医学
随机对照试验
中医药
西医
心力衰竭
单盲板
临床试验
替代医学
多中心研究
传统医学
重症监护医学
内科学
病理
作者
Xianliang Wang,Yazhu Hou,Jingyuan Mao,Yingqiang Zhao,Tianfu Niu,Yuan Ru-yu,Yonggang Wang,Jinrong Cui,Le Shi,Xin Jia,Ruitai Fan,Qian Lin,Zhang Yan,Zhijun Li,Hongcai Shang,Baohe Wang,Hongwu Wang,Heng-he Wang,Xiao-Lei Cui,Soh Shanbin,Jishou Ruan,Boli Zhang
标识
DOI:10.1016/s0254-6272(18)30038-4
摘要
To assess the efficacy and safety in patients with chronic heart failure (CHF) of Western medication plus Traditional Chinese Medicine (TCM) preparations.This prospective, single-blind, randomized, controlled, and multicenter clinical trial began on September 17, 2008, and was completed on June 25, 2011. A total of 340 inpatients, aged 40-79 years, with exacerbating CHF from 10 hospitals were enrolled and randomly allocated within 24 h of admission. The trial included three intervention periods. During hospitalization, the control group received western medication for CHF and the treatment group received Danhong injection with Shenfu injection or Shenmai injection. After discharge, all patients were treated with Qiliqiangxin capsules and Buyiqiangxin tablets or a placebo for 6 months. After the 6-month intervention, both groups received only continuous western medication. The primary endpoint was all-cause mortality. The efficacy assessments were as follows: B-type natriuretic peptide (BNP), Lee's HF score, the 6-minute walking test (6MWT), left ventricular ejection fraction (LVEF), and the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The safety assessments were as follows: blood and urine routine examination, hepatic and renal function, electrolytes in blood and adverse events.Compared with the control group, the treatment group showed a 30.99% reduction in all-cause mortality and an improved survival rate. The treatment group showed greater improvement in 6MWT (P = 0.02) than the control group on discharge, after 12-month follow-up, there was a time-group interaction for MLHFQ (P = 0.03). Incidence rate of adverse events and other relevant safety indexes were not statistically significant between the two groups.Western medication plus TCM treatment can increase 6-minute walking distance (improve exercise tolerance) and quality of life with heart failure patients.