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比较宫腔球囊与宫内节育器在宫腔镜粘连松解术后预防粘连复发疗效的随机对照试验

Randomized, controlled trial comparing the efficacy of intrauterine balloon and intrauterine contraceptive device in the prevention of adhesion reformation after hysteroscopic adhesiolysis.

作者信息

Lin Xiao-Na, Zhou Feng, Wei Min-Ling, Yang Yang, Li Ying, Li T C, Zhang Song-Ying

机构信息

Center for Reproductive Medicine, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Zhejiang, People's Republic of China.

Department of Reproductive Medicine, Prince of Wales Hospital, Chinese University of Hong Kong, Hong Kong, People's Republic of China.

出版信息

Fertil Steril. 2015 Jul;104(1):235-40. doi: 10.1016/j.fertnstert.2015.04.008. Epub 2015 Apr 30.

DOI:10.1016/j.fertnstert.2015.04.008
PMID:25936237
Abstract

OBJECTIVE

To compare the efficacy of heart-shaped intrauterine balloon and intrauterine contraceptive device (IUD) in the prevention of adhesion reformation after hysteroscopic adhesiolysis.

DESIGN

Prospective, randomized, controlled trial.

SETTING

University hospital.

PATIENT(S): A total of 201 women with Asherman syndrome.

INTERVENTION(S): Women were randomized to having either a heart-shaped intrauterine balloon or an IUD fitted after hysteroscopic adhesiolysis. The devices were removed after 7 days. A second-look hysteroscopy was carried out 1 to 2 months after the surgery.

MAIN OUTCOME MEASURE(S): Incidence of adhesion reformation and reduction of adhesion score before and after surgery.

RESULT(S): Initially 201 cases were recruited; 39 cases dropped out, resulting in 82 cases in the balloon group and 80 cases in IUD group. The age, menstrual characteristics, pregnancy history, and American Fertility Society score before surgery were comparable between the two groups. The median adhesion score reduction (balloon group, 7; IUD group, 7) and the adhesion reformation rate (balloon group, 30%; IUD group, 35%) were not significantly different between the two groups.

CONCLUSION(S): The heart-shaped intrauterine balloon and IUD are of similar efficacy in the prevention of adhesion reformation after hysteroscopic adhesiolysis for Asherman syndrome.

CLINICAL TRIAL REGISTRATION NUMBER

ISRCTN 69690272.

摘要

目的

比较心形宫内球囊与宫内节育器(IUD)在宫腔镜粘连松解术后预防粘连复发的疗效。

设计

前瞻性、随机、对照试验。

地点

大学医院。

患者

共201例患有阿谢曼综合征的女性。

干预措施

女性在宫腔镜粘连松解术后被随机分配植入心形宫内球囊或IUD。7天后取出装置。术后1至2个月进行二次宫腔镜检查。

主要观察指标

粘连复发率以及手术前后粘连评分的降低情况。

结果

最初招募了201例患者;39例退出,最终球囊组82例,IUD组80例。两组术前的年龄、月经特征、妊娠史和美国生育协会评分具有可比性。两组的粘连评分中位数降低情况(球囊组为7分;IUD组为7分)和粘连复发率(球囊组为30%;IUD组为35%)无显著差异。

结论

对于阿谢曼综合征,心形宫内球囊与IUD在宫腔镜粘连松解术后预防粘连复发方面疗效相似。

临床试验注册号

ISRCTN 69690272。

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