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经鼻给予催产素治疗慢性盆腔痛:一项随机对照可行性研究。

Intranasal oxytocin as a treatment for chronic pelvic pain: A randomized controlled feasibility study.

机构信息

Department of Psychology, University of Calgary, Calgary, AB, Canada.

Department of Obstetrics & Gynecology, University of Calgary, Calgary, AB, Canada.

出版信息

Int J Gynaecol Obstet. 2021 Mar;152(3):425-432. doi: 10.1002/ijgo.13441. Epub 2020 Dec 8.

Abstract

OBJECTIVE

To investigate the effect of intranasal oxytocin on chronic pelvic pain in a randomized, double-blind, within-subject crossover trial. Aims included: (1) determine intranasal oxytocin's effect on pain intensity and pain interference relative to placebo; (2) assess feasibility and acceptability.

METHODS

Women with chronic pelvic pain were recruited from chronic pain and gynecology clinics between September 2017 and December 2018. Pain was recorded at pre-trial screening, and while administering intranasal oxytocin and placebo. Pain and pain-related interference were measured using the Brief Pain Inventory - Short Form. Feasibility and acceptability were measured using validated measures and interviews.

RESULTS

Twenty-one women were randomized with sufficient data available from 12 to permit analyses. Relative to placebo, a 2-week course of oxytocin administration resulted in improvement in pain severity with no effect on pain-related interference. This effect was driven by four women who demonstrated a minimal clinically significant improvement in pain following intranasal oxytocin (no women met this threshold for placebo). Adherence to dosing was excellent and occurrence of adverse effects did not differ between oxytocin and placebo.

CONCLUSION

Intranasal oxytocin may represent an adjuvant analgesic that could result in a minimal clinically significant improvement in pain among one in three women with chronic pelvic pain. Registration: ClinicalTrials.gov (Registration# NCT02888574).

摘要

目的

在一项随机、双盲、自身交叉试验中,研究鼻内催产素对慢性盆腔疼痛的影响。目的包括:(1)确定鼻内催产素对疼痛强度和疼痛干扰相对于安慰剂的影响;(2)评估可行性和可接受性。

方法

2017 年 9 月至 2018 年 12 月,从慢性疼痛和妇科诊所招募患有慢性盆腔疼痛的女性。在试验前筛查时以及给予鼻内催产素和安慰剂时记录疼痛。使用简明疼痛量表 - 短表评估疼痛和与疼痛相关的干扰。使用经过验证的措施和访谈来衡量可行性和可接受性。

结果

21 名女性被随机分配,有 12 名女性的数据足够进行分析。与安慰剂相比,鼻内催产素给药 2 周可改善疼痛严重程度,但对疼痛相关干扰无影响。这种效果是由四名女性驱动的,她们在鼻内催产素后疼痛有微小的临床显著改善(没有女性达到安慰剂的这一阈值)。给药的依从性非常好,催产素和安慰剂之间不良反应的发生没有差异。

结论

鼻内催产素可能是一种辅助镇痛剂,可以使三分之一患有慢性盆腔疼痛的女性的疼痛得到微小的临床显著改善。注册:ClinicalTrials.gov(注册号 NCT02888574)。

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