| Objective:Observing Wu San Granule supporting the treatment of non-small cell lung cancer (NSCLC) of deficiency of both vital energy and yin and phlegm and blood stasis of the clinical efficacy and safety,and From the theoretical and clinical study of two areas to explore its mechanism.Method:1. Selecting non-small cell lung cancer (NSCLC) in 60 cases, all in April 2005 - 2007 February Chinese medicine hospital in Hubei Province cancer patient, out-patients, TCM is the type of phlegm and blood stasis and deficiency of both vital energy and yin. By order of priority were randomly divided into treatment of and control groups. Treatment group 45 cases, 15 cases with the control group. In the two groups in age, gender, disease, the severity of symptoms and treatment of Chinese medicine, and other aspects of integration there was no significant difference, comparable (P> 0.05).2.In the treatment group were given oral chemotherapy at the same time Wu San Granule, first five grams a day three. And the control group placebo oral chemotherapy at the same time, five grams a day three times. For a period of 21 days, two consecutive cycles. Security checks were conducted (hematuria have three conventional, heart liver and kidney function tests) and the effect of the observation (signs and symptoms observed), before and after treatment TCM Syndrome points, weight,'s score card and T-lymphocyte subsets (CD3, CD4, CD8, CD4/CD8), NK cell changes3.Comparing the two groups before and after treatment TCM Syndrome points, weight,'s score card and T-lymphocyte subsets (CD3, CD4, CD8, CD4/CD8), NK cell changes.4. Statistical analysis: Statistical data applications SPSS13.0 computer software for analysis. Two samples of the two sets of data analyzed by the t-test, according to variance-choice test results P value, both before and after treatment figures compare to a paired t test. Group to compare the single-factor analysis of variance.Resuits:1.Case selected: The treatment group has lost three cases because of the loss, the control group lost one case of medical and loss, the treatment group and control group loss rates were 6.67 percent and 6.67 percent, without excluding cases. A total of 56 patients completed the treatment, the treatment group of 42 cases, 14 cases of the control group.2.Traditional Chinese Medicine Clinical Syndrome: Six weeks after treatment, TCM Syndrome effects of the treatment group was significantly improved in 15 cases, some improvement in 19 cases, eight cases without improving the control group one case of significant improvement, improvement of the six cases, no improvement seven cases, two more significant Difference (P <0.05).3.Changes in body weight: Treatment after six weeks, two groups of weight changes, the treatment group increased by 20 cases, 15 cases of stability, reduce the seven cases, the control group increased three cases, four cases of stability, reduce the seven cases, the two groups was significant difference (P <0.05 ).4.Effect of changes in the quality of life: KPS to be in accordance with the classification, treatment group increase of 30 cases, nine cases of stability, have dropped three cases, the control group have increased five cases, five cases of stability, have dropped four cases, there were significant differences (P < 0.05).5.Immune function: Mainly observed T-lymphocyte subsets (CD3, CD4, CD8, CD4/CD8), NK cell changes, including the treatment group in the CD3, CD4, CD8, CD4/CD8, NK cells to improve compared with the control group were significantly Difference (P <0.05).Conciusion:1.Wu San Granule adjuvant treatment of non-small cell lung cancer patients with phlegm and blood stasis and can not only deficiency of both vital energy and yin protect the immune system and the antagonism of chemotherapy on the immune function of the side effects, but can also adjust and improve the body's immune function.2. Wu San Granule adjuvant treatment of non-small cell lung cancer patients with phlegm and blood stasis and deficiency of both vital energy and yin , the quality of life and the improvement of body weight compared with chemotherapy alone, there are clear advantages that can be attenuated Wu San Granule to improve efficiency, and improve the efficacy, reflects the characteristics of Chinese medicine.3. Wu San Granule has a better clinical safety, in the course of the trial did not appear evident with the experimental drug-related adverse reactions, the non-small cell lung cancer patients with blood, urine, feces conventional and liver and kidney function, no adverse effects on ECG. |