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硝酸甘油对未生育女性宫内节育器放置体验的影响:一项试点研究。

The effect of nitroglycerin on the IUD insertion experience in nulliparous women: a pilot study.

作者信息

Micks Elizabeth A, Jensen Jeffrey T, Bednarek Paula H

机构信息

Department of Obstetrics and Gynecology, University of Washington, Box 356460, Seattle, WA 98195-6460, USA.

Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR, USA.

出版信息

Contraception. 2014 Jul;90(1):60-5. doi: 10.1016/j.contraception.2014.03.012. Epub 2014 Mar 27.

Abstract

OBJECTIVE

Concern about pain during placement of an intrauterine device (IUD) represents a barrier to use, especially among nulliparous women. We hypothesized that nitroglycerin gel applied vaginally 30 min prior to IUD placement would reduce insertion-related pain.

STUDY DESIGN

We designed a randomized, double-blinded, placebo-controlled pilot study to evaluate the efficacy and tolerability of 0.5-mg nitroglycerin gel (1 mL) or identical placebo gel applied vaginally in nulliparous women 30 min prior to IUD placement. The study was limited to women who opted for the levonorgestrel-releasing intrauterine system. Subjects completed a series of 100-mm visual analogue scales at several time points. The primary outcome was subject-reported pain with passage of the IUD through the cervix. Secondary outcomes included subject-reported pain at other time points, provider-reported ease of insertion, side effects, adverse events and need for additional dilation.

RESULTS

A total of 24 women were randomized. Baseline characteristics were similar between groups. The mean pain score with IUD deployment was 55.0 mm [standard deviation (SD) = 29.7 mm] in the placebo group and 57.4 mm (SD 22.1 mm) in the nitroglycerin group (p=.82). There was no difference in ease of insertion reported by providers. Two subjects required dilation, one in each group.

CONCLUSION

Vaginal administration of 0.5-mg nitroglycerin gel 30 min prior to IUD placement does not appear to decrease patient-reported procedural pain among nulliparous women or ease of insertion for providers.

摘要

目的

对于宫内节育器(IUD)放置过程中疼痛的担忧是其使用的一个障碍,在未生育女性中尤为如此。我们假设在放置IUD前30分钟经阴道应用硝酸甘油凝胶可减轻放置相关疼痛。

研究设计

我们设计了一项随机、双盲、安慰剂对照的试验性研究,以评估在未生育女性放置IUD前30分钟经阴道应用0.5毫克硝酸甘油凝胶(1毫升)或相同的安慰剂凝胶的疗效和耐受性。该研究仅限于选择左炔诺孕酮宫内节育系统的女性。受试者在几个时间点完成一系列100毫米视觉模拟评分。主要结局是受试者报告的IUD通过宫颈时的疼痛。次要结局包括受试者在其他时间点报告的疼痛、医护人员报告的放置难易程度、副作用、不良事件以及是否需要额外扩张宫颈。

结果

共有24名女性被随机分组。两组的基线特征相似。安慰剂组IUD放置时的平均疼痛评分为55.0毫米[标准差(SD)=29.7毫米],硝酸甘油组为57.4毫米(SD 22.1毫米)(p = 0.82)。医护人员报告的放置难易程度没有差异。两名受试者需要扩张宫颈,每组各一名。

结论

在未生育女性中,放置IUD前30分钟经阴道给予0.5毫克硝酸甘油凝胶似乎并未减轻患者报告的操作疼痛,也未使医护人员放置更轻松。

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