基于中医辨证及中医机制的稳定型心绞痛的中药治疗：一项随机对照试验的研究方案
Traditional Chinese medicine for stable angina pectoris via TCM pattern differentiation and TCM mechanism: study protocol of a randomized controlled trial.
作者信息
Zhang Zhe, Zhang Fan, Wang Yang, Du Yi, Zhang Huiyong, Kong Dezhao, Liu Yue, Yang Guanlin
机构信息
Liaoning University of Traditional Chinese Medicine, 79, Chong Shan Dong Lu Road, Huanggu District, Shenyang 110032, Liaoning, China.
出版信息
Trials. 2014 Oct 30;15:422. doi: 10.1186/1745-6215-15-422.
BACKGROUND
Stable angina pectoris is experienced as trans-sternal or retro-sternal pressure or pain that may radiate to the left arm, neck or back. Although available evidence relating to its effectiveness and mechanism are weak, traditional Chinese medicine is used as an alternative therapy for stable angina pectoris. We report a protocol of a randomized controlled trial using traditional Chinese medicine to investigate the effectiveness, mechanism and safety for patients with stable angina pectoris.
METHODS/DESIGN: This is a north-east Chinese, multi-center, multi-blinded, placebo-controlled and superiority randomized trail. A total of 240 patients with stable angina pectoris will be randomly assigned to three groups: two treatment groups and a control group. The treatment groups will receive Chinese herbal medicine consisting of Yi-Qi-Jian-Pi and Qu-Tan-Hua-Zhuo granule and Yi-Qi-Jian-Pi and Qu-Tan-Hua-Yu granule, respectively, and conventional medicine. The control group will receive placebo medicine in addition to conventional medicine. All 3 groups will undergo a 12-week treatment and 2-week follow-up. Four visits in sum will be scheduled for each subject: 1 visit each in week 0, week 4, week 12 and week 14. The primary outcomes include: the frequency of angina pectoris attack; the dosage of nitroglycerin; body limited dimension of Seattle Angina Questionnaire. The secondary outcomes include: except for the body limited dimension of SAQ, traditional Chinese medicine pattern questionnaire and so on. Therapeutic mechanism outcomes, safety outcomes and endpoint outcomes will be also assessed.
DISCUSSION
The primary aim of this trial is to develop a standard protocol to utilize high-quality EBM evidence for assessing the effectiveness and safety of SAP via TCM pattern differentiation as well as exploring the efficacy mechanism and regulation with the molecular biology and systems biology.
CLINICAL TRIALS REGISTRATION
ChiCTR-TRC-13003608, registered 18 June 2013.
背景
稳定型心绞痛表现为胸骨后或胸骨下的压榨感或疼痛，可放射至左臂、颈部或背部。尽管关于其有效性和机制的现有证据尚不充分，但中药被用作稳定型心绞痛的替代疗法。我们报告一项使用中药的随机对照试验方案，以研究稳定型心绞痛患者的有效性、机制和安全性。
方法/设计：这是一项在中国东北地区进行的多中心、多盲、安慰剂对照的优效性随机试验。总共240例稳定型心绞痛患者将被随机分为三组：两个治疗组和一个对照组。治疗组将分别接受由益气健脾、祛痰化浊颗粒和益气健脾、祛痰化瘀颗粒组成的中药以及常规药物治疗。对照组除常规药物外将接受安慰剂治疗。所有三组都将接受为期12周的治疗和2周的随访。每个受试者总共将安排4次就诊：在第0周、第4周、第12周和第14周各就诊1次。主要结局包括：心绞痛发作频率；硝酸甘油用量；西雅图心绞痛问卷的身体受限维度。次要结局包括：除西雅图心绞痛问卷的身体受限维度外，还有中医证型问卷等。还将评估治疗机制结局、安全性结局和终点结局。
讨论
本试验的主要目的是制定一个标准方案，利用高质量的循证医学证据，通过中医辨证评估稳定型心绞痛的有效性和安全性，并探索其疗效机制以及分子生物学和系统生物学的调控作用。
临床试验注册
ChiCTR - TRC - 13003608，于2013年6月18日注册。
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