加味知柏地黄丸汤治疗多囊卵巢综合征高雄激素血症的量效分析

Dose-effect analysis of treatment by modified Zhibaidihuang decoction on polycystic ovary syndrome hyperandrogenism.

作者信息

Zhao Yiming, Zheng Dongxue, Cheng Ran, Xu Xin, Liu Xinmin, Lian Fengmei, Tong Xiaolin

机构信息

Trainee Team of Traditional Chinese Medicine, the Second Military Medical University, Shanghai 200433, China.

Department of genecology, Guang'an men Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.

出版信息

J Tradit Chin Med. 2018 Apr;38(2):280-286.

PMID:32186067

Abstract

OBJECTIVE

To observe the efficacy and safety of different dosages of modified Zhibaidihuang decoction (MZBDD) on polycystic ovary syndrome (PCOS) hyperandrogenism (HA) patients.

METHODS

Ninety PCOS HA patients and 30 infertile patients due to tubal factor were selected. Ninety PCOS HA patients were randomly divided into three groups: low dosage group (LDG), medium dosage group (MDG) and high dosage group (HDG) and infertile patients were selected as normal control group (NCG). PCOS HA patients were treated with different dosage of MZBDD for 4 weeks. For HA patients, serum total testosterone (T), estrodial (E2), follicle stimulating hormone (FSH), luteinizing hormone (LH), prolatin (PRL), alanine aminotransferase (AST), aspartate amino transferase (AST) were determined before and after treatment, while acne scores (Rosenfield) were signed. Basal body temperatures (BBT) were asked to be measured every day. And for the else, T, E2, FSH, LH, PRL, AST, and AST were determined before treatment.

RESULTS

Totally 111 patients completed the clinical research. There were no differences among the four groups on serum T before treatment (P = 0.221). Serum T concentration of both MDG and HDG after treatment significantly were lower than that of before treatment (P = 0.039, P = 0.000), while there was no obvious difference in LDG (P = 0.829). Serum T concentration of both MDG and HDG were significantly lower than that of LDG after treatment (P = 0.048, P = 0.006). To compared with before treatment, there were no differences in Serum FSH, LH, E2, P and PRL among the three groups (LDG, MDG, HDG) (as for FSH, P = 0.136, P = 0.503, P = 0.062; as for LH, P = 0.473, P = 0.513, P = 0.096; as for E2, P = 0.206, P = 0.927, P = 0.076; as for PRL, P = 0.120, P = 0.903, P = 0.407, as for P, P = 0.308, P = 0.866, P = 0480). Acne scores of all the three groups were obviously lower than that of before treatment (P = 0.031; P = 0.033; P = 0.002). 39.5% of the patients had biphasic BBT, but there were no differences among the three groups (P = 0.510). There were no differences with ALT and AST between after and before treatment among the three groups (LDG, MDG, HDG) (as for ALT, P = 0.742, P = 0.383, P = 0.053; as for AST, P = 0.732, P = 0.519, P = 0.120).

CONCLUSION

Different dosage of MZBDD has dose-effect relationship in treating PCOS HA.

摘要

目的

观察不同剂量的加味知柏地黄丸（MZBDD）对多囊卵巢综合征（PCOS）高雄激素血症（HA）患者的疗效及安全性。

方法

选取90例PCOS HA患者和30例输卵管因素所致不孕症患者。将90例PCOS HA患者随机分为三组：低剂量组（LDG）、中剂量组（MDG）和高剂量组（HDG），选取不孕症患者作为正常对照组（NCG）。PCOS HA患者用不同剂量的MZBDD治疗4周。对于HA患者，治疗前后测定血清总睾酮（T）、雌二醇（E2）、卵泡刺激素（FSH）、黄体生成素（LH）、泌乳素（PRL）、谷丙转氨酶（AST）、谷草转氨酶（AST），同时记录痤疮评分（罗森菲尔德评分）。要求每天测量基础体温（BBT）。对于其他患者，治疗前测定T、E2、FSH、LH、PRL、AST和AST。

结果

共111例患者完成临床研究。治疗前四组患者血清T水平无差异（P = 0.221）。MDG和HDG治疗后血清T浓度均显著低于治疗前（P = 0.039，P = 0.000），而LDG无明显差异（P = 0.829）。治疗后MDG和HDG血清T浓度均显著低于LDG（P = 0.048，P = 0.006）。与治疗前相比，三组（LDG、MDG、HDG）血清FSH、LH、E2、P和PRL无差异（FSH：P = 0.136，P = 0.503，P = 0.062；LH：P = 0.473，P = 0.513，P = 0.096；E2：P = 0.206，P = 0.927，P = 0.076；PRL：P = 0.120，P = 0.903，P = 0.407；P：P = 0.308，P = 0.866，P = 0.480）。三组痤疮评分均明显低于治疗前（P = 0.031；P = 0.033；P = 0.002）。39.5%的患者基础体温呈双相，但三组间无差异（P = 0.510）。三组（LDG、MDG、HDG）治疗前后ALT和AST无差异（ALT：P = 0.742，P = 0.383，P = 0.053；AST：P = 0.732，P = 0.519，P = 0.120）。