肯尼亚邦多地区女性中，欣妈富隆（II）®的持续使用情况以及同时使用替诺福韦酯富马酸盐-恩曲他滨对血浆左炔诺孕酮浓度的影响
Sino-implant (II)® continuation and effect of concomitant tenofovir disoproxil fumarate-emtricitabine use on plasma levonorgestrel concentrations among women in Bondo, Kenya.
作者信息
Todd Catherine S, Deese Jennifer, Wang Meng, Hubacher David, Steiner Markus J, Otunga Sheila, Van Damme Lut
机构信息
FHI 360, Durham, NC, USA.
FHI 360, Durham, NC, USA.
出版信息
Contraception. 2015 Mar;91(3):248-52. doi: 10.1016/j.contraception.2014.10.008. Epub 2014 Oct 22.
OBJECTIVE
The objective was to assess associations between tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) exposure and levonorgestrel (LNG) concentrations among Kenyan HIV prevention trial participants using Sino-implant (II) LNG implants for contraception.
METHODS
Women were offered implants among other contraceptive methods, were randomized to daily TDF-FTC or placebo, and followed monthly up to 56weeks. Associations between TDF-FTC exposure and mean LNG values were analyzed with linear mixed models.
RESULTS
Of 739 women, 29 (3.9%) received implants with no incident pregnancies and one discontinuation. Mean LNG concentrations over 56weeks among 28 women contributing data ranged between 214.0 and 659.8pg/mL with no significant difference between TDF-FTC and placebo arms or between variable levels of TDF-FTC adherence.
CONCLUSION
Concomitant TDF-FTC use was not associated with a significant change in plasma LNG concentrations among women using Sino-implant (II) in the first year of use.
目的
评估在肯尼亚使用中研Ⅱ型左炔诺孕酮（LNG）宫内节育器避孕的HIV预防试验参与者中，替诺福韦酯富马酸盐-恩曲他滨（TDF-FTC）暴露与左炔诺孕酮（LNG）浓度之间的关联。
方法
为女性提供宫内节育器及其他避孕方法，将她们随机分为每日服用TDF-FTC组或安慰剂组，并随访56周，每月进行一次。采用线性混合模型分析TDF-FTC暴露与平均LNG值之间的关联。
结果
739名女性中，29名（3.9%）接受了宫内节育器，无意外妊娠事件发生，1人停用。28名提供数据的女性在56周内的平均LNG浓度在214.0至659.8pg/mL之间，TDF-FTC组与安慰剂组之间或不同水平的TDF-FTC依从性之间无显著差异。
结论
在使用中研Ⅱ型宫内节育器的女性中，第一年同时使用TDF-FTC与血浆LNG浓度的显著变化无关。
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