陕西中医2026,Vol.47Issue(6):755-760,6.DOI:10.3969/j.issn.1000-7369.2026.06.006
健脾祛湿化痰方治疗脾虚痰湿型多囊卵巢综合征随机双盲对照临床研究
Randomized double-blind controlled clinical study on the treatment of polycystic ovary syndrome with spleen deficiency and phlegm-dampness pattern using Jianpi Qushi Huatan formula
摘要
Abstract
Objective:To evaluate the clinical efficacy and safety of the Jianpi Qushi Huatan formula in treating spleen deficiency with phlegm-dampness pattern polycystic ovary syndrome(PCOS).Methods:A randomized,double-blind,placebo-controlled trial enrolled 64 patients with spleen deficiency and phlegm-dampness pattern PCOS,divided into an observation group and a control group(32 patients each).The observation group received oral administration of the Jianpi Qushi Huatan formula granules,while the control group received a placebo with identical appearance and odor.The treatment course lasted 3 months.Primary outcome measure:spontaneous ovulation rate.Secondary meas-ures:anthropometric parameters(body mass index,waist-to-hip ratio),clinical manifestations of hyper and rogenism(hirsutism,acne,alopecia),glucose and lipid metabolism indicators,sex hormone levels,quality of life scores(PCOSQ)and anxiety and depression scores(HADS-A/D).Results:The monthly spontaneous ovulation rate in the observation group was 48.89%,significantly higher than the 19.05%in the control group(P<0.01).Post-treat-ment,the observation group demonstrated superior improvements compared to the control group in BMI,WHR,insu-lin resistance index,testosterone levels,and LH/FSH ratio(all P<0.05).Additionally,the observation group exhibi-ted significantly enhanced quality of life scores(PCOSQ)and markedly reduced HADS-A/D(P<0.05).No drug-re-lated adverse reactions occurred in either group.Conclusion:The Jianpi Qushi Huatan formula effectively promotes spontaneous ovulation in PCOS patients with spleen deficiency and phlegm-dampness pattern,improves metabolic disorders,hormone levels,and quality of life,with good safety.关键词
多囊卵巢综合征/健脾祛湿化痰方/脾虚痰湿证/随机对照试验/排卵率Key words
Polycystic ovary syndrome/Jianpi Qushi Huatan formula/Spleen deficiency with phlegm-damp-ness syndrome/Randomized controlled trial/Ovulation rate分类
医药卫生引用本文复制引用
邹亚峰,胡雨珊,漆宇琳,彭雪梅,李佩双,彭佳华,梁瑞宁..健脾祛湿化痰方治疗脾虚痰湿型多囊卵巢综合征随机双盲对照临床研究[J].陕西中医,2026,47(6):755-760,6.基金项目
国家自然科学基金资助项目(82060880) (82060880)
江西省科技厅"揭榜挂帅"项目(20223BBG71012) (20223BBG71012)
梁瑞宁全国名老中医药专家传承工作室建设项目(国中医药人教函[2022]75号) (国中医药人教函[2022]75号)
中医女性生殖健康及相关疾病研究与转化江西省重点实验室建设项目(2024SSY06311) (2024SSY06311)
江西中医药大学科技创新团队项目(CXTD22013) (CXTD22013)