芪参益气滴丸治疗ACS介入术后合并糖尿病的临床研究
Clinical study of Qishenyiqi dropping pills in patients with ACS due to PCI and diabetes melli-tus
谷丰 1白瑞娜 1于燕乔 2蔡雅杰 3杨芙蓉 3盛松 1郗瑞席 1杨巧宁 1李立志 1史大卓1
作者信息
- 1. 中国中医科学院西苑医院,国家中医心血管病临床医学研究中心,中药临床疗效和安全性评价国家工程中心,北京 100091
- 2. 北京中医药大学,北京 100029
- 3. 中国中医科学院西苑医院,国家中医心血管病临床医学研究中心,中药临床疗效和安全性评价国家工程中心,北京 100091;中国中医科学院研究生院,北京 100000
- 折叠
摘要
目的 评价芪参益气滴丸治疗急性冠脉综合征(ACS)介入(PCI)术后合并糖尿病患者的有效性和安全性.方法 全国40家三甲医院纳入635例ACS首次PCI术后合并糖尿病的患者,以是否服用芪参益气滴丸为暴露因素,分为芪参益气滴丸组(试验组)和西医常规治疗组(对照组).两组均给予冠心病二级预防用药,芪参益气滴丸用药12个月.主要疗效指标为主要和次要终点事件发生风险,次要疗效指标为血瘀证计分.结果 590例患者完成随访,其中,试验组286例,对照组304例.经Cox分析显示,试验组29例(10.14％)和对照组43例(14.14％)发生主要终点事件(校正后HR 0.60;95％CI 0.36～1.01;P=0.055);试验组29例(10.14％)和对照组53例(17.43％)发生次要终点事件(校正后HR 0.61;95％CI 0.38～0.99;P=0.045).经广义估计方程分析,相较于对照组,芪参益气滴丸可降低ACS PCI术后合并糖尿病患者的血瘀证计分.不良事件两组间无显著差异.结论 芪参益气滴丸可降低ACS PCI术后合并糖尿病患者次要终点事件的发生风险,降低血瘀证计分且具有良好的安全性.
Abstract
Objective To evaluate the effectiveness and safety of Qishenyiqi dropping pills in patients with ACS due to PCI and diabetes mellitus.Methods 635 patients with ACS due to PCI and diabetes mellitus were enrolled in 40 A-class hospitals,and were entered in-to Qishenyiqi dropping pills group and conventional medicine group according to whether they took Qishenyiqi dropping pills as exposure factor.All patients were given secondary cardiovascular prophylaxis according to the guidelines.Patients in Qishenyiqi dropping pill group took Qishenyiqi dropping pill for 12 months on the basis of secondary prophylaxis.The primary outcome was the primary and sec-ondary endpoints.The secondary outcome was the score of blood stasis syndrome.Results 590 patients were followed up,including 286 patients in Qishenyiqi dropping pills group and 304 patients in conventional medicine group.Cox analysis showed that 29 cases(10.14％)in Qishenyiqi dropping pill group and 43 cases(14.14％)in conventional medicine group had primary endpoints(adjusted HR 0.60;95％CI 0.36～1.01;P=0.055);Secondary endpoints occurred in 29 cases(10.14％)of Qishenyiqi dropping pill group and 53 cases(17.43％)of conventional medicine group(adjusted HR 0.61;95％CI 0.38～0.99;P=0.045).The generalized esti-mation equation analysis showed that Qishenyiqi dropping pills reduced the blood stasis score compared with conventional medicine group.Adverse events were not significantly different between the two groups.Conclusion Qishenyiqi dropping pills can reduce the risk of sec-ondary endpoints and the score of blood stasis syndrome,and have good safety.
关键词
芪参益气滴丸/急性冠脉综合征/介入术后/糖尿病/前瞻性队列研究Key words
Qishenyiqi dropping pills/Acute coronary syndrome/After percutaneous coronary intervention/Diabetes mellitus/Prospective cohort study引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据