目的：比较阿立哌唑与奥氮平联合碳酸锂治疗双相Ⅰ型躁狂发作患者的临床疗效和安全性。方法：64例患者随机分为阿立哌唑组(实验组)与奥氮平组(对照组)，于患者治疗前和治疗第1、2、4、6周末分别采用躁狂状态评定量表(BRMS)、临床疗效总评量表(CGI)和治疗中出现的症状量表(TESS)评定疗效及不良反应。于患者治疗前及治疗6周末各检测1次血常规、尿常规、肝和肾功能、血糖、血脂、心电图、脑电图，以评价其安全性。结果：实验组和对照组患者的 BRMS 和 CGI 得分随着治疗时间而逐渐下降，患者治疗前后差异有明显统计学意义(P<0.01)；两组患者间比较差异无统计学意义(P>0.05)。两组患者间在有效率、痊愈率和病情改善方面比较差异无统计学意义(P>0.05)，两组患者均未出现严重的不良事件，阿立哌唑组对患者的血脂几乎无影响，而奥氮平则有显著影响。结论：阿立哌唑组患者治疗双相障碍Ⅰ型躁狂发的疗效与奥氮平组相当，起效快，安全性高，在对血脂的影响方面更具优势。%Objective:To compare clinical efficacy and safety of Aripiprazole and Olanzapine combined with lithium carbonate intreatment of bipolar I manic patients. Methods:64 patients were randomized to Aripiprazole group and Olanzapine group. The effica-cy and adverse reactions were assessed with Bech-Rafaelsdn mania rating scale (BRMS), clinical global impression(CGI), and treat-ment emergent symptom scale (TESS) before and 2, 4, and 6 weeks after the treatment. Before and 6 weeks after the treatment, blood and urine routine examinations, liver and kidney function tests, blood sugar and blood lipid examinations, electrocardiogram (ECG), and electroencephalogram (EEG) were performed to evaluate the safety. Results: The BRMS and CGI scores of experimental group (Aripiprazole) and control group (Olanzapine) gradually decreased with time, there were significantly statistical differences for the two groups before and after the treatment (P<0. 01), however, there were no statistical differences between the two groups (P>0. 05). There were no statistical differences in effective rate, cure rate, and improvements between the two groups (P>0. 05). For the two groups, no serious adverse events occurred. Blood lipid in Aripiprazole group was not almost affected, while that in Olanzapine group was significantly influenced. Conclusions: In the treatment of bipolar I disorder manic episode, Aripiprazole has a similar efficacy with Olanzapine, but it works fast, and has a high safety and an advantage in terms of effects on blood lipids.
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