摘要
目的:探究通心络胶囊对冠心病心绞痛有效性和安全性。方法:采用随机、双盲、安慰剂平行对照、多中心临床试验,选取2017年3月至2018年2月河南省漯河市中心医院收治的冠心病心绞痛患者126例作为研究对象,按照随机数字表法随机分为对照组和观察组,每组63例,均予基础治疗,观察组加用通心络胶囊,对照组加用安慰剂(通心络胶囊模拟剂),3粒/次,2次/d,连续服用2周,从血管内皮功能、炎性反应因子、血脂指标等进行有效性分析,完成治疗后进行疗效评价,并进行安全性观察比较。结果:1)全分析集(FAS)分析,2组患者治疗前TC、TG、HDL-C比较,差异无统计学意义(P>0.05),完成治疗后2组较治疗前TC、TG显著下降,HDL-C显著升高(P<0.05),完成治疗后观察组患者以上指标显著优于对照组(P<0.05),符合方案集(PPS)和FAS结果相似。2)FAS分析,2组患者治疗前TNF-α、CRP、IL-6比较,差异无统计学意义(P>0.05),完成治疗后2组以上指标较治疗前显著下降(P<0.05),完成治疗后观察组患者以上指标显著优于对照组(P<0.05),PPS和FAS结果相似。3)FAS分析,2组患者治疗前NO、ET-1、TXB2比较,差异无统计学意义(P>0.05),完成治疗后2组ET-1、TXB2较治疗前显著下降、NO显著升高(P<0.05),完成治疗后观察组患者以上指标显著优于对照组(P<0.05),PPS和FAS结果相似。4)FAS分析,完成治疗后观察组患者显效率、总有效率明显高于对照组(P<0.05),PPS和FAS结果相似。5)FAS分析,对照组不良反应率6.34%,观察组4.76%,2组比较差异无统计学意义(P>0.05),PPS和FAS结果相似。结论:通心络胶囊能抑制冠心病心绞痛炎性反应水平,提高血管内皮功能,改善疗效,且安全性高。
Objective:To explore the efficacy and safety of Tongxinluo Capsules in treating coronary heart disease with angina pectoris.Methods:A randomized,double-blind,placebo-controlled,multi-center clinical trial was conducted in 126 subjects,who were selected from March 2017 to February 2018,and were randomly divided into a control group and an observation group according to random number table method,with 63 cases in each group.All the subjects were given basic treatment.The observation group was given Tongxinluo Capsules and the control group was given placebo(Tongxinluo Capsule simulator),3 capsules per time,twice a day for 2 weeks.Endothelial function,inflammatory factors,blood lipid index were analyzed to evaluate the efficacy after treatment,and the safety was observed and compared.Results:1)Full analysis set(FAS)analysis showed that there was no significant difference in TC,TG and HDL-C between the 2 groups before treatment(P>0.05).After treatment,TC and TG decreased significantly,and HDL-C increased significantly(P<0.05).After treatment,the above indexes in the observation group were significantly better than those in the control group(P<0.05).The per protocol set(PPS)and the FAS result were similar.2)FAS analysis showed that there was no significant difference in TNF-α,CRP and IL-6 between the 2 groups before treatment(P>0.05).After treatment,the above indexes of the 2 groups decreased significantly(P<0.05).After treatment,the above indexes of the observation group were significantly better than those of the control group(P<0.05).The PPS and FAS results were similar.3)FAS analysis showed that there was no significant difference in NO,ET-1 and TXB2 between the 2 groups before treatment(P>0.05).After treatment,ET-1 and TXB2 decreased significantly and NO increased significantly(P<0.05).After treatment,the above indexes in the observation group were significantly better than those in the control group(P<0.05).The PPS and FAS results were similar.4)FAS analysis showed that the effective rate and total effective rate of the observation group were significantly higher than those of the control group(P<0.05),and the PPS and FAS results were similar.5)FAS analysis showed that the adverse reaction rate was 6.34%in the control group and 4.76%in observation group.There was no significant difference between the 2 groups(P>0.05).The PPS and FAS results were similar.Conclusion:Tongxinluo Capsules can inhibit angina inflammation,improve vascular endothelial function,improve curative effect,and has high safety.
作者
王明磊
杨秀慧
张红雷
Wang Minglei;Yang Xiuhui;Zhang Honglei(Luohe City Central Hospital,Luohe 492300,China)
出处
《世界中医药》
CAS
2019年第11期2973-2977,共5页
World Chinese Medicine
基金
河南省科技攻关项目(301072300450410)
关键词
通心络胶囊
冠心病
心绞痛
血管内皮功能
炎性反应因子
临床试验
平行对照
多中心
Tongxinluo Capsule
Coronary heart disease
Angina pectoris
Vascular endothelial function
Inflammatory factors
Clinical trials
Parallel control
Multicenter
