| Understanding of the subject of non-small cell lung cancer in Chinese and Western medicine treatment conducted a comprehensive literature analysis. The primary mode of treatment of the lung cancer is multidisciplinary participation treatment. Traditional Chinese Medicine (TCM) involved in chemotherapy combined program will not only alleviate negative side effects of chemotherapy medicine, but improve symptoms, thereby improving the quality of life of patients with lung cancer. Distinctive marks of this clinical study, firstly evaluate efficacy and safety of Fuzheng peiyuan decoction, using prospective, randomized, controlled study methods; in addition to assessing on the allieviate negative side effects of the therapy, significantly evaluate Fuzheng peiyuan decoction effect on the quality of life of patients, using evaluation tables of Functional Assessment Cancer Treatment scale of Lung cancer (FACT-L)4.0Chinese version, TCM Syndrome Scale of lung cancer, weight and Karnofsky (KPS) assessments scale, etc. Concurrently estimate sensitiveness of each evalutation for standardization of evaluation system. Dr. Lin Hongsheng and other professional doctors, who are belonging to the oncology department of Guang’anmen Chinese Medicine Hospital, recognize Deficiency of Qi and blood, the spleen and stomach disorders, liver-kidney deficiency, as important Chinese medical symptoms, and formed the experienced TCM decoction, which involved in lung cancer chemotherapy treatment stage,"Fuzheng peiyuan", which medical method is benefiting qi and nourishing blood, strengthening the spleen and stomach,tonify the liver and kidney. This study has theory and clinical significance for TCM involved lung cancer chemotherapy treatment.This study selected January2012to January2013in the oncology department of Guang’anmen Chinese Medicine Hospital inpatient, I1IA-IV non-small cell lung cancer met the inclusion criteria,61patients with chemotherapy, using the prospective, randomized, controlled study method,61patients were randomly divided into two groups; experimental group (the Fuzheng peiyuan decoction plus chemotherapy medicine treatment group), clinical control group (chemotherapy medicine treatment). Two groups were equally given chemotherapy medicine program, NP or TP; the experimental group, at the same time, was given Fuzheng peiyuan decoction,200ml/bd,21days to I treatment process; the control group was given chemotherapy medicine only. Filled cases selected table (-1day), the day before chemotherapy treatment, and filled cases selected table (21days), the21st day of chemotherapy treatment. Indexes used in this study are:the Functional Assessment Cancer Treatment scale of Lung cancer,4.0Chinese version (FACT-L), Karnofsky assessment scale (KPS), TCM Syndrome Scale of lung cancer and WHO acute and sub acute toxicity indexing table, etc. This study, using the FACT-L scale as a main index, which is not fully appearing patients’general status, also uses TCM syndrome scale as an auxiliary measurement method, to complement indexes each other, and try to show the characteristics and advantages of the participation of Chinese medicine treatment efficacy. With SPSS16.0statistical package program, established database and analyzed statistical results.OUTCOME MEASURES:Before treatment-comparative assessment, there is no significant differences in the areas of sex, age, height, weight, vital status, diagnosis method, metastasis, pathological type, clinical period, chemotherapy program, TCM syndrome, KPS status, blood test, liver and kidney, electrocardiogram, etc.,all of which statisticl results show P>0.05. Assessment to reliability and validiy of FACT-L table found that the FACT-L table has reliability (a value near to1) and validity(y>0.5). After treatment-comparative assessment, there are statistical differences in the physical and functional status of FACT-L assessment between experimental group and control group (P<0.05), furthermore highly significance in functional status area (P<0.01). The above result shows that Fuzheng peiyuan decoction involved chemotherapy treatment program gained advantages over the chemotherapy only treatment program in the area of physical and functional status. There is a significant difference in total score of TCM syndrome scale assessment between experimental group and control group (P=0.054). It shows that the experimental group dominant over control group, which means Fuzheng peiyuan decoction involved chemotherapy treatment program more effective than the chemotherapy only treatment in improvement of patients’overall status of TCM syndrome; there are statistical differences in the terms of fatigue, less words, pale face, spontaneous perspiration TCM syndrome between experimental group and control group (P<0.05), experimental group gained advantages over control group. The result means that Fuzheng peiyuan decoction involved chemotherapy treatment program is more efficient in improving the patients’ symptoms of fatigue, less words, pale face, spontaneous perspiration than the chemotherapy only treatment; there is statistical differences of body weight improvement between experimental group’ and control group(P<0.05), shows trend of highly significant difference (P=0.011). The body weight improvement of experimental group better than control group; there is statistical difference of KPS assessment between experimental group and control group (P<0.05), shows experimental group has no side effect on vital energies; there are no statistical differences of blood/liver/kidney/cardiac tests of before-treatment between groups, of after-treatment between groups, of before-and-after-treatment among groups (P>0.05). The results have no found bad and serious reactions among total61cases of this study; there are occurrence rate differences of upper than Ⅱ degree of hemogram-drop reactions between experimental group and control group, upper than Ⅱ degree of WBC-drop reaction of experimental group found5cases (16.12%), control group9cases (30%); upper than Ⅱ degree of HB-drop reaction of experimental group5cases (16.12%), control group9cases (30%); upper than Ⅱ degree of PLT-drop reaction of experimental group3cases (9.67%), control group7cases (23.33%). The results show that white blood cell (WBC),Hemoglobin (HB), boold platelet(PLT) drop reactions occurrence rates of the experimental group are lower than the control group, Fuzheng peiyuan decoction involved chemotherapy treatment program has protection effect in hemogram.Using prospective, randomized, controlled study methods; in addition to assessing on the allieviate negative side effects of the therapy, significantly evaluated Fuzheng peiyuan decoction effect on the quality of life with patients, using evaluation tables of Functional Assessment Cancer Treatment scale of Lung cancer (FACT-L)4.0Chinese version, TCM Syndrome Scale of lung cancer, weight and Karnofsky (KPS) assessments scale, etc., concurrently estimate sensitiveness of each evalutation for standardization of evaluation system. This study verified that through the way of "peiyuan (consolidating internal background of body), Fuzheng peiyuan decoction harmonized internal function of body: improving physical and functional status; improving TCM syndrome; stabilizing body weight and KPS assessment, and primarily protecting hemogram. We also conluded that deficiency of Qi and blood deficiency, the spleen and stomach disorders, liver-kidney deficiency are important Chinese medical symptoms, we can formed the experienced TCM decoction, which involved in lung cancer chemotherapy treatment stage,"Fuzheng peiyuan", which medical method is benefiting qi and nourishing blood, strengthening the spleen and stomach,tonify the liver and kidney.With evaluation tables of Functional Assessment Cancer Treatment scale of Lung cancer (FACT-L)4.0Chinese version, TCM Syndrome Scale of lung cancer, weight and Karnofsky (KPS) assessments scale, etc., on the basis of results this study gained, we conclude that the works of Fuzheng peiyuan decoction is very sensitive on patients with NSCLC chemotherapy in the physical and functional status area of FACT-L assessment; the works of Fuzheng peiyuan decoction is sensitive on patients with NSCLC chemotherapy in terms of fatigue, less words, pale face, spontaneous perspiration of TCM syndrome scale assessment; the works of Fuzheng peiyuan decoction is sensitive on patients with NSCLC chemotherapy in body weight and KPS assessment; the works of Fuzheng peiyuan decoction is relatively sensitive on hemogram protection. The study also has conclusions that the integrated assessment indexes can evaluate apparently the efficacy of Fuzheng peiyuan decoction involved in the stage of NSCLC chemotherapy treatment.The invention points of this study is to focus on evaluating physical and functional status of QOL with NSCLC patients in adtion to evaluating alleviate-negative-side effects. On the base of study results, we build up an elementary evaluation system to evaluate efficacy on Chinese medicine involved lung cancer chemotherapy treatment. Next researchers should use large size samples of NSCLC patients, attest and complete this evaluation system. |
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