阴道地西泮联合经皮电神经刺激治疗前庭性疼痛：一项随机对照试验。

Vaginal diazepam plus transcutaneous electrical nerve stimulation to treat vestibulodynia: A randomized controlled trial.

机构信息

Lower Genital Tract Disease Unit, V. Buzzi Hospital-University of Milan, Milan, Italy.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:148-153. doi: 10.1016/j.ejogrb.2018.06.026. Epub 2018 Jun 27.

DOI:10.1016/j.ejogrb.2018.06.026

PMID:29960200

Abstract

OBJECTIVE

To assess the effectiveness of vaginal diazepam in addition to transcutaneous electrical nerve stimulation (TENS) in the treatment of vestibulodynia (VBD).

STUDY DESIGN

This study was a randomized, double-blind, placebo-controlled trial. Forty-two patients with VBD were randomized, 21 underwent diazepam and TENS (diazepam group) and 21 received placebo and TENS (placebo group). Vulvar pain was assessed on a on a 10-cm visual analogue scale (VAS) and dyspareunia according to the Marinoff dyspareunia scale. Vaginal surface electromyography (EMG) and vestibular current perception threshold (CPT) testing were performed at baseline and 60 days after treatment. The primary endpoints included the change in pain and dyspareunia from baseline to 60 days of pain and dyspareunia. The secondary endpoints was the variation in objectivity of pelvic floor muscle (PFM) function and vestibular nerve fiber current perception threshold (CPT).

RESULTS

The VAS scores for pain from basal values of 7.5 and 7.2 for the diazepam and placebo, respectively, showed significant (p 0.01) decreases from 4.7 to 4.3, but this difference was not statistically significant. The Marinoff dyspareunia scores in the diazepam group showed a significant difference (p 0.05) from values measured in the placebo group. The ability to relax the PFM after contraction (difference between maximal contraction and rest tone) was significantly greater for the diazepam group versus the placebo group (3.8 μv and 2.4 μv, respectively, p 0.01). The CPT values for all of the nerve fibers increased after the treatment, but this increase was significant in the diazepam group only for the values at a 5-Hz stimulation (C fibers) with a change of 47.8% vs 26.9% (p < 0.05). Only two patients reported a mild drowsiness in the diazepam group.

CONCLUSIONS

The present study provided indications that vaginal diazepam plus TENS is useful to improve pain and PFM instability in women with VBD.

摘要

目的

评估阴道地西泮联合经皮电神经刺激（TENS）治疗外阴痛（VBD）的疗效。

研究设计

本研究为随机、双盲、安慰剂对照试验。42 例 VBD 患者随机分为两组，21 例接受地西泮联合 TENS（地西泮组），21 例接受安慰剂联合 TENS（安慰剂组）。采用 10cm 视觉模拟评分（VAS）评估外阴疼痛，采用马里诺夫性交痛量表评估性交痛。治疗前和治疗后 60 天进行阴道表面肌电图（EMG）和前庭电流感知阈值（CPT）检查。主要终点包括疼痛和性交痛从基线到 60 天的变化。次要终点为盆底肌（PFM）功能客观性和前庭神经纤维电流感知阈值（CPT）的变化。

结果

地西泮组和安慰剂组的疼痛 VAS 评分分别从基线的 7.5 和 7.2 显著（p<0.01）下降至 4.7 和 4.3，但差异无统计学意义。地西泮组的马里诺夫性交痛评分与安慰剂组相比有显著差异（p<0.05）。与安慰剂组相比，地西泮组在收缩后放松 PFM 的能力（最大收缩与休息张力之间的差异）明显更大（分别为 3.8μv 和 2.4μv，p<0.01）。所有神经纤维的 CPT 值在治疗后均升高，但仅地西泮组在 5Hz 刺激（C 纤维）时的变化有统计学意义（47.8%比 26.9%，p<0.05）。只有 2 例地西泮组患者出现轻度嗜睡。