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上臂皮下注射 depot 醋酸甲羟孕酮的药代动力学。

Pharmacokinetics of subcutaneous depot medroxyprogesterone acetate injected in the upper arm.

机构信息

FHI 360, Research Triangle Park, NC, USA.

出版信息

Contraception. 2014 Jan;89(1):31-5. doi: 10.1016/j.contraception.2013.07.002. Epub 2013 Jul 12.

DOI:10.1016/j.contraception.2013.07.002
PMID:23993431
Abstract

BACKGROUND

The abdomen and thigh are recommended injection sites in the label for Depo-SubQ Provera 104™. We evaluated the pharmacokinetic profile of medroxyprogesterone acetate (MPA) following injection of Depo-SubQ Provera 104 in the upper arm, a preferred injection site in developing countries.

STUDY DESIGN

Twenty-six women in Norfolk, VA, received a single injection of Depo-SubQ Provera 104 in the upper arm in this prospective noncomparative study. We measured MPA serum concentrations prior to injection (day 1) and 11 times postinjection (days 2, 4, 8, 14, 30, 44, 60, 74, 91, 104 and 120).

RESULTS

Serum MPA levels peaked at 0.953 ng/mL 2-14 days (interquartile range; median=8) after dosing. Mean AUC0-91 was 45.1 ng·day/mL. Mean MPA levels at days 91, 104 and 120 were 0.427, 0.367 and 0.327 ng/mL, respectively. A total of 15 individual measurements of MPA were below 0.2 ng/mL. All women but one had MPA levels above 0.1 ng/mL on day 91.

CONCLUSIONS

Injection of Depo-SubQ Provera 104™ in the upper arm provided sufficient MPA levels for contraceptive protection for 3 months (13 weeks). The uptake and metabolism of MPA when injected in the upper arm may be different from the abdomen and thigh.

摘要

背景

Depo-SubQ Provera 104™ 的标签推荐腹部和大腿为注射部位。我们评估了醋酸甲羟孕酮(MPA)在手臂(发展中国家首选的注射部位)注射 Depo-SubQ Provera 104 后的药代动力学特征。

研究设计

在这项前瞻性非对照研究中,弗吉尼亚州诺福克的 26 名女性在上臂接受了单次 Depo-SubQ Provera 104 注射。我们在注射前(第 1 天)和注射后 11 次(第 2、4、8、14、30、44、60、74、91、104 和 120 天)测量 MPA 血清浓度。

结果

血清 MPA 水平在给药后 2-14 天(四分位距;中位数=8)达到峰值 0.953ng/mL。AUC0-91 的平均值为 45.1ng·day/mL。第 91、104 和 120 天的 MPA 平均水平分别为 0.427、0.367 和 0.327ng/mL。共有 15 个 MPA 测量值低于 0.2ng/mL。所有女性在第 91 天的 MPA 水平均高于 0.1ng/mL,除了 1 人以外。

结论

在上臂注射 Depo-SubQ Provera 104™ 可提供足够的 MPA 水平,以实现 3 个月(13 周)的避孕保护。在上臂注射时,MPA 的吸收和代谢可能与腹部和大腿不同。

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