摘要
目的分析某院60μg乙肝疫苗超说明书用药的合理性,为临床用药提供参考依据.方法借鉴循证药学原理,通过查阅药品说明书、检索近十年相关文献,纳入关于60μg乙肝疫苗用于初免人群的安全性及有效性的研究文献,并分析评价纳入文献的质量,结合某院超说明书用药情况给出评价.结果检索出60μg乙肝疫苗相关文献12篇,其中5篇初免人群接种试验,按证据等级分级最后筛选出3篇文献加以分析.结论60μg乙肝疫苗用于初免人群是安全的,某院60μg乙肝疫苗方案较常规方案效果相当或更好,属合理性用药,但由于相关临床研究较少,其抗体保护时效有待进一步研究.
Objective The rationality of off-label drug use of 60 μg hepatitis B vaccine in our hospital was analyzed to provide reference for clinical drug use.Methods Based on the principle of evidence-based pharmacy, the safety and efficacy of 60μg hepatitis B vaccine for the newly immunized population were included in the research literature by consulting the drug instructions and retrieving the relevant literatures in recent ten years. The quality of the included literatures was analyzed and evaluated, and the off-label drug use in our hospital was evaluated. Results Twelve articles related to 60 μg hepatitis B vaccine were retrieved, and three articles were selected for analysis. Conclusion The 60 μg hepatitis Bvaccine is safe for the initial immunized population, and the 60 μg hepatitis Bvaccine regimen in our hospital is comparable to or better than the conventional regimen, which is reasonable for drug use.However, due to the lack of relevant clinical studies, the efficacy of its antibody protection needs to be further studied.
作者
杨欢
YANG Huan(Peking University International Hospital, Beijing 102206, China.)
出处
《中国处方药》
2019年第8期47-48,共2页
Journal of China Prescription Drug
关键词
重组乙型肝炎疫苗
60μg
超说明书用药
合理性
循证药学
Recombinant hepatitis B vaccine, 60μg
Off-label drug use
Rationality
Evidence-based medicine
