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一项为期 24 周的开放性研究,旨在评估齐拉西酮在伴有代谢紊乱的精神分裂症患者中的疗效及其对糖脂代谢的影响。

A twenty-four-week, open-label study on ziprasidone's efficacy and influence on glucolipid metabolism in patients with schizophrenia and metabolic disorder.

机构信息

Department of Psychiatry, Shanghai Xuhui District Mental Health Center, Shanghai, China.

出版信息

Eur Rev Med Pharmacol Sci. 2013 Aug;17(16):2136-40.

Abstract

BACKGROUND

The risks of antipsychotic drugs on metabolic syndrome (MS) present many challenges for psychiatrists.

AIM

To evaluate the effectiveness and influences on glucolipid metabolism in patients with schizophrenia and metabolic disorders switched from clozapine to ziprasidone.

PATIENTS AND METHODS

Schizophrenic patients with metabolic syndrome who had been treated with clozapine for ≥ 2 years were enrolled in the open-label study. All the patients were switched to ziprasidone from clozapine and followed up for 24-week. The primary endpoints included body mass index (BMI), fasting glucose (FG), triglycerides (TG), HDL cholesterol (HDL-c) and systolic pressure (SP)/diastolic pressure (DP). Secondary endpoints included scores on the Positive and Negative Syndrome Scale (PANSS) and treatment emergent symptom scale (TESS).

RESULTS

A total of 213 cases satisfied the inclusion and exclusion criteria, but only 194 cases eventually completed the 24-week follow-up and were divided into ziprasidone group (n=68, complete substitution) and combined treatment group (n=126, partial substitution). In the ziprasidone group, TG at 4th and 24th week, BMI and HDL-c at 24th week were significantly improved (p < 0.05), while cognitive scores and total score of the PANSS at 4th and 24th week, negative factor, the factor of anxiety and depression at 24th week were significantly lower than those at the baseline (p < 0.05); In the combined group, cognitive factor scores (4 weekend, 24 weekends) and total score of PANSS (24 weeks) was significantly lower than baseline (p < 0.05). There was no significant difference in the TESS score (p > 0.05).

CONCLUSIONS

Ziprasidone completely or partially substituting clozapine can improve both glucolipid metabolism disorders, and cognitive disorders and affective disorders of schizophrenia.

摘要

背景

抗精神病药物治疗代谢综合征(MS)的风险给精神科医生带来了诸多挑战。

目的

评估将氯氮平转换为齐拉西酮治疗代谢紊乱的精神分裂症患者的疗效及其对糖脂代谢的影响。

患者和方法

入组 2 年以上氯氮平治疗的代谢综合征精神分裂症患者,进行开放性研究。所有患者均由氯氮平转换为齐拉西酮,并随访 24 周。主要终点包括体重指数(BMI)、空腹血糖(FG)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-c)和收缩压(SP)/舒张压(DP)。次要终点包括阳性和阴性症状量表(PANSS)和治疗中出现的症状量表(TESS)评分。

结果

共 213 例符合纳入和排除标准,但只有 194 例最终完成 24 周随访,分为齐拉西酮组(n=68,完全替代)和联合治疗组(n=126,部分替代)。在齐拉西酮组,第 4 周和第 24 周 TG、第 24 周 BMI 和 HDL-c 明显改善(p<0.05),而第 4 周和第 24 周认知评分和 PANSS 总分、第 24 周阴性因子、焦虑和抑郁因子明显低于基线(p<0.05);联合组第 4 周末、第 24 周末认知因子评分和第 24 周末 PANSS 总分明显低于基线(p<0.05)。TESS 评分无显著差异(p>0.05)。

结论

齐拉西酮完全或部分替代氯氮平可改善精神分裂症的糖脂代谢紊乱和认知障碍及情感障碍。

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