血塞通软胶囊治疗脑梗死有效性和安全性的系统评价

目的] 系统评价血塞通软胶囊治疗脑梗死的有效性和安全性。方法] 计算机检索中国知网、万方数据库、维普数据库、中国生物医学文献数据库（SinoMed）、PubMed及Embase数据库,检索期限从建库至2021年8月。检索血塞通软胶囊治疗脑梗死的随机对照试验（RCT）,采用Cochrane系统评价手册推荐的偏倚风险评估工具对纳入研究进行质量评价,并对血塞通软胶囊的有效性和安全性进行系统评价。结果] 检索得到683条文献题录,最终纳入16篇RCT,共1 973例患者。16项研究病例数据均完整,但未进行试验注册及方案审批。14项研究未提分配隐藏及受试者盲法,其中6项研究仅提及“随机”但并未描述具体分组方法,1项研究未在结果部分充分报告方法学内容。Meta分析结果：包括临床疗效、美国国立卫生院神经功能缺损评分（NIHSS）和Barthel指数等5项指标,其中13项研究报告了临床疗效,合并结果显示常规治疗联合血塞通软胶囊疗效优于单用常规治疗,OR=3.51（2.01,6.12）,P<0.05]。7项研究报告了NIHSS评分,合并结果显示常规治疗联合血塞通软胶囊疗效优于单用常规治疗,MD=-3.29（-3.89,-2.70）,P<0.05]。3项研究报告了Barthel指数,提示常规治疗基础上联用血塞通软胶囊疗效优于单用常规治疗。5项研究报告了血浆黏度,合并结果显示常规治疗基础上联用血塞通软胶囊疗效明显优于单用常规治疗,MD=-1.17（-1.64,-0.71）,P<0.05]。3项研究报告了全血黏度,合并结果显示常规治疗基础上联用血塞通软胶囊疗效明显优于单用常规治疗,MD=-4.88（-9.09,-0.67）,P<0.05]。结论] 本研究系统评价了血塞通软胶囊治疗脑梗死的有效性和安全性,结果显示相比于单用常规治疗,血塞通软胶囊联合常规治疗可提高脑梗死临床疗效。由于纳入文献的数量和质量等问题,研究结论尚需更多高质量的RCT研究予以验证。

Systematic evaluation of effectiveness and safety of Xuesaitong Soft Capsule in treating cerebral infarction

Objective] To evaluate the efficacy and safety of Xuesaitong Soft Capsule in the treatment of cerebral infarction.Methods] CNKI,Wanfang Database,VIP Database,China Biomedical Literature Database (SinoMed),PubMed and Embase Database were searched from construction to August 2021. Randomized controlled trials (RCTs) of Xuesaitong Soft Capsule in the treatment of cerebral infarction were retrieved,and the quality of the included studies was evaluated using the bias risk assessment tool recommended by the Cochrane Systematic Review Manual,and the efficacy and safety of Xuesaitong Soft Capsule were systematically evaluated.Results] A total of 683 references were retrieved,and 16 RCTs were included,including 1 973 patients. The case data of 16 studies were complete,but trial registration and protocol approval were not conducted. 14 studies did not mention assignment concealment and subject blindness,of which 6 only referred to "randomization" but did not describe specific grouping methods,and 1 study did not adequately report methodological content in the results section. Meta-analysis results including clinical efficacy,NIHSS score and Barthel index and so on,13 studies reported clinical efficacy,and the combined results showed that the efficacy of conventional treatment combined with Xuesaitong Soft Capsule was superior to conventional treatment aloneOR=3.51(2.01,6.12),P<0.05]. NIHSS score was reported in 7 studies,and the combined results showed that the efficacy of conventional treatment combined with Xuesaitong Soft Capsule was superior to conventional treatment aloneMD=-3.29(-3.89,-2.70),P<0.05]. Barthel index was reported in 3 studies,suggesting that combined Xuesaitong Soft Capsule on the basis of conventional treatment had better efficacy than conventional treatment alone. Plasma viscosity was reported in 5 studies,and the combined results showed that combined xuesaitong soft capsule on the basis of conventional treatment had significantly better efficacy than conventional treatment aloneMD=-1.17(-1.64,-0.71),P<0.05]. Three studies reported the whole blood viscosity,and the combined results showed that combined Xuesaitong Soft Capsule on the basis of conventional treatment had significantly better efficacy than conventional treatment aloneMD=-4.88(-9.09,-0.67),P<0.05].Conclusion] This study systematically evaluated the efficacy and safety of Xuesaitong Soft Capsule in the treatment of cerebral infarction,and the results showed that compared with conventional treatment alone,Xuesaitong Soft Capsule combined with conventional treatment can improve the clinical efficacy of cerebral infarction. Due to the quantity and quality of the included literature,the research conclusions need to be verified by more high-quality RCT studies.