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通过子宫内膜活检中神经纤维的检测诊断子宫内膜异位症:一项双盲研究。

Diagnosis of endometriosis by detection of nerve fibres in an endometrial biopsy: a double blind study.

机构信息

Department of Obstetrics and Gynaecology, Queen Elizabeth II Research Institute for Mothers and Infants, University of Sydney, Sydney, NSW 2006, Australia.

出版信息

Hum Reprod. 2009 Dec;24(12):3019-24. doi: 10.1093/humrep/dep275. Epub 2009 Aug 18.

DOI:10.1093/humrep/dep275
PMID:19690352
Abstract

BACKGROUND

Diagnosis of endometriosis currently requires a laparoscopy and this need probably contributes to the considerable average delay in diagnosis. We have reported the presence of nerve fibres in the functional layer of endometrium in women with endometriosis, which could be used as a diagnostic test. Our aim was to assess efficacy of nerve fibre detection in endometrial biopsy for making a diagnosis of endometriosis in a double-blind comparison with expert diagnostic laparoscopy.

METHODS

Endometrial biopsies, with immunohistochemical nerve fibre detection using protein gene product 9.5 as marker, taken from 99 consecutive women presenting with pelvic pain and/or infertility undergoing diagnostic laparoscopy by experienced gynaecologic laparoscopists, were compared with surgical diagnosis.

RESULTS

In women with laparoscopic diagnosis of endometriosis (n = 64) the mean nerve fibre density in the functional layer of the endometrial biopsy was 2.7 nerve fibres per mm(2) (+/-3.5 SD). Only one woman with endometriosis had no detectable nerve fibres. Six women had endometrial nerve fibres but no active endometriosis seen at laparoscopy. The specificity and sensitivity were 83 and 98%, respectively, positive predictive value was 91% and negative predictive value was 96%. Nerve fibre density did not differ between different menstrual cycle phases. Women with endometriosis and pain symptoms had significantly higher nerve fibre density in comparison with women with infertility but no pain (2.3 and 0.8 nerve fibre per mm(2), respectively, P = 0.005).

CONCLUSIONS

Endometrial biopsy, with detection of nerve fibres, provided a reliability of diagnosis of endometriosis which is close to the accuracy of laparoscopic assessment by experienced gynaecological laparoscopists. This study was registered with the Australian Clinical Trials Registry (ACTR) 00082242 (registered: 12/12/2007). The study was approved by the Ethics Review Committee (RPAH Zone) of the Sydney South West Area Health Service (Protocol number X05-0345) and The University of Sydney Human Research Ethics Committee (Ref. No. 10761) and all women gave their informed consent for participation.

摘要

背景

目前诊断子宫内膜异位症需要进行腹腔镜检查,这种需求可能导致诊断的平均延迟时间相当长。我们已经报告了在患有子宫内膜异位症的女性的功能层子宫内膜中存在神经纤维,这些神经纤维可以用作诊断测试。我们的目的是评估在子宫内膜活检中检测神经纤维在诊断子宫内膜异位症方面的功效,通过与经验丰富的妇科腹腔镜检查者进行的专家诊断腹腔镜检查进行双盲比较。

方法

对 99 名因盆腔疼痛和/或不孕而就诊并接受经验丰富的妇科腹腔镜检查者进行诊断性腹腔镜检查的连续女性进行子宫内膜活检,使用蛋白质基因产物 9.5 作为标记物进行免疫组织化学神经纤维检测,并将其与手术诊断进行比较。

结果

在腹腔镜诊断为子宫内膜异位症的女性(n=64)中,子宫内膜活检中功能层的神经纤维密度平均为 2.7 根纤维/平方毫米(+/-3.5 标准差)。只有一位患有子宫内膜异位症的女性没有检测到神经纤维。六位女性的子宫内膜有神经纤维,但腹腔镜检查未见活动型子宫内膜异位症。特异性和敏感性分别为 83%和 98%,阳性预测值为 91%,阴性预测值为 96%。神经纤维密度在不同的月经周期阶段之间没有差异。有疼痛症状的子宫内膜异位症患者的神经纤维密度明显高于无疼痛的不孕患者(分别为 2.3 和 0.8 根纤维/平方毫米,P=0.005)。

结论

检测神经纤维的子宫内膜活检提供了接近经验丰富的妇科腹腔镜检查者评估的子宫内膜异位症诊断的准确性。这项研究在澳大利亚临床试验注册处(ACTR)注册(注册号:ACTR00082242;注册日期:2007 年 12 月 12 日)。该研究得到了悉尼西南地区卫生服务机构(RPAH 区)伦理审查委员会(方案编号 X05-0345)和悉尼大学人类研究伦理委员会(参考编号 10761)的批准,所有女性均签署了知情同意书。

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