口服左炔诺孕酮和炔雌醇在 Roux-en-Y 胃旁路手术后妇女中的药代动力学。
Pharmacokinetics of oral levonorgestrel and ethinylestradiol in women after Roux-en-Y gastric bypass surgery.
机构信息
Grupo de Obesidade e Síndrome Metabólica, Hospital das Clínicas HCFMUSP, Universidade de São Paulo, São Paulo, Brazil.
Grupo de Obesidade e Síndrome Metabólica, Hospital das Clínicas HCFMUSP, Universidade de São Paulo, São Paulo, Brazil; Laboratory of Carbohydrates and Raioimmunoassay, ICHC, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
出版信息
Surg Obes Relat Dis. 2021 Apr;17(4):673-681. doi: 10.1016/j.soard.2020.12.007. Epub 2020 Dec 16.
BACKGROUND
Most patients undergoing Roux-en-Y gastric bypass (RYGB) are women in reproductive age. It is not known if bariatric surgery affects the pharmacokinetics of oral contraceptives.
OBJECTIVES
The primary objective was to evaluate ethinylestradiol (EE) and levonorgestrel (LNG) absorption in women undergoing RYGB, compared with nonoperated controls matched by age and body mass index (BMI). A secondary objective was to assess whether the time since surgery and BMI in the postoperative period influenced the absorption parameters.
SETTING
University hospital, Brazil.
METHODS
This study was designed to compare the maximum plasma concentration (C), the time to the peak plasma level (T), the area under the curve (AUC and AUC) after a single dose of a combined oral contraceptive with 0.03 mg EE and 0.15 mg LNG among 20 women after RYGB and 20 controls. Blood samples were obtained for 8 hours.
RESULTS
The mean LNG AUC and LNG AUC were higher in RYGB group (P = .048 and P = .004, respectively). We found a positive correlation for LNG AUC (P = .045) and AUC (P = .004) and the time since surgery, and we found a negative correlation for LNG C (P = .018), AUC (P = .003), and AUC (P = .001) and BMI.
CONCLUSION
No significant differences were found in oral EE pharmacokinetics. The operated group showed higher mean LNG AUC and AUC but it was not considered clinically significant. The present study suggests that RYGB may not affect EE and LNG absorption.
背景
大多数接受 Roux-en-Y 胃旁路术（RYGB）的患者是育龄期女性。目前尚不清楚减肥手术是否会影响口服避孕药的药代动力学。
目的
主要目的是评估与年龄和体重指数（BMI）相匹配的非手术对照组相比，RYGB 术后女性的炔雌醇（EE）和左炔诺孕酮（LNG）吸收情况。次要目的是评估手术时间和术后 BMI 是否影响吸收参数。
地点
巴西大学医院。
方法
本研究旨在比较 20 例 RYGB 术后女性和 20 例对照组单次服用含有 0.03mg EE 和 0.15mg LNG 的复方口服避孕药后的最大血浆浓度（C）、达峰时间（T）、曲线下面积（AUC 和 AUC）。采集 8 小时的血样。
结果
RYGB 组 LNG AUC 和 LNG AUC 均较高（P=0.048 和 P=0.004）。我们发现 LNG AUC（P=0.045）和 AUC（P=0.004）与手术时间呈正相关，而 LNG C（P=0.018）、AUC（P=0.003）和 AUC（P=0.001）与 BMI 呈负相关。
结论
口服 EE 的药代动力学无显著差异。手术组 LNG AUC 和 AUC 均值较高，但无临床意义。本研究表明 RYGB 可能不会影响 EE 和 LNG 的吸收。
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