Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China.
Technology Center for Protein Sciences, School of Life Sciences, Tsinghua University, Beijing, 100084, China.
Chin J Integr Med. 2019 Apr;25(4):246-251. doi: 10.1007/s11655-018-2947-1. Epub 2019 Jun 25.
To assess the efficacy and safety of the Chinese medicine Dingkun Pill (, DKP) on insulin resistance in women with polycystic ovary syndrome (PCOS).
A total of 117 women with PCOS were randomly assigned to Group A (38 women), Group B (40 women), or Group C (39 women) in a randomization sequence with SAS software and a 1:1:1 allocation ratio using random block sizes of 6, and were given 7 g of oral DKP daily (Group A), 1 tablet of Diane-35 orally daily (Group B), or 7 g of oral DKP daily plus 1 tablet of Diane-35 orally daily (Group C). Patients took all drugs cyclically for 21 consecutive days, followed by 7 drug-free days. The treatment course for the 3 groups was continued for 3 consecutive months. Oral glucose tolerance tests (OGTT) were performed before treatment and again after 2 and 3 months of therapy, respectively, and homeostasis model assessment for insulin resistance (HOMA-IR) and quantitative insulin sensitivity check index (QUICKI) were calculated.
Of 117 women with PCOS, 110 completed the entire course of therapy: 35 in Group A, 36 in Group B, and 39 in Group C. After treatment, all three groups showed significant decreases in fasting glucose: at 1 h glucose decreased significantly in Group A (by 0.5 ± 1.4 mmol/L, P=0.028) and Group C (by 0.5 ± 1.2 mmol/L, P=0.045); while showing a tendency to increase in Group B (by 0.4 ± 1.9 mmol/L, P=0.238). HOMA-IR decreased significantly in Group C [by 0.5 (-2.2 to 0.5) mIU mmol/L, P=0.034]. QUICKI was significantly increased in Groups A and C (by 0.009 ± 0.02, P=0.033 and by 0.009 ± 0.027, P=0.049, respectively), while no change was observed in Group B. Repeated-measure ANOVA showed that the absolute changes in all parameters (except for glucose at 1 h), including glucose and insulin levels at all time-points during OGTT and in HbA1c, HOMA-IR, and QUICKI, were not significantly different among the 3 groups after treatment (P>0.05).
DKP or DKP combined with Diane-35 produce a slight improvement in insulin sensitivity compared with Diane-35 alone in PCOS patients (Trial Registration: ClinicalTrials.gov, NCT03264638).
评估中药定坤丹（DKP）对多囊卵巢综合征（PCOS）妇女胰岛素抵抗的疗效和安全性。
采用 SAS 软件产生随机序列，按 1:1:1 的比例将 117 例 PCOS 患者随机分为 A 组（38 例）、B 组（40 例）和 C 组（39 例），采用随机区组设计，区组大小为 6。A 组给予口服定坤丹 7 g/d，B 组给予口服达英-35 1 片/d，C 组给予口服定坤丹 7 g/d 联合达英-35 1 片/d。所有患者均连续服药 21 天，停药 7 天。3 组患者均连续治疗 3 个月。分别于治疗前和治疗后 2、3 个月进行口服葡萄糖耐量试验（OGTT），计算稳态模型评估的胰岛素抵抗（HOMA-IR）和定量胰岛素敏感指数（QUICKI）。
117 例 PCOS 患者中，110 例完成了整个疗程：A 组 35 例，B 组 36 例，C 组 39 例。治疗后，三组患者空腹血糖均明显下降：A 组（下降 0.5±1.4 mmol/L，P=0.028）和 C 组（下降 0.5±1.2 mmol/L，P=0.045）；B 组则有升高趋势（上升 0.4±1.9 mmol/L，P=0.238）。C 组 HOMA-IR 明显下降[下降 0.5（-2.2 至 0.5）mIU·mmol/L，P=0.034]。A 组和 C 组 QUICKI 明显升高[分别升高 0.009±0.02（P=0.033）和 0.009±0.027（P=0.049）]，B 组无变化。重复测量方差分析显示，治疗后 3 组各参数（1 h 血糖除外）的绝对值变化均无差异，包括 OGTT 各时间点的血糖和胰岛素水平以及 HbA1c、HOMA-IR 和 QUICKI。（P>0.05）。
与单用达英-35 相比，DKP 或 DKP 联合达英-35 可略微改善 PCOS 患者的胰岛素敏感性（临床试验注册：ClinicalTrials.gov，NCT03264638）。
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