屈螺酮炔雌醇在早发性卵巢功能不全患者诱导卵泡发育作用的研究

Study on the effects of drospirenone and ethinylestradiol in inducing follicular development in patients with premature ovarian insufficiency

目的探讨屈螺酮炔雌醇在早发性卵巢功能不全(premature ovarian insufficiency,POI)患者诱导卵泡恢复生长发育的作用。方法随机对照临床研究分析中国人民解放军总医院第七医学中心妇产医学部生殖医学科和第六医学中心妇产科2021年12月至2022年11月期间130例进行辅助生殖助孕治疗的POI患者的临床资料。受试者中心随机分组法进行分配隐藏,无盲法。试验组给予屈螺酮炔雌醇预处理,对照组不做处理。比较两组主要观察指标卵泡恢复生长率,次要观察指标预处理前后雌二醇、卵泡刺激素水平、获卵数、获卵人数占比等胚胎实验室相关指标。结果试验组卵泡恢复生长率[50.77%(33/65)]明显高于对照组[15.38%(10/65)],差异有统计学意义(P<0.001,率差=35.38%,95%CI:19.44%~48.98%)。试验组预处理后卵泡刺激素水平[17.70(8.15,27.00)U/L]较预处理前明显下降[30.30(25.95,48.05)U/L,P<0.001],雌二醇水平[24.00(15.00,90.47)ng/L]较预处理前[15.00(15.00,24.00)ng/L,P<0.001]明显升高,差异均具有统计学意义。结论屈螺酮炔雌醇可有效抑制POI患者升高的卵泡刺激素水平,提高雌二醇水平,增加诱导排卵治疗中卵巢恢复卵泡生长发育的概率。

Objective To investigate the effect of drospirenone and ethinylestradiol in the treatment of ovulation induction in patients with premature ovarian insufficiency(POI).Methods A randomized controlled clinical study analyzed the clinical data of 130 POI patients who underwent assisted reproductive treatment at the Department of Reproductive Medicine,Department of Obstetrics and Gynecology,the Seventh Medical Center and Department of Obstetrics and Gynecology,the Sixth Medical Center of Chinese people's Liberation Army General Hospital from December 2021 to November 2022.The subject-centered randomization method was used to conceal the allocation,and there was no blinding.The patients in experimental group was given drospirenone and ethinylestradiol as pretreatment,while control group was not treated.The main observation indicator of the follicle recovery growth rate and the secondary observation indicators of estradiol and follicle-stimulating hormone(FSH)levels before and after pretreatment,the number of eggs retrieved,the proportion of eggs retrieved,and other embryo laboratory-related indicators were compared between the two groups.Results The recovery rate of follicular growth in the experimental group was significantly higher than that in control group,and the difference was statistically significant[50.77%(33/65)vs.15.38%(10/65),P<0.001,rate difference=35.38%,95%CI:19.44%-48.98%].The levels of FSH[17.70(8.15,27.00)U/L]decreased significantly and estradiol[24.00(15.00,90.47)ng/L]increased significantly in the experimental group after preconditioning with spironolone ethinylestradiol compared with those before preconditioning[30.30(25.95,48.05)U/L,P<0.001;15.00(15.00,24.00)ng/L,P<0.001],the differences were statistically significant.Conclusion The spironolone ethinylestradiol can effectively inhibit the level of FSH and increase the level of estradiol in patients with POI,and increase the probability of ovarian growth and development during ovulation induction therapy.