滋肾育胎丸对孕中期先兆流产患者Th1/Th2、性激素轴及妊娠结局的影响

Effects of Zishen Yutai Pills on Th1/Th2 Cytokines, Sex Hormone Axis and Pregnancy Outcomes in Patients with Threatened Abortion in the Second Trimester

摘要

目的 探讨滋肾育胎丸对孕中期（孕20~27⁺⁶周）先兆流产患者血清Th1/Th2型细胞因子水平、性激素轴及妊娠结局的影响，分析其在先兆流产保胎中的应用效果。方法 选取2021年3月至2024年1月在河北省第一荣军优抚医院妇产科就诊的136例孕中期（孕20~27⁺⁶周）先兆流产患者，采用随机数字表法分为观察组和对照组，各68例。对照组予盐酸利托君治疗，观察组予滋肾育胎丸联合盐酸利托君治疗，均连续治疗2周，比较2组临床疗效、临床症状消失时间、性激素水平、子宫内膜容受性指标、Th1/Th2细胞因子及保胎成功率、足月分娩率等。结果 观察组总有效率为92.65%，显著高于对照组的76.47%（P<0.05）；观察组腹痛消失、腰痛消失、宫缩消失以及阴道出血停止的时间均显著早于对照组（P<0.05）；治疗2周后，观察组孕酮（progesterone，P）、雌二醇（estradiol，E₂）、白细胞介素（interleukin，IL）-4、IL-10水平均显著高于对照组（P<0.05），前列腺素E₂（prostaglandin E₂，PGE₂）、阻力指数（resistance index，RI）、收缩期-舒张期比值（systolic/diastolic ratio，S/D）、搏动指数（pulsatility index，PI）、干扰素-γ（interferon-γ，IFN-γ）、IL-2水平均显著低于对照组（P<0.05）；观察组足月分娩率、保胎成功率均显著高于对照组（P<0.05）。结论 滋肾育胎丸联合盐酸利托君治疗能有效提高孕中期（孕20~27⁺⁶周）先兆流产患者疗效，减轻患者临床症状、调节性激素水平，改善子宫血流动力学和血清Th1/Th2型细胞因子水平失衡，进而提高保胎成功率和足月分娩率。

Abstract

Objective To explore the effects of Zishen Yutai pills on serum Th1/Th2 cytokines, sex hormone axis and pregnancy outcomes in patients with threatened abortion in the second trimester (20-27⁺⁶ weeks of gestation), and to analyze its efficacy in fetal preservation. Methods A total of 136 patients with threatened abortion in the second trimester (20-27⁺⁶ weeks of gestation) admitted to the Department of Obstetrics and Gynecology, the First Rongjun Special Care Hospital of Hebei Province from March 2021 to January 2024 were enrolled. Using the random number table method, they were divided into the control group and the observation group, with 68 cases in each group. The control group was treated with ritodrine hydrochloride, while the observation group received Zishen Yutai pills combined with ritodrine hydrochloride. Both groups received continuous treatment for 2 weeks. The clinical efficacy, time to resolution of clinical symptoms, sex hormone levels, endometrial receptivity indexes, Th1/Th2 cytokines, fetal preservation success rate and full-term delivery rate were compared between the two groups.Results The total effective rate was 92.65% in the observation group, which was significantly higher than 76.47% in the control group (P<0.05). The times to resolution of abdominal pain, lumbago and uterine contractions, as well as the time to cessation of vaginal bleeding, were all significantly shorter in the observation group than in the control group (P<0.05). After 2 weeks of treatment, serum levels of progesterone (P), estradiol (E₂), interleukin (IL)-4 and IL-10 in the observation group were significantly higher than those in the control group (P<0.05), while levels of prostaglandin E₂ (PGE₂), resistance index (RI), systolic/diastolic ratio (S/D), pulsatility index (PI), interferon-γ (IFN-γ) and IL-2 were significantly lower (P<0.05). The full-term delivery rate and fetal preservation success rate in the observation group were significantly higher than those in the control group (P<0.05).Conclusion Zishen Yutai pills combined with ritodrine hydrochloride can effectively improve the clinical efficacy for patients with threatened abortion in the second trimester (20-27⁺⁶ weeks of gestation), alleviate clinical symptoms, regulate sex hormone levels, improve uterine hemodynamics and the imbalance of serum Th1/Th2 cytokines, thus increasing the fetal preservation success rate and full-term delivery rate.

关键词

滋肾育胎丸 / 盐酸利托君 / 先兆流产 / 孕中期 / 保胎成功率 / 足月分娩率

Key words

Zishen Yutai pill / ritodrine hydrochloride / threatened abortion / second trimester / fetal preservation success rate / full-term delivery rate

参考文献

[1] Zhang Z, Yu Y, Yang B,et al. Association between pet ownership and threatened abortion in pregnant women: the China birth cohort study[J].Int J Environ Res Public Health, 2022, 19(23): 16374.

[2] 陈思韵, 郜洁, 邓咏诗, 等. 助孕丸干预肾虚、脾肾两虚型早期先兆流产患者妊娠结局的临床研究[J].中华中医药杂志, 2022, 37(12): 6940-6943.

[3] He X, Liu H. Placenta retention is associated with threatened abortion at the early stage of pregnancy[J].Jogi, 2023, 6(1): 128810.

[4] Lee W L, Yeh C C, Wang P H. Risk to increase threatened abortion: deficiency of some essential trace elements and exposure of toxic heavy metals[J].J Chin Med Assoc, 2019, 82(8): 607-608.

[5] Song C, Zhang S, Gao X,et al. Shoutai pills for threatened abortion: a protocol for systematic review and meta—analysis[J].Medicine, 2023, 102(11): e33173.

[6] 李田田, 赵瑞华. 赵瑞华从带脉论治胎动不安的思想探析[J].中国中医基础医学杂志, 2023, 29(12): 2097-2100.

[7] 冯聪, 齐娜, 韩延华. 韩延华教授治疗肾虚型胎动不安[J].长春中医药大学学报, 2016, 32(3): 478-480.

[8] 余琳, 李倩, 黄靖怡. 滋肾育胎丸治疗雌二醇低下先兆流产的临床效果[J].广东医学, 2021, 42(7): 832-836.

[9] 谢幸, 孔北华, 段涛. 妇产科学[M]. 9版.北京: 人民卫生出版社, 2018: 109-115.

[10] 罗颂平, 谈勇. 中医妇科学[M]. 2版.北京: 人民卫生出版社, 2012: 146-147.

[11] 国家药品监督管理局. 证候类中药新药临床研究技术指导原则[EB/OL]. (2018—11—06)[2025—07—30].https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20181106155701473.html.

[12] Hakeem L A, Bello Y O, Obajimi G O,et al. Inflammatory cytokines in maternal serum between women with threatened miscarriage and normal pregnancy[J].Int J Gynecol Obstet, 2024, 164(1): 255-261.

[13] 赵晴晴, 高翠霞, 周寒雪. 滋肾育胎丸防治反复妊娠丢失作用机制研究进展[J].中国计划生育和妇产科, 2025, 17(8): 3-7, 26.

[14] 位菊峰, 杨琳琳, 方辉, 等. 滋肾育胎丸联合黄体酮治疗黄体功能不全型先兆流产的疗效观察[J].世界中医药, 2022, 17(15): 2195-2198.

[15] 张铭娜, 肖学茹, 王艳. 地屈孕酮联合滋肾育胎丸治疗复发性流产的效果分析[J].河北医药, 2024, 46(21): 3303—3305, 3309.

[16] 郭肖竹, 吴登辉, 张旭, 等. 滋肾育胎丸对多囊卵巢综合征早期流产的调控及其机制[J].辽宁中医药大学学报, 2025, 27(5): 36-41.

[17] 李素芬, 高春燕. 滋肾育胎丸联合屈螺酮炔雌醇片治疗多囊卵巢综合征的疗效分析[J].世界中医药, 2023, 18(22): 3245-3249.

[18] 杨学妞, 廖会姝, 包华琼, 等. 地屈孕酮联合滋肾育胎丸在早期不明原因复发性流产患者保胎治疗中的效果观察[J].中国计划生育和妇产科, 2021, 13(9): 63-67.

基金资助

邢台市重点研发计划项目(2022ZC163)