利培酮治疗儿童期首发精神分裂症的临床研究

An Open-label Clinical Trial of Risperidone in the Treatment of 60 Childhood Patients with First-episode Schizophrenia.

目的探讨利培酮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岁首次发病患儿用利培酮治疗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)和实验室监测评价安全性;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20.0%(12/60),显著进步30.0%(18/60),好转30.0%(18/60)和无效20.0%(12/60)。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),利培酮对阳性、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。结论利培酮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 risperidone in the first-episode schizophrenia. Methods 60 patients with oratory tests were used to assess the adverse effects （age〈 14 years） were included in this 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 Treatment Emergent side Effect scale （TESS） and lab treatment of childhood patients with first-episode schizophrehia. Scales were evaluated at baseline and the end of week 1, 2, 4, 6, 8. Descriptive analsysis and paired t-test were performed in statistical analysis. Results 60 valid cases were collected, among the 60 patients, 20. 0% met the criteria of complete relief, 30.0% significantly improved, 30. 0% improved, and 20. 0% got no change significant differences existed in total PANSS scores and factor scores of PANSS after 8 week treatment of risperidone, Risperidone showed good effect on the positive, negative as well as general psychopathological symptoms of childhood patients with first-episode schizophrenia. No senous adverse events were found during the treatment. Conclusion This study suggests that risperidore is an effective and safe antipsychotic in the treatment of childhood patients with firs-episode schizophrenia.