Abstract:

Objective　To investigate the effect of Taibao Tang combined with dydrogesterone for patients with threatened miscarriage due to luteal insufficiency and its impact on their endocrine and immune parameters. Methods　This study was a prospective clinical controlled trial. Eighty-six patients with threatened miscarriage due to luteal insufficiency treated at Yulin Traditional Chinese Medicine Hospital from April 2021 to March 2023 were selected, and were divided into a control group and a study group by the random number table method, with 43 cases in each group. The study group were (29.39±4.48) years old and (8.93±2.11) weeks pregnant. The control group were (28.89±4.35) years old and (9.10±2.12) weeks pregnant. The control group took dydrogesterone, and the treatment group dydrogesterone and Taibao Tang. The scores of traditional Chinese medicine (TCM) syndrome, pregnancy maintenance rates, endocrine levels [serum progesterone (P), estradiol (E2), and human chorionic gonadotropin (β-hCG)], immune parameters  ( CD4+, CD8+, and CD4+/CD8+ ratio), and pregnancy outcomes were compared between the two groups. t andχ² tests were used for the statistical analysis. Results　After the treatment, the time for the disappearance of abdominal pain, time for vaginal hemostasis, and score of TCM syndromes in the study group were lower than those in the control group [(2.17±0.51) d vs.(2.53±0.49) d,         (2.19±0.40) d vs. (2.48±0.47) d, 5.32±1.13 vs. 6.23±1.07], with statistical differences (t=3.338, 3.081, and 3.834; all P<0.05). After the treatment, the scores of P, E2, and β-hCG in the study group were higher than those in the control group [(48.67±6.30) μg/L vs.(45.16±6.23) μg/L, (638.23±39.18) ng/L vs. (616.06±43.28) ng/L, and (8 536.88±365.02) IU/L vs. (8 343.15±371.29) IU/L], with statistical differences (all P<0.05). After the treatment, the levels of CD4+, CD4+/CD8+, CD8+ in the study group were better than those in the control group (35.55±3.61 vs. 37.27±4.10，1.26±0.33 vs. 1.48±0.32，28.24±3.82 vs.26.16±4.01), with statistical differences (t=2.065, 3.138, and 2.463; all P<0.05). There was no statistical differencein the incidence rate of adverse reactions between the study group and the control group [9.30%(4/43) vs. 13.95%(6/43); χ²=0.453; P>0.05]. The newborns' body weight in the study group was higher than that in the control group [(2 530.32±268.41) g vs. (2 423.31±223.26) g], with a statistical difference (t=2.010; P<0.05). Conclusion　Taibao Tang combined with dydrogesterone in the treatment of patients with with threatened miscarriage due to luteal insufficiency can improve their endocrine levels, immune function, and treatment effect, and reduce the risk of miscarriage.

Key words: Luteal insufficiency,  , Threatened miscarriage,  , Taibao Tang,  , Dydrogesterone,  , Endocrine,  , Immune function

摘要：

目的　探讨胎宝汤联合地屈孕酮对黄体功能不全性先兆流产患者的疗效及对内分泌水平和免疫功能指标的影响。方法　采用前瞻性临床对照研究，共纳入陕西省榆林市中医医院2021年4月至2023年3月收治的86例黄体功能不全性先兆流产患者。按照随机数字表法将患者分为研究组和对照组，每组43例。研究组年龄（29.39±4.48）岁，孕周（8.93±2.11）周；对照组年龄（28.89±4.35）岁，孕周（9.10±2.12）周。对照组给予地屈孕酮治疗，研究组在对照组基础上加用胎宝汤。两组均持续治疗4周。观察两组中医证候积分、保胎成功率、内分泌水平［血清孕酮（P）、雌二醇（E2）、人绒毛膜促性腺激素（β-hCG）］、免疫功能指标［CD4+、CD8+和CD4+/CD8+比值］及妊娠结局。采用t检验及χ2检验进行统计学分析。结果　治疗后，研究组腹痛消失时间、阴道止血时间和中医证候积分均低于对照组［（2.17±0.51）d比（2.53±0.49）d、（2.19±0.40）d比（2.48±0.47）d、（5.32±1.13）分比（6.23±1.07）分］，差异均有统计学意义（t=3.338、3.081、3.834，均P<0.05）。治疗后，研究组P、E2、β-hCG水平均较对照组高        ［（48.67±6.30）μg/L比（45.16±6.23）μg/L、（638.23±39.18）ng/L比（616.06±43.28）ng/L、（8 536.88±365.02）IU/L比（8 343.15±371.29）IU/L］，差异均有统计学意义（均P<0.05）。治疗后，研究组CD4+水平、CD4+/CD8+比值均较对照组低，CD8+水平较对照组高（35.55±3.61比37.27±4.10、1.26±0.33比1.48±0.32、28.24±3.82比26.16±4.01），差异均有统计学意义（t=2.065、3.138、2.463，均P<0.05）。研究组不良反应发生率与对照组比较［9.30%（4/43）比13.95%（6/43）］，差异无统计学意义（χ2=0.453，P>0.05）。研究组新生儿体质量高于对照组［（2 530.32±268.41）g比（2 423.31±223.26）g］，差异有统计学意义（χ2=2.010，P<0.05）。结论　胎宝汤联合地屈孕酮治疗黄体功能不全性先兆流产患者可以有效提高患者的内分泌水平，并改善免疫功能，从而提高治疗效果，降低流产风险。

关键词: 黄体功能不全,  ,  , 先兆流产,  ,  , 胎宝汤,  ,  , 地屈孕酮,  ,  , 内分泌,  ,  , 免疫功能