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目的:探讨帕利哌酮缓释片与奥氮平治疗儿童青少年精神分裂症的临床疗效、社会功能及安全性。方法:将80例儿童青少年精神分裂症患者随机分为帕利哌酮组和奥氮平组,每组40例,进行为期12周的开放性、对照研究。应用阳性与阴性症状量表(PANSS)以及个人和社会功能量表(PSP)评价临床疗效和社会功能,应用副反应量表(TESS)评价不良反应,同时进行实验室监测。结果:最终有67例患者纳入分析,帕利哌酮组35例,奥氮平组32例。治疗12周末时,两组的PANSS总分、阳性症状分、阴性症状分和一般精神病理症状分均较治疗前有显著下降(P<0.01)。帕利哌酮组和奥氮平组的有效率分别为85.7%和87.5%,疗效无显著性差异;治疗2周末,帕利哌酮组PANSS各项减分率下降更明显,两组有显著性差异(P<0.05)。治疗12周末,两组PSP值均有不同程度提高(P<0.01),帕利哌酮组提高更明显,两组间比较有显著性差异(P<0.01)。两组均未发生严重不良反应,帕利哌酮组体质量的增加较奥氮平组少(P<0.05)。结论:帕利哌酮治疗儿童青少年精神分裂症的疗效与奥氮平相当,且起效快、安全性高,能有效改善社会功能。
Objective: To investigate the clinical efficacy, social function and safety of paliperidone sustained-release tablets and olanzapine in the treatment of schizophrenia in children and adolescents. Methods: Eighty children and adolescents with schizophrenia were randomly divided into the paclitaxel group and the olanzapine group, with 40 cases in each group. The open-label and controlled study was performed for 12 weeks. Positive and negative symptom scales (PANSS) and personal and social functional scales (PSP) were used to evaluate the clinical efficacy and social function. Adverse reaction was evaluated by TESS and laboratory monitoring was performed at the same time. Results: A total of 67 patients were included in the analysis, 35 in the paclitaxel group and 32 in the olanzapine group. At 12 weeks of treatment, the PANSS total score, positive symptom score, negative symptom score and general psychopathology symptom score in both groups were significantly lower than those before treatment (P <0.01). Paliperidone group and olanzapine group were 85.7% and 87.5%, respectively, with no significant difference in curative effect. The reduction rates of PANSS in paliperidone group were more obvious after 2 weeks of treatment, and there was significant difference between the two groups Sex differences (P <0.05). After 12 weeks of treatment, the PSP values of both groups were increased to some extent (P <0.01), while those of the paclitaxel group were more obvious. There was significant difference between the two groups (P <0.01). No serious side effects occurred in either group, and body weight increased more in the paliperidone group than in the olanzapine group (P <0.05). Conclusion: The efficacy of paliperidone in treating schizophrenia in children and adolescents is comparable to that of olanzapine, and its efficacy is rapid and safe. It can effectively improve social functions.