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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PCR SSCP 银染法检测 5 4例原发性肺癌患者和 114例良性肺疾患者痰标本中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度 5 5 5 6 %、特异度 98 2 5 %、阳性似然比 31 75。肺癌组p5 3阳性检出率 5 5 5 6 % (30 /5 4 )与痰涂片瘤细胞阳性检出率 35 19% (19/5 4 )比较 :差异性有显著意义 (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 )。非肺癌组一例慢性阻塞性肺病 (COPD)患者检测到E5突变 ,随访四年 ,确诊为肺鳞癌。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 (如吸烟者合并慢性肺疾患 )中作为一项随访监测指标 ,将有助于肺癌早期临床诊断。
Objective To evaluate the method of detecting point mutation of p5 3 gene in sputum and its authenticity and reliability as an indicator of early diagnosis of lung cancer. Methods The SSCP silver staining was used to detect point mutations of exons 5 to 8 of p5 3 gene in sputum specimens of 54 patients with primary lung cancer and 114 patients with benign lung disease. Sputum cytology was also performed. Results The detection rate of p5 3 mutation in the lung cancer group was 55 65% (30/54), and the non-lung cancer group was 75% (2/114) (P 0 01). The sensitivity of sputum specimens for detection of p53 gene mutation as a marker for clinical diagnosis of lung cancer was 55 55%, specificity 98 2 5%, and positive likelihood ratio 31 75. The positive detection rate of p5 3 in lung cancer group was 55.56% (30/54), which was significantly different from that of sputum smear tumor cells in 35 19% (19/5 4) (P <0 0 5), the relevance was significant (P <0.01). The detection rate of p5 3 in lung cancer group was not significantly related to gender, smoking index, pathological classification and disease stage, but was closely related to age. The detection rate of p5 3 was higher in elderly patients (60 years old) (P = 0.002). One case of non-lung cancer patients with chronic obstructive pulmonary disease (COPD) detected E5 mutations, followed up for four years, diagnosed as lung squamous cell carcinoma. Conclusion The detection of p5 3 mutation in sputum by PCR SSCP silver staining can be used as a follow-up monitoring indicator in patients with suspected lung cancer (such as smokers with chronic lung disease), which is helpful for the early clinical diagnosis of lung cancer.