Institute of Mental Health of the Second Xiangya Hospital, Central South University, 139 Middle Renmin Road, Changsha, Hunan, People's Republic of China.
Psychopharmacology (Berl). 2013 Feb;225(3):627-35. doi: 10.1007/s00213-012-2850-6. Epub 2012 Aug 28.
The objective of the study was to compare metabolic effects of ziprasidone versus olanzapine treatment in patients with first-episode schizophrenia.
In this 6-week, multicenter, open-label trial, 260 patients were randomly assigned to receive ziprasidone or olanzapine treatment (130 per group). Primary metabolic measures were changes in weight and body mass index (BMI). Secondary metabolic measures were changes in glucose, insulin, lipids, and blood pressure. Efficacy and safety were also measured additionally.
A total number of 230 patients completed the study. The mean daily dosages were 138.2(28.6) mg for ziprasidone and 19.0(2.3) mg for olanzapine. After 6-week treatment, there were significant between-group differences in change scores on weight [4.22(3.49) kg versus -0.84(2.04) kg, p < 0.001] and BMI [1.59(1.37) versus -0.30(0.74), p < 0.001]. In addition, there were significant between-group differences in change scores on fasting plasma glucose, insulin, homeostasis model assessment 2-insulin resistance, low-density lipoprotein, total cholesterol, and triglycerides (p < 0.001); all the changes were clinically in favor of ziprasidone treatment. Both medications were effective in improving schizophrenia symptoms, but the decreases in Positive and Negative Syndrome Scale total scores of the olanzapine group were significantly greater than that of the ziprasidone group (p < 0.05). Compared with olanzapine, ziprasidone also induced more prolonging of corrected QT interval and extrapyramidal side effects (p < 0.05). Both medications were well tolerated, and no serious adverse events were observed in either group.
Compared with olanzapine, ziprasidone treatment was associated with less adverse effects on glucose and lipid metabolism in patients with first-episode schizophrenia.
本研究旨在比较齐拉西酮与奥氮平治疗首发精神分裂症患者的代谢效应。
在这项为期 6 周的、多中心、开放性试验中,260 名患者被随机分配接受齐拉西酮或奥氮平治疗(每组 130 名)。主要代谢指标为体重和体重指数(BMI)的变化。次要代谢指标为血糖、胰岛素、血脂和血压的变化。此外,还测量了疗效和安全性。
共有 230 名患者完成了研究。齐拉西酮的平均日剂量为 138.2(28.6)mg,奥氮平为 19.0(2.3)mg。经过 6 周的治疗,两组间体重[4.22(3.49)kg 与 -0.84(2.04)kg,p < 0.001]和 BMI[1.59(1.37)与 -0.30(0.74),p < 0.001]的变化评分存在显著差异。此外,空腹血糖、胰岛素、稳态模型评估 2 胰岛素抵抗、低密度脂蛋白、总胆固醇和甘油三酯的变化评分也存在显著差异(p < 0.001);所有这些变化均有利于齐拉西酮治疗。两种药物均能有效改善精神分裂症症状,但奥氮平组阳性和阴性综合征量表总分的下降明显大于齐拉西酮组(p < 0.05)。与奥氮平相比,齐拉西酮还导致校正 QT 间期延长和锥体外系副作用的发生率更高(p < 0.05)。两种药物均耐受良好,两组均未观察到严重不良事件。
与奥氮平相比,齐拉西酮治疗首发精神分裂症患者的血糖和脂代谢不良反应较少。