Liu Ping, He Fang-fang, Bai Wen-pei, Yu Qi, Shi Wei, Wu Yi-yong, He Dan-jun, Xiao Ji-hua, Zheng Ye, Liao Qin-ping
Lilly Research Laboratories, Eli Lilly Shanghai Representative. Office, Shanghai 200001, China.
Chin Med J (Engl). 2004 Feb;117(2):189-94.
To compare the efficacy and safety of hormone replacement therapy (HRT) combined with fluoxetine, with HRT alone, in post-menopausal women suffering from depression.
A randomized, open-label, parallel trial was applied. HRT was administered to all patients for 2 cycles, with 14 days of estrogen therapy and 14 days of estrogen plus progesterone. Patients who were randomly assigned to the HRT plus fluoxetine group were given fluoxetine in combination with HRT. Hamilton Depression Rating Scale (HAMD), Kupperman Menopausal Index (KMI), and Clinical Global Impressions scale were used to measure the efficacy.
One hundred and twenty-three post-menopausal patients with depression were enrolled in the study. Among them, 120 had at least one post-treatment visit and entered into the statistical analysis. The mean total HAMD scores were significantly lower, and the percentages of HAMD score reductions were higher in the HRT plus fluoxetine Group compared with the HRT Group, after at least 3 weeks of treatment, with an average difference of 5 points at the endpoint. The Clinical Global Impression-Severity and Clinical Global Impression-Improvement scores were significantly different in the 2 groups, in favor of the combination therapy. The mean total KMI was significantly lower in the Combination Group compared with the HRT Group, after at least 6 weeks of treatment, with an average 4.5-point difference between the groups. No statistically significant differences were found in most of the adverse events reported in the Combination Group compared with the HRT group, with the exception of 3 symptoms, i.e., dry mouth, loss of appetite, and abdominal distention. They were mild to moderate in severity. Two patients in the HRT group, but none in the combination group, dropped out due to adverse events.
HRT plus fluoxetine therapy was effective in the treatment of menopausal depression with a satisfactory safety profile.
比较激素替代疗法（HRT）联合氟西汀与单纯HRT治疗绝经后抑郁症女性的疗效和安全性。
采用随机、开放标签、平行试验。所有患者接受HRT治疗2个周期，其中雌激素治疗14天，雌激素加孕激素治疗14天。随机分配至HRT加氟西汀组的患者给予氟西汀联合HRT治疗。采用汉密尔顿抑郁量表（HAMD）、库珀曼绝经指数（KMI）和临床总体印象量表评估疗效。
123例绝经后抑郁症患者纳入研究。其中，120例至少有1次治疗后随访并进入统计分析。治疗至少3周后，HRT加氟西汀组的平均HAMD总分显著更低，HAMD评分降低的百分比更高，终点时平均差异为5分。两组的临床总体印象-严重程度和临床总体印象-改善评分有显著差异，联合治疗更具优势。治疗至少6周后，联合组的平均KMI总分显著低于HRT组，两组平均相差4.5分。联合组报告的大多数不良事件与HRT组相比无统计学显著差异，但有3种症状除外，即口干、食欲不振和腹胀。这些症状严重程度为轻至中度。HRT组有2例患者因不良事件退出研究，联合组无患者退出。
HRT加氟西汀疗法治疗绝经后抑郁症有效，安全性良好。
