血府逐瘀胶囊改善不稳定型心绞痛介入术后血瘀证患者近期生活质量的随机双盲对照试验  

A randomized double-blinded controlled trial of Xuefu Zhuyu Capsule on short-term quality of life in unstable anginal patients with blood-stasis syndrome after percutaneous coronary intervention

作　　者：褚福永[1] 王阶[1,2] 孙晓伟[1] 邢雁伟[1] 姚魁武[1] 王师菡[1] 李志忠[3] 

机构地区：[1]中国中医科学院广安门医院心内科,北京100053 [2]湖北中医学院中医临床基础研究室,湖北武汉430065 [3]首都医科大学北京安贞医院急诊抢救中心,北京100029

出　　处：《中西医结合学报》2009年第8期729-735,共7页Journal of Chinese Integrative Medicine

基　　金：国家重点基础研究发展计划(973计划)资助项目(No.2003CB517103);国家自然科学基金资助项目(No.90709048)

摘　　要：背景:随着冠状动脉介入术在冠心病治疗中的广泛应用,怎样促进患者术后早期恢复,提高其生活质量已成为临床医生普遍关注的问题。目的:以生脉胶囊(益气养阴方)为对照药,运用方证对应理论观察血府逐瘀胶囊(活血化瘀方)干预不稳定型心绞痛介入术后血瘀证患者近期生活质量的作用并探讨其安全性。设计、场所、对象和干预措施:所有患者均为2008年3月～2009年2月在首都医科大学北京安贞医院急诊抢救中心成功接受冠状动脉介入治疗的住院患者。采用随机、双盲、双模拟、安慰剂对照试验设计方法,将90例不稳定型心绞痛介入术后血瘀证患者随机分为血府逐瘀胶囊组(方证对应)、生脉胶囊组(方证不对应)和安慰剂组,分别给予相应药物治疗4周。主要结局指标:采用简明生活质量量表(Short-Form36,SF-36)及西雅图心绞痛量表(Seattle Angina Ques-tionnaire,SAQ)评价患者治疗前后生活质量。结果:共纳入患者90例,试验过程中退出4例,脱落率为4.4%。治疗后3组SF-36和SAQ量表部分维度计分较治疗前显著升高(P<0.05,P<0.01),其中血府逐瘀组在躯体疼痛(bodypain,BP)、总体健康(general health,GH)、精力(vitality,VT)、社会功能(social function,SF)、情感职能(role emotional,RE)、心绞痛稳定状态(angina stability,AS)、心绞痛发作情况(angina frequency,AF)、治疗满意程度(treatment satisfaction,TS)维度计分优于安慰剂组(P<0.05,P<0.01)。同时,血府逐瘀组患者BP、GH、SF、AS、AF、TS维度计分优于生脉组(P<0.05,P<0.01)。试验过程中,除血府逐瘀组1例患者诉胃部不适外,其余患者治疗前后未见明显不良反应。结论:和生脉胶囊相比,血府逐瘀胶囊短期应用在改善不稳定型心绞痛介入术后血瘀证患者近期生活质量方面显示出更好的疗效,然而其长期疗效和安全性仍需进一步研究。临床试验注册:ClinicalTrials.gov,注册号为NCT00817024。Background： With the wide application of percutaneous coronary intervention （PCl） in patients with coronary heart disease （CHD）, it is a popularly concerned problem within clinical doctors to promote the patients＇ early recovery and improve their health related quality of life （HR-QoL）. Objective： To evaluate the efficacy and safety of Xuefu Zhuyu （XFZY） Capsule, a compound traditional Chinese herbal medicine for activating blood circulation, in improving HR-QoL in unstable angina （UA） patients with blood-stasis syndrome after PCI, and to make a comparison with Shengmai （SM） Capsule. Design, setting, participants and interventions： The study was performed at Rescue Center of Emergency, Beijing Anzhen Hospital, China Capital University of Medical Science from March 2008 to February 2009. Using a randomized, double-blinded, double-dummy and placebo controlled study design, ninety patients diagnosed as UA and concomitant blood stasis syndrome after successful PCI therapy were enrolled and randomized into three groups： XFZY group, SM group and placebo group, and the patients were administered with the corresponding medications for 4 weeks. Main outcome measures. The Short-Form 36 （SF-36） and Seattle Angina Questionnaire （SAQ） were applied to assess the HR-QoL in each group before and after the treatment. Results, A total of 90 patients were recruited and 4 cases of them withdrew from the study during the treatment period indicating a 4.4% of dropping rate. After the treatment, several domains of scores in SF-36 and SAQ were significantly increased in three groups （P〈0.05, P〈0.01）. The efficacy of XFZY Capsule in improving body pain （BP）, general health （GH）, vitality （VT）, social function （SF）, role emotional （RE）, angina stability （AS）, angina frequency （AF）, as well as treatment satisfaction （TS） was better than that of placebo （P〈0.05, P〈0.01）. Meanwhile, the dimensions of BP, GH, SF, AS, AF, TS were improved as compare

关 键 词：血府逐瘀胶囊 不稳定型心绞痛 生活质量 随机对照试验 双盲 双模拟 

分 类 号：R259[医药卫生—中西医结合]