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一项关于酮洛芬或阴道内米索前列醇用于门诊宫腔镜检查时减轻疼痛的随机、单盲、安慰剂对照试验。

A randomized, single blind, placebo-controlled trial for the pain reduction during the outpatient hysteroscopy after ketoprofen or intravaginal misoprostol.

作者信息

Issat Tadeusz, Beta Jaroslaw, Nowicka Malgorzata A, Maciejewski Tomasz, Jakimiuk Artur J

机构信息

Department of Obstetrics, Women's Diseases, and Oncogynecology, Central Clinical Hospital of Ministry of Interior and Administration; Center for Reproductive Health.

Department of Obstetrics, Women's Diseases, and Oncogynecology, Central Clinical Hospital of Ministry of Interior and Administration.

出版信息

J Minim Invasive Gynecol. 2014 Sep-Oct;21(5):921-7. doi: 10.1016/j.jmig.2014.04.006. Epub 2014 Apr 24.

Abstract

STUDY OBJECTIVE

To assess the efficacy of ketoprofen vs intravaginal misoprostol for pain relief during outpatient hysteroscopy.

DESIGN

Prospective, randomized, single-blind, placebo-controlled clinical trial (Canadian Task Force classification I).

SETTING

Tertiary medical center.

PATIENTS

One hundred fifty women referred for hysteroscopy between January and October 2013.

INTERVENTIONS

Women were randomized to receive vaginal misoprostol, 400 μg, with 100 mL of 5% intravenous glucose (misoprostol arm); intravenous ketoprofen, 50 mg/mL, in 100 mL 5% glucose with intravaginal placebo (ketoprofen arm); or vaginal placebo tablets, 100 mL 5% intravenous glucose (placebo arm) before outpatient hysteroscopy.

MEASUREMENTS AND MAIN RESULTS

A visual analog scale (VAS) was used for 1-dimensional pain assessment. Patients were asked to mark a VAS score before, during, and at 5 and 15 minutes after the procedure. Median VAS scores during and directly after the anesthesia-free hysteroscopy were significantly lower in the misoprostol group than in the ketoprofen (p = .02) or placebo (p = .006) groups. There were no statistical differences between the 3 arms in median VAS score assessed at 15 minutes after the procedure (p = .16). There were no differences in procedure time between groups (p = .16).

CONCLUSION

When administrated 4 hours before the procedure, 400 μg vaginal misoprostol seems to reduce the pain during and immediately after hysteroscopy. The effect does not depend on patient age, hormone status, parity, or type of outpatient hysteroscopy (operative or diagnostic).

摘要

研究目的

评估酮洛芬与阴道用米索前列醇在门诊宫腔镜检查时缓解疼痛的疗效。

设计

前瞻性、随机、单盲、安慰剂对照临床试验(加拿大工作组分类I级)。

地点

三级医疗中心。

患者

2013年1月至10月间转诊来接受宫腔镜检查的150名女性。

干预措施

女性被随机分组,分别在门诊宫腔镜检查前接受阴道用米索前列醇400μg加100mL 5%静脉葡萄糖(米索前列醇组);静脉注射酮洛芬50mg/mL加100mL 5%葡萄糖及阴道用安慰剂(酮洛芬组);或阴道用安慰剂片加100mL 5%静脉葡萄糖(安慰剂组)。

测量指标及主要结果

采用视觉模拟评分法(VAS)进行一维疼痛评估。要求患者在手术前、手术期间以及手术后5分钟和15分钟标记VAS评分。米索前列醇组在无麻醉宫腔镜检查期间及检查刚结束时的VAS评分中位数显著低于酮洛芬组(p = 0.02)或安慰剂组(p = 0.006)。术后15分钟评估的VAS评分中位数在三组之间无统计学差异(p = 0.16)。各组间手术时间无差异(p = 0.16)。

结论

在手术前4小时给药时,400μg阴道用米索前列醇似乎可减轻宫腔镜检查期间及检查刚结束后的疼痛。该效果不取决于患者年龄、激素状态、产次或门诊宫腔镜检查类型(手术或诊断性)。

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