Efficacy and advantages of modified Traditional Chinese Medicine treatments based on "kidney reinforcing" for chronic aplastic anemia:a randomized controlled clinical trial

OBJECTIVE:To compare the efficacy of modified treatments based on "kidney reinforcing" in the management of chronic aplastic anemia(CAA),and explore their advantages and specialties.METHODS:One hundred and eleven patients with CAA were randomly divided into three groups:kidney reinforcing alone(KA),"kidney reinforcing and Qi tonifying"(KQ),and "kidney reinforcing and blood circulation invigorating"(KC).Normal and positive control groups were also formed.All patients were treated for 6 months(two courses).Hemograms,Traditional Chinese Medicine(TCM) syndrome scores,and therapeutic effects were assessed,and changes in T-lymphocyte subsets,regulatory T cells and cytokines were detected.RESULTS:The KQ and KC groups had lower TCM syndrome scores than the positive control group after 6 months(P < 0.05).The KQ group had a higher overall efficacy than the positive control group after 3 months(P < 0.05),while platelet counts increased in the KC group after 6 months(P < 0.05).CD3+ T-lymphocyte ratios decreased only in the KQ group,while CD3 + CD4 + CD8-Tlymphocytes increased only in the KC group after 6 months(P <0.05).Levels of interferon-γ,tumor necrosis fac-tor-α,interleukin(IL)-2 and IL-6 decreased and levels of IL-4 and IL-10 increased in all treated groups after 6 months.Levels of IL-6 in the KQ and KC groups were lower than those in the positive control group(P < 0.05).CONCLUSION:Treatments based on kidney reinforcing have a rebalancing effect on cytotoxic and T helper cells,and regulate expression of interferon-γ,IL-2,IL-6 and IL-4.KQ may be more effective in treating CAA,and KC may have an advantage in platelet recovery.