本文選題：單純中醫(yī)藥 + 非小細胞肺癌�。� 參考：《北京中醫(yī)藥大學》2017年碩士論文

【摘要】：背景:肺癌是全球發(fā)病率和死亡率最高的惡性腫瘤之一,其中有85%的患者非小細胞肺癌,通常有70%的患者發(fā)現(xiàn)時已為不可手術的晚期,而晚期NSCLC的一線治療,能夠一定程度上提高患者的生存率,提高生活質量,但是對于放化療及靶向治療不耐受,一般情況較差或復發(fā)轉移的患者(PS評分:3-4),西醫(yī)只能選用最佳支持治療來控制腫瘤的生長和提高患者的生活質量,以往的研究表明單獨運用最佳支持治療的晚期NSCLC患者的生存期為8-10個月,而如果不接受任何治療的晚期NSCLC患者生存期則6個月。中醫(yī)藥治療是我國防治肺癌的重要特色,中醫(yī)藥治療措施在肺癌治療中的不斷參與,顯示出了一定優(yōu)勢,從國家"六五"—"十一五"科技支撐計劃,研究涉及肺癌辨證分型,治則、治法以及方藥研究,以及中醫(yī)參與或中醫(yī)為主的綜合治療方案的研究等各個層面,現(xiàn)已基本明確了中醫(yī)藥參與在肺癌治療中的明確優(yōu)勢,對于中醫(yī)參與的綜合治療方案患者的生存時間和生活質量均高于單純西醫(yī)治療的患者,運用中醫(yī)藥可以實現(xiàn)穩(wěn)定瘤體,帶瘤生存以及提高患者生活質量的目的。然而迄今為止,循證醫(yī)學所提供的研究數據僅能證明中醫(yī)藥在肺癌治療的不同階段,可以發(fā)揮不同的治療作用,在依據循證研究數據形成的指南中,也是僅僅界定了不同階段治療的中醫(yī)治療大法,仍然不能回答的問題是:是否所有肺癌患者都能從中醫(yī)治療中獲益?究竟哪一類肺癌患者更適合接受中醫(yī)藥的什么方法的治療?中醫(yī)藥什么時間點開始參與治療,干預時間需要多久更加獲益?尤其對于晚期的患者多失去了手術治療的機會,身體情況較差或不愿意接受西醫(yī)治療的患者,篩選中醫(yī)藥治療的優(yōu)勢人群,符合醫(yī)學精準化及個體化的大方向,是進一步提高中醫(yī)藥治療肺癌療效的重要課題。研究目的:本研究從性別、年齡、病理類型、TNM分期、腫瘤分化程度、解剖部位、腫瘤標志物、中藥治療的暴露時間及舌苔脈象、中醫(yī)證候、中醫(yī)證候要素等角度與晚期肺癌患者無進展生存時間、總生存時間相互間的關系進行分層研究,并通過相關因素分析單純中醫(yī)藥治療晚期NSCLC患者優(yōu)勢人群的臨床特征及表型,為最大限度發(fā)揮中醫(yī)藥治療肺癌的優(yōu)勢和特色提供依據。研究方法:本研究的病例資料來源于中國中醫(yī)科學院廣安門醫(yī)院2006/01/01-2016/04/28住院病房,按照納入標準((1)經病理學或細胞學確診的Ⅲ-Ⅳ期非小細胞肺癌帶瘤患者;(2)既往未行化療、放療;或既往接受化療≤2周期,和/或未按計劃完成放療,和/或接受靶向治療≤1個月;接受單純中醫(yī)藥治療≥3個月;(3)生存時間≥1年的患者;(4)年齡≥18歲且≤80歲;(5)可隨訪,將符合研究標準的患者通過回顧性研究的方式記錄其一般資料及治療情況,并對患者進行電話隨訪,記錄其生存時間及無疾病進展時間,通過進行相關因素的分析及影響患者OS、PFS的因素,總結治療優(yōu)勢人群的特征。研究結果:研究共收錄9288例患者,經二次篩選完全符合條件的患者60例:1.一般情況:60例患者的一般特征為發(fā)病高峰年齡在61-80歲之間,男性與女性人數比為2.3:1,吸煙人群占58.3%,腫瘤部位以中央型為主63.3%,右肺發(fā)生率比左肺高,腺癌多于鱗癌(58.3%VS40.0%),Ⅳ期35例(58.3%)為最多,首診時肺轉移最多占33.3%,合并癥以胸腔積液的最多占35.0%。2.生存期分析:中位PFS為12個月,中位OS為28.5個月,明顯高于最佳支持治療的1.35個月及8-10個月,吸煙史、既往治療史、腫瘤類型、腫瘤TNM分期、腫瘤分布、遠處轉移情況,中藥治療時間長短均是影響生存期的重要因素,中藥干預時間大于一年,療效明顯。3.用COX多因素回歸分析:得到年齡和吸煙史是影響患者預后的獨立危險因素。4.Logistic分析顯示:年齡、中藥干預時間長短、肺脾氣虛證及血瘀證與治療療效明顯相關(P0.05),肺脾氣虛證預后較好而血瘀證則預后較差。5.單因素和秩和檢驗:痰濕瘀阻證為此群患者的最多證型,痰濕瘀阻肺脾氣虛氣陰兩虛熱毒壅肺(33.5%27.7%16.4%5.2%),中醫(yī)證候要素:痰濕證陰虛證氣虛證血瘀證(31.0%29.6%24.9%11.5%3.0%);中藥治療特色是口服湯藥+中成藥+中藥注射液的綜合中醫(yī)治療模式,以益肺清化,扶正祛邪,化痰散結為主。結論:1.本研究中顯示了單純中醫(yī)藥治療非小細胞肺癌的優(yōu)勢人群可能為女性,不吸煙,周圍型腺癌患者,年齡≤60歲,既往接受過手術治療,TNM分期為ⅢA期,遠處轉移較少的病人。中醫(yī)證候特點為肺脾氣虛,痰濕瘀阻的虛實夾雜型,同時證候要素以痰濕證和氣虛證為主。2.吸煙史,年齡太大增加了中晚期肺癌患者的死亡風險,中醫(yī)藥長期治療和既往接受一定的治療(尤其是手術治療)是晚期NSCLC肺癌患者有利的生存因素。3.中醫(yī)口服湯藥+中成藥+靜脈注射液的綜合中醫(yī)治療手段可以被推薦使用。推薦中藥干預時間大于一年及以上,對于晚期NSCLC患者的中醫(yī)治療要緊緊抓住其"痰、瘀、虛"夾雜的基本病機,處方用藥選擇上多以扶正培本,化痰散結為主,配以清熱解毒,抗癌的中藥。4.本組患者單純中醫(yī)藥治療晚期NSCLC治療中位生存期為28.5個月,PFS為12個月,體現(xiàn)了中醫(yī)藥在治療這一類人群中的優(yōu)勢。
[Abstract]:Background: lung cancer is one of the most malignant tumors in the world with the highest incidence and mortality, of which 85% of the patients are non small cell lung cancer, and 70% of them are usually found in the late stage of non operation, and the advanced NSCLC therapy can improve the survival rate and improve the quality of life to some extent, but for radiotherapy and chemotherapy and target treatment. Patients with intolerance, poor general condition or relapse (PS score: 3-4), western medicine can only use the best support therapy to control the growth of the tumor and improve the quality of life of the patient. Previous studies have shown that the survival period of the advanced NSCLC patients with the best support treatment alone is 8-10 months, and if no treatment of late NS is accepted. The survival period of CLC patients is 6 months. Traditional Chinese medicine is an important feature of the prevention and treatment of lung cancer in China. The continuous participation of Chinese medicine treatment measures in the treatment of lung cancer shows some advantages, from the national "65" - "11th Five-Year" scientific and technological support plan, involving the syndrome differentiation, treatment, treatment and prescription of lung cancer, as well as Chinese medicine participation or Chinese medicine. All levels of the comprehensive medical treatment plan, such as the comprehensive treatment plan, have now clearly defined the clear advantage of Chinese medicine in the treatment of lung cancer. The survival time and quality of life of the patients who are involved in the comprehensive treatment of Chinese medicine are higher than those of the simple western medicine. But so far, the data provided by evidence-based medicine can only prove that traditional Chinese medicine can play different therapeutic roles in different stages of lung cancer treatment. In the guide of evidence-based research data formation, it is also a traditional Chinese medicine treatment that only defines different stages of treatment, and still can not be answered. The question is: can all lung cancer patients benefit from the traditional Chinese medicine treatment? What kind of lung cancer patients are more suitable for the treatment of traditional Chinese medicine? What time does Chinese medicine begin to take part in the treatment, how long will the time of intervention take more benefit? Especially for late patients, the chances of surgical treatment are lost, and the physical condition is lost. It is an important subject to further improve the curative effect of lung cancer with traditional Chinese medicine, which is an important subject for further improvement of the curative effect of lung cancer in traditional Chinese medicine. The research aim: This study is from sex, age, pathological type, TNM staging, tumor differentiation, anatomical site, and tumor markers. The exposure time and the pulse image of the tongue coating, the TCM syndrome, the TCM syndrome factors and the non progressive survival time of the advanced lung cancer patients and the relationship between the total survival time were stratified, and the clinical characteristics and phenotypes of the superior population in the advanced NSCLC patients were analyzed to the maximum extent. The study method: the case data of this study came from the 2006/01/01-2016/04/28 inpatient ward of Guanganmen Hospital of Chinese Academy of traditional Chinese medicine (Chinese Academy of Chinese Medicine). (1) patients with non small cell lung cancer with stage III - IV confirmed by pathology or cytology; (2) previous chemotherapy, radiotherapy, or radiotherapy; Received chemotherapy less than 2 cycles, and / or not planned radiotherapy, and / or targeted therapy for less than 1 months; receiving simple Chinese medicine for more than 3 months; (3) patients with longer than 1 years of survival; (4) age more than 18 years and less than 80 years of age; (5) can be followed up to record their general data and treatment through retrospective study. The patients were followed up by telephone to record their survival time and the time of disease free progress. Through the analysis of the related factors and the factors affecting the patients' OS and PFS, the characteristics of the treatment dominant population were summarized. The results of the study were included in the study of 9288 patients, and 60 cases of the two cases were screened completely in accordance with the conditions: 1. general cases: 60 patients. The general characteristics were between 61-80 years of age of peak onset, 58.3% for male and female, 63.3% in smokers, 63.3% in central type, higher in right lung than in left lung, more in adenocarcinoma than squamous carcinoma (58.3%VS40.0%), 35 in stage IV (58.3%), 33.3% in first diagnosis and most in pleural effusion. 35.0%.2. survival time analysis: median PFS was 12 months and median OS was 28.5 months. It was significantly higher than 1.35 months and 8-10 months of best support treatment. Smoking history, past history of treatment, tumor type, tumor TNM staging, tumor distribution, distant metastasis, Chinese medicine treatment time were the important factors affecting survival time, and the intervention time of Chinese medicine was greater than that of the traditional Chinese medicine. One year, the curative effect of.3. was analyzed by COX multiple factor regression analysis: age and smoking history were independent risk factors affecting the prognosis of the patients..4.Logistic analysis showed that age, Chinese medicine intervention time, lung qi deficiency syndrome and blood stasis syndrome were significantly related to the therapeutic effect (P0.05), the prognosis of lung qi deficiency syndrome was better, and the poor prognosis of blood stasis syndrome was.5. single cause. Phlegm and rank sum test: the most syndrome type of phlegm damp stasis syndrome, phlegm dampness and stagnation of Qi and spleen qi deficiency and Qi Yin deficiency and heat toxin congestion (33.5%27.7%16.4%5.2%), TCM syndrome factors: phlegm damp syndrome Yin deficiency syndrome Qi deficiency syndrome and blood stasis syndrome (31.0%29.6%24.9%11.5%3.0%); Chinese medicine treatment characteristic is oral Decoction + Chinese patent medicine + Chinese medicine injection Comprehensive Traditional Chinese medicine treatment In the 1. studies, the dominant population of non small cell lung cancer with simple Chinese medicine is female, non smoking, peripheral adenocarcinoma, age less than 60 years old, patients who have been treated by surgery, TNM stage is stage III A, and distant metastasis is less. The characteristics of TCM syndrome are the characteristics of TCM Syndrome The deficiency of lung and spleen qi, phlegm dampness and stasis of deficiency and solid inclusion, and the syndrome factors of phlegm damp syndrome and Qi deficiency syndrome mainly.2. smoking history, the age is too old to increase the risk of death in the middle and late stage lung cancer patients, the long-term treatment of Chinese medicine and the previous acceptance of certain treatment (especially surgical treatment) are the favorable survival factors of the NSCLC lung cancer patients in the late period.3. Chinese medicine oral administration The combination of traditional Chinese medicine and traditional Chinese medicine + intravenous injection can be recommended. The intervention time of Chinese medicine is more than one year or more. For the treatment of advanced NSCLC patients, the basic pathogenesis of "phlegm, blood stasis and deficiency" should be firmly grasped. The median survival time of the patients with advanced NSCLC treatment in this group of Chinese medicine.4. was 28.5 months, and PFS was 12 months, reflecting the advantages of traditional Chinese medicine in the treatment of this type of population.

【學位授予單位】：北京中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R273

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