摘要
目的探讨低剂量氯氮平对稳定期精神分裂症维持治疗的临床疗效及安全性。方法对1141例稳定期精神分裂症患者随访5年(氯氮平组351例,剂量上限为250mg/d,对照组分别为氯丙嗪组260例、奥氮平组170例和利培酮组360例)。用阳性与阴性综合征量表(PANSS)、临床疗效总评量表病情严重程度项目(CGI-SI)、WHO/残疾评价量表-简化版(DAS-S)、副反应量表(TESS)、心电图、生化检验等评估疗效和不良反应。维持治疗期间要求单一用药,如出现脱落、换药、合并其他抗精神病药物者,作为中断治疗。随访时间5年。结果依据CGI-SI评分,氯氮平组症状恶化例次最低(7.4%),低于氯丙嗪组(16.9%)、奥氮平组(8.8%)以及利培酮组(14.2%)。研究终点中断率由高到低的单药治疗依次为:奥氮平、氯丙嗪、利培酮、氯氮平。根据Cox模型回归分析的回归系数和相对危险度的估计值判断,影响氯氮平维持时间由短到长的因素依次为:PANSS中的兴奋、概念紊乱,TESS中的困倦、流涎以及心电图异常。结论低剂量氯氮平对稳定期精神分裂症长期维持治疗具有良好的疗效。
Objeetive: To investigate clinical efficacy and safety of low - dose elozapine in the maintenance treatment of stable schizophrenia. Methods: One thousand one hundred and forty - one patients with stable schizophrenia were followed up to 5 years ( study group includes 351 eases on elozapine, with upper limit of dose at 250rag/d, control groups include 260 eases on ehlorpromazine, 170 eases on olanzapine and 360 eases on risperidone). Efficacy was evaluated using positive and negative syndrome scale ( PANSS ), clinical global impression severity of item ( CGI - SI), WHO / disability assessment schedule - starter edition (DAS- S), and adverse events were evaluated using treatment emergent symptom scale (TESS), EKG and biochemical tests. Monotherapy was required during maintenance treatment. Any drop- off, switch of medication and concomitant use of other antipsychoties was regarded as treament discontinuation. Follow - up lasts for 5 years. Results: Based on CGI - SI score, number of cases with worsening symptoms was lowest in elozapine group (7.4%) , which is lower than in ehlorpromazine group ( 16.9% ) , olanzapine group (8.8%) and risperidone group ( 14.2% ). At study endpoint, rates of treatment discontinuation were ranked from high to low as follows: olanzapine, ehlorpromazine, risperidone, elozapine, in that order. Based on regression coefficients and relative risk using Cox regression analysis, factors that affect duration of clozapine maintenance treatment as from short to long were PANSS excitement and eoneeptual disorganization items, TESS drowsiness and salivation items, and EKG abnormality, in that order. Conclusion: Low - dose elozapine has good efficacy for long - term maintenance treatment of schizophrenia.
出处
《上海精神医学》
2010年第1期9-13,共5页
Shanghai Archives of Psychiatry
关键词
精神分裂症
氯氮平
治疗结果
随访研究
Schizophrenia Clozapine Treatment outcome Follow- up study