帕利哌酮缓释片与利培酮片治疗首发儿童精神分裂症患儿的对照研究

Comparative study of Paliperidone ER tablets and Risperidone tablets in treatment of childhood first episode schizophrenia

目的:观察帕利哌酮缓释片与利培酮片治疗首发儿童精神分裂症患儿的疗效和安全性。方法:将64例首发儿童精神分裂症患儿随机分成帕利哌酮组和利培酮组,每组各32例。帕利哌酮组患儿给予帕利哌酮缓释片治疗;利培酮组患儿给予利培酮片口服治疗。两组患者均治疗8周。在治疗前、治疗第1、2、4、8周末,采用阳性与阴性症状量表(PANSS)和不良反应量表(TESS)评定两组患儿的临床疗效和不良反应。结果:治疗后,两组患者的PANSS量表总分及各因子分较治疗前均有明显下降,差异有统计学意义(P<0.05或P<0.01)。治疗第1周末,帕利哌酮缓组患儿的PANSS总分低于利培酮组,差异有统计学意义(P<0.05)。其余各因子无明显差异(P>0.05)。两组患儿的不良反应比较,帕利哌酮缓组患儿的不良反应发生率明显低于利培酮组,差异有统计学意义(P<0.01)。结论:帕利哌酮缓释片治疗首发儿童精神分裂症患儿较利培酮片起效快,不良反应少,安全性高。

Objective To explore efficacy and safety of Paliperidone extended-release tablets （Paliperidone ER） and Risperidonetablets in treatment of childhood first episode schizophrenia. Methods ： 64 children with first-episode schizophrenia were randomlydivided into Paliperidone group （n = 32, treated with Paliperidone ER） and Risperidone group （n = 32, orally took Risperidone tablets）and treated for 8 weeks. The efficacy and adverse reactions were assessed with positive and negative syndrome scale （PANSS）and treatment emergent symptom scale （ TESS） before and 1, 2, 4, 8 weeks after the treatment. Results ： The total score and the factorscores of PANSS in the two groups were significantly decreased after the treatment, and the differences were statistically significant（ P〈0. 05 or P〈0. 01）. At the first weekend, the score of PANSS was significantly lower in Paliperidone group than that in the Risperidonegroup, and the difference was statistically significant （ P〈 0.05）. The other factors had no significant differences （ P〉0. 05）. Incomparison of the adverse reactions between the two groups, the adverse drug reaction incidence of Paliperidone group was lower thanthat of Risperidone group, and the difference was statistically significant （ P〈0. 01）. Conclusions ： Paliperidone ER in the treatment ofchildhood first episode schizophrenia has a rapid effect, less adverse reactions, and a high safety.