奥氮平和碳酸锂治疗双相障碍躁狂或混合性发作的随机双盲对照试验

A random,blinded and controlled trial for evaluating the efficacy and safety of olanzapine and lithium in the treatment of bipolar or mixed type mania

目的:比较奥氮平与碳酸锂对双相障碍Ⅰ型躁狂或混合性发作患者的疗效和安全性。方法:60例患者随机给予奥氮平或碳酸锂双盲治疗,奥氮平的日剂量为5～20 mg,碳酸锂的日剂量为600～1800 mg。于基线时、治疗第1,2,3,4周末,分别采用临床总体印象疾病严重度量表一双相障碍版(CGI-s-BP)、Young躁狂量表(YMRS)、简明精神病量表(BPRS)、Montgomery-(?)sberg抑郁量表(MADRS)评定疗效1次。基线和终点时进行血生化、血常规、尿常规以及心电图检查,以评价安全性。结果:无论是试验组还是对照组,治疗4周末CGI-S-BP[(2.2±1.21),(2.3±1.10)]、YMRS[(7.6±10.09),(6.7±6.79)]和BPRS[(3.8±6.53),(3.9±4.92)]得分均较治疗前[(5.4±0.77),(5.1±0.70);(33.5±8.13),(31.6±7.69);(13.5±7.41),(14.5±9.20)]有明显下降,差异非常显著(P<0.01),而两组之间在上述指标方面的差异均无显著性(P>0.05)。试验组和对照组在有效率(85.7%,84.4%)和痊愈率(82.1%,81.3%)方面的差异也无显著性(P>0.05)。两组之间不良事件的总发生率没有显著差异(P>0.05)。奥氮平治疗对心电图无明显影响。结论:奥氮平治疗双相障碍Ⅰ型障碍的疗效同碳酸锂相当,但安全性更高。

Objective：To compare the clinical efficacy and safety of olanzapine with those of lithium in the treatment of bipolar or mixed type mania.Methods：Sixty inpatients with bipolar or mixed type mania were treated to olanzapine or lithium in a 4-week random,blinded and controlled trial.To assess the efficacy and side effects, Clinical Global Impression-BP（CGI-S-BP）,Young Mania Rating Scale（YMRS）,Brief Psychosis Rating Scale （BPRS）,and Montgomery-（？）sberg Depression Rating Scale（MADRS）were used before and after treatment for 1, 2,3,4 weeks.The changes of biochemical index,blood tests,urine tests and electrocardiogram were determined before and at the end of treatments.Results：After treatment with olanzapine or lithium for 4 week,the scores of CGI-S-BP were significantly decreased from（5.4±0.77）and（5.1±0.70）to（2.2±1.21）and（2.3±1.10） （P〈0.01）;YMRS from（33.5±8.13）and（31.6±7.69）to（7.6±10.09）and（6.7±6.79）（P〈0.01）; BPRS from（13.5±7.41）and（14.5±9.20）to（3.8±6.53）and（3.9±4.92）（P〈0.01）.However,there were no significant difference between the effects of two drugs（P〉0.05）.After 6-week treatment of olanzapine and lithium,the respond rate（85.7% and 84.4%）and remission rate（82.1% and 81.3%）were similar.There was no significant difference in TEAEs between two groups,and no abnormalities of electrocardiogram were found in olanzapine group.Conclusion：The efficacy of olanzapine is the same as that of lithium in the treatment of bipolar or mixed type mania,but its safety is higher.