Nathirojanakun Prapoj, Taneepanichskul Surasak, Sappakitkumjorn Nattiporn
Department of Obstetrics and Gynecology, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok 10330 Thailand.
Contraception. 2006 Jun;73(6):584-7. doi: 10.1016/j.contraception.2005.09.013. Epub 2006 Apr 17.
This double-blind, placebo-controlled study was conducted to evaluate the efficacy of valdecoxib and placebo for controlling irregular uterine bleeding in depot-medroxyprogesterone acetate (DMPA) users.
A total of 51 DMPA users were enrolled. All subjects in the study had abnormal bleeding and were randomly divided into two groups. One group totaling 22 received valdecoxib, 40 mg, once a day for 5 days, and placebos were given to another 24 in the same manner; 5 subjects dropped out from the study. Analysis of the number of treatment days required for stopping the bleeding episode, percentage of women whose bleeding was stopped in 7 days, total number of bleeding-free days and length of the bleeding-free interval after the initial treatment was determined in the first and the fourth weeks.
The percentage of the subjects whose bleeding was stopped during the first week after the initial treatment and the mean value of the bleeding-free days during the 28 days of the follow-up period were significantly higher in the valdecoxib group than in the placebo group (77.3% vs. 33.3%, p<.01; and 17.8 days vs. 11.5 days, p<.05, respectively). The mean duration of treatment days required for stopping the bleeding episode in the valdecoxib-treated group was 1.7 days, and the mean duration of the bleeding-free interval in valdecoxib-treated group was 18.6 days.
Valdecoxib was more effective than placebo in the short-term control of irregular bleeding in DMPA users. The mechanism of nonsteroidal anti-inflammatory drugs (NSAIDs) for the reduction of endometrial bleeding is likely from COX-2 inhibition.
本双盲、安慰剂对照研究旨在评估伐地昔布和安慰剂对控制使用醋酸甲羟孕酮长效注射剂（DMPA）的女性不规则子宫出血的疗效。
共纳入51名使用DMPA的女性。研究中的所有受试者均有异常出血，并被随机分为两组。一组共22人接受伐地昔布，40毫克，每日一次，共5天，另一组24人接受安慰剂，给药方式相同；5名受试者退出研究。在第一周和第四周测定止血所需的治疗天数、7天内止血的女性百分比、无出血天数总和以及初始治疗后无出血间隔的长度。
伐地昔布组在初始治疗后第一周内止血的受试者百分比以及随访期28天内无出血天数的平均值均显著高于安慰剂组（分别为77.3%对33.3%，p<0.01；17.8天对11.5天，p<0.05）。伐地昔布治疗组止血所需的平均治疗天数为1.7天，伐地昔布治疗组无出血间隔的平均时长为18.6天。
在短期控制使用DMPA的女性不规则出血方面，伐地昔布比安慰剂更有效。非甾体抗炎药（NSAIDs）减少子宫内膜出血的机制可能是通过抑制COX-2。
