单纯中医药治疗晚期非小细胞肺癌优势人群特征的回顾性研究

发布时间：2018-05-04 16:48

本文选题：单纯中医药 + 非小细胞肺癌　；参考：《北京中医药大学》2017年硕士论文

【摘要】：背景:肺癌是全球发病率和死亡率最高的恶性肿瘤之一,其中有85%的患者非小细胞肺癌,通常有70%的患者发现时已为不可手术的晚期,而晚期NSCLC的一线治疗,能够一定程度上提高患者的生存率,提高生活质量,但是对于放化疗及靶向治疗不耐受,一般情况较差或复发转移的患者(PS评分:3-4),西医只能选用最佳支持治疗来控制肿瘤的生长和提高患者的生活质量,以往的研究表明单独运用最佳支持治疗的晚期NSCLC患者的生存期为8-10个月,而如果不接受任何治疗的晚期NSCLC患者生存期则6个月。中医药治疗是我国防治肺癌的重要特色,中医药治疗措施在肺癌治疗中的不断参与,显示出了一定优势,从国家"六五"—"十一五"科技支撑计划,研究涉及肺癌辨证分型,治则、治法以及方药研究,以及中医参与或中医为主的综合治疗方案的研究等各个层面,现已基本明确了中医药参与在肺癌治疗中的明确优势,对于中医参与的综合治疗方案患者的生存时间和生活质量均高于单纯西医治疗的患者,运用中医药可以实现稳定瘤体,带瘤生存以及提高患者生活质量的目的。然而迄今为止,循证医学所提供的研究数据仅能证明中医药在肺癌治疗的不同阶段,可以发挥不同的治疗作用,在依据循证研究数据形成的指南中,也是仅仅界定了不同阶段治疗的中医治疗大法,仍然不能回答的问题是:是否所有肺癌患者都能从中医治疗中获益?究竟哪一类肺癌患者更适合接受中医药的什么方法的治疗?中医药什么时间点开始参与治疗,干预时间需要多久更加获益?尤其对于晚期的患者多失去了手术治疗的机会,身体情况较差或不愿意接受西医治疗的患者,筛选中医药治疗的优势人群,符合医学精准化及个体化的大方向,是进一步提高中医药治疗肺癌疗效的重要课题。研究目的:本研究从性别、年龄、病理类型、TNM分期、肿瘤分化程度、解剖部位、肿瘤标志物、中药治疗的暴露时间及舌苔脉象、中医证候、中医证候要素等角度与晚期肺癌患者无进展生存时间、总生存时间相互间的关系进行分层研究,并通过相关因素分析单纯中医药治疗晚期NSCLC患者优势人群的临床特征及表型,为最大限度发挥中医药治疗肺癌的优势和特色提供依据。研究方法:本研究的病例资料来源于中国中医科学院广安门医院2006/01/01-2016/04/28住院病房,按照纳入标准((1)经病理学或细胞学确诊的Ⅲ-Ⅳ期非小细胞肺癌带瘤患者;(2)既往未行化疗、放疗;或既往接受化疗≤2周期,和/或未按计划完成放疗,和/或接受靶向治疗≤1个月;接受单纯中医药治疗≥3个月;(3)生存时间≥1年的患者;(4)年龄≥18岁且≤80岁;(5)可随访,将符合研究标准的患者通过回顾性研究的方式记录其一般资料及治疗情况,并对患者进行电话随访,记录其生存时间及无疾病进展时间,通过进行相关因素的分析及影响患者OS、PFS的因素,总结治疗优势人群的特征。研究结果:研究共收录9288例患者,经二次筛选完全符合条件的患者60例:1.一般情况:60例患者的一般特征为发病高峰年龄在61-80岁之间,男性与女性人数比为2.3:1,吸烟人群占58.3%,肿瘤部位以中央型为主63.3%,右肺发生率比左肺高,腺癌多于鳞癌(58.3%VS40.0%),Ⅳ期35例(58.3%)为最多,首诊时肺转移最多占33.3%,合并症以胸腔积液的最多占35.0%。2.生存期分析:中位PFS为12个月,中位OS为28.5个月,明显高于最佳支持治疗的1.35个月及8-10个月,吸烟史、既往治疗史、肿瘤类型、肿瘤TNM分期、肿瘤分布、远处转移情况,中药治疗时间长短均是影响生存期的重要因素,中药干预时间大于一年,疗效明显。3.用COX多因素回归分析:得到年龄和吸烟史是影响患者预后的独立危险因素。4.Logistic分析显示:年龄、中药干预时间长短、肺脾气虚证及血瘀证与治疗疗效明显相关(P0.05),肺脾气虚证预后较好而血瘀证则预后较差。5.单因素和秩和检验:痰湿瘀阻证为此群患者的最多证型,痰湿瘀阻肺脾气虚气阴两虚热毒壅肺(33.5%27.7%16.4%5.2%),中医证候要素:痰湿证阴虚证气虚证血瘀证(31.0%29.6%24.9%11.5%3.0%);中药治疗特色是口服汤药+中成药+中药注射液的综合中医治疗模式,以益肺清化,扶正祛邪,化痰散结为主。结论:1.本研究中显示了单纯中医药治疗非小细胞肺癌的优势人群可能为女性,不吸烟,周围型腺癌患者,年龄≤60岁,既往接受过手术治疗,TNM分期为ⅢA期,远处转移较少的病人。中医证候特点为肺脾气虚,痰湿瘀阻的虚实夹杂型,同时证候要素以痰湿证和气虚证为主。2.吸烟史,年龄太大增加了中晚期肺癌患者的死亡风险,中医药长期治疗和既往接受一定的治疗(尤其是手术治疗)是晚期NSCLC肺癌患者有利的生存因素。3.中医口服汤药+中成药+静脉注射液的综合中医治疗手段可以被推荐使用。推荐中药干预时间大于一年及以上,对于晚期NSCLC患者的中医治疗要紧紧抓住其"痰、瘀、虚"夹杂的基本病机,处方用药选择上多以扶正培本,化痰散结为主,配以清热解毒,抗癌的中药。4.本组患者单纯中医药治疗晚期NSCLC治疗中位生存期为28.5个月,PFS为12个月,体现了中医药在治疗这一类人群中的优势。
[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.

【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R273

【参考文献】