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培门冬酶(Peg-asp)与左旋门冬酰胺酶(L-asp)是治疗急性淋巴细胞白血病(ALL)的常用药物。为评估Peg-asp与L-asp在治疗儿童初发急性淋巴细胞白血病的安全性以及为这两种制剂的临床应用提供合理的参考依据,本研究选取初发ALL患儿,分别采用包含L-asp (L-asp组)及含Peg-asp联合化疗方案(Peg-asp组)进行诱导治疗,分析比较两组患儿的药物不良反应。结果显示,最终纳入研究的ALL患儿共427例,其中L-asp组233例、Peg-asp组194例。两组患儿男女性别比、月龄、初诊时WBC<50×109/L与≥50×109/L的人数比、各级危险度的人数比差异均无统计学意义;L-asp组的过敏反应、谷丙转氨酶升高、纤维蛋白原降低、活化部分凝血活酶时间延长、抗凝血酶Ⅲ降低的发生率均高于Peg-asp组;其他反映不良反应的指标组间差异无统计学意义。该研究表明L-asp与Peg-asp治疗儿童初发急性淋巴细胞白血病的安全性较高,不良反应类似,但Peg-asp的过敏反应、肝功能损害、凝血异常等发生率较L-asp更低。
Abstract：L-asparaginase(L-asp) and polyethylene glycol conjugated asparaginase(or pegaspargase, Peg-asp) are commonly used drugs for the treatment of acute lymphoblastic leukemia(ALL). In order to evaluate L-asp and Peg-asp in the treatment of children with ALL and provide a reasonable reference for the clinical application of these two preparations, Initial ALL children was selected in this study, including L-asp(L-asp group) and Peg-asp combined chemotherapy(Peg-asp group) for induction therapy, analysis and comparison of adverse drug reactions in the two groups of children. The results showed that there were 427 children with ALL who were included in the study, including 233 in the L-asp group and 194 in the Peg-asp group. There was no significant difference in the ratio of male to female sex, age, and the number of WBC<50×109/L and ≥50×109/L at the time of initial diagnosis and the number of people at all levels of risk in the two groups; Allergic reactions, elevated alanine aminotransferase, decreased fibrinogen, prolonged activation of partial thromboplastin, and decreased incidence of antithrombinⅢ were higher in the Peg-asp group; there were no differences in other indicators reflecting adverse reactions.Learning meaning. This study shows that L-asp and Peg-asp are safer for children with acute lymphoblastic leukemia, and the adverse reactions are similar, but the incidence of Peg-asp allergic reaction, liver damage,coagulation abnormalities is lower than L-asp.
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基本信息:
DOI：10.13417/j.gab.037.005006
中图分类号:R733.71
引用信息:
[1]郝琴,贺智英.Peg-asp与L-asp治疗儿童初发急性淋巴细胞白血病的安全性评估[J].基因组学与应用生物学,2018,37(11):5006-5011.DOI:10.13417/j.gab.037.005006.
基金信息:
延安大学医学院内儿护理学教研室资助
2018-11-25
2018-11-25