Miner Cherri, Brown Eileen, McCray Susan, Gonzales Jill, Wohlreich Madelaine
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, USA.
Clin Ther. 2002 Mar;24(3):417-33. doi: 10.1016/s0149-2918(02)85043-3.
Because the symptoms of premenstrual dysphoric disorder (PMDD) are limited to the luteal phase of the menstrual cycle, the potential benefit of luteal-phase dosing has been hypothesized.
This multicenter, randomized, double-blind, placebo-controlled, parallel-group trial evaluated the efficacy and tolerability of enteric-coated fluoxetine 90 mg given once or twice during the luteal phase for the treatment of PMDD.
Study drug was given 14 and 7 days before expected menses during the luteal phase of 3 menstrual cycles. After a screening period and single-blind placebo lead-in period, eligible women were randomized to I of 3 treatment groups: enteric-coated fluoxetine 90 mg on both days (LPWDx2); placebo 14 days before menses and enteric-coated fluoxetine 90 mg 7 days before menses (LPWDx1); or placebo on both days (PLC). The primary efficacy measure was change from baseline in mean luteal-phase scores on the Daily Record of Severity of Problems (DRSP). Secondary efficacy measures included scores on the Rating Scale for Premenstrual Tension Syndrome, Clinician-Rated (PMTS-C); the Clinical Global Impression (CGI)-Severity scale; and the Patient Global Impression (PGI)-Improvement scale. Quality of life was assessed using the Sheehan Disability Scale.
Two hundred fifty-seven women were randomized to treatment. At the end of the study, the LPWDx2 group had statistically significant improvements in DRSP total, DRSP mood subtotal, DRSP social functioning subtotal, PMTS-C, CGI-Severity, PGI-Improvement, and Sheehan Disability Scale work and family life scores compared with LPWDx1 and PLC (each measure, P < 0.05). There was also a statistically significant improvement in the score on the social life section of the Sheehan Disability Scale with LPWDx2 compared with PLC (P = 0.037). Across all treatment groups, 5 patients discontinued due to nonserious adverse events. Rates of discontinuation for any reason did not differ between the 3 treatment groups.
The findings of this study support the efficacy and tolerability of enteric-coated fluoxetine 90 mg given twice during the luteal phase of the menstrual cycle for the treatment of PMDD.
由于经前烦躁障碍（PMDD）的症状仅限于月经周期的黄体期，因此推测了黄体期给药的潜在益处。
这项多中心、随机、双盲、安慰剂对照、平行组试验评估了在黄体期每日服用一次或两次90毫克肠溶氟西汀治疗PMDD的疗效和耐受性。
在3个月经周期的黄体期，于预期月经前14天和7天给予研究药物。经过筛选期和单盲安慰剂导入期后，符合条件的女性被随机分为3个治疗组之一：两天均服用90毫克肠溶氟西汀（LPWDx2）；月经前14天服用安慰剂，月经前7天服用90毫克肠溶氟西汀（LPWDx1）；或两天均服用安慰剂（PLC）。主要疗效指标是问题严重程度每日记录（DRSP）中黄体期平均得分相对于基线的变化。次要疗效指标包括经前紧张综合征临床评定量表（PMTS-C）得分、临床总体印象（CGI）严重程度量表得分以及患者总体印象（PGI）改善量表得分。使用希恩残疾量表评估生活质量。
257名女性被随机分配接受治疗。研究结束时，与LPWDx1和PLC组相比，LPWDx2组在DRSP总分、DRSP情绪子总分、DRSP社会功能子总分、PMTS-C、CGI严重程度、PGI改善以及希恩残疾量表工作和家庭生活得分方面有统计学显著改善（每项指标，P<0.05）。与PLC组相比，LPWDx2组在希恩残疾量表社会生活部分的得分也有统计学显著改善（P = 0.037）。在所有治疗组中，有5名患者因非严重不良事件停药。3个治疗组因任何原因停药的发生率无差异。
本研究结果支持在月经周期黄体期每日两次服用90毫克肠溶氟西汀治疗PMDD的疗效和耐受性。
