中药天癸胶囊治疗多囊卵巢综合征的随机对照疗效观察

背景：多囊卵巢综合征（polycystic ovary syndrome,PCOS）是一组复杂的症候群。许多研究表明,中草药可作为治疗PCOS的替代疗法,故分析和观察中国传统医药对PCOS的疗效是必要和有价值的。目的：观察中药天癸胶囊治疗PCOS的有效性,比较天癸胶囊与二甲双胍和达英-35治疗PCOS在调整卵巢功能、改善胰岛素抵抗和改变卵巢形态学等方面的效果。设计、场所、对象和干预措施：收集复旦大学附属妇产科医院门诊符合PCOS诊断标准的PCOS患者共47例,随机分入A、B、C三个治疗组。A组（19例）给予天癸胶囊治疗,B组（17例）给予二甲双胍治疗,C组（11例）给予达英-35治疗,3组均治疗3个月。主要结局指标：检测治疗前后雄激素（testosterone,T）、性激素结合球蛋白（sex hormone binding globulin,SHBG）、硫酸脱氢表雄酮（dehydroepiandrosterone sulfate,DHEA-S）水平以及游离雄激素指数（freeandrogenindex,FAI）、空腹血糖（fasting blood glucose,FPG）、空腹胰岛素（fastinginsulin,FINS）、胰岛素稳态模型指数（hemeostasis model assessment-insulin resistance,HOMA-IR）、胰岛素敏感指数（insulinsensitive index,ISI）和双侧卵巢体积的变化。结果：A组治疗后血清T、SHBG水平及FAI、FINS下降（P〈0.05）,双侧卵巢缩小（P〈0.05）,血清DHEA-S水平增加（P〈0.05）,FPG有增加趋势但无统计学意义。治疗3个月后3组间血清T水平比较虽无差异,但在降低FAI及增加血SHBG作用方面A组比B组强,比C组弱;3种药物降低FINS水平作用相似,但仅B组治疗后胰岛素敏感性增加;3组治疗后FPG均似有增加趋势,但C组FPG水平增加幅度最大。结论：中药天癸胶囊改善高雄激素血症作用比达英-35弱,优于二甲双胍;改善高胰岛素血症作用比二甲双胍弱,优于达英-35。天癸胶囊在不抑制下丘脑-垂体-卵巢轴功能的基础上,通过调整卵巢功能、改善胰岛素水平及改变卵巢形态等多方面治疗PCOS。以上结果值得进一步扩大样本量予以证实。

Efficacy of Chinese patent medicine Tian Gui Capsule in patients with polycystic ovary syndrome: a randomized controlled trial

Background: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.Objective: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.Main outcome measures: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.Results: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.Conclusion:The effects of Tian Gui Capsule on hyperandrogenism are not as significant as Diane35,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.