Yang Feng-Wen, Zou Jia-Han, Wang Yuan, Sun Chong-Xiang, Ge Long, Tian Jin-Hui, Zhang Jun-Hua
Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.
Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.
Zhongguo Zhong Yao Za Zhi. 2018 Mar;43(6):1247-1253. doi: 10.19540/j.cnki.cjcmm.2018.0049.
To assess the clinical efficacy of Chinese medical injection (CMI) for heart failure by using network Meta-analysis method. The relative randomized controlled trials (RCTs) of CMI for heart failure were retrieved from China National Knowledge Infrastructure (CNKI), WanFang Database, Chinese Biomedical Literature Database (SinoMed), PubMed, Cochrane Library and EMbase in July 2017. RCTs on the comparison of two kinds of CMIs for heart failure were included. Two researchers independently completed the literature screening, data extraction and quality evaluation according to the pre-determined inclusion and exclusion criteria, and the results were crossed checked. The data were analyzed by Win Bugs, and STATA software was used for plotting. Finally, 13 RCTs were included, involving 5 kinds of CMIs and 1 538 patients. According to the quality evaluation, the appropriate random dividing methods were reported in only two RCTs, double-blindness was used in only one RCT, and even none of the RCTs mentioned allocation concealment. Network Meta-analysis showed that Shenmai injection had the greatest effect in the clinical efficacy for patients with heart failure, which was followed by Shenfu Injection. However, Shenfu Injection was most effective in improving the patients' left ventricular ejection fraction (LVEF), which was followed by Shenmai Injection. Therefore, Shenfu Injection and Shenmai Injection had certain advantages in treating heart failure. However, due to the limited sample size and the poor literature quality, more studies were required to verify the strength of evidence. We suggest that further studies shall pay more attention to the improvement of the methodological quality, increase the follow-up period, and strengthen the observation of cardiovascular end points.
采用网状Meta分析方法评估中药注射剂治疗心力衰竭的临床疗效。于2017年7月从中国知网、万方数据库、中国生物医学文献数据库(SinoMed)、PubMed、Cochrane图书馆和EMbase中检索有关中药注射剂治疗心力衰竭的相关随机对照试验(RCT)。纳入比较两种中药注射剂治疗心力衰竭的RCT。两名研究人员根据预先确定的纳入和排除标准独立完成文献筛选、数据提取和质量评估,并对结果进行交叉核对。采用Win Bugs软件进行数据分析,并用STATA软件绘图。最终纳入13项RCT,涉及5种中药注射剂和1538例患者。根据质量评估,仅两项RCT报告了合适的随机分组方法,仅一项RCT采用了双盲法,甚至没有一项RCT提及分配隐藏。网状Meta分析显示,参麦注射液治疗心力衰竭患者的临床疗效最佳,其次是参附注射液。然而,参附注射液在改善患者左心室射血分数(LVEF)方面最有效,其次是参麦注射液。因此,参附注射液和参麦注射液在治疗心力衰竭方面具有一定优势。然而,由于样本量有限和文献质量较差,需要更多研究来验证证据强度。我们建议进一步研究应更加关注方法学质量的提高,延长随访期,并加强心血管终点观察。