Mirtazapine orally disintegrating tablet versus sertraline:: A prospective onset of action study
Mirtazapine orally disintegrating tablet versus sertraline:: A prospective onset of action study
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DOI：
10.1097/01.jcp.0000085408.08426.05
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发表时间：
2003-08-01
影响因子：
2.9
通讯作者：
Vester-Blokland, ED
中科院分区：
文献类型：
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作者：
Behnke, K;Sogaard, J;Vester-Blokland, ED
这项多国、随机、双盲研究专门设计用于前瞻性比较米氮平口腔崩解片和舍曲林在临床实践中常用剂量下的抗抑郁疗效。共有 345 名重度抑郁发作 (DSM-IV) 患者接受米氮平 (30-45 mg/d) 或舍曲林 (50-150 mg/d) 治疗 8 周。米氮平以新开发的快速溶解口腔崩解片剂型给药。在基线以及第 4、7、10、14、28、42 和 56 天进行评估。主要疗效变量（汉密尔顿抑郁量表 [HAMD] 总分 [17 项] 相对于基线的平均绝对变化）显示，在研究的前 2 周内，在所有评估中，米氮平均显着 (P < 0.05) 比舍曲林更有效。此后，两组的 HAMD 总分相似。这些发现得到了 HAMD 缓解率（即 HAMD 总分较基线下降大于或等于 50%）、HAMD 缓解率（HAMD 总分小于或等于 7）和 Montgomery-Asberg 抑郁量表 (MADRS) 分析的支持。两种治疗均具有良好的耐受性。此外，米氮平对性功能的影响比舍曲林更大。总之，这项首次使用口腔崩解片的前瞻性起效研究表明，米氮平的起效速度比舍曲林更快。众所周知，本研究中使用的米氮平口腔崩解片制剂可以提高患者的便利性和依从性。
This multinational, randomized, double-blind study was specifically designed to prospectively compare the onset of antidepressant efficacy of mirtazapine orally disintegrating tablets and sertraline at dosages commonly used in clinical practice. A total of 345 patients with major depressive episode (DSM-IV) received mirtazapine (30-45 mg/d) or sertraline (50-150 mg/d) for 8 weeks. Mirtazapine was administered in the newly developed fast dissolving, orally disintegrating tablet formulation. Assessments were performed at baseline and on days 4, 7, 10, 14, 28, 42, and 56. The primary efficacy variable (mean absolute change from baseline in the Hamilton Depression Rating Scale [HAMD] total score [17 items]) showed that mirtazapine was significantly (P < 0.05) more effective than sertraline at all assessments during the first 2 weeks of the study. After this time, HAMD total scores were similar in both groups. These findings were supported by analysis of the HAMD response rate (ie, greater than or equal to50% reduction in HAMD total score from baseline), HAMD remission rate (HAMD total score of less than or equal to7), and the Montgomery-Asberg Depression Rating Scale (MADRS). Both treatments were well tolerated. In addition, mirtazapine had a greater effect than sertraline on sexual functioning. In conclusion, this first prospective onset of action study using the orally disintegrating tablet indicates that mirtazapine has a faster onset of therapeutic effect than sertraline. The orally disintegrating tablet formulation of mirtazapine used in this study is known to enhance the convenience and compliance by the patient.