非小細(xì)胞肺癌經(jīng)EGFR-TKI治療出現(xiàn)耐藥患者的中醫(yī)虛實(shí)證候研究
本文選題:EGFR-TKI + 虛證; 參考:《福建中醫(yī)藥大學(xué)》2017年碩士論文
【摘要】:研究目的:觀察接受EGfR-TKI治療的非小細(xì)胞肺癌患者的中醫(yī)證候分布情況;觀察患者中醫(yī)虛實(shí)證候變化情況,為臨床的辨證施治提供參考。研究方法:分析76例接受EGFR-TKI治療的非小細(xì)胞肺癌患者,收集一般資料(性別、年齡、吸煙史等)、臨床資料(病理類型、疾病診斷、治療史、皮疹及中醫(yī)四診信息等)。以患者首次用藥、用藥1個(gè)月后、3個(gè)月后以及末次隨訪(是指對(duì)隨訪中評(píng)價(jià)為耐藥的時(shí)間點(diǎn)及研究結(jié)束時(shí)尚未評(píng)價(jià)為耐藥以截題時(shí)間點(diǎn)作為末次隨訪)作為隨訪時(shí)間點(diǎn),以無進(jìn)展生存期(PFS)作為研究終點(diǎn),研究對(duì)象的中醫(yī)證候辨證由3名副主任中醫(yī)師指導(dǎo)并統(tǒng)一辨證。并將收集的資料使用SPSS 19.0進(jìn)行統(tǒng)計(jì)分析,計(jì)量資料采用非參數(shù)檢驗(yàn),計(jì)數(shù)資料用卡方檢驗(yàn),對(duì)生存分析,采用Log Rank檢驗(yàn)中位生存期有無差異。研究結(jié)果:1.收錄76例研究對(duì)象,平均年齡為56.3±11.5歲,主要分布于40-70歲;經(jīng)χ2檢驗(yàn),性別、吸煙史、用藥時(shí)機(jī)、用藥后皮疹分組的虛實(shí)證候構(gòu)成差異性無統(tǒng)計(jì)學(xué)意義(P0.05);突變位點(diǎn)分組的虛實(shí)證候構(gòu)成差異性有統(tǒng)計(jì)學(xué)意義(P0.05)。2.接受TKI治療后,末次隨訪時(shí)以氣虛占比(16.7%)、陰虛占比(16.7%)、痰濕占比(12.0%)為主要構(gòu)成,較首次用藥時(shí)氣虛占比(2.2%)、陰虛占比(8.0%)、痰濕占比(18.8%)有明顯變化,差異性有統(tǒng)計(jì)學(xué)意義(P0.05)。3.分析76例接受EGFR-TKI治療的非小細(xì)胞肺癌患者,辨證為虛證占比不斷增大(10.5%、12.5%、24.1%、30.6%),辨證為實(shí)證占比不斷下降(56.6%、44.6%、34.5%、27.8%)。4.分析40例耐藥患者,首次用藥時(shí)辨證為虛證共4例(10.0%),中位PFS為6個(gè)月;辨證為實(shí)證23例(57.5%),中位PFS為9個(gè)月。性別、吸煙史、病理類型、皮疹、虛實(shí)辨證差異性無統(tǒng)計(jì)學(xué)意義(P0.05),不同突變位點(diǎn)有差異性統(tǒng)計(jì)學(xué)意義(P0.01)。5.對(duì)76例患者隨訪觀察中,共出現(xiàn)81人次的不良反應(yīng)記錄,皮疹為30人次(37%),腹瀉為20人次(25%),惡性、嘔吐5人次(6%),食欲下降22人次(27%),肝功能異常4人次(5%),未發(fā)生嚴(yán)重藥物不良反應(yīng)(ADRs)。結(jié)論:1.接受TKI治療后,中醫(yī)證候分布以氣虛(16.7%)、陰虛(16.7%)、痰濕(12.0%)為主要構(gòu)成,提示在臨床辨證施治時(shí),注重補(bǔ)氣、養(yǎng)陰、祛痰濕,提高中西醫(yī)結(jié)合綜合治療療效。2.接受EGFR-TKI治療的非小細(xì)胞肺癌患者,隨用藥時(shí)間延長,證候由實(shí)證向虛實(shí)夾雜、虛證轉(zhuǎn)歸,提示在臨床辨證施治時(shí),不同用藥階段祛邪與扶正有所側(cè)重,提高中西醫(yī)結(jié)合綜合治療療效。3.接受EGFR-TKI治療的非小細(xì)胞肺癌患者,實(shí)證患者無進(jìn)展生存期可能優(yōu)于虛證患者。
[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 鹵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.
【學(xué)位授予單位】:福建中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】:碩士
【學(xué)位授予年份】:2017
【分類號(hào)】:R734.2
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