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首页> 外文期刊>JAMA: the Journal of the American Medical Association >Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive: a randomized controlled trial.
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Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive: a randomized controlled trial.

机译：评估口服避孕药与经皮避孕药的避孕效果和周期控制：一项随机对照试验。

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CONTEXT: Oral contraceptive (OC) pills are effective, but poor compliance increases rates of pregnancy during treatment. OBJECTIVE: To compare the contraceptive efficacy, cycle control, compliance, and safety of a transdermal contraceptive patch and an OC. DESIGN: Randomized, open-label, parallel-group trial conducted October 1997 to June 1999. SETTING: Forty-five clinics in the United States and Canada. PARTICIPANTS: A total of 1417 healthy adult women of child-bearing potential. INTERVENTIONS: Participants were randomly assigned to receive a transdermal contraceptive patch (n = 812) vs an OC (n = 605) for 6 or 13 cycles. Patch treatment consisted of application of 3 consecutive 7-day patches followed by 1 patch-free week. MAIN OUTCOME MEASURES: Overall and method-failure Pearl Indexes (number of pregnancies/100 person-years of use) and life-table estimates of the probability of pregnancy were calculated. Cycle control, compliance, patch adhesion, and adverse events were also assessed. RESULTS: Overall and method-failure Pearl Indexes were numerically lower with the patch (1.24 and 0.99, respectively) vs the OC (2.18 and 1.25, respectively); this difference was not statistically significant (P =.57 and.80, respectively). The incidence of breakthrough bleeding and/or spotting was significantly higher only in the first 2 cycles in the patch group, but the incidence of breakthrough bleeding alone was comparable between treatments in all cycles. The mean proportion of participants' cycles with perfect compliance was 88.2% (811 total participants, 5141 total cycles) with the patch and 77.7% (605 total participants, 4134 total cycles) with the OC (P <.001). Only 1.8% (300/16 673) of patches completely detached. Both treatments were similarly well tolerated; however, application site reactions, breast discomfort, and dysmenorrhea were significantly more common in the patch group. CONCLUSION: The contraceptive patch is comparable to a combination OC in contraceptive efficacy and cycle control. Compliance was better with the weekly contraceptive patch than with the OC.
机译：背景：口服避孕药是有效的，但是依从性差会增加治疗期间的怀孕率。目的：比较透皮避孕贴和OC的避孕功效，周期控制，依从性和安全性。设计：1997年10月至1999年6月进行的随机，开放标签，平行组试验。地点：美国和加拿大的45家诊所。参与者：共有1417名有生育能力的健康成年女性。干预措施：随机分配参与者接受6或13个周期的透皮避孕贴片（n = 812）和OC（n = 605）。贴剂治疗包括连续3天7天贴剂，然后每周1次无贴剂。主要观察指标：计算总体和方法失败的珍珠指数（妊娠数/每100人年使用次数）和生命表中估计的怀孕概率。还评估了周期控制，顺应性，贴剂粘附和不良事件。结果：该补丁的总体和方法失败的珍珠指数在数值上较低（分别为1.24和0.99），而OC分别为（2.18和1.25）。这种差异没有统计学意义（分别为P = 0.57和.80）。仅在贴剂组的前两个周期中，突破性出血和/或斑点的发生率才显着更高，但是在所有周期的治疗之间，仅突破性出血的发生率是可比的。补丁程序的完全遵守的参与者周期的平均比例是88.2％（总共811个参与者，总共5141个周期），使用OC的平均比例是77.7％（总共605个参与者，总共4134个周期）（P <.001）。只有1.8％（300/16 673）的修补程序完全脱离。两种疗法的耐受性相似。但是，贴剂组中的应用部位反应，乳房不适和痛经明显更为常见。结论：该避孕贴片在避孕功效和周期控制方面可与组合OC相媲美。每周避孕贴片的依从性比OC好。

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