心脉隆注射液治疗慢性心力衰竭(气阳两虚、瘀血内阻证)的多中心随机对照研究  

Treatment of Chronic Heart Failure Patients with Qi-Yang Deficiency and Blood Stasis Resistance Syndrome by Xinmailong Injection: a Multi-center Randomized Control Study

作　　者：薛金贵[1] 王肖龙[1] 许勇[2] 李逢春 刘莉[4] 王兴[5] 王建中[6] 刘凡[7] 邓悦[8] 

机构地区：[1]上海中医药大学附属曙光医院心内科,上海201203 [2]成都中医药大学附属医院心内科,成都610072 [3]西安市中医医院心内科,西安710001 [4]黑龙江中医药大学附属第一医院心内科,哈尔滨150040 [5]黑龙江中医药大学附属第二医院心内科,哈尔滨150001 [6]四平市中心人民医院心内科,吉林136000 [7]重庆市第一人民医院心内科,四川400011 [8]长春中医药大学附属医院心内科,长春132011

出　　处：《中国中西医结合杂志》2015年第7期796-800,共5页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：上海市科委科技支撑计划资助项目(No.12401903400);上海市中医临床重点实验室科技专项(No.14DZ2273200);国家"863"项目"综合性中医院信息系统研发与示范"(No.2012AA02A610);上海市科委科研项目(No.13401904400);上海市自然科学基金资助项目(No.12ZR1432600);上海市卫生局青年基金资助项目(No.20124y029)

摘　　要：目的评价心脉隆注射液治疗慢性心力衰竭(气阳两虚、瘀血内阻证)患者的有效性及安全性。方法采用随机、双盲、安慰剂平行对照的方法,将238例诊断为慢性心力衰竭,中医辨证为气阳两虚、瘀血内阻的患者,随机分为治疗组(118例)和对照组(120例)。两组均给予西医标准治疗,在此基础上治疗组联合心脉隆注射液(100 mg/2 m L),以5 mg/kg剂量静脉滴注,对照组给予等量心脉隆注射液模拟剂,每日2次,连续用药5天。通过观察治疗前后患者纽约心脏病协会(New York Heart Association,NYHA)心功能分级、6 min步行距离、左心室射血分数(left ventricular ejection fractions,LVEF)及中医证候评分评价疗效,并对其安全性进行评价。结果实际进入全分析集(full analysis set,FAS)235例,其中对照组120例,治疗组115例。治疗组心功能疗效总有效率、治疗后6 min步行距离及其较治疗前增加距离均优于对照组,差异有统计学意义(均P<0.05);与对照组比较,治疗组治疗后LVEF较治疗前升高值、中医证候疗效总有效率、中医证候积分及其较治疗前下降值均明显改善(均P<0.05)。两组不良事件发生率比较,差异无统计学意义(P>0.05)。结论心脉隆注射液治疗可改善慢性心力衰竭患者心功能,改善中医症状,提高患者的运动耐量,改善LVEF,未见明显毒副反应。Objective To evaluate the efficacy and safety of Xinmailong Injection（ XI） in treatment of chronic heart failure（ CHF） patients with qi-yang deficiency and blood stasis resistance syndrome（ QYDBSRS）. Methods Totally 238 CHF patients with QYDBSRS were assigned to the treatment group（ 118 cases） and the control group（ 120 cases） by randomized,double-blind,placebo parallel controlled method. Patients in the treatment group received routine therapy and XI（ 100 mg /2 m L,by dripping at 5 mg / kg,twice per day for 5 consecutive days）,while those in the control group received routine therapy and XI mimetic agent（ 100 mg /2 m L,by dripping at 5 mg / kg,twice per day for 5 consecutive days）. The heart function classification of New York Heart Association（ NYHA）,6-min walking distance,left ventricular ejection fraction（ LVEF）,scores for Chinese medical symptoms were observed before and after treatment,and safety assessed. Results Totally 235 patients actually entered full analysis set（ FAS）,including 120 cases in the control group and 115 cases in the treatment group. The total effective rate of heart function,6-min walking distance and increased post-pre-treatment distance in the experimental group were superior to those of the control group with statistical difference（ all P〈0. 05）. Compared with the control group,increased value of post-pre-treatment LVEF,the total effective rate of Chinese medical syndrome efficacy,scores for Chinese medical symptoms and decreased post-pre-treatment value of Chinese medical syndrome scores were obviously improved（ all P〈0. 05）. There was no significant difference in the incidence of adverse events between the two groups（P〉0. 05）. Conclusions XI could improve the heart function of CHF patients,improve Chinese medical symptoms,elevate exercise tolerance,and improve LVEF. It had no obvious toxic and side effects.

关 键 词：心脉隆注射液 慢性心力衰竭 气阳两虚 瘀血内阻 多中心随机对照研究 

分 类 号：R259[医药卫生—中西医结合]