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| 中国双相躁狂患者应用喹硫平或锂盐治疗4周的反应率和复发率：一项随机、双盲研究 |
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| Response and remission rates in Chinese patients with bipolar mania treated for 4 weeks with either quetiapine or lithium: A randomized and double-blind study |
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| Li H., Ma C., Wang G., Zhu X., Peng M., Gu N. 2009/5/29 18:39:20 |
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Current Medical Research and Opinion, 2008, Volume 24, Issue 1
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| Objective: To assess the efficacy and tolerability of quetiapine in Chinese patients hospitalized with acute bipolar mania. Methods: This was a 4-week, multicenter, randomized, double-blind, lithium-controlled, parallel-group study. Secondary endpoints in the primary analysis were: response rate (≥ 50% decrease from baseline in YMRS total score) and remission rate as defined using 3 criteria: YMRS total score ≤ 12, YMRS total score ≤ 12 + MADRS total score ≤ 8, and YMRS total score ≤ 8. Other measures included: change from baseline at Day 28 in YMRS, PANSS, and MADRS total score. Adverse event (AE) data were collected throughout the study. Results: 73 (94.8%) quetiapine and 62 (80.5%) lithium patients completed the study. Mean (SD) quetiapine doses for the ITT population and responders were 648.2 (111.84) mg/day and 637.5 (118.78) mg/day, respectively, while mean lithium concentrations for the ITT population and responders were 0.80 (0.28) mmol/L and 0.80 (0.22) mmol/L, respectively. Of patients who responded to quetiapine at Day 28, 88.3% were receiving 600-800 mg/day. At Day 28 YMRS response rate was significantly greater with quetiapine than lithium (77.9% vs. 59.7%, p = 0.0132), and remission rates using the 3 criteria were significantly greater with quetiapine than lithium: YMRS total score ≤ 12 (70.1% vs. 48.1%, p = 0.0071), YMRS ≤ 12 + MADRS ≤ 8 (70.1% vs. 48.1%; p = 0.0071), and YMRS ≤ 8 (51.9% vs. 32.5%; p = 0.0147). Significant decreases were observed in PANSS, YMRS, and MADRS total scores for both groups. The most common AEs experienced by patients receiving quetiapine were constipation, dizziness, diarrhea, alanine aminotransferase increase, palpitations, aspartate aminotransferase increase, pharyngolaryngeal pain, upper respiratory tract infection and dry mouth. In patients receiving lithium, the most common AEs were nausea (16.9%), constipation (13.0%), vomiting (13.0%), nasopharyngitis (11.7%), dizziness (6.5%), diarrhea (6.5%), and upper respiratory tract infection (6.5%). Conclusion: Quetiapine was shown to be clinically effective in patients with acute bipolar mania. There were side effects with quetiapine similar to those reported in other studies that included other ethnic populations of patients. © 2008 Librapharm Limited All rights reserved. |
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| Correspondence Address: Gu, N.; Shanghai Mental Health Center, Shanghai, China; email: lhlh5@yahoo.com.cn |
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 疾病资源中心
王燕燕 王曙
上海交通大学附属瑞金医院内分泌科
患者，女，69岁。2009年1月无明显诱因下出现乏力，当时程度较轻，未予以重视。2009年3月患者乏力症状加重，尿色逐渐加深，大便习惯改变，颜色变淡。4月18日入我院感染科治疗，诉轻度头晕、心慌，体重减轻10kg。无肝区疼痛，无发热，无腹痛、腹泻、腹胀、里急后重，无恶性、呕吐等。入院半月前于外院就诊，查肝功能：ALT 601IU/L，AST 785IU/L，TBIL 97.7umol/L，白蛋白 41g/L，甲状腺功能：游离T3 30.6pmol/L，游离T4 51.9pmol/L，心电图示快速房颤。
医学数据库
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