Prescrire Int. 2004 Oct;13(73):163-5.
(1) Four drugs are approved in France for patients with obsessive-compulsive disorders, namely clomipramine and three selective serotonin reuptake inhibitors (SSRIs): fluoxetine, paroxetine and sertraline. None of the four has emerged as a reference treatment. For children with obsessive-compulsive disorder, the treatment hierarchy is as follows: psychotherapy; behaviour therapy; clomipramine; sertraline. (2) Fluvoxamine, another SSRI, has now been approved in France for the treatment of obsessive-compulsive disorder in patients aged at least 8 years, after European harmonisation of SPCs for fluvoxamine-based preparations. (3) In adults, two placebo-controlled trials and the six trials versus clomipramine show that fluvoxamine, like clomipramine, is only partially effective (about one-third of patients "respond"). (4) In the only placebo-controlled trial in 120 children and adolescents aged from 8 to 17 years, who were treated for 10 weeks, efficacy was even more modest (response rate 15%, compared to 10% with placebo). (5) The safety profile of fluvoxamine is the same as that of all SSRIs but it has a potential for more drug interactions. (6) In practice, approval of fluvoxamine in adults or children with obsessive-compulsive disorder will have no impact on their management.
(1)在法国,有四种药物被批准用于治疗强迫症患者,即氯米帕明和三种选择性5-羟色胺再摄取抑制剂(SSRI):氟伏沙明、帕罗西汀和舍曲林。这四种药物均未成为标准治疗药物。对于患有强迫症的儿童,治疗顺序如下:心理治疗;行为治疗;氯米帕明;舍曲林。(2)另一种SSRI氟伏沙明,在欧洲对基于氟伏沙明的制剂的产品特性摘要进行统一后,现已在法国被批准用于治疗至少8岁患者的强迫症。(3)在成人中,两项安慰剂对照试验以及六项与氯米帕明对比的试验表明,氟伏沙明与氯米帕明一样,仅部分有效(约三分之一的患者“有反应”)。(4)在唯一一项针对120名8至17岁儿童和青少年进行的为期10周的安慰剂对照试验中,疗效更为有限(反应率为15%,而安慰剂组为10%)。(5)氟伏沙明的安全性与所有SSRI相同,但它有更多药物相互作用的可能性。(6)实际上,氟伏沙明在成人或儿童强迫症患者中的获批对其治疗管理并无影响。