国外针灸治疗原发性高血压RCT 试验设计特点分析

原发性高血压是临床常见慢性疾病之一，也是中医防治的重点。作者检索PubMed 数据库关于针灸治疗原发性高血压的RCT 文献加以分析，表明国外针灸治疗原发性高血压临床试验方法学质量较高，然而和其他针灸临床试验一样，存在治疗方案的中医理论不足，这可能是研究者中医学习不充分和文化背景的差异所致，加之样本量较少，治疗干预方式较多，未设立空白对照，且大部分为采用24 h 动态血压指标，难以客观评价针灸临床疗效。因此本研究团队在国家“973 课题”的资助下，采纳严格的研究方法学时结合中医传统循经和辨证结合的干预方案基础上加以改进，进行高质量的RCT 研究，以期进一步探讨经穴效应特异性的临床疗效规律。

Reviews on RCT Design Characteristic of Primary Hypertension Treatment with Acupuncture Abroad

Primary hypertension is one of the common chronic diseases, as well as the key disease for prevention and treatment by traditional Chinese medicine (TCM). The authors searched and analyzed RCTs studies on primary hypertension treatment with acupuncture in the PubMed. It showed that primary hypertension treatment with acupuncture abroad had high quality methodologies. However, the deficiencies of TCM theories in the treatment plan in these studies were the same as RCTs of acupuncture treatment design of other diseases. It may due to the insufficiency of TCM knowledge and culture differences of researchers aboard. Besides, the small sample amount, various interventions, no blank control, and the using of 24-hour ambulatory blood pressure most of the time, may difficult to objectively evaluate the clinical effect of acupuncture. Therefore, our research team will carry out high quality RCT studies under the guidance of TCM theories of meridians and syndrome differentiation to further discuss the specificity of acupoints.