前列腺癌的前列腺特异性抗原 (PSA) 筛查导致前列腺癌死亡率略有下降，但同时也导致低风险肿瘤的过度诊断。前列腺特异性抗原水平受使用降胆固醇他汀类药物的影响，但他汀类药物使用与 PSA 筛查性能的关联尚不清楚。调查他汀类药物的使用是否与基于 PSA 的随机前列腺癌筛查干预的结果相关。

这项基于人群的随机临床试验队列的事后亚组分析使用了基于人群的芬兰前列腺癌筛查随机研究的数据，该研究将 1996 年 3 月 1 日至 12 月 31 日期间的男性随机分配到 PSA 筛查或常规护理组， 1999 年，随访一直持续到 2015 年 12 月 31 日。人口包括基线时年龄在 55 至 67 岁之间并居住在芬兰坦佩雷或赫尔辛基地区的所有男性。 1996 年至 2009 年他汀类药物的购买信息来自国家处方登记处。符合条件的男性是从芬兰的人口登记处确定的。基线时流行的前列腺癌病例被排除在外。数据分析时间为 2019 年 1 月 1 日至 2021 年 3 月 31 日。

该研究包括 78 606 名男性（中位年龄，59 岁 [范围，55-67 岁]），并提供他汀类药物购买数据。尽管 PSA 筛查与未使用他汀类药物的人前列腺癌发病率增加有关（筛查与对照，每 1000 人年分别为 11.2 和 8.6）；比率 [RR], 1.31; 95% CI，1.24-1.38），在他汀类药物使用者中未观察到类似的发病率增加（每 1000 人年 6.9 对 5.9；RR，1.02；95% CI，0.95-1.10；交互作用 P < .001）。低风险（格里森评分 6）和局限性肿瘤的发生率在他汀类药物使用者中较低，而格里森评分为 8 至 10 的肿瘤检出率相似。无论是否使用他汀类药物，筛查都与较低的转移性肿瘤发生率相关。

Abstract

Importance: Prostate-specific antigen (PSA) screening for prostate cancer has resulted in a slight reduction in prostate cancer mortality but also a concomitant overdiagnosis of low-risk tumors. Prostate-specific antigen levels are affected by use of cholesterol-lowering statin drugs, but the association of statin use with PSA screening performance is unknown.

Objective: To investigate whether statin use was associated with outcomes of a randomized PSA-based prostate cancer screening intervention.

Design, setting, and participants: This post hoc subgroup analysis of a cohort from a population-based randomized clinical trial used data from the population-based Finnish Randomized Study of Prostate Cancer Screening, which randomized men to PSA screening or routine care from March 1, 1996, to December 31, 1999, with follow-up continuing until December 31, 2015. The population included all men aged 55 to 67 years at baseline and residing in the Tampere or Helsinki districts of Finland. Information on statin purchases from 1996 to 2009 was obtained from a national prescription registry. Eligible men were identified from the population registry of Finland. Prevalent prostate cancer cases at baseline were excluded. Data were analyzed from January 1, 2019 to March 31, 2021.

Interventions: Three invitations for PSA screening at 4-year intervals from 1996 to 2007 vs routine care.

Main outcomes and measures: Risk for prostate cancer overall, high-risk disease, and prostate cancer mortality in the screening group vs the control group as an intention-to-treat analysis. The analysis was stratified by statin use.

Results: The study comprised 78 606 men (median age, 59 years [range, 55-67 years]) with statin purchase data available. Although PSA screening was associated with increased prostate cancer incidence among statin nonusers (screening vs control, 11.2 vs 8.6 per 1000 person-years); rate ratio [RR], 1.31; 95% CI, 1.24-1.38), no similar increase in incidence was observed among statin users (6.9 vs 5.9 per 1000 person-years; RR, 1.02; 95% CI, 0.95-1.10; P < .001 for interaction). Incidence of low-risk (Gleason score 6) and localized tumors was lower among statin users, whereas detection of tumors with a Gleason score of 8 to 10 was similar. Screening was associated with a lower incidence of metastatic tumors regardless of statin use.

Conclusion and relevance: In this post hoc subgroup analysis of a cohort from a population-based randomized clinical trial, PSA screening among statin users was associated with a decreased incidence of advanced prostate cancer that was similar among statin nonusers, but with less increase in detection of low-grade localized tumors in statin users than in nonusers. These findings suggest that statin use does not materially compromise benefits of PSA-based screening.

原文链接

pubmed.ncbi.nlm.nih.gov/34817559/

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