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Multicenter Study
. 2017 Jan 20;37(1):18-23.
doi: 10.3969/j.issn.1673-4254.2017.01.04.

[Clinical efficacy and safety of controlled-release dinoprostone insert: a multicenter retrospective study]

[Article in Chinese]
Affiliations
Multicenter Study

[Clinical efficacy and safety of controlled-release dinoprostone insert: a multicenter retrospective study]

[Article in Chinese]
Xue-Yuan Li et al. Nan Fang Yi Ke Da Xue Xue Bao. .

Abstract

Objective: To analyze the effectiveness and safety of controlled-release dinoprostone insert for term labor induction in the Pearl River Delta of Guangdong province.

Methods: Twenty hospitals using controlled-release dinoprostone insert for term labor induction in the Pearl River Delta of Guangdong province were stratified into provincial hospitals and municipal hospitals, and three hospitals of each level were selected as research units. According to the inclusion and exclusion criteria, 1390 pregnant women receiving term labor induction using controlled-release dinoprostone insert were retrospectively analyzed to evaluate the the effectiveness and safety with another 957 pregnant women with induced abortion using oxytocin as the control group.

Results: Compared with the control group, the controlled-release dinoprostone insert group showed a significantly longer length of the latent phase of labor (4.06∓2.65 vs 3.20∓2.08 h, P=0.003, 95%CI [0.182, 0.920]) and shorter lengths of the active phase (1.73∓1.32 vs 2.22∓1.75 h, P=0.000, 95%CI [-0.795, -0.363]) and the second stage of labor (0.49∓0.37 vs 0.54∓0.43 h, P=0.003, 95%CI [-0.137, -0.028]). No significant differences were found in the length of the first stage of labor, the vaginal delivery rate, adverse reactions, or fetal outcomes between the two groups.

Conclusion: Controlled-release dinoprostone insert is effective and safe for labor induction at term.

目的: 大样本分析广东省珠三角地区5年中地诺前列酮栓用于孕晚期引产的临床疗效和安全性。

方法: 将广东省珠三角地区使用地诺前列酮栓进行孕晚期引产的20家医院按医院级别分层,省级医院和市区级医院各选取三家医院作为研究单位。按照严格的纳入标准和剔除标准筛选出6家医院2010年1月~2014年12月1390例地诺前列酮栓引产病例作为研究组,并抽取同期957例单纯使用缩宫素引产病例作为对照组,回顾性分析地诺前列酮栓的临床疗效及安全性。

结果: 地诺前列酮栓组的第1产程潜伏期时长为4.06±2.65 h,长于缩宫素组3.20±2.08 h,2组相比结果有统计学意义[P=0.003,95% CI(0.182,0.920)],地诺前列酮栓组活跃期及第2产程时长为1.73±1.32 h/0.49±0.37 h,短于缩宫素组2.22±1.75 h/0.54±0.43 h,两组相比结果有统计学意义[P=0.000,95% CI(-0.795,-0.363)/P=0.003,95% CI(-0.137,-0.028)],两组相比第1产程及总产程无统计学差异;两组经阴道分娩率无统计学差异;母婴不良反应发生率无统计学差异。

结论: 孕晚期地诺前列酮栓引产的安全性与缩宫素相似,临床疗效优于缩宫素,是一种安全有效的引产方法。

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