Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China.
Chin J Integr Med. 2020 Dec;26(12):883-889. doi: 10.1007/s11655-020-3097-4. Epub 2020 Sep 11.
To evaluate the effects of Chinese medicine Dingkun Pill () alone or in combination with Diane-35 on patients with polycystic ovary syndrome (PCOS).
This is a prospective randomized controlled trial conducted at Peking Union Medical College Hospital Beijing, China, from December 2016 to September 2017. Totally 117 PCOS patients were randomly assigned to the Dingkun Pill group (38 cases), Diane-35 group (40 cases), or combined group (39 cases). Patients in the Dingkun Pill group or Diane-35 group took daily 7 g of oral Dingkun Pill or 1 tablet of oral Diane-35, respectively, for 21 consecutive days followed by 7 drug-free days. And the combined group received a combination of Dingkun Pill and Diane-35. The treatment course was 3 months. Fasting plasma glucose and insulin, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), free fatty acids (FFA) and sex hormones were analyzed, quantitative insulin sensitivity check index (QUICKI) was calculated, and menstruation and acne scores were recorded at baseline and after 3-month treatment.
Compared with before treatment, QUICKI decreased significantly in the Dingkun Pill and combined groups after 3-month treatment (P<0.05); TC, LDL-C and FFA decreased significantly in the Dingkun Pill group (P<0.01), LDL-C also decreased obviously in the Diane-35 group (P<0.01), while TC increased significantly in the combined group (P<0.01), TG increased significantly in all groups (P<0.01); total testosterone (TT) and menstruation regularity was improved significantly in the Diane-35 and combined groups (P<0.01); acne scores were improved in all groups (P<0.01). After treatment, TC and FFA in the Dingkun Pill group were significantly lower than the Diane-35 group (P<0.05 or P<0.01); TT was lower and regular menstruation rate was higher in the Diane-35 and combined groups than the Dingkun Pill group (P<0.01), and no differences were observed between Diane-35 group and combined group (P>0.05).
Dingkun Pill showed better effects than Diane-35 in improving insulin sensitivity, lowering TC and FFA. Diane-35 was more efficient in regulating menstruation and lowering androgen than Dingkun Pill. Combination of Dingkun Pill and Diane-35 may be a better choice to regulate menstruation, lower androgens while improve glucose metabolism in PCOS patients. (Registered on ClinicalTrials.gov, registration No. NCT03264638).
评价中药定坤丹单用或联合达英-35 治疗多囊卵巢综合征（PCOS）患者的效果。
这是一项前瞻性随机对照试验，在北京协和医院进行，于 2016 年 12 月至 2017 年 9 月期间招募了 117 名 PCOS 患者，将其随机分配至定坤丹组（38 例）、达英-35 组（40 例）或联合组（39 例）。定坤丹组或达英-35 组患者每日分别口服 7 g 定坤丹或 1 片达英-35，连续 21 天，随后停药 7 天。联合组接受定坤丹和达英-35 的联合治疗。疗程为 3 个月。治疗前后检测空腹血糖和胰岛素、总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）、甘油三酯（TG）、游离脂肪酸（FFA）和性激素水平，计算定量胰岛素敏感指数（QUICKI），并记录月经和痤疮评分。
与治疗前相比，治疗 3 个月后定坤丹组和联合组的 QUICKI 显著降低（P<0.05）；TC、LDL-C 和 FFA 均显著降低（P<0.01），Diane-35 组 LDL-C 也显著降低（P<0.01），联合组 TC 显著升高（P<0.01），各组 TG 均显著升高（P<0.01）；Diane-35 组和联合组总睾酮（TT）和月经规律程度显著改善（P<0.01）；各组痤疮评分均显著改善（P<0.01）。治疗后，定坤丹组 TC 和 FFA 显著低于达英-35 组（P<0.05 或 P<0.01）；Diane-35 组和联合组 TT 更低，月经规律率更高（P<0.01），而定坤丹组与联合组之间无差异（P>0.05）。
与达英-35 相比，定坤丹在改善胰岛素敏感性、降低 TC 和 FFA 方面效果更好。达英-35 在调节月经和降低雄激素方面比定坤丹更有效。定坤丹和达英-35 的联合治疗可能是一种更好的选择，可以调节月经，降低雄激素，同时改善 PCOS 患者的葡萄糖代谢。（在 ClinicalTrials.gov 注册，注册号：NCT03264638）。
