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宫腔镜手术前米索前列醇当日宫颈准备的不同给药途径:一项随机双盲试验

Different Routes of Misoprostol for Same-Day Cervical Priming Prior to Operative Hysteroscopy: A Randomized Blinded Trial.

作者信息

Ganer Herman Hadas, Kerner Ram, Gluck Ohad, Feit Hagit, Keidar Ran, Bar Jacob, Sagiv Ron

机构信息

Department of Obstetrics and Gynecology, Edith Wolfson Medical Center, Holon, Israel, affiliated with the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Department of Obstetrics and Gynecology, Edith Wolfson Medical Center, Holon, Israel, affiliated with the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

出版信息

J Minim Invasive Gynecol. 2017 Mar-Apr;24(3):455-460. doi: 10.1016/j.jmig.2016.12.024. Epub 2017 Jan 7.

Abstract

STUDY OBJECTIVE

To compare the effectiveness of and patient satisfaction with different routes of misoprostol administration for short-term cervical priming before operative hysteroscopy.

DESIGN

Randomized blinded trial (Canadian Task Force classification I).

SETTING

University hospital.

PATIENTS

One hundred and twenty patients undergoing operative hysteroscopy.

INTERVENTIONS

Patients were randomly assigned to receive 400 μg of misoprostol administered orally (n = 40), vaginally (n = 40), or sublingually (n = 40) for cervical priming at 1.5 to 4 hours before undergoing operative hysteroscopy.

MEASUREMENTS AND MAIN RESULTS

The primary outcome was preoperative cervical dilatation. Secondary outcomes included cervical consistency, ease of dilation and time of dilation, patient discomfort, and side effects. No differences were noted among the 3 groups in terms of patient age, parity, previous vaginal delivery, menopausal status, and time interval from preparation to procedure. Patients in the 3 groups reported similar discomfort and side effects. Initial mean cervical dilatation was 6.1 ± 2.0 mm in the oral group, 6.4 ± 2.1 in the vaginal group, and 6.4 ± 1.8 mm in the sublingual group (p = .75). Cervical consistency and ease of dilation were similar among the groups. The mean time of dilation was 37.2 ± 30.6 seconds in the oral group, 31.7 ± 29.0 seconds in the vaginal group, and 31.5 ± 21.7 seconds in the sublingual group (p = .59). Additional subanalyses according to menopausal status and parity did not demonstrate any differences among the groups.

CONCLUSION

Same-day cervical priming for operative hysteroscopy is achieved equally with all routes of misoprostol administration, with similar patient satisfaction and side effects.

摘要

研究目的

比较米索前列醇不同给药途径用于宫腔镜手术前短期宫颈准备的有效性及患者满意度。

设计

随机双盲试验(加拿大工作组分类I级)。

地点

大学医院。

患者

120例行宫腔镜手术的患者。

干预措施

患者被随机分配在宫腔镜手术前1.5至4小时接受400μg米索前列醇口服(n = 40)、阴道给药(n = 40)或舌下含服(n = 40)进行宫颈准备。

测量指标及主要结果

主要结局为术前宫颈扩张情况。次要结局包括宫颈质地、扩张的难易程度及扩张时间、患者不适情况和副作用。三组患者在年龄、产次、既往阴道分娩史、绝经状态以及从准备到手术的时间间隔方面无差异。三组患者报告的不适和副作用相似。口服组初始平均宫颈扩张为6.1±2.0mm,阴道组为6.4±2.1mm,舌下含服组为6.4±1.8mm(p = 0.75)。各组间宫颈质地及扩张的难易程度相似。口服组平均扩张时间为37.2±30.6秒,阴道组为31.7±29.0秒,舌下含服组为31.5±21.7秒(p = 0.59)。根据绝经状态和产次进行的额外亚组分析未显示各组间存在差异。

结论

米索前列醇的所有给药途径在宫腔镜手术当日宫颈准备方面效果相同,患者满意度及副作用相似。

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