Sairei-to. one of the Japanese-Chinese herbal medicines has been used for the treatment of various diseases, especially collagen disease and edema in nephrotic syndrome. However. the mechanism of the therapeutic effects remains uncertain. Therefore. we investigated the immunological changes of skin, kidney, spleen cells and scrum in autoimmune-prone MRL lpr. MRL/n and C57BL 6J mice treated with Sairei-to. In MRL lpr mice treated with Sairei-to, the improvement of proteinuria. reduction in the number of hematoxylin bodies in kidney, and reduced serum levels of blood urea nitrogen were observed. These results indicate that Sairei-to can improve or inhibit file progression of lupus nephritis. The proportion of CD19 and the Serum levels of IgG1. which is one of the pathogenesis of lupus dermatoses and lupus nephritis. were significantly reduced in Sairei-to-treated MRL lpr mice. Therefore, it is suspected that the B cell function was suppressed by Sairei-to. In addition, CD4 8 ratio in spleen cells and the degree of lymphoproliferation in MRL/lpr mice also decreased. Interestingly. IL-4 producing spleen cells were increased significantly by ELISPOT assay, and IFN-gamma mRNA expressions were reduced in Sairei-to-reated MRL lpr mice. Regal-ding the Th balance. an imbalance towards Th1 predominance may, plan a significant role in MRL lpr mice, and the Th1 axis was suppressed and the Th2 axis became predominant in Sairei-to-treated MRL lpr mice. On the other hand. Th2 cell type immunoglobulins (IgG1) were Suppressed, These results suggested that Sairei-to is potential for impairing shifted Th1 Th2 balance and hypergammablobulinemia resulting in therapeutic effects, (C) 2002 Elsevier Science Ireland Ltd. All rights reserved.