中医治疗原发性高血压临床研究文献的评价

Review on clinical research literature of treatment of primary hypertension with Chinese medicine

目的对中医药治疗原发性高血压(EH)的临床研究文献的总体水平做出初步评价。方法选择中国生物医学文献数据库,检出截止到2005年的中医药治疗EH的临床研究文献,按标准纳入文献,搜集其研究方法和内容,建立数据库,运用统计软件进行整体评价。结果在1185项纳入的临床研究中,说明诊断标准的917项(77.38%),辨证论治的492项(41.52%),有疗效标准的932项(78.65%),随机对照试验534项(45.06%),进行了统计学分析的791项(66.75%),报告有不良反应的157项(13.25%),有随访报告的98项(8.27%)。结论EH的中医治疗性临床研究呈递增态势,但也存在着很多有待提高之处。应该进行多中心大样本的试验,采用先进的疗效评价标准和指标,完善统计方法、不良反应报告和随访等。

Objective To review initially on the general level of clinical research literature of the treatment of primary hypertension with Chinese medicine. Methods The clinical research literature of the treatment of primary hypertension with Chinese medicine was searched （until 2005 ） from Chinese Biological and Medical Database according to the inclusion criteria. The research methods and contents were collected for the establishment of clinical research literature database, which was then reviewed generally by using statistical software. Results Among 1185 clinical research items included there were 917 items （77.38 %） having diagnostic standards, 492 （41.52 % ） having syndrome differentiation and treatment, 932 （78.65 % ） having curative effect standard, 534 （45.06 %） for random control test, 791 （66.75 %） having statistical analysis, 157 （13.25 %） with side effects, and 98 （8.27 %） with follow-up reports. Conclusion The clinical research of the treatment of primary hypertension with Chinese medicine has an increasing trend, but it should be improved. The test of multi-center and large-sample should be carried out, advanced review criteria and indexes should be applied, and the statistical methods, side-effect reports and follow-up visits should be developed.