银杏酮酯滴丸治疗冠心病稳定型心绞痛(心血瘀阻证)的随机对照、多中心临床研究  

Randomized Controlled,Multi-center Clinical Study on Ginkgo Ketone Ester Dropping Pills in Treatment of Stable Angina Pectoris of Coronary Heart Disease(Heart Blood Stasis Syndrome)

作　　者：孙兴华[1] 李书霖[1] 张淼 张鸿婷[1] 李正荣 董彬[3] 陈守强[4] 覃松柏 朱涛 宋颖民 陈英华[8] SUN Xinghua;LI Shulin;ZHANG Miao;ZHANG Hongting;LI Zhengrong;DONG Bin;CHEN Shouqiang;QIN Songbai;ZHU Tao;SONG Yingmin;CHEN Yinghua(The Second Affiliated Hospital,Heilongjiang University of Chinese Medicine,Harbin 150001 Heilongjiang,China;Fenyang Hospital,Shanxi province,Kenyang 032299 Shanxi,China;Heping Hospital Affiliated to Changzhi Medical College,Changzhi 046000 Shanxi,China;The Second Affiliated Hospital of Shandong Traditional Chinese Medicine University,Weifang 261041 Shandong,China;Jingzhou Hospital of Traditional Chinese Medicine,Jingzhou 434000 Hubei,China;Kaifeng Hospital of TCM,Kaifeng 475000 Henan,China;Luohe Hospital of Chinese Medicine,Luohe 462000 Henan,China;First Affiliated Hospital,Heilongjiang University of Chinese Medicine,Harbin 150040 Heilongjiang,China)

机构地区：[1]黑龙江中医药大学附属第二医院,黑龙江哈尔滨150001 [2]山西省汾阳医院,山西汾阳032299 [3]长治医学院附属和平医院,山西长治046000 [4]山东中医药大学第二附属医院,山东潍坊261041 [5]荆州市中医医院,湖北荆州434000 [6]开封市中医院,河南开封475000 [7]漯河市中医院,河南漯河462000 [8]黑龙江中医药大学附属第一医院,黑龙江哈尔滨150040

出　　处：《中药新药与临床药理》2021年第6期880-885,共6页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：重大新药创制“科技重大专项”-示范性新药临床评价技术平台建设(2018ZX09734-002-004);黑龙江中医药大学工程中心建设资助项目(2017SEC01)。

摘　　要：目的评价银杏酮酯滴丸治疗冠心病稳定型心绞痛(心血瘀阻证)的有效性和安全性。方法采用随机、双盲双模拟、阳性药平行对照、多中心临床试验方法,将240例冠心病稳定型心绞痛(心血瘀阻证)患者随机分为试验组(120例)和对照组(120例)。两组均给予常规基础治疗,对照组口服灯盏花素片和银杏酮酯滴丸模拟剂治疗,试验组口服银杏酮酯滴丸和灯盏花素片模拟剂治疗,疗程均为8周。比较2组患者治疗前后心绞痛症状、心绞痛严重程度分级、中医证候积分、中医单项症状积分、西雅图心绞痛量表评分的变化以及治疗过程中硝酸甘油片使用量,评价银杏酮酯滴丸治疗的临床疗效和安全性。结果全分析数据集(FAS)分析显示,试验组总有效率为62.50%(75/120),对照组总有效率为44.17%(53/120),试验组临床疗效优于对照组(P<0.05);治疗后,2组患者中医证候积分较治疗前均显著减少(P<0.01),试验组中医证候积分明显低于对照组(P<0.01);治疗后,2组患者单项症状积分较治疗前均显著减少(P<0.01),试验组单项症状胸闷、胸痛、心悸不宁、疲倦乏力积分均明显低于对照组(P<0.01);治疗后,2组患者西雅图心绞痛量表评分较治疗前均显著增加(P<0.01),且试验组西雅图心绞痛量表评分显著高于对照组(P<0.01);试验组硝酸甘油片使用量与对照组比较,差异无统计学意义(P>0.05)。试验组不良事件发生率为6.72%(8/119),对照组为9.17%(11/120),差异无统计学意义(P>0.05)。结论银杏酮酯滴丸治疗冠心病稳定型心绞痛(心血瘀阻证)临床疗效确切,安全性较好。Objective To evaluate the efficacy and safety of Ginkgo Ketone Ester Dropping Pills in treatment of stable angina pectoris of coronary heart disease(heart blood stasis syndrome).Methods A randomized,doubleblind double-simulation,parallel control with positive drug,multi-center clinical trial was adopted.240 patients with stable angina pectoris of coronary heart disease(heart blood stasis syndrome)were randomly divided into experimental group(120 cases)and control group(120 cases).Both groups were given routine basic treatment.The control group was treated with Breviscapine tablets and the Ginkgo Ketone Ester Dropping Pills simulant.The experimental group was treated with Ginkgo Ketone Ester Dropping Pills and Breviscapine tablets simulant.The course of treatment is 8 weeks.The changes of angina pectoris symptoms,angina pectoris severity grade,the traditional Chinese medicine syndrome scores,the single symptom scores,Seattle angina scale,and the use of nitroglycerin tablets during the treatment were compared between the two groups to evaluate the clinical efficacy and safety of Ginkgo Ketone Ester Dropping Pills.Results FAS analysis showed the total effective rate in the experimental group and control group was 62.50%(75/120)and 44.17%(53/120)(P<0.05).The clinical effect of the experimental group was better than that of the control group.After treatment,the TCM syndrome scores of the two groups were significantly decreased(P<0.01),and the score of the experimental group was significantly lower than that of the control group(P<0.01).After treatment,the single symptom scores in the two groups were significantly decreased(P<0.01),and the symptoms scores of chest tightness,chest pain,palpitations,tiredness and fatigue in the experimental group were significantly lower than that of the control group(P<0.01).After treatment,the scores of Seattle angina scale in 2 groups were significantly higher than those before treatment(P<0.01),and the score of the experimental group was significantly higher than that of the control

关 键 词：银杏酮酯滴丸 冠心病 心绞痛 心血瘀阻证 多中心临床试验 

分 类 号：R285.6[医药卫生—中药学]