To observe the clinical efficacy and safety of allylestrenol tablet combined with ritodrine hydrochloride tablet in the treatment of patients with gestational diabetes mellitus and threatened premature labor.

The patients with gestational diabetes mellitus threatened premature delivery were divided into treatment group and control group according to the treatment method. The control group received conventional treatment+ritodrine hydrochloride injection (100 mg, intravenous drip, continuous infusion after stopping uterine contraction for 12 h)+ritodrine hydrochloride tablets (10 mg, oral, q2 h on the first day, q4 h on the second day, q6 h on the day 3-7); on the basis of control group, the treatment group was added with allylestradiol tablets (5 mg, orally, 3-4 times a day). The course of treatment for both groups was 7 days. The clinical efficacy, blood glucose-related indicators, inflammatory-related indicators, pregnancy outcomes and neonatal outcomes were compared between the two groups, and safety was evaluated.

A total of 98 cases were included in this study, including 50 cases in control group and 48 cases in treatment group. After treatment, the total clinical effective rates in treatment group and control group were 93.75% (45 cases/48 cases) and 80.00% (40 cases/50 cases), respectively, with statistically significant difference (P<0.05). After treatment, the fasting blood glucose (FBG) levels in treatment group and control group were (5.26±0.11) and (5.28±0.17) mmol·L^-1, respectively; the 2-hour postprandial blood glucose (2 h PG) levels were (6.35±0.25) and (6.42±0.24) mmol·L^-1, respectively; interleukin-6 (IL-6) levels were (6.49±1.06) and (7.13±1.43) pg·mL^-1, respectively; IL-8 levels were (12.59±2.17) and (13.94±2.60) pg·mL^-1, respectively; IL-10 levels were (12.30±2.49) and (11.09±1.95) pg·mL^-1, respectively; prolonged pregnancy duration were (11.67±3.84) and (9.82±2.96) days, respectively; the proportions of vaginal delivery was 66.67% (32 cases/48 cases) and 46.00% (23 cases/50 cases), respectively; postpartum blood loss levels were (185.21±21.49) and (196.58±24.75) mL, respectively; the 1-minute Apgar scores of newborns were (9.04±0.20) and (8.86±0.35) points, respectively; the live birth rates were 97.92% (47 cases/48 cases) and 90.00% (45 cases/50 cases), respectively; the incidences of neonatal respiratory distress syndrome (NRDS) were 4.17% (2 cases/48 cases) and 20.00% (10 cases/50 cases), respectively; the incidences of apnea in premature infants were 4.17% (2 cases/48 cases) and 18.00% (9 cases/50 cases), respectively; the incidences of hematosepsis were 6.25% (3 cases/48 cases) and 14.00% (7 cases/50 cases), respectively; the incidences of neonatal pneumonia were 2.08% (1 cases/48 cases) and 6.00% (3 cases/50 cases), respectively. Except for FBG, 2 h PG, live birth rate, incidences of neonatal sepsis and neonatal pneumonia, the differences in the above indicators between treatment group and control group were all statistically significant (P<0.05, P<0.01). The adverse drug reactions in treatment group were primarily palpitations, nausea and vomiting, and headache, while those in control group mainly included palpitations, constipation, nausea and vomiting. The incidences of adverse drug reactions in treatment group and control group were 6.25% (3 cases/48 cases) and 8.00% (4 cases/50 cases), respectively, with no statistically significant difference (P>0.05).

Allylestrenol tablet combined with ritodrine hydrochloride tablet can effectively treat threatened preterm labor in gestational diabetes mellitus, significantly prolong gestational age, improve inflammatory responses, and optimize pregnancy and neonatal outcomes without increasing the risk of adverse drug reactions.