摘要
目的:为静脉用药调配中心(PIVAS)安全合理管理中药注射剂提供参考。方法:检索收集中药注射剂说明书,以PIVAS为中心,从安全用药角度出发,提取分析说明书各项信息,对比不同厂家同一品种的差异。结果:纳入说明书309份,涉及129个品种、211家企业,发现不同品种之间或同一品种不同厂家中药注射剂贮藏条件存在差异;54个品种缺乏传统功能主治的阐述;禁忌及不良反应信息丰富,禁用、忌用、慎用描述多样;28个品种推荐使用一种溶媒,26个品种明确滴速,81个品种没有明确用药疗程;辅料含有聚山梨酯80、苯甲醇、乙醇等。结论:中药注射剂在贮藏、辨证、辅料、输注、监测等环节可能存在风险。建议PIVAS从贮藏环境、医师处方以及临床应用展开警戒工作,建立PIVAS手册进行规范与宣教,防控用药风险。
Objective:To provide a reference for the safe and reasonable management of traditional Chinese medicine injections in pharmacy intravenous admixture services(PIVAS).Methods:The study searched and collected the drug instructions of traditional Chinese medicine injections.It was based on PIVAS and from the perspective of safe medication to extract and analyze the information,and compare the differences of the same species among different manufacturers.Results:There were included 309 drug instructions involving 129 kinds of traditional Chinese medicine injections and 211 companies.There were differences in storage conditions between different varieties or different manufacturers of the same species.Fifty-four species lacked the elaboration of functional indications about traditional Chinese medicine.The contraindications and ADR were informative,and the descriptions about taboos were not unified.Twenty-eight species were recommended to use the same solvent.Twenty-six species specified the drip rate.Eighty-one species did not specify the duration of administration.Excipients included polysorbate 80,benzyl alcohol,ethanol,etc..Conclusion:Traditional Chinese medicine injections had possible risk in storage,dialectical treatment,excipients,infusion,and monitoring.It was suggested that PIVAS could provide pharmacovigilance from storage environment,physician prescription,and clinical application.We should establish a PIVAS manual for standardization and education to prevent and control drug use risks.
作者
姜皓
张冰
章之琪
马冰冰
吕锦涛
JIANG Hao;ZHANG Bing;ZHANG Zhi-qi;MA Bing-bing;LYU Jin-tao(Beijing University of Chinese Medicine,Beijing 100029,China)
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2021年第10期6184-6188,共5页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
国家中医药管理局-国家中医药领军人才支持计划“岐黄学者”项目(No.10400633210004)
第三批国家高层次人才特殊支持计划(万人计划)教学名师项目(No.2020063320001)
中华医学会教育研究课题(No.2018B-N20020)。
关键词
中药注射剂
静脉用药调配中心
药品说明书
药物警戒
Traditional Chinese medicine injection
Pharmacy intravenous admixture services(PIVAS)
Drug instructions
Pharmacovigilance
