摘要
目的：评价中医药治疗急性心肌梗死临床研究的质量。方法：①以（中文标题：心肌梗塞or心肌梗死）and（全部检索条目：中医or中药or中西医结合）的检索式检索中国生物医学文献光盘数据库，年限为1978年1月至2004年11月。②由2位研究者独立进行文献筛选，获取文献的相关研究特征资料，并加以评价，意见不同者通过讨论解决。结果：①共检索到1621个文献。②经两次筛选，最终共有252篇文献入选评价。③临床研究文献存在遵循标准的程度不足、研究设计缺陷较明显（特别是随机、盲法和统计学方法）、观察指标选择不尽理想（特别是缺乏远期预后指标）等问题。对提到“随机”的文献进行Jadad评分，高质量的随机对照试验（3～5分）只有1篇。而非随机对照临床研究质量评分结果，也没有1篇得分超过6分（总分是12分）。结论：中医药治疗急性心肌梗死的临床研究应加强对循证医学原则的重视，同时探讨能够体现中医药特色和优势的评价体系。
Objective： Study on the methodological quality of clinical trials used Chinese medicine for acute myocardial infarction（ AMI）. Method ： ① Search items were （ Title ： myocardial infarction） AND （ All field： Chinese medicine OR Chinese herb OR Integrated applied to the CBM database （1978. 1-2004. 11 ） Chinese and Western Medicine）, the search was ② Data selection was performed by 2 reviewers independently, different opinions should be solved through out. OThrough negotiation. Result ： ① 1621 literatures were found twice selection, there were 252 clinical study literatures meet the evaluate procedure. ② Many questions were found on the methodology of these studies. The first question was lack of standards, including diagnosis and effectiveness standard. The second, there were many obviously defects on the designation, especially in randomization, blinding and statistics method. The third, the choice of observed index was not perfect, lacked of long-term indexes. The literatures mentioned about ＂randomize＂ were evaluated according to Jadad score, only 1 study get 3 score （total score was 5 ）. The evaluation of non-randomized controlled trial was also unsatisfactory, no studies get 50 % score. Conclusion： Clinical studies of Chinese Medicine for AMI should confirm to the principle of Evidence Based Medicine, and try to build up a new evaluation system that can manifest the advantage of Chinese Medicine.
出处
《中国中医基础医学杂志》
CAS
CSCD
北大核心
2006年第7期489-491,共3页
JOURNAL OF BASIC CHINESE MEDICINE
基金
国家973计划资助课题(2003CB517103)
关键词
中医药
急性心肌梗死
临床研究
系统评价
Chinese medicine
acute myocardial infarction
clinical trial systematic
review
