Efficacy and advantages of modified Traditional Chinese Medicine treatments based on"kidney reinforcing"for chronic aplastic ane-mia: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.

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： kid- ney 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 pa- tients were treated for 6 months （two courses）. He- mograms, Traditional Chinese Medicine （TCM） syn- drome scores, and therapeutic effects were as- sessed, and changes in T-lymphocyte subsets, regu- latoryT cells and cytokines were detected. RESULTS： The KQ and KC groups had lower TCM syndrome scores than the positive control group af- ter 6 months （P 〈 0.05）. The KQ group had a higher overall efficacy than the positive control group af- ter 3 months （P 〈 0.05）, while platelet counts in- creased 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 in- creased only in the KC group after 6 months （P 〈 0.05）. Levels of interferon-y, tumor necrosis fac-tor-α, interleukin （IL）-2 and IL-6 decreased and lev- els 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 con- trol group （P 〈 0.05）.CONCLUSION： Treatments based on kidney rein- forcing have a rebalancing effect on cytotoxic and T helper cells, and regulate expression of interfer- on-y, IL-2, IL-6 and IL-4. KQ may be more effective in treating CAA, and KC may have an advantage in platelet recovery.