Objective To study the effect of kidney-tonifying and spleen-strengthening prescription(KTSSP) on the expression of programmed death-1(PD-1) and programmed death-ligand 1(PD-L1) in HBe Ag-positive chronic hepatitis B(CHB) patients with slightly increased alanine aminotransferase(ALT) levels.Methods This study included 32 HBe Ag-positive CHB patients with slightly increased ALT levels who were admitted to Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from September1,2010 to December 31,2013.These cases were divided into treatment group and control group using the randomized controlled method.Peripheral blood mononuclear cells were separated,and the expression levels of PD-1 on peripheral blood T lymphocytes and PD-L1 on dendritic cells were measured before and after treatment by flow cytometry.Comparison of continuous data between groups was made by independent-samples t test,while comparison of categorical data between groups was made by chi-square test.Results After treatment,the treatment group had a significantly reduced percentage of peripheral blood CD4+T cells with PD-1 expression(P < 0.01) and a significantly reduced mean fluorescence intensity(MFI) of PD-1 expression on CD4 + T cells(P < 0.05); there were significant differences in the percentage of CD 4+T cells with PD-1 expression and the MFI of PD-1 expression between the treatment group and control group(both P<0.05).After treatment,the treatment group had a significantly reduced percentage of peripheral blood CD8+T cells with PD-1 expression(P < 0.01) and a significantly reduced MFI of PD-1 expression on CD8+T cells(P < 0.01); there were significant differences in the percentage of CD8+T cells with PD-1 expression and the MFI of PD-1 expression between the two groups(both P < 0.05).After treatment,the treatment group had a significantly reduced MFI of PD-L1 expression on dendritic cells(P < 0.05) and myeloid dendritic cells(P < 0.01); there were no significant differences in the expression levels of PD-L1 on dendritic cells and myeloid dendritic cells between the two groups(both P >0.05).Conclusion For HBe Ag-positive CHB patients,KTSSP can reduce the expression levels of PD-1 on peripheral blood CD4+T and CD8+T cells and PD-L1 on dendritic cells and myeloid dendritic cells,which is associated with its clinical efficacy.