非小细胞肺癌经EGFR-TKI治疗出现耐药患者的中医虚实证候研究

发布时间：2018-06-11 21:11

本文选题：EGFR-TKI + 虚证　；参考：《福建中医药大学》2017年硕士论文

【摘要】：研究目的:观察接受EGfR-TKI治疗的非小细胞肺癌患者的中医证候分布情况;观察患者中医虚实证候变化情况,为临床的辨证施治提供参考。研究方法:分析76例接受EGFR-TKI治疗的非小细胞肺癌患者,收集一般资料(性别、年龄、吸烟史等)、临床资料(病理类型、疾病诊断、治疗史、皮疹及中医四诊信息等)。以患者首次用药、用药1个月后、3个月后以及末次随访(是指对随访中评价为耐药的时间点及研究结束时尚未评价为耐药以截题时间点作为末次随访)作为随访时间点,以无进展生存期(PFS)作为研究终点,研究对象的中医证候辨证由3名副主任中医师指导并统一辨证。并将收集的资料使用SPSS 19.0进行统计分析,计量资料采用非参数检验,计数资料用卡方检验,对生存分析,采用Log Rank检验中位生存期有无差异。研究结果:1.收录76例研究对象,平均年龄为56.3±11.5岁,主要分布于40-70岁;经χ2检验,性别、吸烟史、用药时机、用药后皮疹分组的虚实证候构成差异性无统计学意义(P0.05);突变位点分组的虚实证候构成差异性有统计学意义(P0.05)。2.接受TKI治疗后,末次随访时以气虚占比(16.7%)、阴虚占比(16.7%)、痰湿占比(12.0%)为主要构成,较首次用药时气虚占比(2.2%)、阴虚占比(8.0%)、痰湿占比(18.8%)有明显变化,差异性有统计学意义(P0.05)。3.分析76例接受EGFR-TKI治疗的非小细胞肺癌患者,辨证为虚证占比不断增大(10.5%、12.5%、24.1%、30.6%),辨证为实证占比不断下降(56.6%、44.6%、34.5%、27.8%)。4.分析40例耐药患者,首次用药时辨证为虚证共4例(10.0%),中位PFS为6个月;辨证为实证23例(57.5%),中位PFS为9个月。性别、吸烟史、病理类型、皮疹、虚实辨证差异性无统计学意义(P0.05),不同突变位点有差异性统计学意义(P0.01)。5.对76例患者随访观察中,共出现81人次的不良反应记录,皮疹为30人次(37%),腹泻为20人次(25%),恶性、呕吐5人次(6%),食欲下降22人次(27%),肝功能异常4人次(5%),未发生严重药物不良反应(ADRs)。结论:1.接受TKI治疗后,中医证候分布以气虚(16.7%)、阴虚(16.7%)、痰湿(12.0%)为主要构成,提示在临床辨证施治时,注重补气、养阴、祛痰湿,提高中西医结合综合治疗疗效。2.接受EGFR-TKI治疗的非小细胞肺癌患者,随用药时间延长,证候由实证向虚实夹杂、虚证转归,提示在临床辨证施治时,不同用药阶段祛邪与扶正有所侧重,提高中西医结合综合治疗疗效。3.接受EGFR-TKI治疗的非小细胞肺癌患者,实证患者无进展生存期可能优于虚证患者。
[Abstract]:Objective: to observe the distribution of TCM syndromes in patients with non-small cell lung cancer treated with EGfR-TKI, and to observe the changes of deficiency syndrome of TCM in order to provide reference for clinical treatment based on syndrome differentiation. Methods: 76 patients with non-small cell lung cancer (NSCLC) treated with EGFR-TKI were analyzed. General data (sex, age, smoking history, etc.), clinical data (pathological type, diagnosis of disease, history of treatment, rash and four-diagnosis information of TCM) were collected. The patients were followed up for the first time, 1 month, 3 months and the last follow-up (that is, the time point at which the drug resistance was evaluated at the follow-up and the time point at the end of the study was not evaluated as the last time point of the drug resistance) as the follow-up time point. Using PFS as the end point, the TCM syndromes differentiation of the subjects was guided by three deputy director TCM doctors and unified syndrome differentiation. SPSS 19.0 was used to analyze the collected data, non-parametric test was used to measure the data, chi-square test was used to count the data, and the median survival time was tested by Log Rank test. The result of the study was: 1. The average age of 76 subjects was 56.3 卤11.5 years old, which was mainly distributed between 40 and 70 years old. There was no significant difference in the composition of deficiency and consolidation syndrome after drug use, but there was no significant difference in the composition of deficiency and excess syndrome in the mutation locus group. After TKI treatment, at the last follow-up, there were significant changes in the ratio of deficiency of qi (16.7%), the ratio of deficiency of yin (16.710) and the ratio of phlegm and dampness (12.0), which was significantly different from that of Qi deficiency (2.2%), Yin deficiency (8.0%), phlegm and dampness (18.8%) at the first time of treatment. 76 cases of non-small cell lung cancer treated with EGFR-TKI were analyzed. The proportion of deficiency syndrome was increased by 10.5% and 12.5% and 24.51%. The proportion of syndrome differentiation was decreased continuously (56.6%) and the ratio of 44.6N (34.5U) was 27.80.4.The ratio of syndrome differentiation was 56.6N, 44.6N, 34.5and 27.80.4.The proportion of syndrome differentiation was lower than that of non-small cell lung cancer (NSCLC) treated with EGFR-TKI. 40 patients with drug resistance were analyzed, 4 patients were diagnosed as deficiency syndrome (n = 4) and the median PFS was 6 months (n = 4), and 23 patients (n = 23) were diagnosed as 57.5A and a median PFS = 9 months (n = 23). Sex, smoking history, pathological type, rash, deficiency and deficiency syndrome differentiation difference was not statistically significant (P 0.05), different mutation sites had statistical difference (P 0.01). During the follow-up of 76 patients, there were 81 adverse reactions, including 30 rashes, 20 patients with diarrhea, 5 patients with malignancy and vomiting, 22 patients with loss of appetite, and 4 patients with abnormal liver function. There were no serious adverse drug reactions (ADRs). Conclusion 1. After TKI treatment, the distribution of TCM syndromes was mainly composed of deficiency of Qi and 16.7U, Yin deficiency of 16.7am, phlegm dampness 12.0), which suggested that in clinical treatment of syndrome differentiation, attention should be paid to reinforcing qi, nourishing yin, expelling phlegm and dampness, and improving the curative effect of integrated treatment of traditional Chinese and western medicine. In patients with non-small cell lung cancer treated with EGFR-TKI, the syndromes changed from positive evidence to deficiency and deficiency syndrome with the prolongation of medication time. Improve the curative effect of integrated traditional Chinese and western medicine treatment. The progressive survival of patients with non-small cell lung cancer treated with EGFR-TKI may be better than that of patients with deficiency syndrome.
【学位授予单位】：福建中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R734.2

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