Yin Yan, Zhang Yingchun, Zhang Hua, Jiang Duosheng, Guo Guirong
Department of TCM, Hubei Maternal and Child Care Service Center, Wuhan 430070, China.
Teaching and Research Room of Acupuncture and Moxibustion, Hubei University of CM.
Zhongguo Zhen Jiu. 2018 Jan 12;38(1):27-32. doi: 10.13703/j.0255-2930.2018.01.006.
To evaluate the clinical therapeutic effects and safety on infertility of polycystic ovary syndrome (PCOS) in the patients with ovulation induction with letrozole in the treatment with the formula for regulating menstruation and removing phlegm and electroacupuncture (EA).
A total of 120 patients of PCOS infertility were randomized into 3 groups, 40 cases in each one. In the group A, diane-35 was prescribed for oral administration (one tablet a day since the 5th day of menstruation, continuously for 21 days). After 1 course of treatment (3 months), letrozole was used (one tablet a day since the 5th day of menstruation, continuously for 5 days) for ovulation induction for another 1 course (3 months). In the group B, on the basis of the treatment as the group A, since the 5th day of menstruation, the Chinese herbal formula was combined to regulate menstruation and remove phlegm, one dose a day and discontinued during menstruation. In the group C, on the basis of the treatment as the group B, EA was added since the 5th day of menstruation. The main acupoints were Guanyuan (CV 4), Zusanli (ST 36) and Fenglong (ST 40), etc. EA was applied once every 2 days and discontinued during menstruation. In all of the 3 groups, the treatment for 3 months was as 1 course and the 2 courses were required continuously. Before and after treatment, the menstruation improvements, body weight, body mass index (BMI), serum sex hormones [luteal production hormone (LH), follicle stimulating hormone (FSH), LH/FSH, total testosterone (T) and estradiol (E)] were observed in the patients of each group. The enzyme linked immunosorbent assay was adopted to determine the content of anti-mullerian hormone (AMH) and inhibin B (IHNB). The therapeutic effects, safety, ovulation rate and pregnancy rate were compared among the 3 groups.
(1) The differences were significant statistically in the total effective rate, ovulation rate and pregnancy rate in comparison of the 3 groups (all <0.05). The results in the group C were the best and those in the group B were the better in the comparison of the 3 groups. (2) After treatment, the menstrual cycle was remarkably shortened in the 3 groups (all <0.05). The result in the group C was better than that in the group A (<0.05). After treatment, the body weight in the group B and group C was all reduced (both <0.05). The reducing degree in the group C was better than that in the group A (<0.05). The differences in BMI were not significant statistically before and after treatment in each group as well as in comparison among the groups (all >0.05). (3) After treatment, the levels of LH and LH/FSH were all reduced remarkably in the 3 groups (all <0.05). The differences were not significant statistically in comparison among the three groups (all >0.05). After treatment, in the group B and group C, the levels of T and AMH were all reduced remarkably (all <0.05), in which, T value in the group C was lower than that in the group A and group B, that in the group B was lower than the group A (all <0.05). AMH value in the group C was lower than that in the group A (<0.05). The differences were not significant statistically in FSH, E and IHNB before and after treatment in each group as well as in comparison among the 3 groups (all >0.05). (4) The luteinized unreuptured follicle syndrome (LUFS) did not happen in the group C. There were 3 cases of LUFS (7.5%) in the group B and 5 cases (12.5%) in the group A.
For PCOS infertility patients receiving ovulation induction with letrozole, the combined treatment with the Chinese herbal formula for regulating menstruation and removing phlegm and EA remarkably improves the menstrual cycle, reduces body weight and the levels of LH, LH/FSH, T and AMH, improves ovulation and pregnancy rates. This therapy does not induce adverse reactions and the therapeutic effects are better than the simple application of letrozole or the combined therapy of letrozole and Chinese herbal medicine.
评价来曲唑促排卵联合调经化痰方及电针治疗多囊卵巢综合征（PCOS）不孕患者的临床疗效及安全性。
将120例PCOS不孕患者随机分为3组，每组40例。A组口服达英-35（月经第5天起每日1片，连服21天），治疗1个疗程（3个月）后，于月经第5天起口服来曲唑（每日1片，连服5天）促排卵，再治疗1个疗程（3个月）。B组在A组治疗基础上，月经第5天起加用调经化痰方，每日1剂，经期停服。C组在B组治疗基础上，月经第5天起加用电针，主穴取关元（CV4）、足三里（ST36）、丰隆（ST40）等，每2天治疗1次，经期停针。3组均以3个月为1个疗程，连续治疗2个疗程。观察各组患者治疗前后月经改善情况、体重、体重指数（BMI）、血清性激素[黄体生成素（LH）、卵泡刺激素（FSH）、LH/FSH、总睾酮（T）、雌二醇（E）]，采用酶联免疫吸附法测定抗苗勒管激素（AMH）和抑制素B（IHNB）含量，比较3组的疗效、安全性、排卵率及妊娠率。
（1）3组总有效率、排卵率及妊娠率比较，差异有统计学意义（均P<0.05），C组效果最佳，B组次之。（2）治疗后，3组月经周期均明显缩短（均P<0.05），C组优于A组（P<0.05）。治疗后，B组和C组体重均减轻（均P<0.05），C组减轻程度优于A组（P<0.05）。各组治疗前后BMI比较，差异无统计学意义（均P>0.05），组间比较差异亦无统计学意义（均P>0.05）。（3）治疗后，3组LH及LH/FSH水平均明显降低（均P<0.05），组间比较差异无统计学意义（均P>0.05）。治疗后，B组和C组T及AMH水平均明显降低（均P<0.05），其中C组T值低于A组和B组，B组低于A组（均P<0.05），C组AMH值低于A组（P<0.05）。各组治疗前后FSH、E及IHNB比较，差异无统计学意义（均P>0.05），组间比较差异亦无统计学意义（均P>0.05）。（4）C组未发生黄素化未破裂卵泡综合征（LUFS），B组发生3例（7.5%），A组发生5例（12.5%）。
来曲唑促排卵的PCOS不孕患者，联合调经化痰方及电针治疗可明显改善月经周期，降低体重及LH、LH/FSH、T、AMH水平，提高排卵率及妊娠率，且无不良反应，疗效优于单纯来曲唑或来曲唑联合中药治疗。
