通脉强心胶囊治疗慢性心力衰竭随机对照研究(1)
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【摘要】 目的 观察通脉强心胶囊治疗慢性心力衰竭的疗效和安全性。方法 采用随机对照试验设计方法，选择120例慢性心力衰竭患者，随机分为治疗组60例和对照组60例，两组均采用最佳西医治疗方案，并在此基础上分别加用通脉强心胶囊和安慰剂胶囊，4周为1疗程，共治疗3疗程。分别于治疗前、治疗1疗程、治疗2疗程、治疗3疗程，计算中医证候评分、心衰积分以及再次住院率和病死率等疗效指标及安全性指标。结果 ①中医证候疗效比较：治疗组总有效率为88.33%，对照组总有效率为66.67%；两组比较差异有统计学意义(u=2.989，P<0.01)。②心功能疗效:治疗组和对照组总有效率分别为78.33%(47/60)和51.67%(31/60)，两组比较差异有统计学意义(u=3.176，P<0.01)；③生活质量: 治疗组改善患者生活质量优于对照组(P<0.01)。④再次住院情况，治疗组与对照组比较，总再次住院率分别为:15.78%(9/57)和34.55%(19/55)，差异有统计学意义(P<0.01)；⑤安全性观察:治疗组和对照组无明显不良反应。结论 通脉强心胶囊能改善慢性心力衰竭心功能，是一种治疗慢性心力衰竭较好的中药制剂。
【关键词】 慢性心力衰竭;通脉强心胶囊;可重复性；安全性
文章编号：1003-1383(2011)05-0550-04 中图分类号：R 541.6文献标识码：A
doi:10.3969/j.issn.1003-1383.2011.05.002
Randomized controlled clinical study of Tongmai Qiangxin capsule in treatment of chronic heart failure
HE Jiang，GUAN Hui，ZHOU Mianyong，LI Shihong
(Department of Cardiology，Hospital of Tradition Chinese Medicine of Qiannan Autonomous
Prefecture，Duyun 558000，Guizhou，China)
【Abstract】 Objective To observe the efficacy and safety of Tongmai Qiangxin capsule in treatment of chronic heart failure.
Methods The randomized controlled trial design method will be adopted.120 patients with chronic heart failure were randomly divided into two groups: the treatment group (60 patients) and the control group (60 patients). The best treatment plan of western medicine was adopted for both groups. And based on this plan, Tongmai Qiangxin capsules and placebo capsules were added respectively, with 4 weeks for a course of treatment and there were total three courses of treatment. Traditional Chinese Medicine syndrome scores，heart failure integrals，readmission rates，mortality，and other indicators of efficacy and safety were calculated before the treatment，at the 1st course of treatment，the 2nd course of treatment and 3rd course of treatment respectively ......
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