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二甲双胍作为奥氮平治疗期间控制体重和代谢功能障碍的辅助治疗:一项多中心、双盲、安慰剂对照试验。

Metformin as an adjunctive treatment to control body weight and metabolic dysfunction during olanzapine administration: a multicentric, double-blind, placebo-controlled trial.

作者信息

Baptista Trino, Rangel Nairy, Fernández Virginia, Carrizo Edgardo, El Fakih Yamily, Uzcátegui Euderruh, Galeazzi Tatiana, Gutiérrez María A, Servigna Mercedes, Dávila Adriana, Uzcátegui Marycelvia, Serrano Ana, Connell Lisette, Beaulieu Serge, de Baptista Enma Araujo

机构信息

Department of Physiology, Los Andes University Medical School, PO Box 93, Mérida, 5101-A, Venezuela.

出版信息

Schizophr Res. 2007 Jul;93(1-3):99-108. doi: 10.1016/j.schres.2007.03.029. Epub 2007 May 8.

DOI:10.1016/j.schres.2007.03.029
PMID:17490862
Abstract

BACKGROUND

Excessive body weight gain (BWG) is a clinically relevant side effect of olanzapine administration. The primary objective of this study was to assess whether metformin prevents or reverses BWG in patients with schizophrenia or bipolar disorder under olanzapine administration. Secondarily we evaluated diverse metabolic variables.

METHODS

Eighty patients taking olanzapine (5-20 mg daily for more than 4 consecutive months) were randomly allocated to metformin (n=40; 850 to 2550 mg daily) or placebo (n=40) group in a 12-week double-blind protocol. Waist circumference (WC) body weight (BW), body mass index (BMI) fasting glucose, glycated hemoglobin (Hb1c), insulin, an insulin resistance index (HOMA-IR) lipids, leptin, c-reactive protein, fibrinogen, cortisol and the growth hormone (GH) were evaluated at baseline and at week 12 of treatment.

RESULTS

The metformin group lost 1.4+/-3.2 kg (p=0.01) and tended to decrease its leptin levels, whereas the placebo group maintained a stable weight: -0.18+/-2.8 kg (p=0.7). The HOMA-IR significantly increased after placebo (p=0.006) and did not change after metformin (p=0.8). No ostensible differences were observed in the other variables, even though metformin did not improve the lipid profile and the Hb1c levels.

CONCLUSIONS

Metformin may safely assist olanzapine-treated patients in body weight and carbohydrate metabolism control.

摘要

背景

体重过度增加(BWG)是服用奥氮平的一种临床相关副作用。本研究的主要目的是评估二甲双胍是否能预防或逆转服用奥氮平的精神分裂症或双相情感障碍患者的体重增加。其次,我们评估了各种代谢变量。

方法

80名服用奥氮平(每日5 - 20毫克,连续服用超过4个月)的患者按照12周双盲方案随机分配到二甲双胍组(n = 40;每日850至2550毫克)或安慰剂组(n = 40)。在基线和治疗第12周时评估腰围(WC)、体重(BW)、体重指数(BMI)、空腹血糖、糖化血红蛋白(Hb1c)、胰岛素、胰岛素抵抗指数(HOMA - IR)、血脂、瘦素、C反应蛋白、纤维蛋白原、皮质醇和生长激素(GH)。

结果

二甲双胍组体重减轻了1.4±3.2千克(p = 0.01),且瘦素水平有下降趋势,而安慰剂组体重保持稳定:-0.18±2.8千克(p = 0.7)。安慰剂组后HOMA - IR显著升高(p = 0.006),二甲双胍组后未变化(p = 0.8)。即使二甲双胍未改善血脂谱和Hb1c水平,但在其他变量上未观察到明显差异。

结论

二甲双胍可安全地帮助服用奥氮平的患者控制体重和碳水化合物代谢。

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