A Clinic Study On PA-MSHA Vaccine Adjuvant Therapy For Stomach And Intestine Tumors

Objective:Objective To evaluate the effectiveness and safety of pseudomonas aeruginous MSHA(PA-MSHA)vaccine used as an immune modulator on patients with tumors of stomach and intestine in perioperative period。Methods:1.103 patients with tumors of stomach and intestine were divided randomly into trial group(n=50) and control group(n=53).2.Patients in trial group were injected or sprayed pseudomonas aeruginous MSHA(PA-MSHA) vaccine 5ml in the abdominal cavity near the tumor when operation.,on the third day after operation,they were also injected subcutaneously PA-MSHA 1ml on alternative day until one month. patients in control group didn't use relative agent.3.Peripheral venous blood samples were taken on the third day before operation,the third day,the seventh day and the one month after operation for the determination of subgroups of T cell and NK cell:the percentage of CD3~+T cells,CD4~+T cells,CD8~+T cells,and the ratio of CD4~+Tcells/CD8~+T cells,also the absolute counting of CD 16~+56~+cells.Results:1.Compared with the levels before the operation,the percentage of CD3~+T cells,CD4~+T cells,CD8~+T cells and the ratio of CD4~+T cells /CD8~+T cells decreased markedly in both groups(P＜0.05) on the third day after the operation,especially in trial group;of which there was significant difference between the two group s(P＜0.05).2.On the seventh day after the operation,the percentage of CD3~+T cells,CD4~+T cells,CD8~+T cells and the ratio of CD4~+T cells /CD8~+T cells recovered to preoperational levels in both groups,compared with the two groups,there was no significant difference(P＞0.05).3.On the one month after the operation day,the percentage of CD3~+T cells,CD4~+T cells,CD8~+T cells and the ratio of CD4~+T cells/ CD8~+T cells keep the same level compared with the levels before the operation,the percentage of CD3~+T cells,CD4~+T cells and the ratio of CD4~+T cells/CD8~+T cells increased markedly in trial group(P＜0.05) on the one month after the operation.The percentage of CD8~+T cells decreased markedly in trial group,of which there was significant difference between the two group s(P＜0.05).4.Compared with the levels before the operation,the absolute counting of CD16~+56~+ decreased markedly in both group s(P＜0.05) on the third day and the seventh day after the operation,especially the third day in the trial group and the seventh day in the control group;there was significant difference between the two group s(P＜0.05),On the one month after the operation day,the absolute counting of CD16~+CD56~+ recovered to preoperational levels in control group;Compared with the levels before the operation,the absolute counting of CD16~+56~+increased markedly in trial group,there was significant difference between the two group s(P＜0.05).5.The rate of complication of infection is lower in the trial group, there was significant difference between the two groups(P＜0.05).Conclusion:1.pseudomonas aeruginous MSHA(PA-MSHA) can alleviate the immune inhibited condition of patients with tumors of stomach and intestine in perioperative period and can promote the recovery of the immune after operation to patients with tumors of stomach and intestine.2.pseudomonas aeruginous MSHA(PA-MSHA) also can reduce the rate of complication of infection to patients with tumors of stomach and intestine.