通元针法联合补肾活血膏方治疗肾虚血瘀型多囊卵巢综合征所致不孕症的疗效观察及机制探讨

Investigation on Therapeutic Effect and Mechanism of Tongyuan Acupuncture Combined with Bushen Huoxue Soft Extract in Treating Infertility Induced by Polycystic Ovary Syndrome of Kidney Deficiency and Blood Stasis Type

【目的】观察在促排卵基础上应用通元针法联合补肾活血膏方治疗肾虚血瘀型多囊卵巢综合征(PCOS)所致不孕症患者的临床疗效,探索提高患者妊娠成功率的方法及可能的疗效机制。【方法】将120例肾虚血瘀型PCOS所致不孕症患者随机分为西药组、膏方组、针灸组和联合组4组,每组各30例。所有患者均给予来曲唑片促排卵治疗,在此基础上,西药组不加用其他干预措施,膏方组给予补肾活血膏方治疗,针灸组给予通元针法治疗,联合组给予通元针法联合补肾活血膏方治疗,共治疗6个月经周期。观察各组患者治疗前后中医证候积分及血清抗缪勒氏管激素(AMH)、促卵泡刺激素(FSH)、促黄体生成素(LH)、雌二醇(E2)、泌乳素(PRL)和睾酮(T)水平的变化情况,观察各组患者的卵泡发育情况、子宫内膜厚度及子宫内膜类型,计算排卵率和妊娠率,评价各组患者的中医证候疗效、临床综合疗效和安全性。【结果】(1)中医证候疗效方面,联合组的总有效率为83.33%(25/30),西药组为43.33%(13/30),膏方组为66.67%(20/30),针灸组为50.00%(15/30),组间比较,联合组的中医证候疗效明显优于其他3组(P<0.01)。(2)临床综合疗效方面,联合组的总有效率为83.33%(25/30),西药组为46.67%(14/30),膏方组为60.00%(18/30),针灸组为70.00%(21/30),组间比较,联合组的临床综合疗效明显优于其他3组(P<0.05)。(3)中医证候积分方面,治疗后,各组患者的中医证候积分均较治疗前明显下降(P<0.01),且联合组的下降幅度明显优于其他3组(P<0.05)。(4)性激素方面,治疗后,各组患者的血清AMH、LH、T水平均较治疗前明显下降(P<0.05或P<0.01),而血清FSH、E2、PRL水平均较治疗前无明显下降(P>0.05);治疗后组间比较,联合组对血清AMH、LH、T水平的下降幅度均明显优于其他3组(P<0.05)。(5)卵泡发育方面,联合组对卵泡发育情况包括优势成熟卵泡数量、排卵期最大卵泡直径、卵泡期天数的改善作用均明显优于其他3组(P<0.05)。(6)排卵期子宫内膜厚度及子宫内膜类型方面,联合组的子宫内膜明显厚于其他3组(P<0.05),A型子宫内膜所占比例明显高于其他3组(P<0.05)。(7)排卵率和妊娠率方面,联合组的排卵率和妊娠率均明显高于其他3组,差异均有统计学意义(P<0.05)。(8)安全性方面,研究过程中,各组患者均无明显不良反应发生,且患者的血常规、肝功能、肾功能等安全性指标均无明显异常变化。【结论】在促排卵基础上应用通元针法联合补肾活血膏方治疗肾虚血瘀型PCOS所致不孕症患者具有明显优势,可有效调节患者的性激素水平,改善患者的卵巢功能,提高患者的妊娠成功率,可为中西医结合治疗PCOS所致不孕症开辟新的途径。

Objective To observe the clinical efficacy of Tongyuan acupuncture(an acupuncture therapy for dredging the Governor Vessel to regulate mind and conducting qi back to its source)combined with Bushen Huoxue Soft Extract based on ovulation induction in treating patients with infertility induced by polycystic ovary syndrome(PCOS)of kidney deficiency and blood stasis type,and to explore the approach to improve the successful rate of pregnancy as well as the possible therapeutic mechanism.Methods A total of 120 patients with infertility induced by PCOS of kidney deficiency and blood stasis type were randomly divided into four groups,namely western medicine group,soft extract group,acupuncture group and combined group,with 30 patients in each group.All patients were given Letrozol Tablets to induce ovulation.Moreover,western medicine group had no other interventions,soft extract group was treated with Bushen Huoxue Soft Extract orally,acupuncture group was treated with Tongyuan acupuncture therapy,and the combined group was treated with Tongyuan acupuncture therapy combined with oral use of Bushen Huoxue Soft Extract.The treatment for all of the patients covered 6 menstrual cycles.Before and after the treatment,the 4 groups were observed in the changes of traditional Chinese medicine(TCM)syndrome scores and serum levels of anti-Mullerian hormone(AMH),follicle stimulating hormone(FSH),luteinizing hormone(LH),estradiol(E2),prolactin(PRL),and testosterone(T).The follicular development,endometrial thickness,and endometrial types of the patients in each group were observed,and the ovulation rate and pregnancy rate were calculated.After treatment,the TCM syndrome efficacy,clinical comprehensive efficacy and safety of each group were evaluated.Results(1)The total effective rate for TCM syndrome efficacy was 83.33%(25/30)in the combined group,43.33%(13/30)in the western medicine group,66.67%(20/30)in the soft extract group,and 50.00%(15/30)in the acupuncture group,and the intergroup comparison showed that the TCM syndrome efficacy in the combined group was significantly superior to that in the other 3 groups(P<0.01).(2)The total effective rate for clinical comprehensive efficacy was 83.33%(25/30)in the combined group,46.67%(14/30)in the western medicine group,60.00%(18/30)in the soft extract group,and 70.00%(21/30)in the acupuncture group,and the intergroup comparison showed that the clinical comprehensive efficacy in the combined group was significantly superior to that in the other 3 groups(P<0.05).(3)After treatment,the TCM syndrome scores in all groups were significantly decreased compared with those before treatment(P<0.01),and the decrease in the combined group was significantly superior to that in the other 3 groups(P<0.05).(4)After treatment,the serum levels of sex hormones of AMH,LH,and T in each group were decreased significantly compared with those before treatment(P<0.05 or P<0.01),while no obvious decrease was presented in the serum FSH,E2,and PRL levels of each group(P>0.05).The post-treatment intergroup comparison showed that the decrease of serum AMH,LH,and T levels in the combined group was significantly superior to that in the other 3 groups(P<0.05).(5)The combined group was significantly superior to the other 3 groups in improving follicular development indicators of the number of dominant mature follicles,the diameter of the largest follicle at ovulation,and the days of follicular phase(P<0.05).(6)The observation of endometrial thickness and endometrial type during ovulation showed that the endometrium of the combined group was significantly thicker(P<0.05)and the proportion of endometrium type A was significantly higher than those of the other 3 groups(P<0.05).(7)The ovulation rate and pregnancy rate of the combined group were significantly higher than those of the other 3 groups,and the differences were statistically significant(P<0.05).(8)During the trial,no significant adverse reactions occurred in any patients,or there were no obvious abnormal changes in the patients’safety indicators of blood routine test,liver function and renal function.Conclusion The application of Tongyuan acupuncture therapy combined with Bushen Huoxue Soft Extract based on ovulation induction has obvious advantages in the treatment of patients with PCOS-induced infertility of kidney deficiency and blood stasis type.The combined therapy is effective on regulating the sex hormone level,improving the ovarian function,and enhancing the successful rate of pregnancy,which will supply a new way for the treatment of infertility induced by PCOS with the integrated Chinese and western medicine therapy.