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首页> 外文期刊>Current medical research and opinion >Safety and efficacy of olanzapine monotherapy and olanzapine with a mood stabilizer in 18-week treatment of manic/mixed episodes for Japanese patients with bipolar i disorder
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Safety and efficacy of olanzapine monotherapy and olanzapine with a mood stabilizer in 18-week treatment of manic/mixed episodes for Japanese patients with bipolar i disorder

机译：奥氮平单药和奥氮平联合情绪稳定剂在日本双相性i障碍患者躁狂/混合发作18周治疗中的安全性和有效性

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Objective: To assess the safety and efficacy of 18-week olanzapine monotherapy in Japanese patients with bipolar mania, following a 6-week, placebo-and haloperidol-controlled double-blind study (acute study). For those who discontinued the acute study due to lack of efficacy, safety and efficacy was assessed with a combination therapy of olanzapine and a mood stabilizer. Research design and methods: In this open-label, multicenter extension study, patients who completed the acute study received olanzapine (520mg/day) as monotherapy, and patients who discontinued the acute study due to lack of efficacy with greater Young Mania Rating Scale (YMRS) total score than the acute study baseline, received olanzapine in combination with one of three mood stabilizers: lithium, carbamazepine, or valproate. Safety was assessed by treatment-emergent adverse events (TEAEs), vital signs, weight, and extrapyramidal symptoms (EPSs). Efficacy measures included YMRS total score, and response and remission rates of manic symptoms. Main outcome and measures: There were no deaths or serious adverse events considered potentially related to olanzapine in the monotherapy group (N100) or the combination-therapy group (N39). TEAEs occurred in 59.0 and 79.5 of patients in the monotherapy and combination-therapy groups, respectively, and their severities were mostly mild or moderate. Regarding the efficacy measures, in the monotherapy group, mean YMRS change from extension study baseline to endpoint was -3.0, and the response and remission rates at endpoint were 97.0 and 93.0, respectively. In the combination-therapy group, mean YMRS change from extension-study baseline was -19.8; response and remission rates increased from the extension-study baseline (both 0.0) to 64.1 and 61.5 respectively by endpoint. Conclusion: Olanzapine was generally well tolerated during the 18-week extension period in Japanese patients with bipolar mania. Results of both groups were also generally consistent with US and European studies. Monitoring of metabolic parameters is recommended.
机译：目的：在一项为期6周的安慰剂和氟哌啶醇对照双盲研究（急性研究）之后，评估18周奥氮平单一疗法在日本双相躁狂症患者中的安全性和有效性。对于因缺乏疗效而中止急性研究的患者，使用奥氮平和情绪稳定剂联合治疗评估安全性和疗效。研究设计和方法：在这项开放性，多中心扩展研究中，完成急性研究的患者接受奥氮平（520毫克/天）作为单药治疗，而由于缺乏疗效而因年轻躁狂症评分量表而终止急性研究的患者（ YMRS）总分高于急性研究基线，接受奥氮平与三种情绪稳定剂之一的组合：锂，卡马西平或丙戊酸盐。通过治疗紧急不良事件（TEAE），生命体征，体重和锥体外系症状（EPS）评估安全性。疗效指标包括YMRS总分，躁狂症状的缓解率和缓解率。主要结果和措施：在单一疗法组（N100）或联合疗法组（N39）中，没有死亡或严重的不良事件被认为与奥氮平潜在相关。在单一疗法和联合疗法组中，分别有59.0和79.5例患者发生TEAE，其严重程度大多为轻度或中度。关于疗效指标，在单一治疗组中，从扩展研究基线到终点的平均YMRS变化为-3.0，终点的缓解率和缓解率分别为97.0和93.0。在联合治疗组中，平均YMRS从扩展研究基线的变化为-19.8;响应和缓解率从扩展研究基线（均为0.0）分别由终点提高至64.1和61.5。结论：日本双相躁狂症患者在延长的18周内对奥氮平的耐受性良好。两组的结果通常也与美国和欧洲的研究一致。建议监测代谢参数。

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