Clinical Study On Treatment Of Gastric Cancer With Anemia By Traditional Chinese Medicine

Objective:In this prospective, multicenter, randomized trial, YizhongShengxue capsule is used as the experimental drug to compare with FufangEjiaoJiang combined with western medicine’s treatment (positive control group) and western medicine’s monotherapy (negative control group) to have a comprehensive evaluation of the clinical efficacy and safety of the use of YizhongShengxue capsule in combination with western medicine in the treatment of advanced stage gastric cancer related anemia.Method:A total of 72 eligible patients were randomized into 3 groups:19 patients in the negative control group,18 patients in the positive control group (with FufangEjiaoJiang) and 35 patients in the experimental group (with YizhongShengxue capsule).All 3 groups received the same basic treatment of western medicine. The experimental group received YizhongShengxue capsule at the dosage of 3 capsules,3 times daily and the positive control group received FufangEjiaoJiang at the dosage of 20ml 3 times daily for 5 weeks continuously(35 days). The negative control group received only the basic treatment of western medicine. The clinical efficacy and safety of the medications were evaluated at the end of the treatment. The main observation indexes include the peripheral blood examination, the degree of anemia, the TCM syndrome, the quality of life, and the related signs of laboratory.Results:(1) The main observation indexes in the peripheral blood examination are RBC, HGB, HCT, MCV and RDW. There were no statistically significant difference (P>0.05)of RBC, HCT, MCV and RDW in 3 groups before the treatment. The HGB has unequal distribution as the FufangEjiaoJiang and the other 2 groups have no comparability (P<0.05) but the negative control group and the YizhongShengxue group have comparability. There was no statistically significant difference (P>0.05) in the negative control group before and after the treatment. There were improvement in the peripheral blood examination(HGB, HCT, MCV)for the FufangEjiaoJiang group and the YizhongShengxue group after the treatment. There were no statistically significant difference between both groups after the treatment. However the increment of HGB level in both FufangEjiaoJiang group and the YizhongShengxue group were higher than the negative control group with the YizhongShengxue group higher than the FufangEjiaoJiang group. (2) the therapeutic effect of anemia:The efficiency of 3 groups are as follow:negative control group 21.1%, FufangEjiaoJiang group 27.8%, the YizhongShengxue group 48.6%. There was statistically significant difference between YizhongShengxue group and negative control group(P<0.05). (3) The TCM syndrome:there was improvement of the sallow facial complexion in the negative control group after the treatment (P<0.05). The TCM syndrome overall score, sallow facial complexion, lost of appetite and thin body have improvement after the treatment in the FufangEjiaoJiang group (P<0.05). The TCM syndrome overall score improved after the treatment in the YizhongShengxue group. The comparison of the TCM syndrome and overall score between the groups has shown no statistically significant difference. The therapeutic effect of TCM syndrome:The efficiency of 3 groups are as follow: negative control group 26.3%, FufangEjiaoJiang group 61.1%, the YizhongShengxue group 65.7%.The comparison of the efficiency in between groups has shown significant difference in all 3 groups (P<0.05) and no difference between FufangEjiaoJiang group and the YizhongShengxue group. (4)KPS score before and after the treatment:no statistically significant difference between all 3 groups(P>0.05).YizhongShengxue group has improved KPS score after the treatment (P<0.05). (5)The related signs of laboratory:peripheral blood examination (WBC, PLT, MPV, PDW), serum iron, EPO, folic acid, vitamin B12 have no statistically significant difference between groups and within group before and after the treatmentConclusion:FufangEjiaoJiang and YizhongShengxue capsule are able to effectively treat advanced stage gastric cancer related anemia, YizhongShengxue capsule has significant higher efficacy compares with the negative control group (negative control group 21.1%, the YizhongShengxue group 48.6%), the increment of hemoglobin is higher after the treatment by YizhongShengxue capsule compared with FufangEjiaoJiang. Both FufangEjiaoJiang and the YizhongShengxue capsule are able to improve the weakness of stomach and spleen system, the deficiency in Qi and Blood syndrome, YizhongShengxue capsule has shown improvement in various syndrome,and it can improve patient’s quality of life.