摘要
目的:了解某院临床吉西他滨超适应证用药情况,为临床合理使用该药提供参考。方法:调取某院2018年1月~2019年6月住院病历中使用吉西他滨的全部医嘱数据,对患者基本情况、诊断等进行统计分析,将诊断与最新版药品说明书进行比对,将所有超适应证用药诊断与美国食品药品管理局(FDA)批准的适应证、中国指南或专家共识、美国国立综合癌症网络指南以及《马丁代尔药物大典》等进行比对,并参照Micromedex数据库的Thomson分级系统对超适应证用药进行循证医学证据等级评价。结果:共收集到该院使用吉西他滨的医嘱137例,其中符合说明书适应证用药47例(34.31%),超适应证用药90例(65.69%)。超适应证用药临床诊断有12种,其中膀胱癌、B细胞淋巴瘤及外周T细胞淋巴瘤位居前3位。超适应证用药中有10种在国内外指南、专家共识或《马丁代尔药物大典》(原著第37版)中有不同级别的循证医学证据支持,但有2种(腺性膀胱炎和胃恶性肿瘤)诊断缺少高级别循证医学证据支持。结论:该院吉西他滨超适应证用药现象普遍,虽大部分有较为充分的证据支持,但仍需进一步规范,促进临床合理用药。
Objective:To investigate the off-label indications use of gemcitabine in a hospital and provide reference for rational drug use in clinic.Methods:Extract all medical records of gemcitabine from the hospitalized medical records from January 1,2018 to June 30,2019 from information system in this hospital.The basic information and diagnosis of patients were statistically analyzed,and the diagnosis was compared with the latest version of drug instructions,then through consulting the indications approved by the U.S.Food and Drug Administration(FDA),Chinese guidelines or expert consensus,U.S.National Comprehensive Cancer Network(NCCN)guidelines,and Martindale The Complete Drug Reference and Thomson Micromedex database to analyze the off-label indications use of gemcitabine.Results:A total of 137 patients were given gemcitabine hydrochloride in a hospital,of which 90(65.69%)were off-label indications.The off-label indications were used for 12 diagnosis,the top three were bladder cancer,B cell lymphoma and peripheral T cell lymphoma.There were 10 kinds of off-label indications that were supported by different levels of evidence-based medicine evidence in domestic and foreign guidelines,expert consensus,or Martindale The Complete Drug Reference(37 th edition).However,there were two diagnosis(glandular cystitis and gastric malignant tumor)that lack high-level evidence-based medical evidence to support.Conclusion:The off-label indications use of gemcitabine in this hospital is widespread,and it is still necessary to further regulate the off-label indications to promote the rationality and safety of clinical drug use.
作者
朱玲娜
汪龙
张冠军
陈静
Zhu Lingna;Wang Long;Zhang Guanjun;Chen Jing(Department of Pharmacy,the Third People's Hospital of Bengbu,Bengbu 233099,Anhui,China)
出处
《药物流行病学杂志》
CAS
2020年第12期834-838,共5页
Chinese Journal of Pharmacoepidemiology
基金
蚌埠市级科技创新指导类项目(编号:蚌科[2019]90号)。
关键词
吉西他滨
超适应证用药
循证医学
合理用药
Gemcitabine
Off-label indications
Evidence-based medicine
Rational drug use
