目的 探讨嗣育保胎丸联合地屈孕酮片治疗早期先兆流产（肾虚证）的临床疗效。方法 纳入南阳市中心医院妇产科2024年1月—2024年12月收治的早期先兆流产（肾虚证）的孕妇120例，按照随机数字表法分为对照组（60例）和治疗组（60例）。对照组口服地屈孕酮片，1片/次，3次/d。治疗组在对照组的基础上口服嗣育保胎丸，2丸/次，3次/d。两组患者治疗2周。观察两组患者临床疗效，比较治疗前后两组患者中医症候评分、每周阴道流血次数、下腹部疼痛评分，血清雌激素雌二醇（E₂）水平、孕激素孕酮（Prog）水平、炎症因子肿瘤坏死因子-α（TNF-α）和白细胞介素-10（IL-10）水平，血清凝血指标D-二聚体和纤维蛋白原（FIB）水平。结果 治疗后，治疗组总有效率为93.33%，显著高于对照组总有效率80.00%（P＜0.05）。治疗后，两组中医症候评分、每周阴道流血次数、下腹部VAS评分均显著降低（P＜0.05），且与对照组相比，治疗组在中医症候评分、每周阴道流血次数、下腹部VAS评分降低更为显著（P＜0.05）。治疗后，两组血清E₂、Prog和IL-10水平均显著升高，而TNF-α、D-二聚体、FIB水平均显著降低（P＜0.05），且与对照组相比，治疗组这些指标水平改善更显著（P＜0.05）。结论 嗣育保胎丸联合地屈孕酮治疗早期先兆流产（肾虚证）的临床疗效显著，能显著缓解孕妇阴道出血及下腹部疼痛症状，可能机制与调节炎症状态、凝血功能以及雌激素、孕激素水平有关。

Objective To explore the clinical efficacy of Siyu Baotai Pills combined with dydrogesterone in treatment of early threatened abortion (syndrome of kidney deficiency). Methods Patients (120 cases) with early threatened abortion (syndrome of kidney deficiency) in Nanyang Central Hospital from January 2024 to December 2024 were divided into control (60 cases) and treatment (60 cases) group according to random number table method. Patient in control group were po administered with Dydrogesterone Tablets, 1 tablet/time, three times daily. Patient in treatment group were po administered with Siyu Baotai Pills on the basis of the control group, 2 pills/time, three times daily. Patient in two groups were treated for 2 weeks. After treatment, the clinical evaluations were evaluated, and the TCM symptom scores, vaginal bleeding times per week and VAS scores of lower abdominal, serum E₂ and P levels, serum IL-10 and TNF-αlevels, serum D-dimer and FIB levels in two groups before and after treatment were compared. Results After treatment, the total effective rate in the treatment group was 93.33%, which was significantly higher than that in the control group (80.00%, P < 0.05). After treatment, the TCM symptom score, the vaginal bleeding times per week, and the VAS score of the lower abdomen were significantly reduced in two groups (P < 0.05). Compared with the control group, the TCM symptom score, vaginal bleeding times per week, and the VAS score of the lower abdomen were significantly reduced in the treatment group (P < 0.05). After treatment, the serum E₂, Prog and IL-10 levels were significantly increased in two groups, but the levels of TNF-α, D-dimer, and FIB were significantly decreased (P < 0.05). Compared with the control group, the level of these indicators in the treatment group improved more significantly (P < 0.05). Conclusion Siyu Baotai Pills combined with dydrogesterone has a significant clinical efficacy in treatment of early threatened abortion (syndrome of kidney deficiency), which can significantly relieve the symptoms of vaginal bleeding and lower abdominal pain in pregnant women. The possible mechanism may be related to the regulation of the inflammatory state, coagulation function, and the levels of estrogen and progesterone.

R984

河南省医学科技攻关计划项目（LHGJ20200525）