Brocklehurst Paul, Kujan Omar, O'Malley Lucy A, Ogden Graham, Shepherd Simon, Glenny Anne-Marie
School of Dentistry, The University of Manchester, Coupland III Building, Oxford Road, Manchester, UK, M13 9PL.
Cochrane Database Syst Rev. 2013 Nov 19;2013(11):CD004150. doi: 10.1002/14651858.CD004150.pub4.
Oral cancer is an important global healthcare problem, its incidence is increasing and late-stage presentation is common. Screening programmes have been introduced for a number of major cancers and have proved effective in their early detection. Given the high morbidity and mortality rates associated with oral cancer, there is a need to determine the effectiveness of a screening programme for this disease, either as a targeted, opportunistic or population-based measure. Evidence exists from modelled data that a visual oral examination of high-risk individuals may be a cost-effective screening strategy and the development and use of adjunctive aids and biomarkers is becoming increasingly common.
To assess the effectiveness of current screening methods in decreasing oral cancer mortality.
We searched the following electronic databases: the Cochrane Oral Health Group's Trials Register (to 22 July 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 6), MEDLINE via OVID (1946 to 22 July 2013), EMBASE via OVID (1980 to 22 July 2013) and CANCERLIT via PubMed (1950 to 22 July 2013). There were no restrictions on language in the search of the electronic databases.
Randomised controlled trials (RCTs) of screening for oral cancer or potentially malignant disorders using visual examination, toluidine blue, fluorescence imaging or brush biopsy.
Two review authors screened the results of the searches against inclusion criteria, extracted data and assessed risk of bias independently and in duplicate. We used mean differences (MDs) and 95% confidence intervals (CIs) for continuous data and risk ratios (RRs) with 95% CIs for dichotomous data. Meta-analyses would have been undertaken using a random-effects model if the number of studies had exceeded a minimum of three. Study authors were contacted where possible and where deemed necessary for missing information.
A total of 3239 citations were identified through the searches. Only one RCT, with 15-year follow-up met the inclusion criteria (n = 13 clusters: 191,873 participants). There was no statistically significant difference in the oral cancer mortality rates for the screened group (15.4/100,000 person-years) and the control group (17.1/100,000 person-years), with a RR of 0.88 (95% CI 0.69 to 1.12). A 24% reduction in mortality was reported between the screening group (30/100,000 person-years) and the control group (39.0/100,000) for high-risk individuals who used tobacco or alcohol or both, which was statistically significant (RR 0.76; 95% CI 0.60 to 0.97). No statistically significant differences were found for incidence rates. A statistically significant reduction in the number of individuals diagnosed with stage III or worse oral cancer was found for those in the screening group (RR 0.81; 95% CI 0.70 to 0.93). No harms were reported. The study was assessed as at high risk of bias.
AUTHORS' CONCLUSIONS: There is evidence that a visual examination as part of a population-based screening programme reduces the mortality rate of oral cancer in high-risk individuals. In addition, there is a stage shift and improvement in survival rates across the population as a whole. However, the evidence is limited to one study, which has a high risk of bias and did not account for the effect of cluster randomisation in the analysis. There was no evidence to support the use of adjunctive technologies like toluidine blue, brush biopsy or fluorescence imaging as a screening tool to reduce oral cancer mortality. Further RCTs are recommended to assess the efficacy and cost-effectiveness of a visual examination as part of a population-based screening programme in low, middle and high-income countries.
口腔癌是一个重要的全球卫生保健问题,其发病率在上升,且晚期就诊很常见。针对多种主要癌症已推行了筛查计划,并已证明在早期检测中有效。鉴于口腔癌相关的高发病率和死亡率,有必要确定针对该疾病的筛查计划的有效性,无论是作为有针对性的、机会性的还是基于人群的措施。模型数据表明,对高危个体进行口腔视觉检查可能是一种具有成本效益的筛查策略,辅助工具和生物标志物的开发与使用也越来越普遍。
评估当前筛查方法在降低口腔癌死亡率方面的有效性。
我们检索了以下电子数据库:Cochrane口腔健康小组试验注册库(至2013年7月22日)、Cochrane对照试验中心注册库(CENTRAL)(《Cochrane图书馆》2013年第6期)、通过OVID检索的MEDLINE(1946年至2013年7月22日)、通过OVID检索的EMBASE(1980年至2013年7月22日)以及通过PubMed检索的CANCERLIT(1950年至2013年7月22日)。电子数据库检索无语言限制。
使用视觉检查、甲苯胺蓝、荧光成像或刷检活检筛查口腔癌或潜在恶性疾病的随机对照试验(RCT)。
两名综述作者根据纳入标准筛选检索结果,独立且重复地提取数据并评估偏倚风险。对于连续数据,我们使用均数差(MDs)和95%置信区间(CIs),对于二分数据,使用95%CI的风险比(RRs)。如果研究数量超过至少三项,将使用随机效应模型进行Meta分析。如有可能并认为必要,会联系研究作者获取缺失信息。
通过检索共识别出3239条引文。仅有一项进行了15年随访的RCT符合纳入标准(n = 13个群组:191,873名参与者)。筛查组(15.4/100,000人年)和对照组(17.1/100,000人年)的口腔癌死亡率无统计学显著差异,RR为0.88(95%CI 0.69至1.12)。对于使用烟草或酒精或两者皆用的高危个体,筛查组(30/100,000人年)和对照组(39.0/100,000)之间报告死亡率降低了24%,具有统计学显著性(RR 0.76;95%CI 0.60至0.97)。发病率未发现统计学显著差异。筛查组中被诊断为III期或更严重口腔癌的个体数量有统计学显著减少(RR 0.81;95%CI 0.70至0.93)。未报告有危害。该研究被评估为存在高偏倚风险。
有证据表明,作为基于人群的筛查计划的一部分,视觉检查可降低高危个体的口腔癌死亡率。此外,总体人群存在分期转移且生存率有所提高。然而,证据仅限于一项研究,该研究存在高偏倚风险且在分析中未考虑整群随机化的影响。没有证据支持使用甲苯胺蓝、刷检活检或荧光成像等辅助技术作为筛查工具来降低口腔癌死亡率。建议进行进一步的RCT,以评估在低收入、中等收入和高收入国家,作为基于人群的筛查计划一部分的视觉检查的疗效和成本效益。