Azorin Jean Michel, Findling Robert L
Hôpital de Sainte-Marguerite, Marseille, France.
CNS Drugs. 2007;21(12):1019-33. doi: 10.2165/00023210-200721120-00005.
This review aims to provide an update on valproate use in children and adolescents with bipolar disorder by summarising currently available clinical trials results. Guidelines for the treatment of type I bipolar disorder in children and adolescents, with or without psychotic features, recommend valproate, alone or in combination with an atypical antipsychotic, as a first-line treatment option; however, most randomised and open-label studies investigating valproate in paediatric populations have only evaluated a small number of participants. Therefore, the data from these studies need to be interpreted cautiously. A further complicating issue is the controversy surrounding the definition and diagnosis of bipolar disorders in this age group. Data suggest that valproate may be particularly useful for patients whose symptoms have not been responsive to lithium, or as part of combination therapy. Evidence from randomised controlled trials show that valproate monotherapy is associated with a Young Mania Rating Scale (YMRS) response rate (percentage of patients with a reduction in YMRS score from baseline to endpoint of >/=50%) of 53%, while combination therapy with valproate plus quetiapine is associated with a YMRS response rate of 87%; however, placebo response rates were high, emphasising the need for caution when interpreting data from open-label trials. At present, data supporting the efficacy and safety of mood stabilisers for the treatment of bipolar disorders in children and adolescents are limited; therefore, well designed, randomised controlled clinical studies are needed to identify and confirm the potential roles of valproate in children and adolescents with bipolar disorders, particularly in those with psychiatric co-morbidities. Furthermore, clinical studies are required to clarify the efficacy and tolerability profile of valproate in comparison with other agents used in paediatric and adolescent bipolar disorder.
本综述旨在通过总结当前可用的临床试验结果,提供关于丙戊酸盐在儿童和青少年双相情感障碍治疗中应用的最新情况。对于有或无精神病性特征的儿童和青少年I型双相情感障碍的治疗指南推荐,丙戊酸盐单独使用或与非典型抗精神病药物联合使用,作为一线治疗选择;然而,大多数在儿科人群中研究丙戊酸盐的随机和开放标签研究仅评估了少数参与者。因此,这些研究的数据需要谨慎解读。另一个复杂的问题是该年龄组双相情感障碍的定义和诊断存在争议。数据表明,丙戊酸盐可能对症状对锂盐无反应的患者特别有用,或作为联合治疗的一部分。随机对照试验的证据表明,丙戊酸盐单药治疗的青年躁狂评定量表(YMRS)反应率(YMRS评分从基线到终点降低≥50%的患者百分比)为53%,而丙戊酸盐加喹硫平联合治疗的YMRS反应率为87%;然而,安慰剂反应率很高,这强调了在解读开放标签试验数据时需要谨慎。目前,支持心境稳定剂治疗儿童和青少年双相情感障碍有效性和安全性的数据有限;因此,需要设计良好的随机对照临床研究,以确定和确认丙戊酸盐在儿童和青少年双相情感障碍患者中的潜在作用,特别是在那些有精神共病的患者中。此外,需要进行临床研究,以阐明丙戊酸盐与用于儿科和青少年双相情感障碍的其他药物相比的疗效和耐受性。