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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
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| 篇名： | 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 |
| TITLE： | |
| 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。 |
| 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 instructions were glibenclamide， 3 were glipizide， 3 were glimepiride， and 3 were gliclazide， among which 7 drug instructions were sulfonamide allergy contraindication. However， there were great differences in the sulfonamide allergy annotation of drug instructions between US and Europe. CONCLUSIONS： There are great differences in the annotation for sulfonamide allergy in drug instructions of sulfonylureas at home and abroad， which indicates that there are different opinions on the clinical significance of sulfa cross-reaction in patients with sulfonamide allergy， and sulfonamide cross-allergy is a controversial issue. It is necessary to promote the research of sulfonamide cross-allergy from the perspectives of scientific researchers， medical associations， pharmaceutical manufacturers， medical staff and patients， and to clarify its mechanism and clinical significances. |
| 期刊： | 2019年第30卷第4期 |
| 作者： | 卫菁，蔡俊，李曼，张忠华 |
| AUTHORS： | WEI Jing，CAI Jun，LI Man，ZHANG Zhonghua |
| 关键字： | 磺胺类过敏；药品说明书；磺脲类药物；交叉过敏 |
| KEYWORDS： | Sulfonamide allergy； Drug instrcution； Sulfonylureas； Cross-allergy |
| 阅读数： | 590 次 |
| 本月下载数： | 16 次 |
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