注射用灯盏花素治疗心绞痛真实世界研究  

The medication of Breviscapine injection in the treatment of angina pectoris in the real world

作　　者：张蕾 黎元元[1] 谢雁鸣[1] 王连心[1] 杨晓晨 ZHANG Lei;LI Yuanyuan;XIE Yanming;WANG Lianxin;YANG Xiaochen(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;School of Statistics,Renmin University of China,Beijing 100872,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]中国人民大学统计学院,北京100872

出　　处：《中国药物警戒》2022年第8期857-861,880,共6页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(81973982);国家重点研发计划项目(2018YFC1707400);中央级公益性科研所基本科研业费专项资金资助(Z0737)。

摘　　要：目的基于真实世界数据,探究注射用灯盏花素治疗心绞痛时疗效与剂量的相关关系,为该药的临床使用提供参考。方法从全国37家三级甲等医院的医院信息管理系统(HIS)中提取2002年5月20日至2019年11月8日诊断为心绞痛的2181例患者的诊疗数据。通过SAS 9.2统计软件进行数据整理分析,并以SPSS Clementine12.0对药品疗效及剂量数据的关联情况进行分析。结果2181例患者中,老年患者居多,合并疾病以原发性高血压患者数最多。静脉滴注给药3174例次中超说明书剂量使用2009例次(63.30%)。合并用药前3位为阿司匹林、美托洛尔、氨氯地平,是治疗冠心病心绞痛常用药。1569例患者有有效结局指标,药品剂量与疗效间关系分析显示,说明书剂量范围内,治疗剂量为50 mg,患者的治愈率和好转率均更高;超说明书剂量时,治疗剂量为100 mg患者的治愈率和好转率均更高。卡方检验及回归分析显示,对照组治疗心绞痛效果优于注射用灯盏花素。结论临床治疗中应遵循安全用药的原则,在规范指导下合理使用药品。注射用灯盏花素治疗冠心病心绞痛与常规药物联合使用有助于提高临床获益,且注射用灯盏花采用静脉滴注方式给药,剂量50 mg,每日1次疗效更好。Objective To explore the correlation of therapeutic effect and dosage of Breviscapine injection in the treatment of angina pectoris in the real world so as to provide reference for clinical use.Methods The clinical data on 2181 patients treated with Breviscapine injection in the treatment of angina pectoris from 37 big hospitals in China between May 20,2002 and November 8,2019 was analyzed based on the hospital information system(HIS).The software of SAS 9.2 was used to process data first and SPSS Clementine 21.0 was used to analyze the correlation of therapeutic effect and dosage.Results Among the 2181 patients,most of them were elderly patients who mostly have comorbidities with essential hypertension.Among the 3174 cases of intravenous administration,2009 cases(63.30%)of the doses beyond the instructions were used.The top three drug combinations were listed in order of frequency:aspirin,metoprolol and amlodipine,which were commonly used drugs for the treatment of angina pectoris.1569 patients had effective outcome indicators.Analysis of the relationship between the dosage and therapeutic effect showed that within the range of the prescribed dosage,the cure rate and recovery rate of 50 mg were higher.At the off-label dosage,the cure rate and recovery rate of 100 mg were higher.The results of chi-square test and regression analysis showed that the effect of the control group better than breviscapine injection when dealing with angina pectoris.Conclusion Clinical treatment should adhere to the principle of safe drug use and rational drug use under standardized guidance.The drug combination of Breviscapine injection in the treatment of angina pectoris could help to improve the clinical benefit.It will works better when administered intravenously at a dose of 50 mg once a day.

关 键 词：注射用灯盏花素 心绞痛 真实世界 量效关系 

分 类 号：R972[医药卫生—药品]