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在中国对首发精神分裂症患者进行52周随访,观察帕利哌酮缓释片、阿立哌唑和齐拉西酮的疗效及代谢影响。

Efficacy and metabolic influence of paliperidone ER, aripiprazole and ziprasidone to patients with first-episode schizophrenia through 52 weeks follow-up in China.

作者信息

Zhang Yinbo, Dai Guangzhi

机构信息

Chengdu Mental Health Center, Fourth People's Hospital, Chengdu, China.

出版信息

Hum Psychopharmacol. 2012 Nov;27(6):605-14. doi: 10.1002/hup.2270.

DOI:10.1002/hup.2270
PMID:24446539
Abstract

BACKGROUND

There are no direct comparisons of paliperidone extended-release (ER), aripiprazole and ziprasidone in efficacy and metabolic influence in patients with first-episode schizophrenia.

OBJECTIVE

The present study examined the efficacy and metabolic influence of paliperidone ER, aripiprazole and ziprasidone in patients with first-episode schizophrenia in China.

METHODS

Subjects were recruited from outpatient and 254 patients entered the trial. These patients received treatment randomly with paliperidone ER, aripiprazole and ziprasidone and were assessed at baseline, 13, 26 and 52 weeks, respectively with Positive and Negative Syndrome Scale (PANSS), 7-item Clinical Global Impressions-Severity (CGI-S), anthropometric (weight, body mass index and waist circumference) and metabolic (fasting blood glucose, HbA1c, cholesterol, high density lipoproteins (HDL), low density lipoproteins and triglycerides) measures.

RESULTS

A total of 203 patients completed the trial. Paliperidone group had significant greater reduction in PANSS than aripiprazole group and ziprasidone group from 13 weeks, although the a reduction in PANSS of each group was more than 20%. There was no difference in CGI-S among the three groups, and all three groups had a significant reduction from baseline in CGI-S. Aripiprazole group increased in weight and body mass index despite no statistical change in waist circumference. Other two groups showed no changes in anthropometric measure. At the end of the study, two glucose metabolic indices (fasting blood glucose and HbA1c) of aripiprazole group were significantly higher than that of baseline. In lipid metabolism, aripiprazole group reduced triglycerides significantly and had no changes in other indices. Paliperidone group reduced HDL and increased triglycerides despite no changes in glucose metabolism. Ziprasidone group also had no significant changes in glucose metabolism, but reduced cholesterol, low density lipoproteins and increased HDL. Furthermore, 22 subjects in three groups reached the diagnostic criteria of metabolic syndrome.

CONCLUSIONS

Paliperidone ER, aripiprazole and ziprasidone are effective in treating first-episode schizophrenia, and the ranking of efficacy from high to low is paliperidone ER > aripiprazole > ziprasidone. Paliperidone ER can impair lipid metabolism potentially but had no influence on glucose metabolism. Aripiprazole can damage glucose metabolism and has little influence on lipid metabolism. Ziprasidone is considered an atypical antipsychotic with no evidence of harm to glucose and lipid metabolism.

摘要

背景

在首发精神分裂症患者中,尚无关于帕利哌酮缓释片(ER)、阿立哌唑和齐拉西酮疗效及代谢影响的直接比较。

目的

本研究探讨帕利哌酮ER、阿立哌唑和齐拉西酮在中国首发精神分裂症患者中的疗效及代谢影响。

方法

从门诊招募受试者,254例患者进入试验。这些患者随机接受帕利哌酮ER、阿立哌唑和齐拉西酮治疗,并分别在基线、第13、26和52周采用阳性与阴性症状量表(PANSS)、7项临床总体印象-严重程度量表(CGI-S)、人体测量指标(体重、体重指数和腰围)以及代谢指标(空腹血糖、糖化血红蛋白、胆固醇、高密度脂蛋白(HDL)、低密度脂蛋白和甘油三酯)进行评估。

结果

共203例患者完成试验。从第13周起,帕利哌酮组的PANSS减分显著大于阿立哌唑组和齐拉西酮组,尽管每组的PANSS减分均超过20%。三组的CGI-S无差异,且三组的CGI-S均较基线显著降低。阿立哌唑组体重和体重指数增加,尽管腰围无统计学变化。其他两组人体测量指标无变化。研究结束时,阿立哌唑组的两个葡萄糖代谢指标(空腹血糖和糖化血红蛋白)显著高于基线。在脂质代谢方面,阿立哌唑组甘油三酯显著降低,其他指标无变化。帕利哌酮组葡萄糖代谢无变化,但高密度脂蛋白降低,甘油三酯升高。齐拉西酮组葡萄糖代谢也无显著变化,但胆固醇、低密度脂蛋白降低,高密度脂蛋白升高。此外,三组中有22名受试者达到代谢综合征诊断标准。

结论

帕利哌酮ER、阿立哌唑和齐拉西酮治疗首发精神分裂症均有效,疗效由高到低依次为帕利哌酮ER>阿立哌唑>齐拉西酮。帕利哌酮ER可能损害脂质代谢,但对葡萄糖代谢无影响。阿立哌唑可损害葡萄糖代谢,对脂质代谢影响较小。齐拉西酮被认为是一种非典型抗精神病药物,尚无证据表明其对葡萄糖和脂质代谢有损害。

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