A 12-week randomized clinical trial to evaluate metabolic changes in drug-naive, first-episode psychosis patients treated with haloperidol, olanzapine, or risperidone
A 12-week randomized clinical trial to evaluate metabolic changes in drug-naive, first-episode psychosis patients treated with haloperidol, olanzapine, or risperidone
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DOI：
10.4088/jcp.v68n1113
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发表时间：
2007-11-01
影响因子：
5.3
通讯作者：
Vazquez-Barquero, Jose Luis
中科院分区：
文献类型：
--
作者：
Perez-Iglesias, Rocio;Crespo-Facorro, Benedicto;Vazquez-Barquero, Jose Luis
目的：本研究探讨了抗精神病药物治疗引起的主要代谢副作用在一个队列的首次发作药物naive subjects.Method：一个随机的，开放标签，前瞻性临床试验进行。参与者是2002年2月至2005年2月期间纳入首次精神病发作计划（PAFlP）的145名连续受试者，他们经历了第一次精神病发作（DSM-IV代码295、297和298），并且从未接受过抗精神病药物治疗。在12周内，患者被分配接受氟哌啶醇、奥氮平或利培酮治疗。主要结果指标为12周时体重、体重指数和空腹12小时早晨总胆固醇、甘油三酯、低密度脂蛋白（LDL）胆固醇、高密度脂蛋白胆固醇、血糖、稳态模型评估（HOMA）指数和胰岛素水平的变化。平均剂量为氟哌啶醇= 4.2 mg/天，奥氮平= 12.7 mg/天，利培酮= 3.6 mg/天。观察到3种抗精神病药物的体重显著增加：氟哌啶醇= 3.8（SD = 4.9）kg，奥氮平= 7.5（SD = 5.1）kg，利培酮= 5.6（SD = 4.5）kg。代谢参数显示3种治疗组的血脂谱恶化（总胆固醇和LDL胆固醇水平统计学显著性升高）。只有奥氮平组显示甘油三酯水平显著升高。经过12周的研究期间，有没有显着的变化，涉及任何group.Conclusions参数葡萄糖代谢：药物初治患者经历了非凡的体重增加与第一和第二代抗精神病药物治疗后的第一个12周。总胆固醇和LDL胆固醇水平的显著增加与3种治疗相关。抗精神病药物引起的体重增加和代谢紊乱可能会增加患心血管疾病的风险。
Objective: This study examined the main metabolic side effects induced by antipsychotic treatment in a cohort of first-episode drug-naive subjects.Method: A randomized, open-label, prospective clinical trial was conducted. Participants were 145 consecutive subjects included in a first-episode psychosis program (PAFlP) from February 2002 to February 2005, experiencing their first episode of psychosis (DSM-lV codes 295, 297, and 298), and never treated with antipsychotic medication. Patients were assigned to haloperidol, olanzapine, or risperidone treatment during 12 weeks. The main outcome measures were changes at 12 weeks in body weight; body mass index; and 12-hours-fasting morning levels of total cholesterol, triglycerides, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein cholesterol, glucose, homeostasis model assessment (HOMA) index, and insulin.Results: At the endpoint, 128 patients were evaluated (88.3%). The mean doses were haloperidol = 4.2 mg/day, olanzapine = 12.7 mg/day, and risperidone = 3.6 mg/day. A significant weight gain was observed with the 3 antipsychotics: haloperidol = 3.8 (SD = 4.9) kg, olanzapine = 7.5 (SD = 5.1) kg, and risperidone = 5.6 (SD = 4.5) kg. Metabolic parameters showed a worsening lipid profile with the 3 treatments (statistically significant increase in total cholesterol and LDL cholesterol levels). Only the olanzapine group showed significant increases in triglyceride levels. After the 12-week study period, there were no significant changes in parameters involving glucose metabolism for any group.Conclusions: Drug-naive patients experienced an extraordinary weight gain with first- and second-generation antipsychotics after the first 12 weeks of treatment. Significant increases in total cholesterol and LDL cholesterol levels are associated with the 3 treatments. Weight gain and metabolic disturbances induced by antipsychotics may increase the risk of developing cardiovascular disease.