中文摘要：

目的观察重组人p53腺病毒注射液Ad-p53治疗上皮异常增生型口腔白斑引起的生物学反应。方法对18例上皮异常增生型口腔白斑患者进行为期15d的Ad-p53局部黏膜内注射治疗。每3d注射1次,以1cm^2作为一个注射点,每点注射1×10^8vp,0.5mL。在最后一次注射后24～48h内行病变组织活检,并用免疫组化法检测Ad-p53治疗前后组织内P53蛋白和P21^CIP/WAF蛋白的表达。结果P53蛋白和P21^CIP/WAF蛋白在Ad-p53治疗后组织内的阳性表达率分别为100%和89.9%,明显高于治疗前的表达,并且二者的高表达呈正相关（r=0.598,P〈0.01）。结论Ad-p53治疗上皮异常增生型口腔白斑有良好的生物学反应,有广阔的临床应用前景。

英文摘要：

Objective Advances in tumor biology and clinical trials indicate that p53 transfer is an alternative therapy for head and neck squamous cell carcinoma. The aim of this study is to evaluate the biologic activity of multiple intraepithelial injections of Ad-p53 in patients with dysplastic oral leukoplakia, which is the most common premalignant lesion of the oral squamous cell carcinoma. Methods From 2006 to 2007, 18 Chinese patients clinically and histopathologically diagnosed as dysplastic oral leukoplakia were recruited for this study. On a 15-day cycle, intraepithelial injections of Ad-p53 were administered once every three days at dose levels dependent upon lesion size/dose escalation sequence（1×10^8 vp）. 24-48 h after the last injection, incisional biopsy were performed, and immunohistochemistry was used to examine the protein expression of P53 and P21^CIP/WAF. Results In the postreatment patients, P53 protein and P21^CIP/WAF protein expression were significantly enhanced （100%, 89.9%, respectively） and statistical analysis revealed the expression of P53 protein had a positive correlation with that of P21^CIP/WAF protein （r= 0.598, P〈0.01）. Conclusion Intraepithelial injections of gendicine is biologically active in patients with dysplastic oral leukoplakia. It may be a promising treatment for oral leukoplakia.