【作者】 阮氏秋恒；

【导师】 陈锐深；

【作者基本信息】 广州中医药大学 ， 中西医结合临床， 2012， 博士

【摘要】 目的通过观察益气化痰法中药经验方对65岁以上老年晚期非小细胞肺癌治疗,能稳定瘤体、改善主要临床症状、提高患者生活质量的作用。益气化痰法中药与化疗联合治疗可以减轻化疗毒副反应,提高疗效。论证益气化痰法是治疗老年晚期非小细胞肺癌行之有效的重要方法。以丰富老年晚期肺癌的临床治疗手段,提高老年晚期非小细胞肺癌的临床疗效。方法将90例不宜或不愿意行手术、介入、放疗以及靶向治疗的老年晚期非小细胞肺癌患者分为中医组,中西医组,西医组每组各30例。中医组采用益气化痰法中药方包括：党参25g、茯苓25g,甘草6g、枳壳15g、天冬15g、猫爪草30g、枇杷叶15g、浙贝15g、仙鹤草15g、守宫5g。西医组,可按患者情况选用化疗GP、TP、DP、培美曲赛单药的方案。中西医组采用中医组治疗方案+西医组治疗方案,中西医结合进行治疗,各组分别治疗两个周期。主要观察指标为症状改善、生存质量和化疗中的毒副反应,其他指标为肿瘤缓解、KPS评分、CEA、体重变化等。结果三组患者主要临床症状的改善情况比较,中医与中西医组治疗前后主要症状积分比较减少明显,经统计处理有统计学意义(P<0.05)。西医组治疗前后主要症状积分比较减少无明显,无有统计学意义(P>0.05)。中医组与中西医组治疗前后在咳嗽、咳痰、血痰、气短、乏力、纳差的情况比较差异有统计学意义(P<0.05)。西医组治疗前后在咳嗽、咳痰、血痰、血痰、气短、乏力、纳差的情况比较差异无统计学意义(P>0.05)。说明中医组与中西医组对临床症状改善具较好的效果,中医组与中西医组优于西医组,特别在咳嗽、咳痰、血痰、气短、乏力、纳差方面。三组患者瘤体变化情况比较,均未有病例达到CR,但有效率、稳定率中西医组最高(40%、76,6%),有效率西医组(11例占36,6%)所占比例高于中医组(1例占3.3%)但稳定率西医组(17例占56.7%)所占比例低于中医组(18例占60%)。三组治疗后肿瘤均缓解,差异有统计学意义(P<0.01),说明中药与化疗联合治疗后在肿瘤缓解情况最佳,中医组在缩小肿瘤方面不如西医组,但稳定瘤体方面有一定优势。生存质量方面,三组治疗后,KPS评分均有一定程度的改善,其中中医组与中西医组优于西医组,三组在统计学上比较有统计学意义(P<0.05)。本研究是采用卡氏评分还是采用肺癌治疗功能评价表(FACT-L)来患者生存质量的变化均提示中医组与中西医组在身体状况、情绪状况、功能状况、附加关注状况治疗前后较明显改善,有统计学意义(P<0.05),西医组治疗前后较差异无统计学意义(P>0.05)。说明中药能改善患者身体状况和功能状况相关,通过改善身体状况及功能状况从而改善患者的情绪状况和肺癌特异性功能状况,提高患者生存质量。三组治疗期间均在血液系统包括血红蛋白、白细胞、血小板降低比较差异均有显著性,经过统计分析(P<0.001),中医组基本无明显血液系统不良反应,中西医组的发生率显著低于西医组。三组在消化系统包括恶心呕吐、腹泻、肝功能毒副反应方面比较有显著性差异(P<0.05),其中中医组无发生毒副反应,中西医组毒副反应发生率低于西医组。在肾功能影响方面,中西医组不良反应发生率(13.33%)低于西医组不良反应发生率(20%)。研究的结果表明,中医药能减轻化疗毒副反应,有一定保护肝肾功能的作用。中西医组治疗后比治疗前肿瘤指标(CEA)平均明显下降,经统计学有统计学意义(P<0.05)。中医与西医组治疗前后肿瘤指标(CEA)平均无明显下降,差异无统计学意义(P>0.05)。中西医组治疗后肿瘤指标(CEA)明显下降,符合中西医组稳定瘤体率和有效率最高。三组治疗前患者体重平均比较差异无显著性意义(P>0.05),中医组与中西医组治疗后体重平均有明显增加,差异有统计学意义(P<0.05)。西医组治疗后体重平均明显下降,差异有统计学意义(P<0.05)结论(1)中医益气化痰法经验方能改善老年晚期NSCLC主要临床症状,特别在咳嗽、咳痰、血痰、气短、乏力方面尤为明显。(2)中医益气化痰法经验方对晚期老年非小细胞肺癌患者具有稳定瘤体作用(3)中医益气化痰法经验方可以明显提高患者生存质量与改善患者身体状况和功能状况,通过改善身体状况及功能状况从而改善患者的情绪状况和肺癌特异性功能状况,增加体重。(4)中医益气化痰法经验方与化疗联合能提高化疗药物的治疗效果,减轻其毒副反应。(5)益气化痰法是治疗老年晚期非小细胞肺癌行之有效的重要方法。更多还原

【Abstract】 Objective:Observation of the traditional Chinese medicines (TCM)"Device of Nourishing Qi and Eliminating Phlegm" therapy in patients of60years of age and above who are having non-small cell lung cancer at the last stage to figure out the impacts of the traditional medicines in preventing the development of tumors, improving major clinical symptoms in order to enhance the quality of life. The combination of the traditional Chinese medicines "device of Nourishing Qi and Eliminating" and chemotherapy can help reduce toxicity of the chemicals enhancing treatment effects. The therapy "Device of Nourishing Qi and Eliminating Phlegm" for the elderly having non-small cell lung cancer is an important and effective treatment that could contribute in enriching the clinical therapies for elderly patients having lung cancer at the last stage, improving clinical treatment effects on elderly having non-small cell lung cancer at the last stageMethod:Ninety elderly patients with non-small cell lung cancer of the last stage who cannot or do not wish to undergo a surgery, vascular obstruction, or radiotherapy, targeted therapy are sampled for the research. The targeted therapy was broken in three groups including treatment of TCM (group Ⅰ), combination of treatment of TCM and chemotherapy (group Ⅱ), treatment of chemotherapy only (group Ⅲ). Each group involves30patients. Group Ⅰ receives treatment of traditional Chinese medicines "device of Nourishing Qi and Eliminating Phlegm" only. The ingredients include:Dangshen25g, Fuling25g, Gancao6g, Zhike15g, Tiandong15g, Maozhaocao30g, Pipayel5g, Zhebeimul5g, Xianhecaol5g, Shougong5g. Group Ⅲ:Platinum-based chemotherapy was used either TP, GP, DP and Almita single regimen. Group Ⅱ: the treatment of TCM is the same as that of group Ⅰ and chemotherapy is the same as that of group Ⅲ. The three groups all undergo two three-week treatment phases. The key indicators observed include (Ⅰ) improvement of the major symptoms,(Ⅱ) quality of lives,(Ⅲ) side effects of the chemicals during treatment, and other indicators such as reduction of the tumor sizes, KSP average, CEA, body weight changes, etc.Results:The comparison of improvement of the major symptoms among the three groups: shows significant symptom reduction in group Ⅰ and group Ⅱ (P<0.05). There is no clear reduction in the group Ⅲ in comparison between before and after since the results are not significant (P>0.05). Group Ⅰ and Group Ⅱ have remarkable improvement of the major symptoms and better than that of group Ⅲ, especially with the symptoms of coughing, sputum release, anhelation, tiredness, and eating less. The changes are statistically significant with (P<0.05). This proves that treatment of TCM clearly works well on improvement of the major symptoms.Comparison of before and after treatment tumor changes among the three groups:There is no absolute elimination of tumor in any groups. Nevertheless, proportion of effective treatment (reduction of tumor sizes), proportion of stable tumor without any changes are highest in the group Ⅱ (40%and76.6%respectively). Proportion of effective treatment is higher in the group Ⅲ (11cases accounting for36.6%) than that of the group Ⅰ (1case accounting for3.3%). Nevertheless, proportion of patients with unchanged tumor sizes remains the same in the group Ⅲ (17cases accounting for56.7%), which is lower than that of the group Ⅰ (18cases accounting for60%). There tumor size changes are significant in all three groups (P<0.01). Apparently, combination of the TCM and chemotherapies has the most powerful impacts in tumor reduction. Traditional Chinese medicines only treatment helps prevent the tumor from getting larger.Comparison of quality of lives after treatment among three groups:after treatment, KPS average increases in all three groups, of those group Ⅰ and group Ⅱ have clearer increase than group Ⅲ. The changes are significant in all three groups (P<0.05). This research, aside KPS average, employs a Functional Assessment of Cancer Threapy-Lung (FACT-L) to assess post-treatment changes in patients’quality of lives. The results show significant improvement in terms of physical situation, mental situation, functional situation, and other signs in the two group Ⅰ and group Ⅱ (P<0.05). There are no significant changes in group Ⅲ (P>0.05). This proves that TCM helps improve physical health and functions of the body so as improve emotional situation and abnormalities caused by lung cancers. Hence, it helps enhance the patients quality of lives. Comparison of side effects during treatment among three groups:there are decreases in numbers of platelets, leucocytes, erythrocytes, and hemoglobin, and the changes are significant in all three groups (P<0.001). Basically, there is no side effect of the serium system found in group Ⅰ, group Ⅱ has the lower proportion of side effects than groupⅢ. Side effects on the digestive system include vomiting, nausea, diarrhea, and liver functions are significantly different among three groups (P<0.05). Of those, no side effects observed in group Ⅰ, and group Ⅱ has lower proportion of side effects than does group Ⅲ. This indicates that the Traditional Chinese medicines help reduce side effects of the chemotherapy.In group Ⅱ, comparison between before and after treatment shows significant decreases in CEA indicator(P<0.05). This is not the case for group Ⅰ and group Ⅲ while (P>0.05). The result of significant decrease of CEA indicator in group Ⅱ matches perfectly with the result of having highest proportion of patients with down-sized or undeveloped tumors in this group.Before treatment, there are no significant changes in average body weight in all three groups. After treatment, there is significant increase in average body weight of the patients of group Ⅰ and Ⅱ (P<0.05). The average body weight of the patients of group Ⅲ is significantly decreased (P<0.05).Conelusion:(1) The device of Nourishing Qi and Eliminating Phlegm therapy (drawn from treatment experiences) that could clearly improve major symptoms of elderly patients having non-small cell lung cancer, especially for the symptoms such as coughing, sputum release, bloody sputum, anhelation, tiredness, and eating less.(2)The device of Nourishing Qi and Eliminating Phlegm therapy (drawn from treatment experiences) inhibit (stabilize) the tumor development(3)The device of Nourishing Qi and Eliminating Phlegm therapy (drawn from treatment experiences) enhance the quality of lives of patients and improve the physical and functional status so as improves emotional situation and abnormalities caused by lung cancers, and increases the body weight. (4)The device of Nourishing Qi and Eliminating Phlegm therapy (drawn from treatment experiences) coupled with chemotherapy could enhance the treatment effects reducing the toxicity of the chemicals.(5) Therefore, it is clear that device of Nourishing Qi and Eliminating Phlegm therapy appears to be an important and effective therapy for elderly patients having non-small cell lung cancer at the last stage.更多还原