摘要
目的通过对疑似清开灵注射液死亡不良事件(AE)病例文献的整理和分析,获得其严重不良反应的相关信息,为临床医师、研究者提供决策帮助。方法计算机检索1975-2016年7月中国知网、万方、维普、CBM 4个数据库。根据纳入排除标准筛选文献并提取文献信息,共获得疑似清开灵注射液死亡AE文献19篇,死亡AE病例24例,分析24例疑似清开灵注射液死亡AE病例的人口学、诊断信息、联合用药、不良反应发生情况、用药医疗机构、病案报告的规范性。结果在24例报告中17例出现联合用药现象,2例为超说明书适应证使用;24例不良反应表现均为过敏性休克,11例患者用药机构为个体诊所,18篇报告的撰写格式不规范。结论不良反应/事件的发生与临床上不合理用药有关,建议严格按照说明书规定用药;对于所发生的AE按照相关法规进行不良反应判断,明确与药物的因果关系。
Objective To provide information for clinicians and researchers through analyzing the literatures of suspected cases of adverse events （AE）. Methods Literatures from 1975 to July 2016 were collected on CNKI, wanfang, vip, CBM. Totally 19 articals were included and 24 cases were evaluated. The 6 aspects of epidemiology, diagnostic information, combined medication, adverse reactions occur, medication medical institutions, medical records of the normative of the 24 cases were analyzied. Results In the 24 cases, 17 showed a combination of drug use, 2 were off-label drug use. All the 24 cases of AE showed allergic shock, 11 were treated in individual clinics, 18 reports were not standardized. Conclusion The AEs are associated with irrational use of drugs, We should be strictly in accordance with the specification to use of the preparation, and determine AEs according the relevant regulations to deny causality between drugs and AEs.
出处
《中南药学》
CAS
2017年第7期993-997,共5页
Central South Pharmacy
基金
中央级公益性科研院所基本业务费项目(No.Z0406
PY1303)
国家"重大新药创制"科技重大专项(No.2014ZX09201022-005)
关键词
清开灵注射液
文献分析
致死不良事件
Qingkailing injection
literature analysis
adverse event death
作者简介
刘福梅，女，硕士研究生，主要从事中医临床评价方法研究，Tel：18363080187，E—mail：1475869085@qq．com
通讯作者：谢雁鸣，女，研究员，主要从事中医临床评价方法研究，Tel：（010）64014411-3302，E-mail：zhinanb2012@ya-hoo．com.cn
