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术前氢溴酸东莨菪碱预处理对不明原因不孕妇女行子宫输卵管造影诊断近端输卵管阻塞的效果:一项随机双盲对照试验。

Effect of Premedication Hyoscine-N-Butylbromide before Hysterosalpingography for Diagnosis of Proximal Tubal Obstruction in Infertile Women: A Randomized Double-Blind Controlled Trial.

机构信息

Department of Obstetrics and Gynaecology, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.

Department of Obstetrics and Gynaecology, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.

出版信息

J Minim Invasive Gynecol. 2019 Jan;26(1):110-116. doi: 10.1016/j.jmig.2018.03.034. Epub 2018 Apr 24.

DOI:10.1016/j.jmig.2018.03.034
PMID:29702271
Abstract

STUDY OBJECTIVE

To assess the effect of hyoscine-N-butylbromide (HBB) as premedication on the rate of proximal tubal obstruction during hysterosalpingography (HSG).

DESIGN

A randomized, double-blind controlled trial (Canadian Task Force classification I).

SETTING

The Infertility Clinic of Songklanagarind Hospital.

PATIENTS

One hundred and forty-six infertile women indicated for HSG investigation.

INTERVENTIONS

Between May 1, 2016, and March 31, 2017, patients were assigned at random to receive either oral HBB 20 mg or placebo 30 minutes before the HSG procedure. If proximal tubal obstruction was found, participants were be assigned to undergo a second confirming HSG or laparoscopy with chromopertubation within 6 months.

MEASUREMENTS AND MAIN RESULTS

The primary outcome was the rate of proximal tubal obstruction. The secondary outcome was the false-positive result of proximal tubal occlusion from HSG. Proximal tubal obstruction was found in 6 of 70 patients in the HBB group and in 16 of 71 in the placebo group. The rate of proximal tubal obstruction was significantly lower in the HBB group than in the placebo group (8.6% vs 22.5%; p = .04; absolute difference, 13.9%; 95% confidence interval [CI], 0.02-0.26; relative risk, 0.38; 95% CI, 0.16-0.92). After the second HSG or laparoscopy was performed (n = 22), the rate of false occlusion was 20% (1 of 6 patients) in the HBB group, compared with 69.2% (9 of 16 patients) in the placebo group.

CONCLUSION

Premedication with HBB before HSG can reduce the rate of diagnosis of proximal tubal obstruction and false occlusion.

摘要

研究目的

评估氢溴酸东莨菪碱(HBB)作为术前用药对子宫输卵管造影(HSG)中近端输卵管阻塞率的影响。

设计

随机、双盲对照试验(加拿大任务组分类 I)。

地点

宋卡那桂医院不孕不育科。

患者

146 名因 HSG 检查而就诊的不孕女性。

干预措施

2016 年 5 月 1 日至 2017 年 3 月 31 日期间,患者被随机分配口服 HBB 20mg 或安慰剂 30 分钟后进行 HSG 检查。如果发现近端输卵管阻塞,患者将在 6 个月内进行第二次确认性 HSG 或腹腔镜下 chromopertubation。

测量和主要结果

主要结局是近端输卵管阻塞率。次要结局是 HSG 显示近端输卵管闭塞的假阳性结果。HBB 组 70 例患者中有 6 例发现近端输卵管阻塞,安慰剂组 71 例中有 16 例。HBB 组近端输卵管阻塞率明显低于安慰剂组(8.6%比 22.5%;p=0.04;绝对差异,13.9%;95%置信区间[CI],0.02-0.26;相对风险,0.38;95%CI,0.16-0.92)。在进行第二次 HSG 或腹腔镜检查后(n=22),HBB 组中有 1 例(6 例中的 1 例)发生假阻塞,而安慰剂组中有 9 例(16 例中的 9 例)发生假阻塞。

结论

HSG 前用 HBB 进行预处理可以降低近端输卵管阻塞和假阻塞的诊断率。

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