复合甾体避孕药经阴道给药的临床药理研究

STUDIES ON CLINICAL PHARMACOLOGY OF INTRAVAGINAL ADMINISTRATION OF COMPLEX STERIODAL CONTRACEPTIVES

本文用随机分配方法,比较中国妇女使用复合甾体避孕药地索高诺酮(地索高诺酮0.15mg+炔雌醇0.03mg)、左旋18-甲基炔诺酮(简称左旋18-甲)(左旋18-甲0.25mg+炔雌醇0.05mg)阴道给药及左旋18-甲口服给药的临床药理研究。共接受合格、健康育龄妇女132例;其中地索高诺酮阴道给药34例,左旋18-甲阴道给药66例和口服给药32例。按生命表法统计,其使用一年的累积续用率分别为79.5,84.9和90.7%,三组在统计学上无显著差别。副反应的发生率左旋18-甲阴道给药滴血较口服少(p<0.05)。在一年使用中妊娠者,地索高诺酮一例;左旋18-甲阴道给药二例,均承认在受孕月的给药周期曾漏服避孕药。除地索高诺酮组的甘油三酯(TG)含量非常显著高于左旋18-甲组外(p<0.001),其余指标和肝功能均在正常值范围。地索高诺酮组6/11妇女血孕酮水平提示有排卵;左旋18-甲阴道、口服给药分别有12/15和1/11妇女血孕酮水平提示有排卵;左旋18-甲二种途径给药对抑制排卵有非常显著差别(p<0.01)。结果表明:口服给药主要通过抑制排卵产生避孕;而阴道给药可能通过影响宫颈粘液和子宫内膜而阻止受孕。本临床试验提示:复合甾体避孕药经阴道给药具有较满意的避孕效果,可以作为一种较好的抗生育给药途径。

A randomized study to compare clinical pharmacology of three methods of complexsteriodal contraceptives was carried out in Chinese women from 1988 through 1989. These 3 contraceptivepreparations contain desogestrel (DG) (DG 0.15 mg/EE 0.03 mg). Levonorgestrel(LNG) (LNG 0.25mg/EE 0.05 mg) respectively, and the first 2 were given via intravaginal route, while the last orally. Thenumber of volunteers recuited for the 3 drugs groups was 34.66 and 32. Using the statistical life table calculation, the cumulative continuation rates at the end of one year for the 3 groups were 79.5%, 84.9%and 90.7%. The incidence of side-effect in the LNC (Vaginal) group was less vaginal bleeding than theLNG (oral) group(p<0.05). The influence of three contraceptives on liver function and lipid metabolismwas as follows: the mean value of triglyceride(TG) in DG group was significantly higher than that of LNGgroup(p<0.001), while the other indices or the liver function tests showed no significant change from thenormal values. As to the inhibition on ovulation, the ovulation rates of the 3 groups were 6/11, 12/15, 1/11 women respectively, indicating significant suppression on ovulation in the DG vaginal and LNG oralgroups, the oral group significantly different from the other group. The results thus showed that oral ad-ministration of contraceptive induced contraception through its inhibition on ovulation, while vaginal routeof such medications induced contraception through their influence on the cervical mucus and endometriaresulting in suppression of pregnancy. This clinical trial indicates that vaginal administration of complexsteriodal contraceptives may produce satisfactory antifertile effect and therefore can be a good route ofmedicatiion.