健脾补肾法联合克罗米芬改善多囊卵巢综合征不孕症患者妊娠率的临床观察

Clinical observation on therapy of strengthening spleen and tonifying kidney combined with clomiphene in improving the pregnancy rate of infertile patients with polycystic ovary syndrome

目的:观察健脾补肾法联合克罗米芬治疗多囊卵巢综合征(PCOS)不孕症患者的临床疗效。方法:纳入63例脾肾气虚型PCOS不孕症患者,随机分为对照组31例和治疗组32例。对照组患者给予克罗米芬口服治疗,治疗组患者在对照组治疗基础上配合补肾健脾方口服治疗。两组均以3个月经周期为1个疗程,共治疗2个疗程。评价两组患者的中医证候疗效、月经周期改善疗效,比较两组患者的中医证候积分,检测两组患者的血清黄体生成素(LH)、睾酮(T)、硫酸脱氢表雄酮(DHEAS)、抗缪勒管激素(AMH)及肿瘤坏死因子-α(TNF-α)水平。2个疗程后停药,随访3个月。记录治疗及随访期间每组的总妊娠人数,计算妊娠率。结果:①治疗后,两组患者的中医证候积分均显著降低(P<0.05),且治疗组患者的积分低于对照组(P<0.05)。治疗后,治疗组的中医证候疗效总有效率为90.63%,对照组为61.29%,组间比较差异具有统计学意义(P<0.05),治疗组的疗效优于对照组。②治疗后,治疗组的月经周期改善总有效率为65.63%,对照组为38.71%,治疗组的疗效优于对照组(P<0.05)。③治疗后,两组患者的AMH、TNF-α水平较治疗前均降低(P<0.05),治疗组患者的T、DHEAS、LH水平较治疗前亦降低(P<0.05),且治疗组患者的AMH、T、DHEAS及TNF-α水平明显低于对照组(P<0.05)。④治疗及随访期间,治疗组的妊娠率为46.88%,对照组为19.35%,治疗组的妊娠率明显高于对照组(P<0.05)。结论:与单纯应用克罗米芬相比,健脾补肾法联合克罗米芬治疗PCOS不孕症患者,能更有效地改善患者的临床症状与月经周期,提高妊娠率,其作用机制可能与降低体内性激素和TNF-α水平相关。

Objective:To observe the clinical efficacy of therapy of strengthening spleen and tonifying kidney combined with clomiphene in the treatment of infertile patients with polycystic ovary syndrome(PCOS).Methods:Sixty-three infertile patients of PCOS with syndrome of qi-deficiency of spleen and kidney were included and randomly divided into the control group(31 cases)and treatment group(32 cases).The patients in the control group were orally treated with clomiphene,and the patients in the treatment group were orally treated with prescription of strengthening spleen and tonifying kidney combined with clomiphene.Three menstrual cycles were taken as one treatment course,and a total of two treatment courses were performed.The efficacy of Chinese medical syndrome and the efficacy of menstrual cycle improvement were evaluated in the two groups,the scores of Chinese medical syndrome were compared between the two groups,and the serum levels of luteinizing hormone(LH),testosterone(T),dehydroepiandrosterone sulfate(DHEAS),anti-mullerian hormone(AMH)and tumor necrosis factor-α(TNF-α)were detected.After two treatment courses,drug withdrawal was done.The patients were followed-up for 3 months.During the treatment and follow-up course,the total number of pregnancy in each group was recorded,and the pregnancy rate was calculated.Results:(1)After treatment,the scores of Chinese medical syndrome in both groups were significantly decreased(P<0.05),and the score of the treatment group was lower than that of the control group(P<0.05).After treatment,the total effective rates of Chinese medical syndrome were 90.63%in the treatment group and 61.29%in the control group respectively,with statistically significant difference between the two groups(P<0.05),and the efficacy of the treatment group was better than that of the control group.(2)After treatment,the total effective rates of menstrual cycle improvement were 65.63%in the treatment group and 38.71%in the control group respectively,and the efficacy of the treatment group was better than that of the control group(P<0.05).(3)After treatment,the levels of AMH and TNF-αwere decreased in both groups compared with before treatment(P<0.05),the levels of T,DHEAS and LH in the treatment group were also decreased compared with before treatment(P<0.05),and the levels of AMH,T,DHEAS and TNF-αin the treatment group were significantly lower than those in the control group(P<0.05).(4)During the treatment and follow-up course,the pregnancy rates of the treatment group and control group were 46.88%and 19.35%respectively,and the pregnancy rate of the treatment group was significantly higher than that of the control group(P<0.05).Conclusion:Compared with clomiphene alone,therapy of strengthening spleen and tonifying kidney combined with clomiphene can more effectively improve the clinical symptoms and menstrual cycle in infertile patients with PCOS,and enhance the pregnancy rate.Its mechanisms may be related to reducing the levels of sexual hormone and TNF-α.