中国组织工程研究

中国组织工程研究 ›› 2024, Vol. 28 ›› Issue (19): 3037-3041.doi: 10.12307/2024.129

• 细胞相关实验/试验研究Cell related experimental/trial studies • 上一篇    下一篇

滋肾育胎丸在卵巢功能下降患者再次冻融胚胎移植中的作用

张敬华，白利晶，于春梅   

  1. 常州市妇幼保健院生殖中心，江苏省常州市   213003
  • 收稿日期:2023-02-16 接受日期:2023-04-07 出版日期:2024-07-08 发布日期:2023-09-26
  • 通讯作者: 于春梅，硕士， 副主任医师，常州市妇幼保健院生殖中心，江苏省常州市 213003
  • 作者简介:张敬华，女， 1982年生，江苏省丰县人，汉族，2018年南京医科大学毕业，硕士，副主任医师，主要从事生殖医学临床工作，研究领域为卵巢功能下降患者的治疗。
  • 基金资助:
    南京医科大学常州医学中心临床研究项目(CMCC202206)，项目负责人：于春梅

Effect of Zishen-Yutai pills on refrozen-thawed embryo transfer in patients with diminished ovarian reserve

Zhang Jinghua, Bai Lijing, Yu Chunmei   

  1. Center of Reproductive Medicine, Changzhou Maternal and Child Health Care Hospital, Changzhou 213003, Jiangsu Province, China
  • Received:2023-02-16 Accepted:2023-04-07 Online:2024-07-08 Published:2023-09-26
  • Contact: Yu Chunmei, Master, Associate chief physician, Center of Reproductive Medicine, Changzhou Maternal and Child Health Care Hospital, Changzhou 213003, Jiangsu Province, China
  • About author:Zhang Jinghua, Master, Associate chief physician, Center of Reproductive Medicine, Changzhou Maternal and Child Health Care Hospital, Changzhou 213003, Jiangsu Province, China
  • Supported by:
    Clinical Research Project of Changzhou Medical Center of Nanjing Medical University, No. CMCC202206 (to YCM)

PDF

237

摘要：


文题释义：

卵巢功能下降：是指卵巢内存留的可募集卵泡数量减少，卵泡发育障碍，并伴随卵母细胞质量降低，临床表现为月经异常及生育能力下降。流行病学显示，卵巢功能下降的发病率在一般人群中占0.9%-3%，其中20岁以前占0.01%，30岁以前占0.1%，40岁以前占约1%。卵巢作为女性的性腺器官，在维持女性特征及生殖方面扮演着重要角色。研究证实，卵巢功能下降患者如若延误病情、失治误治，在1-6年内可最终发展成为卵巢早衰。关于卵巢功能下降的病因研究尚不清楚，主要涉及年龄、遗传、免疫等因素。
冻融周期移植：是一项应用广泛的辅助生殖技术，其成功妊娠的2个关键因素是发育潜能好的胚胎和准备良好的子宫内膜。冻融周期移植技术因其具有提高累积妊娠率、降低卵巢过度刺激综合征发生率等优点，在过去十余年间取得了巨大的进步，已成为人类辅助生殖技术的重要组成部分。


背景：目前西医对卵巢功能下降患者的主要治疗方法为激素替代治疗，但是这类患者对外源性激素不敏感导致治疗效果不理想。滋肾育胎丸具有养血安胎、补肾健脾、益气培元和强壮身体之功效。有研究证实滋肾育胎丸在降低卵巢功能下降患者促卵泡生成素指标和改善中医症状方面确实有一定的疗效，但是其通过改善内膜容受性提高患者种植率的研究比较少。

目的：评价滋肾育胎丸对卵巢功能下降患者再次进行冻融胚胎移植后临床结局的影响。
方法：选取2019年1月至2021年12月在常州市妇幼保健院生殖中心首次失败后再次接受冻融胚胎移植助孕的300例卵巢功能下降患者为研究对象，受试者按1∶2的比例随机接受安慰剂或滋肾育胎丸治疗，治疗组100例，对照组200例，但13例患者由于无法联系、拒绝吃药或其他原因而脱落，最终治疗组90例，对照组197例纳入研究。在冻融胚胎移植前7 d开始口服药物，服用剂量为5 g/次，3次/d。研究服用滋肾育胎丸是否能改善卵巢功能下降患者再次冻融胚胎移植后的临床结局，主要结局指标为临床妊娠率、种植率、流产率、活产率以及子代出生体质量和出生缺陷等。

结果与结论：与对照组比较，口服滋肾育胎丸后临床妊娠率(P < 0.05)和种植率(P=0.009)明显提高；相关性分析显示服用滋肾育胎丸与着床胚胎数呈正相关关系(r=0.200，P=0.001)，与临床妊娠呈正相关关系(r=0.235，P=0.000)；服用滋肾育胎丸与子宫内膜厚度及血流的各项指标无相关性。提示：滋肾育胎丸可能改善卵巢功能下降患者再次冻融胚胎移植的临床妊娠率和种植率。

https://orcid.org/0000-0008-7556-3533 (于春梅) 

中国组织工程研究杂志出版内容重点：干细胞；骨髓干细胞；造血干细胞；脂肪干细胞；肿瘤干细胞；胚胎干细胞；脐带脐血干细胞；干细胞诱导；干细胞分化；组织工程

关键词: 滋肾育胎丸, 卵巢功能减退, 冻融胚胎移植, 临床妊娠率, 种植率

Abstract: BACKGROUND: Currently, hormone replacement therapy is the main treatment in Western medicine for patients with decreased ovarian function, but these patients are not sensitive to exogenous hormones, leading to unsatisfactory therapeutic effect. Zishen-Yutai pills can nourish the blood and calm the fetus, tonify the kidney and spleen, invigorate qi and strengthen the body. Studies have confirmed that Zishen-Yutai pill is effective in reducing follicle-stimulating hormone index and improving traditional Chinese medicine symptoms in patients with diminished ovarian reserve. However, few studies have been conducted to improve the implantation rate of patients by improving endometrial receptivity. 
OBJECTIVE: To evaluate the effect of Zishen-Yutai pills on the clinical outcome of patients with diminished ovarian reserve undergoing frozen-thawed embryo transfer again.  
METHODS:  A total of 300 patients with diminished ovarian reserve who underwent frozen-thawed embryo transfer to assist pregnancy after the first failure in the Center of Reproductive Medicine, Changzhou Maternal and Child Health Care Hospital from January 2019 to December 2021 were selected as the study subjects. Subjects were randomly treated with a placebo or Zishen-Yutai pills in a ratio of 1:2, with 100 cases in the treatment group and 200 cases in the control group. However, 13 patients fell off due to lack of contact, refusal to take medicine or other reasons. Finally, 90 cases in the treatment group and 197 cases in the control group were included in the study. Oral medication was administered 7 days before frozen-thawed embryo transfer transplantation at a dose of 5 g/time, 3 times/day. To investigate whether taking Zishen-Yutai pills could improve the clinical outcome of patients with diminished ovarian reserve after frozen-thawed embryo transfer again, the primary outcome measures included clinical pregnancy rate, implantation rate, abortion rate, live birth rate, offspring birth weight and birth defects.
RESULTS AND CONCLUSION: Compared with the control group, the clinical pregnancy rate (P < 0.05) and implantation rate (P=0.009) were significantly increased after the oral administration of Zishen-Yutai pills. Correlation analysis showed that taking the Zishen-Yutai pill was positively correlated with the number of implanted embryos (r=0.200, P=0.001) and clinical pregnancy (r=0.235, P=0.000). There was no correlation between taking Zishen-Yutai pills and indexes of endometrial thickness and blood flow. It is indicated that Zishen-Yutai pills can improve the clinical pregnancy rate and implantation rate of frozen-thawed embryo transfer recurrence in patients with diminished ovarian reserve.

Key words: Zishen-Yutai pill, diminished ovarian reserve, frozen-thawed embryo transfer, clinical pregnancy rate, implantation rate

中图分类号: