目的 探討輔酶Q₁₀片聯(lián)合雌二醇片/雌二醇地屈孕酮片治療早發(fā)性卵巢功能不全（POI）所致不孕癥的臨床療效及安全性。方法 回顧性選擇北京市房山區(qū)婦幼保健院2019年1月-2021年1月收治的180例POI所致不孕癥患者作為研究對象，根據(jù)治療方法將入選患者分為對照組和試驗(yàn)組，每組各90例。對照組患者口服雌二醇片/雌二醇地屈孕酮片復(fù)合包裝[雌二醇片（磚紅色片）含雌二醇2 mg，雌二醇地屈孕酮片（黃色片）含雌二醇2 mg+地屈孕酮10 mg]治療，每次1片，每天1次，以28 d為1個(gè)療程，前14 d服用磚紅色片，后14 d服用黃色片。試驗(yàn)組在對照組基礎(chǔ)上聯(lián)合輔酶Q₁₀片治療，每次10 mg，每天3次，以28 d為1個(gè)療程。連續(xù)治療3個(gè)療程后評價(jià)兩組療效，比較兩組臨床療效及排卵率、妊娠率，并于療程結(jié)束后隨訪6個(gè)月統(tǒng)計(jì)兩組成功妊娠率。比較治療前后兩組患者血清生殖激素[雌二醇（E₂）、卵泡刺激素（FSH）、促黃體生成素（LH）]水平及卵巢儲備功能相關(guān)指標(biāo)[血清抗繆勒管激素（AMH）水平、基礎(chǔ)竇狀卵泡數(shù)（AFC）]。同時(shí)統(tǒng)計(jì)兩組不良反應(yīng)發(fā)生情況。結(jié)果 試驗(yàn)組總有效率為95.56%，與對照組的85.56%相比顯著升高（P<0.05）。治療期間，試驗(yàn)組排卵率、妊娠率分別為87.78%、24.44%，均顯著高于對照組（68.89%、7.78%，P<0.05）。隨訪6個(gè)月內(nèi)，試驗(yàn)組成功妊娠率16.98%顯著高于對照組的3.39%（P<0.05）。治療后兩組患者血清E₂水平均較本組治療前顯著升高（P<0.05），血清FSH、LH水平均較本組治療前顯著降低（P<0.05）；且治療后，試驗(yàn)組比對照組對血清E₂水平的提高作用及對血清FSH、LH水平的降低作用更顯著（P<0.05）。兩組治療后血清AMH水平和AFC均較本組治療前顯著增加（P<0.05）；治療后，試驗(yàn)組血清AMH水平顯著高于同期對照組（P<0.05），AFC顯著多于同期對照組（P<0.05）。兩組治療前后血清丙氨酸氨基轉(zhuǎn)移酶（ALT）、天冬氨酸氨基轉(zhuǎn)移酶（AST）、肌酐（Cr）水平組內(nèi)和組間比較差異均無統(tǒng)計(jì)學(xué)意義（P>0.05）。所有患者均未出現(xiàn)明顯藥物相關(guān)不良反應(yīng)。結(jié)論 輔酶Q₁₀片聯(lián)合雌二醇片/雌二醇地屈孕酮片能有效改善POI所致不孕癥患者體內(nèi)生殖激素水平與卵巢儲備功能，提高妊娠率，且安全性較高。

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

北京市醫(yī)院管理中心臨床醫(yī)學(xué)發(fā)展專項(xiàng)經(jīng)費(fèi)資助（ZYLX202119）