Clinical Study On Patients With Mid And Late Stage Ensophageal Cancer Treated By Invigorating Spleen And Harmonizing Stomach Combined With NDP+5-FU+PTX/TXT Chemotherapy

Background:Esophageal cancer is one of the common malignant tumors in digestive tract. Patients with advanced esophageal cancer often feel dysphagia, have chest pain, vomit mucus, lost appetite, feel fatigue.This type of esophageal cancer patients are given with invigorating spleen and harmonizing stomach decoction to observe the effects.Objective:To investigate the clinical effect and mechanism of the invigorate spleen and harmonize stomach decoction combined with chemotherapy for advanced esophageal cancer. To evaluate advanced esophageal cancer by the five symptoms (dysphagia, chest pain, vomiting mucus, loss of appetite, fatigue), find the effective ways to improve the clinical symptoms, establish the effects of invigorating spleen and harmonizing stomach decoction, observe the state of life of patients, tumor markers and toxicity, and give methods to prevent the recurrence.Methods:According to the diagnostic criteria of western medicine and TCM, assessment criteria of clinical effect, and in the light of the relevant standards refer to the China's cancer diagnosis and treatment of common norms and guiding principles of Chinese medicine clinical research new drugs (PRC Ministry of Health, Medical Administration). Selected 40 patients with advanced esophageal cancer were randomly divided into treatment and control groups.20 patients in treatment group received 2 cycles of chemotherapy until the end, continuing to take invigorate spleen and harmonize stomach decoction and joint chemotherapy, the specific drug is: NDP 80～100 mg/m2, intravenous infusion, d1; 5-FU 500～750 mg/m2, intravenous infusion, d1～5,TXT 60～90 mg/m2 (PTX 175mg/m2), intravenous infusion. every 3 weeks as a cycle,2 consecutive chemotherapy cycles.20 cases in control group, simply to NDP/5-FU/TXT(PTX) chemotherapy. After 2 cycles, patients were compared changes in clinical symptoms, living conditions, tumor markers and side effects, and statistical analysis of differences between two groups.Results:This study showed that the integration of the treatment group before and after, was notable different in statistics (P<0.05); while the control group the difference was not statistically significant (P>0.05); After treatment, the symptom score compared the difference was statistically significant (P<0.05).About traditional chinese medicine symptoms, the treatment group that were 5 cases significantly effective,15 cases effective,0 ineffective; the control group were 0,9,11 cases, by rank sum test, the difference was significant (P= 0.000<0.05), show that the TCM treatment group more effective than the control group, and dysphagia, chest pain,have no significant difference (P>0.05), after the treatment group compared with the control group, vomiting mucus, loss of appetite, fatigue have statistically significant (P<0.05).QOL score before treatment groups showed no significant (P>0.05); after treatment was statistically significant difference (t=2.109, P=0.042<0.05). Before treatment Karnofsky score by t test, there was no conspicuous significant; and KPS score in the treatment group, improved in 10 cases, stable in 9 patients, decreased in 1 case, while the control group were 4,13,3 cases.Two groups by rank sum test, the difference was statistically significant (P<0.05).After treatment,11 patients gained weight, stable in 7 cases, decreased in 3 patients, in the control group were 4,10,6 cases, the two groups by rank sum test, the difference was statistically significant (P<0.05).The difference was no statistically significant in CEA and side effect between the two groups.Conclusion:Using invigorate spleen and harmonize stomach decoction combined with chemotherapy than chemotherapy alone in treatment of advanced esophageal cancer, in particular in improving clinical symptoms of vomiting mucus, loss of appetite, fatigue, the treatment group is better than the control group;also in improving the quality of life of patients.But have no effect in CEA level, and did not increase the toxicity. Invigorate spleen and harmonize stomach decoction is the effective way in advanced esophageal cancer.