Page 119 - 2019年2月第30卷第4期

·药师与药学服务·

国内外常用磺脲类药物的药品说明书中磺胺类过敏事项标注情

况分析 Δ

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卫 菁 ，蔡 俊 ，李 曼 ，张忠华 （1.江苏省中医院药学部，南京 210029；2.南京大学医学院附属鼓楼医院
1 #
1＊
药学部，南京 210008；3.南京大学医学院附属鼓楼医院老年科，南京 210008）
中图分类号 R952 文献标志码 A 文章编号 1001-0408（2019）04-0538-04
DOI 10.6039/j.issn.1001-0408.2019.04.21

摘 要 目的：了解磺脲类药物的药品说明书中磺胺类过敏事项标注情况，为促进该类药物的临床合理应用提供参考。方法：于
2018年10月通过查询MCDEX 软件（网络版）、美国食品药品监督管理局网站的Drugs@FDA以及DailyMed网站、欧洲药品管理
局网站以及英国电子医药汇编网站，收集国内外常用磺脲类药物的药品说明书，将磺胺类过敏事项标注分为未标注磺胺类过敏事
项、仅标注磺胺类过敏禁用、仅标注磺脲类过敏禁用以及同时标注磺胺类和磺脲类过敏禁用，并计算磺胺类过敏禁用的标注比
例。结果：在174份国内药品说明书中有格列齐特67份、格列吡嗪48份、格列本脲23份、格列美脲23份、格列喹酮13份；不同的药
品生产厂家在格列喹酮和格列本脲的磺胺类过敏事项标注上取得了较为一致的看法，在药品说明书中标注磺胺类过敏禁用的比
例分别为100％和95.65％；在格列吡嗪、格列美脲、格列齐特的磺胺类过敏事项标注上存在较大分歧，标注磺胺类过敏禁用的比例
分别为70.83％、65.22％、49.25％。在13份国外药品说明书中有格列本脲4份、格列吡嗪3份、格列美脲3份、格列齐特3份；有7
份药品说明书标注磺胺类过敏禁用；但美国与欧洲磺脲类药物的药品说明书在磺胺类过敏事项标注上存在较大差异。结论：国内
外磺脲类药物的药品说明书中磺胺类过敏事项标注情况存在较大差异，说明对于磺胺类药物交叉过敏在磺胺类过敏患者中的临
床意义存在不同看法，反映出对于磺胺类药物交叉过敏存在较大争议。这需要从科研工作者、医药协会、药品生产厂家、医务人员
和患者等多方面共同推进对磺胺类药物交叉过敏的研究，明确其机制和临床意义。
关键词 磺胺类过敏；药品说明书；磺脲类药物；交叉过敏

Statistical Analysis of Sulfonamide Allergy Item Annotation in Drug Instructions of Commonly-used
Sulfonylureas at Home and Abroad
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WEI Jing ，CAI Jun ，LI Man ，ZHANG Zhonghua（1. Dept. of Pharmacy，Jiangsu Hospital of TCM，Nanjing
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210029，China；2. Dept. of Pharmacy，Nanjing Drum Tower Hospital Affiliated to Medical College of Nanjing
University，Nanjing 210008，China；3. Dept. of Geriatrics，Nanjing Drum Tower Hospital Affiliated to Medical
College of Nanjing University，Nanjing 210008，China）
ABSTRACT OBJECTIVE：To investigate sulfonamide allergy item annotation in drug instructions of sulfonylureas，and to
provide reference for the promoting rational clinical use of the drugs. METHODS：In Oct. 2018，the drug instructions of
commonly-used sulfonylureas at home and abroad were collected by MCDEX software（online version），Drugs@FDA of the US
Food and Drug Administration website，DailyMed website，European Medicines Agency website and UK electronic Medicines
Compendium website. The annotation of sulfonamide allergy was analyzed statistically in respects of non-labeled sulfonamide
allergy，only labeled sulfonamide allergy contraindication，only labeled sulfonylureas allergy contraindication，labeled sulfonamide
and sulfonylureas allergy contraindication. The proportion of sulfonamide allergy contraindication labelling was calculated.
RESULTS：Among 174 pieces of domestic drug instructions，67 pieces of drug instructions were gliclazide，48 were glipizide，23
were glibenclamide，23 were glimepiride and 13 were gliquidone. Different pharmaceutical manufacturers reached a consensus on
the sulfonamide allergy of gliquidone and glibenclamide. The proportions of sulfonamide allergy contraindication labelling were
100％ and 95.65％，respectively. However，there were great differences on the sulfonamide allergy of glipizide，glimepiride and
gliclazide，and the proportions of sulfonamide allergy contraindication labelling were 70.83％，65.22％ and 49.25％，respectively.
Among 13 foreign drug instructions， 4 pieces of drug
Δ 基金项目：江苏省卫生和计划生育委员会干部保健科研课题
instructions were glibenclamide， 3 were glipizide， 3 were
（No.BJ17003）
glimepiride， and 3 were gliclazide， among which 7 drug
＊药师。研究方向：医院药学。电话：025-86617141。E-mail：
instructions were sulfonamide allergy contraindication.
guansuanna1@163.com
# 通信作者：主任药师。研究方向：医院药学。电话：025- However， there were great differences in the sulfonamide
86617141。E-mail：zzh6807@163.com allergy annotation of drug instructions between US and

·538 · China Pharmacy 2019 Vol. 30 No. 4 中国药房 2019年第30卷第4期