奥氮平治疗60例儿童期首发精神分裂症的临床研究

An open-label clinical trial of Olanzapine in the treatment of 60 childhood patients with the First-episode Schizophrenia

目的:探讨奥氮平对儿童期首发精神分裂症的临床疗效和安全性。方法:对60例年龄<14岁首次发病患儿用奥氮平治疗8周,以阳性和阴性症状量表(PANSS)评定临床疗效,以副反应量表(TESS)和实验室监测评定安全性;于基线时,实验第1、2、4、6、8周末分别评定各量表。统计方法为描述性分析和配对t检验。结果:60例患儿基本痊愈30%(18/60),显著进步30%(18/60),好转23.3%(14/60)和无效10%(6/60)。PANSS总分及各分量表分治疗前后比较均有显著性差异(P<0.01)奥氮平对阳性、阴性症状以及一般精神病性症状均有良好疗效,无严重不良反应。结论:奥氮平能缓解儿童期首发精神分裂症的精神病性症状,疗效好,安全性高。

Objective：To evaluate the efficacy and safety of Olanzapine in the first -episode Schizophrenia. Methods ：60 pa- tients with oratory tests were used to assess the adverse effects（ age 〈 14 years） were included in the 8 week open clinical study. The positive and Negative syndrome scale （PANSS） was used to evaluate the severity and the improvement of mental symptoms. The Treat- ment Emergent Side Effect Scale （TESS） and lab treatment of childhood patients with first -episode Schizophrenia, Scales were evalu- ated at baseline and the end of week 1 ~2 ~4 ~6~8, Descriptive analysis and paired t -test were performed in statistical analysis. Results： 60 valid cases were collected among the 60 patients30.0% met the criteria of complete relief, 30.0% significantly improved, 23.3% improved and 10.0% got no change significant olifferenees existed in total PANSS scores and factor scores of PANSS after 8 week treat- ment of Olanzapine, Olanzapine showed good effect on the positive, negative as well as general psychopathoiogical symptoms of child- hood patients with first - episode Schizophrenia. No serous act verse events were found during the treatment. Conclusions： This study suggests that Olanzapine is an effective and safe antipsyehotie in the treatment of childhood patients with first - episode Schizophrenia.