奎硫平与锂盐治疗双相障碍急性躁狂的随机双盲对照多中心研究

目的 评价奎硫平单药治疗双相障碍急性躁狂患者的疗效及安全性.方法 采用随机、双盲双模拟、阳性药物平行对照、多中心研究.根据中国精神障碍分类与诊断标准第3版诊断为双相障碍躁狂发作,并且根据Young躁狂评定量表(YMRS)总分≥20分的住院患者被随机分配接受奎硫平(每日2次口服,最大剂量达800 mg/d)或碳酸锂(每日2次口服,最大剂量达2000 mg/d)治疗,共观察4周.主要疗效指标为从基线至治疗第28天YMRS总分的改变(末次观察值结转).安全性指标包括不良事件、实验室和心电图检查等.结果 共随机分配155例患者(奎硫平组为78例,碳酸锂组为77例).意向性治疗人群共154例(两组各77例).奎硫平和碳酸锂的平均剂量分别为642.9 mg/d和1377.7 mg/d.从基线至治疗第28天奎硫平组和碳酸锂组YMRS减分值分别为-18.2分和-15.9分.治疗第28天,奎硫平组的有效率(78%)明显高于碳酸锂组(60%),差异有统计学意义(P=0.013).奎硫平组和碳酸锂组的不良事件发生率分别为78%和69%.奎硫平在最大剂量达800 mg/d的情况下耐受性较好,其最常见的不良事件为便秘(35%)、头晕(15%)和腹泻(10%);碳酸锂组最常见的不良事件为恶心(17%)、便秘(13%)和呕吐(13%).碳酸锂组中有3例患者因不良事件而中止研究,其中有1例为严重不良事件;奎硫平组无因不良事件而中止的研究者.结论 奎硫平单药治疗双相障碍急性躁狂有效,且耐受性较好.

Efficacy and safety of quetiapine in the treatment of bipolar acute mania: a randomized, double-blind, lithium-controlled multicenter study

Objective To evaluate the efficacy and safety of quetiapine fumarate as mono-therapy for acute mania in patients with bipolar disorder.Methods The study design was randomized,double blind,double dummy.lithium controlled.multicenter trial.Patients with bipolar disorder were hospitalized for the treatment of an acute manic episode according to the Chinese Classification of Mental Disorders 3rd edition criteria.and with the Young Mania Rating Scale(YMRS)total score≥20 were randomized to receive quetiapine(twice daily up to 800 mg/d)or lithium(twice daily up to 2000 mg/d).The primary endpoint was the change of YMRS total score from baseline to Day 28(last observation carried forward;LOCF).The safety was evaluated with the rate of adverse events(AEs),laboratory test and ECG.Results The ITTincluded 154 subjects.with 77 in each treatment group.Mean doses were 642.9 mg/d and 1377.7 mg/d for quetiapine and lithium respectively.Changes of YMRS total score from baseline to Day 28 in quetiapine and lithium group were-18.2 and-15.9,respectively.At Day 28,the response rate was significantly higher in quetiapine-treated patients(78%vs.60%;P=0.013).Quetiapine was well tolerated up to doses of 800 mg/d,and 78%of patients in quetiapine group and 69%in lithium group reported AEs.The most frequently reported AEs in quetiapine group were constipation(35%),dizziness(15%),and diarrhea (10%),and in lithium group were nausea(17%),constipation(13%),and vomiting(13%).Three subjects in lithium group but none in quetiapine group withdrew due to AEs.Conclusions The study resuhs support that quetiapine monotherapy is effective and well tolerated in the treatment of acute mania.