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反射式共聚焦显微镜在英国诊断基底细胞癌中的应用:一项前瞻性观察性单中心试验。

Reflectance confocal microscopy in diagnosing basal cell carcinoma in the UK: a prospective observational single-centre trial.

作者信息

Stevens Howard P, Pampena Riccardo, Farnetani Francesca, Pellacani Giovanni, Angus Colin, El-Jabbour Joseph N

机构信息

The Skin Care Network, London, UK.

Università degli Studi di Modena e Reggio Emilia, Modena, Italy.

出版信息

Br J Dermatol. 2025 Jan 24;192(2):206-214. doi: 10.1093/bjd/ljae356.

DOI:10.1093/bjd/ljae356
PMID:39259284
Abstract

BACKGROUND

Previous work with reflectance confocal microscopy (RCM) has shown high sensitivity and specificity for basal cell carcinoma (BCC); however, to date, there have been few studies in UK cohorts.

OBJECTIVES

To assess the potential of RCM to accurately diagnose BCC in a private UK secondary care, single-clinician setting, and to investigate the potential of RCM as a routine diagnostic procedure.

METHODS

In total, 522 lesions where BCC featured in the differential diagnosis after clinical examination were prospectively recruited; 78 lesions were subsequently excluded. We used an arm-mounted confocal microscope unless access to the lesion was awkward and required a handheld probe to be used. The likelihood of BCC was scored for each modality (clinical examination, dermoscopy and RCM), with each diagnosis building on the last. Histology was assessed by a single blinded histopathologist. The study was registered with ClinicalTrials.gov (NCT03509415).

RESULTS

The analysis included 444 lesions (327 BCCs) from 326 patients. The median maximum lesion diameter was 6 mm. The sensitivity and specificity for BCC were 69.4% [95% confidence interval (CI) 64.1-74.4] and 53.0% (95% CI 43.6-62.3), respectively, for clinical examination alone; 91.8% (95% CI 88.3-94.5) and 41.0% (95% CI 32.0-50.5), respectively, for clinical examination plus dermoscopy; and 98.8% (95% CI 96.9-99.7) and 85.5% (95% CI 77.8-91.3), respectively, for clinical examination plus dermoscopy plus RCM. For RCM, the positive predictive value in diagnosing BCC was 95.0% (95% CI 92.1-97.1) and the negative predictive value was 96.2% (95% CI 90.4-98.9). The area under the curve increased from 0.61 to 0.66 to 0.92 as the respective modalities were added.

CONCLUSIONS

This study demonstrates that RCM can reliably and quickly diagnose BCC, and that the addition of RCM to dermoscopy permits higher diagnostic accuracy for BCC in the UK. The specificity and sensitivity of the RCM diagnosis did not alter significantly with experience, reflecting the ease and speed of acquiring the skills required to use this modality.

摘要

背景

先前使用反射式共聚焦显微镜(RCM)的研究表明,其对基底细胞癌(BCC)具有较高的敏感性和特异性;然而,迄今为止,针对英国人群的研究较少。

目的

评估RCM在英国私立二级医疗单医生环境中准确诊断BCC的潜力,并探讨RCM作为常规诊断程序的可能性。

方法

前瞻性招募了522例临床检查后鉴别诊断中包含BCC的病变;随后排除了78例病变。除非病变位置难以触及而需要使用手持探头,否则我们使用臂式共聚焦显微镜。对每种检查方式(临床检查、皮肤镜检查和RCM)评估BCC的可能性,每次诊断都基于前一次检查结果。由一名单盲组织病理学家评估组织学。该研究已在ClinicalTrials.gov注册(NCT03509415)。

结果

分析纳入了326例患者的444个病变(327个BCC)。病变最大直径的中位数为6毫米。仅临床检查对BCC的敏感性和特异性分别为69.4% [95%置信区间(CI)64.1 - 74.4]和53.0%(95% CI 43.6 - 62.3);临床检查加皮肤镜检查的敏感性和特异性分别为91.8%(95% CI 88.3 - 94.5)和41.0%(95% CI 32.0 - 50.5);临床检查加皮肤镜检查加RCM的敏感性和特异性分别为98.8%(95% CI 96.9 - 99.7)和85.5%(95% CI 77.8 - 91.3)。对于RCM,诊断BCC的阳性预测值为95.0%(95% CI 92.1 - 97.1),阴性预测值为96.2%(95% CI 90.4 - 98.9)。随着依次增加相应的检查方式,曲线下面积从0.61增加到0.66再增加到0.92。

结论

本研究表明,RCM能够可靠且快速地诊断BCC,并且在英国,将RCM添加到皮肤镜检查中可提高对BCC的诊断准确性。RCM诊断的特异性和敏感性不会随着经验的增加而显著改变,这反映了掌握使用这种检查方式所需技能的 ease 和速度。 (注:“ease”此处可能有误,结合语境推测可能是“ease of use”即“易用性”之意,但按要求不添加解释,保留原文)

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