CrI 0.39-2.32），优于对照的后验概率50.0%。
- 非重症患者住院生存率：伊维菌素组84.1%（37/44），对照组77.8%（35/45），校正OR 1.16（95%CrI 0.5-3.07），优于对照的后验概率63.3%。
临床怎么用
- 结果不支持对新冠住院重症或非重症患者使用伊维菌素以改善无器官支持天数或住院生存。
局限性
- 研究因操作层面无效提前终止入组，重症61例、非重症89例，样本量有限。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
Crit Care Med. 2026 Jul 1;54(7):1546-1562. doi: 10.1097/CCM.0000000000007134. Epub 2026 May 8. ABSTRACT OBJECTIVE: To determine whether ivermectin improves outcomes for critically and noncritically ill hospitalized patients with COVID-19. DESIGN: An ongoing international, multifactorial, adaptive platform, randomized, controlled trial. SETTING: Hospitals in Pakistan, India, and Ireland between June 11, 2021, and September 9, 2022. PATIENTS: Critically and noncritically ill patients. INTERVENTIONS: Randomized to ivermectin or no ivermectin (control). MEASUREMENTS AND MAIN RESULTS: The primary outcome was respiratory and cardiovascular organ support-free days, assessed on an ordinal scale combining in-hospital death (assigned a value of -1) and days free of organ support through day 21 in survivors. Analyses used a Bayesian cumulative logistic model. Enrollment was closed for operational futility, following external evidence suggesting no benefit with ivermectin in nonhospitalized patients with COVID-19. Among 61 critically ill patients, the median number of organ support-free days was -1, indicating death was the most common vital outcome (interquartile range [IQR], -1 to 17), for the ivermectin group and -1 (IQR, -1 to 17.25) for the control group (adjusted proportional odds ratio [OR], 0.94; 95% credible interval [CrI], 0.40-2.07) and the posterior probability of superiority to control was 44.2%. Among 89 noncritically ill patients, the median number of organ support-free days was 22 (IQR, 18.5-22) for ivermectin and 22 (IQR, 16-22) for control (adjusted proportional OR, 1.04; 95% CrI, 0.48-2.34) and the posterior probability of superiority was 53.7%. Among critically ill patients, hospital survival was 35.1% (13/37) for ivermectin and 37.5% (9/24) for control (adjusted OR, 1.00; 95% CrI, 0.39-2.32), posterior probability of superiority was 50.0%. Among noncritically ill patients, hospital survival was 84.1% (37/44) for ivermectin and 77.8% (35/45) for control (adjusted OR, 1.16; 95% CrI, 0.5-3.07), posterior probability of superiority was 63.3%. CONCLUSIONS: For critically and noncritically ill hospitalized patients with COVID-19, ivermectin was unlikely to improve the primary composite outcome of organ support-free days and hospital survival. PMID: 42101205 | PMC: PMC13322157 | DOI: 10.1097/CCM.0000000000007134
引用
- PubMed 高证据 · 肺炎：Ivermectin for Critically and Noncritically Ill Hospitalized Patients With COVID-19: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP)
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。