氯氮平联合帕利哌酮缓释片治疗难治性精神分裂症疗效观察

目的：探讨氯氮平联合帕利哌酮缓释片治疗难治性精神分裂症住院患者的疗效及安全性。方法：本研究为12周的随机、对照的临床研究，将70例难治性精神分裂症住院患者随机分为研究组（氯氮平联合帕利哌酮）和对照组（氯氮平加安慰剂组）各35例，疗程12周，主要疗效指标为12周末阳性和阴性症状量表（ PANSS）较基线的变化，次要指标为个人和社会功能量表（ PSP ）。采用治疗中出现的症状量表（ TESS）评定安全性。结果：治疗后两组PANSS 总分均较治疗前降低，但研究组PANSS总分降低更明显，差异具有统计学意义（P＜0．05），研究组PSP改善好于对照组（P＜0．01），不良反应差异无统计学意义。结论：在难治性精神分裂症住院患者中，氯氮平联合帕利哌酮能取得较单用氯氮平治疗更好的疗效，并且有较好的安全性和耐受性。

Paliperidone ER Combined Clozapine in Treatment of Patients with Refractory Schizophrenia

Objective：To evaluate clinical efficacy and safety of paliperidone extended-release tablets （ Paliperidone ER ） combined clozapine in the treatment of patients with refractory schizophrenia .Method：In a randomized, double-blind, 12-week trial, 70 refractory schizophrenia patients received a steady dose of clozapine combined with either up to 12 mg per day of paliperidone ER （N=35） or placebo （N=35）.The primary efficacy measure was the total score changes of the positive and negative syndrome scale （PANSS）, personal and social performance scale （ PSP ） was adopted as secondary efficacy measures , and TESS were used to assess the safety .Result： The mean total PANSS scores were reduced significantly in both groups, but the reductions were significantly greater with clozapine /paliperidone ER treatment （ P 〈0.05） , and mean total PSP score increased significantly greater with clozapine /paliperidone treatment than with clozap-ine/placebo （ P 〈0.01） .The adverse event profile for clozapine/paliperidone ER treatment was similar to that for clozapine/placebo .Conclusion： It indicates that paliperidone ER combined clozapine is safe , well tolerated and effective in the treatment of adult refractory schizophrenia patients .