| 王辰,张艳,宫丽鸿.参草通脉颗粒治疗慢性心力衰竭的多中心随机双盲平行对照研究[J].,2012,32(5):612-615 |
| 参草通脉颗粒治疗慢性心力衰竭的多中心随机双盲平行对照研究 |
| Treatment of Chronic Heart Failure by Shencao Tongmai Granule:a Multi-centered,Double-blinded,Randomized,Parallel Controlled Trial |
| |
| DOI： |
| 中文关键词: 参草通脉颗粒 慢性心力衰竭 随机对照试验 双盲 多中心 |
| 英文关键词:Shencao Tongmai Granule chronic heart failure randomized control trial double blinded multi-centre |
| 基金项目:国家“十一五”科技支撑计划资助项目(No.2007BAI20B076) |
|
| Hits: 1763 |
| Download times: 7 |
| 中文摘要: |
| 目的评价参草通脉颗粒治疗慢性心力衰竭[美国纽约心脏病学会(NYHA)分级Ⅱ、Ⅲ级]气虚血瘀水停证的有效性与安全性。方法本研究为多中心、随机、双盲、安慰剂平行对照研究。280例气虚血瘀水停型慢性心力衰竭患者以1∶1比例随机分为试验组和对照组,两组在血管紧张素转化酶抑制剂、利尿剂和地高辛等西药治疗基础上,分别服用参草通脉颗粒或安慰剂,疗程12周。比较两组NYHA心功能分级、中医证候积分和左室射血分数(LVEF),并进行安全性评价。结果共有265例患者完成试验(试验组138例,对照组127例)。治疗后试验组NYHA心功能分级总有效率和中医证候积分总有效率均明显高于对照组(分别为94.20%vs55.90%,97.83%vs70.08%,P<0.01)。两组患者治疗前LVEF比较,差异无统计学意义(P>0.05);与本组治疗前比较,治疗后两组LVEF均明显增加(P<0.05),且试验组LVEF增加值明显大于对照组[(6.55±6.23)%vs(3.14±4.99)%,P<0.05]。两组不良反应发生率均为0.71%(1/140)。结论参草通脉颗粒对NYHA分级属Ⅱ、Ⅲ级的气虚血瘀水停型慢性心力衰竭患者具有良好的疗效,且安全性良好。 |
| 英文摘要: |
| Objective To assess the clinical effects and safety of Shencao Tongmai Granule(STG)in treatment of patients with chronic heart failure(CHF)(NYHA functional class Ⅱ-Ⅲ)of qi deficiency blood stasis and water retention syndrome(QDBSWRS).Methods This was a multi-centered,double blinded,randomized,and placebo parallel controlled study.A total of 280 CHF patients of QDBSWRS were randomly assigned to the trial group and the control group in the ratio of 1:1.All patients received Western medicine(WM)treatment such as ACEI,diuretics,Digoxin Elixirs,and so on.Additionally,patients in the trial group took STG while those in the control group took the placebo.The therapeutic course for all was twelve weeks.The NYHA functional classification,Chinese medicine(CM)syndrome integral,and left ventricular ejection fraction(LVEF)were compared between the two groups.The safety assessment was also carried out.Results Totally 265 patients completed this trial(138 cases in the trial group and 127 cases in the control group).The effective rate of NYHA functional classification and CM syndrome integral were obviously higher in the trial group than in the control group(94.20% vs 55.90%,97.83% vs 70.08% respectively),showing statistical difference(P<0.01).There was no statistical difference in LVEF between the two groups before treatment(P>0.05).The LVEF both increased in the two groups when compared with before treatment(P<0.05).The post-treatment increment of LVEF was obviously higher in the trial group than in the control group(6.55%±6.23% vs 3.14%±4.99%,P<0.05).The rate of adverse reaction was 0.71% in the two groups(1/140).Conclusion STG showed good therapeutic effectiveness and safety in treating CHF patients of QDBSWRS. |
| View Full Text View/Add Comment Download reader |
|
|
|
