烯丙雌醇联合地屈孕酮治疗先兆流产高龄初产妇的临床研究  

Clinical trial on the treatment of threatened abortion in elderly primiparas with allylestrenol combined with dydrogesterone

作　　者：鲁晨[1] 丁晨晨[2] 王青[1] 董婷婷 LU Chen;DING Chen-chen;WANG Qing;DONG Ting-ting(Department of Obstetrical,Tengzhou Central People's Hospital,Zaozhuang 277599,Shandong Province,China;Department of Reproductive Medicine,Tengzhou Central People's Hospital,Zaozhuang 277599,Shandong Province,China)

机构地区：[1]滕州市中心人民医院产科,山东枣庄277599 [2]滕州市中心人民医院生殖医学科,山东枣庄277599

出　　处：《中国临床药理学杂志》2024年第24期3553-3557,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察烯丙雌醇片联合地屈孕酮片治疗先兆流产高龄初产妇的临床疗效及其与核因子活化B细胞κ轻链增强(NF-κB)信号通路的关系。方法将先兆流产的高龄初产妇患者随机分为试验组和对照组。对照组给予地屈孕酮片口服,初始剂量为每次30 mg,后续剂量为每次20 mg,tid;试验组在对照组治疗的基础上给予烯丙雌醇片每次5 mg,每天4次。2组患者均持续治疗14 d。比较2组的患者子宫血流搏动指数(PI)与血流阻力指数(RI)、性激素水平、NF-κB、核因子κB p65亚单位(p65)、核因子κB激酶β亚单位(IKK-β)表达。分析NF-κB信号通路及阴道超声参数的相关性,并进行安全性评价。结果试验过程中共脱落5例,最终试验组和对照组分别纳入91例和59例。治疗后,对照组和试验组的保胎成功率分别为79.66%和91.21%,在统计学上差异有统计学意义(P<0.05)。治疗后,对照组和试验组的腹痛时间分别为(5.89±0.94)和(4.26±0.81)d,阴道出血时间分别为(4.75±0.72)和(3.71±0.69)d,PI分别为2.59±0.32和2.15±0.39,RI分别为0.75±0.15和0.69±0.12,β-人绒毛膜促性腺激素水平分别为(6840.31±742.35)和(8042.46±704.51)U·mL^(-1),孕酮水平分别为(29.02±3.26)和(32.18±2.62)nmol·L^(-1),雌二醇水平分别为(914.20±84.34)和(1094.37±85.29)pg·mL^(-1),NF-κB mRNA相对表达水平分别为0.81±0.12和0.74±0.11,p65mRNA相对表达水平分别为0.87±0.11和0.82±0.13,IKK-βmRNA相对表达水平分别为0.85±0.14和0.79±0.12,辅助性T细胞比例分别为(34.18±3.26)%和(32.09±3.15)%,抑制性T细胞比例分别为(30.85±3.62)%和(33.51±3.40)%,Th/Ts值分别为1.05±0.20和0.94±0.18,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(均P<0.05)。试验组和对照组药物不良反应主要有乳房疼痛、恶心呕吐、头痛、下肢轻度水肿、食欲缺乏等。试验组和对照组的药物不良反应总发生率分别为8.79%(8例/91例)和10.17%(6例Objective To observe the clinical efficacy of allylestrenol tablets combined with dydrogesterone tablets in the treatment of threatened abortion of elderly primiparas and its relationship with the nuclear factor kappa-B(NF-κB)signaling pathway.Methods The elderly primiparas with threatened abortion were divided into treatment group and control group according to simple random method.Patients in the control group were po administered with dydrogesterone tablets,the initial dose was 30 mg each time,and the follow-up dose was 20 mg each time,tid.On the basis of the treatment in the control group,the treatment group was treated with allylestradiol tablets 5 mg orally each time,four time a day,and the patients in the two groups were treated continuously for 14 days.The uterine blood flow pulsation index(PI)and blood flow resistance index(RI),sex hormone levels,NF-κB,nuclear factorκB p65subunit(p65),inhibitor kappa B kinase-β(IKK-β)expression were compared between the two groups.The correlation between NF-κB signaling pathway and vaginal ultrasound parameters was analyzed;and conducted safety evaluation.Results A total of 5 cases dropped out during the trial.Finally,91 cases and 59 cases were included in the treatment group and the control group respectively.After treatment,the success rates of fetus preservation in the control group and the treatment group were 79.66%and 91.21%,respectively,and the difference was statistically significant(P<0.05).After treatment,the abdominal pain time of the control group and the treatment group were(5.89±0.94)and(4.26±0.81)d,respectively;the vaginal bleeding time were(4.75±0.72)and(3.71±0.69)d,respectively;the PI were 2.59±0.32 and 2.15±0.39,respectively;the RI were 0.75±0.15 and 0.69±0.12,respectively;β-human chorionic gonadotropin were(6840.31±742.35)and(8042.46±704.51)U·mL^(-1),respectively;progesterone were(29.02±3.26)and(32.18±2.62)nmol·L^(-1),respectively;estradiol were(914.20±84.34)and(1094.37±85.29)pg·mL^(-1),respectively;NF-κB mRNA relative expressi

关 键 词：烯丙雌醇片 地屈孕酮片 先兆流产 高龄初产妇 核因子活化B细胞κ轻链增强信号通路 保胎效果 

分 类 号：R979.2[医药卫生—药品]