基于循证的中成药治疗原发性高血压临床证据评价

Evaluation of the clinical evidence-body of Chinese patent medicine in the treatment of essential hypertension

目的 汇总和评价降压类中成药的临床研究证据。方法 计算机检索8个主要的中英文数据库,搜集2020年医保目录中收载的降压中成药治疗原发性高血压的所有临床研究(包括二次研究),检索时限从建库初始至2020年7月底。参照牛津大学循证医学中心证据分级和推荐标准对证据进行分级。采用Cochrane协作网随机对照试验偏倚风险评估工具评估临床研究的方法学质量,采用中医药复方临床试验报告的统一标准评估报告质量。结果 共检索到66种具有降压循证支持的中成药且部分中成药已积累了大量的临床证据。临床研究以随机对照试验为主,其次为非随机对照研究;部分研究尚有结合证型、临床症状、合并症或靶器官损害等的临床证据。证据评价分级显示,50种中成药具有1级证据。总体上临床研究的方法学质量不高,多体现在无盲法应用。报告质量不高多表现在研究对象无辨证分型及对干预措施的细节描述。结论 临床医生对中成药在高血压防治中发挥的作用有较高的关注度,但各类临床研究总体上方法学质量不高且报告不够规范,影响了研究结果的可靠性。相关研究缺乏中医特色。

Objective To summarize and evaluate the clinical research evidence of antihypertensive Chinese patent medicine. Methods Eight major Chinese and English databases were searched to identify all clinical studies(including secondary studies) of antihypertensive Chinese patent medicine in the treatment of essential hypertension listed on the 2020 Directory of Insured Medicine. The retrieval time was from the establishment of the database to July 2020.The evidence was graded according to the evidence classification and recommendation standard of Oxford University Evidence-Based Medicine Center. The methodological quality of clinical research was evaluated using Cochrane’s risk of bias tool, and the reporting quality was evaluated using consolidated standards for reproting trials of traditional Chinese medicine(CONSORT for TCM). Results A total of 66 Chinese patent medicines with evidence-based support for reducing blood pressure were retrieved, and a large amount of clinical evidence was accumulated for some Chinese patent medicines. Randomized controlled trials were the main clinical research, followed by non-randomized controlled trials. Some studies still had clinical evidence for the treatment of hypertension with clinical symptoms/comorbidities and target organ damage. Fifty drugs had level 1 evidence. The low quality of methodology was mainly reflected in the absence of "double blind" application. The report quality was not high, mostly in the absence of traditional Chinese medicine syndrome description and detailed description of intervention measures. Conclusions Clinicians pay high attention to the role of proprietary Chinese medicines in the prevention and treatment of hypertension, but the overall legal quality of all clinical studies is not high, and the report is not standardized, which will affect the reliability of research results. Relevant research lack traditional Chinese medicine characteristics.