抗胸腺细胞免疫球蛋白治疗儿童再生障碍性贫血的不良反应相关因素及疗效相关性研究

Adverse reactions management of Antithymocyte Globulin in treatment of childhood with aplastic anemia

摘要:

目的  归纳抗胸腺细胞免疫球蛋白（ATG）免疫抑制治疗儿童再生障碍性贫血（AA）不良反应防治对策，评价不良反应与疗效的关系，分析不良反应发生的相关因素。方法  采用ATG联合环孢菌素A（CsA）联合免疫抑制疗法（CIS）治疗儿童再生障碍性贫血共61例，其中使用美国（Genzyme公司）R-ATG 31例，使用德国（Fresenius公司）R-ATG 30例。采取不良反应综合防治措施，比较两种ATG不良反应发生率，分析不良反应与疗效关系，分析不良反应的相关因素。结果  Fresenius-ATG相关类过敏反应、血清病、感染和需加输血小板等不良反应发生率分别为40.00%（12例）、43.30%（13例）、16.70%（5例）和23.33%（7例）；Genzyme-ATG相关类过敏反应、血清病、感染和需加输血小板等不良反应发生率分别为35.48%（11例）、35.48%（11例）、9.70%（3例）和29.03%（9例），两种制剂ATG不良反应发生率差异无统计学意义（P >0.05）。不良反应的发生与否疗效比较差异无统计学意义，不良反应发生率在不同年龄，性别和疾病分型中差异无统计学意义。经综合防治，所有不良反应均得以及时控制，无治疗相关死亡。结论  ATG联合CsA治疗儿童再生障碍性贫血安全有效，综合防治措施可有效防治不良反应。Fresenius-ATG和Genzyme-ATG治疗儿童再生障碍性贫血不良反应发生率相当；不良反应的发生并不影响ATG治疗效果；不同年龄、性别及疾病严重程度与不良反应发生无直接相关性。

Abstract:

Objective To summarize the adverse reactions of rabbit antithymocyte globulin in treatment of children with aplastic anemia. Methods 61 children with AA treated with ATG and CsA in our department were analyzed, 31 of them received (Genzyme) R-ATG and CsA, the other 30 received Fresenius-ATG and CsA therapy, comprehensive measures were used to prevent and control ATG related adverse reactions. The incidence of adverse effects between the two groups were compared, the relationship between adverse reactions and efficacy rate, adverse related factors were also analyzed. Results There were no significant differences in ATG-induced adverse reactions between the (Genzyme) R-ATG and Fresenius-ATG groups. The incidence of anaphylactoid reactions, serum sickness, platelet transfusion and infection were 35.48 % versus 40.00 %, 35.48 % versus 43.3 %, 9.70 % versus 16.70 %, 29.03 % versus 23.33 % respectively. There were no significant differences for Efficacy rates of group with adverse reactions and group without adverse reactions. The incidence of adverse reactions were not significantly different for gender, age and severity. Conclusion The immunosuppressive treatment with antithymocyte globulin and cyclosporin is safe and effective for children with AA. Adverse reactions could be avoided and treated with comprehensive measures. Adverse reactions did not affect the therapy efficacy. Gender, age and severity may not related with adverse reactions.