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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 efficacy and safety of different doses of paliperidone sustained-release tablets in the treatment of schizophrenia. Methods: Eighty patients with schizophrenia were randomly divided into 4 groups. Patients were treated with 3, 6, 9, and 12 mg oral paracetamol sustained-release tablets for 8 weeks, respectively, before treatment and at the end of treatment 2, 4 and 8 Positive and Negative Syndrome Scale (PANSS) and Treatment Emergent Symptoms Scale (TESS) were used to assess the efficacy and safety. Results: At the end of the 4th, 4th, and 8th week of treatment, the PANSS total scores, factor scores and the reduction rates of the 4 groups were significantly different from those of the baseline (P <0.05) Group PANSS score was significantly lower than the 3 mg group (P <0.01). At the end of the 8th week, the PANSS scores of the 6, 9 and 12 mg groups were significantly lower than those of the 3 mg group (P <0.05). The difference was statistically significant. Paliperidone sustained release tablets of the main adverse reactions are extrapyramidal reactions, insomnia, dizziness and headache. Conclusion: Paliperidone sustained-release tablets are safe and effective in the treatment of schizophrenia, showing a certain dose-effect relationship.