帕利哌酮缓释片与利培酮治疗精神分裂症对照研究

目的比较帕利哌酮缓释片与利培酮对男性急性期精神分裂症患者疗效及社会功能的影响。方法 83例精神分裂症患者随机分为治疗组42例和对照组41例,进行为期12周的对照研究。治疗组口服推荐剂量帕利哌酮缓释片6 mg/d;对照组口服利培酮片1 mg/d起始,1周内增至4~6 mg/d,两组在治疗前、治疗至4、8、12周末分别采用阳性与阴性症状量表（PANSS）评定疗效,个人和社会功能量表（PSP）评定社会功能,治疗时出现的症状量表（TESS）评定不良反应,同时实验室监测血清催乳素水平。结果研究终点两组有效率差异无统计学意义（χ2=0.001,P〉0.05）;两组PANSS评分总分及各因子分均较治疗前下降明显,PSP总分较治疗前显著升高,差异有统计学意义（P〈0.05）;治疗至12周末,两组患者血清催乳素均明显升高（P〈0.05）,对照组尤为显著（P〈0.05）。而治疗组催乳素水平在治疗8、12周末较治疗至4周末持续下降,且无相关高崔乳素血症症状。第12周末,TESS评分对照组显著较高（t=-1.67,P〈0.05）。两组均无严重不良反应,治疗组更轻微（χ2=3.871,P〈0.05）。结论帕利哌酮缓释片治疗急性期男性精神分裂症与利培酮疗效相当,且症状控制快、不良反应小、安全性好,能更好的改善患者社会功能。

Control study of paliperidone extended-release tablets and risperidone in the treatment of schizophrenia

Objective To compare the curative effects and influence on social function of paliperidone extended-release tablets and risperidone in the treatment of male patients with acute schizophrenia. Methods A total of 83 cases of schizophrenia were randomly divided into treatment group （n=42） and control group （n=41）. The control study lasted for 12 weeks. The treatment group received paliperidone extended-release tablets 6 mg/d by oral administration. The control group recevied risperidone tablets by oral administration, which began with 1 mg/d and increased to 4~6 mg/d after 1 week. Curative effects were evaluated by positive and negative symptoms scale （PANSS） and social function was evaluated by personal and social function of scale （PSP） before the treatment and at the end of the 4th, 8th, 12th week in the treatment. Adverse reactions were evaluated by treatment of symptoms scale （TESS）, and serum prolactin levels were monitored. Results The effective rates of the two groups at the end of the research had no significant difference （χ2=0.001, P〈0.05）. PANSS scores and total scores of the two groups were all significantly lower than before the treatment, and the PSP total scores were remarkably increased. The differences had statistical significance （P〈0.05）. At the end of the 12th week in treatment, serum prolactin were significantly increased in both groups （P〈0.05）, and the increase in the control group was much more significant （P〈0.05）. And serum prolactin level in the treatment at the end of 8th and 12th week continuously declined, compared with the level at the end of the 4th week. There were no related symptoms of hyperprolactinemia. At the end of the 12th week, TESS score was significantly higher in the control group （t=-1.67, P〈0.05）. There were no serious adverse reactions in both groups, and the reactions in treatment group were more mild （χ2=3.871, P〈0.05）. Conclusion Paliperidone extended-release tablets and risperidone in the treatment of male p