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目的探讨低剂量甲酰四氢叶酸钙(CF)延迟解救大剂量氨甲喋呤(HDMTX)应用安全性及机制。方法32例急性淋巴细胞白血病(ALL)109例次HDMTX治疗病例(HDMTX:标危3.0g/m2,高危5.0g/m2)。A组(55例次)MTX滴注起第42小时应用CF解救[15mg/(m2·次),q6h×3次,水化方案改良];B组(54例次)第36小时应用CF解救[15mg/(m2·次),q6h×7次]。血清MTX浓度测定用荧光偏振免疫分析法。不良反应评估标准按WHO抗癌药物急性与亚急性毒性反应分度标准。结果MTX滴入24h血清MTX浓度两组均无升高;48hMTX5.0g/m2患儿A组与B组差异有极显著性(P<0.001);肝损及口腔粘膜损害差异有显著意义(P均<0.05);Ⅲ~Ⅳ级肝损和口腔粘膜损害与对照组相比尤其是5.0g/m2HDMTX患儿差异有极显著意义(P均<0.001)。结论在充分合理的水化基础上应用CF低限量及42h延迟解救HDMTX的毒副作用临床应用是安全的。
Objective To investigate the safety and mechanism of low dose levofloxacin (CF) delayed rescue high dose methotrexate (HDMTX). Methods A total of 109 cases of HDMTX were treated in 32 ALL patients with acute lymphoblastic leukemia (HDMTX: standard risk 3.0g / m2, high risk 5.0g / m2). The patients in group A (55 cases) were treated with CF rescue [15mg / (m2 · times), q6h × 3 times, improvement of hydration plan at 42 hours after MTX instillation]; Group B (54 cases) [15mg / (m2 · times), q6h × 7 times]. Serum MTX concentration was measured by fluorescence polarization immunoassay. Adverse reaction evaluation criteria according to WHO anticancer drugs acute and subacute toxicity response indexing standards. Results There was no significant difference in serum MTX concentration between MTX and 24h groups (P <0.001), while there was significant difference between group A and group B (P <0.001) (All P <0.05). There was significant difference in grade Ⅲ ~ Ⅳ liver damage and oral mucosal damage compared with the control group, especially 5.0g / m2 HDMTX children (all P <0.001). Conclusion It is safe to use the low dose of CF and the delay of 42h to rescue the toxic side effects of HDMTX on the basis of adequate and reasonable hydration.