| 邹旭,尹克春,吴焕林,盛小刚,潘光明,林晓忠,李松,李健.暖心胶囊治疗慢性心力衰竭的随机双盲对照研究[J].中国中西医结合杂志,2011,31(1):19-22 |
| 暖心胶囊治疗慢性心力衰竭的随机双盲对照研究 |
| Double Blinded Randomized and Controlled Study on Treatment of Chronic Heart Failure by Nuanxin Capsule |
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| DOI： |
| 中文关键词: 慢性心力衰竭 暖心胶囊 随机双盲设计 |
| 英文关键词:chronic heart failure Nuanxin Capsule double blinded randomized design |
| 基金项目:国家重点基础研究发展计划973计划资助项目(No.2005CB523502) |
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| 中文摘要: |
| 目的观察暖心胶囊治疗慢性心力衰竭的疗效和安全性。方法采用随机双盲安慰剂对照试验设计方法,选择150例慢性心力衰竭患者,随机分为治疗组和对照组,每组75例,两组均采用最佳西医治疗方案,并在此基础上分别加用暖心胶囊和安慰剂胶囊,疗程24周。观察中医证候、心功能分级、心脏收缩功能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)心功能疗效:治疗组和对照组总有效率分别为78.87%(56/71)和64.38%(47/73),2组比较差异有统计学意义(P<0.05);(2)中医证候疗效:治疗组和对照组总有效率分别为85.9%(61/71)和63.0%(46/73),2组比较差异有统计学意义(P<0.01);(3)心脏收缩功能:治疗组改善心脏收缩功能优于对照组(P<0.05);(4)生活质量:治疗组改善患者生活质量优于对照组(P<0.01)。(5)再次住院情况,治疗组与对照组比较,总再次住院率分别为:23.9%(17/71)和53.4%(39/73),差异有统计学意义(P<0.05),其中心衰急性发作22.5%(16/71)和42.5%(31/73),差异有统计学意义(P<0.05)。(6)病死率:两组病死率分别为2.90%和8.95%,差异无统计学意义(P>0.05)。(7)安全性观察:治疗组和对照组无明显不良反应。结论暖心胶囊能改善慢性心力衰竭心功能,具有明显疗效,和良好的安全性。 |
| 英文摘要: |
| Objective To evaluate the effect and safety of Nuanxin Capsule (NXC) in treating patients with chronic heart failure (CHF). Methods Adopting the randomized,positive controlled,double-blinded design,150 CHF patients were assigned to the treatment group and the control group equally,they were treated with optimal western medical therapeutic scheme in combining respectively with NXC and placebo for 24 weeks. The indices for effectiveness and safety evaluation,such as Chinese medicine syndrome,grade of heart function,myocardial contraction,as well as the re-hospitalization rate and mortality,were observed. ResultsThe total effective rate on heart function in the treatment group and the control group was 78.87% and 64.38% respectively,that on Chinese medicine syndrome was 85.9% and 63.0% respectively,comparisons of the two indices between the two groups all showed significant difference (P<0.05,P<0.01). And a better efficacy for improving patients’ cardiac contraction function and quality of life was shown in the treatment group (P<0.05,P<0.01). The re-hospitalization rates in them were 23.9% and 53.4% respectively (P<0.05),and 22.54% and 42.5% of the re-hospitalized patients had attack of acute heart failure,a significant difference was found between the two groups (P<0.05).The mortality in them was 2.90% and 8.95% respectively,showing no significant difference between groups (P>0.05). No obvious adverse effect was found in both groups. Conclusions NXC could improve the heart function of patients,it has obvious curative effect and good safety in treating chronic heart failure. |
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