Emslie Graham J, Findling Robert L, Yeung Paul P, Kunz Nadia R, Li Yunfeng
Dr. Emslie is with University of Texas Southwestern Medical Center at Dallas; Dr. Findling is with Case Western Reserve University, Cleveland; Dr. Yeung was formerly with Yale University School of Medicine, and is now with Wyeth Research, Collegeville, PA; Dr. Kunz is with Wyeth Research, in Collegeville, PA; and Dr. Li was formerly with Wyeth Research, Collegeville, PA, and is now with Shire Development, Wayne PA.
Dr. Emslie is with University of Texas Southwestern Medical Center at Dallas; Dr. Findling is with Case Western Reserve University, Cleveland; Dr. Yeung was formerly with Yale University School of Medicine, and is now with Wyeth Research, Collegeville, PA; Dr. Kunz is with Wyeth Research, in Collegeville, PA; and Dr. Li was formerly with Wyeth Research, Collegeville, PA, and is now with Shire Development, Wayne PA.
J Am Acad Child Adolesc Psychiatry. 2007 Apr;46(4):479-488. doi: 10.1097/chi.0b013e31802f5f03.
The safety, efficacy, and tolerability of venlafaxine extended release (ER) in subjects ages 7 to 17 years with major depressive disorder were evaluated in two multicenter, randomized, double-blind, placebo-controlled trials conducted between October 1997 and August 2001.
Participants received venlafaxine ER (flexible dose, based on body weight; intent to treat, n = 169) or placebo (intent to treat, n = 165) for up to 8 weeks. The primary efficacy variable was the change from baseline in the Children's Depression Rating Scale-Revised score at week 8.
There were no statistically significant differences between venlafaxine ER and placebo on the Children's Depression Rating Scale-Revised in either study. A post hoc age subgroup analysis of the pooled data showed greater improvement on the Children's Depression Rating Scale-Revised with venlafaxine ER than with placebo (-24.4 versus -19.9; p = .022) among adolescents (ages 12-17), but not among children (ages 7-11). The most common adverse events were anorexia and abdominal pain. Hostility and suicide-related events were more common in venlafaxine ER-treated participants than in placebo-treated participants. There were no completed suicides.
Venlafaxine ER may be effective in depressed adolescents. However, its safety and efficacy in pediatric patients has not been established. Prescribers should monitor for signs of suicidal ideation and hostility in pediatric patients taking venlafaxine ER.
在1997年10月至2001年8月期间进行的两项多中心、随机、双盲、安慰剂对照试验中，评估了文拉法辛缓释剂（ER）在7至17岁重度抑郁症患者中的安全性、有效性和耐受性。
参与者接受文拉法辛ER（灵活剂量，基于体重；意向性治疗，n = 169）或安慰剂（意向性治疗，n = 165）治疗长达8周。主要疗效变量是第8周时儿童抑郁评定量表修订版得分相对于基线的变化。
在两项研究中，文拉法辛ER与安慰剂在儿童抑郁评定量表修订版上均无统计学显著差异。对汇总数据进行的事后年龄亚组分析显示，在青少年（12 - 17岁）中，文拉法辛ER治疗组在儿童抑郁评定量表修订版上的改善程度大于安慰剂组（-24.4对-19.9；p = 0.022），但在儿童（7 - 11岁）中并非如此。最常见的不良事件是厌食和腹痛。与安慰剂治疗组相比，文拉法辛ER治疗组的敌意和自杀相关事件更为常见。没有发生自杀身亡事件。
文拉法辛ER可能对抑郁青少年有效。然而，其在儿科患者中的安全性和有效性尚未确立。处方医生应监测服用文拉法辛ER的儿科患者是否有自杀意念和敌意的迹象。
