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目的 2008年中国小儿血液病协作组制定了儿童急性淋巴细胞白血病(ALL)诊疗建议CCLGALL 08方案,本研究旨在评估08方案治疗儿童ALL的相关毒副作用。方法 114例新诊断的ALL患儿采用CCLG-ALL 08方案诊治,分为诱导缓解(VDLD)、早期强化(CAM)、巩固治疗、延迟强化(DIa&DIb)和维持治疗5部分,采用CTCAE v4.0评估药物相关毒副作用。结果毒副作用主要见于VDLD方案,以肝功能损害(87.7%)、口腔溃疡(20.2%)、高血糖(20.2%)、活化部分凝血酶时间延长(21.1%)、纤维蛋白原降低(34.2%)为主,其重度损害的发生率分别为7%、0、1.3%、0.8%、2.7%。L-ASP过敏发生率在延迟强化DIa方案(28.0%)显著高于VDLD方案(7.9%),其中15例换用培门冬酶后未再发生过敏反应。无严重心律失常、心肌缺血及左心功能降低;无骨坏死和肌病发生;无脏器功能衰竭发生;无治疗相关死亡发生。结论 CCLG-ALL 08方案药物相关毒副作用常见于VDLD方案,毒副作用轻微且可逆,无治疗相关死亡发生,提示此方案治疗儿童ALL是安全的。
Objectives 2008 China pediatric hematology collaboration group developed a diagnosis and treatment of childhood acute lymphoblastic leukemia (ALL) CCLGALL 08 program, the purpose of this study is to evaluate the 08 program for the treatment of children with ALL related side effects. Methods One hundred and fourteen newly diagnosed ALL children were diagnosed and treated with CCLG-ALL 08 regimen and divided into five parts: induction of remission (VDLD), early stage of reinforcement (CAM), consolidation therapy, delayed-phase reinforcement (DIa & DIb) and maintenance therapy. CTCAE v4.0 Assess drug-related side effects. Results The toxicities and side effects were mainly found in the VDLD regimen. Liver damage (87.7%), oral ulcer (20.2%), hyperglycemia (20.2%), activated thromboplastin time prolongation (21.1%) and fibrinogen reduction (34.2% The incidence of severe injuries were 7%, 0,1.3%, 0.8% and 2.7%, respectively. The incidence of L-ASP allergy was significantly higher in delayed-potentiation DIa regimen (28.0%) than that in VDLD regimen (7.9%), of which 15 patients did not re-develop allergic reactions after switching to pegaspargase. No serious arrhythmia, myocardial ischemia and left ventricular function was reduced; no osteonecrosis and myopathy; no organ failure occurred; no treatment-related deaths occurred. Conclusion The drug-related toxicities and side effects of CCLG-ALL 08 regimen are common in the VDLD regimen. The side effects of CCLG-ALL 08 are mild and reversible with no treatment-related deaths, suggesting that this regimen is safe for pediatric ALL.