目的 探讨安胎丸联合黄体酮软胶囊治疗早期先兆流产的临床效果。方法 选取2019年7月—2021年7月南开大学附属医院收治的98例早期先兆流产患者，使用随机数字表法分成对照组和治疗组，每组各49例。对照组口服黄体酮软胶囊，0.2 g/次，1次/d。治疗组在对照组基础上口服安胎丸，1丸/次，2次/d。所有患者均连续治疗14 d。观察两组临床疗效，统计两组典型临床症状消失时间。比较治疗前后两组子宫螺旋动脉血流参数[阻力指数（RI）、搏动指数（PI）]及血清生殖激素[孕酮（P）、人绒毛膜促性腺激素β亚基（β-hCG）]、辅助性T细胞（Th）1/Th2细胞因子[肿瘤坏死因子（TNF）-α、白细胞介素（IL）-10]水平。结果 治疗组保胎有效率是93.9%，较对照组（79.6%）显著提高（P＜0.05）。治疗组阴道出血停止时间、腹痛消失时间、腰痛消失时间均显著短于对照组（P＜0.05）。与治疗前对比，两组治疗后子宫螺旋动脉RI、PI均显著降低（P＜0.05）；且均以治疗组的下降更显著（P＜0.05）。治疗后，两组血清P、β-HCG水平均较治疗前显著升高（P＜0.05）；且均以治疗组的改善更显著（P＜0.05）。与治疗前相比，两组治疗后血清TNF-α水平均显著下降，血清IL-10水平均显著上升（P＜0.05）；且治疗后，治疗组血清TNF-α水平低于对照组，血清IL-10水平高于对照组（P＜0.05）。结论 安胎丸联合黄体酮对早期先兆流产患者具有确切的临床疗效，是缓解患者症状的安全有效方案，并能进一步改善子宫血流状态、提高体内生殖激素水平及纠正Th1/Th2细胞因子的失衡状态。

Objective To explore the clinical effect of Antai Pills combined with progesterone in treatment of early threatened abortion. Methods A total of 98 patients with early threatened abortion admitted to The Affiliated Hospital of Nankai University from July 2019 to July 2021 were selected and divided into control group and treatment group by random number table method, with 49 cases in each group. Patients in the control group were po administered with Progesterone Soft Capsules, 0.2 g/time, once daily. Patients in the treatment group were po administered with Antai Pills on the basis of the control group, 1 pill/time, twice daily. Patients in two groups were treated for 14 d. The efficacy of the two groups was observed, and the disappearance time of the typical clinical manifestations of the two groups was counted. The blood flow parameters of the uterine spiral arteries [resistance index (RI), pulsatility index (PI)] and serum reproductive hormones [progesterone (P), human chorionic gonadotropin β subunit (β-hCG)], Pregnancy-associated plasma protein-A (PAPP-A), helper T cells (Th)1/Th2 cytokines [tumor necrosis factor (TNF)-α, interleukin (IL)-10], progesterone induction block Factor (PIBF) level before and after treatment were compared. Results The effective rate of foetus preservation in treatment group was 93.9%, significantly higher than 79.6% in control group (P < 0.05). The stop time of vaginal bleeding, the disappear time of abdominal pain and the disappear time of back pain in two groups were significantly shorter than those in the control group (P < 0.05). Compared with before treatment, the uterine spiral artery RI and PI in two groups was significantly decreased after treatment (P < 0.05). The decrease was more significant in the treatment group (P < 0.05). After treatment, the levels of serum P and β-HCG in two groups were significantly increased compared with before treatment (P < 0.05). The improvement was more significant in the treatment group (P < 0.05). Compared with before treatment, serum TNF-α level was significantly decreased, but serum IL-10 level was significantly increased in two groups after treatment (P < 0.05). After treatment, the serum TNF-α level in the treatment group was lower than that in the control group, but the serum IL-10 level was higher than that in the control group (P < 0.05). Conclusion Antai Pills combined with progesterone has a definite clinical effect on patients with early threatened abortion. It is a safe and effective solution to relieve the symptoms of patients, and can further improve the uterine blood flow, increase the level of pregnancy maintenance related factors in the body, and correct Th1/Th2 cytokines state of imbalance.

R984

天津市卫生和计划生育委员会科研基金项目(2017kz183)