摘要
目的基于“治未病”理念和真实世界数据,研究养阴舒肝方对不同阶段卵巢功能减退肾虚肝郁证患者的临床疗效,为中医药防治早发性卵巢功能不全(POI)的最佳介入时机提供参考。方法将2020年1月—2023年12月广东省中医院门诊电子病历系统登记的40岁以下卵巢功能减退肾虚肝郁证患者分为亚临床期POI组、POI组、卵巢早衰(POF)组,比较养阴舒肝方对3组患者的临床疗效,疗效指标包括中医证候总有效率、月经总有效率和复常(痊愈)率、基础卵泡刺激素(FSH)总有效率和复常率,抗米勒管激素(AMH)水平等。结果共纳入符合研究标准的患者307例(亚临床期POI组97例、POI组112例、POF组98例)。中医证候总有效率从高到低为亚临床期POI组98.97%(96/97)、POI组95.54%(107/112)、POF组83.67%(82/98),POF组低于亚临床期POI组及POI组(P<0.017),亚临床期POI组与POI组比较,差异无统计学意义。月经总有效率由高到低为亚临床期POI组97.22%(70/72)、POI组72.32%(81/112)、POF组51.02%(50/98),3组组间及事后比较,差异有统计学意义(P<0.01,P<0.017);月经复常率由高到低为亚临床期POI组90.28%(65/72)、POI组54.46%(61/112)、POF组26.53%(26/98),3组组间及事后比较,差异有统计学意义(P<0.01,P<0.017)。FSH总有效率由高到低为亚临床期POI组89.69%(87/97)、POI组81.25%(91/112)、POF组60.20%(59/98),POF组低于亚临床期POI组及POI组(P<0.017),亚临床期POI组与POI组比较,差异无统计学意义;FSH复常率由高到低为亚临床期POI组71.13%(69/97)、POI组53.57%(60/112)、POF组16.33%(16/98),3组组间及事后比较,差异有统计学意义(P<0.01,P<0.017);与治疗前比较,治疗后3组FSH水平均下降(P<0.01),POF组及POI组FSH降低幅度均大于亚临床期POI组(P<0.017),POI组与POF组FSH降低幅度差异无统计学意义。治疗后亚临床期POI组和POI组的AMH水平均增高(P<0.01)。结论养阴舒肝方可有效改善不同阶段卵巢功能减退患者月经情况及中医证候;可有效降低异常升高的FSH水平;有一定的使月经及FSH水平恢复正常的效果;可提高亚临床期POI及POI组患者的AMH水平。以上体现了中医药防治POI的优势,值得推广应用。
Objective Based on the"preventive treatment of disease"theory and real-world data,this study aimed to evaluate the clinical efficacy of Yangyin Shugan Formula in patients with ovarian dysfunction characterized by the syndrome of kidney deficiency and liver depression at different stages and to provide evidence for optimizing the timing of traditional Chinese medicine(TCM)in premature ovarian insufficiency(POI)management.Methods Ovarian dysfunction patients under 40 years old characterized by syndrome of kidney deficiency and liver depression,registered in the outpatient electronic medical records of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine from January 2020 to December 2023,were stratified into three groups:subclinical POI,POI,and premature ovarian failure(POF)groups.The therapeutic outcomes of the three groups of patients were compared,including TCM syndrome total response rates,menstrual total response rates/normalization(cured)rates,base follicle-stimulating hormone(FSH)total response rate/normalization rates and anti-Müllerian hormone(AMH)levels.Results A total of 307 patients meeting the research criteria were included(97 cases in subclinical POI group,112 cases in POI group,and 98 cases in POF group).The TCM syndrome total response rates ranked as subclinical POI group(98.97%,96/97)>POI group(95.54%,107/112)>POF group(83.67%,82/98),with the POF group was lower than that of the subclinical POI and POI groups(P<0.017);while the difference of the subclinical POI group with the POI group was not significant.Menstrual total response rates ranked as subclinical POI group(97.22%,70/72)>POI group(72.32%,81/112)>POF group(51.02%,50/98),the differences among the three groups and in the post-hoc comparisons were significant(P<0.01,P<0.017);normalization rates ranked as subclinical POI group(90.28%,65/72)>POI group(54.46%,61/112)>POF group(26.53%,26/98),the differences among the three groups and in the post-hoc comparisons were significant(P<0.01,P<0.017).FSH total response rates ranked as subclinical POI group(89.69%,87/97)>POI group(81.25%,91/112)>POF group(60.20%,59/98),while POF group was lower than that of the other two groups(P<0.017),and the difference of the subclinical POI group with the POI group was not significant.Normalization FSH rates ranked as subclinical POI group(71.13%,69/97)>POI group(53.57%,60/112)>POF group(16.33%,16/98),the differences among the three groups and in the post-hoc comparisons were significant(P<0.01,P<0.017).Compared with before treatment,the FSH levels in all three groups decreased after treatment(P<0.01).The reduction of FSH in the POF and POI groups were better than that in the subclinical POI group(P<0.017).No significant difference was observed in the reduction of FSH between the POI and POF groups.Post-treatment AMH elevation observed in the subclinical POI and POI groups(P<0.01).Conclusion Yangyin Shugan Formula improves the menstrual conditions and TCM syndromes across all the stages.It also improves elevated FSH levels across all the stages and has a specific effect on normalizing FSH and menstruation.Yangyin Shugan Formula increases the AMH levels of patients with subclinical POI and POI,highlighting the applicability of TCM in staged preventive management.
作者
黄旭春
王菲菲
梁娜
黄爽
陈飘盈
侯佳睿
成芳平
曹晓静
王小云
HUANG Xuchun;WANG Feifei;LIANG Na;HUANG Shuang;CHEN Piaoying;HOU Jiarui;CHENG Fangping;CAO Xiaojing;WANG Xiaoyun(The Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510120,China;Guangzhou University of Chinese Medicine,Guangzhou 510405,China)
出处
《北京中医药大学学报》
北大核心
2025年第7期943-953,共11页
Journal of Beijing University of Traditional Chinese Medicine
基金
国家重点研发计划项目(No.2018YFC1704102)
王小云全国名老中医药专家传承工作室建设项目(〔2016〕42号)
岭南妇科流派传承工作室建设项目(〔2013〕233号)
广东省中医院中医药科学技术研究专项(No.YN2023MS21)
第七批全国老中医药专家学术经验继承工作项目(国中医药办人教函〔2021〕272号)。
关键词
养阴舒肝方
早发性卵巢功能不全
肾虚肝郁证
真实世界
回顾性研究
治未病
Yangyin Shugan Formula
premature ovarian insufficiency
kidney deficiency and liver depression syndrome
real world
retrospective study
preventive treatment of disease
