OBJECTIVE: To study the effect of Yanshu Injection (YI) used in comprehensive treatment on mid-late stage cancer. METHODS:One hundred and fifty patients with malignant cancer were equally randomized into the comprehensive treatment group (group A) and the control group (group B), both groups were treated systematically according to the NCCN 2005 cancer practice guideline, but 20 ml of YI was given additionally to group A every day. RESULTS: After treatment, the level of plasma CD4 and CD4/CD8 ratio were significantly lower in group B than those in group A (P < 0.05); the response rate (RR) was 32.00% (24/75) and 38.67% (29/75) in group B and A respectively, showing insignificant difference (P>0.05), and the clinical benefit rate (CBR)was 58.67% (44/75) in group A, lower than that in group B (85.33% (64/75), P< 0.05); the quality of life (QOL) in group A was superior to that in group B (P<0.05); and the incidence of main adverse reaction to chemotherapeutic agents was significantly lower in group A as compared to that in group B (P<0.05). CONCLUSION: YI could regulate the function of T-lymphocyte subsets, raise the CBR and QOL and reduce adverse reaction of chemotherapy in patients with mid-late stage cancer.
RCT Entities:
OBJECTIVE: To study the effect of Yanshu Injection (YI) used in comprehensive treatment on mid-late stage cancer. METHODS: One hundred and fifty patients with malignant cancer were equally randomized into the comprehensive treatment group (group A) and the control group (group B), both groups were treated systematically according to the NCCN 2005 cancer practice guideline, but 20 ml of YI was given additionally to group A every day. RESULTS: After treatment, the level of plasma CD4 and CD4/CD8 ratio were significantly lower in group B than those in group A (P < 0.05); the response rate (RR) was 32.00% (24/75) and 38.67% (29/75) in group B and A respectively, showing insignificant difference (P>0.05), and the clinical benefit rate (CBR)was 58.67% (44/75) in group A, lower than that in group B (85.33% (64/75), P< 0.05); the quality of life (QOL) in group A was superior to that in group B (P<0.05); and the incidence of main adverse reaction to chemotherapeutic agents was significantly lower in group A as compared to that in group B (P<0.05). CONCLUSION: YI could regulate the function of T-lymphocyte subsets, raise the CBR and QOL and reduce adverse reaction of chemotherapy in patients with mid-late stage cancer.