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口服屈螺酮前和 Roux-en-Y 胃旁路手术后女性患者的炔诺孕酮血浆浓度:一项药代动力学研究。

Plasma concentrations of etonogestrel in women using oral desogestrel before and after Roux-en-Y gastric bypass surgery: a pharmacokinetic study.

机构信息

Department of Obstetrics and Gynaecology and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.

Department of Surgery and Department of Clinical and Experimental Medicine, Linköping University, Norrköping, Sweden.

出版信息

BJOG. 2019 Mar;126(4):486-492. doi: 10.1111/1471-0528.15511. Epub 2018 Nov 16.

Abstract

OBJECTIVE

To investigate whether Roux-en-Y gastric bypass (RYGB) affects oral desogestrel (etonogestrel) pharmacokinetics.

DESIGN

Single centre, open label, phase-2 pharmacokinetic study.

SETTING

University hospital of Linköping, Sweden.

POPULATION

Fourteen women with planned RYGB surgery were included; nine women aged 18-45 years using 75 micrograms desogestrel completed the study.

METHODS

Steady-state etonogestrel pharmacokinetic (PK) parameters were measured on three occasions for each individual (at 8 ± 6 weeks before surgery, and at 12 ± 2 and 52 ± 2 weeks after surgery). Each patient served as her own control. On each occasion, serum samples were collected during a 24-hour period and etonogestrel concentrations were determined with ultra-performance liquid chromatography/tandem mass spectrometry.

MAIN OUTCOME MEASURES

Area under the plasma concentration time curve of etonogestrel (AUC ).

RESULTS

All women had significant postoperative weight loss. There were no significant differences in AUC , terminal half-lives (t ), time to peak serum concentrations (T ), or apparent oral clearances of etonogestrel (CL ) before and after gastric bypass surgery on any occasion. Peak serum concentrations (C ) increased after 52 ± 2 weeks compared with preoperative values (0.817 ng/ml versus 0.590 ng/ml, P = 0.024).

CONCLUSION

To our knowledge, this is the first study to investigate the effects on desogestrel pharmacokinetics after RYGB. This study did not reveal any clinically significant changes in etonogestrel pharmacokinetics, suggesting that oral desogestrel may be used by women after RYGB surgery. The sample size was limited, however, and therefore the results should be interpreted cautiously.

TWEETABLE ABSTRACT

The pharmacokinetics of oral desogestrel does not appear to change after gastric bypass surgery.

摘要

目的

研究 Roux-en-Y 胃旁路术(RYGB)是否会影响口服去氧孕烯(依托孕烯)的药代动力学。

设计

单中心、开放标签、2 期药代动力学研究。

地点

瑞典林雪平大学医院。

人群

14 名计划接受 RYGB 手术的女性,9 名年龄在 18-45 岁之间、使用 75 微克去氧孕烯的女性完成了研究。

方法

每位个体进行了 3 次稳态依托孕烯药代动力学(PK)参数测量(手术前 8 ± 6 周、手术后 12 ± 2 周和 52 ± 2 周)。每位患者均作为自身对照。每次采集 24 小时内的血清样本,采用超高效液相色谱/串联质谱法测定依托孕烯浓度。

主要观察指标

依托孕烯的血浆浓度时间曲线下面积(AUC)。

结果

所有女性术后均有明显的体重减轻。在任何情况下,手术后和手术前相比,AUC、终末半衰期(t)、达峰时间(T)或依托孕烯的表观口服清除率(CL)均无显著差异。与术前值相比,52 ± 2 周时 C 峰值升高(0.817ng/ml 比 0.590ng/ml,P=0.024)。

结论

据我们所知,这是第一项研究 RYGB 后对去氧孕烯药代动力学影响的研究。本研究未发现依托孕烯药代动力学有任何临床显著变化,提示 RYGB 手术后女性可以使用口服去氧孕烯。但是,样本量有限,因此结果应谨慎解读。

推文摘要

胃旁路手术后,口服去氧孕烯的药代动力学似乎没有改变。

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