口服两种剂量黄体酮胶丸的孕激素作用比较

Comparing the progestogen effect of oral progesterone capsule in two kinds of dosage

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）nm01／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组约旱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 Comparing the progestogen effect of oral domestic Progesterone capsule （Qining）in two kinds of dosage. Methods A total of 58 patients who lacked progesterone were divided into two groups randomly ： Qining 300mg and Qining 200mg group. Observation index ： the serum progesterone （P） , basal body temperature （BBT） , withdrawal bleeding,adverse effect and liver and kidney function （ ALT, CR, DBIL） . Results After oral taking of 300mg and 200mg Qining, the serum progesterone level rose notably , being 71.80 ± 41.49nmol/L and 42.05 ± 20.25nmol/L respectively; 41 patients had withdrawal bleeding , and the withdrawal bleeding rate of 300mg and 200 mg group was 79. 3% and 62.1% respectively, which had no significant difference. The main adverse effects were dizziness and breast gas pains, incidence of dizziness being 10. 3% , incidence of breast gas pains 17.2% and 3.33% respectively. Liver and kidney function was normal before taking medicine, which did not change after taking medicine. Conclusion The oral Qining （300mg and 200mg） can raise the serum progesterone level obviously, and the progestogen effect of 300mg group is stronger than 200mg group ,but incidence of breast gas pain is more than the latter.