丁苯酞联合阿加曲班治疗急性脑梗死的Meta分析

Meta-analysis of combination therapy of butylphthalide and argatroban in acute cerebral infarction

目的 评估丁苯酞与阿加曲班联合治疗急性脑梗死(AIS)的疗效和安全性。方法 计算机检索数据库筛选出丁苯酞与阿加曲班联合治疗AIS的随机对照试验,根据纳入标准和排除标准,对纳入的文献进行数据提取及质量评价后,使用软件RevMan5.3进行Meta分析。评价指标包括美国国立卫生研究院卒中量表(National Institute of Health Stroke Scale,NIHSS)评分、Barthel指数量表(Barthel Index,BI)评分、改良的Rankin量表(Modified Rankin Scale,mRS)评分、临床有效率(NIHSS评分减少>18%,症状基本恢复或症状部分改善)以及不良反应。风险比(risk ratio,RR)及95%可信区间(confidence interval,CI)用作计数资料的效应值,均数差(mean difference,MD)及95%CI用作计量资料的效应值。结果共纳入8篇文献,966例AIS患者。Meta分析结果显示:丁苯酞联合阿加曲班组的NIHSS评分改善(MD=-3.91,95%CI [-5.09,-2.73],P<0.00001),临床有效率(RR=1.22,95%CI[1.14,1.31],P<0.00001),BI评分(MD=12.96,95%CI [3.60,22.32],P <0.00001),mRS评分(MD=-0.94,95%CI[-1.22,-0.66],P<0.00001)均优于单用阿加曲班组。两组不良反应发生率无明显差异(RR=1.27,95%CI [0.57,2.74],P=0.54)。结论 AIS患者联合使用丁苯酞和阿加曲班可提高总的有效率,短期内神经功能缺损和日常生活能力比单用阿加曲班有明显改善,无明显严重不良反应。

Objective To evaluate the efficacy and safety of the combination therapy of butylphthalide and argatroban in patients with acute ischemic stroke(AIS).Method We collected all published studies by systematically searching databases for randomized controlled trials(RCTs)of butylphthalide combined with argatroban in the treatment of AIS.Data extraction and quality evaluation were performed from the RCTs.RevMan 5.3 was used to conduct Meta-analysis.Outcome measures include National Institute of Health Stroke Scale(NIHSS)score,Barthel Index(BI)score,Modified Rankin Scale(mRS)score,clinical effective rate(NIHSS score reduction >18%,completely recovery or partial improvement of symptoms)and adverse reactions.Risk ratio(RR)and 95%confidence interval(CI)were used as effect values for discontinuous data,and mean difference(MD)and 95%CI were used as effect values for continuous data.Results A total of 966 patients with AIS were included in 8 RCTs.Meta-analysis showed that the combination therapy group of butylphthalide and argatroban was better than the control group in improving patients'therapeutic efficiency(RR=1.22,95%CI[1.14,1.31],P 0.00001),NIHSS scores(MD=-3.91,95%CI[-5.09,-2.73],P<0.00001),BI scores(MD=12.96,95%CI[3.60,22.32],P<0.00001),mRS scores(MD=-0.94,95%CI[-1.22,-0.66],P<0.00001).No significant difference was found between the two groups in the incidence of adverse reactions(RR=1.27,95%CI[0.57,2.74],P=0.54).Conclusion Compared with argatroban alone,butylphthalide combined with argatroban could improve therapeutic efficiency,neurological impairment and activities of daily abilities in patients of AIS in the short term and had no severe reactions.