Linselle Mélanie, Sommet Agnès, Bondon-Guitton Emmanuelle, Moulis Florence, Durrieu Geneviève, Benevent Justine, Rousseau Vanessa, Chebane Leila, Bagheri Haleh, Montastruc François, Montastruc Jean-Louis
Service de Pharmacologie Médicale et Clinique, Faculté de Médecine de Toulouse, Centre Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Pharmacopôle Midi-Pyrénées, Equipe de Pharmacoépidémiologie de l'INSERM UMR 1027, CIC INSERM 1436, Centre Hospitalier Universitaire, Toulouse, France.
Fundam Clin Pharmacol. 2017 Jun;31(3):359-366. doi: 10.1111/fcp.12264. Epub 2017 Feb 2.
The potential favorizing role of drugs in sleep apnea syndrome (SAS) is unknown. This study investigates drugs associated with SAS in a pharmacovigilance database. SAS recorded as adverse drug reactions (ADRs) in VigiBase , the WHO pharmacovigilance database (more than 11 million reports), from 1978 to 2015 was selected. The risk of SAS reports was estimated using the case-noncase method, with cases being SAS and noncases all other recorded ADRs. During this 37-year period, 3325 ADRs including the word SAS were registered (0.05% of the database). Mean age was 51.2 ± 16.9 years with 52% men. ADRs were 'serious' in around 82% of cases. The case-noncase study found an association between SAS and exposition with sodium oxybate, rofecoxib, quetiapine, and clozapine for individual drugs and coxibs, antipsychotics, benzodiazepines, and opium alkaloids for drug classes. The potential role of other drugs is discussed. This study suggests that SAS can be associated with some drugs (mainly psychotropics) that are able to reveal or aggravate such a disease. Physicians should take into account the role of drugs in the etiological appraisal and management of SAS.
药物在睡眠呼吸暂停综合征(SAS)中可能的促发作用尚不清楚。本研究在一个药物警戒数据库中调查与SAS相关的药物。选取了1978年至2015年期间在世界卫生组织药物警戒数据库VigiBase(超过1100万份报告)中记录为药物不良反应(ADR)的SAS病例。采用病例-非病例法估计SAS报告的风险,病例为SAS,非病例为所有其他记录的ADR。在这37年期间,共登记了3325例包含“SAS”一词的ADR(占数据库的0.05%)。平均年龄为51.2±16.9岁,男性占52%。约82%的病例中ADR为“严重”。病例-非病例研究发现,对于个别药物,SAS与使用羟丁酸钠、罗非昔布、喹硫平和氯氮平有关;对于药物类别,SAS与环氧化酶抑制剂、抗精神病药、苯二氮䓬类药物和鸦片生物碱有关。文中还讨论了其他药物的潜在作用。本研究表明,SAS可能与某些能够引发或加重该疾病的药物(主要是精神药物)有关。医生在SAS的病因评估和管理中应考虑药物的作用。