Bourgeois Anne Laure, Auriche Pascal, Palmaro Aurore, Montastruc Jean Louis, Bagheri Haleh
Service de pharmacologie clinique, Centre Midi-Pyrénées de pharmacovigilance, de pharmacoépidémiologie et d'informations sur le médicament, Inserm U1027, faculté de médecine, 37, allées Jules-Guesde, 31000 Toulouse, France.
Département de pharmacovigilance, Agence nationale de sécurité du médicament et des produits de Santé ANSM, 143/147, boulevard Anatole, 93285 Saint-Denis cedex, France.
Ann Endocrinol (Paris). 2016 Feb;77(1):14-21. doi: 10.1016/j.ando.2015.12.001. Epub 2016 Jan 29.
After the diagnosis of transsexualism, hormone therapy is an established stage of gender identity disorder treatment for inducing secondary sex characteristic development of the target gender while reducing that of the birth sex. The aim of this study was to review existing data about the risk of hormone therapy in transsexual people.
A PubMed search was done to identify relevant data about adverse drug reactions (ADRs) and mortality associated to hormones exposure. Furthermore, case reports of hormonal therapy-induced ADRs were identified in the French Pharmacovigilance DataBase (FPDB).
Review of currently available data showed an increase of thromboembolic effects and hyperprolactinemia with oestrogens. Both oestrogens and testosterone derivatives could induce hepatic effects. Currently, there is no significant association between hormone exposure and cancer or mortality in transsexual people. Five ADRs were found in FPDB, and two of them were related to misuse (voluntary overdose and prescription error).
Potential for under-reporting and under-identification in the FPDB of hormonal therapy-induced ADRs in transsexual people should be underlined. Technical improvement of the FPDB could facilitate further identification of reports concerning the risk associated with hormonal therapy in transsexual subjects.
在易性癖诊断后，激素治疗是性别认同障碍治疗的既定阶段，用于诱导目标性别的第二性征发育，同时减少出生时性别的第二性征发育。本研究的目的是回顾关于易性癖者激素治疗风险的现有数据。
通过PubMed检索，以确定与激素暴露相关的药物不良反应（ADR）和死亡率的相关数据。此外，在法国药物警戒数据库（FPDB）中识别激素治疗引起的ADR的病例报告。
对现有数据的回顾显示，雌激素会增加血栓栓塞效应和高泌乳素血症。雌激素和睾酮衍生物均可引起肝脏效应。目前，易性癖者的激素暴露与癌症或死亡率之间无显著关联。在FPDB中发现了5例ADR，其中2例与误用（自愿过量用药和处方错误）有关。
应强调FPDB中易性癖者激素治疗引起的ADR可能存在报告不足和识别不足的情况。FPDB的技术改进有助于进一步识别与易性癖者激素治疗风险相关的报告。
