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控释地诺前列酮栓的临床疗效与安全性:一项多中心回顾性研究

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

作者信息

Li Xue-Yuan, Guo Yue-Wen, Xu Yan-Wen, Zhu Bin, Wu Xue-Xue, Chen Xiang, Wang Xiao-Yi, Chen Dun-Jin, Chen Hui, Zhang Jian-Ping, Wang Zhi-Jian, An Sheng-Li

机构信息

Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.E-mail:

出版信息

Nan Fang Yi Ke Da Xue Xue Bao. 2017 Jan 20;37(1):18-23. doi: 10.3969/j.issn.1673-4254.2017.01.04.

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.

摘要

目的

分析控释地诺前列酮栓用于广东省珠江三角洲地区足月引产的有效性和安全性。

方法

将广东省珠江三角洲地区20家使用控释地诺前列酮栓进行足月引产的医院分为省级医院和市级医院,各选取3家医院作为研究单位。根据纳入和排除标准,回顾性分析1390例使用控释地诺前列酮栓进行足月引产的孕妇,以另外957例使用缩宫素引产的孕妇作为对照组,评估其有效性和安全性。

结果

与对照组相比,控释地诺前列酮栓组的潜伏期明显延长(4.06±2.65 vs 3.20±2.08小时,P = 0.003,95%CI [0.182, 0.920]),活跃期(1.73±1.32 vs 2.22±1.75小时,P = 0.000,95%CI [-0.795, -0.363])和第二产程(0.49±0.37 vs 0.54±0.43小时,P = 0.003,95%CI [-0.137, -0.028])明显缩短。两组在第一产程长度、阴道分娩率、不良反应或胎儿结局方面未发现显著差异。

结论

控释地诺前列酮栓用于足月引产有效且安全。

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