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目的探讨大剂量甲氨蝶呤(HD-MTX)3·0g/m2与5·0g/m2(按体表面积计)应用后24、44、68h的血药浓度变化与临床毒副反应相关性,以提高急性淋巴细胞白血病治疗效果。方法观察15例急性淋巴细胞白血病住院患儿,接受大剂量MTX共50例次,按ALL危险度分为为两组,低危治疗组接受MTX剂量为3·0g/m2为Ⅰ组;中高危治疗组接受MTX剂量为5·0g/m2为Ⅱ组;观察临床出现MTX毒副反应的时间及程度,观察每个病例毒副反应出现程度与MTX血药浓度关系,两组毒副反应程度比较,进行统计学分析。结果①25例次接受MTX3·0g/m2患儿用药24、44、68h血药浓度分别是(30·09±7·04)umol/L、(0·39±0·42)umol/L、(0·06±0·13)umol/L;25例次接受MTX5·0g/m2患儿用药24、44、68h血药浓度分别是(54·37±11·12)umol/L、(0·46±0·32)umol/L、(0·07±0·08)umol/L,两组统计学分析24hMTX血药浓度有显著性差异,Ⅱ组MTX血药浓度明显高于Ⅰ组(P<0·05);②两组MTX毒副反应比较差异无统计学意义(P>0·05),MTX严重毒副反应与MTX血药浓度具有相关性,MTX浓度超过危险域值(44hMTX血药浓度>1umol/L;68hMTX血药浓度>0·1umol/L),临床毒副反应相对较重,均大于Ⅱ度以上,且持续时间较长。结论甲氨蝶呤临床给药剂量增加,其稳态血药浓度亦增高,毒副反应出现程度与中毒浓度呈相关性,在可靠的MTX血药浓度监测情况下提高MTX给药剂量是安全的,MTX血药浓度监测能可靠指导临床治疗,MTX出现中毒浓度时,可及时调整LV用量和次数,减少MTX严重及不可逆性毒副反应程度,保证ALL患儿按时开始下一疗程化疗,提高ALL患儿治疗效果。
Objective To investigate the relationship between the change of plasma concentration of 24 h, 44 h and 68 h after high dose methotrexate (HD-MTX) 3.0 g / m 2 and 5.0 g / m 2 (body surface area) To improve the therapeutic effect of acute lymphoblastic leukemia. Methods Fifteen children hospitalized with acute lymphoblastic leukemia were enrolled in this study. A total of 50 cases of high dose MTX were enrolled in this study. The patients were divided into two groups according to the risk of ALL. The patients in low risk group received MTX at a dose of 3.0 g / The MTX dose was 5.0 g / m2 in the treatment group, and the time and degree of clinical MTX toxicity were observed. The relationship between the degree of toxicity and MTX concentration in each case was observed. The degree of toxicity was compared between the two groups , For statistical analysis. Results ① The plasma concentrations of 24 cases, 44 cases and 68 cases of MTX3 · 0g / m2 were (30 · 09 ± 7 · 04) umol / L and (0 · 39 ± 0.42) umol / 0 · 06 ± 0 · 13) umol / L; 25 cases of children receiving MTX5 · 0g / m2 drug 24,44,68 h plasma concentrations were (54 · 37 ± 11 · 12) umol / L, 46 ± 0.32) umol / L, (0.07 ± 0.08) umol / L, 24hMTX plasma concentrations of the two groups were statistically significant differences in group Ⅱ MTX plasma concentration was significantly higher than the group Ⅰ (P <0.05). ② There was no significant difference in the MTX toxicities between the two groups (P> 0.05). The MTX serious toxicity was correlated with the MTX plasma concentration, and the MTX concentration exceeded the risk threshold (44hMTX blood Drug concentration> 1umol / L; 68hMTX plasma concentration> 0 · 1umol / L), the clinical toxicity was relatively heavy, were greater than Ⅱ degrees and longer duration. Conclusions Methotrexate dose increased and its steady-state plasma concentration increased. The degree of toxic reaction was correlated with the concentration of methotrexate, and it was safe to increase MTX dosage in the case of reliable MTX blood concentration monitoring , MTX blood concentration monitoring can reliably guide clinical treatment, MTX toxic concentrations, the timely adjustment of LV dosage and frequency, reduce the severity of MTX and irreversible toxicity, to ensure that ALL children start the next course of chemotherapy on time, improve the ALL Children with treatment.