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目的比较口服两种剂量国产黄体酮胶丸的孕激素作用,供临床用药参考。方法选择2004年9月至2005年6月北京协和医院内分泌和妇女健康中心收治的孕激素缺乏患者58例,以开放随机法分为两组:黄体酮胶丸300mg组(29例)及黄体酮胶丸200mg组(29例)。观察两组血清孕酮(P)、基础体温(BBT)、撤药性出血情况、不良反应和肝肾功能。结果(1)口服300mg、200mg黄体酮胶丸后血清孕酮分别为(71.80±41.49)nmol/L和(42.05±20.25)nmol/L,两组比较P<0.05。(2)两组服药期间基础体温比用药前高约0.2~0.3℃,300mg组达峰值比200mg组约早3d。(3)共41例患者出现撤药性出血,300mg、200mg组撤药性出血率分别为79.3%和62.1%(P>0.05)。(4)药物不良反应头晕发生率均为10.3%,300mg、200mg组乳胀发生率分别为17.2%和3.33%;用药前肝肾功能正常,用药后无改变。结论口服黄体酮胶丸300mg和200mg均可以明显升高血清孕酮值,300mg组的孕激素作用比200mg强,但乳胀反应的发生率比后者高。
Objective To compare the effects of oral progesterone with two doses of domestic progesterone capsules for clinical reference. Methods Fifty-eight patients with progestin deficiency admitted to the Endocrine and Women’s Health Center of Peking Union Medical College Hospital from September 2004 to June 2005 were divided into two groups according to open-label randomization: 300 mg progesterone capsules (n = 29) and progesterone Capsules 200mg group (29 cases). Serum progesterone (P), basal body temperature (BBT), withdrawal bleeding, adverse reactions and liver and kidney function were observed in two groups. Results (1) Serum progesterone after oral administration of 300mg and 200mg progesterone capsules were (71.80 ± 41.49) nmol / L and (42.05 ± 20.25) nmol / L respectively, P <0.05. (2) The basal body temperature in the two groups was about 0.2 ~ 0.3 ℃ higher than before treatment. The peak value in the 300mg group was about 3d earlier than that in the 200mg group. (3) A total of 41 patients had withdrawal bleeding. The withdrawal bleeding rate was 79.3% and 62.1% in 300mg and 200mg groups respectively (P> 0.05). (4) The incidence of dizziness caused by adverse drug reactions were 10.3%. The incidences of breast swelling in 300mg and 200mg groups were 17.2% and 3.33% respectively. The liver and kidney function was normal before treatment and no change after treatment. Conclusion Both oral progesterone capsules 300mg and 200mg can significantly increase serum progesterone, 300mg progesterone group than the 200mg stronger, but the incidence of breast swelling reaction than the latter.