基于真实世界定坤丹治疗排卵障碍性不孕症的临床疗效  

Clinical Efficacy of Dingkundan in Treatment of Ovulatory Disorder Infertility Based on Real-world

作　　者：唐培培 谈勇 TANG Peipei;TAN Yong(Affiliated Hospital of Nanjing University of Chinese Medicine/Jiangsu Province Hospital of Chinese Medicine,Nanjing 210000,China;The First School of Clinical Medicine,Nanjing University of Chinese Medicine,Nanjing 210000,China)

机构地区：[1]南京中医药大学附属医院/江苏省中医院,南京210000 [2]南京中医药大学第一临床医学院,南京210000

出　　处：《中国实验方剂学杂志》2023年第18期95-101,共7页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家自然科学基金项目(82174425);江苏省卫建委“强卫工程”中医妇科临床医学中心项目(YXZXB2016006);南京中医药大学横向科研项目(2020066);江苏省中医院院级课题(Y2020CX15)。

摘　　要：目的:基于真实世界探讨定坤丹对排卵障碍性不孕症的临床疗效,为临床提供可靠的循证医学依据。方法:通过医路云系统,收集真实世界中治疗排卵障碍性不孕症的临床诊疗数据。按真实诊疗分组,观察总有效率、周期排卵率、卵泡发育天数、促性腺激素(Gn)量、成熟卵泡性激素、子宫内膜厚度及分型、周期妊娠率、临床妊娠率、异位妊娠率及早期妊娠丢失率。结果:共纳入207例患者,全人群中医证型以肝郁肾虚最为常见。分组如下:中药组(定坤丹组)60例,西药组(促排卵组)51例,中西医结合组(定坤丹联合促排卵组)96例。总有效率比较,中西医结合组(98.96%,95/96)最高,与中药组(88.33%,53/60)差异具有统计学意义(χ^(2)=8.328,P<0.05)。成熟卵泡雌二醇(E2)、促黄体生成素(LH)均为中西医结合组最高,且与西药组差异具有统计学意义(P<0.01)。子宫内膜厚度中药组、中西医结合组高于西药组,且差异均有统计学意义(P<0.01),A型子宫内膜比例中西医结合组(85.90%,201/234)最高,且与西药组(73.81%,93/126)差异具有统计学意义(χ^(2)=7.993,P<0.01)。临床妊娠率中西医结合组60.42%(58/96),高于中药组的36.67%(22/60)(χ^(2)=8.336,P<0.01)和西药组的39.22%(20/51)(χ^(2)=6.011,P<0.05)。与西药组比较,中西医结合组总有效率、周期排卵率、卵泡发育天数、Gn使用量、周期妊娠率、异位妊娠率、早期妊娠丢失率数据呈良性趋势,但差异均无统计学意义。结论:真实世界临床实践中定坤丹联合促排卵可增加子宫内膜厚度、提高A型子宫内膜比例、改善卵子质量、提高临床妊娠率,值得临床进一步研究及应用。Objective:To explore the clinical efficacy of Dingkundan in the treatment of ovulation disorder infertility based on the real world and provide reliable evidence-based medical support for clinical practice.Method:Clinical diagnosis and treatment data of patients with ovulation disorder infertility in the real world were collected through the Medroad Cloud system.Patients were grouped according to their real-world treatments,and the total effective rate,ovulation rate per cycle,number of days of follicle development,gonadotropin(Gn)dosage,levels of mature follicle-related hormones,endometrial thickness and classification,pregnancy rate per cycle,clinical pregnancy rate,ectopic pregnancy rate,and early pregnancy loss rate were observed.Result:A total of 207 patients were included,and the most common traditional Chinese medicine(TCM)syndrome in the entire population was liver depression and kidney deficiency.The patients were divided into a Chinese medicine group(Dingkundan,60 cases),a western medicine group(ovulation induction,51 cases),and a combination group(Dingkundan+ovulation induction,96 cases).The combination group(98.96%,95/96)had the highest total effective rate,which was statistically significant when compared with the Chinese medicine group(88.33%,53/60)(χ^(2)=8.328,P<0.05).The mature follicle estradiol(E2)and luteinizing hormone(LH)levels were the highest in the combination group,and there were statistically significant differences when compared with the western medicine group(P<0.01).The endometrial thickness was higher in the Chinese medicine group and the combination group than in the western medicine group(P<0.01).The proportion of type A endometrium was highest in the combination group(85.90%,201/234),and there was a statistically significant difference when compared with the western medicine group(73.81%,93/126)(χ^(2)=7.993,P<0.01).The clinical pregnancy rate was 60.42%(58/96)in the combination group,which was higher than 36.67%(22/60)in the Chinese medicine group(χ^(2)=8.336,P<0.01)and 39.22%(

关 键 词：定坤丹 排卵障碍 不孕症 真实世界 证型 

分 类 号：R2-0[医药卫生—中医学] R22R285.5R2-031R271.14