| Objective1. To evaluate the efficacy and safety of combination of low does cyclosporine A and androgen in the treatment of non-severe aplastic anemia.2. To investigate at different time points, the influence of valley value and peak value of small does cyclosporine A on the effectiveness and adverse effects in the treatment of non-severe aplastic anemia. Methods1. We collect the clinical data of patients of non-severe aplastic anemia in the Department of hematology of the 88 th Hospital of PLA from September 2011 to December 2013. According to the inclusion criteria and exclusion criteria, we screen out 44 eligible patients with non-severe aplastic anemia,Were randomly divided into group A and group B.Group A had 21 patients,was treated with 3mg/kg?d in two times, and group B had 23 patients,using 5mg/kg?d in two times. Blood count and reticulocyte count were tested every week, blood biochemical, the valley value and peak value of cyclosporine A were tested every month. Since the begging of the treatment, the judgment of treatment efficacy were taken in the third, sixth and twelfth month, including calculate the cure rate, remission rate, efficient rate and incidence of adverse reactions in the patients after treatment.2. High performance liquid chromatography were used to test the plasma concentration of the low dose cyclosporine A at different time points. The blood count and blood biochemical were tested and noted at the same time points as well as the incidence of adverse effects.3.Using SPSS 17.0 statistical software, first of all, the above information is for signal factor analysis: categorical data using x 2 test, measurement data using t test, non-normal distribution level of measurement data and categorical data using rand and inspection(P<0.05 there is statistical significance). Results1.The clinical effectiveness of group A and group B in the treatment of patients with non-severe aplastic anemia were equal. In group A, totally 21 cases, during 3 months treatment, there were none of them were cured( 0%), 3 cases got remised( 14.29%), 8 cases were improved significantly( 38.10%), and 10 cases got nothing better( 47.61%); After 6 months treatment, 2 patient got cured(9.52%), 5 of them got remised( 23.81%), 6 of them were significantly improved(28.57%), but 8 of them still got nothing improved( 38.10%); When it comes to 12 moths treatment, 5 cases got cured( 23.81%), 5 cases got remised( 23.81%), 6 cases got significantly improved( 28.57%), however, 5 cases still has no clinical effects( 23.81%). In this study, there were no clinical effect differences between the two groups, as well no statistical difference(P>0.05); In group A, after 3 moths treatment, the patients, WBC 3.1±0.8×109/L,BPC 52±17×109/L,Hb72±18 g/L; at 6 moths, the results of blood count expressed as below, WBC3.6±0.4×109/L, BPC 67±22×109/L,Hb89±19 g/L; And at 12 months, the blood count of the patients were WBC3.9±0.2×109/L,BPC 89±14×109/L,Hb97±15 g/L. There were no statistical difference between the two groups at different time points.2.Group A had little adverse effects on blood biochemical, and the complication rate was lower than the control group. After 3 month and 6 month treatment, we had not found kidney and liver function damage in group B; When it comes to 12 months, one patient got kidney damaged, expressed as the high level of creatinine. In 6 months after the treatment, the rate of liver function damage in group A, is lower than that of group B, in 12 months, the rate of kidney function damage in group A, is lower than that of group B(P<0.05).3. The initial plasma concentration of the cyclosporine A had no influence on the outcome of non severe aplastic anemia patients during the 12 moths treatment; If the C0<80ng/ml or C2<230ng/ml in 6 moths, these data indicated that these patients might got no clinical effects; If the C2>450ng/ml in 12 moths, indicated that higher chance of implication rate. Conclusion1. Low doses(3mg) of cyclosporine A had almost the same clinical effect on the treatment of non severe aplastic anemia patients as the 5mg dose group had, at the same time, low doses of cyclosporine A can down regulate the complication rate significantly.2. The initial plasma concentration of the cyclosporine A had no influence on the outcome of non severe aplastic anemia patients; However, when the therapy comes to 6 months, C0 and C2 of cyclosporine A can influence the efficient rate, and in 12 months, the level of C2 can regulate the complication rate. |
PDF Full Text Request