中国中西医结合杂志2017，Vol.37Issue(3)：277-282,6.DOI:10.7661/CJIM.2017.03.0277
心脉隆注射液治疗慢性心力衰竭气阳两虚、瘀血内阻证的开放、多中心临床研究
Treatment of Chronic Heart Failure with Qi-Yang Deficiency, Blockage of Static Blood Syndrome by Xinmailong Injection: an Open Multi-center Clinical Study
摘要
Abstract
Objective To assess the safety and effectiveness of Xinmailong Injection (XI) for treating chronic heart failure (CHF) patients with qi-yang deficiency,blockage of static blood syndrome (QYDBSBS).Methods Totally 2 104 patients with QYDBSBS at 25 centers were recruited.XI at 5 mg/kg was intravenously injected to all patients after skin test,twice per day for 5 successive days.The safety and effectiveness were observed within 8 days after injection (5 days of treatment and 3 days of followups).Results were analyzed after full analysis set (FAS) and safety set (SS).Efficacy of heart function (HF) and efficacy of Chinese medicine (CM) syndrome were subgroup analyzed by age (≤65 years old or ＞65 years old) or types of HF (whole HF,right HF,or left HF).Results FAS analysis showed after treatment markedly effective of HF in 550 cases,effective in 873 cases,ineffective in 673 cases,deteriorated in 8 cases.The markedly effective rate was 26.14％ and the total effective rate was 67.63％.After treatment markedly effective of CM syndrome was shown in 795 cases,effective in 1 009 cases,ineffective in 288 cases,deteriorated in 12 cases.The markedly effective rate was 37.79％ and the total effective rate was 85.74％.Results of CM symptom score:CM symptom score was (11.381 ±4.574) before treatment and (4.987 ±3.984) after treatment,with statistical difference (P ＜0.01).The decrease rate was 56.8％ ±27.0％.Results of subgroup analysis showed that markedly effective rates of HF efficacy and CM syndrome efficacy were superior in patients ≤65 years old than in patients ＞65 years old (P＜0.01).Efficacy of HF was superior in patients with left HF than in those with whole HF or with right HF (P ＜0.01).In aspect of efficacy of CM,the markedly effective rate and the total effective rate were superior in patients with left HF or with whole HF than in those with right HF (P ＜0.01).No death occurred during the trial.No severe adverse event occurred either.Conclusions Ⅺl could improve clinical symptoms of CHF patients with QYDBSBS,reduce CM symptom score.No severe adverse event was observed.关键词
心脉隆注射液/慢性心力衰竭/多中心临床试验Key words
Xinmailong Injection/chronic heart failure/multi-center clinical trial引用本文复制引用
姚成增,王肖龙..心脉隆注射液治疗慢性心力衰竭气阳两虚、瘀血内阻证的开放、多中心临床研究[J].中国中西医结合杂志,2017,37(3):277-282,6.基金项目
国家自然科学基金资助项目(No.81573647,81273959) （No.81573647,81273959）
上海市科委资助项目(No.13401904400) （No.13401904400）
上海市卫计委资助项目(No.zxbz2012-08) （No.zxbz2012-08）
上海市中医临床重点实验室建设项目(No.C10dz2220200) （No.C10dz2220200）
