稳心汤治疗不稳定性心绞痛的随机对照研究

目的:观察稳心汤治疗不稳定性心绞痛的临床疗效。方法:本研究共纳入经冠脉造影确诊的冠心病不稳定性心绞痛病例228例,所有病例冠状动脉狭窄50%~70%,未行介入治疗,中医辨证为阳气亏虚,痰瘀阻络型,随机分为治疗组(n=118例)和对照组(n=110例)。治疗组给予稳心汤+西药常规治疗,对照组给予西药常规治疗。疗程60 d,比较两组治疗前后心绞痛疗效、硝酸甘油消耗量、高敏C-反应蛋白(hs-CRP)、低密度脂蛋白-C(LDL-C)的变化;比较两组60 d不良心脑血管事件(MACCE)的发生率。结果:两组基线临床资料无统计学意义。治疗60 d后治疗组,对照组总有效率分别为86.4%,72.7%(P0.01);两组治疗后硝酸甘油的消耗量明显降低(P0.05),治疗组优于对照组;治疗组治疗后hs-CRP,LDL-C均较治疗前明显降低,与对照组相比均有显著性差异(P0.01)。随访平均时间(54.5±8.5)d,治疗组和对照组MACCE发生率分别为12.7%,24.5%(P0.05),其中非致死性心肌梗死分别为1.7%,10.0%,差异有统计学意义(P0.01),而血运重建、脑卒中、心性死亡无显著性差异。结论:稳心汤治疗不稳定性心绞痛在改善心绞痛症状,降低hs-CRP,LDL-C有较好疗效,可降低UA患者的MACCE发生率,尤其可减少非致死性心肌梗死的发生。

Randomized Controlled Trial of Wenxin Decoction for Unstable Angina

Objective: To observe clinical efficacy of Wenxin decoction for unstable angina (UA). Method: A total of 228 patients with unstable angina and diagnosed as coronary heart disease via coronary angiography were enrolled in this study. Coronary artery stenosis occurred in 50%-70% of all the subjects, without any interventional therapy. In respect of traditional Chinese medicine syndrome, this disease was of phlegm and blood stasis stagnation with Yang Qi deficiency. The subjects were randomly divided into treatment group (n=118) and control group (n=110). Patients in treatment group were treated with Wenxin decoction+routine western medicine, while the patients in control group were treated with routine western medicine only. After 60 days of therapy, improvement of angina, consumption of nitroglycerin, changes of high sensitivity C reactive protein (hs-CRP) and low density lipoprotein cholesterol (LDL-C) before and after treatment were compared between two groups. The incidence of major adverse cardiovascular events (MACCE) within 60 days in two groups were compared. Result: There was no statistically significant difference in baseline clinical information between two groups. Total effective rate was 86.4% and 72.7% in treatment group and control group respectively after 60 days of treatment (P<0.01). After treatment, consumption of nitroglycerin was significantly reduced in treatment group, with significant difference as compared with control group (P<0.05). Levels of hs-CRP and LDL-C were also significantly reduced in treatment group, with significant difference as compared with control group (P<0.01). During the follow-up (54.5±8.5 days on average), incidence of MACCE was 12.7% and 24.5% respectively in treatment group and control group (P<0.05), and the non-lethal myocardial infarction rate was 1.7% and 10.0% respectively with statistically significant difference between two groups (P<0.01). There was no significant difference in incidence of revascularization, stroke and cardiac between two groups. Conclusion: Wenxin decoction has better effect in improving the angina symptoms and decreasing hs-CRP, LDL-C in the treatment of unstable angina. It could reduce the incidence of MACCE, especially the incidence of non-lethal myocardial infarction in patients with unstable angina.