齐拉西酮注射液与氟哌啶醇注射液治疗急性精神分裂症患者躁动的疗效和安全性。

IF 1.3 Q3 PSYCHIATRY
Alpha psychiatry Pub Date : 2025-04-28 eCollection Date: 2025-04-01 DOI:10.31083/AP40032
Sufang Qi, Wenjie Li, Limin Yang, Guangwei Sun, Xinming Li, Xin Liu, Zhicheng Xue, Yue Zhang, Guanglei Xun
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引用次数: 0

摘要

目的:躁动是急性精神分裂症中一种严重而普遍的症状。本研究旨在对肌注齐拉西酮(IM)与氟哌啶醇(IM)治疗急性精神分裂症患者躁动的疗效和安全性进行细致的比较。方法:本研究是一个随机的,3天的研究,采用灵活的给药策略。其中包括69名被诊断为精神分裂症的患者,他们被随机分配接受IM齐拉西酮(n = 35、20至40毫克/天)或IM氟哌啶醇(n = 34、5至10毫克/天)。主要终点包括两组从基线到研究完成的阳性和阴性症状量表(PANSS)总分和阳性和阴性症状量表兴奋成分(PANSS- ec)评分变化的比较分析。结果:在基线时,IM齐拉西酮组和氟哌啶醇组之间没有显著差异。两种治疗均显著降低PANSS-EC总分(氟哌啶醇,p = 0.001;齐拉西酮,p = 0.001)和PANSS总分(氟哌啶醇,p = 0.001;齐拉西酮,p = 0.001),从基线到研究终点。然而,从基线到终点,两组之间PANSS- ec评分(p = 0.312)和PANSS总分(p = 0.159)的变化无显著差异。氟哌啶醇组不良事件发生率高于齐拉西酮组,差异有统计学意义(p = 0.027)。结论:我们的研究结果表明,两种药物在控制躁动症状方面同样有效。然而,齐拉西酮在安全性和耐受性方面表现出优越的特点,特别是在减少锥体外系症状的发生率方面。临床试验注册:该研究注册于https://www.chictr.org.cn/showproj.html?proj=246996,注册号:ChiCTR2500100002,注册日期:2025年4月1日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and Safety of Ziprasidone Injection vs Haloperidol Injection for Agitation in Patients with Acute Schizophrenia.

Objective: Agitation represents a serious and prevalent symptomatology within acute schizophrenia. This study aims to conduct a nuanced comparison of the efficacy and safety profiles of intramuscular (IM) ziprasidone versus IM haloperidol in the management of agitation among patients with acute schizophrenia.

Methods: This investigation was structured as a randomized, 3-day study, utilizing flexible dosing strategies. It included 69 patients diagnosed with schizophrenia, who were randomly allocated to receive either IM ziprasidone (n = 35, 20 to 40 mg/day) or IM haloperidol (n = 34, 5 to 10 mg/day). The primary endpoints included comparative analyses of the change in Positive and Negative Syndrome Scale (PANSS) total scores and Positive and Negative Syndrome Scale Excited Component (PANSS-EC) scores from baseline to study completion across the two groups.

Results: At baseline, there were no significant differences between the IM ziprasidone and haloperidol groups. Both treatments led to significant reductions in PANSS-EC total scores (haloperidol, p = 0.001; ziprasidone, p = 0.001) and PANSS total scores (haloperidol, p = 0.001; ziprasidone, p = 0.001) from baseline to study endpoint. Nevertheless, no significant difference was observed between the two groups in terms of changes in PANSS-EC scores (p = 0.312) and PANSS total scores (p = 0.159) from baseline to endpoint. The haloperidol group exhibited a higher incidence of adverse events compared with the ziprasidone group, reaching statistical significance (p = 0.027).

Conclusions: Our findings indicate that both medications are equally effective in controlling agitation symptoms. However, ziprasidone exhibited superior characteristics in safety and tolerability, particularly in reducing the incidence of extrapyramidal symptoms.

Clinical trial registration: The study was registered at https://www.chictr.org.cn/showproj.html?proj=246996, registration number: ChiCTR2500100002, date of registration: 1 April 2025.

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