Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Laarbeeklaan 101, B-1090 Brussels, Belgium.
Hum Reprod. 2010 Jun;25(6):1451-7. doi: 10.1093/humrep/deq076. Epub 2010 Apr 10.
This study aimed to evaluate the potential benefit, in terms of pain relief, of the new oral fast-release orodispersible galvanic form of tramadol in women undergoing hysterosalpingography (HSG) with either a metal cannula or a balloon catheter.
In a randomized, double-blind, placebo-controlled, 2 x 2 factorial-design trial, conducted at a single academic centre, 128 women were assigned into groups: (I) tramadol and a metal cannula, (II) tramadol and a balloon catheter, (III) placebo and a metal cannula or (IV) placebo and a balloon catheter. The primary end-point was pain registered by the patients on 10-cm visual analogue scales (VASs) at various times during and after the procedure. Secondary end-points included side effects and pain as assessed by the same physician during HSG.
The main effect of tramadol versus placebo medication (i.e. I and II versus III and IV) was a statistically significant difference (P < 0.001) in self-reported VAS of -0.91 (-1.35 to -0.47) on the absolute and -33% (-48% to -17%) on the relative scale in favour of tramadol. Likewise, there was a significant benefit for tramadol against placebo medication for physician-perceived VAS pain scores (39% relative reduction; P < 0.001). The main effect of the balloon catheter versus metal cannula (i.e. II and IV versus I and III) was a non-significant (P = 0.82) difference in patient-reported VAS of -0.05 (-0.49 to +0.39) and -2% (-21% to +17%). There were no medication-HSG device interactions and no differences in side effects.
During and after HSG, fast-release orodispersible tramadol significantly reduces pain without increasing side effects.
本研究旨在评估新的口服速释口腔分散片型曲马多在使用金属管或球囊导管进行子宫输卵管造影（HSG）的女性中在缓解疼痛方面的潜在益处。
在一项在单一学术中心进行的随机、双盲、安慰剂对照、2 x 2 析因设计试验中，将 128 名女性分为四组：（I）曲马多+金属管，（II）曲马多+球囊导管，（III）安慰剂+金属管或（IV）安慰剂+球囊导管。主要终点是患者在手术期间和之后的不同时间使用 10 厘米视觉模拟量表（VAS）记录的疼痛。次要终点包括在 HSG 期间和之后由同一位医生评估的副作用和疼痛。
曲马多与安慰剂药物（即 I 和 II 与 III 和 IV）的主要作用是在自我报告的 VAS 上有统计学显著差异（P < 0.001），绝对值为-0.91（-1.35 至-0.47），相对值为-33%（-48%至-17%），有利于曲马多。同样，曲马多在医生感知的 VAS 疼痛评分方面也明显优于安慰剂药物（相对减少 39%；P < 0.001）。球囊导管与金属管的主要作用（即 II 和 IV 与 I 和 III）是患者报告的 VAS 差异无统计学意义（P = 0.82），差异为-0.05（-0.49 至+0.39）和-2%（-21%至+17%）。药物与 HSG 设备之间没有相互作用，副作用也没有差异。
在 HSG 期间和之后，速释口腔分散片型曲马多可显著减轻疼痛，而不会增加副作用。
