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目的 评价痰标本检测p5 3基因点突变方法及其作为肺癌早期临床诊断监测指标的真实性和可靠性。方法 用聚合酶链反应 (PCR) 单链多肽性 (SSCP) 银染法检测 5 4例原发性肺癌患者和 114例良性肺疾病患者痰标本中p5 3基因第 5～ 8外显子的点突变 ,同时进行痰涂片细胞学检查。结果 p5 3突变在肺癌组检出率为 5 5 5 6 % (30 / 5 4) ,非肺癌组检出率为 1 75 % (2 / 114) ,P <0 0 0 1。痰标本检测p5 3基因突变作为肺癌临床诊断监测指标的灵敏性为 5 5 5 6 % ,特异性为 98 2 5 % ,阳性似然比为 31 75。肺癌组p5 3阳性检出率 (5 5 5 6 % )与痰涂片瘤细胞阳性检出率 (35 19% )比较 ,差异有显著性 (P <0 0 5 ) ,关联性有极显著意义 (P <0 0 1)。肺癌组p5 3检出率与性别、吸烟指数、病理分型、疾病分期均无明显关系 ,但与年龄有密切关系 ,高龄患者 (≥ 6 0岁 )检出率高 (P =0 0 2 )。结论 PCR SSCP 银染法检测痰标本p5 3突变可以在可疑肺癌患者 (如吸烟并慢性肺疾患者 )中作为一项随访监测指标 ,并将有助于肺癌的早期临床诊断
Objective To evaluate the point mutation detection method of p53 gene in sputum specimens and its validity and reliability as an early clinical diagnosis indicator for lung cancer. Methods Polymerase chain reaction (PCR) single-stranded polypeptide (SSCP) silver staining was used to detect the exons 5-8 exon 5 of the p53 gene in sputum samples from 54 patients with primary lung cancer and 114 patients with benign lung disease. Mutations were performed simultaneously with sputum smear cytology. Results The detection rate of p53 mutation in lung cancer group was 55.56 % (30 / 54), and that in non-lung cancer group was 175% (2 / 114), P <0 01. The sensitivity of p53 gene mutation in sputum specimens as a clinical diagnostic indicator for lung cancer was 5 55 6 %, the specificity was 98 2 5 %, and the positive likelihood ratio was 31 75. The positive rate of p53 in the lung cancer group (55.56 %) was significantly higher than that of the smear smear cells (35 19%) (P < 0.05). The correlation was extremely significant. (P < 0 0 1). The detection rate of p53 in the lung cancer group was not significantly related to gender, smoking index, pathological type, and disease stage, but it was closely related to age. The detection rate of elderly patients (≥ 60 years) was high (P =0 2). . Conclusion The detection of p53 mutations in sputum specimens by PCR SSCP silver staining can be used as a follow-up monitoring indicator in suspicious lung cancer patients (such as patients with smoking and chronic lung disease) and will contribute to the early clinical diagnosis of lung cancer.