To investigate the changes in immune factors and clinical curative effects of fuzheng buxue granules combined with immunosuppressive therapy(IST) in treatment of children with aplastic anemia (AA).

From January 2009 to June 2013, a total of 44 children with AA who were hospitalized in Ezhou Central Hospital and consistent with inclusion and exclusion criteria of this study were recruited. According to their odd and even number of admission, they were randomly divided into combined therapy group (n=22, treated by fuzheng buxue granules combined with IST) and IST group (n=22, only treated by IST). The levels of peripheral hemogram and peripheral lymphocyte subsets were detected by flow cytometry before and after treatment, reverse transcriptase polymerase chain reaction (RT-PCR) technique was used to detect levels of blood cell interferon (IFN)-γ and interleukin (IL)-4 before and after treatment, and evaluated clinical curative effects of two groups after treatment. The procedure of this study was consistent with ethical standard established by the committee of investigation in human beings of Ezhou Central Hospital. And it was approved by this committee. Guardians of patients were informed of grouping and informed consent was obtained from them before clinical studies. There were no significant difference between two groups among age, gender ratio, course and severity of AA, white blood cell count, level of hemoglobin and platelet count before treatment(P>0.05).

①After treatment, rate of total clinical curative effect in combined therapy group was much higher than that in IST group [68.2% (15/22) and 95.5% (21/22), respectively], and there was significant difference (P<0.05). ②After treatment, white blood cell count, level of hemoglobin and platelet count in peripheral blood increased at different degree than those before treatment; After treatment, white blood cell count, level of hemoglobin and platelet count in combined therapy group were much higher than those in IST group, and there were significant differences (P<0.05). ③Before treatment, two groups of patients peripheral blood with CD₃⁺ CD₈⁺ cells(CD₈⁺ T cells) increased and CD₃⁺ CD₄⁺ cells(CD₄⁺ T cells) and CD₃^-CD₅₆⁺ cells[natural killer (NK)cells] decreased significantly than those normal control values, and there also were significant differences (P<0.05). After treatment, detection indexes of peripheral blood lymphocyte subsets in combined therapy group and IST group were gradually returned to normal levels, and those of detection indexes in combined treatment group recovered slightly better than those in IST group. The value of CD₄⁺ /CD₈⁺ in patients in two groups of large deviation before treatment than that CD₄⁺ /CD₈⁺ normal value, but after treatment it gradually restored to that CD₄⁺ /CD₈⁺ normal value, and there was significant difference (P<0.05). ④After treatment, relative levels of IFN-γ and IL-4 mRNA in blood in two groups were significantly decreased than those before treatment, and there were significant differences (P<0.05). Relative levels of IFN-γ mRNA and IL-4 mRNA in combined therapy group were much lower than those in IST group, and there were significant differences (P<0.05).

Fuzheng buxue granules combined with IST in treatment of children with AA, could promote hematopoietic function recovery, reduce levels of immune factors and regulate immune function, the clinical curative effects were better than those treatment only by IST.