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

TANG Peipei; TAN Yong

doi:10.13422/j.cnki.syfjx.20240491

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

更新时间：2023-08-22

- Clinical Efficacy of Dingkundan in Treatment of Ovulatory Disorder Infertility Based on Real-world
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 29, Issue 18, Pages: 95-101(2023)
- 作者机构：
  
  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
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.20240491
  CLC： R2-0;R22;R285.5;R2-031;R271.14
- Published：20 September 2023，
  
  Published Online：20 July 2023，
  
  Received：19 February 2023，
- 稿件说明：
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唐培培,谈勇.基于真实世界定坤丹治疗排卵障碍性不孕症的临床疗效[J].中国实验方剂学杂志,2023,29(18):95-101.

TANG Peipei,TAN Yong.Clinical Efficacy of Dingkundan in Treatment of Ovulatory Disorder Infertility Based on Real-world[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(18):95-101.
唐培培,谈勇.基于真实世界定坤丹治疗排卵障碍性不孕症的临床疗效[J].中国实验方剂学杂志,2023,29(18):95-101. DOI： 10.13422/j.cnki.syfjx.20240491.

TANG Peipei,TAN Yong.Clinical Efficacy of Dingkundan in Treatment of Ovulatory Disorder Infertility Based on Real-world[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(18):95-101. DOI： 10.13422/j.cnki.syfjx.20240491.

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（

=8.328，

0.05）。成熟卵泡雌二醇（E

）、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（

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（

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（

=7.993，

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）（

=8.336，

0.01）和西药组的39.22%（20/51）（

=6.011，

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。

Abstract

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）（

=8.328，

0.05）. The mature follicle estradiol （E

） 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 （

0.01）. The endometrial thickness was higher in the Chinese medicine group and the combination group than in the western medicine group （

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）（

=7.993，

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 （

=8.336，

0.01） and 39.22%（20/51） in the western medicine group （

=6.011，

0.05）. Compared with the western medicine group， the combination group showed a favorable trend in total effective rate， ovulation rate per cycle， number of days of follicle development， Gn dosage， pregnancy rate per cycle， ectopic pregnancy rate， and early pregnancy loss rate， but the differences were not statistically significant.

Conclusion

In real-world clinical practice， the combination of Dingkundan with ovulation induction can increase endometrial thickness， improve the proportion of type A endometrium， enhance egg quality， and increase the clinical pregnancy rate in patients with ovulation disorder infertility. This approach deserves further clinical research and application.

关键词

定坤丹排卵障碍不孕症真实世界证型

Keywords

Dingkundanovulatory disorderinfertilityreal worldsyndrome type

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