Objective: The aim of this systematic review and meta-analysis was to qualitatively and quantitatively evaluate the current evidence on the significance of the loss of early stages of oral carcinogenesis in lesions diagnosed according to clinical and/or histopathological criteria and their evolution to oral cancer. Materials and Methods: We searched MEDLINE (through PubMed), Embase, Scopus and Web of Science for primary-level studies published before November 2024, designed as prospective or retrospective longitudinal cohorts, and not restricted by language or publication date. The risk of bias was critically assessed using the QUIPS tool. Meta-analyses, heterogeneity exploration, sensitivity and small-study effect analyses were conducted. Results: The inclusion criteria were met by six primary-level studies, which recruited 330 patients with OPMDs with follow-up data. The loss of pRb expression, assessed through immunohistochemistry, was significantly associated with a higher malignant transformation risk of OPMDs (RR = 1.92, 95%CI = 1.25–2.94,p= 0.003). The leukoplakia subgroup retained this significant association (p= 0.006), being the OPMD where the loss of pRb expression showed the best predictive value for malignant transformation (RR = 2.00, 95%CI = 1.22–3.29). Regarding the immunohistochemical technique and scoring methods, better performance and results were achieved by applying a cutoff point > 10% pRb-positive cells with nuclear staining (RR = 2.10, 95%CI = 1.30–3.38, 95%CI = 0.002). Conclussion: The present systematic review and meta-analysis supports that the loss of expression of the tumor suppressor pRb, assessed through immunohistochemistry, is a predictor of the malignant transformation risk of oral leukoplakias. Future studies are needed in other OPMDs following the recommendations provided based on current evidence gaps.
目的：本系统综述与荟萃分析旨在定性和定量评估现有证据，探讨经临床和/或组织病理学标准诊断的口腔癌前病变中早期癌变标志物缺失的意义及其向口腔癌转化的关联。材料与方法：我们检索了截至2024年11月前发表于MEDLINE（通过PubMed）、Embase、Scopus和Web of Science数据库的原始研究，研究设计限定为前瞻性或回顾性纵向队列研究，不限制语言或发表时间。采用QUIPS工具对偏倚风险进行严格评估，并进行了荟萃分析、异质性检验、敏感性分析及小样本效应分析。结果：共纳入6项符合标准的原始研究，涉及330例具有随访数据的口腔潜在恶性病变（OPMDs）患者。免疫组化检测显示，pRb表达缺失与OPMDs的恶性转化风险显著相关（RR = 1.92，95%CI = 1.25–2.94，p = 0.003）。在口腔白斑亚组中，该关联性仍然显著（p = 0.006），且pRb表达缺失对恶性转化的预测价值最佳（RR = 2.00，95%CI = 1.22–3.29）。在免疫组化技术与评分方法方面，采用核染色pRb阳性细胞数>10%作为截断值时，其预测效能更优（RR = 2.10，95%CI = 1.30–3.38，p = 0.002）。结论：本系统综述与荟萃分析证实，通过免疫组化检测的抑癌基因pRb表达缺失是口腔白斑恶性转化风险的预测指标。未来需针对其他OPMDs开展进一步研究，并基于现有证据缺口提出相应建议。
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