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尽管遵循了临床指南,但“不应发生的事件”仍时有发生:以卵巢透明细胞癌与其他上皮组织学亚型相比,静脉血栓栓塞症的情况为例。

When 'never-events' occur despite adherence to clinical guidelines: the case of venous thromboembolism in clear cell cancer of the ovary compared with other epithelial histologic subtypes.

机构信息

Division of Gynecologic Oncology, University of Virginia Health Systems, Charlottesville, VA 22903, USA.

出版信息

Gynecol Oncol. 2010 Mar;116(3):374-7. doi: 10.1016/j.ygyno.2009.10.069.

DOI:10.1016/j.ygyno.2009.10.069
PMID:19922988
Abstract

OBJECTIVE

To determine the incidence of clinically significant venous thromboembolism (VTE) in women diagnosed with clear cell carcinoma of the ovary (CCC-O) interpreted in the context of Centers for Medicare and Medicaid Services (CMS) 'never-events.'

METHODS

Using the institutional pathology Tumor Registry at the Massachusetts General Hospital (MGH), all women diagnosed with a CCC-O from 1994 to 2004 were identified. Controls with epithelial ovarian cancer of other histologies were matched for stage, age and year of diagnosis. Medical records were abstracted and pathology reviewed. All patients had surgical staging and/or cytoreductive surgery by a Gynecologic Oncologist at the MGH. All patients received appropriate peri- and post-operative prophylaxis with subcutaneous heparin and/or sequential compression devices. VTE was diagnosed with standard imaging techniques when clinical suspicion arose.

RESULTS

Fifty-eight (58) women were diagnosed with CCC-O during the study period, 43 of whom had complete data available for analysis. Patients with Stage I or II disease comprised 70% of the patients. The mean age of the cohort was 55 and the mean weight 71 kg. Eighty-six (86) age, stage, and year of diagnosis matched controls were selected. The majority of controls had serous tumors (47%) with the remainder being endometrioid (33%), mucinous (14%), transitional cell (2%), sarcoma (2%) and mixed (2%). CCC-O was often seen in association with endometriosis 70% compared with 22% of controls (p<0.0001). Overall, 18 of 43 CCC-O patients (42%) had VTE while only 19 of 86 control patients (22%) had VTE (p=0.024, OR=2.5 CI 1.1504-5.60). The rate of VTE was not influenced by weight or smoking. In the CCC-O patients, seventeen percent (17%) of VTE was diagnosed at presentation while 50% was diagnosed postoperatively and 33% at the time of disease recurrence or progression. Overall, including cases and controls, late stage disease was more likely associated with VTE (18 of 39, 46%) vs. early stage disease (19 of 90, 21%), p=0.004.

CONCLUSIONS

Women with CCC-O have a 2.5-times greater risk of disease related VTE than women with other histologies of epithelial ovarian cancer despite adherence to prophylactic guidelines. Given the high rate of VTE postoperatively as well as with disease recurrence, one should consider indefinite therapeutic anticoagulation in women with CCC-O. The case of CCC-O is one example of the impracticality of payment denial for 'never-events,' as VTE arises despite best efforts at prevention.

摘要

目的

确定在医疗保险和医疗补助服务中心(CMS)“永不发生”的背景下,被诊断为透明细胞卵巢癌(CCC-O)的女性中临床显著静脉血栓栓塞(VTE)的发生率。

方法

利用马萨诸塞州综合医院(MGH)的机构病理学肿瘤登记处,确定了 1994 年至 2004 年间所有被诊断为 CCC-O 的女性。与其他组织学上皮性卵巢癌的对照者按分期、年龄和诊断年份相匹配。提取病历并进行病理复查。所有患者均由 MGH 的妇科肿瘤学家进行了手术分期和/或减瘤手术。所有患者均接受了皮下肝素和/或序贯压迫装置等适当的围手术期和术后预防。当临床怀疑时,使用标准影像学技术诊断 VTE。

结果

在研究期间,58 名女性被诊断为 CCC-O,其中 43 名患者有完整的数据可供分析。I 期或 II 期疾病患者占患者的 70%。队列的平均年龄为 55 岁,平均体重为 71 公斤。选择了 86 名年龄、分期和诊断年份匹配的对照组。大多数对照组为浆液性肿瘤(47%),其余为子宫内膜样(33%)、黏液性(14%)、移行细胞(2%)、肉瘤(2%)和混合性(2%)。CCC-O 常与子宫内膜异位症有关,占 70%,而对照组为 22%(p<0.0001)。总体而言,43 名 CCC-O 患者中有 18 名(42%)发生 VTE,而 86 名对照组患者中有 19 名(22%)发生 VTE(p=0.024,OR=2.5,CI 1.1504-5.60)。VTE 的发生率不受体重或吸烟的影响。在 CCC-O 患者中,17%(17%)的 VTE 在就诊时诊断,50%在术后诊断,33%在疾病复发或进展时诊断。总体而言,包括病例和对照组,晚期疾病与 VTE 更相关(39 例中有 18 例,46%),而早期疾病(90 例中有 19 例,21%),p=0.004。

结论

尽管遵循预防指南,患有 CCC-O 的女性发生与疾病相关的 VTE 的风险是其他上皮性卵巢癌组织学类型女性的 2.5 倍。鉴于术后以及疾病复发时 VTE 的高发生率,应对 CCC-O 患者进行无限期的抗凝治疗。CCC-O 病例是“永不发生”的支付否决不切实际的一个例子,因为尽管尽了最大努力预防,但仍会发生 VTE。

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