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【文献翻译】荷兰宫颈细胞学异常女性的临床实践差异和过度治疗风险:关于先活检再治疗与即诊即治法的比较

背景

1

只有不多的小型研究将两步法(活检后再治疗)和“see-and-treat”(即诊即治)在细胞学提示低级别或高级别病变转诊阴道镜的女性中做出比较。在荷兰既往的临床实践中,方法的选择各不相同,也没有综述进行归纳总结。

Only a few small studies compared the two-step method (biopsy followed by treatment) with see-and-treat (immediate treatment) in women with both low-grade or high-grade referral cytology. The clinical practice variation in the Netherlands has not been reviewed before.

目的

2

本研究旨在探讨术前辅助放疗或放化疗联合根治性手术对宫颈癌患者病理结果的影响。

To investigate the effect of preoperative radiotherapy or chemoradiotherapy combined with radical surgery on pathological outcomes in cervical cancer patients.

为了确定因为细胞学异常而转诊阴道镜的女性中先活检后治疗和即诊即治法的过度治疗率,同时评估在荷兰的临床实践中的差异。

To determine overtreatment rates in the two-step versus see-and-treat approach in women referred for colposcopy because of abnormal cytology and to evaluate clinical practice variation in the Netherlands.

研究设计

3

本研究是一项基于人群的回顾性队列研究,囊括了2016至2017年之间在荷兰病理注册中心(PALGA)有明确宫颈病变组织学结果的36,581名女性。过度治疗的比值比(OR)被定义为最终病理结果≤CIN1,并且确定先活检后治疗和即诊即治法与年龄、hr-HPV和细胞学的关系。

A population-based retrospective cohort study including 36,581 women with a histologic result of the cervix identified from the Dutch Pathology Registry (PALGA) between 2016-2017. Odds ratios of overtreatment primarily defined as cervical intraepithelial neoplasia grade 1 or less were determined for the two-step and see-and-treat approach in relation to age, high risk human papillomavirus status, and referral cytology.

结果

4

在纳入的女性中,有10,713名女性(占29.3%)接受了两步法,有6,851名女性(占18.7%)接受了即诊即治法,19,017名妇女(52.0%)在接受阴道镜检查-组织学评估-细胞学随访后选择了保守治疗或其他类型治疗。尽管国际指南中仅推荐在已生育且怀疑高级别病变的情况下选择即诊即治,但是荷兰的临床实践对于两种策略的选择存在较大差异,选择即诊即治的女性比例可从7.0%到88.3%。在接受即诊即治和两步法治疗的女性中,细胞学检查和治疗的中位间隔时间分别为1个月和2个月(范围为0-12个月)。共有4,119名妇女(23.5%)被过度治疗,其中老年女性、高危HPV阴性、细胞学检查提示低级别病变均是过度治疗的高危因素。具有低级别细胞学结果且接受即诊即治的女性比接受两步法的女性的过度治疗率更高(65.0% (1,414/ 2,174) 比32.1% (1,161/ 3,613);OR 3.34;95%CI 2.92-3.82)。在细胞学结果为高级别病变的女性中,即诊即治组比两步法组的过度治疗率低(11.3% (529/ 4,677) 比 14.3% (1,015/ 7,100) ; OR 0.68; 95%CI 0.58 to 0.81).。

Of the included women 10,713 women (29.3%) received the two-step method, 6,851 women (18.7%) underwent see-and-treat, and 19,017 women (52.0%) received conservative management after colposcopy with histologic assessment with cytologic follow-up or another type of treatment. Despite the existence of a national guideline, advising see-and-treat only in case of suspecting high-grade disease in women who completed their childbearing, there is a wide practice variation between the two strategies in the Netherlands with 7.0-88.3% of the women receiving see-and-treat per laboratory. The median time between cytology and treatment was one and two months (range 0-12) in women receiving see-and treat and the two-step method, respectively. A total of 4,119 women (23.5%) were overtreated with older women, high risk human papillomavirus negative women, and women with low-grade cytology being more likely to be overtreated. Women with low-grade cytology and see-and-treat were associated with a higher overtreatment rate than women receiving the two-step method (65.0% (1,414/ 2,174) versus 32.1% (1,161/ 3,613), respectively; OR 3.34; 95%CI 2.92 to 3.82). However, in women with high-grade cytology see-and-treat was inversely associated with overtreatment (11.3% (529/ 4,677) versus 14.3% (1,015/ 7,100), respectively; OR 0.68; 95%CI 0.58 to 0.81).

结论

5

在已完成生育且细胞学结果提示高级别病变的情况下,适宜推荐选择即诊即治法。在荷兰,两种医疗策略的实践之间存在广泛差异,妇科医生应接受指南推荐以防止过度治疗。

See-and-treat is only justified in women with high-grade cytology and who completed their childbearing. There is a wide practice variation between the two strategies in the Netherlands and gynecologists should adhere to the guidelines to prevent overtreatment.

译者注:即诊即治是一种不同于宫颈癌“三阶梯”诊断的筛查策略,在细胞学及阴道镜均提示高级别病变时直接行宫颈锥切术,省略了活检的步骤。在明确手术指征的前提下,即诊即治减少了就诊次数,节约了医疗费用及时间,但应警惕过度治疗的可能。

参考文献

Loopik D L, Siebers A G, Melchers W J G, et al. Clinical practice variation and overtreatment risk in women with abnormal cervical cytology in the Netherlands; two-step versus see-and-treat approach[J]. American journal of obstetrics and gynecology, 2019.

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撰稿 | 刘硕子

编辑 | 陈丹

责任编辑 | 刘雨奇

审稿 | 樊碧娆 江路

审核 | 陶霞

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