丹红注射液治疗急性脑梗死疗效和安全性的系统评价和Meta分析

Systematic evaluation and meta analysis of efficacy and safety of Danhong Injection in the treatment of acute cerebral infarction

关键词:  丹红注射液  急性脑梗死  随机对照试验  系统评价  Meta分析

Key words:  Danhong Injection  acute cerebral infarction  randomized controlled trial  system evaluation  Meta analysis

摘要:

[目的] 系统评价丹红注射液治疗急性脑梗死的有效性和安全性。[方法] 计算机检索中国知网（CNKI）、万方数据库（WanfangData）、维普数据库（VIP）、中国生物医学文献数据库（SinoMed）、PubMed和Embase数据库，检索期限自建库至2022年1月。检索丹红注射液治疗急性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，并对丹红注射液的有效性和安全性进行系统评价。[结果] 检索得到2511条文献题录，最终纳入23篇RCT，共3169例患者。23项研究病例数据均完整，但未进行试验注册及方案审批，未提分配隐藏及受试者盲法。其中15项研究仅提及“随机”但并未描述具体分组方法，2项研究仅报告主观结局指标。Meta分析结果显示，在临床疗效[RR=1.23（1.19，1.28），P<0.05]、神经功能缺损评分（NIHSS）[MD=-3.64（-3.80，-3.47），P<0.05]、纤维蛋白原[MD=-0.83（-0.99，-0.68），P<0.05]、血浆黏度[MD=-0.20（-0.27，-0.14），P<0.05]、全血低切黏度[MD=-1.58（-1.90，-1.25），P<0.05]、全血高切黏度[MD=-0.56（-0.69，-0.44），P<0.05]方面，西药常规治疗基础上联用丹红注射液疗效明显优于西药常规治疗。纳入研究共报告了23例不良反应，其中治疗组16例，对照组7例。[结论] 本研究系统评价了丹红注射液治疗急性脑梗死的有效性和安全性，结果显示与单用西药常规治疗比较，丹红注射液联合西药常规治疗可改善急性脑梗死临床疗效。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。

Abstract:

[Objective] To systematically evaluate the efficacy and safety of Danhong Injection in the treatment of acute cerebral infarction.[Methods] CNKI,Wanfang,VIP,SinoMed,PubMed and Embase databases were searched by computer from the time of database establishment to January 2022. Randomized controlled trials(RCTs) of Danhong Injection in the treatment of acute 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 Danhong Injection were systematically evaluated.[Results] A total of 2 511 studies were retrieved,and 23 RCTS were eventually included,with a total of 3 169 patients. The data of the 23 studies were complete,but there was no trial registration,protocol approval,allocation concealment and subject blindness. The 15 of the studies only referred to "randomization" but did not describe specific grouping methods,and 2 only reported subjective outcome measures. Meta-analysis showed that clinical efficacy[RR=1.23(1.19,1.28),P<0.05],neurological deficit score (NIHSS)[MD=-3.64(-3.80,-3.47),P< 0.05],fibrinogen[MD=-0.83(-0.99,-0.68),P<0.05],the plasma viscosity[MD=-0.20(-0.27,-0.14),P<0.05],whole blood low shear viscosity[MD=-1.58(-1.90,-1.25),P<0.05],whole blood high shear viscosity[MD=-0.56(-0.69,-0.44),P<0.05],combined with Danhong Injection on the basis of conventional treatment of Western medicine was significantly better than conventional treatment of Western medicine. A total of 23 adverse reactions were reported in the included study,including 16 in the treatment group and 7 in the control group.[Conclusion] This study systematically evaluated the efficacy and safety of Danhong Injection in the treatment of acute cerebral infarction and the results showed that compared with conventional treatment alone,Danhong Injection combined with conventional treatment can improve the clinical efficacy of acute 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.