目的 探讨银杏二萜内酯葡胺注射液对不同肝肾功能状态的急性缺血性脑卒中患者疗效和安全性差异。方法 本研究数据来自于一项随机、双盲、安慰剂平行对照、多中心临床试验。研究对象为发病48 h内的急性缺血性脑卒中患者，按照1∶1随机接受银杏二萜内酯葡胺注射液和安慰剂治疗14 d。研究对象按照肝肾功能异常和正常分为2组。主要疗效指标为随机化后（90±7）d发生mRS评分完全生活自理（mRS达到0～1分）的比例。主要安全性指标为随机化后（90±7）d内发生的不良事件。二分类结局指标采用Logistic回归模型进行比较，计算比值比（OR）和95%可信区间（95% CI）。结果 共纳入3 337例缺血性脑卒中患者，其中肝肾功能正常的患者1 841例（55.2%），肝肾功能异常的患者1 496例（44.8%）。肝肾功能正常（OR，1.38；95% CI，1.15～1.66；P＜0.001）和异常（OR，1.22；95% CI，1.00～1.50；P＝0.05）的患者中，银杏二萜内酯葡胺注射液相比于安慰剂均可显著提高90 d mRS评分0～1分患者的比例。结论 肝肾功能状态与不同治疗方式的交互作用未达到统计学意义（交互P＝0.28）。不同肝肾功能状态的患者中，银杏二萜内酯葡胺注射液均未显著增加不良事件的发生（交互P＝0.41）。在不同肝肾功能状态患者中，银杏二萜内酯葡胺注射液可以有效提高急性缺血性脑卒中患者90 d的功能预后且未增加不良事件的发生。

Objective To investigate the efficacy and safety of Diterpene Ginkgolides Meglumine Injection (DGMI) in patients with acute ischemic stroke hepatorenal status.Methods Data were obtained from a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. Patients with acute ischemic stroke within 48 h. They were randomized to receive DGMI or placebo once daily in a 1∶1 ratio. Patients were divided by hepatorenal statuses, as normal and abnormal group. The primary outcome was the proportion of patients with a modified Rankin Scale (mRS) of 0 or 1 on day (90 ± 7) after randomization. The primary safety outcome was adverse events within 90 d.Results A total of 3 337 patients were enrolled, with 1 841 (55.2%) patients with normal and 1 496 (44.8%) with abnormal hepatorenal status. DGMI was associated with a higher proportion of mRS score of 0-1 in both normal (OR, 1.38; 95% CI, 1.15-1.66; P<0.001) and abnormal (OR, 1.22; 95% CI, 1.00-1.50; P = 0.05) hepatorenal status groups, compared to the placebo group. There was no significant interaction between hepatorenal status with treatment (P = 0.28 for interaction). The rates of adverse events were similar between DGMI and placebo group across different hepatorenal status (P = 0.41 for interaction).Conclusion Among patients with AIS in this randomized clinical trial, DGMI improved the proportion of patients achieving favorable clinical outcomes at 90 d compared with placebo, regardless of hepatorenal status.

R971

江苏省院士工作站（BM2023118）