绝经后出血的诊断性检查：一项随机对照试验。

Diagnostic workup for postmenopausal bleeding: a randomised controlled trial.

机构信息

Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, the Netherlands.

Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, Maastricht, the Netherlands.

出版信息

BJOG. 2017 Jan;124(2):231-240. doi: 10.1111/1471-0528.14126. Epub 2016 May 26.

DOI:10.1111/1471-0528.14126

PMID:27225535

Abstract

OBJECTIVE

To evaluate the effectiveness of hysteroscopy for the detection and treatment of endometrial polyps versus expectant management in women with postmenopausal bleeding (PMB), a thickened endometrium and benign endometrial sampling.

DESIGN

Multicentre, randomised controlled trial.

SETTING

Three academic hospitals and nine non-academic teaching hospitals in the Netherlands.

POPULATION

Women with PMB, an endometrial thickness >4 mm and benign result from endometrial sampling.

METHODS

Women were randomised to either further diagnostic workup by hysteroscopy (preceded by saline infusion sonography) or expectant management.

MAIN OUTCOMES

The primary outcome measure was recurrence of PMB within a year after randomisation. Secondary outcome measures were time to recurrent bleeding and recurrent bleeding after more than 1 year. In the hysteroscopy group, the presence of polyps and the results of their histology were registered.

RESULTS

Between January 2010 and October 2013, 200 women were randomised; 98 to hysteroscopy and 102 to expectant management. Within 1 year a total of 15 women (15.3%) in the hysteroscopy group experienced recurrent bleeding, versus 18 (18.0%) in the expectant management group (relative risk 0.85 (95% CI 0.46-1.59). In the hysteroscopy group, 50/98 (51%) polyps were diagnosed of which 6/98 (6%) showed evidence of endometrial (pre)malignancy; final pathology results after hysterectomy showed three women with hyperplasia with atypia and three women with endometrial cancer.

CONCLUSION

In women with PMB, a thickened endometrium and benign endometrial sampling, operative hysteroscopy does not reduce recurrent bleeding. Hysteroscopy detected focal endometrial (pre)malignancy in 6% of women who had benign endometrial sampling. This finding indicates that in these women, further diagnostic workup is warranted to detect focal (pre)malignancies, missed by blind endometrial sampling.

TWEETABLE ABSTRACT

In women with PMB, hysteroscopy does not reduce recurrent bleeding but is warranted to detect focal malignancy.

摘要

目的

评估宫腔镜检查在绝经后出血（PMB）、子宫内膜增厚和良性子宫内膜取样的女性中检测和治疗子宫内膜息肉的有效性，与期待治疗相比。

设计

多中心、随机对照试验。

地点

荷兰 3 家学术医院和 9 家非学术教学医院。

人群

PMB、子宫内膜厚度>4mm 和子宫内膜取样良性的女性。

方法

将女性随机分为进一步行宫腔镜检查（盐水灌注超声检查前）或期待治疗。

主要结果测量

随机分组后 1 年内 PMB 复发的主要结局指标。次要结局指标是再次出血的时间和 1 年以上再次出血。在宫腔镜组，记录息肉的存在及其组织学结果。

结果

2010 年 1 月至 2013 年 10 月期间，共随机分配了 200 名女性，98 名接受宫腔镜检查，102 名接受期待治疗。在 1 年内，宫腔镜组共有 15 名（15.3%）女性出现再次出血，而期待治疗组有 18 名（18.0%）（相对风险 0.85（95%CI 0.46-1.59）。在宫腔镜组中，诊断出 50/98（51%）息肉，其中 6/98（6%）显示子宫内膜（前）恶性证据；子宫切除术后的最终病理结果显示 3 例为不典型增生，3 例为子宫内膜癌。