Gao Hui, Xia Tian, Ma Ruihong, Zhao ZhimeiDepartment Of Reproductive Center, Wang Baojuan, Song Xueru, Liu Lijing, Han Kaimei, Wang Guoqing, Fu Yu, Hao Guimin
Department of Traditional Chinese Medicine, Affiliated Hospital of Chengde Medical College, Chengde 067000, China.
Department of Reproductive Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.
J Tradit Chin Med. 2017 Aug;37(4):530-537.
To evaluate the clinical efficacy and safety of Heyan Kuntai capsule (HYKT) in treating women with infertility caused by diminished ovarian reserve (DOR).
One hundred eight eligible patients from three Chinese hospitals were randomly divided into an HYKT treatment group (n = 55) or a dehydroepiandrosterone (DHEA) treatment group (n = 53). Patients in the HYKT group were treated orally with four 0.5 g HYKT three times a day; patients in the DHEA group were treated with one 25.0 mg DHEA capsule three times a day. All patients were treated for 3 months and followed up over a 3-month period.
Of 108 patients, 12 dropped out: six from the HYKT group, and six from the DHEA group. Eleven patients got pregnant during the treatment. Serum anti-Müllerian hormone levels and antral follicle counts increased significantly in both groups after treatment (P < 0.05) especially in the HYKT group (P < 0.05). Serum follicle stimulating hormone (FSH) levels and FSH/luteinizing hormone ratios decreased (P < 0.05) with no significant difference between the two groups. Estradiol levels in the HYKT group and DHEA-sulfate levels in the DHEA group both increased (P < 0.05). The spontaneous pregnancy rates were 12% and 11% in the HYKT and DHEA groups, respectively (not significant). During the follow-up period, 16 patients in the HYKT group underwent in vitro fertilization-embryo transfer (IVF-ET) and the number of retrieved oocytes was (5.1 c1.8). In DHEA group, 20 patients underwent IVF-ET and the number of retrieved oocyte was (4.2 ± 1.9) (not significant); clinical pregnancy rates were 38% in the HYKT group and 20% in DHEA group (not significant). No significant adverse reactions were observed.
HYKT can improve the ovarian reserve and hormone levels in patients with infertility caused by DOR. Pregnancy rates after HYKT treatment were similar to those of DHEA treatment. HYKT might be an alternative to the treatment of infertility caused by DOR.
评估和颜坤泰胶囊（HYKT）治疗卵巢储备功能减退（DOR）所致女性不孕症的临床疗效及安全性。
来自三家中国医院的108例符合条件的患者被随机分为HYKT治疗组（n = 55）或脱氢表雄酮（DHEA）治疗组（n = 53）。HYKT组患者口服0.5 g HYKT，每日3次，每次4粒；DHEA组患者口服25.0 mg DHEA胶囊，每日3次，每次1粒。所有患者均接受3个月治疗，并随访3个月。
108例患者中，12例退出：HYKT组6例，DHEA组6例。治疗期间11例患者怀孕。两组治疗后血清抗苗勒管激素水平和窦卵泡计数均显著升高（P < 0.05），尤其是HYKT组（P < 0.05）。血清促卵泡生成素（FSH）水平及FSH/黄体生成素比值降低（P < 0.05），两组间差异无统计学意义。HYKT组雌二醇水平及DHEA组硫酸脱氢表雄酮水平均升高（P < 0.05）。HYKT组和DHEA组的自然妊娠率分别为12%和11%（无统计学意义）。随访期间，HYKT组16例患者接受体外受精-胚胎移植（IVF-ET），获卵数为（5.1 ± 1.8）枚。DHEA组20例患者接受IVF-ET，获卵数为（4.2 ± 1.9）枚（无统计学意义）；HYKT组临床妊娠率为38%，DHEA组为20%（无统计学意义）。未观察到明显不良反应。
HYKT可改善DOR所致不孕症患者的卵巢储备功能及激素水平。HYKT治疗后的妊娠率与DHEA治疗相似。HYKT可能是治疗DOR所致不孕症的一种替代方法。
