北京中医药大学学报2024，Vol.47Issue(12)：1735-1744,10.DOI:10.3969/j.issn.1006-2157.2024.12.013
基于真实世界的养阴舒肝方治疗早发性卵巢功能不全的临床疗效研究
A clinical efficacy study of Yangyin Shugan Decoction to treat premature ovarian insufficiency based on real-world evidence
摘要
Abstract
Objective Based on the real-world data,we aimed to study the clinical efficacy and safety of Yangyin Shugan(method of nourishing yin and soothing liver)Decoction,an empirical prescription of famous traditional Chinese medicine(TCM)practitioners,in the treatment of premature ovarian insufficiency(POI)with pattern of kidney deficiency and liver depression.Methods A total of 618 POI patients with pattern of kidney deficiency and liver depression who registered in the outpatient electronic medical record system of Guangdong Provincial Hospital of Chinese Medicine were collected from January 2020 to December 2023.After 1:1 propensity matching,a total of 222 patients with POI who met the criteria were included and assigned to a Yangyin Shugan Decoction group(treated with Yangyin Shugan Decoction only)and a hormone control group(hormone treatment only),with 111 cases in each group.Age,age at menarche,marriage status,duration,times of pregnancy,times of miscarriage,menstrual total score,total score of TCM syndrome,basal serum follicle-stimulating hormone(bFSH),and anti-Müllerian hormone(AMH)were recorded and compared.After 3 to 4 months of treatment,the clinical efficacy between the two groups include TCM syndromes,menstrual,bFSH,and menstrual normalization rates during the follow-up period(3 months after discontinuation of medication)were compared.Additionally,comparisons were also made before and after treatment for the total score of TCM syndrome and scores of individual symptom,menstrual total score and scores of indicator,bFSH level,and AMH levels in both groups.Results(ⅰ)The total effective rate of the TCM syndrome in the Yangyin Shugan Decoction group and hormone control group were 85.59%and 52.25%,respectively;the total effective rate of menstrual were 54.95%and 90.99%,respectively;the menstrual normalization rate during the follow-up period were 31.53%and 9.01%,respectively;and regarding bFSH efficacy,the total effective rate were 70.27%and 27.03%,respectively,and the normalization rate of bFSH were 35.14%and 9.01%,respectively.The differences between the two groups were statistically significant(P<0.01).(ⅱ)The bFSH value in the Yangyin Shugan Decoction group decreased after treatment compared to before treatment(P<0.01),while the bFSH value in the hormone control group showed no change before and after treatment.The AMH value increased after treatment compared to before treatment in Yangyin Shugan Decoction group(P<0.01),while the AMH value in the hormone control group showed no change before and after treatment.The difference of bFSH and AMH between the two groups after treatment was statistically significant(P<0.01).(ⅲ)After treatment,the total score of TCM syndrome and the scores of individual symptom in the Yangyin Shugan Decoction group were lower than those before treatment(P<0.01);the total score of TCM syndrome,scores of hot flushes and sweating,hyposexuality,and insomnia in the hormone control group were lower than those before treatment(P<0.01).After treatment,the total score of TCM syndrome and the scores of individual symptom in the Yangyin Shugan Decoction group were lower than those in the hormone control group(P<0.01).(ⅳ)After treatment,the menstrual total score,scores of menstrual cycle,period,menstrual flow,and menstrual blood color in the Yangyin Shugan Decoction group were lower than those before treatment(P<0.01);the menstrual total score,score of menstrual cycle,period,and menstrual flow in the hormone control group were lower than those before treatment(P<0.01);after treatment,the menstrual total score and menstrual cycle score in the hormone control group were better than those in the Yangyin Shugan Decoction group(P<0.01).(ⅴ)No adverse reactions were observed in the Yangyin Shugan Decoction group and 29 cases of adverse reactions were observed in the hormone control group.Conclusion Yangyin Shugan Decoction can effectively improve TCM syndrome in POI patients with pattern of kidney deficiency and liver depression;downregulate the elevated bFSH level,increase the low AMH level,and effectively improve ovarian function,even continue to maintain menstruation after drug withdrawal.In the real world,Yangyin Shugan Decoction got satisfactory efficacy and good safety in the treatment of POI,which deserves clinical promotion and application.关键词
早发性卵巢功能不全/养阴舒肝方/肾虚肝郁证/真实世界/回顾性研究Key words
premature ovarian insufficiency/Yangyin Shugan Decoction/pattern of kidney deficiency and liver depression/real world/retrospective study分类
医药卫生引用本文复制引用
黄旭春,李灵通,侯佳睿,梁娜,曹晓静,成芳平,老膺荣,王小云..基于真实世界的养阴舒肝方治疗早发性卵巢功能不全的临床疗效研究[J].北京中医药大学学报,2024,47(12):1735-1744,10.基金项目
国家重点研发计划项目(No.2018YFC1704102) （No.2018YFC1704102）
王小云全国名老中医药专家传承工作室建设项目(No.[2016]42) （No.[2016]42）
岭南妇科流派传承工作室建设项目(No.[2013]233) （No.[2013]233）
广东省中医院中医药科学技术研究专项(No.YN2023MS21) （No.YN2023MS21）
广东省科技计划项目(No.2021B1212100007) National Key R&D Program of China(No.2018YFC1704102) （No.2021B1212100007）
