依达拉奉联合吡拉西坦注射液治疗大面积 脑梗死的临床疗效系统评价

Systematic Review of Clinical Efficacy of Edaravone Combined with Piracetam Injection for Massive Cerebral Infarction

摘要: 目的：评价依达拉奉联合吡拉西坦注射液治疗大面积脑梗死的临床效果与安全性。方法：检索中国知网、万方、维普及PubMed等数据库(建库至2025年7月)，筛选相关随机对照试验(RCT)。由2名研究者独立筛选文献、提取数据，参照系统评价规范进行质量评价，采用STATA 18.0软件进行Meta分析。结果：共纳入16项RCT (1275例患者)。联合治疗组临床总有效率显著高于单用依达拉奉组(OR = 4.54, 95% CI: 3.10~6.64, P < 0.001)；治疗后NIHSS评分更低(MD = −1.94, P < 0.001)、MMSE评分更高(MD = 1.71, P < 0.001)、CSS评分改善更明显(MD = −5.03, P < 0.001)。亚组分析显示，疗程 ≥ 14天亚组OR = 4.72 (95% CI: 3.21~6.93, I² = 0%)，疗效更稳定；异质性主要来源于吡拉西坦剂量(4.0 g/日vs 8.0 g/日)、疗程及患者基线特征。8项研究报告安全性，两组不良反应(轻度胃肠道反应、皮疹)发生率无显著差异(P > 0.05)。结论：依达拉奉联合吡拉西坦注射液治疗大面积脑梗死可有效改善神经功能与认知水平，安全性良好，疗程建议≥14天，适合基层临床推广使用。

Abstract: Objective: To evaluate the clinical efficacy and safety of edaravone combined with piracetam injection in the treatment of massive cerebral infarction. Methods: Databases including CNKI, Wanfang, VIP, and PubMed were searched from their inception to July 2025 to screen relevant randomized controlled trials (RCTs). Two independent reviewers screened the literature, extracted data, and assessed quality according to systematic review standards. Meta-analysis was performed using STATA 18.0 software. Results: A total of 16 RCTs involving 1275 patients were included. The total clinical effective rate in the combination therapy group was significantly higher than that in the edaravone monotherapy group (OR = 4.54, 95% CI: 3.10~6.64, P < 0.001). After treatment, the combination group showed lower NIHSS scores (MD = −1.94, P < 0.001), higher MMSE scores (MD = 1.71, P < 0.001), and more significant improvement in CSS scores (MD = −5.03, P < 0.001). Subgroup analysis demonstrated more stable efficacy in the subgroup with a treatment course ≥14 days (OR = 4.72, 95% CI: 3.21~6.93, I² = 0%). The main sources of heterogeneity were piracetam dosage (4.0 g/day vs 8.0 g/day), treatment course, and baseline patient characteristics. Eight studies reported safety outcomes, showing no significant difference in the incidence of adverse reactions (mild gastrointestinal reactions, rash) between the two groups (P > 0.05). Conclusion: The combination of edaravone and piracetam injection for massive cerebral infarction can effectively improve neurological function and cognitive levels with good safety. A treatment course of at least 14 days is recommended, making it suitable for promotion in primary clinical settings.