自然状态帕利哌酮缓释片治疗精神分裂症患儿的疗效和安全性研究及用药建议

Efficacy and safety of paliperidone ER in the treatment of child and adolescent inpatients with schizophrenia in a natural state and the clinical recommendation

目的:探讨帕利哌酮缓释片对精神分裂症住院患儿的疗效及安全性,提出利培酮滴定渐换帕利哌酮缓释片以及其他抗精神病药渐换帕利哌酮缓释片的用药建议。方法:入组2009年6月-2011年7月入住我院、接受口服帕利哌酮缓释片治疗、疗程满12周的所有精神分裂症患儿,共55例。帕利哌酮缓释片采用利培酮滴定逐渐加量方法,在基线时及治疗后第2,4,6,8,10和12周末应用阳性与阴性症状量表(PANSS)评定疗效,使用不良反应量表(TESS)评价安全性,并于基线和治疗后第4,8和12周进行血常规、血生化、泌乳素、心电图检查,每周进行生命体征及体重测量。结果:全部患儿加药过程顺利,没有患儿因为帕利哌酮缓释片加量而出现耐受性问题。自第2周开始单用组、合用或换用帕利哌酮缓释片组PANSS总分、阳性量表分、阴性量表分、一般精神病理量表分均低于基线,差异均具有显著性意义(P<0.05)。单用组、合用或换用组均未见严重不良反应。单用组对体重影响较小,两组对泌乳素的影响无统计学差异。结论:帕利哌酮缓释片可有效改善精神分裂症患儿的阳性症状、阴性症状,安全性高,适合青少年精神分裂症的治疗。在青少年中使用时可尝试采用利培酮滴定逐渐换用和增加帕利哌酮缓释片剂量的方法。

Objective： To evaluate the efficacy and safety of paliperidone ER in the treatment of child and adolescent inpatients with schizophrenia for providing a clinical recommendation how to increase the dosage of pali- peridone ER and transfer paliperidone from other antipsychotics. Methods： Patients who were admitted in Jun 2009 to July 2011 （n = 55） were enrolled and treated with paliperidone ER for 12 weeks. We used dosage titration to increase the dose of paliperidone ER. Positive and Negative Syndrome Scale （PANSS） was adopted as the efficacy measure before treatment and at 2, 4, 6, 8, 10 and 12 week after treatment. Treatment Emergent Symptom Scale （TESS） and laboratory examinations were adopted as safety measures. Results： All the patients were successfully to increase the dosage of paliperidone ER. None of them have the problem of tolerance. The total PANSS score,positive scale, negative scale, and general psychopathology scale scores demonstrated a significant improvement from the second week in paliperidone ER alone, combination and exchange groups （P 〈 0.05）. The adverse events were less severe. The influence on the weight was smaller in paliperidone ER alone group than other two groups. The influence on the prolactin had no statisticalXy significant difference. Conclusion： Paliperidone ER can improve the positive and negative symptoms in child and adolescent patients with schizophrenia. It has demonstrated a favorable safety. When used in the young patients, a way of increasing the dosage of paliperidone ER thought the titration of risperidone can be recommended.