van der Klauw M M, Wilson J H, Stricker B H
Drug Safety Unit of the Dutch Inspectorate for Health Care, Rijswijk, The Netherlands.
Clin Exp Allergy. 1996 Dec;26(12):1355-63. doi: 10.1046/j.1365-2222.1996.d01-300.x.
Since 1963, the Drug Safety Unit of the Dutch Inspectorate for Health Care (DSU) holds a voluntary reporting system.
To analyse all reports received in the years 1974 to 1994, registered as anaphylaxis or as a diagnosis that could contain cases of anaphylaxis.
All reports were classified as probable or possible anaphylaxis according to previously described criteria and the causal relationship between exposure and anaphylaxis was assessed.
Nine hundred and ninety-two reports possibly concerning anaphylaxis were received between 1974 and 1994. Fifty-six were unclassifiable. The remaining 936 reports concerned 326 men and 610 women. Three hundred and forty-five reports were classified as anaphylaxis probable, 485 as anaphylaxis possible, and 106 as anaphylaxis unlikely by previously specified criteria. Drugs frequently associated with anaphylaxis (causal relationship certain or probable) were: glafenine (326 reports classified as anaphylaxis probable or possible), combination preparations with (propy)phenazone or propyphenazone/phenacetine (39), diclofenac (30), dextran (20), ibuprofen (14), floctafenine (12), allergen extracts (12), sulfamethoxazole with trimethoprim (12), and trimethoprim (11). There is probably substantial under-reporting as well as reporting bias in these data. Furthermore, many reports were classified as possible and not as probable anaphylaxis because the temporal relationship was unknown or not reported.
Drugs that caused anaphylaxis most frequently were glafenine, NSAID and certain antibiotics. Data from a voluntary reporting system such as the DSU are valuable as an early warning system for drugs that may induce anaphylactic reactions.
自1963年以来，荷兰医疗保健检查局药品安全部门（DSU）设有一个自愿报告系统。
分析1974年至1994年期间收到的所有报告，这些报告登记为过敏反应或可能包含过敏反应病例的诊断。
根据先前描述的标准，将所有报告分类为可能或疑似过敏反应，并评估暴露与过敏反应之间的因果关系。
1974年至1994年期间共收到992份可能与过敏反应有关的报告。其中56份无法分类。其余936份报告涉及326名男性和610名女性。根据先前指定的标准，345份报告被分类为可能的过敏反应，485份为疑似过敏反应，106份为不太可能的过敏反应。经常与过敏反应相关（因果关系确定或可能）的药物有：格拉非宁（326份报告分类为可能或疑似过敏反应）、含（丙）非那宗或丙非那宗/非那西汀的复方制剂（39份）、双氯芬酸（30份）、右旋糖酐（20份）、布洛芬（14份）、氟苯那酸丁酯（12份）、变应原提取物（12份）、磺胺甲恶唑与甲氧苄啶（12份）以及甲氧苄啶（11份）。这些数据可能存在大量漏报以及报告偏差。此外，许多报告被分类为疑似过敏反应而非可能的过敏反应，因为时间关系未知或未报告。
最常引起过敏反应的药物是格拉非宁、非甾体抗炎药和某些抗生素。像DSU这样的自愿报告系统的数据作为可能引发过敏反应药物的早期预警系统很有价值。
