芪苈强心胶囊治疗慢性心力衰竭随机双盲、多中心临床研究

目的观察芪苈强心胶囊治疗慢性心力衰竭的疗效和安全性。方法采用平行随机、阳性药对照、双盲双模拟、多中心临床试验设计方法,488例冠心病、高血压病心力衰竭患者随机分为芪苈强心胶囊治疗组(326例)和心宝丸对照组(162例),疗程4周,观察心功能分级、Lee氏心力衰竭计分、心脏收缩和舒张功能、中医证候和生活质量等疗效指标及安全性指标。结果(1)心功能疗效:治疗组和对照组显效率分别为48.8%和41.4%,总有效率分别为78.5%和71.6%,2组比较差异无显著意义(P>0.05);(2)Lee氏心力衰竭计分疗效:治疗组和对照组显效率分别为42.3%和32.1%,总有效率分别为82.5%和72.8%,2组比较差异有显著意义(P<0.05,P<0.01);(3)中医证候疗效:治疗组和对照组显效率分别为46.6%和32.1%,总有效率分别为90.2%和82.1%,2组比较差异有显著意义(P<0.05,P<0.01);(4)心脏收缩和舒张功能:治疗组明显提高患者左室射血分数(LVEF)和E/A比值,改善心脏收缩和舒张功能;(5)生活质量:治疗组改善患者生活质量优于对照组(P<0.01)。(6)安全性观察:治疗组未见不良反应。结论芪苈强心胶囊治疗慢性心力衰竭具有明显疗效和良好的安全性。

Clinical observation of randomized double-blind and multicenter trial on Qiliqiangxin capsule in the treatment of chronic heart failure

ObjectiveTo observe the effect and safety of the Qiliqiangxin capsule in the treatment of chronic heart failure.MethodsUsing the parallel randomized,positive control,double-blind,double-simulation and multi-center clinical research method,488 patients with coronary disease,heart failure duo to hypertension were randomly divided into Qiliqiangxin capsule treatment group(326 cases) and Xinbao pill control group(162 cases),with a treatment course of 4 weeks for both groups.The heart function grading,Lee's scoring of heart failure,cardiac systolic and diastolic function,traditional Chinese medicine symdromes,quality of life and parameters of safety were observed.Results(1) The effective rates in treatment group and control group were 48.8% and 41.4% respectively,there was no significant difference in total effective rates(78.5% vs 71.6%) between the two groups(P>0.05).(2) The effective rates of Lee's scoring in treatment group and control group were 42.3% and 32.1% respectively,and the total effective rates were 82.5% and 72.8% respectively,there was a significant difference between the two groups(P<0.05 or P<0.01).(3)The effective rates for traditional Chinese medicine syndromes in treatment group and control group were 46.6% and 32.1% respectively,and the total effective rates were 90.2% and 82.1% respectively,there was a significant difference between the two groups(P<0.05 or P<0.01).(4) The LVEF and E/A ratio in treatment group were obviously increased,and the cardiac systolic and diastolic function were improved.(5)The improvement of life quality in treatment group was obviously superior to that in control group.(6) No adverse effect was found in treatment group.ConclusionQiliqiangxin capsule has obvious curative effect and safety in the treatment of chronic heart failure.