子宫内膜取样器用于子宫内膜组织学诊断的可行性研究

Clinical feasibility of endometrial sampler in the histological diagnosis of endometrial lesions

目的探讨子宫内膜取样器(简称取样器)用于子宫内膜组织学诊断的可行性。方法采用前瞻性自身对照的方法,通过与宫腔镜下诊断性刮宫比较,评价取样器获取子宫内膜组织及组织学诊断的可靠性、可信性和安全性。结果取样器和诊断性刮宫组获取子宫内膜标本的一致性良好(McNemar检验,P=0.791),子宫内膜组织病理制片质量分级评价两组比较,差异无统计学意义(χ^2=0.188,P=0.910),两组子宫内膜组织学诊断符合率92.56%(137/148)(Kappa=0.870,P<0.001)。取样器取材失败率为12.08%(22/182),制片的失败率为3.16%(5/158),两组取材和制片总的病理诊断失败率分别15.93%(29/182)和14.28%(26/182)(χ^2=0.193,P=0.770),差异无统计学意义。绝经后患者两组取材失败率均为28.99%(20/69),绝经前患者两组取材失败率分别为3.54%(4/113)和1.76%(2/113),两种器械取材均呈现绝经后子宫内膜组织获取率明显低于绝经前(取样器取材组χ^2=25.116,P<0.001;诊断性刮宫χ^2=32.928,P<0.001)。经二元Logistic回归分析显示子宫内膜厚度是取样器和诊断性刮宫失败的唯一独立危险因素。取样器取材无严重不良事件发生。结论子宫内膜取样器可以获取满意的子宫内膜标本,操作简单、患者疼痛感小,对于育龄期及大多数绝经后女性可替代大部分诊断性刮宫。

Objective To investigate the clinical feasibility of endometrial sampler in the diagnosis of endometrial lesions. Methods Prospective self-control method was applied to observe the reliability and feasibility of the endometrial sampler used in patients with endometrial biopsy indications,in compared with hysteroscopic endometrial biopsy subsequently. Endometrial tissue adequacy and histopathologic diagnoses were evaluated and compared between the two different sampling methods of endometrial biopsy in the same patient. The causes of biopsy failure and endometrial tissue inadequacy to make pathological diagnosis were also analyzed. Results The McNemar test for matched-pairs data about obtaining endometrial tissue shows the high consistency between the two groups(McNemar P =0. 791). The coincidence rate of pathological diagnosis of endometrial tissue between the sampler and the curettage group was 92. 56%.The overall diagnostic failure rates were 15. 93%(29/182) and 14. 28%(26/182)(χ2= 0. 193,P = 0. 770) for the sampler and the curettage group,respectively. The rates of none tissue obtained by the two methods were 13. 18%(24/182) and 12. 08%(22/182)(χ2=0. 100,P = 0. 875),respectively. There was no significant difference in the quality of endometrial tissue obtained by the two sampling methods(χ2= 0. 188,P = 0. 910). Endometrial thickness was an independent risk factor for failure in the sampler group by multivariate analysis of high risk factors. The sampling failure rate in postmenopausal women in both groups was significantly higher than that in fertile women(both P < 0. 001). The failure rate in both curettage and sampler groups was 28. 99% in postmenopausal patients. The failure rates of the two sampling methods were 1. 77% and 3. 54% for women of reproductive age,respectively. Conclusion Endometrial sampler was comparable to curettage in terms of tissue adequacy. The operation is simple,and patients have less pain. We definitively recommend the use of endometrial sampler in place of curettage for women of reproductive age and most menopause.