心脑宁胶囊治疗慢性稳定型心绞痛（气滞血瘀证）的疗效与安全性：一项多中心、随机、双盲、安慰剂对照试验的研究方案
Efficacy and safety of Xinnaoning capsule in treating chronic stable angina (qi stagnation and blood stasis syndrome): Study protocol for a multicenter, randomized, double-blind, placebo-controlled trial.
作者信息
Zhao Jun-Nan, Zhang Ying, Lan Xu, Chen Yao, Li Jing, Zhang Ping, Wu Li-Qi, Jia Shu-Ting, Liu Yue, Xu Feng-Qin
机构信息
Institute of Geriatric Medicine, Xiyuan Hospital of China Academy of Chinese Medical Sciences.
Beijing Duheng for Drug Evaluation and Research Co., Ltd.
出版信息
Medicine (Baltimore). 2019 Aug;98(31):e16539. doi: 10.1097/MD.0000000000016539.
BACKGROUND
Chronic stable angina (CSA) is a cardiovascular disease with high prevalence. At present, drug treatment is still the main measure of stable angina pectoris. Traditional Chinese medicine has a long history in the treatment of CSA. Qi stagnation and Blood stasis syndrome is a common syndrome of CSA. Xinnaoning (XNN) capsule is considered as an effective adjuvant treatment for CSA with the efficacy of promoting qi and blood circulation but lack of high-quality clinical evidence. The purpose of this study is to evaluate the efficacy and safety of XNN capsule compared with placebo by clinical trial.
METHODS
This multicenter, randomized, double-blind, placebo-controlled trial will be conducted with a total of 240 participants diagnosed with chronic stable angina (qi stagnation and blood stasis syndrome). The participants will be randomized (1:1) into groups receiving either XNN or placebo for 12 weeks. After a 2-week run-in period, they will receive either XNN or placebo (3 pills, 3 times daily) for 12 weeks on the basis of conventional therapy. The primary outcomes include changes in the integral scores of angina symptoms. The secondary outcome measures include changes in the total score of traditional Chinese medicine syndrome, severity grading of angina pectoris, the number of angina pectoris per week, nitroglycerin dosage, score of seattle angina scale, serum homocysteine, incidence of cardiovascular events. Safety outcomes will also be assessed. Adverse events will be monitored throughout the trial.
RESULTS
This study will investigate whether XNN capsule can alleviate clinical symptoms, and improve quality of life of patients with chronic stable angina (qi stagnation and blood stasis syndrome). The results of this study will provide clinical evidence for the application of XNN capsule in the treatment of chronic stable angina.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT03914131.
背景
慢性稳定型心绞痛（CSA）是一种高发性心血管疾病。目前，药物治疗仍是稳定型心绞痛的主要治疗措施。中医在CSA的治疗方面历史悠久。气滞血瘀证是CSA的常见证型。心脑宁（XNN）胶囊被认为是CSA的一种有效辅助治疗药物，具有促进气血循环的功效，但缺乏高质量的临床证据。本研究旨在通过临床试验评估XNN胶囊与安慰剂相比的疗效和安全性。
方法
本多中心、随机、双盲、安慰剂对照试验将纳入240名被诊断为慢性稳定型心绞痛（气滞血瘀证）的参与者。参与者将按1:1随机分组，分别接受XNN或安慰剂治疗12周。在为期2周的导入期后，他们将在常规治疗的基础上接受XNN或安慰剂（每日3次，每次3粒）治疗12周。主要结局包括心绞痛症状积分的变化。次要结局指标包括中医证候总分的变化、心绞痛严重程度分级、每周心绞痛发作次数、硝酸甘油用量、西雅图心绞痛量表评分、血清同型半胱氨酸、心血管事件发生率。还将评估安全性结局。在整个试验过程中监测不良事件。
结果
本研究将调查XNN胶囊是否能缓解慢性稳定型心绞痛（气滞血瘀证）患者的临床症状并提高其生活质量。本研究结果将为XNN胶囊在慢性稳定型心绞痛治疗中的应用提供临床证据。
试验注册
ClinicalTrials.gov：NCT03914131。
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