Sicat Brigitte L
Department of Pharmacy, Virginia Commonwealth University, School of Pharmacy, Smith Building, Room 437, 410 North 12th Street, P.O. Box 980533, Richmond, VA 23298-0533, USA.
Pharmacotherapy. 2003 Apr;23(4):472-80. doi: 10.1592/phco.23.4.472.32120.
Ortho Evra is the first transdermal patch approved for the prevention of pregnancy. Comparative trials have shown that Ortho Evra has efficacy similar to the oral contraceptives Mercilon (not available in the United States) and Triphasil for the prevention of pregnancy when used as directed. Adverse effects with Ortho Evra are similar to those reported with combined oral contraceptives, with the exceptions of mild-to-moderate application-site reactions and an increased frequency of breast symptoms. The most commonly reported adverse reactions were breast symptoms, headache, application-site reactions, nausea and vomiting, dysmenorrhea, and abdominal pain. Approximately 5% of study subjects had at least one patch that did not stay attached to their skin, and about 2% of women withdrew from clinical trials due to irritation from the patch. In clinical studies, the patch appeared to be less effective in women weighing more than 90 kg than in women with lower body weights. More research is needed on the relationship between body weight and contraceptive patch efficacy. In two clinical trials, compliance was greater with the patch than with oral contraceptives. Whether this will result in reduced pregnancy rates in general use is unknown. Additional studies are warranted to determine if the patch offers any significant efficacy or safety advantages over current methods of hormonal contraception.
“欧乐透”(Ortho Evra)是首个获批用于避孕的透皮贴剂。对比试验表明,“欧乐透”在按说明使用时,其避孕效果与口服避孕药“美欣乐”(Mercilon,在美国未上市)及“特居乐”(Triphasil)相似。“欧乐透”的不良反应与复方口服避孕药所报告的不良反应相似,但有轻度至中度的贴剂部位反应以及乳房症状出现频率增加的情况除外。最常报告的不良反应为乳房症状、头痛、贴剂部位反应、恶心和呕吐、痛经及腹痛。约5%的研究对象至少有一片贴剂未粘贴在皮肤上,约2%的女性因贴剂刺激而退出临床试验。在临床研究中,该贴剂对体重超过90千克的女性似乎不如对体重较轻的女性有效。体重与避孕贴剂效果之间的关系还需要更多研究。在两项临床试验中,使用贴剂的依从性高于口服避孕药。在常规使用中这是否会导致妊娠率降低尚不清楚。有必要进行更多研究,以确定该贴剂与目前的激素避孕方法相比是否具有任何显著的效果或安全性优势。