摘要
目的:探讨广西壮族自治区梧州市(以下简称“梧州地区”)中药注射剂新的/严重的药品不良反应(adverse drug reaction,ADR)与药品说明书的相关性。方法:采用回顾性分析方法,统计2011年1月至2020年6月梧州地区中成药注射剂“新的一般的”“新的严重的”和“严重的”ADR以及相关药品说明书,归纳分析患者性别、患者年龄、ADR累及器官和(或)系统及临床表现等方面内容;对中药注射剂的药品说明书中“不良反应”项目描述情况(是否有不良反应分类、是否有警示严重不良反应)与梧州地区上报的中药注射剂ADR发生情况进行相关性分析。结果:共收集到602例中药注射剂致ADR报告以及50份相关药品说明书(涉及39家生产企业);其中,新的一般的ADR 429例(占71.26%),严重的ADR 114例(占18.94%),新的严重的ADR 59例(占9.80%)。梧州地区中成药注射剂新的/严重的ADR主要涉及注射用血栓通(111例);临床主要表现以发热伴全身性损害为最多(占19.64%)。中药注射剂致新的一般的、新的严重的ADR与药品说明书“不良反应”项目描述(是否有不良反应分类、是否有警示严重不良反应)存在相关性;不同企业生产的同一通用名的药品说明书中不良反应内容存在差异。结论:中药注射剂说明书内容不完善、“不良反应”项目分类描述不规范、普遍缺乏特殊人群用药内容,仍需不断完善。
OBJECTIVE:To probe into the correlation between new/severe adverse drug reaction(ADR)of traditional Chinese medicine injections and drug instructions in Wuzhou,Guangxi Zhuang Autonomous Region(hereinafter referred to as“Wuzhou”).METHODS:Retrospective analysis method was adopted,statistics of“new general”,“new severe”and“severe”ADR of traditional Chinese medicine injections and related drug instructions in Wuzhou from Jan.2011 to Jun.2020 were made.Patient’s gender,age,ADR involved organs and/or systems and clinical manifestations were summarized and analyzed.Correlation analysis was performed between the description of“adverse drug reaction”items(adverse drug reaction classification or severe adverse drug reaction)in the drug instructions of traditional Chinese medicine injections and the reported occurrence of ADR of traditional Chinese medicine injections in this region.RESULTS:A total of 602 cases of ADR of traditional Chinese medicine injections and 50 drug instructions(with 39 manufacturers)were collected.There were 429 cases(71.26%)of new general ADR,114 cases(18.94%)of severe ADR,and 59 cases(9.80%)of new severe ADR.New/severe ADR of traditional Chinese medicine injections in this region mainly concentrated in Xueshuantong injection(111 cases);the main clinical manifestations were fever with systemic damage(19.64%).There was a correlation between the new general and new severe ADR caused by traditional Chinese medicine injection and the item description of“adverse reactions”in the drug instructions(whether there is adverse reaction classification and whether there is warning serious adverse reaction).There were differences in the content of ADR in the same generic name drug package produced by different manufacturers.CONCLUSIONS:The contents of instructions for traditional Chinese medicine injections are imperfect,the classification and description of“adverse drug reactions”items are not standardized,and the contents of medications for special populations are generally lacking,which still needs to be improved continuously.
作者
李甜
黎鹂
梁健龙
李菁芸
杨琴
黎丁溧
梁俊
邝俊健
梁杰豪
LI Tian;LI Li;LIANG Jianlong;LI Jingyun;YANG Qin;LI Dingli;LIANG Jun;KUANG Junjian;LIANG Jiehao(Dept.of Pharmacy,Wuzhou Hospital of Traditional Chinese Medicine,Guangxi Wuzhou 543002,China)
出处
《中国医院用药评价与分析》
2020年第12期1516-1519,共4页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
广西壮族自治区中医药局自筹经费科研课题(No.GZZC2019276、No.GZZC2019275)。
关键词
中药注射剂
药品不良反应
药品说明书
Traditional Chinese medicine injections
Adverse drug reaction
Drug instructions
