Article(id=1292130222858592628, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130221843571059, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.08.003, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1773417600000, receivedDateStr=2026-03-14, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785997451747, onlineDateStr=2026-08-06, pubDate=1777305600000, pubDateStr=2026-04-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785997451747, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785997451747, creator=13701087609, updateTime=1785997451747, updator=13701087609, issue=Issue{id=1292130221843571059, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='8', pageStart='1051', pageEnd='1200', issueExtLink='null', onlineDate='null', pubDate='1777305600000', pubDateStr='2026-04-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785997451505, creator='13701087609', updateTime=1786014411018, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201355276480844, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130221843571059, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201355276480845, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130221843571059, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1064, endPage=1069, ext={EN=ArticleExt(id=1292130223047336309, articleId=1292130222858592628, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of allylestrenol combined with ritodrine hydrochloride in the treatment of pregnant women with gestational diabetes mellitus and threatened premature labor, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective 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.
Methods 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.
Results 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).
Conclusion 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.
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目的 观察烯丙雌醇片联合盐酸利托君片治疗妊娠期糖尿病先兆早产患者的临床疗效和安全性。
方法 将本院收治的妊娠期糖尿病先兆早产患者依据治疗方法分为试验组和对照组。对照组进行常规治疗+盐酸利托君注射液（100 mg，静滴，宫缩停后继续滴注12 h）+盐酸利托君片（10 mg，口服，第1天q2 h；第2天q4 h；第3~7天q6 h）；试验组在对照组基础上加用烯丙雌醇片（5 mg，口服，每日3~4次）。2组疗程均为7 d。比较2组患者的临床疗效、血糖相关指标、炎症相关指标、妊娠临床结局、新生儿临床结局，并进行安全性评价。
结果 本研究共纳入98例，其中对照组50例、试验组48例。治疗后，试验组和对照组的治疗临床总有效率分别为93.75%（45例/48例）和80.00%（40例/50例），在统计学上差异有统计学意义（P<0.05）。治疗后，试验组和对照组的空腹血糖（FBG）分别为（5.26±0.11）和（5.28±0.17）mmol·L-1，餐后2 h血糖（2 h PG）分别为（6.35±0.25）和（6.42±0.24）mmol·L-1，白介素-6（IL-6）分别为（6.49±1.06）和（7.13±1.43）pg·mL-1，IL-8分别为（12.59±2.17）和（13.94±2.60）pg·mL-1，IL-10分别为（12.30±2.49）和（11.09±1.95）pg·mL-1，妊娠延长时间分别为（11.67±3.84）和（9.82±2.96）d，阴道分娩比例分别为66.67%（32例/48例）和46.00%（23例/50例），产后出血量分别为（185.21±21.49）和（196.58±24.75）mL，新生儿1 min阿普加（Apgar）评分分别为（9.04±0.20）和（8.86±0.35）分，活产比例分别为97.92%（47例/48例）和90.00%（45例/50例），新生儿呼吸窘迫综合征（NRDS）发生率分别为4.17（2例/48例）和20.00%（10例/50例），早产儿呼吸暂停发生率分别为4.17%（2例/48例）和18.00%（9例/50例），新生儿败血症发生率分别为6.25%（3例/48例）和14.00%（7例/50例），新生儿肺炎发生率分别为2.08%（1例/48例）和6.00%（3例/50例）。除FBG、2 h PG、活产比例及新生儿败血症、新生儿肺炎的发生率外，试验组的上述指标与对照组比较，在统计学上差异均有统计学意义（P<0.05，P<0.01）。试验组的药物不良反应主要有心悸、恶心呕吐和头痛，对照组主要有心悸、便秘和恶心呕吐。试验组和对照组的药物不良反应总发生率分别为6.25%（3例/48例）和8.00%（4例/50例），在统计学上差异无统计学意义（P>0.05）。
结论 烯丙雌醇片联合盐酸利托君片可以有效治疗妊娠期糖尿病先兆早产，显著延长孕周，改善炎症反应，并优化妊娠结局与新生儿结局，且不增加药物不良反应风险。
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郭云霞（1985-），女，主治医师，主要从事围产医学方面的临床工作和研究
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