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齐拉西酮与奥氮平治疗首发精神分裂症的疗效和耐受性:一项 6 周、随机、开放标签、灵活剂量的研究。

Efficacy and tolerability of ziprasidone vs. olanzapine in naive first-episode schizophrenia: a 6-week, randomized, open-label, flexible-dose study.

机构信息

Mental Health Institute of The Second Xiangya Hospital Changsha, Central South University, Hunan, People's Republic of China.

出版信息

Pharmacopsychiatry. 2012 Jul;45(5):177-81. doi: 10.1055/s-0031-1299769. Epub 2012 Jan 30.

DOI:10.1055/s-0031-1299769
PMID:22290206
Abstract

INTRODUCTION

Although some previous studies have compared the 2 medicines, ziprasidone and olanzapine most selected chronic patients as subjects. Therefore, the present study was designed to compare the efficacy and safety of ziprasidone vs. olanzapine in naive first-episode schizophrenia.

METHODS

80 patients were randomly assigned to a 6-week treatment either with 80-160 mg/day of ziprasidone or 10-20 mg/day of olanzapine. The primary efficacy measurements were the Positive and Negative Syndrome Scale and Clinical Global Impression-severity scale scores. The second efficacy measurement was the response rate of treatment. Tolerability assessments were also performed.

RESULTS

79 patients completed the trial. The average dose was 127.5 mg/day with ziprasidone and 19.1 mg/day with olanzapine. No significant differences were found between the 2 groups in primary or secondary efficacy measurements at each visit point (all p>0.05). Body weight significantly increased with olanzapine, and more extrapyramidal symptoms were observed with ziprasidone (all p<0.05). Both medicines were well tolerated, and no serious adverse events were observed.

CONCLUSION

Ziprasidone was as effective as olanzapine in short-term treatment for first-episode schizophrenia, and both medicines were well tolerated.

摘要

简介

尽管先前有一些研究比较了这两种药物,但大多数选择慢性患者作为研究对象。因此,本研究旨在比较齐拉西酮与奥氮平治疗首发精神分裂症的疗效和安全性。

方法

80 名患者被随机分为 6 周的治疗组,分别接受 80-160mg/天的齐拉西酮或 10-20mg/天的奥氮平治疗。主要疗效测量指标为阳性和阴性症状量表及临床总体印象严重程度量表评分。第二个疗效测量指标是治疗的反应率。同时还进行了耐受性评估。

结果

79 名患者完成了试验。齐拉西酮的平均剂量为 127.5mg/天,奥氮平的平均剂量为 19.1mg/天。在每个访视点,两组在主要或次要疗效测量方面均未发现显著差异(均 P>0.05)。奥氮平治疗后体重显著增加,而齐拉西酮治疗后出现更多的锥体外系症状(均 P<0.05)。两种药物均具有良好的耐受性,未观察到严重不良事件。

结论

齐拉西酮在首发精神分裂症的短期治疗中与奥氮平同样有效,且两者均具有良好的耐受性。

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