中成药联合依达拉奉右莰醇治疗急性脑梗死的临床疗效及安全性Meta分析

Meta-Analysis of Clinical Efficacy and Safety of Chinese Patent Medicine Combined with Edaravone Dextrorphan in the Treatment of Acute Cerebral Infarction

摘要: 目的：系统评价中成药联合依达拉奉右莰醇治疗急性脑梗死的临床疗效及安全性，为临床用药选择提供循证学支持。方法：经计算机检索中国知网(CNKI)、万方、维普、PubMed、Web of Science、Cochrane Library、SinoMed和Embase数据库。检索时间为建库至2024年7月1日，对中成药联合依达拉奉右莰醇治疗急性脑梗死的临床随机对照试验(RCT)进行检索，并对符合纳入标准的文件进行资料提取。使用Stata 18.0软件进行Meta分析，ROB 2.0工具评估偏倚风险。结果：共纳入10项RCT研究，涉及1058例患者。Meta分析结果显示，与对照组相比，试验组总有效率[RR = 1.14, 95% CI (1.08, 1.20), P = 0.132]、日常生活活动能力量表评分[SMD = 2.34, 95% CI (0.93, 3.76), P < 0.001]较对照组显著提高，美国国立卫生研究院脑卒中量表评分[SMD = −2.03, 95% CI (−2.41, −1.66), P < 0.001]、超敏C反应蛋白水平[SMD = −2.37, 95% CI (−2.83, −1.92), P = 0.040]、白介素-6水平[SMD = −1.64, 95% CI (−2.05, −1.22), P = 0.022]显著降低，两组不良反应发生率比较，差异无统计学意义[RR = 0.88, 95% CI (0.45, 1.72), P = 0.445]。结论：共纳入10项随机对照试验，结果提示中成药联合依达拉奉右莰醇治疗可提高急性脑梗死病人的临床疗效，且安全性相当。未来还需要高质量的研究来进一步验证我们的结论。

Abstract: Objective: To systematically evaluate the clinical efficacy and safety of Chinese patent medicine combined with Edaravone dextrorphan in the treatment of acute cerebral infarction, and provide evidence-based support for clinical drug selection. Methods: The databases of China National Knowledge Infrastructure (CNKI), Wanfang Database, VIP, PubMed, Web of Science, Cochrane Li-brary, SinoMed and Embase were searched. The search period extended from the inception of the database up to July 1, 2024. The clinical randomized controlled trials (RCTS) of Chinese patent medicine combined with edaravone dextrorphan and the data were extracted from the documents that met the inclusion criteria. Stata 18.0 software was used for Meta-analysis, and ROB 2.0 tool was used to assess the risk of bias. Results: Participants included 10 RCT studies involving 1058 pa-tients. Meta-analysis results show that, compared with the control group, total effective rate of ex-perimental group [RR = 1.14, 95% CI (1.08, 1.20), P = 0.132] and daily life activities ability rating scale [SMD = 2.34, 95% CI (0.93, 3.76), P < 0.001] were significantly higher than the control group, and the national institutes of health stroke scale score [SMD = −2.03, 95% CI (−2.41, −1.66), P < 0.001], hypersensitive C-reactive protein level [SMD = −2.37, 95% CI (−2.83, −1.92), P = 0.040], and interleukin-6 level [SMD = −1.64, 95% CI (−2.05, −1.22), P = 0.022] were significantly reduced. The occurrence of adverse reactions was comparable between the two groups, with no statistically sig-nificant differences observed [RR = 0.88, 95% CI (0.45, 1.72), P = 0.445]. Conclusion: A total of 10 randomized controlled trials were included, and the results suggested that Chinese patent medicine combined with edaravone dextrorphan could improve the clinical efficacy of patients with acute cerebral infarction, and the safety was equivalent. High-quality studies are needed to further verify our conclusions.