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首页> 外文期刊>Journal of the American Academy of Child and Adolescent Psychiatry >Venlafaxine ER for the treatment of pediatric subjects with depression: results of two placebo-controlled trials.
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Venlafaxine ER for the treatment of pediatric subjects with depression: results of two placebo-controlled trials.

机译:Venlafaxine ER用于治疗抑郁症的小儿科:两项安慰剂对照试验的结果。

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OBJECTIVE: 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. METHOD: 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. RESULTS: 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. CONCLUSIONS: 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.
机译:目的:在1997年10月至2001年8月进行的两项多中心,随机,双盲,安慰剂对照试验中,评估了文拉法辛缓释(ER)在7至17岁患有严重抑郁症的受试者中的安全性,有效性和耐受性方法:参与者接受文拉法辛ER(根据体重而定的灵活剂量;意图治疗,n = 169)或安慰剂(意图治疗,n = 165),最多8周。主要疗效变量是在第8周时儿童抑郁评估量表修订的得分与基线相比的变化。结果:在这两项研究中,文拉法辛ER和安慰剂在儿童抑郁评估量表修订中均无统计学差异。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,使用文拉法辛ER修订的儿童抑郁量表比安慰剂组有更大的改善(-24.4对-19.9; P = 022),但在安慰剂组中则没有。儿童(7-11岁)。最常见的不良反应是厌食和腹痛。与服用安慰剂的受试者相比,接受文拉法辛ER治疗的受试者中与敌意和自杀相关的事件更为常见。没有完整的自杀。结论:文拉法辛ER可能对抑郁的青少年有效。但是,尚未确定其在儿科患者中的安全性和有效性。开处方者应监测服用文拉法辛ER的小儿患者的自杀意念和敌意迹象。

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