【摘要】 目的研究可变剂量的帕利哌酮缓释剂治疗急性期精神分裂症患者的有效性、耐受性与安全性。方法采用开放性、单组、多中心研究,使用可变剂量的帕利哌酮缓释剂(3～12mg/d)治疗急性期精神分裂症患者608例,观察期8周,通过阳性和阴性综合征量表(PANSS)评价有效性。通过体检、实验室检查、心电图检查及其他不良事件的报告评价安全性。结果治疗有效率(PANSS减分率≥30%)随治疗时间而增加,治疗8周末有效率为82.6%。研究终点PANSS总分与基线相比,差异具有统计学意义(P<0.01)。终点平均剂量为(7.9±2.2)mg/d。治疗8周时40.11%患者的治疗剂量保持6mg/d的水平,4.44%患者的治疗剂量下调至3mg/d。常见的不良事件为锥体外系反应、便秘、肝功能异常、睡眠障碍、嗜睡、疲乏及恶心。结论可变剂量帕利哌酮缓释剂(3～12mg/d)治疗急性期精神分裂症有效,且耐受性、安全性良好。更多还原

【Abstract】 Objective:Evaluate flexible-dose treatment with paliperidone extended release tablets in acute schizophrenia. Methods: Patients with acute schizophrenia (N = 608) participated in an open label, 8-week, one-arm, multicenter trial of flexible dose treatment with paliperidone extended release tablets (3-12 mg/d). The Positive and Negative Syndrome Scale (PANSS) was used to evaluate effectiveness. Safety was assessed. The results of a physical examination, lab tests, an electrocardiogram and an adverse events scale were used to evaluate safety. Results:The response rate (that is, the proportion of subjects with at least 30% drop from the baseline PANSS total score) increased with the duration of treatment and was 82.6% at week 8. The baseline and 8-week PANSS total scores were significantly different (P<0.01). The average dosage was (7.9±2.2) mg/d at week 8. The dose of paliperidone in 40.11% patients remained 6 mg/d and 4.44% down to 3 mg/d at endpoint. Common adverse events included extrapyramidal symptoms, constipation, hepatic dysfunction, sleeping disorder, drowsiness, fatigue, and nausea. Conclusion:Flexible dosing (3~12 mg/d) treatment with paliperidone extended release tablets is safe, well-tolerated and effective for patients with acute schizophrenia.更多还原