【摘要】 目的观察奎硫平不同剂量快速加量治疗精神分裂症急性期患者的安全性、耐受性及疗效。方法前瞻性、多中心、随机、平行对照研究。共入组134例,其中:(1)研究组65例;奎硫平起始剂量为200 mg/d,以后每天增加200 mg,4 d 内日剂量达到600 mg。(2)对照组69例,起始剂量为100 mg/d,以后每天增加100 mg/d,7 d 内日剂量达到600 mg。两组的观察疗程均为4周。以阳性和阴性症状量表总分减分率为主要疗效评价指标,以临床疗效总评量表、简明精神症状评定量表总分减分率为次要疗效评估指标。结果治疗第1周末,研究组和对照组的有效率分别为17%和13%,治疗第4周末分别为80%和70%,两组间的差异均无统计学意义(P>0.05)。奎硫平主要不良反应为头晕、嗜睡。治疗第1周末,研究组和对照组的不良反应发生率分别为55%和33%,差异有统计学意义(X~2=6.6042,P=0.01);治疗第4周末分别为58%和48%,差异无统计学意义(X~2=1.5198,P=0.218)。结论奎硫平100 mg/d 快速加量治疗精神分裂症急性期患者的疗效与200 mg/d 快速加量的疗效相似,但前者不良反应的发生低于后者。更多还原

【Abstract】 Objective The objective of this trial was to assess the safety,tolerability and efficacy in different rapid dose-escalation schedules for initiating and 4-week therapy with quetiapine treatment of patients with acute schizophrenia.Methods In this multi-center,controlled study,134 patients with 18— 65 years old meeting the Diagnostic and Statistical Manual of Mental Disorders(DSM-Ⅳ)schizophrenia criteria were involved.The patients had the Positive and Negative Syndrome Scale score of ≥60,and the Clinical Global Impression-Severity score of ≥3.They were randomly assigned to escalation schedules that would achieve a target dosage of 600 mg/d in either 4 days(200 mg/d group)or 7 days(100 mg/d group).Safety,tolerability and efficacy were assessed by interview,physical examinations and laboratory tests in days 0,7,14,21 and 28.Results The response rates at days 7 and 28 were 17% and 80% in 200 mg/d group,and 13% and 70% in 100 mg/d group,without significant difference(P>0.05).The total rate of adverse events in 200 mg/d group(55%)was significantly higher than that in 100 mg/d group (33%)in first week.Somnolence and dizziness were common adverse events in both groups.Conclusion The results suggest that the efficacy of rapid escalation of 200 mg/d with quetiapine in treating acute schizophrenia is similar to the one of 100 mg/d in the first week and fourth week,with the higher rate of adverse events in 200 mg/d group in the first week.更多还原