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理气活血滴丸治疗冠心病慢性稳定型心绞痛安全性及有效性的前瞻性、单臂、多中心Ⅳ期临床研究
Efficacy and Safety of Liqi Huoxue Dripping Pill in the Treatment of Chronic Stable Angina Pectoris:a Prospective,One-arm,Multi-center,Phase Ⅳ Clinical Trials
【摘要】 目的系统阐明理气活血滴丸在冠心病慢性稳定型心绞痛人群广泛使用条件下的安全性和有效性。方法 2016年3月—2017年8月在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病人2 433例,口服理气活血滴丸,每次10粒,每日3次,连服4周进行治疗,评估疗效、安全性和生活质量等指标。结果服用4周后,心绞痛症状总有效率为72.45%,硝酸甘油停减率为88.80%,心电图疗效总有效率为52.53%。共发生不良事件494例(20.27%),与药物可能有关的不良事件123例(5.06%)。治疗4周后和筛选期相比,病人生活质量显著提高(P <0.001)。结论理气活血滴丸治疗冠心病稳定型心绞痛有效可靠,安全性好。
【Abstract】 Objective To systematically clarify the safety and efficacy of Liqi Huoxue dropping pill(LHDP)in the treatment of of chronic stable angina pectoris(SAP)in patients with coronary heart disease(CHD).Methods From March 2016 to August 2017,2 433 patients with chronic SAP were randomly enrolled from41 centers including Shanghai Changzheng Hospital.The patients were treated with LHDP oral administration,10 pills each time,thrice daily.The period of treatment was 4 weeks.Efficacy,safety,quality of life,and other indicators were assessed.Results After 4 weeks of treatment,the effective rate of symptoms of angina pectoris were 72.45%.The rate of nitroglycerin reduction was 88.80%,and the effective rate of electrocardiogram was 52.53%.A total of 494(20.27%)adverse events occurred,and 123(5.06%)might related with the medicine.The quality of life of patients were significantly improved compared with that in the screening period(P <0.001).Conclusion LHDP is safe and effective in treating CHD.
【Key words】 coronary heart disease; stable angina pectoris; Liqi Huoxue dripping pill; phase Ⅳ clinical trials; safety; efficacy;
- 【文献出处】 中西医结合心脑血管病杂志 ,Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease , 编辑部邮箱 ,2019年05期
- 【分类号】R259
- 【被引频次】12
- 【下载频次】277