急性期精神分裂症转换帕利哌酮治疗的疗效及安全性

摘要/Abstract

摘要： 目的: 对接受足疗程奥氮平单一治疗无效的急性期精神分裂症住院患者,逐步替换为帕利哌酮缓释片单一治疗后,观察其疗效和不良反应,以及对患者个人和社会功能的改善作用。方法: 将45例受试者随机分为两组,研究组23例,由原先的奥氮平替换为帕利哌酮缓释片治疗6周;对照组22例,由原先的奥氮平替换为利培酮治疗6周。治疗前后分别用阳性与阴性症状量表(PANSS)、个人与社会功能量表(PSP)和不良反应量表(TESS)评价疗效和不良反应。结果: 研究组PANSS总分、阳性症状分、阴性症状分和一般精神病理分自基线降低,以及PSP总分自基线升高均具有统计学意义(P<0.01)。研究组发生失眠、嗜睡、锥体外系不良反应(EPS)、血清催乳素升高各1例,但均可耐受。结论: 对于奥氮平治疗无效的急性期精神分裂症患者,替换为帕利哌酮缓释片治疗或能安全有效地控制阳性/阴性症状,且明显改善患者的个人和社会功能。

关键词: 帕利哌酮, 奥氮平, 利培酮, PSP, 精神分裂症

Abstract: AIM: To evaluate the efficacy, safety and effect on personal and social function of paliperidone extended-release tablets (paliperidone ER) as substitution in inpatients experiencing an acute episode of schizophrenia, and unresponsive to prior medications of olanzapine besids.METHODS: Forty-five patients enrolled were assigned to receive paliperidone ER or risperidone for 6 weeks, meanwhile their prior medications of olanzapine were slowly tapered off within first 2 weeks. Positive and Negative Symptom Scale (PANSS) was used to assess the efficacy, Personal and Social Performance Scale (PSP) for social function, Treatment Emergent Symptom Scale (TESS) for tolerability and safety.RESULTS: PANSS total and PANSS factors scores significantly decreased from baseline to end point in paliperidone ER treatment group (P<0.01), moreover, significant improvements in mean PSP scale scores were observed (P<0.01). Paliperidone ER treatment was associated with low incidence of adverse events including insomnia, somnolence, extrapyramidal disorder, increased serum prolactin concentration, which could be well tolerated.CONCLUSION: This study demonstrated that paliperidone ER, as substitution for olanzapine combines consistent efficacy in significantly improving the symptoms of schizophrenia and personal and social functioning with a favorable safety profile, may provide a valuable new alternative for schizophrenia.

Key words: Paliperidone, Olanzapine, Risperidone, PSP, Schizophrenia

中图分类号:

R749.3

许本健, 陈菊凤. 急性期精神分裂症转换帕利哌酮治疗的疗效及安全性[J]. 中国临床药理学与治疗学, 2012, 17(2): 215-219.

XU Ben-jian, CHEN Ju-feng. Efficacy and safety of paliperidone extended-release tablets as substituting medication in acute patients with schizophrenia[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2012, 17(2): 215-219.

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