| Objective: To observe the clinical efficacy of Shoutai Pill combined with dydrogesterone tablets in patients with recurrent spontaneous abortion (RSA) during pregnancy and explore the mechanism of its pregnancy protection effect from the perspective of maternal-fetal immune regulation. Methods: A total of 70 patients with unexplained RSA who visited the Reproductive Medicine Department of Hebei Yanda Hospital from August 2023 to January 2025 were randomly divided into a study group and a control group, with 35 cases in each group. The control group was treated with dydrogesterone tablets, while the study group was treated with Shoutai Pill in addition to the medication of the control group. Both groups were treated until the 12th week of pregnancy. The changes in laboratory indicators of lymphocyte subsets, including the proportion of CD4+ and CD8+ lymphocytes and the CD4+/CD8+ ratio, before and after treatment were observed and compared, as well as the rate of continuous pregnancy at the 12th week. Results: 1. Comparison of laboratory test indicators: Intra-group comparison: The proportion of CD4+ lymphocytes and the CD4+/CD8+ ratio in the peripheral blood of RSA patients in both groups after treatment were lower than those before treatment; the proportion of CD8+ lymphocytes was higher than that before treatment. Inter-group comparison: After treatment, the proportion of CD4+ lymphocytes and the CD4+/CD8+ ratio in the study group were significantly lower than those in the control group, and the proportion of CD8+ lymphocytes was significantly higher than that in the control group, with statistically significant differences (P < 0.05). 2. Rate of continuous pregnancy at the 12th week: The rate in the study group was significantly higher than that in the control group, with a statistically significant difference (P < 0.05). Conclusion: The application of Shoutai Pill combined with dydrogesterone can significantly improve the proportion of T lymphocyte subsets in the peripheral blood of RSA patients, shift the CD4+/CD8+ ratio towards a CD8+ advantage, induce pregnancy immune tolerance, correct the immune imbalance of the mother, and increase the rate of continuous pregnancy, with satisfactory clinical efficacy. |