Goldberg Alisa B, Cardenas Lilia H, Hubbard Alan E, Darney Philip D
The Department of Obstetrics, Gynecology and Reproductive Sciences, Center for Reproductive Health Research and Policy, San Francisco General Hospital, University of California-San Francisco, 94110, USA.
Contraception. 2002 Oct;66(4):215-20. doi: 10.1016/s0010-7824(02)00391-8.
Irregular menstrual bleeding is a common reason for discontinuation of depot medroyprogesterone acetate (DMPA) contraception. We conducted a double-blind, randomized placebo controlled trial to estimate if transdermal estradiol used in a cyclic fashion could make DMPA bleeding patterns more acceptable and improve DMPA continuation rates. Women initiating DMPA contraception immediately post-abortion (N = 132) were randomized to receive either a low sustained dose of transdermal 17-beta estradiol (0.10 mg/day, Climara) or an identical placebo to be used in a cyclic manner for 3 months. Bleeding patterns, contraceptive use, and pregnancy rates were measured for 1 year after enrollment. Cyclic transdermal estrogen did not create regular bleeding patterns in new users of DMPA and had no effect on DMPA continuation rates (relative hazard = 0.93, 95%CI 0.65-1.33). By 12 months after enrollment, 19.4% of those randomized to estrogen and 23.9% of those randomized to placebo were still using DMPA for contraception. There was no difference in the frequency of DMPA discontinuation primarily for abnormal uterine bleeding between groups (relative risk ratio = 0.95, 95%CI 0.40-2.23). Few women who discontinued DMPA switched to highly effective methods of contraception and within 1 year of an abortion, there were 18 repeat pregnancies (21.9%). Compliance with the estrogen patches was poor resulting in early study termination and inadequate statistical power to detect a clinically significant difference in DMPA continuation rates. Continuation rates of DMPA were low and repeat pregnancy rates were high among women initiating DMPA at the time of abortion. Cyclic transdermal estradiol use is an unacceptable regimen for preventing the irregular bleeding associated with DMPA initiation.
月经不规则出血是停用醋酸甲羟孕酮长效避孕针(DMPA)避孕的常见原因。我们进行了一项双盲、随机、安慰剂对照试验,以评估周期性使用经皮雌二醇是否能使DMPA的出血模式更易接受,并提高DMPA的继续使用率。流产后立即开始使用DMPA避孕的女性(N = 132)被随机分为两组,分别接受低剂量持续释放的经皮17-β雌二醇(0.10 mg/天,克龄蒙)或相同的安慰剂,以周期性方式使用3个月。入组后1年测量出血模式、避孕方法使用情况和妊娠率。周期性经皮雌激素并未使新使用DMPA的女性形成规律的出血模式,对DMPA的继续使用率也没有影响(相对风险= 0.93,95%置信区间0.65 - 1.33)。入组12个月后,随机分配至雌激素组的女性中有19.4%仍在使用DMPA避孕,随机分配至安慰剂组的女性中有23.9%仍在使用DMPA避孕。两组因子宫异常出血而停用DMPA的频率没有差异(相对风险比= 0.95,95%置信区间0.40 - 2.23)。很少有停用DMPA的女性转而采用高效避孕方法,且在流产后1年内有18例再次妊娠(21.9%)。对雌激素贴片的依从性较差,导致研究提前终止,且检测DMPA继续使用率的临床显著差异的统计效力不足。在流产时开始使用DMPA的女性中,DMPA的继续使用率较低,再次妊娠率较高。周期性使用经皮雌二醇作为预防与开始使用DMPA相关的不规则出血的方案是不可接受的。