Abadie Delphine, Durrieu Geneviève, Roussin Anne, Montastruc Jean-Louis
Laboratoire de Pharmacologie Médicale et Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, et Centre Midi-Pyrénées d'Évaluation et d'Information sur la Pharmacodépendance-Addictovigilance, Université de Toulouse, Faculté de Médecine, Centre hospitalier universitaire, Toulouse, France.
Therapie. 2013 Mar-Apr;68(2):77-84. doi: 10.2515/therapie/2013021. Epub 2013 Jun 18.
Tramadol is a weak opioid used as a step 2 analgesic, approved in France for moderate to severe pain. After dextropropoxyphene withdrawal, a national pharmacovigilance follow-up of tramadol was decided by the French Drug Agency.
All Serious Adverse Drug Reactions (SADR) notified with tramadol to the French PharmacoVigilance Centres (CRPV) and pharmaceutical companies between August 1(st), 2010 and July 31(th), 2011 were analyzed.
During the study period, 296 cases of SADR were notified to CRPV and 59 to pharmaceutical companies. Apart from opiate-related SADR, tramadol induced serotoninergic SADR, including seizures or serotoninergic syndromes. Several « unlabelled » SADR were also identified: some of them, like hyponatremia or hypoglycemia, are poorly known by health professionals. Other were never published: peripheral edema or pancreatitis.
This study shows that besides well-known opioid or serotoninergic ADR, tramadol can also induce 2 other relatively unknown ADR: hypoglycemia and hyponatremia.
曲马多是一种弱阿片类药物，用作二级镇痛药，在法国被批准用于治疗中度至重度疼痛。在右丙氧芬撤市后，法国药品管理局决定对曲马多进行全国性药物警戒随访。
分析了2010年8月1日至2011年7月31日期间向法国药物警戒中心（CRPV）和制药公司通报的所有与曲马多有关的严重药品不良反应（SADR）。
在研究期间，向CRPV通报了296例SADR，向制药公司通报了59例。除了与阿片类药物相关的SADR外，曲马多还引发了5-羟色胺能SADR，包括癫痫发作或5-羟色胺能综合征。还发现了几种“未标明的”SADR：其中一些，如低钠血症或低血糖症，医护人员了解较少。其他的从未发表过：外周水肿或胰腺炎。
本研究表明，除了众所周知的阿片类或5-羟色胺能不良反应外，曲马多还可引发另外两种相对不为人知的不良反应：低血糖症和低钠血症。
