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喹硫平缓释片与阿立哌唑治疗首发精神病儿童及青少年期间的心脏代谢不良反应及其预测因素:来自儿童和青少年精神病患者抗精神病药物耐受性和疗效(TEA)试验的12周结果

Cardiometabolic Adverse Effects and Its Predictors in Children and Adolescents With First-Episode Psychosis During Treatment With Quetiapine-Extended Release Versus Aripiprazole: 12-Week Results From the Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis (TEA) Trial.

作者信息

Jensen Karsten Gjessing, Correll Christoph U, Rudå Ditte, Klauber Dea Gowers, Decara Marie Stentebjerg, Fagerlund Birgitte, Jepsen Jens Richardt Møllegaard, Eriksson Frank, Fink-Jensen Anders, Pagsberg Anne Katrine

机构信息

Child and Adolescent Mental Health Center, Mental Health Services, Capital Region of Denmark, Copenhagen, Denmark, and the Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.

Hofstra Northwell School of Medicine and The Zucker Hillside Hospital, New York, NY, and the Charité Universitätsmedizin, Berlin, Germany.

出版信息

J Am Acad Child Adolesc Psychiatry. 2019 Nov;58(11):1062-1078. doi: 10.1016/j.jaac.2019.01.015. Epub 2019 Mar 9.

DOI:10.1016/j.jaac.2019.01.015
PMID:30858012
Abstract

OBJECTIVE

To investigate cardiometabolic effects and their predictors in youths with first-episode psychosis (FEP) treated with quetiapine-extended release (ER) versus aripiprazole.

METHOD

Youths with FEP who were 12 to 17 years of age were randomized to quetiapine-ER or aripiprazole in the 12-week, double-blinded, Tolerability and Efficacy of Antipsychotics (TEA) trial. Primary outcome was change in body weight; secondary outcomes were changes in body mass index (BMI) and waist circumference (WC), blood pressure (BP), heart rate, and lipid and glucose metabolism parameters. Possible predictors of cardiometabolic changes were examined.

RESULTS

Altogether, 113 patients (schizophrenia-spectrum disorders = 93%; age [mean ± SD] = 15.7 ± 1.4 years; male participants = 30.1%) were randomized to quetiapine-ER (n = 55) or aripiprazole (n = 58). Quetiapine-ER led to significant increases in body weight (4.88 kg, 95% CI = 3.92-5.83, p < .0001), BMI z-score (0.43, 95% CI = 0.33-0.53, p < .0001), and WC z-score (0.97, CI = 0.7-1.23, p < .0001). Changes were significantly smaller with aripiprazole (all between-group p values <.0001): body weight: 1.97 kg (CI = 0.97-2.97, p = .0001), BMI z-score: 0.10 (CI = -0.01 to 0.20, p = .0646), and WC z-score: 0.18 (CI = -0.09 to 0.45, p = .1968). Lipid and glucose metabolism parameters increased significantly at week 4 and week 12 only with quetiapine-ER (p range = 0.0001-0.037). Quetiapine-ER was associated with an increased occurrence of obesity, elevated blood lipids and hyperinsulinemia (p range = 0.004-0.039). Early weight gain, obesity, or type 2 diabetes in the family significantly predicted weight and BMI gain at week 12.

CONCLUSION

In youths with FEP, quetiapine-ER was associated with significantly greater weight gain and adverse changes in metabolic outcomes than was aripiprazole. Early weight gain must be addressed and family lifestyle factors taken into consideration when treating youths with antipsychotics.

CLINICAL TRIAL REGISTRATION INFORMATION

Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis (TEA); https://clinicaltrials.gov; NCT01119014.

摘要

目的

研究接受喹硫平缓释剂(ER)与阿立哌唑治疗的首发精神病(FEP)青年患者的心脏代谢效应及其预测因素。

方法

12至17岁的FEP青年患者在为期12周的双盲抗精神病药物耐受性和疗效(TEA)试验中被随机分配至喹硫平-ER组或阿立哌唑组。主要结局是体重变化;次要结局是体重指数(BMI)、腰围(WC)、血压(BP)、心率以及脂质和葡萄糖代谢参数的变化。研究了心脏代谢变化的可能预测因素。

结果

总共113例患者(精神分裂症谱系障碍=93%;年龄[均值±标准差]=15.7±1.4岁;男性参与者=30.1%)被随机分配至喹硫平-ER组(n=55)或阿立哌唑组(n=58)。喹硫平-ER导致体重显著增加(4.88kg,95%CI=3.92-5.83,p<.0001)、BMI z评分(0.43,95%CI=0.33-0.53,p<.0001)和WC z评分(0.97,CI=0.7-1.23,p<.0001)。阿立哌唑组的变化显著更小(所有组间p值<.0001):体重:1.97kg(CI=0.97-2.97,p=.0001)、BMI z评分:0.10(CI=-0.01至0.20,p=.0646)和WC z评分:0.18(CI=-0.09至0.45,p=.1968)。仅喹硫平-ER组在第4周和第12周时脂质和葡萄糖代谢参数显著增加(p范围=0.0001-0.037)。喹硫平-ER与肥胖、血脂升高和高胰岛素血症的发生率增加相关(p范围=0.004-0.039)。家族中早期体重增加、肥胖或2型糖尿病显著预测了第12周时体重和BMI的增加。

结论

在FEP青年患者中,与阿立哌唑相比,喹硫平-ER与显著更多的体重增加和代谢结局不良变化相关。在使用抗精神病药物治疗青年患者时,必须关注早期体重增加并考虑家庭生活方式因素。

临床试验注册信息

抗精神病药物对精神病儿童和青少年的耐受性和疗效(TEA);https://clinicaltrials.gov;NCT01119014

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