通补心宝胶囊治疗气虚血瘀水泛型慢性心力衰竭患者的临床观察

Clinical Efficacy of Tongbu Xinbao Capsule on Qi Deficiency Blood Stasis and Water Flux Type Chronic Heart Failure

目的：观察通补心宝胶囊对气虚血瘀水泛型慢性心力衰竭患者的临床疗效,以探讨其对慢性心力衰竭的作用机制。方法：将120例门诊或住院慢性心力衰竭患者随机分治疗组及对照组,各60例。对照组为西药基础治疗,治疗组为在西药基础治疗的基础上加用通补心宝胶囊4粒,每日3次,两组疗程均为4周。疗程结束后观察两组患者临床疗效,并观察两组患者治疗前后中医证候积分,中医证候疗效,N端前BNP（N-terminal-pro BNP,NT-pro BNP）,肾素（plasma renin aetivity,PRA）,血管紧张素Ⅱ（angiotensinⅡ,AngⅡ）,醛固酮（aldosterone,ALD）,同型半胱氨酸（homocysteic acid,HCY）水平及心室重构指标变化,并观察血常规、尿常规、便常规、肝、肾功能等实验室检查指标,确定通补心宝胶囊是否有毒、副作用。结果：中医证候疗效总有效率（91.67%）,明显高于对照组（81.67%）,两组治疗后PRA,AngⅡ,ALD,HCY,NT-pro BNP较治疗前均明显下降,治疗后治疗组优于对照组（P〈0.05）。结论：常规西药联合通补心宝胶囊治疗效果明显,提示联合通补心宝胶囊能更好抑制心力衰竭患者RAAS活性及降低HCY水平,其靶点可能与抑制PRA,AngⅡ,ALD,HCY等有关,未发生毒、副作用,疗效可靠。

Objective： To observe the clinical efficacy of Tongbu Xinbao capsule on chronic heart failure（Qi deficiency blood stasis and water flux type）,in order to investigate the mechanism of Tongbu Xinbao capsule on chronic heart failure. Method： A total of 120 patients with chronic heart failure outpatients or inpatient patients were randomly divided into treatment group and control group,with 60 cases in each group. The control group got western medicine for basic treatment; in addition to the therapy of the control group,the treatment group was also given Tongbu Xinbao capsule,4 capsule,tid,for 4 weeks. After the treatment,the clinical efficacy of the two groups were observed; and before and after treatment,symptom score,N-terminal-pro BNP（NT-pro BNP）,plasma renin aetivity（PRA）,aldosterone（ALD）,angiotensin Ⅱ（Ang Ⅱ） and homocysteic acid（HCY） levels were observed,and the blood,urine,stool routine,liver and kidney function and other laboratory parameters were detected to determine the toxic and side effects of Tongbu Xinbao capsule. Result： Efficacy of traditional Chinese medicine（TCM） syndrome of treatment group was 91. 67%,which was significantly higher than 81. 67% of control group. After treatment,PRA,Ang Ⅱ,ALD,HCY,NT-pro BNP were significantly decreased than before treatment,and those in the treatment group were superior to those of the control group（P〈 0. 05）. Conclusion：Conventional western medicine combined with Tongbu Xinbao capsule showed a significant therapeutic effect,suggesting that the combined administration can better inhibit RASS activity and reduced HCYof patients with heart failure,which may be related to the inhibition of PRA,Ang11,ALD,HCY,with no toxic or side effect and a reliable efficacy.