帕利哌酮缓释片与齐拉西酮治疗精神分裂症对照研究

Efficacy and safety of paliperidone extended-release tablets in treatment of patients with schizophrenia:a randomized ziprasidone hydrochloride capsules controlled study

目的:比较帕利哌酮缓释片与齐拉西酮治疗精神分裂症的疗效与安全性。方法:99例精神分裂症患者随机分为帕利哌酮组48例和齐拉西酮组51例,分别给予帕利哌酮缓释片和齐拉西酮治疗6周。采用阳性与阴性症状量表(PANSS)、个人与社会功能量表(PSP)和治疗中出现的症状量表(TESS)作为评价指标。结果:治疗2周及6周后,两组PANSS评分均低于治疗前(P均<0.05);组间比较,以帕利哌酮组PANSS评分显著低于对照组(P均<0.05)。与治疗前比较,帕利哌酮组个人与社会功能改善显著[PSP评分治疗前和治疗后分别平均(49.85±7.64)分和(60.32±8.24)分];而齐拉西酮组改善不明显[PSP评分分别平均(48.92±5.40)分和((53.38±6.90)分],组间比较,差异有显著性(P<0.001)。帕利哌酮缓释片的主要不良反应为锥体外系不良反应、失眠、便秘、泌乳素升高,齐拉西酮主要为心电图QTc间期延长、失眠、头痛、恶心等。结论:帕利哌酮缓释片治疗精神分裂症的疗效和改善社会功能方面均优于齐拉西酮。

Objective： The study was designed to evaluate the efficacy and safety of paliperidone extended-release tablets comparing with ziprasidone hydrochloride capsules in outpatient with schizophrenia. Method：There were 48 schizophrenic patients in study group treated with paliperidone extended-release tablets and 51 schizophrenic patients in control group with ziprasidone hydroehloride capsules for the treatment of 6 weeks. They were assessed with positive and negative symptoms scales （PANSS） , treatment emergent symptom scale（TESS） and personal and social performance （PSP） in the treatment period. Results：The scores of PANSS in the 2nd and 6th week of treatment were all significantly lower than those in basline （ P 〈 0.05 ）, the total and factors scores of PANSS in study group were all significantly lower than those in control group （P 〈 0. 05 ）, and the scores of PSP in study group was significantly higher than in control group PSP（60.32 ± 8.24） vs （53. 38 ± 6.90） （P 〈 0. 001 ）. The common adverse events were extrapyramidal symptoms, insomnia, constipation and prolactin increasing in paliperidone ER group, and QTc interval prolongation, insomnia, headache and nausea in ziprasidone hydrochloride group. Conclusion：Paliperidone extended-release tablet is more effective in improving positive symptoms, negative symptoms and social function of schizophrenic patients than ziprasidone hydroehloride capsule.