参草通脉颗粒治疗气虚血瘀水停型慢性心力衰竭的临床研究

Clinical research of Shencaotongmai Granule on patients with chronic heart failure of qi deficiency,blood stasis and water retention syndrome

目的:观察益气活血法治疗慢性心力衰竭(CHF)疗效并探讨其中西医结合治疗优势。方法:选择280例气虚血瘀水停型慢性心力衰竭患者进行前瞻性随机、安慰剂平行对照、双盲的临床试验。治疗组和对照组各140例,两组均以血管紧张素转换酶抑制剂(ACEI)、利尿剂、地高辛为基础治疗,治疗组加服参草通脉颗粒,对照组口服参草通脉颗粒模拟剂。疗程为3个月。于治疗前后观察并记录心衰疗效(Lee氏)记分、地高辛/氢氯噻嗪停减情况及心功能测定情况。结果:两组受试者Lee氏记分和停减率疗效比较差异有统计学意义(P<0.05),扣除中心效应CMH卡方分析,结果一致;左室射血分数(LVEF)计量分析显示组内治疗前后及组间同期比较差异均有统计学意义(P<0.05)。结论:参草通脉颗粒治疗慢性心力衰竭有效,且明显降低西药用量,证明中医药干预的优势作用。

Objective： To investigate the efficacy of Shencaotongmai Granule（SCTM） on patients with Chronic Heart Failure（CHF） and evaluate the superiority of integrated traditional Chinese and western medicine.Methods： 280 patients with CHF of qi deficiency,blood stasis and water retention syndrome were selected to have a randomized,placebo-controlled,double-blind multicentered trial.All patients were divided into 2 groups and each group were 140 cases respectively.Based on ACEI,diuretics and digoxin treatment,treatment group patients were administered Shencaotongmai Granule as oral drugs,while control group were treated simulation of Shencaotongmai Granule for 3 months.CHF curative effect scores,diuretics and digoxin withdrawal situation and cardiac function determination were recorded before and after treatment.Results： CHF curative effect scores and withdrawal situation of 280 participants from both groups were significantly different（P0.05）.Chi-square analysis deducting center effect showed the same result.LVEF quantitative analysis showed comparison among groups and intra-groups were significantly different（P0.05）.Conclusion： Shencaotongmai Granule was effective to treat CHF and lower the dosage of west medicine,which proved the superiority of TCM intervention.