不同剂量帕利哌酮缓释片治疗精神分裂症的临床观察

Clinical efficacy and safety of paliperidone extended-release tablets in different dosage groups in the treatment of schizophrenia

目的:比较不同剂量的帕利哌酮缓释片治疗精神分裂症的疗效和安全性。方法:将80例精神分裂症患者随机分成4组,分别给予帕利哌酮缓释片3,6,9和12 mg口服治疗8周,在治疗前及治疗第2,4和8周末采用阳性与阴性症状量表(Positive and Negative Syndrome Scale,PANSS)和不良反应症状量表(Treatment Emergent Symptoms Scale,TESS)评定疗效和安全性。结果:在治疗的第2,4和8周末,4组的PANSS量表总分及各因子分及减分率与基线相比均有统计学差异(P<0.05);第4周末,12 mg组的PANSS评分明显低于3 mg组(P<0.01),治疗第8周末,6,9和12 mg组的PANSS评分明显低于3 mg组(P<0.05),差异有统计学意义。帕利哌酮缓释片的主要不良反应为锥体外系反应、失眠、头晕和头痛。结论:帕利哌酮缓释片治疗精神分裂症安全有效,呈一定的量效关系。

Objective： To compare the clinical effect and safety of paliperidone extended-release tablets （paliperidone ER） treatment in different dosage groups of schizophrenics. Methods： 80 schizophrenics were randomly divided into 3, 6, 9 or 12 mg paliperidone ER treatment group for 8 weeks. The efficacy and side effect were assessed with PANSS and TESS before treatment and after 2, 4, 8 weeks. Results： After treatment, there were significant differences in scores of total PANSS, positive factor, negative factor and general factor（P 〈 0.05）. At the 4th weekend, the score of PANSS was significantly lower in 12 mg group than that in 3 mg group（P 〈0.01 ）. The PANSS score of 3 mg group was significantly higher than that of 6, 9 or 12 mg group at the 8tb weekend（P 〈 0.05）. The common side effects of paliperidone ER were extrapyramidal symptoms （EPS） , insomnia, dizziness and headache. Conclusion： Paliperidone ER is an effective and safe drug in the treatment of schizophrenia. There may be some dose-effect relationshio between Dalineridone ER and therapeutic effect.