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未产妇行门诊宫腔镜检查时米索前列醇给药的最佳时机:一项随机、双盲、安慰剂对照研究。

Optimal timing of misoprostol administration in nulliparous women undergoing office hysteroscopy: a randomized double-blind placebo-controlled study.

机构信息

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

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

出版信息

Fertil Steril. 2016 Jul;106(1):196-201. doi: 10.1016/j.fertnstert.2016.03.022. Epub 2016 Mar 31.

Abstract

OBJECTIVE

To determine the optimal timing of vaginal misoprostol administration in nulliparous women undergoing office hysteroscopy.

DESIGN

Randomized double-blind placebo-controlled study.

SETTING

University teaching hospital.

PATIENT(S): One hundred twenty nulliparous patients were randomly allocated in a 1:1 ratio to the long-interval misoprostol group or the short-interval misoprostol group.

INTERVENTION(S): In the long-interval misoprostol group, two misoprostol tablets (400 μg) and two placebo tablets were administered vaginally at 12 and 3 hours, respectively, before office hysteroscopy. In the short-interval misoprostol group, two placebo tablets and two misoprostol tablets (400 μg) were administered vaginally 12 and 3 hours, respectively, before office hysteroscopy.

MAIN OUTCOME MEASURE(S): The severity of pain was assessed by the patients with the use of a 100-mm visual analog scale (VAS). The operators assessed the ease of the passage of the hysteroscope through the cervical canal with the use of a 100-mm VAS as well.

RESULT(S): Pain scores during the procedure were significantly lower in the long-interval misoprostol group (37.98 ± 13.13 vs. 51.98 ± 20.68). In contrast, the pain scores 30 minutes after the procedure were similar between the two groups (11.92 ± 7.22 vs. 13.3 ± 6.73). Moreover, the passage of the hysteroscope through the cervical canal was easier in the long-interval misoprostol group (48.9 ± 17.79 vs. 58.28 ± 21.85).

CONCLUSION(S): Vaginal misoprostol administration 12 hours before office hysteroscopy was more effective than vaginal misoprostol administration 3 hours before office hysteroscopy in relieving pain experienced by nulliparous patients undergoing office hysteroscopy.

CLINICAL TRIAL REGISTRATION NUMBER

NCT02316301.

摘要

目的

确定经阴道给予米索前列醇对行门诊宫腔镜检查的初产妇的最佳时机。

设计

随机、双盲、安慰剂对照研究。

地点

大学教学医院。

患者

120 名初产妇被随机分为 1:1 比例的长间隔米索前列醇组或短间隔米索前列醇组。

干预

在长间隔米索前列醇组中,分别于门诊宫腔镜检查前 12 小时和 3 小时阴道给予 2 片米索前列醇(400μg)和 2 片安慰剂。在短间隔米索前列醇组中,分别于门诊宫腔镜检查前 12 小时和 3 小时阴道给予 2 片安慰剂和 2 片米索前列醇(400μg)。

主要观察指标

患者采用 100mm 视觉模拟评分(VAS)评估疼痛严重程度。操作者也采用 100mm VAS 评估宫腔镜通过宫颈管的难易程度。

结果

长间隔米索前列醇组术中疼痛评分显著低于短间隔米索前列醇组(37.98±13.13 比 51.98±20.68)。相比之下,两组术后 30 分钟疼痛评分相似(11.92±7.22 比 13.3±6.73)。此外,长间隔米索前列醇组宫腔镜通过宫颈管更容易(48.9±17.79 比 58.28±21.85)。

结论

门诊宫腔镜检查前 12 小时经阴道给予米索前列醇比门诊宫腔镜检查前 3 小时经阴道给予米索前列醇更能有效缓解初产妇门诊宫腔镜检查时的疼痛。

临床试验注册号

NCT02316301。

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