Day-patient treatment after short inpatient care versus continued inpatient treatment in adolescents with anorexia nervosa (ANDI): a multicentre, randomised, open-label, non-inferiority trial
Day-patient treatment after short inpatient care versus continued inpatient treatment in adolescents with anorexia nervosa (ANDI): a multicentre, randomised, open-label, non-inferiority trial
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DOI：
10.1016/s0140-6736(13)62411-3
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发表时间：
2014-04-05
期刊：
影响因子：
168.9
通讯作者：
Dempfle, Astrid
中科院分区：
文献类型：
--
作者：
Herpertz-Dahlmann, Beate;Schwarte, Reinhild;Dempfle, Astrid
背景：住院治疗（IP）是中度至重度神经性厌食症青少年的首选治疗环境，但其成本高昂，复发和再入院的风险也很高。日间病人治疗（DP）费用较低，并且可以通过减轻从医院到家庭的过渡，避免复发和再入院的问题。我们调查了短期住院治疗后DP与持续IP的安全性和有效性。在这项多中心、随机、开放标签、非劣效性试验中，我们招募了来自德国6个中心的神经性厌食症女性患者（11-18岁）。如果患者的身体质量指数（BMI）低于10%，并且这是他们第一次因神经性厌食症入院，则符合条件。我们使用计算机生成的随机化序列，在住院治疗3周后随机分配患者继续IP或DP（1:1；根据入院时的年龄和BMI分层）。两个研究组的治疗方案和治疗强度相同。主要结局是入院至12个月随访期间BMI的增加，调整了年龄和病程（非劣效差为0.75 kg/m(2)）。采用改良意向治疗法进行分析。该试验已注册国际标准随机对照试验注册号为ISRCTN67783402，德国Klinischer学生注册号为DRKS00000101。在2007年2月2日至2010年4月27日期间，我们筛选了660例患者，其中172例随机分配到治疗组：85例接受IP治疗，87例接受DP治疗。就主要结局而言，DP不逊于IP， 12个月随访时的BMI（平均差0.46 kg/m(2)）有利于DP （95% CI, -0.11至1.02;p（非劣效性）< 0.0001）。两个研究组中与治疗相关的严重不良事件数量相似（IP组为8例，DP组为7例）。IP组有3例严重不良事件与自杀意念有关，DP组有2例；其中一名病人在出院3个月后企图自杀。解释：青少年非慢性神经性厌食症患者在入院后第一年的短期住院治疗后，DP在体重恢复和维持方面的效果并不亚于IP。因此，DP可能是一种安全且成本较低的IP替代方案。我们的结果证明了这种方法的广泛实施。
Background In-patient treatment (IP) is the treatment setting of choice for moderately-to-severely ill adolescents with anorexia nervosa, but it is costly, and the risks of relapse and readmissions are high. Day patient treatment (DP) is less expensive and might avoid problems of relapse and readmission by easing the transition from hospital to home. We investigated the safety and efficacy of DP after short inpatient care compared with continued IP.Methods For this multicentre, randomised, open-label, non-inferiority trial, we enrolled female patients (aged 11-18 years) with anorexia nervosa from six centres in Germany. Patients were eligible if they had a body-mass index (BMI) below the tenth percentile and it was their first admission to hospital for anorexia nervosa. We used a computer-generated randomisation sequence to randomly assign patients to continued IP or DP after 3 weeks of inpatient care (1:1; stratified for age and BMI at admission). The treatment programme and treatment intensity in both study groups were identical. The primary outcome was the increase in BMI between the time of admission and a 12-month follow-up adjusted for age and duration of illness (non-inferiority margin of 0.75 kg/m(2)). Analysis was done by modified intention to treat. This trial is registered with the International Standard Randomised Controlled Trial Number Register, number ISRCTN67783402, and the Deutsches Register Klinischer Studien, number DRKS00000101.Findings Between Feb 2, 2007, to April 27, 2010, we screened 660 patients for eligibility, 172 of whom we randomly allocated to treatment:85 to IP and 87 to DP. DP was non-inferior to IP with respect to the primary outcome, BMI at the 12-month follow-up (mean difference 0.46 kg/m(2) in favour of DP (95% CI, -0.11 to 1.02; p(non-inferiority) < 0.0001). The number of treatment-related serious adverse events was similar in both study groups (eight in the IP group, seven in the DP group). Three serious adverse events in the IP group and two in the DP group were related to suicidal ideation; one patient in the DP attempted suicide 3 months after she was discharged.Interpretation DP after short inpatient care in adolescent patients with non-chronic anorexia nervosa seems no less effective than IP for weight restoration and maintenance during the first year after admission. Thus, DP might be a safe and less costly alternative to IP. Our results justify the broad implementation of this approach.