培门冬酶及左旋门冬酰胺酶治疗儿童急性淋巴细胞白血病的疗效及不良反应

Drug-related side effects and adverse reactions of L-asparaginase and pegaspargase in treatment of children with lymphoblastic leukemia

目的:评估培门冬酶(Peg-asp)与左旋门冬酰胺酶(L-asp)治疗儿童初发急性淋巴细胞白血病的疗效与安全性,为临床合理应用这两种制剂提供参考依据。方法:选取2016年1—12月间湖南省儿童医院就诊的初发急性淋巴细胞白血病(acute lymphoblastic leukemia, ALL)患儿,分别采用包含L-asp (L-asp组)及Peg-asp联合化疗方案(Peg-asp组)进行诱导治疗,比较2组患儿的疗效及药物不良反应。结果: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。2组患儿第15天及第33天完全缓解率(M_1)及部分缓解率(M_2)等骨髓状态差异均无统计学意义(P>0.05)。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降低的发生率高于Peg-asp组,差异均有统计学意义(P<0.05);其他不良反应的指标组间差异无统计学意义(P>0. 05)。结论:L-asp与Peg-asp治疗儿童初发急性淋巴细胞白血病的疗效相当,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。

ObjectiveTo evaluate the safety of L-asparaginase （L-asp） and pegaspargase （Peg-asp） in the treatment of acute lymphoblastic leukemia （ALL） in children,so as to provide suggestions in clinical application of the 2 medicines.MethodsNewly diagnosed ALL children from January to December in 2016 in the Hunan Children′s Hospital were selected and divided into L-asp group and Peg-asp group according to the inductive treatment program.Adverse reactions of the 2 groups were compared.ResultsA total of 427 patients were enrolled,with 233 in the L-asp group and 194 in the Peg-asp group.There was no difference of complete response （M1） and partial response （M2） marrow sratus on th 15th and 33rd day between the 2 groups （P〉0.05）. Incidence of allergic reactions,increase of glutamic-pyruvic transaminase,decrease of fibrinogen,extension of activated partial thromboplastin time,reduce of antithrombin Ⅲ activity in the L-asp group is significantly higher than the Peg-asp group（P〈0.05）,while the other markers reflecting the occurrence of adverse actions were not significant between the 2 groups（P〉0.05）.ConclusionL-asp and Peg-asp are similar in terms of effectiveness,safety and adverse reactions in the treatment of newly diagnosed acute lymphoblastic leukemia in children.But Peg-asp has lower incidence of allergic reactions,liver function lesion,coagulation abnormality.