CAJ | 학술논문

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(free androgen index,FAI)、空腹血糖(fasting blood glucose,FPG)、空腹胰岛素(fasting insulin,FINS)、胰岛素稳态模型指数(hemeostasis model assessment-insulin resistance,HOMA-IR)、胰岛素敏感指数(insulin sensitive 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. 揹景:多囊卵巢綜閤徵(polycystic ovary syndrome,PCOS)是一組複雜的癥候群.許多研究錶明,中草藥可作為治療PCOS的替代療法,故分析和觀察中國傳統醫藥對PCOS的療效是必要和有價值的.目的:觀察中藥天癸膠囊治療PCOS的有效性,比較天癸膠囊與二甲雙胍和達英-35治療PCOS在調整卵巢功能、改善胰島素牴抗和改變卵巢形態學等方麵的效果.設計、場所、對象和榦預措施:收集複旦大學附屬婦產科醫院門診符閤PCOS診斷標準的PCOS患者共47例,隨機分入A、B、C三箇治療組.A組(19例)給予天癸膠囊治療,B組(17例)給予二甲雙胍治療,C組(11例)給予達英-35治療,3組均治療3箇月.主要結跼指標:檢測治療前後雄激素(testosterone,T)、性激素結閤毬蛋白(sex hormone binding globulin,SHBG)、硫痠脫氫錶雄酮(dehydroepiandrosterone sulfate,DHEA-S)水平以及遊離雄激素指數(free androgen index,FAI)、空腹血糖(fasting blood glucose,FPG)、空腹胰島素(fasting insulin,FINS)、胰島素穩態模型指數(hemeostasis model assessment-insulin resistance,HOMA-IR)、胰島素敏感指數(insulin sensitive index,ISI)和雙側卵巢體積的變化.結果:A組治療後血清T、SHBG水平及FAI、FINS下降(P＜0.05),雙側卵巢縮小(P＜0.05),血清DHEA-S水平增加(P＜0.05),FPG有增加趨勢但無統計學意義.治療3箇月後3組間血清T水平比較雖無差異,但在降低FAI及增加血SHBG作用方麵A組比B組彊,比C組弱；3種藥物降低FINS水平作用相似,但僅B組治療後胰島素敏感性增加；3組治療後FPG均似有增加趨勢,但C組FPG水平增加幅度最大.結論:中藥天癸膠囊改善高雄激素血癥作用比達英-35弱,優于二甲雙胍；改善高胰島素血癥作用比二甲雙.胍弱,優于達英-35.天癸膠囊在不抑製下丘腦-垂體-卵巢軸功能的基礎上,通過調整卵巢功能、改善胰島素水平及改變卵巢形態等多方麵治療PCOS.以上結果值得進一步擴大樣本量予以證實.
배경:다낭란소종합정(polycystic ovary syndrome,PCOS)시일조복잡적증후군.허다연구표명,중초약가작위치료PCOS적체대요법,고분석화관찰중국전통의약대PCOS적료효시필요화유개치적.목적:관찰중약천계효낭치료PCOS적유효성,비교천계효낭여이갑쌍고화체영-35치료PCOS재조정란소공능、개선이도소저항화개변란소형태학등방면적효과.설계、장소、대상화간예조시:수집복단대학부속부산과의원문진부합PCOS진단표준적PCOS환자공47례,수궤분입A、B、C삼개치료조.A조(19례)급여천계효낭치료,B조(17례)급여이갑쌍고치료,C조(11례)급여체영-35치료,3조균치료3개월.주요결국지표:검측치료전후웅격소(testosterone,T)、성격소결합구단백(sex hormone binding globulin,SHBG)、류산탈경표웅동(dehydroepiandrosterone sulfate,DHEA-S)수평이급유리웅격소지수(free androgen index,FAI)、공복혈당(fasting blood glucose,FPG)、공복이도소(fasting insulin,FINS)、이도소은태모형지수(hemeostasis model assessment-insulin resistance,HOMA-IR)、이도소민감지수(insulin sensitive index,ISI)화쌍측란소체적적변화.결과:A조치료후혈청T、SHBG수평급FAI、FINS하강(P＜0.05),쌍측란소축소(P＜0.05),혈청DHEA-S수평증가(P＜0.05),FPG유증가추세단무통계학의의.치료3개월후3조간혈청T수평비교수무차이,단재강저FAI급증가혈SHBG작용방면A조비B조강,비C조약；3충약물강저FINS수평작용상사,단부B조치료후이도소민감성증가；3조치료후FPG균사유증가추세,단C조FPG수평증가폭도최대.결론:중약천계효낭개선고웅격소혈증작용비체영-35약,우우이갑쌍고；개선고이도소혈증작용비이갑쌍.고약,우우체영-35.천계효낭재불억제하구뇌-수체-란소축공능적기출상,통과조정란소공능、개선이도소수평급개변란소형태등다방면치료PCOS.이상결과치득진일보확대양본량여이증실.
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.