年龄对针灸治疗早发性卵巢功能不全疗效影响的真实世界研究

Effects of age on the efficacy of acupuncture treatment of premature ovarian insufficiency based on real-world study

目的:基于真实世界数据探讨针灸治疗早发性卵巢功能不全(POI)的疗效,分析年龄对针灸治疗POI疗效的影响。方法:通过国际针灸病例注册登记平台全面收集真实世界中针灸治疗POI的临床诊疗数据。采用多重插补法填补缺失数据,采用分层分析、多因素调整分析和倾向性评分(逆概率处理加权法)平衡混杂因素,利用广义混合相加模型拟合针灸与卵巢功能指标的量效关系曲线,分析年龄与针灸疗效的关系。结果:189例POI患者纳入分析。(1)总体疗效:针灸可不同程度改善POI患者血清促卵泡生成素(FSH)、促黄体生成素(LH)、雌二醇(E2)、抗苗勒氏管激素(AMH)水平,可平均提高1个窦卵泡数(AFC),并能使部分POI患者上述卵巢功能指标恢复正常;(2)年龄与针灸疗效的关系:针灸改善FSH水平的效果受年龄影响,31岁前效果优于31岁后;随着年龄的增长,针灸改善AFC的效果减弱,33岁前可提高2个AFC,33岁后可提高1个;其他卵巢功能指标受年龄影响不大;(3)孕产情况:妊娠率16.67%(16/96),其中自然妊娠比例为9.38%(9/96),体外受精妊娠比例为7.29%(7/96);活产率12.5%(12/96)。结论:真实世界中,针灸可不同程度改善卵巢功能指标并使部分患者卵巢功能恢复正常,对年轻患者治疗效果更好;针灸可提高POI患者孕产率。

Objective:We explore the efficacy of acupuncture in the treatment of premature ovarian insufficiency(POI) based on real-world data,and analyze the influence of age factors on the efficacy of acupuncture in the treatment of POI.Methods:Clinical case data on acupuncture treatment POI in the real world through the International Patient Registry Platform of Acupuncture-Moxibustion(www.amreg.org) were collected.Extract effective data according to the research norms and quality control methods formulated in the previous stage.Using Multiple interpolation method(Multiple Imputation,MI) fill the missing data,using hierarchical analysis,factorial analysis and adjust the propensity score(inverse probability weighting method) balance the confounding factors,the hybrid Generalized Additive Model(Generalized Additive Mixed Model,GAMM) fitting acupuncture relation with ovarian function index of the concentration-response curves and analyzes the relations between age and acupuncture curative effect.Results:A total of 189 patients with POI were included.(1)Overall efficacy:Acupuncture can improve the levels of serum follicle-stimulating hormone(FSH),luteinizing hormone(LH),estradiol(E2) and anti-Müllerian hormone(AMH) in POI patients,increase the number of follicles in one sinus(AFC) on average,and restore the above ovarian function indexes in some POI patients to normal.(2)The relationship between age and acupuncture curative effect:It may be related to the effect of acupuncture on improving serum FSH:The effect was better before age 31 than after age 31.The effect of acupuncture on AFC was related to the improvement of AFC:2 AFC increases before age 33 and 1 AFC increases after age 33;Age has nothing to do with the effect of acupuncture on improving serum LH,E2 and AMH of POI patients;(3)Pregnancy:the pregnancy rate was 16.67%(16/96),of which the natural pregnancy rate was 9.38%(9/96),and the in vitro fertilization pregnancy rate was 7.29%(7/96),the live birth rate was 12.5%(12/96).Conclusion:In the real world,acupuncture can improve the levels of serum FSH,LH,E2 and AMH in POI patients to varying degrees,increase AFC,and restore the above ovarian function indexes in some POI patients to normal.The efficacy of acupuncture in improving the ovarian function in young patients.Acupuncture can also improve pregnancy rates in POI patients.