中国临床药学杂志

目的探讨坤泰胶囊联合人工周期治疗早发性卵巢功能不全(POI)的临床疗效及对性激素、相关免疫抗体水平的影响。方法选择本院妇科门诊2019年6月至2020年8月收治的POI患者86例,按照随机数字表法分为观察组和对照组,每组43例。对照组应用人工周期治疗,观察组在人工周期治疗基础上予坤泰胶囊治疗。2组均治疗6个月经周期。比较2组治疗前后临床症状评分(中医证候评分和Kupperman评分),卵巢功能相关指标[卵巢平均容积(OVA)、窦卵泡数(AFC)和平均卵巢最大径(MOD)],卵巢血流动力学指标[收缩期峰值流速(PSV)、阻力指数(RI)和搏动指数(PI)],血清性激素[雌二醇(E2)、黄体生成素(LH)、卵泡刺激素(FSH)和抗米勒管激素(AMH)]和相关免疫抗体[抗核抗体(ANA)、抗心磷脂抗体(ACA)和抗卵巢抗体(AOA)]水平。结果治疗后观察组中医证候评分和Kupperman评分均低于对照组(P <0.01),OVA、MOD大于对照组(P <0.01),AFC多于对照组(P <0.01),卵巢动脉PSV高于对照组(P <0.01),RI和PI均低于对照组(P <0.01),血清E₂、AMH水平高于对照组(P <0.01),LH、FSH、ANA和AOA水平低于对照组(P <0.01)。结论坤泰胶囊联合人工周期治疗更有利于缓解POI患者临床症状,调节性激素分泌,改善卵巢微循环和卵巢功能,其机制可能与调节机体免疫紊乱有关。

AIM To investigate the effect of Kuntai capsule combined with artificial cycle in the treatment of premature ovarian insufficiency(POI) and its influence on sex hormones and related immune antibody levels. METHODS A total of 86 patients with POI addimitted to our hospital from June 2019 to August 2020 were selected and divided into observation group and control group according to random number table method, with 43 patients in each group. The control group were treated with artificial cycle, and the observation group were treated with Kuntai capsule on the basis of the control group. Both groups were treated for 6 menstrual cycles. Clinical symptom score(TCM syndrome score and Kupperman score) were compared between 2 groups before and after treatment, and the levels of ovarian function related indexes, ovarian hemodynamic indexes, serum sex hormones and related immune antibodies were compared between 2 groups. RESULTS After treatment, TCM syndrome score and Kupperman score of the observation group were significantly lower than those in the control group(P < 0.01), the ovarian average volume(OVA) and the mean diameter(MOD) were significantly higher than those in the control group(P < 0.01), the number of antral follicles(AFC) was more than that of control group(P < 0.01). The peak systolic velocity(PSV) of ovarian artery of the observation group was higher than that of the control group(P < 0.01), and the resistance index(RI) and pulsatility index(PI) of the observation group were lower than those of the control group(P < 0.01). The levels of E₂ and AMH were higher of the observation group than those of the control group(P < 0.01), while the levels of luteinizing hormone(LH), follicle stimulating hormone(FSH), antinuclear antibody(ANA) and anti ovarian antibody(AOA) in the observation group were lower than those in the control group(P < 0.01). CONCLUSION Kuntai capsule combined with artificial cycle is more beneficial to relieve the clinical symptoms of patients with POI, regulate the secretion of sex hormones, improve ovarian microcirculation and ovarian function, and the mechanism may be related to the regulation of immune disorders.