大剂量甲氨蝶呤治疗儿童急性淋巴细胞白血病的临床观察

Clinical observation of high-dose methotrexate treatment for children with acute lymphoblastic leukemia

目的探讨大剂量甲氨蝶呤(MTX)治疗儿童急性淋巴细胞白血病的临床效果。方法选取2011年1月至2013年12月间收治的急性淋巴细胞白血病患儿96例,采用随机数字表法分为对照组和治疗组,每组48例,对照组患者采用VDLP方案[长春新碱(VCR)、柔红霉素(DXR)、左旋门冬酰胺酶(L-ASP)、泼尼松(Pre)]进行治疗,治疗组患者采用大剂量MTX治疗,观察两组患儿治疗后的疗效、安全性,并对治疗组患儿血浆MTX的血药浓度进行监测。结果治疗组完全缓解率和总有效率分别为66.7%(32/48)和89.6%(43/48),显著高于对照组的37.5%(18/48)和70.8%(34/48),差异有统计学意义(P<0.05);治疗组患者不良反应发生率为20.8%,对照组患者不良反应发生率为35.4%,差异有统计学意义(P<0.05);治疗组患儿48 h血浆MTX浓度<0.25μmol/L者39例,占81.3%;患儿48 h血浆MTX浓度≥1μmol/L者3例,占6.3%。结论大剂量MTX治疗儿童急性淋巴细胞白血病临床效果显著,在血浆MTX浓度监测下,实施个体化甲酰四氢叶酸钙解救,毒副反应轻微,值得临床推广。

Objective To observe the effect and safety of high-dose methotrexate （MTX） treatment for children with acute lymphoblastic leukemia. Methods From January 2011 to December 2013, 96 pa- tients with acute lymphoblastic leukemia were enrolled in the study. According to the random control clinical trial principle, the patients were divided into two groups： the control group and the treatment group, 48 ca- ses in each group. The patients in the control group accepted VCR ＋ DXR ＋ L-ASP ＋ Pre （VDLP） scheme and the patients in the treatment group accepted high dose MTX. The curative effects and safety of the two groups were observed. MTX blood concentration of the treatment group was monitored. Results The com- plete response rate and total effective rate were 66. 7% （32/48） and 89.6% （43/48）, significantly higher than those of the control group 37. 5% （18/48） and 70. 8% （34/48）, with significant differences （P 〈 0. 05 ）. The incidence rate of adverse reaction of treatment group was 20. 8% ; and the adverse reaction rate of control group was 35.4%, the difference was statistically significant（P 〈 0. 05） ; In the treatment group, 48 h plasma MTX concentration of 〈0. 25 μmol/L occurred in 39 cases, accounting for 81.3% , 48 h plas- ma MTX concentration was 1 mol/L occurred in 3 cases, accounting for 6. 3%. Conclusions High dose MTX in the treatment of acute lymphoblastic leukemia children could achieved good clinical efficacy. Its toxicities are mild and it is worthy of clinical promotion.