资癸女贞胶囊对卵巢储备功能减退女性妊娠结局的影响

Effect of Zi Gui Nv Zhen Capsules on pregnancy outcome in women with diminished ovarian reserve

目的评价资癸女贞胶囊对女性卵巢储备功能减退(diminished ovarian reserve,DOR)的疗效及其对DOR女性妊娠率和活产率的影响,为伴有DOR女性的治疗及妊娠提供新思路。方法本研究为前瞻性随机试验,在组间基线资料均衡可比的原则上,将60例患者采用数字表法随机分为观察组(n=30)和对照组(n=30)。观察组采用口服资癸女贞胶囊(每次3粒,每天3次),对照组无药物治疗。3个月后观察早卵泡期窦卵泡数(antral follicle count,AFC)、排卵日子宫内膜厚度(endometrium thickness,EMT)、卵泡期抗苗勒管激素(anti-Müllerian hormone,AMH)、妊娠率和活产率。结果基线时观察组和对照组的年龄、身高、体质量及体质量指数(body mass index,BMI)等指标差异均无统计学意义(P>0.05);3个月后,观察组的卵泡期AMH浓度、排卵日EMT以及早卵泡期AFC均显著高于对照组(P<0.05)。跟踪随访3年后,观察组的妊娠率、活产率也显著高于对照组(P<0.05)。结论口服资癸女贞胶囊通过提高卵巢储备及女性血清AMH浓度,增加早卵泡期AFC以及EMT,有效改善女性卵巢储备功能,提高患者的妊娠率和活产率。

Objective To evaluate the effect of Zi Gui Nv Zhen Capsules(ZGNZC)on pregnancy rate and live birth rate in women with diminished ovarian reserve(DOR),and to provide a new method for clinical treatment of DOR.Methods This study is a prospective randomized trial,60 DOR patients(aged 20–40 years)were randomly divided into an experimental group(n=30)and a control group(n=30)with a random number table method.The experimental group received oral administration of ZGNZC(3 capsules,tid),while the control group received no medication treatment.Three months later,the data of antral follicle count(AFC)during early follicular phase,thickness of the endometrium(EMT)during ovulation day,anti-Müllerian hormone(AMH)level in the follicular phase,pregnancy rate and live birth rate were collected.Results At baseline,there was no significantly statistical difference in age,height,weight,and body mass index(BMI)between experimental group and control group(P>0.05).After three months of treatment with ZGNZC,the AMH level in the follicular phase,the EMT in ovulation day,and the AFC during early follicaler phase in the experimental group were significantly higher than those in the control group(P<0.05).After 3 years of follow-up,the pregnancy rate and the live birth rate of the experimental group were also significantly higher than those of the control group(P<0.05).Conclusions Oral administration of ZGNZC can increase the number of antral follicles,promote endometrial thickness by increasing serum AMH levels in women with DOR,improve ovarian reserve function,raise pregnancy rate and live birth rate of patients.