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育龄期患者诊断性宫腔镜检查前使用阴道米索前列醇:一项随机临床试验。

Vaginal misoprostol prior to diagnostic hysteroscopy in patients of reproductive age: a randomized clinical trial.

作者信息

Valente Emanuelle Pessa, de Amorim Melania Maria Ramos, Costa Aurélio Antônio Ribeiro, de Miranda Danielle Veríssimo

机构信息

Instituto Materno-Infantil Prof. Fernando Figueira, Recife, Brazil.

出版信息

J Minim Invasive Gynecol. 2008 Jul-Aug;15(4):452-8. doi: 10.1016/j.jmig.2008.04.001. Epub 2008 Jun 6.

DOI:10.1016/j.jmig.2008.04.001
PMID:18539093
Abstract

STUDY OBJECTIVE

To assess pain during and after diagnostic hysteroscopy in patients of reproductive age according to use of vaginal misoprostol.

DESIGN

A randomized, triple-masked, controlled clinical trial (Canadian Task Force classification I).

SETTING

Diagnostic center at Instituto Materno Infantil de Pernambuco-Brazil.

PATIENTS

A total of 45 women of reproductive age underwent diagnostic anesthesia-free hysteroscopy.

INTERVENTIONS

In all, 400 mg of vaginal misoprostol or placebo was administered to randomized patients before diagnostic hysteroscopy.

MEASUREMENTS AND MAIN RESULTS

The clinical trial was interrupted in patients receiving misoprostol because of significant vaginal bleeding precluding the procedure (p = .0006). No significant difference existed in pain scores between the groups. Vaginal bleeding was the main side effect occurring in 11 patients of the misoprostol group. No vaginal bleeding occurred in the placebo group (p = .00002).

CONCLUSION

In the doses used, vaginal misoprostol induced vaginal bleeding and precluded diagnostic hysteroscopy in patients of reproductive age that limits continuation of this line of research. Further studies are needed to reassess the use of the drug in patients of this age group.

摘要

研究目的

根据阴道米索前列醇的使用情况,评估育龄期患者在诊断性宫腔镜检查期间及之后的疼痛情况。

设计

一项随机、三盲、对照临床试验(加拿大工作组分类I级)。

地点

巴西伯南布哥州妇幼研究所诊断中心。

患者

共有45名育龄期女性接受了无麻醉诊断性宫腔镜检查。

干预措施

在诊断性宫腔镜检查前,将400毫克阴道米索前列醇或安慰剂随机给予患者。

测量指标及主要结果

由于米索前列醇组患者出现大量阴道出血,无法进行该检查,导致该临床试验中断(p = 0.0006)。两组之间的疼痛评分无显著差异。阴道出血是米索前列醇组11名患者出现的主要副作用。安慰剂组未出现阴道出血(p = 0.00002)。

结论

在所使用的剂量下,阴道米索前列醇会引起阴道出血,导致育龄期患者无法进行诊断性宫腔镜检查,这限制了该研究方向的继续进行。需要进一步研究重新评估该药物在这个年龄组患者中的使用情况。

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引用本文的文献

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The use of misoprostol for cervical priming prior to hysteroscopy: a systematic review and analysis.米索前列醇在宫腔镜检查前用于宫颈准备:一项系统评价与分析
Drug Des Devel Ther. 2016 Sep 6;10:2789-2801. doi: 10.2147/DDDT.S111625. eCollection 2016.