帕利哌酮缓释片治疗精神分裂症的疗效和耐受性以及对生活质量及社会功能的影响

目的:探讨帕利哌酮缓释片与利培酮治疗精神分裂症在疗效、耐受性、改善生活质量及社会功能方面的差异。方法:符合入组标准的精神分裂症患者被随机分为研究组(n=48)和对照组(n=62),分别接受帕利哌酮缓释片或利培酮治疗12周。分别在治疗前及治疗后评定两组病例的阳性和阴性症状量表(PANSS)、锥体外系症状评定量表(ESRS)、健康状况调查问卷(SF-36)及个人和社会功能量表(PSP)评分,并统计两组病例在治疗期间的不良事件。结果:研究组和对照组各有2例和3例患者脱落。与治疗前及对照组相比,研究组在治疗d 7,142,8,568,4时PANSS总分均显著下降;从治疗d 4开始,研究组各个治疗时间点的阳性症状因子评分显著下降;治疗d 84时,研究组PANSS其他因子评分、SF-36总分及PSP总分明显改变(P<0.05)。与治疗前相比,对照组在治疗d 142,8,568,4的PANSS总分、阳性症状及焦虑抑郁因子评分显著改变;治疗d 28,568,4的阴性症状、敌意/兴奋因子评分有显著变化;d 56和d 84时思维混乱因子评分有明显改变(P<0.05)。治疗期间,研究组与对照组不良事件的发生率分别为33.3%(16/48)和53.2%(33/62),二者差异有统计学意义(P<0.05)。治疗d 28,568,4时,两组病例的催乳素浓度与其基线值均有统计学显著差异;治疗d 28和d 84时研究组的催乳素浓度与对照组有显著差异(P<0.05)。与治疗前以及对照组相比,研究组在治疗各个时间点的ESRS总分、体重、血糖、血脂及QTc间期没有明显改变。结论:帕利哌酮缓释片治疗精神分裂症在疗效(包括起效时间)、耐受性、改善生活质量及社会功能方面均优于利培酮,可为精神分裂症患者的治疗提供更新、更有益的选择。

Efficacy,tolerability,quality of life and social functioning in schizophrenia patients after treatment with oral paliperidone extended-release tablets

Objective: To compare the efficacy,tolerability,quality of life and social functioning in schizophrenia patients after treatment with paliperidone extended-release(ER) and risperidone.Methods: Totally 110 patients were randomly assigned into paliperidone and risperidone groups.The positive and negative syndrome scale(PANSS),Extrapyramidal Symptom Rating Scale(ESRS),the Short Form-36 Health Survey(SF-36),the Personal and Social Performance(PSP) and the adverse events were assessed in schizophrenia patients before and during the 12-week treatment.Results: In paliperidone group,46 patients completed 12 weeks of treatment and 2 patients dropped out;in risperidone group,59 patients completed and 3 dropped out.Compared to the data before treatment and the data of risperidone group,paliperidone significantly improved PANSS score from day 7 to the endpoint,positive syndrome factor score from day 4 to the endpoint,other PANSS Marder factor scores,SF-36 score and PSP score at the endpoint(P<0.05).Contrasted with the baseline data,risperidone significantly improved PANSS score,positive syndrome and anxiety/depression factor score from day 14 to the endpoint,negative syndrome and hostility/excited factor score from day 28 to the endpoint,thinking confusion factor score from day 56 to the endpoint(P<0.05).The incidence rate of adverse events(33.3%,16/48) during the treatment with paliperidone ER was significantly lower than that(53.2%,33/62,P<0.05).Compared to the data of baseline,the serum prolactin at days 28,56 and 84 significantly changed in the two groups(P<0.05),and there was significant difference in the serum prolactin at days 28 and 84 between risperidone and paliperidone groups(P<0.05).Compared to the baseline and the data of risperidone group,paliperidone group demonstrated no significant difference in ESRS score,weight,blood glucose,blood cholesterol and QTc period at all treatment points.Conclusion: Paliperidone ER is effective in improving the symptoms of schizophrenia,the quality of life and social functioning,and is generally well tolerated.Paliperidone ER may offer a beneficial new treatment option for patients with schizophrenia.