目的 探討銀杏二萜內(nèi)酯葡胺注射液對(duì)不同肝腎功能狀態(tài)的急性缺血性腦卒中患者療效和安全性差異。方法 本研究數(shù)據(jù)來自于一項(xiàng)隨機(jī)、雙盲、安慰劑平行對(duì)照、多中心臨床試驗(yàn)。研究對(duì)象為發(fā)病48 h內(nèi)的急性缺血性腦卒中患者，按照1∶1隨機(jī)接受銀杏二萜內(nèi)酯葡胺注射液和安慰劑治療14 d。研究對(duì)象按照肝腎功能異常和正常分為2組。主要療效指標(biāo)為隨機(jī)化后（90±7）d發(fā)生mRS評(píng)分完全生活自理（mRS達(dá)到0～1分）的比例。主要安全性指標(biāo)為隨機(jī)化后（90±7）d內(nèi)發(fā)生的不良事件。二分類結(jié)局指標(biāo)采用Logistic回歸模型進(jìn)行比較，計(jì)算比值比（OR）和95%可信區(qū)間（95% CI）。結(jié)果 共納入3 337例缺血性腦卒中患者，其中肝腎功能正常的患者1 841例（55.2%），肝腎功能異常的患者1 496例（44.8%）。肝腎功能正常（OR，1.38；95% CI，1.15～1.66；P＜0.001）和異常（OR，1.22；95% CI，1.00～1.50；P＝0.05）的患者中，銀杏二萜內(nèi)酯葡胺注射液相比于安慰劑均可顯著提高90 d mRS評(píng)分0～1分患者的比例。結(jié)論 肝腎功能狀態(tài)與不同治療方式的交互作用未達(dá)到統(tǒng)計(jì)學(xué)意義（交互P＝0.28）。不同肝腎功能狀態(tài)的患者中，銀杏二萜內(nèi)酯葡胺注射液均未顯著增加不良事件的發(fā)生（交互P＝0.41）。在不同肝腎功能狀態(tài)患者中，銀杏二萜內(nèi)酯葡胺注射液可以有效提高急性缺血性腦卒中患者90 d的功能預(yù)后且未增加不良事件的發(fā)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

江蘇省院士工作站（BM2023118）