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首页> 外文期刊>BMC Pediatrics >Evaluation of the efficacy and safety of olanzapine as an adjunctive treatment for anorexia nervosa in adolescent females: a randomized, double-blind, placebo-controlled trial
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Evaluation of the efficacy and safety of olanzapine as an adjunctive treatment for anorexia nervosa in adolescent females: a randomized, double-blind, placebo-controlled trial

机译：评价奥氮平作为青少年女性神经性厌食症的辅助治疗的有效性和安全性：一项随机，双盲，安慰剂对照试验

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Background Anorexia Nervosa (AN) is a serious, debilitating condition that causes significant physical, emotional, and functional impairment. The condition is characterized by destructive weight loss behaviours and a refusal to maintain body weight at or above a minimally normal weight for age and height. AN often develops in adolescence and is a predominantly female disorder. Treatment for AN typically involves medical, nutritional and psychological interventions. Pharmacotherapy is also often used; however, the literature on the effectiveness of these drugs in a pediatric population is very limited. Olanzapine, which is an 'atypical' antipsychotic, is becoming more widespread in the treatment of AN. Olanzapine is hypothesized to facilitate weight gain, while decreasing levels of agitation and decreasing resistance to treatment in young women with AN. This randomized, double-blind placebo-controlled trial seeks to examine the effectiveness and safety of olanzapine in female youth with AN. Methods/Design Adolescent females between the ages of 12 and 17 diagnosed with AN (either restricting or binge/purge type) or Eating Disorder Not Otherwise Specified with a Body Mass Index of less than or equal to 17.5, will be offered inclusion in the study. Patients will be randomly assigned to receive either olanzapine or placebo. Patients assigned to receive olanzapine will start at a low dose of 1.25 mg/day for three days, followed by 2.5 mg/day for four days, 5 mg/day for one week, then 7.5 mg/day (the target dose chosen) for 10 weeks. After 10 weeks at 7.5 mg the medication will be tapered and discontinued over a period of two weeks. The effectiveness of olanzapine versus placebo will be determined by investigating the change from baseline on measures of eating attitudes and behaviors, depression and anxiety, and change in Body Mass Index at week 12, and after a follow-up period at week 40. It is anticipated that 67 participants will be recruited over two years to complete enrollment. Discussion Randomized controlled trials designed to measure the safety and effectiveness of olanzapine in comparison to placebo are desperately needed, particularly in the adolescent population. Trial registration Current Controlled Trials ISRCTN23032339
机译：背景神经性厌食症（AN）是一种严重的衰弱性疾病，会导致严重的身体，情感和功能障碍。该疾病的特征在于破坏性的减肥行为以及拒绝将体重维持在年龄和身高的最低正常体重或以上的水平。 AN通常在青春期发展，并且是女性的主要疾病。 AN的治疗通常涉及医学，营养和心理干预。还经常使用药物疗法。然而，关于这些药物在儿科人群中的有效性的文献非常有限。奥氮平是一种“非典型”抗精神病药，在AN治疗中正变得越来越普遍。假设奥氮平可促进体重增加，同时可降低年轻AN患者的躁动水平并降低其对治疗的抵抗力。这项随机，双盲安慰剂对照试验旨在研究奥氮平在患有AN的女性青年中的有效性和安全性。方法/设计将被纳入研究的年龄在12至17岁之间的被诊断患有AN（限制型或暴饮暴食型或吹扫型）或饮食失调（未指定体重指数小于或等于17.5）的青春期女性。 。患者将被随机分配接受奥氮平或安慰剂治疗。被分配接受奥氮平的患者将以低剂量1.25 mg /天开始三天，然后以2.5 mg /天连续4天，5 mg /天持续一周，然后以7.5 mg /天（选定的目标剂量）开始10个星期以7.5 mg服用10周后，药物将逐渐减量，并在两周内停用。奥氮平与安慰剂的有效性将通过调查饮食态度和行为，抑郁和焦虑的测量值相对于基线的变化以及在第12周时以及在第40周的随访期之后的体重指数变化来确定。预计两年内将招募67名参与者以完成注册。讨论迫切需要旨在评估奥氮平与安慰剂相比安全性和有效性的随机对照试验，尤其是在青少年人群中。试用注册电流对照试验ISRCTN23032339

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