| Objective: Combined immunosuppressive therapy(IST) is the main treatment for patients with severe and very severe aplastic anemia worldwide, while rabbit anti-human thymocyte immunoglobulin(r-ATG) or porcine anti-human lymphocyte immunoglobulin(p-ALG) is the main drug in IST. In this article the efficacy and safety of the application of r-ATG and p-ALG in the treatment of children with severe aplastic anemia was compared.Methods: The clinical data of patients diagnosed with severe aplastic anemia in Suzhou Children’s Hospital from February 2009 to July 2015 and received IST based r-ATG or p-ALG therapy was analyzed. And the hierarchical analysis was performed according to the incidence of gender, age, severity of disease, interval time from diagnosis to treatment.Results: 1.Patients with severe aplastic anemia by IST were 144 cases(78 males, 66 females), including 86 cases of r-ATG and 58 cases of p-ALG.There was no significant difference in gender, age and risk group between the two groups. The median time of two groups from diagnosis to therapy were 19 days and 18 days, which were no significant difference. 2. The response rates of r-ATG and p-ALG in3, 6, 9 and 12 months were 59.30%versus46.55%、72.09% versus 74.14%、80.23% versus 74.14%、80.23% versus 75.86%,respectively. The P values were 0.196, 0.659, 0.497 and 0.663,and were no significant difference between the two groups,respectively. The difference of the response rates of severe aplastic anemia and very severe aplastic anemia group was no significant(r-ATG group 77.08% versus 78.94%, P=0.494;p-ALG group 82.50% versus 83.33%, p=0.919). 3. The response rates of patients who diagnosed to therapy time less than 30 days was higher than that who diagnosed to therapy time more than 30 days in the two groups(r-ATG group 86.88% versus 52%, p=0.004; p-ALG group 78.72% versus 72.72%, p=0.011). 4. The white blood cells recovering of r-ATG group was slower than that of p-ALG group in 3 and 6 months(p=0.032 and p=0.007), and the whole amount of white blood cells was no statistical significant difference in 9 and 12 months according to the comparative analysis of two groups of blood routine in 3, 6, 9 and 12 months.5. The overall survival rate of r-ATG group and p-ALG group were 78.9% versus 84.8%, and there were no differences between the two groups(p = 0.530).6. In three weeks of study of Side-effects, anaphylaxis in r-ATG group and p-ALG group(p=0.033) appeared in 43 cases(50.0%) and 19 cases(32.7%).The main clinical manifestations included fever, headache, rash and so on, which showed that r-ATG was more likely to cause allergic reactions. Serum sickness reaction in r-ATG group and p-ALG group(p=0.941) appeared in 53 cases(61.6%) and 35 cases(61.0%). The main clinical manifestations included fever, rash and painful joint, which was no statistically significant difference. Pneumonia in two groups(p=0.680) appeared in 30 cases(34.8%) and in 19 cases(32.7%).The main clinical manifestations included pulmonary infection and fungus infection, which were no statistically significant difference between the two groups.Conclusions: 1.The overall curative effects of r-ATG and p-ALG combined with cyclosporine in treatment of children with severe aplastic anemia are similar. 2. r-ATG has more inhibitory effect on lymphocyte than p-ALG after treatment in the first six months. 3. Patients with longer time from diagnosis to treatment have poor effect. 4. r-ATG is more likely to cause allergic reactions in patients with severe aplastic anemia. The probability of serum sickness reaction and infection occurred after the two treatments are similar. There was no significant difference in the overall safety. |
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