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。
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 unre- sponsive 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 ed with low incidence of treatment was assoclat- 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.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2012年第2期215-219,共5页
Chinese Journal of Clinical Pharmacology and Therapeutics