Zhao Zhiqiang, Wang Xianliang, Hou Yazhu, Wang Shuai, Zhai Jingbo, Wang Cong, Mao Jingyuan, Zhang Boli
Cardiovascular Department of First Teaching Hospital of Tianjin University of Traditional Chinese Medicine.
Tianjin University of Traditional Chinese Medicine, Tianjin, China.
Medicine (Baltimore). 2018 Nov;97(45):e13085. doi: 10.1097/MD.0000000000013085.
The prognosis of ischemic heart failure (IHF) is worse than non-IHM. Improving the management of IHF remains an urgent demand. In recent years, Qishen Yiqi dripping pills (QSYQ), a type of Chinese herbal medicine (CHM), has been popular for IHF combined with standard western medicine. However, relevant scientific evidence from the real clinical practice still is insufficient. The prospective cohort study aims to assess the effectiveness and safety of QSYQ plus standard western medicine for IHF in the real clinical practice.
It is a multicenter, prospective, observational cohort study. A total of 1200 patients with IHF recruited from 84 hospitals in China will be assigned to exposure group (patients with QSYQ treatment) or non-exposed group (patients without QSYQ treatment) mainly according to patients' preference in real clinical situation. The primary outcomes include New York Heart Association (NYHA) cardiac functional classification and Minnesota Living with Heart Failure Questionnaire (MLHFQ). The secondary outcomes include composite outcomes (all-cause mortality, frequency of re-admission or emergency due to cardiovascular events), left ventricular ejection fraction and cardiothoracic ratio, symptoms and signs obtained by the 4 Tradiational Chinese Medicine (TCM) diagnostic methods. Assessments will be performed at baseline, 1st and 3rd month after enrollment.
It will provide new evidence on QSYQ for IHF in real clinical practice.
This study has been registered on the Chinese Clinical Trial Registry (No: ChiCTR-ONRC-14004407).
缺血性心力衰竭（IHF）的预后比非缺血性心力衰竭更差。改善缺血性心力衰竭的管理仍然是一项迫切需求。近年来，中药芪参益气滴丸（QSYQ）联合标准西药治疗缺血性心力衰竭受到广泛关注。然而，来自实际临床实践的相关科学证据仍然不足。这项前瞻性队列研究旨在评估芪参益气滴丸联合标准西药在实际临床实践中治疗缺血性心力衰竭的有效性和安全性。
这是一项多中心、前瞻性、观察性队列研究。在中国84家医院招募的1200例缺血性心力衰竭患者将主要根据实际临床情况中患者的偏好分为暴露组（接受芪参益气滴丸治疗的患者）或非暴露组（未接受芪参益气滴丸治疗的患者）。主要结局包括纽约心脏协会（NYHA）心功能分级和明尼苏达心力衰竭生活质量问卷（MLHFQ）。次要结局包括复合结局（全因死亡率、因心血管事件再次入院或急诊的频率）、左心室射血分数和心胸比、通过中医四诊获得的症状和体征。评估将在基线、入组后第1个月和第3个月进行。
本研究将为芪参益气滴丸在实际临床实践中治疗缺血性心力衰竭提供新的证据。
本研究已在中国临床试验注册中心注册（注册号：ChiCTR-ONRC-14004407）。
