摘要
目的探讨坤泰胶囊治疗卵巢储备功能低下不孕症患者的临床疗效和安全性。方法将卵巢储备功能低下不孕症患者68例随机分为治疗组33例及对照组35例。治疗组给予坤泰胶囊口服,每日3次,每次2.0 g;对照组给予脱氢表雄酮口服,每日3次,每次25 mg。两组疗程均为3个月经周期。治疗期间观察患者的用药情况、不良反应、妊娠情况。治疗结束后随访4个体外受精-胚胎移植周期。比较两组患者治疗前后血清基础卵泡刺激素(FSH)、基础雌二醇(E2)、促黄体生成素(LH)、卵泡期抗苗勒激素(AMH)水平、基础窦卵泡数(AFC),随访期间的体外受精-胚胎移植临床妊娠率及周期临床妊娠率。结果两组患者治疗前后比较,FSH、E2、LH及AFC差异均无统计学意义(P>0.05)。治疗组5例未行体外受精-胚胎移植,治疗组临床妊娠5例,对照组9例。第1周期治疗组临床妊娠3例(17例移植患者,下同),对照组1例(21例);第2周期治疗组临床妊娠1例(9例),对照组2例(20例);第3周期治疗组临床妊娠1例(2例),对照组4例(6例);第4周期治疗组无移植患者,对照组临床妊娠2例(2例)。研究过程对照组部分患者出现面部痤疮,治疗组未发现不良事件。结论坤泰胶囊对卵巢储备功能低下不孕症患者的卵巢储备功能的改善效果及临床妊娠率与脱氢表雄酮相当,且安全性好。
Objective To explore the clinical effect and safety of Kuntai Jiaonang（坤泰胶囊） in treating patients with hypofunction of ovarian reserve infertility. Methods Sixty-eight patients with hypofunction of ovarian reserve infertility were randomized into a treatment group（ 33 cases） and a control group（ 35 cases）. The treatment group was given oral Kuntai Jiaonang,2. 0 g each time,3 times each day. The control group was given oral dehydroepiandrosterone,25 mg each time,3 times each day. The course in both groups was 3 menstrual cycles. During treatment,patients＇ medication,side effect and pregnancy were examined. At the end of treatment,follow-up was carried out for 4 cycles of in vitro fertilization and embryo transfer. Patients＇ serum levels of basal follicle stimulate hormone（ FSH）,basal estradiol（ E2）,luteinizing hormone（ LH） and follicular stage anti-Mullerian hormone（ AMH）,as well as basal antral follicle number（ AFC）,clinical pregnancy rate of in vitro fertilization and embryo transfer during follow-up and periodic clinical pregnancy rate were compared between two groups before and after treatment.Results Compared between patients in two groups before and after treatment,there were no significant differences in levels of FSH,E2,LH and AFC（ P 0. 05）. In the treatment group,5 patients did not go through in vitro fertilization and embryo transfer. The clinical pregnancy was 5 cases in the treatment group,and 9 cases in the control group.In the first cycle,the clinical pregnancy was 3 of 17 cases in the treatment group,and 1 of 21 cases in the control group. In the second cycle,the clinical pregnancy was 1 of 9 cases in the treatment group,and 2 of 20 cases in the control group. In the third cycle,one of two patients in the treatment group,and 4 of 6 patients in the control group were pregnant. In the forth cycle,there was no transfer patient in the treatment group,and the pregnancy in the control group was 2 of 2 cases. During the research,some patients in the control group had facial acne. No side effect was found in the treatment group. Conclusion The improvement of ovarian reserve function and clinical pregnancy rate in patients with hypofunction of ovarian reserve infertility by Kuntai Jiaonang was equivalent to that by dehydroepiandrosterone. Moreover,Kuntai Jiaonang seems to be safe.
出处
《中医杂志》
CSCD
北大核心
2018年第2期132-136,共5页
Journal of Traditional Chinese Medicine
关键词
卵巢储备功能低下
不孕症
妊娠结局
坤泰胶囊
脱氢表雄酮
hypofunction of ovarian reserve
infertility
pregnancy outcome
Kuntai Jiaonang
dehydroepiandrosterone
