Yu Dan-Dan, Xie Yan-Ming, Zhang Yun-Ling, Liao Xing, Zhi Ying-Jie, Zhao Hui
Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences Beijing 100700,China.
Xiyuan Hospital,China Academy of Chinese Medical Sciences Beijing 100091,China.
Zhongguo Zhong Yao Za Zhi. 2019 Jan;44(2):372-380. doi: 10.19540/j.cnki.cjcmm.2019.0008.
To systematically review the effectiveness and safety of Kudiezi Injection in treating patients with acute cerebral infarction( ACI). Four Chinese databases( CNKI,VIP,Wan Fang,Sino Med),three English databases( Cochrane Library,EMbase,Medline)and Clinical Trail.gov were systematically and comprehensively retrieved. The retrieval time was from the establishment of each database to November 2017. Randomized controlled trials( RCTs) for the treatment of acute cerebral infarction with Kudiezi Injection were screened out according to pre-established inclusion criteria and exclusion criteria. The quality of the included studies was assessed using the Cochrane Risk Assessment Tool,and the included studies were put into descriptive analysis or Meta-analysis using the Rev Man 5. 3 software. A total of 932 articles were retrieved,and finally 14 studies were included. Except for 2 multi-arm trials,the total sample size was 1 244 in the experimental group and 638 in the control group. The overall quality of the included studies was not high. The results of Meta-analysis showed that Kudiezi + conventional therapy for acute cerebral infarction was superior to conventional therapy in total effective rate( RR = 0. 86,95% CI[0. 77,0. 96],P = 0. 006); Kudiezi + conventional therapy for acute cerebral infarction was superior to conventional therapy in serum inflammatory factors( MDhs-CRP=-3. 77,95% CI[-4. 17,-3. 37],P < 0. 000 01; MDIL-18=-16. 18,95% CI[-19. 26,-13. 11],P<0. 000 01); Kudiezi + conventional therapy was superior to conventional therapy in Barthel index( MD = 12. 52,95%CI[8. 93,16. 10],P<0. 000 01). Adverse reactions included in the study reports showed mild adverse reactions. Based on the results of this study,Kudiezi Injection combined with conventional therapy or other Western medicine had a certain curative effect on acute cerebral infarction,with no serious adverse reactions. However,due to the low quality of the included research methodology,the conclusions of this study were not recommended. In addition,in order to produce high-quality evidence for the clinical application of Kudiezi Injections,more randomized controlled trials with a large sample size,scientific design and strict implementation were required to study the effectiveness and safety of Kudiezi Injection in the treatment of cerebral infarction.
系统评价苦碟子注射液治疗急性脑梗死（ACI）患者的有效性和安全性。系统全面地检索了4个中文数据库（中国知网、维普、万方、中国生物医学文献数据库）、3个英文数据库（考克兰图书馆、EMbase、Medline）以及Clinical Trail.gov。检索时间为各数据库建库至2017年11月。根据预先制定的纳入标准和排除标准，筛选出苦碟子注射液治疗急性脑梗死的随机对照试验（RCT）。采用Cochrane风险评估工具对纳入研究的质量进行评估，使用Rev Man 5.3软件对纳入研究进行描述性分析或Meta分析。共检索到932篇文章，最终纳入14项研究。除2项多臂试验外，试验组总样本量为1244例，对照组为638例。纳入研究的整体质量不高。Meta分析结果显示，苦碟子注射液联合传统疗法治疗急性脑梗死在总有效率方面优于传统疗法（RR = 0.86，95%CI[0.77，0.96]，P = 0.006）；苦碟子注射液联合传统疗法治疗急性脑梗死在血清炎症因子方面优于传统疗法（MDhs-CRP=-3.77，95%CI[-4.17，-3.37]，P < 0.000 01；MDIL-18=-16.18，95%CI[-19.26，-13.11]，P<0.000 01）；苦碟子注射液联合传统疗法在Barthel指数方面优于传统疗法（MD = 12.52，95%CI[8.93，16.10]，P<0.000 01）。研究报告中纳入的不良反应显示为轻度不良反应。基于本研究结果，苦碟子注射液联合传统疗法或其他西药对急性脑梗死有一定疗效，且无严重不良反应。然而，由于纳入研究方法的质量较低，本研究结论不被推荐。此外，为了为苦碟子注射液的临床应用提供高质量证据，需要更多大样本量、科学设计和严格实施的随机对照试验来研究苦碟子注射液治疗脑梗死的有效性和安全性。
