救心丸对冠心病稳定型心绞痛患者运动耐量及生活质量的影响——一项随机、双盲、安慰剂对照、多中心临床研究  

Effect of Jiuxin Pill(救心丸)on Exercise Tolerance and Quality of Life in Patients of Stable Angina Pectoris:A Randomized,Double-Blind,Placebo-Controlled,Multi-Center Clinical Trial

作　　者：王贤良[1] 朱明军 倪代梅 伍建光[4] 薛一涛[5] 王承龙[6] 戴小华 林谦 李军[9] 赵志强[1] 王帅[1] 毕颖斐[1] 刘桐作 周宙 毛静远[1] WANG Xianliang;ZHU Mingjun;NI Daimei;WU Jianguang;XUE Yitao;WANG Chenglong;DAI Xiaohua;LIN Qian;LI Jun;ZHAO Zhiqiang;WANG Shuai;BI Yingfei;LIU Tongzuo;ZHOU Zhou;MAO Jingyuan(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine/National Clinical Research Center for Chinese Medi-cine Acupuncture and Moxibustion,Tianjin,300381;The First Affiliated Hospital of Henan University of Chinese Medicine;Taihe Hospital of Traditional Chinese Medicine,Anhui University of Chinese Medicine;The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine;The Affiliated Hospital of Shandong University of Traditional Chinese Medicine;Xiyuan Hospital,China Academy of Chinese Medical Sciences;The First Affiliated Hospital of Anhui University of Chinese Medicine;Dongzhimen Hospital,Beijing University of Chinese Medicine;Guang'anmen Hospital,China Academy of Chinese Medical Sciences;Tianjin University of Traditional Chinese Medicine)

机构地区：[1]天津中医药大学第一附属医院/国家中医针灸临床医学研究中心,天津市300381 [2]河南中医药大学第一附属医院 [3]安徽中医药大学附属太和中医院 [4]江西中医药大学附属医院 [5]山东中医药大学附属医院 [6]中国中医科学院西苑医院 [7]安徽中医药大学第一附属医院 [8]北京中医药大学东直门医院 [9]中国中医科学院广安门医院 [10]天津中医药大学

出　　处：《中医杂志》2024年第24期2549-2557,共9页Journal of Traditional Chinese Medicine

基　　金：国家中医药管理局中医药创新团队项目(ZYYCXTD-C-202203);中华中医药学会联合攻关项目(CACMLHJJ-D2022001)。

摘　　要：目的评价救心丸对冠心病稳定型心绞痛患者运动耐量及生活质量的影响和安全性。方法采用随机、双盲、安慰剂对照、多中心研究设计,纳入9个中心的冠心病稳定型心绞痛患者170例,按照1∶1比例分为试验组和对照组各85例。两组均维持原西药治疗方案,试验组和对照组分别加用救心丸和救心丸安慰剂口服,每次2粒(0.05 g),每日2次,用药28天。主要疗效指标为运动平板试验总运动时间(TED)、西雅图心绞痛量表(SAQ)评分[包括躯体活动受限程度(PL)、心绞痛稳定状态(AS)、心绞痛发作情况(AF)、治疗满意程度(TS)和疾病认知程度(DP)];次要疗效指标为运动平板试验其他指标[包括1分钟心率恢复(HRR1)、代谢当量(METs)、ST段压低最大幅度、运动后Borg自感劳累评分]、平均每周心绞痛发作次数、硝酸甘油停减率、中医证候积分、主要不良心血管事件发生率,并进行安全性指标评价,记录试验期间不良事件发生情况。访视时点为治疗前、治疗后即治疗(28±2)天、56天随访时即治疗结束后第(28±2)天。结果符合全分析集(FAS)和安全性数据集(SS)试验组和对照组分别有84例和85例。与本组治疗前及与对照组治疗后比较,试验组治疗后TED、HRR1、METs升高,ST段压低最大幅度及Borg自感劳累评分降低(P<0.01)。与本组治疗前及与对照组治疗后、随访时比较,试验组治疗后及随访时SAQ总评分及AS、AF、TS、DP评分均升高,平均每周心绞痛发作次数及中医证候积分降低(P<0.01)。两组间硝酸甘油停减率比较差异无统计学意义(P>0.05)。主要不良心血管事件试验组发生1例(1/84,1.19%),对照组1例(1/85,1.18%),两组比较差异无统计学意义(P>0.05)。试验组共发生不良事件3例(3/84,3.57%),对照组共发生不良事件6例(6/85,7.06%),两组间不良事件发生率比较差异无统计学意义(P>0.05)。结论在西医常规治疗基础上加用救心丸可进一步Objective To evaluate the effect and safety of Jiuxin Pill(救心丸)on exercise tolerance and quality of life in patients with stable angina pectoris(SAP).Methods A randomised,double-blind,placebo-controlled,multicentre study design was used to enroll 170 patients of SAP from nine centres,which were divided into 85 patients each in the trial group and control group with 1∶1 ratio.Both groups maintained the original western medicine treatment plan,and added Jiuxin Pill or placebo respectively,2 pills(0.05 g)each time twicely for 28 days.The main out⁃comes were total exercise time(TED)in the exercise treadmill test and Seattle Angina Questionnaire(SAQ)scores including physical limitation(PL),angina stability(AS),angina frequency(AF),treatment satisfaction(TS),and disease perception(DP).The secondary outcomes were exercise treadmill test indicators including heart rate recovery in 1 min(HRR1),metabolic equivalents(METs),maximum magnitude of ST-segment depression,and the Borg rating of perceived exertion scale,the average number of angina attacks per week,withdrawal and reduction rate of nitroglycerin,traditional Chinese medicine syndrome scores,incidence of major adverse cardiovascular events.Safety indicators were evaluated and the occurrence of adverse events during the trial was recorded.Data was collected before treatment,day 28±2 in treatment period,and follow-up at day 56 which is 28±2 days after treatment period finished.Results Eighty-four and eighty-five patients respectively from trial group and control group were included to the full analysis set(FAS)and safety analysis set(SS).Compared with the group before treatment and with the control group after treatment,the trial group had higher TED,HRR1,and METs,and lower maximum magni⁃tude of ST-segment depression and Borg rating of perceived exertion scores after treatment(P<0.01).Compared with the group before treatment and with the control group after treatment and at follow-up,the total SAQ score and scores of AS,AF,TS and DP of the trial group afte

关 键 词：冠心病 稳定型心绞痛 救心丸 运动耐量 生活质量 随机对照试验 

分 类 号：R259[医药卫生—中西医结合]