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一项随机、安慰剂对照研究佐米曲普坦预防奥氮平相关体重增加。

A randomized, placebo-controlled study of zonisamide to prevent olanzapine-associated weight gain.

机构信息

Lindner Center of HOPE, Mason, OH 45040, USA.

出版信息

J Clin Psychopharmacol. 2012 Apr;32(2):165-72. doi: 10.1097/JCP.0b013e3182488758.

DOI:10.1097/JCP.0b013e3182488758
PMID:22367654
Abstract

Weight gain is commonly observed with olanzapine treatment. Zonisamide is an antiepileptic drug associated with weight loss. This study examined the effectiveness of zonisamide in preventing weight gain in 42 patients beginning olanzapine for bipolar disorder or schizophrenia. Each patient had a body mass index of 22 mg/kg or greater and was randomized to taking olanzapine with either zonisamide (n = 20) or placebo (n = 22) for 16 weeks. The primary outcome measure was change in body weight in kilograms from baseline. In the primary analysis using longitudinal regression, patients who received zonisamide had a significantly slower rate of weight gain and increase in body mass index than those who received placebo. The patients treated with zonisamide gained a mean (SD) of 0.9 (3.3) kg, whereas those treated with placebo gained a mean (SD) of 5.0 (5.5) kg; P = 0.01. None of the patients in the zonisamide group, compared with 7 patients (33%) in the placebo group, gained 7% of body weight or greater from baseline (Fisher exact test, P = 0.009). The zonisamide group, however, reported significantly more cognitive impairment as an adverse event than the placebo group (25% vs 0, respectively; P = 0.02). Zonisamide was effective for mitigating weight gain in patients with bipolar disorder or schizophrenia initiating treatment with olanzapine but was associated with cognitive impairment as an adverse event.

摘要

体重增加是奥氮平治疗中常见的现象。佐尼沙胺是一种抗癫痫药物,与体重减轻有关。本研究考察了佐尼沙胺在预防 42 名开始使用奥氮平治疗双相情感障碍或精神分裂症的患者体重增加方面的有效性。每位患者的体重指数均为 22mg/kg 或更高,并随机分为佐尼沙胺组(n=20)或安慰剂组(n=22),接受奥氮平治疗 16 周。主要观察指标为从基线开始的体重变化(以千克为单位)。在使用纵向回归进行的主要分析中,接受佐尼沙胺治疗的患者体重增加速度和体重指数增加速度明显低于接受安慰剂的患者。接受佐尼沙胺治疗的患者平均(标准差)增加 0.9(3.3)kg,而接受安慰剂治疗的患者平均(标准差)增加 5.0(5.5)kg;P=0.01。与安慰剂组相比,佐尼沙胺组没有患者体重增加 7%或更多(Fisher 确切检验,P=0.009),而安慰剂组有 7 名(33%)患者体重增加 7%或更多。然而,佐尼沙胺组报告的认知障碍不良事件明显多于安慰剂组(分别为 25%和 0%;P=0.02)。佐尼沙胺在预防开始使用奥氮平治疗的双相情感障碍或精神分裂症患者体重增加方面有效,但与认知障碍不良事件相关。

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