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米索前列醇与膀胱充盈子宫复位术用于绝经后患者诊断性宫腔镜检查时缓解疼痛的比较:一项随机对照非劣效性试验

Misoprostol versus uterine straightening by bladder distension for pain relief in postmenopausal patients undergoing diagnostic office hysteroscopy: a randomised controlled non-inferiority trial.

作者信息

Fouda Usama M, Elshaer Hesham S, Elsetohy Khaled A, Youssef Mohamed A

机构信息

Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2016 Aug;203:326-30. doi: 10.1016/j.ejogrb.2016.06.024. Epub 2016 Jul 1.

Abstract

OBJECTIVE

To compare the effectiveness of misoprostol with uterine straightening by bladder distension in minimising the pain experienced by postmenopausal patients during diagnostic office hysteroscopy.

STUDY DESIGN

Seventy-six postmenopausal patients were randomly allocated in a 1:1 ratio to the misoprostol group or to the bladder distension group. Patients in the misoprostol group were instructed to insert two misoprostol tablets (400μg) in the vagina 12h before office hysteroscopy. Patients in the bladder distension group were instructed to drink one litre of water and to avoid urination during a period of 2h before office hysteroscopy. The severity of pain experienced by the patients during and at 30min after the procedure was measured using a 100-mm visual analogue scale (VAS). The ease of passing the hysteroscope through the cervical canal was assessed by the hysteroscopists using a 100-mm VAS.

RESULTS

The passage of the hysteroscope through the cervical canal was easier in the misoprostol group [60.37±15.78 vs. 50.05±19.88, p=0.015]. The mean VAS pain score during the procedure was significantly lower in the misoprostol group [39.47±13.96 vs. 50.18±15.44, p=0.002]. The mean VAS pain score 30min post-procedure was comparable between both groups [11.82±3.71 vs. 12.61±4.06, p=0.379].

CONCLUSION

Vaginal misoprostol is more effective than uterine straightening by bladder distension in relieving the pain experienced by postmenopausal patients during office hysteroscopy.

TRIAL REGISTRATION

Clinicaltrials.gov [NCT02328495]. https://clinicaltrials.gov/ct2/show/NCT02328495.

摘要

目的

比较米索前列醇与膀胱充盈使子宫伸直在减轻绝经后患者诊断性门诊宫腔镜检查时疼痛方面的效果。

研究设计

76例绝经后患者按1:1比例随机分为米索前列醇组或膀胱充盈组。米索前列醇组患者在门诊宫腔镜检查前12小时被指导在阴道内放置两片米索前列醇片(400μg)。膀胱充盈组患者被指导在门诊宫腔镜检查前2小时饮用1升水并避免排尿。使用100毫米视觉模拟量表(VAS)测量患者在手术期间及术后30分钟时经历的疼痛严重程度。宫腔镜检查者使用100毫米VAS评估宫腔镜通过宫颈管的难易程度。

结果

米索前列醇组宫腔镜通过宫颈管更容易[60.37±15.78对50.05±19.88,p = 0.015]。米索前列醇组手术期间的平均VAS疼痛评分显著更低[39.47±13.96对50.18±15.44,p = 0.002]。两组术后30分钟的平均VAS疼痛评分相当[11.82±3.71对12.61±4.06,p = 0.379]。

结论

在减轻绝经后患者门诊宫腔镜检查时的疼痛方面,阴道米索前列醇比膀胱充盈使子宫伸直更有效。

试验注册

Clinicaltrials.gov [NCT02328495]。https://clinicaltrials.gov/ct2/show/NCT02328495

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