探讨子宫内膜癌(EC)术中冷冻切片病理检查的诊断准确性及其影响因素。

选择2006年1月至2014年12月，北京军区总医院妇产科诊治的170例EC患者为研究对象。以术后石蜡包埋切片病理检查结果为诊断金标准，比较所有EC患者术中冷冻切片病理检查在诊断肿瘤细胞级别、组织学类型、肌层浸润深度及宫颈累及方面的敏感度和特异度差异，及影响术中冷冻切片病理检查粗符合率的临床因素。本研究遵循的程序符合北京军区总医院人体试验委员会制定的伦理学标准，得到该委员会批准，并与患者签署临床研究知情同意书。

①在肿瘤细胞级别的诊断上，术中冷冻切片病理检查诊断低分化的敏感度(87.5%)分别较诊断高分化、中分化的敏感度(74.7%、56.1%)高，且差异有统计学意义(χ²＝4.28、23.97，P＝0.028、0.000)；诊断低分化的特异度(98.4%)较诊断高分化的特异度(75.4%)高，且差异有统计学意义(χ²＝22.65，P＝0.000)。②在肿瘤组织学类型的诊断上，术中冷冻切片病理检查诊断为Ⅰ型的敏感度(88.5%)较诊断为Ⅱ型的敏感度(33.3%)高，诊断为Ⅰ型的特异度(45.5%)较诊断为Ⅱ型的特异度(88.8%)低，且差异均有统计学意义(χ²＝63.99、43.03，P＝0.000、0.000)。③在诊断肿瘤肌层浸润深度上，术中冷冻切片病理检查诊断深肌层浸润的敏感度(95.0%)较诊断浅肌层浸润的敏感度(86.5%)高，且差异有统计学意义(χ²＝4.61，P＝0.032)；诊断深肌层浸润的特异度(99.2%)与浅肌层浸润的特异度(95.5%)比较，差异则无统计学意义(χ²＝1.52，P＝0.218)。④在诊断宫颈累及方面，术中冷冻切片病理检查诊断宫颈累及的敏感度(20.0%)较诊断无宫颈累及的敏感度(100.0%)低，诊断宫颈累及的特异度(100.0%)较无宫颈累及的特异度(20.0%)高，且差异均有统计学意义(χ²＝133.33、133.33，P＝0.000、0.000)。⑤研究的10项临床因素中，肥胖、组织学类型为Ⅰ型及低分化EC患者术中冷冻切片病理检查在诊断肿瘤细胞级别方面的粗符合率(81.9%、72.4%、91.7%)较无肥胖、组织学类型为Ⅱ型及高/中分化EC患者(63.8%、0、65.6%)高，且差异均有统计学意义(P<0.05)；有阴道异常出血或排液、肥胖、有高血压和(或)糖尿病及宫腔深度≥8 mm的EC患者术中冷冻切片病理检查在诊断肌层浸润深度上准确性较高，但在诊断肌层浸润深度方面的粗符合率(91.4%、94.5%、93.4%、95.2%)较无阴道异常出血或排液、无肥胖、无高血压和(或)糖尿病及宫腔深度<8 mm的EC患者(28.6%、78.3%、84.3%、86.0%)高，且差异均有统计学意义(P<0.05)。

术中冷冻切片病理检查在诊断肌层浸润深度上准确性较高，但在EC肿瘤细胞级别、组织学类型、宫颈累及的诊断上有一定局限性。EC患者在术中的手术范围不能完全依据冷冻切片病理检查结果进行判断。

To investigate the diagnostic accuracy and influencing factors of intraoperative frozen section pathological examination in endometrial carcinoma(EC).

From January 2006 to December 2014, 170 patients with EC who were hospitalized in the department of Gynecology and Obstetrics, Military General Hospital of Beijing, were chosen as study objects. The diagnostic gold standard was postoperative paraffin embedded biopsy results. The sensitivity and specificity differences of intraoperative frozen biopsy in the diagnosis of tumor cell level, tumor histological type, depth of myometrial infiltration and cervical involvement of all EC patients, and clinical influencing factors of rough coincidence rate of intraoperative frozen section pathological examination were analyzed. The procedures of this study accord with the ethical standards established by the Human Testing Committee of Military General Hospital of Beijing, and get the approval of the committee, and the patients signed the informed consent.

①For intraoperative frozen section pathological examination in the diagnosis of tumor cell level, the sensitivity of poorly differentiated(87.5%) was higher than that of well or moderately differentiated (74.7%, 56.1%) , respectively, and the differences were statistically significant(χ²=4.28, 23.97; P=0.028, 0.000). The specificity of poorly differentiated(98.4%) was higher than that of well-differentiated (75.4%), and the difference was statistically significant(χ²=22.65, P=0.000). ②For intraoperative frozen section pathological examination in the diagnosis of tumor histological type, the sensitivity of type Ⅰ(88.5%) was higher than that of type Ⅱ(33.3%), the specificity of typeⅠ(45.5%) was lower than that of type Ⅱ(88.8%), and the differences were statistically significant(χ²=63.99, 43.03; P=0.000, 0.000). ③For intraoperative frozen section pathological examination in the diagnosis of depth of myometrial infiltration, the sensitivity of deep myometrial infiltration(95.0%) was higher than that of no invasion or superficial myometrial infiltration(86.5%), and the difference was statistically significant(χ²=4.61, P=0.032). There was no significant difference between specificity of deep myometrial infiltration and no invasion or superficial myometrial infiltration(99.2%vs 95.5%, χ²=1.52, P=0.218). ④For intraoperative frozen section pathological examination in the diagnosis of cervical involvement, the sensitivity of cervical involvement(20.0%) was lower than that of without cervical involvement(100.0%), the specificity of cervical involvement(100.0%) was higher than that of without cervical involvement(20.0%), and the differences were statistically significant (χ²=133.33, 133.33; P=0.000, 0.000). ⑤Among 10 clinical factors of this study, the rough coincidence rate of obesity, type Ⅰ tumor histology and poorly differentiated(81.9%, 72.4%, 91.7%) of EC patients with intraoperative frozen section pathological examination in the diagnosis of tumor cell level, were higher than those of no obesity, type Ⅱ tumor histology and well and moderately differentiated(63.8%, 0, 65.6%), and the differences were statistically significant(P<0.05). The rough coincidence rate of abnormal vaginal bleeding or discharge, obesity, hypertension and (or) diabetes mellitus and uterine cavity depth more than or equal 8 mm(91.4%, 94.5%, 93.4%, 95.2%) of EC patients with intraoperative frozen section pathological examination in the diagnosis of myometrial infiltration depth, were higher than those of without abnormal vaginal bleeding or discharge, no obesity, no hypertension and(or) diabetes mellitus and uterine cavity depth less than 8 mm (28.6%, 78.3%, 84.3%, 86.0%), and the differences were statistically significant(P<0.05).

Intraoperative frozen section pathological examination has a higher accuracy in the diagnosis of depth of muscular layer invasion, but has some limitations in the diagnosis of tumor cell level, tumor histological type and cervical involvement. Surgery intraoperative scope of EC cannot be completely based on the results of frozen section pathological examination.