Rochoy Michaël, Zakhem-Stachera Christina, Béné Johana, Berkhout Christophe, Gautier Sophie
Département de médecine générale, université de Lille, 59000 Lille, France.
Département de médecine générale, université de Lille, 59000 Lille, France; Département de pharmacologie médicale, université Lille Nord-de-France, 59045 Lille cedex, France.
Therapie. 2018 Oct;73(5):389-398. doi: 10.1016/j.therap.2018.02.006. Epub 2018 Mar 1.
Most antidepressants have been associated with a risk of hyponatremia in the literature. This effect is not always reported in monographs. The aim of our study was to clarify the difference of increased risk of hyponatremia among various antidepressants.
Retrospective study of such cases/non-cases from observations recorded in the French national pharmacovigilance between 01/01/2004 and 31/12/2013. We studied all antidepressants marketed in 2014 in France, with a positive control (haloperidol) and a negative one (amoxicillin). The association between exposure to a given drug and the occurrence of an adverse event was estimated by calculating the reporting odds ratio (ROR). His confidence interval (CI) was calculated with the method of Woolf, with an alpha risk of 5%. The disproportionality is defined by an ROR>1, the 95% CI did not include the value 1.
Between 2004 and 2013, 3397 cases of hyponatremia were. All antidepressants were associated with hyponatremia among these cases, with the exception of: milnacipran, amoxapine, dosulepine, doxepine, trimipramine, iproniazide. The effect was predominant for the class of selective inhibitors of serotonin reuptake (SSRIs), inhibitors of serotonin reuptake and noradrenaline (SNRIs) and other antidepressants; it seemed more doubtful for tricyclic and monoamine oxidase inhibitors (MAOIs). Contrary to the literature, we found an association between hyponatremia and exposure to agomelatine (ROR=4.1, CI [2.2 to 7.7]), mianserine (ROR=2.7, CI [2.0 to 3.7]) and tianeptine (ROR=6.1, CI [4.7 to 7.9]).
This study suggests to stay alert to electrolyte disorders when using all antidepressants, not only serotonin reuptake inhibitors.
文献表明，大多数抗抑郁药都与低钠血症风险相关。但这一效应在药品说明书中并非总是有报道。我们研究的目的是阐明各类抗抑郁药导致低钠血症风险增加的差异。
对2004年1月1日至2013年12月31日法国国家药物警戒记录中的此类病例/非病例进行回顾性研究。我们研究了2014年在法国上市的所有抗抑郁药，设置了阳性对照（氟哌啶醇）和阴性对照（阿莫西林）。通过计算报告比值比（ROR）来评估接触某特定药物与不良事件发生之间的关联。其置信区间（CI）采用伍尔夫方法计算，α风险为5%。不成比例定义为ROR>1，95%CI不包括值1。
2004年至2013年期间，有3397例低钠血症病例。在这些病例中，除米那普明、阿莫沙平、度硫平、多塞平、曲米帕明、异烟肼外，所有抗抑郁药都与低钠血症有关。这种效应在5-羟色胺再摄取选择性抑制剂（SSRI）类、5-羟色胺再摄取和去甲肾上腺素抑制剂（SNRI）类以及其他抗抑郁药中最为显著；对于三环类和单胺氧化酶抑制剂（MAOI）类，情况似乎更难确定。与文献不同的是，我们发现低钠血症与阿戈美拉汀（ROR=4.1，CI[2.2至7.7]）、米安色林（ROR=2.7，CI[2.0至3.7]）和噻奈普汀（ROR=6.1，CI[4.7至7.9]）的暴露之间存在关联。
本研究表明，使用所有抗抑郁药时都要警惕电解质紊乱，而不仅仅是5-羟色胺再摄取抑制剂。
