| Objectives:To further evaluate the effect of Jianpi Yangzheng Xiaozheng Decoction in combination with chemotherapy as an individualized treatment in survival status of patients with advanced gastric cancer, this research observes the patients’survival time, clinical symptoms, the quality of life and so on. It is in order to preliminary reflect the features and advantages of Jianpi Yangzheng Xiaozheng Decoction in the treatment of advanced gastric cancer.Methods:89 clinical cases meeting the inclusion and exclusion criteria of this reasearch with a clear diagnosis of phase IV gastric cancer are selected according to the diagnostic standards of traditional Chinese medicine and modern medical science. The patients are divided into the trail group and the control group. There are 46 cases in the trail group which are given Jianpi Yangzheng Xiaozheng Decoction and the chemotheraphy regimens in NCCN guidelines. While in the control group,43 patients receive chemotherapy alone. After recording patients’ follow-up time, quality of life score, adverse events, the data of baseline information, survival time, survival rate, prognostic factors, quality of life and safety are analyzed by SPSS 19.0 to draw conclusions.Results:There is no statistically significant difference in baseline information between two groups, so the further analysis can be proceeded. In survival analysis, the trail group shows remarkable higher level than that of control group in the average survival time, the median survival time and 1 year survival rate. And the difference reaches statistical significance. The average survival times are 420.89±24.07 days and 325.84±18.88 days (P=0.007),1 year survival rates are 69.4%±0.079 and 45.7%±0.079. In prognostic factors analysis, the covariant of group difference has great significance to survival time. Its regression coefficient is-1.172 which is less than 0, and it indicates that the group difference is the protective factor in prognosis of advanced gastric cancer(Wald=9.613, P=0.002). Relative risk is 0.310 in Cox regression analysis which shows that compared with the control group, the patients’death risk is 69%(1 - 0.310) lower in trail group. The results showing that the group given Jianpi Yangzheng Xiaozheng Decoction is obviously better than the chemotherapy group in prognosis, which means combination with traditional Chinese medicine is the independent factor influencing the prognosis of advanced gastric cancer patients. In this research, gender, age, primary tumor site, pathological types and treatment metods has no significant correlation with prognosis. In quality of life score, the two groups have no obvious differences in terms of functional domains at different follow-up points. Nausea and vomiting apparently improved in the trail group since 2 months, with statistical significance (P<0.01). And at each follow-up point, the trail group mostly scores less in the symptom domains than control group. It is concluded that since the 2nd follow-up traditional Chinese medicine cooperating with chemotherapy group shows the trend of improving patients’symptoms to some extent. Pain and general health domains varies since the beginning of the research speculating that the group differences maybe the reason. In safety and adverse reactions, no serious adverse event occurs in this research. The main adverse reactions are about hematology toxicity, including grade 3 leucopenia and grade 3 —4 anemia. And the incidence rates of adverse reactions betweens the two groups have no statistically significant difference(P>0.05).Conclusions:Jianpi Yangzheng Xiaozheng Decoction combined with chemotherapy can bring survival benefit to patients of phase Ⅳ gastric cancer than receiving chemotherapy alone. At the same time, the Chinese medicine also has the effect of improving the quality of life and symptoms, reducing the adverse reaction of chemotherapy to a certain extent with good safety. |
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