Sánchez Guillermo, Nova John, Rodriguez-Hernandez Andrea Esperanza, Medina Roger David, Solorzano-Restrepo Carolina, Gonzalez Jenny, Olmos Miguel, Godfrey Kathie, Arevalo-Rodriguez Ingrid
Instituto de Evaluación Tecnológica en Salud, Bogotá D.C., Colombia.
Cochrane Database Syst Rev. 2016 Jul 25;7(7):CD011161. doi: 10.1002/14651858.CD011161.pub2.
'Keratinocyte cancer' is now the preferred term for the most commonly identified skin cancers basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC), which were previously commonly categorised as non-melanoma skin cancers (NMSC). Keratinocyte cancer (KC) represents about 95% of malignant skin tumours. Lifestyle changes have led to increased exposure to the sun, which has, in turn, led to a significant increase of new cases of KC, with a worldwide annual incidence of between 3% and 8%. The successful use of preventive measures could mean a significant reduction in the resources used by health systems, compared with the high cost of the treatment of these conditions. At present, there is no information about the quality of the evidence for the use of these sun protection strategies with an assessment of their benefits and risks.
To assess the effects of sun protection strategies (i.e. sunscreen and barrier methods) for preventing keratinocyte cancer (that is, basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC) of the skin) in the general population.
We searched the following databases up to May 2016: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trial registries and the bibliographies of included studies for further references to relevant trials.
We included randomised controlled clinical trials (RCTs) of preventive strategies for keratinocyte cancer, such as physical barriers and sunscreens, in the general population (children and adults), which may provide information about benefits and adverse events related to the use of solar protection measures. We did not include trials focused on educational strategies to prevent KC or preventive strategies in high-risk groups. Our prespecified primary outcomes were BCC or cSCC confirmed clinically or by histopathology at any follow-up and adverse events.
Two review authors independently selected studies for eligibility using Early Review Organizing Software (EROS). Similarly, two review authors independently used predesigned data collection forms to extract information from the original study reports about the participants, methods of randomisation, blinding, comparisons of interest, number of participants originally randomised by arm, follow-up losses, and outcomes, and they assessed the risk of bias. We resolved any disagreement by consulting a third author and contacted trial investigators of identified trials to obtain additional information. We used standard methodological procedures expected by Cochrane.
We included one RCT (factorial design) that randomised 1621 participants.This study compared the daily application of sunscreen compared with discretionary use of sunscreen, with or without beta-carotene administration, in the general population. The study was undertaken in Australia; 55.2% of participants had fair skin, and they were monitored for 4.5 years for new cases of BCC or cSCC assessed by histopathology. We found this study to be at low risk of bias for domains such as allocation, blinding, and incomplete outcome data. However, we found multiple unclear risks related to other biases, including an unclear assessment of possible interactions between the effects of the different interventions evaluated (that is, sunscreen and beta-carotene). We found no difference in terms of the number of participants developing BCC (n = 1621; risk ratio (RR) 1.03, 95% confidence interval (CI) 0.74 to 1.43) or cSCC (n = 1621; RR 0.88, 95% CI 0.50 to 1.54) when comparing daily application of sunscreen with discretionary use, even when analyses were restricted to groups without beta-carotene supplementation. This evidence was of low quality, which means that there is some certainty that future studies may alter our confidence in this evidence.We reported adverse events in a narrative way and included skin irritation or contact allergy.We identified no studies that evaluated other sun protection measures, such as the use of sun-protective clothing, sunglasses, or hats, or seeking the shade when outdoors.
AUTHORS' CONCLUSIONS: In this review, we assessed the effect of solar protection in preventing the occurrence of new cases of keratinocyte cancer. We only found one study that was suitable for inclusion. This was a study of sunscreens, so we were unable to assess any other forms of sun protection. The study addressed our prespecified primary outcomes, but not most of our secondary outcomes. We were unable to demonstrate from the available evidence whether sunscreen was effective for the prevention of basal cell carcinoma (BCC) or cutaneous squamous cell carcinoma (cSCC).Our certainty in the evidence was low because there was a lack of histopathological confirmation of BCC or cSCC in a significant percentage of cases. Amongst other sources of bias, it was not clear whether the study authors had assessed any interaction effects between the sunscreen and beta-carotene interventions. We think that further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
“角质形成细胞癌”现在是最常见的皮肤癌即基底细胞癌(BCC)和皮肤鳞状细胞癌(cSCC)的首选术语,它们以前通常被归类为非黑素瘤皮肤癌(NMSC)。角质形成细胞癌(KC)约占恶性皮肤肿瘤的95%。生活方式的改变导致人们更多地暴露在阳光下,进而导致KC新病例显著增加,全球年发病率在3%至8%之间。与这些疾病高昂的治疗成本相比,成功采取预防措施可能意味着卫生系统资源的大幅减少。目前,尚无关于这些防晒策略的证据质量及其益处和风险评估的信息。
评估防晒策略(即防晒霜和屏障方法)对预防普通人群角质形成细胞癌(即皮肤的基底细胞癌(BCC)和皮肤鳞状细胞癌(cSCC))的效果。
截至2016年5月,我们检索了以下数据库:Cochrane皮肤组专业注册库、CENTRAL、MEDLINE、Embase和LILACS。我们还检索了五个试验注册库以及纳入研究的参考文献,以获取更多相关试验的参考文献。
我们纳入了针对普通人群(儿童和成人)的角质形成细胞癌预防策略的随机对照临床试验(RCT),如物理屏障和防晒霜,这些试验可能提供与使用防晒措施相关的益处和不良事件的信息。我们未纳入侧重于预防KC的教育策略或高危人群预防策略的试验。我们预先设定的主要结局是在任何随访中经临床或组织病理学确诊的BCC或cSCC以及不良事件。
两位综述作者使用早期综述组织软件(EROS)独立选择符合条件的研究。同样,两位综述作者独立使用预先设计的数据收集表,从原始研究报告中提取有关参与者、随机化方法、盲法、感兴趣的比较、按组最初随机分组的参与者数量、随访失访情况和结局的信息,并评估偏倚风险。我们通过咨询第三位作者解决任何分歧,并联系已识别试验的试验研究者以获取更多信息。我们采用了Cochrane期望的标准方法程序。
我们纳入了一项RCT(析因设计),该试验随机分配了1621名参与者。本研究在普通人群中比较了每日使用防晒霜与酌情使用防晒霜(无论是否给予β-胡萝卜素)的情况。该研究在澳大利亚进行;55.2%的参与者皮肤白皙,通过组织病理学对他们进行了4.5年的监测,以评估BCC或cSCC的新病例。我们发现该研究在分配、盲法和不完整结局数据等领域的偏倚风险较低。然而,我们发现与其他偏倚相关的多个不明确风险,包括对所评估的不同干预措施(即防晒霜和β-胡萝卜素)效果之间可能的相互作用评估不明确。当比较每日使用防晒霜与酌情使用防晒霜时,我们发现发生BCC(n = 1621;风险比(RR)1.03,95%置信区间(CI)0.74至1.43)或cSCC(n = 1621;RR 0.88,95%CI 0.50至1.54)的参与者数量没有差异,即使分析仅限于未补充β-胡萝卜素的组。该证据质量较低,这意味着有一定把握认为未来的研究可能会改变我们对该证据的信心。我们以叙述方式报告了不良事件,包括皮肤刺激或接触性过敏。我们未识别出评估其他防晒措施的研究,如使用防晒服装、太阳镜或帽子,或在户外时寻找阴凉处。
在本综述中,我们评估了防晒在预防角质形成细胞癌新病例发生方面的效果。我们仅发现一项适合纳入的研究。这是一项关于防晒霜的研究,因此我们无法评估任何其他形式的防晒。该研究涉及了我们预先设定的主要结局,但未涉及我们的大多数次要结局。我们无法从现有证据中证明防晒霜是否对预防基底细胞癌(BCC)或皮肤鳞状细胞癌(cSCC)有效。我们对该证据的把握度较低,因为在相当比例的病例中缺乏BCC或cSCC的组织病理学确诊。在其他偏倚来源中,尚不清楚研究作者是否评估了防晒霜和β-胡萝卜素干预措施之间的任何相互作用效应。我们认为进一步的研究很可能会对我们对效应估计的信心产生重要影响,并可能改变该估计。