Liu Lanchun, Wang Jie, Li Jun, Li Xiao, Li Rong, Liu Yongmei, Yang Guang, Mao Qiyuan, Wang Lin, Yao Zhengyang, Wang Yongcheng, Zong Shuli, Liu Chao
Department of Cardiology, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.
Department of Cardiology, Affiliated Hospital of Shandong University of Chinese Medicine, Jinan, Shandong, China.
Front Cardiovasc Med. 2024 Jun 4;11:1293818. doi: 10.3389/fcvm.2024.1293818. eCollection 2024.
Coronary heart disease (CHD) is representative of cardiovascular disease and the leading cause of death in humans. Previous studies have shown that kidney disease is associated with CHD, and current treatment options that can improve both cardiac and renal functions still have some limitations. The traditional Chinese medicine Bu-Shen-Huo-Xue granule (BSHXG) can promote blood rheology, inhibit platelet agglutination, and improve heart and kidney functions.
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 210 participants will be randomized to the intervention group and the placebo group. The Guang'anmen Hospital of China Academy of Chinese Medical Sciences is the leading center, and the Affiliated Hospital of Shandong University of Chinese Medicine and the First Affiliated Hospital of Guangzhou University of Chinese Medicine are the participating units. In addition to conventional pharmacotherapy for angina, the intervention group will receive BSHXG while the placebo group will receive BSHXG placebo. All participants will receive 2 months of treatment with 6 months of follow-up. The primary outcome is the efficacy of angina pectoris symptoms in CHD. Secondary outcomes are nitroglycerin arrest, ECG efficacy, Seattle Angina Questionnaire score, serology indicators, assessment of safety, and cardiovascular endpoint events. The transcriptome and metabolome will be used to screen biomarkers for diagnosis and efficacy evaluation.
This study aimed to evaluate the efficacy and safety of Bu-Shen-Huo-Xue granule in the treatment of coronary heart disease, and to evaluate the benefits to patients with coronary heart disease from both cardiac and renal indicators.
This trial is approved by the Ethical Review Committee of the Guang'anmen Hospital China Academy of Chinese Medical Sciences with the number 2022-224-KY-01, and has been registered on the Chinese Clinical Trials Registry with the number ChiCTR2300070977 on 27 April 2023.
冠心病（CHD）是心血管疾病的代表，也是人类主要死因。既往研究表明，肾脏疾病与冠心病相关，目前能够同时改善心脏和肾脏功能的治疗方案仍存在一定局限性。中药补肾活血颗粒（BSHXG）可促进血液流变学，抑制血小板凝集，并改善心肾功能。
这是一项多中心、随机、双盲、安慰剂对照的临床试验。共210名参与者将被随机分为干预组和安慰剂组。中国中医科学院广安门医院为牵头中心，山东中医药大学附属医院和广州中医药大学第一附属医院为参与单位。除了对心绞痛进行常规药物治疗外，干预组将接受补肾活血颗粒治疗，而安慰剂组将接受补肾活血颗粒安慰剂治疗。所有参与者将接受2个月的治疗，并随访6个月。主要结局是冠心病心绞痛症状的疗效。次要结局包括硝酸甘油停药情况、心电图疗效、西雅图心绞痛问卷评分、血清学指标、安全性评估以及心血管终点事件。转录组和代谢组将用于筛选诊断和疗效评估的生物标志物。
本研究旨在评估补肾活血颗粒治疗冠心病的疗效和安全性，并从心脏和肾脏指标两方面评估对冠心病患者的益处。
本试验已获得中国中医科学院广安门医院伦理审查委员会批准，批准号为2022-224-KY-01，并于2023年4月27日在中国临床试验注册中心注册，注册号为ChiCTR2300070977。
