Shulman L P, Oleen-Burkey M, Willke R J
Department of Obstetrics and Gynecology, University of Illinois at Chicago 60612-7313, USA.
Contraception. 1999 Oct;60(4):215-22. doi: 10.1016/s0010-7824(99)00082-7.
The results from a User Satisfaction Questionnaire, Treatment Assessment Questionnaire, and Global Well-Being Schedule questionnaire administered to women participating in an open-labeled, nonrandomized, parallel, controlled study comparing a new monthly injectable contraceptive containing 25 mg of medroxyprogesterone acetate (MPA) and 5 mg of estradiol cypionate (E2C) (MPA/E2C) (Lunelle Monthly Contraceptive Injection) and a triphasic norethindrone (0.5, 0.75, 1.0 mg)/0.035 mg ethinyl estradiol (NET/EE) oral contraceptive (Ortho-Novum 7/7/7) are reviewed. Approximately 85% of all 1103 women enrolled in the comparative trial completed their initial and final questionnaires. To better assess the comparison of a new and extant method of contraception, outcome data were divided among MPA/E2C users and new and previous oral contraceptive (OC) users. Despite the inherent inequalities in comparing an injectable to an oral method of contraception, few treatment assessment and satisfaction outcomes were significantly different when comparing MPA/E2C users to new OC (NET/EE) users. More women in the MPA/E2C study group reported discomfort with their method than women in either NET/EE study group; however, only 19.4% of MPA/E2C users rated the administration of their contraceptive to be moderately uncomfortable or worse, compared to 11.7% of new NET/EE users and 13.4% of previous OC users. Among MPA/E2C users, 86.3% reported no interference with social activities compared with 90.4% of new NET/EE users. MPA/E2C and new NET/EE users were also similar in their responses recommending their respective contraceptive method to friends, with > 90% of both groups stating that they had a very favorable experience and would definitely recommend their method to a friend. In general, MPA/E2C was well accepted by women in the study group. Their attitudes and perceptions are similar to those of women who were starting OCs for the first time. These data support the premise that MPA/E2C may become a well accepted, first-line contraceptive option for women in the US.
对参与一项开放标签、非随机、平行对照研究的女性进行了用户满意度问卷、治疗评估问卷和总体幸福感量表问卷调查,该研究比较了一种新的每月注射用避孕药,其含有25毫克醋酸甲羟孕酮(MPA)和5毫克环丙孕酮(E2C)(MPA/E2C)(鲁内尔每月避孕注射剂)和一种三相炔诺酮(0.5、0.75、1.0毫克)/0.035毫克炔雌醇(NET/EE)口服避孕药(炔诺酮三相片7/7/7)。在1103名参与比较试验的女性中,约85%完成了初始和最终问卷。为了更好地评估一种新的和现有的避孕方法的比较,结果数据在MPA/E2C使用者以及新的和以前的口服避孕药(OC)使用者之间进行了划分。尽管将注射用避孕方法与口服避孕方法进行比较存在内在的不平等,但将MPA/E2C使用者与新的OC(NET/EE)使用者进行比较时,很少有治疗评估和满意度结果存在显著差异。MPA/E2C研究组中报告对其避孕方法感到不适的女性比NET/EE研究组中的女性更多;然而,只有19.4%的MPA/E2C使用者将其避孕药物的使用评为中度不适或更差,相比之下,新的NET/EE使用者为11.7%,以前的OC使用者为13.4%。在MPA/E2C使用者中,86.3%报告对社交活动没有干扰,而新的NET/EE使用者为90.4%。MPA/E2C使用者和新的NET/EE使用者在向朋友推荐各自避孕方法的回答上也相似,两组中超过90%的人表示他们有非常好的体验,并肯定会向朋友推荐他们的方法。总体而言,MPA/E2C在研究组女性中得到了很好的接受。她们的态度和看法与首次开始使用OC的女性相似。这些数据支持了MPA/E2C可能成为美国女性广泛接受的一线避孕选择的前提。