目的:观察帕利哌酮治疗精神分裂症的疗效、不良反应,以及对血清泌乳素水平的影响.方法:将80例精神分裂症患者随机分为帕利哌酮组(治疗组,40例)和利培酮组(对照组,40例),对两组进行为期8周的开放性对照研究,观察8周.以阳性和阴性症状量表(PANSS)评估疗效,治疗时出现的症状量表(TESS)评估不良反应,同时于治疗前和治疗第4和8周末检测两组的血清泌乳素水平.结果:至研究终点,两组患者的PANSS评分总分及分量表分较治疗前均有明显下降,差异有统计学意义(P＜0.01);治疗后组间比较仅第2周末时帕利哌酮组各评分差异有统计学意义(P＜0.05).治疗第4,8周末,血清泌乳素水平在两组受试者中均有明显升高(P＜0.05),利培酮组血清泌乳素水平升高更明显.帕利哌酮组血清泌乳素水平在治疗8周末较治疗4周末下降,且无月经紊乱及泌乳等相关症状.两组均未出现严重不良反应,而帕利哌酮组不良反应更轻(P＜O.05).结论:帕利哌酮治疗精神分裂症的疗效与利培酮相当,且安全性好.%Objective: To investigate the clinical efficacy and adverse effects of paliperidone ER, and its influence on serum prolactin in the treatment of schizophrenia. Methods: In an 8-week open-label study, 80 patients with schizophrenia were randomly assigned into 2 groups (n = 40 in each group), and treated with paliperidone ER or risperidone (control). The clinical efficacy was evaluated with the positive and negative syndrome scale (PANSS), and adverse effects with the treatment emergent symptom scale (TESS). Serum level of prolactin was detected before, and 4, 8 weeks after treatment respectively. Results: At the end of study, the total score and subscores of PANSS were significantly reduced ( P ＜ 0.01 ) in 2 groups. There were differences in total score and subscores of PANSS (P ＜ 0.05 ) between groups only at the second week. The effective rates in two groups (62.5％ and 67.5 ％ ) had no statistically significant difference ( P ＞ 0.05 ). The serum prolatin levels increased after treatment (P ＜ 0.05 ). The serum prolatin level was lower in paliperidone group than in control group at the end, and no prolactin-related adverse reactions was found in paliperidone group. No severe adverse effects were found in both groups, and the incidence of treatment-emergent adverse events were lower in paliperidone group ( P ＜ 0.05 ).Conclusion: Paliperidone ER is as effective as risperidone, and its safety is superior.
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