| ObjectiveTo investigate the relevance between the the EGFR gene statement and the TCM syndrome type of cold or heat in NSCLC patients. In Chinese medicine terms, to provide more efficacy predictors for targeted therapy, and to provide a reference for screening for the crowd of targeted therapy.MethodsFrom using prospective epidemiological methods, and using the gene technology, Gathering information of EGFR gene status in newly discovered NSCLC patients, and gathering information on Chinese medicine look and smell in these patients in multiple centers. According to the Chinese medical diagnostic criteria, patients were classified into the "cold and heat" TCM symptoms. And all patients were divided into wild-type group and mutantion group by EGFR gene status. Quantitative information such as symptoms and signs, to establish a database for statistical analysis.Results1.From March 2013 to February 2015, we included 253 cases of newly discovered NSCLC patients in the Hospital of General Hospital of Guangdong Province, Fangcun Branch, University City Branch and the Guangdong Provincial People’s Hospital multiple centers(Guangdong Provincial Hospital, General Hospital 108 cases, Fangcun Branch 9 cases, University City Branch of the 18 cases, the Guangdong Provincial People’s Hospital, 118 cases). Among them, male 170 cases (67.2%), female 83 cases (32.8%); cold syndrome were 131 cases (51.8%), heat syndrome were 122 cases (48.2%); non-smokers,112 (44.3%),141 smokers (55.7%); EGFR wild-type patients with 167 cases (66%), EGFR mutations in patients with 86 cases (34%).2. In the wild-type group:cold syndrome 72 cases(43.1%), heat syndrome 95 cases(56.9%); In the mutantion group:cold syndrome 59cases (68.6%), heat syndrome 27 cases(31.4%). The difference between the two groups in TCM syndromes of cold and heat was statistically significant (P<0.001).3. In the cold syndrome patients:65 males (38.2%),66 women (79.5%); In the heat syndrome patients:105 males (61.8%),17 women (20.5%). The difference between the two groups in gender was statistically significant (P<0.001).4. In the cold syndrome patients:no smoking 85 cases(75.9%), smoking 46 cases (32.6%); In the heat syndrome patients:no smoking 27 cases(24.1%).smoking 95 cases(67.4%).Smoking history was significant difference between the two groups (P<0.001).5. In the wild-type group:no pleural effusion 134 cases (80.2%), had pleural effusion 32 cases(19.2%); In the mutantion group:no pleural effusion 57 cases(66.3%), had pleural effusion 29 cases(33.7%). Differences between the two groups in the presence of pleural effusion was statistically significant (P<0.001).6. In the wild-type group:no distant metastasis 49 cases (29.3%), with distant metastasis 116 cases(69.5%), unknown 2 cases(1.2%); In the mutantion group:no distant metastasis 12 cases(14.0%), with distant metastases 73 cases(84.9%), unknown leased.2%). The difference between the two groups in distant metastases was statistically significant (P <0.001).7.In the wild-type group:no bone metastasis 110 cases(65.9%), with bone metastases 55 cases (32.9%), unknown 2 (1.2%); In the mutant group: no bone metastases 36 cases (41.9%), with bone metastases 44 cases (51.2%), unknown 1 case(1.2%). The difference between the two groups in bone metastases was statistically significant(P<0.001).In the wild-type group:no brain metastasis 145 cases (86.8%), with brain metastasis 21 cases(12.6%), unknown 1 (0.6%); In the mutant group:no brain metastases 55 cases(64.0%), with brain metastasis 27 cases(31.4%), unknown 4 cases(4.7%). The difference between the two groups in brain metastases was statistically significant(P<0.001).8. In the wild-type group:no veinlets 135 cases (80.8%), with veinlets 32 cases (19.2%); In the mutant group:no veinlets 54 cases (62.8%), with veinlets 32cases (37.2%). The difference between the two groups in the veinlets was statistically significant (P<0.01).In the wild-type groups:no weak pulse 165 cases (98.8%), with weak pulse 2 cases (1.2%); In the mutant group:no weak pulse 79 cases(91.9%),with weak pulse 7 cases (8.1%). The difference between the two groups in weak pulse was statistically significant (P<0.05).9. In the wild-type group:51 cases with night sweats (30.5%), no night sweats 112 cases (67.1%), unknown 4 cases (2.4%); In the mutant group: 39 cases with night sweats(45.3%), no night sweats 44 cases (51.2%), unknown 3 cases (2.4%). The difference between the two groups in the night sweats was statistically significant (P<0.01).10. In the wild-type group:no sputum 49 cases (29.3%), dilute sputum 33 cases (19.8%), frothy sputum 25 cases (15.0%), thick sputum 57 cases (34.1%), unknown in 3 cases (1.8); In the mutant group:no sputum 40 cases (46.5%), diluted sputum 10 cases (11.6%), frothy sputum 17 cases (19.8%), thick sputum 15 cases (17.4%), unknown four cases (4.7). The difference between the two groups in the nature of sputum was statistically significant differences(P<0.01).11.For the cool degree of limb skin temperature, In the wild-type group:not cold 134 cases (80.2%), a little 30 cases (18.0%), general cold 3 cases (1.8%), very cold 0 cases (0%); In the mutant group:not cold 57 cases (66.3%), a little 19 cases (22.1%), general cold 7 cases (8.1%), very cold 3 cases (3.5%). The difference between the two groups in the cool degrees of limb skin temperature was statistically significant differences(P<0.01).12. For degree of powerlessness in defecation, In the wild-type group: no fell 125 cases (74.9%),24 cases were mild(14.4%),9 cases were moderate (5.4%),6 cases were severe (3.6%), unknown 3 cases (1.8%); In the mutant group:no fell 48 patients (55.8%),18 cases were mild (20.9%),11 cases were moderate (12.8%),5 cases were severe (5.8%), unknown 4 cases (4.7%). The difference between the two groups in the degree of powerlessness in defecation was statistically significant differences(P <0.05).Conelusion1. EGFR gene status associated with TCM syndromes of cold and heat: Patients with wild-type EGFR gene on TCM syndrome were heat syndrome mainly, and patients with mutant EGFR gene were cold syndrome mainly.2. TCM syndromes of cold and heat was significantly associated with sex and smoking history:Women were more performance for cold syndrome, men were more performance for heat syndrome; Patients with no smoking were more performance for cold syndrome, patients with history of smoking more performance for heat syndrome.3. EGFR gene status was associated with pleural effusion:The ratio of wild-type patients with no pleural effusion was higher than mutantion patients; The ratio of mutantion patients with pleural effusion was higher than wild-type patients.4. EGFR gene status was associated with distant metastasis:The ratio of mutantion patients with distant metastases was higher than wild-type patients. The ratio of mutantion patients with bone metastases and brain metastases was higher than wild-type patients.5. EGFR gene status was associated with veinlets, weak pulse, night sweats, dilute sputum and cool skin temperature:The ratio of mutantion patients with veinlets, weak pulse, night sweats, dilute sputum, and cool skin temperature was higher than wild-type patients, but not rapid pulse. |