控释地诺前列酮阴道栓治疗过期妊娠的临床研究

来源 :中国临床药理学杂志 | 被引量 : 0次 | 上传用户:wang____jiang
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目的观察控释地诺前列酮阴道栓与米索前列醇治疗过期妊娠的临床疗效及安全性。方法 58例过期妊娠患者随机分为对照组与试验组,各29例。对照组给予米索前列醇,每次25μg,置于阴道后穹窿,平卧30 min未出现宫缩者,24 h后重复给药1次,连用2 d,重复不超过3次;试验组给予控释地诺前列酮阴道栓,每次10 mg,置于阴道后穹窿深处,平卧30 min,出现规律有效宫缩或24 h后取出药物,连用2 d,重复不超过3次。比较2组患者用药到临产的时间、总产程、分娩过程中出血量、24 h内临产率、引产成功率、临床疗效及安全性。结果治疗后,试验组与对照组用药到临产的时间分别为(18.45±2.63),(27.64±3.67)h,产程分别为(8.87±1.41),(13.56±1.79)h,分娩过程中出血量分别为(24.98±3.56),(43.28±6.15)mL,24 h内临产率分别为72.41%(21/29例),55.17%(16/29例),引产成功率分别为89.66%(26/29例),75.86%(22/29例),2组差异均有统计学意义(均P<0.05)。试验组与对照组的临床有效率分别为93.10%(27/29例),79.31%(23/29例),差异有统计学意义(P<0.05)。对照组出现强直性宫缩2例,胎儿窘迫2例,新生儿窒息1例,产后出血1例,药物不良反应的发生率为20.69%(6/29例);试验组出现强直性宫缩1例,药物不良反应的发生率为3.44%(1/29例),2组药物不良反应发生率差异有统计学意义(P<0.05)。结论与米索前列醇比较,控释地诺前列酮阴道栓能够更有效地促进过期妊娠患者宫颈成熟,引产疗效及安全性均较高。 Objective To observe the clinical efficacy and safety of controlled release dinoprostone vaginal suppository and misoprostol in the treatment of expired pregnancy. Methods 58 cases of obese pregnancy were randomly divided into control group and experimental group, each 29 cases. Control group was given misoprostol, each 25μg, placed in the vaginal fornix, supine 30min did not appear contractions were repeated 24 hours after administration, once every 2 d, repeated no more than 3 times; test group given Controlled release dinoprostone vaginal suppository, each 10 mg, placed in the vaginal vault deep, supine 30 min, the law of effective contractions or withdrawal of drugs after 24 h, once every 2 d, repeated no more than 3 times. The duration of labor, total labor, bleeding during labor, labor productivity within 24 h, success rate of induced labor, clinical efficacy and safety were compared between the two groups. Results After treatment, the time between the treatment and the control group was (18.45 ± 2.63) and (27.64 ± 3.67) h, and the duration of labor was (8.87 ± 1.41) and (13.56 ± 1.79) h respectively. The amount of bleeding during labor (24.98 ± 3.56) and (43.28 ± 6.15) mL, respectively, and the rates of spontaneous labor were 72.41% (21/29) and 55.17% (16/29) respectively within 24 h and 89.66% 29 cases) and 75.86% (22/29 cases) respectively. There were significant differences between the two groups (all P <0.05). The clinical effective rates of the experimental group and the control group were 93.10% (27/29 cases) and 79.31% (23/29 cases) respectively, the difference was statistically significant (P <0.05). In the control group, there were 2 cases of tonic contractions, 2 cases of fetal distress, 1 case of neonatal asphyxia and 1 case of postpartum hemorrhage. The incidence of adverse drug reactions was 20.69% (6/29 cases). In the test group, Cases, the incidence of adverse drug reactions was 3.44% (1/29 cases), two groups of adverse drug reaction rates were statistically significant (P <0.05). Conclusion Compared with misoprostol, controlled release dinoprostone vaginal suppository can more effectively promote cervical maturity in patients with obstetric pregnancy, induction of labor and safety are higher.
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