Objectives:To observe the clinical efficacy and safety of replenishing qi nourishing yin resolving stasis detoxing formula on advanced middle-late gastric cancer patients. Evaluate the effect of the Chinese herbal compound formula created under the guidance of this method and elaborate the characteristics and advantages of middle-late gastric cancer treatment by Traditional Chinese Medicine in order to lay the foundation for relating the efficient evaluation system of Chinese medicine.Methods:A radomized-controlled approach was used in this paper. By the sequence of patients order numbers(1-40) and with SPSS 16.0, the computer generated random numbers correspongding with the patients order numbers. Placing the random numbers in ascending order, the patients who were corresponding to the 1-20 random numbers were in the treatment group, 21-40 were in the control group, and each group has 20 cases.40 cases of middle-late gastric cancer were randomly divided into two groups with the randomized-controlled method:20 cases in the treatment group while the other 20 cases in the control group. Both groups use DCF model regimen,21 days for 1 period of 2 cycles of chemotherapy, therapeutic evaluations were taken after three moths. Cases in the treatment group took replenishing qi nourishing yin resolving stasis detoxing formula one dose each day during intermittent chemotherapy periods. Score of TCM symptoms, toxicity and Quality of Life were assessed before and after the treatment. The results were analyzed by the statistical software.Result:Comparison of TCM symptoms:19 cases(95%) were effective and 1 case(5%) invalid in treatment group. While in the control group 9 cases (45%) were effective and 11 cases (55%) invalid. The treatment group was significant difference (P<0.05), which was comparable. In the response rate, CEA, CA199 and toxicity, there is no significant difference (P>0.05) between the two groups. EORCT QLQ C-30 V3.0(Chinese version) was used to measure quality of life of patients, the results showed that the treatment group had higher score than the control group in the field of physical function, role function, social function and overall quality of life, the difference was statistically significant(P<0.05). The treatment group had lower score than the control group in the field of tired, naphtha and appetite loss, the difference was statistically significant (P<0.05).Conclusion:Replenishing qi nourishing yin resolving stasis detoxing formula combined with DCF chemotherapy for middle-late gastric cancer is superior to chemotherapy alone in improving patients'quality of life, TCM symptoms, and toxicity. |