Kuek Susuana, Wang Wen-jun, Gui Sui-qi
Department of Integrated Traditional Chinese and Western Medicine, Fudan University, Shanghai, China.
Zhong Xi Yi Jie He Xue Bao. 2011 Sep;9(9):965-72. doi: 10.3736/jcim20110907.
Polycystic ovary syndrome (PCOS) is a complex hormonal disorder and one of the most common reproductive endocrinology abnormalities in women. Recently, many studies have been conducted assessing Chinese herbal medicine as an alternative treatment for women with PCOS, it is, therefore, worthwhile to analyze and observe the curative effects of traditional Chinese medicine treatment in PCOS.
To evaluate the efficacy of the Chinese patent medicine Tian Gui Capsule, in women with PCOS and compare its effects with metformin and ethinyl estradiol plus cyproterone acetate (Diane-35).
DESIGN, SETTING, PARTICIPANTS AND INTERVENTION: A total of 47 PCOS outpatients from the Obstetrics and Gynecology Hospital of Fudan University were randomly divided into 3 groups. Patients in group A (n=19) were given Tian Gui Capsule, patients in group B (n=17) were given metformin, and patients in group C (n=11) were given Diane-35. The 3 groups of patients were treated for 3 months.
Serum testosterone (T), sex hormone binding globulin (SHBG) and dehydroepiandrosterone sulfate (DHEA-S) levels, free androgen index (FAI), fasting blood glucose (FPG), fasting insulin (FINS), homeostasis model assessment of insulin resistance (HOMA-IR), insulin sensitive index (ISI) and left and right ovary volumes of the 3 groups were evaluated before and after treatment .
After 3 months of treatment, when compared with before treatment data, group A patients showed decreased serum T and SHBG levels, FAI, FINS, and left and right ovary volumes (P<0.05), and increased serum DHEA-S (P<0.05), while the FPG level showed no significant change. Although the level of serum T and FINS among the 3 groups after the treatment were similar, group A demonstrated better results than group B in reducing the FAI and increasing the serum SHBG, but less significant results than group C besides, group B was the only group showed improved insulin sensitivity. Although the level of FPG of the 3 groups after treatment were similar, group C had the most increased FPG.
The effects of Tian Gui Capsule on hyperandrogenism are not as significant as Diane-35, but more effective than metformin. The effects of Tian Gui Capsule on hyperinsulinemia are not as significant as metformin but better than Diane-35. Tian Gui Capsule treats PCOS by regulating ovarian functions and reducing blood insulin level without inhibiting the function of the hypothalamic-pituitary-ovarian axis. Further studies with larger sample size are needed to confirm the above results.
多囊卵巢综合征（PCOS）是一种复杂的激素紊乱疾病，也是女性最常见的生殖内分泌异常之一。近年来，许多研究对中药作为PCOS女性的替代治疗方法进行了评估，因此，分析和观察中医治疗PCOS的疗效是值得的。
评价中成药天癸胶囊对PCOS女性的疗效，并将其与二甲双胍以及炔雌醇环丙孕酮（达英-35）进行疗效比较。
设计、场所、参与者与干预措施：复旦大学附属妇产科医院的47例PCOS门诊患者被随机分为3组。A组（n = 19）给予天癸胶囊，B组（n = 17）给予二甲双胍，C组（n = 11）给予达英-35。3组患者均接受3个月的治疗。
治疗前后评估3组患者的血清睾酮（T）、性激素结合球蛋白（SHBG）、硫酸脱氢表雄酮（DHEA-S）水平以及游离雄激素指数（FAI）、空腹血糖（FPG）、空腹胰岛素（FINS）、胰岛素抵抗稳态模型评估（HOMA-IR）、胰岛素敏感指数（ISI），以及左右卵巢体积。
治疗3个月后，与治疗前数据相比，A组患者血清T、SHBG水平、FAI、FINS以及左右卵巢体积降低（P < 0.05），血清DHEA-S升高（P < 0.05），而FPG水平无显著变化。虽然治疗后3组患者的血清T和FINS水平相似，但A组在降低FAI和升高血清SHBG方面的效果优于B组，但不如C组显著；此外，B组是唯一胰岛素敏感性得到改善的组。虽然治疗后3组患者的FPG水平相似，但C组FPG升高最多。
天癸胶囊对高雄激素血症症状的治疗效果不如达英-35显著，但优于二甲双胍。天癸胶囊对高胰岛素血症的治疗效果不如二甲双胍，但优于达英-35。天癸胶囊通过调节卵巢功能并降低血胰岛素水平来治疗PCOS，且不抑制下丘脑-垂体-卵巢轴的功能。需要进一步开展更大样本量的研究来证实上述结果。
