Department of Respiratory Medicine, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, China.
J Altern Complement Med. 2011 Jul;17(7):579-87. doi: 10.1089/acm.2010.0354.
This study sought to evaluate the efficacy and safety of shenmai injection for chronic pulmonary heart disease (CPHD).
A systematic review was conducted of clinical trials that compared shenmai injection plus conventional medicine treatment versus conventional medicine treatment alone. Randomized controlled trials of clinical therapeutic studies on CPHD by shenmai injection were included. Searches were applied to the following electronic databases: the PubMed (1977-2008), the Cochrane Library, EMBASE, AMED, Chinese BioMedical Literature Database, and CBM. No blinding and language restriction was used. Data were extracted independently by 2 reviewers. All trials included were analyzed according to the criteria of the Cochrane Handbook. Review Manager 5.0 software was used for data analysis.
Thirty-three (33) randomized clinical trials (2617 patients) with low methodological quality were included. Compared to conventional medicine treatment alone, shenmai plus conventional medicine treatment showed significant improvement in New York Heart Association classification of clinical status (odds ratio 0.24; 95% confidence interval 0.19-0.30), five studies had reported adverse events. No serious adverse effects were reported in any of the included trials.
While there is some evidence that suggests potential effectiveness of shenmai plus conventional medical treatment for CPHD, the results of this study were limited by the methodological flaws, unknowns in concealment of allocation, number of dropouts, and blinding methods in the studies. Long-term and high-quality studies are needed to provide clear evidence for the future use of shenmai injection.
本研究旨在评价参麦注射液治疗慢性肺源性心脏病（CPHD）的疗效和安全性。
系统检索了比较参麦注射液加常规药物治疗与单纯常规药物治疗的临床试验。纳入参麦注射液治疗 CPHD 的临床治疗研究的随机对照试验。检索了以下电子数据库：PubMed（1977-2008）、Cochrane 图书馆、EMBASE、AMED、中国生物医学文献数据库和 CBM。未使用盲法和语言限制。由 2 名评价者独立提取数据。根据 Cochrane 手册的标准分析所有纳入的试验。使用 Review Manager 5.0 软件进行数据分析。
共纳入 33 项（33 项）随机临床试验（2617 例患者），方法学质量较低。与单纯常规药物治疗相比，参麦加常规药物治疗在纽约心脏协会临床状态分类方面有显著改善（优势比 0.24；95%置信区间 0.19-0.30），5 项研究报告了不良反应。任何纳入的试验均未报告严重不良事件。
虽然有一些证据表明参麦加常规药物治疗 CPHD 可能有效，但本研究结果受到研究中方法学缺陷、分配隐匿性、脱落病例数和盲法方法的限制。需要长期、高质量的研究为参麦注射液的未来应用提供明确的证据。
