注射用帕潘立酮与利培酮治疗精神分裂症的对照研究

目的:比较帕潘立酮棕榈酸盐与注射用利培酮微球治疗精神分裂症的疗效和不良反应。方法:96例精神分裂症患者被随机分为两组,分别给予帕潘立酮棕榈酸盐与注射用利培酮微球治疗,其中帕潘立酮组43例,利培酮组53例,疗程12周。分别采用阳性、阴性症状量表(PANSS)、人际和社会能力量表(PSP)评定疗效,采用不良反应量表(TESS)、锥体外系症状量表(BARS)、异常不自主运动量表(AIMS)以及临床实验室检查、生命体征、心电图以及体格检查对药物安全性进行全面评估。结果:在疗效方面,对PANSS、PSP量表评分进行两组总体疗效轮廓分析或协方差分析,两组药物在总体疗效、社会功能改善方面均较治疗前明显改善(P0.05),但是两组药物之间比较无明显差异,疗效相当(P0.05);在安全性方面,两组药物对体重的影响均较小,无明显锥体外系不良反应。心电图指标、体格检查以及生命体征亦均无明显改变。结论:帕潘立酮棕榈酸盐与注射用利培酮微球相比,疗效及安全性相当。

Efficacy and Safety of Paliperidone Palmitate or Long-acting Injectable Risperidone in Patients with Schizophrenia

ABSTRACT Objective: To compare the efficacy and safety of Paliperidone palmitate and long-acting injectable risperidone (LAIR) in treatment of patients with schizophrenia. Methods: 43 schizophrenic patients in study group were treated with Paliperidone palmitate and 53 schizophrenic patients in control group were treated with LAIR. The treatment lasted for 12 weeks. The patients were assessed with Positive and Negative Symptoms Scales (PANSS), Personal and Social Performance Scale (PSP), Treatment Emergent Symptom Scale (TESS), Barnes Akathisis Scale (BARS) and Abnormal Involuntary Movement Scale (AIMS). At the same time, the weights, waistlines, ECGs were detected and the side-effects of both drugs were evaluated. Results: The overall clinical symptoms and the social function were obviously improved after Paliperidone or LAIR treatment (P < 0.05), but there were no significant differences in the scores of PANSS (F = 0.918, P = 0.405) and PSP (P = 0.134) between two groups when analyzed by Contour Analysis or Covariance Analysis. Both drugs induced limited weight changes and extra pyramidal symptoms, and the electrocardiogram index, physical examination and vital signs as well. Conclusion: The efficacy and safety are comparable between Paliperidone palmitate and LAIR.