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五种非典型抗精神病药物用于首发未用药精神分裂症患者的疗效、可接受性及安全性:一项随机对照试验

The efficacy, acceptability, and safety of five atypical antipsychotics in patients with first-episode drug-naïve schizophrenia: a randomized comparative trial.

作者信息

Wang Congjie, Shi Wenjie, Huang Chengbing, Zhu Jiannan, Huang Wenzhong, Chen Gang

机构信息

Department of Psychiatry, Huaian No. 3 People's Hospital, and Teaching Hospital of Xuzhou Medical University, No. 272 West Huaihai Road, Huai'an, Zip code: 223001 Jiangsu China.

Psycological Department, Huaian No. 3 People's Hospital, and Teaching Hospital of Xuzhou Medical University, No. 272 West Huaihai Road, Huai'an, Zip code: 223001 Jiangsu China.

出版信息

Ann Gen Psychiatry. 2017 Dec 22;16:47. doi: 10.1186/s12991-017-0170-2. eCollection 2017.

Abstract

BACKGROUND

Differences in effectiveness and tolerability between different atypical antipsychotics may affect schizophrenic patients' treatment adherence or prognosis. However, which kind of antipsychotic was more effective and safe in the treatment of schizophrenia is still being debated. This study attempted to understand whether there are any differences in efficacy, acceptability, and safety between the five atypical antipsychotics in patients with first-episode schizophrenia.

METHODS

Two hundred cases of inpatients with first-episode drug-naïve schizophrenia were randomly assigned to 6-8 weeks of treatment with either of aripiprazole, risperidone, quetiapine, olanzapine, or ziprasidone from October 2012 to November 2014. The efficacy, acceptability, and safety measurement after 6-8 weeks of treatment of the five kinds of antipsychotics were evaluated by the deduction rate of Brief Psychiatric Rating Scale (BPRS) total score, the proportion of treatment discontinuation, and adverse events, respectively. Whether the treatment discontinuation or combination therapy for baseline antipsychotics after titration mainly depended on ineffective or less effective on an initial-assigned antipsychotic during the study period.

RESULTS

BPRS total scores in each antipsychotic group were significantly decreased at the end of the study ( < 0.01), and only the deduction rate of BPRS total scores in the risperidone group was markedly higher than those in the groups of aripiprazole ( < 0.01) and olanzapine ( < 0.05) after controlling the impact of the differences of age of onset. There were significant differences between quetiapine ( = 5.46,  = 0.019), olanzapine ( = 5.6,  = 0.018), and ziprasidone regarding the proportion of maintaining on initially allocated therapy. In addition, the difference in treatment discontinuation between male and female patients was also significant ( = 9.897,  = 0.002), and odds ratio of treatment discontinuation in male and female patients was 0.37 (95% CI 0.198-0.693); however, no difference in treatment discontinuation was found between five antipsychotics. Extrapyramidal symptoms in the groups of quetiapine and olanzapine were notably less than the other three kinds of antipsychotics ( < 0.05), but there were no significant differences in other adverse events between the five antipsychotic groups.

CONCLUSIONS

Risperidone was more effective than aripiprazole and olanzapine in treating first-episode schizophrenia. The present study revealed the superiority of quetiapine and olanzapine over ziprasidone with remarkably less severe extrapyramidal adverse effects, especially with lower drop-out and treatment discontinuation. There were no differences in terms of other adverse events although the risk of treatment discontinuation was higher in female patients. 2012-3-88. Registered 20 July 2012.

摘要

背景

不同非典型抗精神病药物在疗效和耐受性上的差异可能会影响精神分裂症患者的治疗依从性或预后。然而,哪种抗精神病药物在治疗精神分裂症方面更有效和安全仍存在争议。本研究试图了解五种非典型抗精神病药物在首发精神分裂症患者中的疗效、可接受性和安全性是否存在差异。

方法

2012年10月至2014年11月,将200例首次发作、未用过药的精神分裂症住院患者随机分为五组,分别接受阿立哌唑、利培酮、喹硫平、奥氮平或齐拉西酮治疗6 - 8周。分别通过简明精神病评定量表(BPRS)总分减分率、治疗中断比例及不良事件来评估这五种抗精神病药物治疗6 - 8周后的疗效、可接受性和安全性。滴定后是否停用治疗药物或联合使用基线抗精神病药物主要取决于在研究期间初始分配的抗精神病药物无效或效果较差。

结果

研究结束时,各抗精神病药物组的BPRS总分均显著降低(P < 0.01),在控制起病年龄差异的影响后,仅利培酮组的BPRS总分减分率显著高于阿立哌唑组(P < 0.01)和奥氮平组(P < 0.05)。喹硫平组(χ² = 5.46,P = 0.019)、奥氮平组(χ² = 5.6,P = 0.018)和齐拉西酮组在维持初始分配治疗的比例上存在显著差异。此外,男性和女性患者在治疗中断方面的差异也很显著(χ² = 9.897,P = 0.002),男性和女性患者治疗中断的比值比为0.37(95%CI 0.198 - 0.693);然而,五种抗精神病药物之间在治疗中断方面未发现差异。喹硫平组和奥氮平组的锥体外系症状明显少于其他三种抗精神病药物(P < 0.05),但五种抗精神病药物组在其他不良事件方面无显著差异。

结论

利培酮在治疗首发精神分裂症方面比阿立哌唑和奥氮平更有效。本研究显示喹硫平和奥氮平优于齐拉西酮,锥体外系不良反应明显较轻,尤其是停药率和治疗中断率较低。尽管女性患者治疗中断的风险较高,但在其他不良事件方面没有差异。2012 - 3 - 88。2012年7月20日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d1c/5740943/dc45ac047148/12991_2017_170_Fig1_HTML.jpg

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