益气化瘀颗粒治疗慢性收缩性心力衰竭气虚血瘀证100例临床研究

目的观察益气化瘀颗粒治疗慢性收缩性心力衰竭气虚血瘀证的临床疗效及安全性。方法将200例心功能Ⅱ～Ⅲ级的慢性收缩性心力衰竭患者随机分为2组,均予常规抗心力衰竭治疗,治疗组100例在此基础上予益气化瘀颗粒,对照组100例予安慰剂。2组疗程均为2个月。观察2组治疗前后心功能分级、左心室射血分数(LVEF)变化,对2组中医气虚血瘀证候疗效进行比较,评价2组安全性。结果 2组治疗后心功能Ⅰ级及Ⅲ级者所占比率与本组治疗前比较差异均有统计学意义(P<0.05,P<0.01);治疗组治疗后心功能Ⅰ级及Ⅲ级者所占比率与对照组比较差异有统计学意义(P<0.01)。治疗组治疗后LVEF值<30%者、30%～40%者及>45%者所占比率与本组治疗前、对照组治疗后比较差异均有统计学意义(P<0.01);对照组治疗后LVEF值30%～40%者、>45%者所占比率与治疗前比较差异有统计学意义(P<0.05)。治疗组中医气虚血瘀证候总有效率91.7%,对照组53.2%,2组中医气虚血瘀证候总有效率比较差异有统计学意义(P<0.01),治疗组中医气虚血瘀证候疗效优于对照组。结论益气化瘀颗粒治疗慢性收缩性心力衰竭气虚血瘀证疗效肯定,安全性好。

Clinical research on Yiqi Huayu Granule for 100 case of chronic systolic heart failure with qi deficiency to blood stasis

Objective To observe the effect and safety of Yiqi Huayu Granule on chronic systolic heart fail- ure （CSHF） with qi deficiency to blood stasis. Methods Totally 200 CSHF cases with the heart function degree Ⅱ or Ⅲ were randomized into trial group and control group with 100 in each. Both group were treated routinely for resis- ting heart failure, based on which, the trial group was administered Yiqi Huayu granule while the control group was given placebo, one dose per day, two months as one course. Before and after treatment, the patients of both groups were scored with New York Heart Association heart function classification, determined by echocardiography for the leftventricular ejection fraction （ LVEF）, evaluated on the effect for qi deficiency to blood stasis syndrome, and observed on the incidence of adverse reactions for comparison. Results After treatment, the percentage of heart function of degree I and degree m was statistically different in comparing with before treatment, and the difference of both groups after treatment was significant （ P 〈 0.01 ） ; the percentage of patients with LVEF 〈 30% , 30% - 40% , and 〉 45% was statistically different in comparing with before treatment in the trail group （ P 〈 0.01 ） , and the difference be- tween the two groups after treatment was significant （ P 〈 0.01 ）. The total effective rate of the trial group was 91.7%, while it was 53.2% in the control group, the therapeutic effect of the trial group was significantly superior to the control （P 〈 0.01 ）. Conclusion Yiqi Huayu granule is effective and safe for the CSHF patients with qi defi- ciency to blood stasis.