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宫腔镜检查前阴道米索前列醇促宫颈成熟的最佳剂量:一项随机双盲研究。

Optimal Dose of Vaginal Misoprostol for Cervical Ripening before Hysteroscopy: A Randomized Double-Blind Study.

机构信息

Department of Obstetrics and Gynecology, CHA Gumi Medical Center, CHA University, Seoul, Republic of Korea.

Comprehensive Gynecologic Cancer Center, Department of Obstetrics and Gynecology, CHA Bundang Medical Center, CHA University, Seoul, Republic of Korea.

出版信息

J Minim Invasive Gynecol. 2018 Sep-Oct;25(6):1031-1034. doi: 10.1016/j.jmig.2018.01.022. Epub 2018 Jan 31.

DOI:10.1016/j.jmig.2018.01.022
PMID:29409965
Abstract

STUDY OBJECTIVE

To evaluate the optimal dose of vaginal misoprostol (200 and 400 µg) for cervical priming before operative hysteroscopy.

DESIGN

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

SETTING

A university hospital.

PATIENTS

Sixty-eight patients undergoing operative hysteroscopy.

INTERVENTIONS

Patients were randomized to receive a low (200 µg) or high (400 µg) dose of misoprostol administered vaginally 8 hours before operative hysteroscopy.

MEASUREMENTS AND MAIN RESULTS

The primary outcome was perioperative dilatation time, and the secondary outcome measurements included the subjective difficulty of cervical dilatation assessed by the surgeon, operative time, self-reported adverse events after vaginal administration and before the start of the operation, and complications during the procedure. A comparison of the 200-µg (n = 34) and 400-µg (n = 34) misoprostol cohorts revealed similarities when comparing time with cervical dilatation, operative difficulty, result, and time. Misoprostol-related adverse events were significantly lower in the 200-µg cohort than the 400-µg cohort (58.8% vs 85.3%, p = .015). Abdominal pain was the most common adverse event and was higher in the 400-µg cohort compared with the 200-µg cohort (73.5% vs 50.0%, p = .046). However, there were no operative delays resulting from adverse events, and all individuals reported the procedure to be tolerable and recovered without medication or treatment.

CONCLUSION

Both 200 µg and 400 µg vaginally administered misoprostol are effective for cervical dilatation, and we recommend vaginal administration of 200 µg misoprostol for cervical dilatation 8 hours before operative hysteroscopy because of lower adverse events in the 200-µg group as well as similar efficacy between cohorts.

摘要

研究目的

评估阴道给予米索前列醇(200 和 400μg)用于宫腔镜术前宫颈预处理的最佳剂量。

设计

随机、对照、双盲试验(加拿大治疗强度分级 I 类)。

地点

一所大学医院。

患者

68 例行宫腔镜手术的患者。

干预措施

患者随机接受低剂量(200μg)或高剂量(400μg)米索前列醇阴道给药,于宫腔镜术前 8 小时给药。

测量和主要结果

主要结局为围手术期扩张时间,次要结局测量指标包括术者评估的宫颈扩张主观难度、手术时间、阴道给药后和手术开始前的自我报告不良事件,以及手术过程中的并发症。比较 200μg(n=34)和 400μg(n=34)米索前列醇组时,两组在宫颈扩张时间、手术难度、结果和时间方面均相似。低剂量组米索前列醇相关不良事件发生率显著低于高剂量组(58.8%比 85.3%,p=0.015)。腹痛是最常见的不良事件,高剂量组发生率高于低剂量组(73.5%比 50.0%,p=0.046)。然而,没有因不良事件导致手术延迟,所有患者均报告手术耐受,无需药物或治疗即可恢复。

结论

阴道给予 200μg 和 400μg 米索前列醇均能有效扩张宫颈,我们建议在宫腔镜术前 8 小时阴道给予 200μg 米索前列醇进行宫颈扩张,因为低剂量组不良事件发生率较低,且两组间疗效相似。

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Effectiveness of Misoprostol in Office Hysteroscopy in Premenopausal Nulliparous Women: A Prospective Randomized Double-Blind Placebo-Controlled Trial.米索前列醇在绝经前未生育女性门诊宫腔镜检查中的有效性:一项前瞻性随机双盲安慰剂对照试验
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