中晚期原发性肺癌痰证证候特征及量化判别要点研究

【作者】 张玲；

【导师】 张培彤；

【作者基本信息】 北京中医药大学 ， 中医内科学， 2011， 硕士

【摘要】 原发性肺癌是世界上最常见的恶性肿瘤之一,且是发病率持续增高的少数几种肿瘤之一。肺癌的生物学特性十分复杂,恶性程度高,80%的患者在确诊时已处于中晚期。西医学认为,非小细胞肺癌的5年生存率只有15%,晚期非小细胞肺癌(ⅢB期、Ⅳ期)的5年生存率不足2%。而中医的介入使得很多中晚期患者维持了较好的生活质量。在肺癌的证型分类研究中,对血瘀证、气虚证、阴虚证等证的证候特征均已达成一些共识,但对于肺癌痰证,目前众多开展中医证候研究的医家采用的临床研究方法各异,缺少公认、规范、统一的标准,可重复性不太理想,无法在临床广泛应用,不利于中医在诊治肺癌方面的发展。本课题在对相关文献进行分析后挑选了广义痰证诊断标准,作为入组标准,通过观察308例中晚期原发性肺癌患者,分析归纳出肺癌痰证的某些临床症状体征,初步拟定出中晚期原发性肺癌痰证证候的判别要点,并分析了一些常用实验室指标与痰证的相关性,以求为肺癌痰证的进一步研究提供参考。研究对象：观察2009年11月至2011年3月在中国中医科学院广安门医院肿瘤科11区、15区及19区住院治疗的中晚期原发性肺癌患者,共308例。每位患者于入院第二天晨起空腹抽血,送检验科查血常规、生化全项及肿瘤标记物,并记录患者相关症状体征。研究方法：1.拟定初步分组标准：因目前尚无统一的痰证诊断标准,通过对文献中所列举的痰证诊断标准进行整理,结合导师多年临床经验,选用方永奇的广义痰证诊断标准作为课题的初步分组标准,将入组的病例分为痰证组、非痰证组；2.选择符合纳入标准的患者,分别纳入痰证组、非痰证组,作为观察对象；3.整理文献研究所列举的所有痰证诊断标准中的症状体征,挑选出现频率较高的项目,经专家初筛后,挑选出19项症状体征列为临床观察项目：咳嗽、咯痰、痰多、喉中痰鸣、头晕、胸闷、喘憋、气短、乏力、纳呆、恶呕、失眠、嗜睡、形体肥胖、体表无痛无痒肿块、内脏肿物、舌胖边有齿痕、苔腻、脉滑。实验室指标的选择参考文献研究中所列举的指标,挑选出临床普遍适用、检测方便的14项实验室指标:WBC、PLT、NEUT%, HDL、APOA1、APOB、CHO、ALP、TG、LDH, CA199、CEA、CA153、CA125。4.观察样本的基本情况：观察入组病例的基本临床特征,包括：年龄、性别、原发部位、病理组织学类型、手术情况、临床分期、卡式评分、伴发肺部感染、吸烟史、肿瘤家族史等。5.进行统计学分析：对上述观察项目进行统计学分析,得出各项与肺癌痰证是否关联；对于临床症状体征,筛选出肺癌痰证证候判别要点,确定其判别阈值；对于实验室指标,分析出其对肺癌痰证的诊断意义。研究结果：1.痰证组在性别、原发部位、分期、KPS评分、肿瘤家族史方面与非痰证组相比无统计学差异。年龄方面,痰证组的年龄偏大,老年患者较多。病理组织学方面,痰证组鳞癌较多而非痰证组腺癌较多；对于手术情况,痰证组未手术者较多；痰证组伴发肺部感染者较多,与非痰证组比较有统计学意义；痰证组吸烟者较多,烟龄也较非痰证组的长。2.经统计分析后,确定中晚期肺癌痰证的量化诊断阈值为37分,拟定中晚期肺癌痰证证候的判别要点为：主症：1.咳嗽(17分)2.咯痰(12分)3.胸闷(12分),次症：1.痰多(10分)2.苔腻(6分)3.体表无痛无痒肿块(5分),证候判别要点：具备主症3项,或具备主症2项加次症2项。即可诊断。经回顾性检验,该判别要点敏感度、特异度、准确度和阳性似然比分别为90.24%、77.97%、83.00%、1.98%。3.实验室指标中,仅乳酸脱氢酶的值在痰证组较非痰证组高,两组间比较有统计学意义,其他指标均未见差异。结论：本研究中痰证组在性别、原发部位、分期、KPS评分、肿瘤家族史方面与非痰证组相比无统计学差异。与非痰证组相比,痰证组年龄较大、鳞癌较多、未手术者较多、伴发肺部感染者较多、吸烟者较多、烟龄也较长。确定中晚期肺癌痰证的量化诊断阈值为37分,拟定中晚期肺癌痰证证候的判别要点为：主症：1.咳嗽(17分)2.咯痰(12分)3.胸闷(12分),次症：1.痰多(10分)2.苔腻(6分)3.体表无痛无痒肿块(5分),证候判别要点：具备主症3项,或具备主症2项加次症2项。即可诊断。所观察的实验室指标中,仅乳酸脱氢酶的值在痰证组较非痰证组高,两组间有统计学差异。更多还原

【Abstract】 Primary lung cancer is one of the most common cancer in the world, and is one of the few tumors continued to increase in the incidence. Biological characteristics of lung cancer is complex, high degree of malignant, in 80% of patients with confirmed was in advanced. Western medicine believes that 5-year survival rate is only for non-small cell lung cancer 15%, advanced non-small cell lung cancer (ⅢB or IV stage) 5-year survival rate of less than 2%. And intervention of traditional Chinese medicine makes many of the advanced patients maintain a better quality of life. In study on classification of syndrome of lung cancer, blood stasis and Qi deficiency and Yin deficiency have been reached some consensus, but at the moment of study on TCM syndrome of lung cancer in many clinical research methods doctors used different, lack of recognized, standardized, unified standards, repeatability less ideal, not widely used in clinical, is not conducive to the development of Chinese medicine in the diagnosis and treatment of lung cancer. This subjects in on related literature for analysis then selected has generalized phlegm card diagnosis standard, as into group standard. We observated 308 cases of advanced primary lung cancer to sum up some clinical characteristics and establish the discriminant points of advanced primary lung cancer:main symptoms. At the same time,the subject analysed the correlation between some common laboratory indicators and phlegm syndrome to provide a reference to the study of lung cancer.Research Objects:The subject observed 308 patients with advanced primary lung cancer who were in Oncology ward 11,15 and 19 of Guang’an men Hospital during 2009.11～2011.3. Each patient in the hospital the next day early morning on an empty stomach blood to laboratory investigation of blood routine and biochemical and tumor markers, and record the related symptoms in patients with signs.Research Methods:1. To draw up the initial subgroup standard:Because there is no uniform diagnostic criteria of phlegm, through the documents listed in the diagnostic criteria for finishing of phlegm, combined with the tutor for many years of clinical experience, selection of Fang Yongqi’s generalized criteria of phlegm syndrome as the initial subgroup standard, divide into phlegm syndrome group and non-phlegm syndrome group; 2.Select the patients met the inclusion criteria, divide into phlegm syndrome group and non-phlegm syndrome group, as the observation of objects;3. Cleared up the phlegm symptoms and laboratory indicators involved in the literature and chose the higher frequency entries. After initial screening by experts,we observed 19 symptoms and 14 laboratory indicators. Symptoms:cough, expectoration, excessive phlegm, phlegm sound of throat, dizzy, chest tightness, asthma holding, shortness of breath, weak, poor appetite, nausea and vomiting, insomnia, deep sleep, obesity, painless and itch-free lump of cutis, visceral lump, fat tongue with tooth-trace, carex greasy, slip pulse. Laboratory indicators:WBC, PLT, NEUT%, HDL, APOA1, APOB, CHO, ALP, TG, LDH,CA199, CEA, CA153, CA125.4. Observed the basic situation of the sample:sex, age, the primary site, histopathology, surgery, clinical stage, KPS score, with lung infections, smoking history, family history of cancer.5.Statistical analysis:statistical analysis of the above observation project, came to the phlegm are associated with lung cancer; for clinical symptoms and signs, filter out lung cancer syndromes of phlegm distinguishing points determines its discrimination threshold; for laboratory indicators, analyze its significance in the diagnosis of lung phlegm.Results:1. Group of phlegm in sex, primary site, stage, KPS score, family history of cancer, with no statistically significant difference compared to non- phlegm syndrome group of. The phlegm syndrome group, more elderly patients. Phlegm syndrome group more squamous cell carcinoma and adenocarcinoma of the non- phlegm syndrome group more; for surgical cases, group is not more surgery of phlegm; groups with more people living with lung of phlegm, and non-statistically significant comparison of phlegm; phlegm syndrome group smoke longer than non-phlegm syndrome group.2. By clinical observation and statistical analysis, we established the syndromic discriminant points:Main symptoms:1. cough (17) 2. expectoration (12) 3. chest stuffy (12), second symptoms:1. excessive phlegm (10) 2. carex greasy (6) 3. painless and itch-free lump of cutis (5).Having the 3 main symptoms or 2 main symptoms plus 2 of second symptoms can form the diagnoses. By retrospective test, the sensitivity, specificity, accuracy and positive likelihood ratio was 90.24%,77.97%,83%,1.98%.3.In laboratory indicators, only LDH in phlegm syndrome group was lower than non-phlegm syndrome group, statistically with statistical difference.Conclusion: The phlegm in the research groups in sex, primary site, stage, KPS score, family history of cancer, with no statistically significant difference compared to non- phlegm syndrome group. Compared with non- phlegm syndrome group, group of older, more squamous cell carcinoma of phlegm, more no surgery, more complicated by lung infection, more smokers, tobacco age longer. Determine in the advanced lung cancer phlegm syndrome of quantitative diagnosis threshold value for 37, by clinical observation and statistical analysis, we established the syndromic discriminant points:Main symptoms:1. cough (17) 2. expectoration (12) 3. chest stuffy (12), second symptoms:1. excessive phlegm (10) 2. carex greasy (6) 3. painless and itch-free lump of cutis (5).Having the 3 main symptoms or 2 main symptoms plus 2 of second symptoms can form the diagnoses. In laboratory indicators, only LDH in phlegm syndrome group was lower than non- phlegm syndrome group, statistically with statistical difference.更多还原