目的 探讨辅酶Q₁₀片联合雌二醇片/雌二醇地屈孕酮片治疗早发性卵巢功能不全（POI）所致不孕症的临床疗效及安全性。方法 回顾性选择北京市房山区妇幼保健院2019年1月-2021年1月收治的180例POI所致不孕症患者作为研究对象，根据治疗方法将入选患者分为对照组和试验组，每组各90例。对照组患者口服雌二醇片/雌二醇地屈孕酮片复合包装[雌二醇片（砖红色片）含雌二醇2 mg，雌二醇地屈孕酮片（黄色片）含雌二醇2 mg+地屈孕酮10 mg]治疗，每次1片，每天1次，以28 d为1个疗程，前14 d服用砖红色片，后14 d服用黄色片。试验组在对照组基础上联合辅酶Q₁₀片治疗，每次10 mg，每天3次，以28 d为1个疗程。连续治疗3个疗程后评价两组疗效，比较两组临床疗效及排卵率、妊娠率，并于疗程结束后随访6个月统计两组成功妊娠率。比较治疗前后两组患者血清生殖激素[雌二醇（E₂）、卵泡刺激素（FSH）、促黄体生成素（LH）]水平及卵巢储备功能相关指标[血清抗缪勒管激素（AMH）水平、基础窦状卵泡数（AFC）]。同时统计两组不良反应发生情况。结果 试验组总有效率为95.56%，与对照组的85.56%相比显著升高（P<0.05）。治疗期间，试验组排卵率、妊娠率分别为87.78%、24.44%，均显著高于对照组（68.89%、7.78%，P<0.05）。随访6个月内，试验组成功妊娠率16.98%显著高于对照组的3.39%（P<0.05）。治疗后两组患者血清E₂水平均较本组治疗前显著升高（P<0.05），血清FSH、LH水平均较本组治疗前显著降低（P<0.05）；且治疗后，试验组比对照组对血清E₂水平的提高作用及对血清FSH、LH水平的降低作用更显著（P<0.05）。两组治疗后血清AMH水平和AFC均较本组治疗前显著增加（P<0.05）；治疗后，试验组血清AMH水平显著高于同期对照组（P<0.05），AFC显著多于同期对照组（P<0.05）。两组治疗前后血清丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）、肌酐（Cr）水平组内和组间比较差异均无统计学意义（P>0.05）。所有患者均未出现明显药物相关不良反应。结论 辅酶Q₁₀片联合雌二醇片/雌二醇地屈孕酮片能有效改善POI所致不孕症患者体内生殖激素水平与卵巢储备功能，提高妊娠率，且安全性较高。

Objective To investigate the clinical efficacy and safety of Coenzyme Q₁₀ Tablets combined with Estradiol Tablets/Estradiol Didroxyprogesterone Tablets in the treatment of infertility caused by early-onset ovarian insufficiency (POI). Methods A total of 180 patients with infertility caused by POI treated in Beijing Fangshan District Maternal and Child Health Care Hospital from January 2019 to January 2021 were selected as the research object. They were randomly divided into control group and experimental group, with 90 cases in each group. The patients in the control group were treated with oral Estradiol Tablets/Estradiol Didroxyprogesterone Tablets in composite packaging (Estradiol Tablets (brick red tablets) containing estradiol 2 mg, Estradiol Didroxyprogesterone Tablets (yellow tablets) containing estradiol 2 mg + didroxyprogesterone 10 mg), one tablet each time, once a day, taking 28 days as a treatment course, brick red tablets for the first 14 days and yellow tablets for the second 14 days. The experimental group was treated with Coenzyme Q₁₀ Tablets on the basis of the control group, 10 mg each time, three times a day, with 28 days as a course of treatment. After three consecutive courses of treatment, the curative effects of the two groups were evaluated, and the clinical curative effects, ovulation rate and pregnancy rate of the two groups were compared. After the course of treatment, the successful pregnancy rate of the two groups was followed up for six months. The levels of serum reproductive hormones[estradiol (E₂), follicle stimulating hormone (FSH), luteinizing hormone (LH)] and the related indexes of ovarian reserve function[serum anti-Mullerian hormone (AMH) level, basal sinus follicle number (AFC)] were compared between the two groups before and after treatment. At the same time, the adverse reactions of the two groups were counted. Results The total effective rate of the experimental group was 95.56%, which was significantly higher than 85.56% of the control group (P < 0.05). During the treatment period, the ovulation rate and pregnancy rate of the experimental group were 87.78% and 24.44% respectively, which were significantly higher than those of the control group (68.89% and 7.78%, P < 0.05). Within six months of follow-up, the successful pregnancy rate of the experimental group was 16.98%, which was significantly higher than that of the control group (3.39%, P < 0.05). After treatment, the serum E₂ level of the two groups was significantly higher than that before treatment (P < 0.05). The level of LH was significantly lower than that before treatment (P < 0.05). After treatment, the experimental group had more significant effects on the increase of serum E 2 level and the decrease of serum FSH and LH level than the control group (P < 0.05). The levels of serum AMH and AFC in the two groups after treatment were significantly higher than those before treatment (P < 0.05). The serum level AMH and AFC in the treatment group was significantly higher than that in the control group (P < 0.05). There was no significant difference in the levels of serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine (Cr) between the two groups before and after treatment (P > 0.05). All subjects had no obvious drug-related adverse reactions. Conclusion Coenzyme Q₁₀ Tablets combined with Estradiol Tablets/Estradiol Didroxyprogesterone Tablets can effectively improve the level of reproductive hormone and ovarian reserve function in patients with infertility caused by POI, improve the pregnancy rate, and have high safety.

R984

北京市医院管理中心临床医学发展专项经费资助（ZYLX202119）