帕利哌酮缓释片对精神分裂症男性患者的疗效及社会功能影响  

Efficacy and Safety of Paliperidone Extended-Release Tablets in Treatment of Male Patients with Acute Schizophrenia

作　　者：苏伟[1] 那万秋[1] 李建华[1] 杨剑虹[1] 陈海支[1] 周虎江[1] 

机构地区：[1]浙江省湖州市第三人民医院精神科,313000

出　　处：《医药导报》2012年第6期731-734,共4页Herald of Medicine

摘　　要：目的观察帕利哌酮缓释片对男性急性期精神分裂症患者的疗效及社会功能的影响。方法将65例患者随机分为治疗组33例,对照组32例,进行为期12周的开放性对照研究。治疗组给予帕利哌酮缓释片6 mg.d-1;对照组给予利培酮片1 mg.d-1起始,1周内增至4 mg.d-1。于治疗前、治疗第2,4,8,12周末分别采用阳性与阴性症状量表(PANSS)、个人和社会功能量表(PSP)、不良反应症状量表(TESS)评定疗效、社会功能和不良反应,并进行实验室监测。于治疗前和治疗第4,8,12周末检测两组的血清催乳素水平。结果至研究终点,两组有效率相似(66.7%,62.5%,P>0.05);两组PANSS评分总分及分量表分较治疗前均有明显下降,PSP总分显著高于治疗前,差异有统计学意义(P<0.05);组间比较,治疗第2,12周末时,治疗组显著优于对照组(P<0.05)。治疗后,两组受试者血清催乳素水平均明显升高(P<0.05),对照组升高更明显(P<0.05)。治疗组血清催乳素水平在治疗8,12周末较治疗4周末持续下降,且无高催乳素血症相关症状。两组均未出现严重不良反应,治疗组不良反应较轻微(P<0.05)。结论帕利哌酮缓释片治疗男性急性期精神分裂症的疗效与利培酮相当,安全性好,能有效改善社会功能。Objective To explore the efficacy of paliperidone extended-release tablets in the treatment of male patients with acute schizophrenia. Methods In a 12-week open-label study, 65 schizophrenics were randomly divided into study group [ treated with paliperidone extended-release tablets （n= 33, 6 mg per morning）] and control group [ risperidone tablets （n= 32, starting dose： 1 mg ~ d-l ; in a week the dose was increased to 2 rag, twice a day, in the afternoon and evening）]. They were assessed and analyzed by Positive and Negative Symptoms Scales （PANSS） , Personal and Social Performance Scale （PSP） , and Treatment Emergent Symptom Scale （TESS） before the treatment, in the 2nd, 4th, 8th and 12th weekends of the treatment. The level of serum prolactin was detected before the treatment, at the 4th, 8th and 12th weekends of the treatment. Results At the end of the study, two groups had similar response rates （66.7% vs. 62.5%, P〉0.05）. After the treatment, the factors and total scores of PANSS in the two groups were all significantly lower than those before treatment （P〈0.05）. In the 2nd and 12th weekends of the treatment, the factors and total scores of PANSS in the study group were all significantly lower than those in the control group （P〈0.05）. After the treatment, the total scores of PSP of both groups were significantly higher than those at baseline （ P〈0.05 ）. In the study group, the total scores of PSP in the 2nd and 12th weekends of the treatment were significantly higher than those in the control group （ P〈0.05 ）. The serum prolaetin levels were increased after the treatment （ P〈0.05 ）. The serum prolatin level was lower in the study group than in the control group at the end （ P〈0.05 ）, and no hyperprolaetinemia adverse reaction was found in the study group. No severe adverse effects were found in both groups, and the incidence of treatment-emergent adverse events were lower in the study group （P 〈 0. 05 ）. Condusion Paliperidone extended-rel

关 键 词：帕利哌酮 利培酮 精神分裂症 社会功能 催乳素 

分 类 号：R971.41[医药卫生—药品] R749.3[医药卫生—药学]