理气活血滴丸治疗冠心病慢性稳定型心绞痛Ⅳ期临床研究——糖尿病亚组分析

A phase Ⅳ clinical study on Liqi Huoxue Gutta Pills for treating chronic stable angina pectoris of coronary heart disease: an analysis in diabetes subgroup

目的系统阐明理气活血滴丸在冠心病慢性稳定性心绞痛合并糖尿病人群广泛使用条件下的安全性和有效性。方法2016年3月至2017年8月于上海长征医院等全国41家中心随机纳入冠心病慢性稳定型心绞痛患者2433例,口服理气活血滴丸,每次10粒,3/d,连服4周治疗,合并糖尿病患者有效性、安全性和生活质量等指标的分析。结果服用4周后,合并糖尿病患者心绞痛症状有效率70.80%,硝酸甘油停减率83.00%,心电图疗效有效率70.30%。合并糖尿病患者新发生不良事件208例。和筛选期相比,治疗4周后患者生活质量显著提高(P<0.001)。结论理气活血滴丸治疗冠心病稳定性心绞痛合并糖尿病人群疗效可靠,安全性好,患者生活质量明显提高,值得临床推广应用。

Objective To clarify the safety and efficacy of Liqi Huoxue Gutta Pills in extensive administration in population with chronic stable angina pectoris(SAP)of coronary heart disease(CHD)complicated by diabetes.Methods The patients with chronic SAP of CHD(n=2433)were randomly chosen from 41 medical units including Shanghai Changzheng Hospital from Mar.2016 to Aug.2017.All patients were treated with Liqi Huoxue Gutta Pills 10 pills a time and 3 times a day for 4 weeks.The indexes of efficacy and safety of Liqi Huoxue Gutta Pills and quality of life(QOL)of patients were analyzed.Results After 4 weeks,the effective rate for symptoms of angina pectoris was 70.80%,stopping or reducing rate of nitroglycerin was 83.00%and effective rate of electrocardiogram curative effect was 70.30%in patients with chronic SAP of CHD complicated by diabetes.There were 208 cases with new adverse events.QOL was significantly improved after treatment for 4 weeks compared with screening period(P<0.001).Conclusion Liqi Huoxue Gutta Pills has reliable curative effect and higher safety in population patients with chronic SAP of CHD complicated by diabetes and patients’QOL is significantly improved,which is well worth clinical application.