Objective:To compare characteristics of endometrial and serum progesterone distribution after vaginal and intramuscular administration of progesterone.Methods:This is an open-label,prospective randomized controlled trial.51 healthy postmenopausal women were recruited and randomized to 2 groups(90 mg vaginal progesterone gel(Crinone 8％) or 20mg intramuscular progesterone in oil once daily) for 7 days.Serum samples were obtained before the first dose and after the last dose.Endometrial specimens were obtained after the last dose and radioimmunoassay(RIA) was used to detectthe endometrial progesterone levels.ANOVA and paired t test were used to analyze the data.Results:39 samples were included into research.The baseline in two groups including age,menopausal time,basic hormone level has no statistical difference(P ＞0.05).Vaginal administration group has no difference with intramuscular administration group in progesterone concentration which has no statistical significance(P ＞ 0.05).After the last dose,the mean serum progesterone levels in vaginal and intramuscular administration were 20.03 ±12.08 nmol/L and 19.71 ±9.22 nmol/L(P=0.822),respectively.Vaginal administration achieved significantly higher endometrial progesterone level than intramuscular administration (11.13 ± 11.44 nmol/L vs 2.54 ± 1.90 nmol/L,P =0.005).Conclusions:Vaginal delivery of progesterone achieved higher endometrial concentrations and lower systemic exposures than intramuscular progesterone.%目的:探讨阴道给药和肌内注射黄体酮给药后在血中和子宫内膜激素水平的影响.方法:采用单中心、前瞻性、随机对照研究方法,随机选择2009年12月至2011年8月在北京协和医院妇科51例健康绝经后女性,知情同意后随机分为两组,临床常规给药剂量阴道给药组给予黄体酮阴道缓释凝胶90 mg阴道给药,肌内注射给药组肌内注射黄体酮油剂20 mg,两组均每日1次,连续用药7天.在给药5～7天后测定血激素水平,活检取子宫内膜组织并利用放射免疫法(RIA)测定内膜孕酮浓度.比较两组用药后子宫内膜组织中及血中孕酮浓度及用药前后血中孕酮浓度.结果:完成研究并符合条件共39例,两组基线水平包括年龄、停经时间、基础激素水平差异无统计学意义(P＞0.05),阴道给药组血中孕酮浓度与肌内注射组差异无统计学意义(P＞0.05).阴道给药组子宫内膜孕酮浓度(11.13±11.44 nmol/L)与肌内注射组(2.54±1.90 nmol/L)比较,差异有统计学意义(P =0.005).阴道给药组用药前后血孕酮浓度变化(20.03±12.08 nmol/L)与肌内注射组(19.71±9.22 nmol/L)比较,差异无统计学意义(P=0.822).结论:与肌内注射给药相比,阴道凝胶经阴道给药的子宫局部吸收更高,值得临床推广.
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