Duloxetine efficacy for major depressive disorder in male vs. female patients: Data from 7 randomized, double-blind, placebo-controlled trials
Duloxetine efficacy for major depressive disorder in male vs. female patients: Data from 7 randomized, double-blind, placebo-controlled trials
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DOI：
10.4088/jcp.v67n0510
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发表时间：
2006-05-01
影响因子：
5.3
通讯作者：
Stewart, Donna E.
中科院分区：
文献类型：
--
作者：
Kornstein, Susan G.;Wohlreich, Madelaine M.;Stewart, Donna E.
目的：许多研究表明，抗抑郁药物的疗效存在潜在的性别差异。来自双盲、安慰剂对照研究的汇总数据用于比较度洛西汀治疗男性和女性重度抑郁症（MDD）患者的疗效。方法：收集7个随机、双盲、安慰剂对照的度洛西汀临床试验的疗效数据。这些研究代表了美国关于度洛西汀治疗重度抑郁症的急性期、安慰剂对照研究的所有可用数据。符合DSM-IV MDD标准的患者（年龄>= 18岁）接受度洛西汀（40- 120mg /天；男性，N = 318；女性，N = 578）或安慰剂（男性，N = 242；女性，N = 484）治疗长达9周。疗效测量包括17项汉密尔顿抑郁量表（HAM-D-17）总分、HAM-D-17亚量表（core、Maier、anxiety、retarded、sleep）、临床总体印象-疾病严重程度量表（CGI-S）和患者总体印象改善量表（gi -i）、抑郁生活质量量表（QLDS）和疼痛视觉模拟量表（VAS）。患者首次就诊时间为1999年2月1日，最后一次就诊时间为2002年11月27日。结果：在男性和女性患者中，与安慰剂相比，度洛西汀对HAM-D-17、CGI-S和cgi - i的改善显著更大（p < 0.05）。性别治疗相互作用没有达到统计学意义，说明度洛西汀治疗效果的大小在男女患者之间没有显著差异。然而，女性患者对度洛西汀和安慰剂的反应有比男性患者更强烈的趋势。根据疼痛严重程度的VAS评估，度洛西汀治疗的女性患者似乎比男性患者表现出更大的改善，而接受安慰剂治疗的女性患者的反应比安慰剂治疗的男性患者要小。与安慰剂相比，接受度洛西汀治疗的男性（p = 0.006）和女性（p = 0.001）的生活质量均有显著提高，且性别差异无统计学意义。结论：在本汇总数据分析中，度洛西汀在男性和女性患者中的疗效无显著差异。
Objective: A number of studies have suggested potential gender differences in the efficacy of antidepressant medications. Pooled data from double-blind, placebo-controlled studies were utilized to compare the efficacy of duloxetine in the treatment of major depressive disorder (MDD) in male and female patients.Method: Efficacy data were pooled from 7 randomized, double-blind, placebo-controlled clinical trials of duloxetine. These studies represent all available data from U.S. acute-phase, placebo-controlled studies of duloxetine for the treatment of MDD. Patients (aged >= 18 years) meeting DSM-IV criteria for MDD received duloxetine (40-120 mg/day; men, N = 318; women, N = 578) or placebo (men, N = 242; women, N = 484) for up to 9 weeks. Efficacy measures included the 17-item Hamilton Rating Scale for Depression (HAM-D-17) total score, HAM-D-17 subscales (core, Maier, anxiety, retardation, sleep), the Clinical Global Impressions-Severity of Illness scale (CGI-S) and Patient Global Impression of Improvement scale (PGI-I), the Quality of Life in Depression Scale (QLDS), and Visual Analog Scales (VAS) for pain. The first patient visit was February 1, 1999, and the last patient visit was November 27, 2002.Results: In both male and female patients, duloxetine produced significantly greater improvement in HAM-D-17, CGI-S, and PGI-I when compared with placebo (p < .05). Treatment-by-gender interactions did not reach statistical significance, indicating that the magnitude of duloxetine's treatment effects did not differ significantly between male and female patients. However, there was a trend for female patients to show a more robust response than male patients to both duloxetine and placebo. On the basis of VAS assessments of pain severity, duloxetine-treated female patients appeared to exhibit greater improvement than male patients, while women receiving placebo had smaller responses than placebo-treated men. Improvements in quality of life were significantly greater for both men (p = .006) and women (p = .001) receiving duloxetine than placebo and showed no significant difference by gender.Conclusion: In this analysis of pooled data, the efficacy of duloxetine did not differ significantly in male and female patients.