HeJie1ChenWanqing1LiNi1CaoWei1YeDingwei2MaJianhui1XingNianzeng1PengJi3TianJinhui4China Prostate Cancer Screening and Early Diagnosis and Early Treatment Guidelines Development Expert GroupWorking Group on Formulation of Guidelines for Prostate Cancer Screening, Early Diagnosis and Early Treatment in China1National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China2Fudan University Shanghai Cancer Center, Shanghai 200032, China3Shenzhen Center for Chronic Disease Control and Prevention, Shenzhen 518020, China4Evidence-Based Medicine Center of Lanzhou University, Lanzhou 730000, China
通信作者:赫捷,国家癌症中心 国家肿瘤临床医学研究中心 中国医学科学院北京协和医学院肿瘤医院,北京 100021, Email: hejie@cicams.ac.cnCorresponding author: He Jie, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China, Email: hejie@cicams.ac.cn
证据检索与评价小组对纳入的随机对照试验采用Cochrane偏倚风险评价工具进行评价[9],对纳入的队列研究采用纽卡斯尔-渥太华量表进行评价[10],对病例系列研究采用英国国立临床优化研究所的评价工具进行评价[11],对指南使用AGREEⅡ进行评价[12]。评价过程由两人独立完成,若存在分歧,则共同讨论或咨询第三方解决。使用推荐意见分级的评估、制定及评价(Grading of Recommendations Assessment,Development and Evaluation,GRADE)方法对证据质量和推荐意见进行分级[13],详见表1。
2014年发表的一项Meta分析(AMSTAR=6)显示,1995年前列腺特异抗原(prostate specific antigen, PSA)检测时代之前,吸烟与前列腺癌的发生风险呈正相关(RR=1.06,95% CI:1.00~1.12)[35],GRADE分级为极低。同年美国卫生部门报告指出,吸烟与晚期及低分化前列腺癌的风险增加有关[36]。但PSA检测时代之前与之后患者群的巨大变化、吸烟是否会导致前列腺癌发生风险的上升尚不明确,需要更多高质量研究证据。同时,吸烟所处生命时期及戒烟情况对前列腺癌发生的影响也需要进一步深入探究[37]。
对于肥胖与前列腺癌发生风险的关联报告并不一致。2014年一篇Meta分析(AMSTAR=6)结果表明,体质指数(body mass index, BMI)每增加5 kg/m2,患前列腺癌的风险增加15%(OR=1.15,95% CI:0.98~1.34)[38],GRADE分级为极低,而一些研究中未观察到成年早期至中年的体重增加与前列腺癌发生的关联[39,40]。二者的关联也可能因疾病阶段不同而存在差异。2013年发表的一篇系统评价表明,肥胖可能与侵袭性前列腺癌的发生有关[41]。2012年发表的一篇Meta分析(AMSTAR=5)结果表明,BMI每增加5 kg/m2,局限性前列腺癌发病风险降低6%(RR=0.94,95% CI:0.91~0.97),而恶性前列腺癌发病风险增加9%(RR=1.09,95% CI:1.02~1.16)[42],GRADE分级为极低。因此,肥胖可能会增加前列腺癌的发生风险,但需要更高级别的证据阐明二者之间的关联,目前尚缺乏亚洲人群的大型研究数据。
基于PSA检测开展的前列腺癌筛查可能引起筛查假阳性。大型随机对照研究中,约1/4~1/3接受PSA筛查的男性至少有1次阳性筛查结果,超过10%的男性经历了至少1次假阳性结果[64,65]。在美国大规模前列腺、肺、结直肠、卵巢癌筛查试验(prostate,lung,colorectal and ovarian cancer screening trial, PLCO)中,筛查假阳性导致约10%的男性经历了至少1次活检[66]。欧洲前列腺癌筛查随机试验(the European randomized study of screening for prostate cancer, ERSPC)中,70岁以上男性的假阳性率高于55岁以下年轻男性(分别为20.6%和3.5%)[64]。在英国的一项前瞻性队列研究中,经历活检后7.3%的男性报告有中重度疼痛,5.5%的男性报告中度至重度发热,26.6%的男性报告活检后35 d内出现血精症[67]。英国队列中1.3%的男性、美国退伍军人队列中1.6%的男性和鹿特丹研究队列中0.5%的男性因PSA结果阳性而接受活检后出现并发症而需要住院治疗[67,68,69]。在这些研究中,2/3~3/4的活检并未作出前列腺癌的诊断[66,70,71]。
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