加入改良Jadad法评价超说明书用药的合理性:以纳洛酮为例  

Addition of Modified Jadad Method to Evaluate the Rationality of Off-label Drug Use:Taking Naloxone as An Example

作　　者：邹清梅[1] ZOU Qingmei(Department of Pharmacy,Sichuan Chongzhou People's Hospital,Chengdu 611230,China)

机构地区：[1]四川省崇州市人民医院药剂科,成都611230

出　　处：《药学与临床研究》2021年第1期61-64,共4页Pharmaceutical and Clinical Research

摘　　要：目的:采用循证医学和加入改良Jadad量表法点评纳洛酮注射超药品说明书的合理性,建立该药超说明书合理用药评价标准。方法:提取2019年所有使用过纳洛酮的540份病历,并收集纳洛酮超说明书使用的循证医学证据和通过改良Jadad量表法对文献进行评分,将≥4分作为高质量文献。以循证医学结合改良Jadad量表法,对540份使用过纳洛酮的病历进行点评。结果:在《颅脑创伤临床救治指南》中,明确提出纳洛酮注射液在颅脑损伤的适应症及用法用量和疗程。而通过改良Jadad量表对2013年后的文献进行筛选评分,确定脑梗死所致的昏迷也为合理的超说明书适应症。结合循证医学和改良Jadad量表法,本院纳洛酮注射液使用适应证有87.3%在合理用药范围内,并建立纳洛酮超说明书合理用药评价标准。结论:通过上述两种办法评价超说明书用药,提供了循证依据的一种新的尝试,所建立药物合理使用的评价标准切实可行。Objective:To evaluate the rationality of off-label usel of naloxone injections by evidence-based medicine and modified Jadad scale,so as to establish an evaluation criteria for rational off-label drug use.Methods:All 540 medical records used naloxone in 2019 were extracted and reviewed based on medical evidence and literature scored≥4 points by the modified Jadad scalemethod.Results:As the medical evidence,the"guidelines for clinical treatment of craniocerebral trauma"clearly put forward craniocerebral injury as an indication of naloxone injections with clear dosage and course of treatment.The literatures since 2013 screened and scored by the modified Jadad scale confirmed that coma caused by cerebral infarction was also a reasonable off label indication.Based on the above evidence and literatures,87.3%of the indications of naloxone injections in our hospital were reviewed as within the scope of rational drug use,and the evaluation standard of rational off-label drug use of naloxone was established.Conclusion:The evaluation of off-label drug use by evidence-based medicine and modified Jadad scale is a new attempt,which is feasible to establish evaluation criteria for rational drug use.

关 键 词：循证医学 改良Jadad量表法 纳洛酮注射剂 超说明书用药 合理性 

分 类 号：R969.3[医药卫生—药理学]