培门冬酶与左旋门冬酰胺酶治疗儿童急性淋巴细胞白血病不良反应的对比研究

Comparative study on the adverse reactions of pegaspargase and L-asparaginase in the treatment of childhood acute lymphoblastic leukemia

目的比较培门冬酶(PEG-ASP)和左旋门冬酰胺酶(L-ASP)治疗儿童急性淋巴细胞白血病(ALL)过程中常见不良反应的发生率及其严重程度,为化疗安全性提供参考依据。方法收集接受PEG-ASP或L-ASP治疗的ALL患儿38例(化疗162例次)。根据使用的ASP制剂不同分为PEG-ASP组(81例次)及L-ASP组(81例次),观察不良反应发生率及其严重程度,比较两组化疗前(d_0)及化疗1周后(d_8)的肝功能及血凝常规数据。结果两组在不同化疗时期(诱导缓解期及定期强化期)临床不良反应发生率差异无统计学意义(P>0.05);PEG-ASP组过敏反应发生率(0.00%)明显低于L-ASP组(7.41%,P<0.05);与化疗前相比,PEG-ASP组及L-ASP组总蛋白变化均值分别下降(7.33±5.54)g/L和(5.60±4.39)g/L,白蛋白变化均值分别下降(5.21±4.53)g/L和(3.90±3.73)g/L,组间比较显示PEG-ASP组总蛋白及白蛋白下降较L-ASP组更明显(P<0.05)。两组间其他常见不良反应和各项实验指标异常的发生率和程度差异均无统计学意义(P>0.05)。结论 PEGASP在临床应用中过敏反应发生率较L-ASP低,但对蛋白合成的抑制程度高于L-ASP,更易出现低蛋白血症,值得临床关注。

Objective To compare the common adverse reactions of pegaspargase(PEG-ASP) and L-asparaginase(L-ASP) in the treatment of childhood acute lymphoblastic leukemia(ALL), to provide references to chemotherapy safety. Methods Thirty-eight cases ALL children, who received treatment with PEG-ASP or L-ASP(162 times chemotherapy) were divided into PEG-ASP group(81 times) and L-ASP group(81 times). The incidence rates and the degree of common adverse reactions were observed. The liver function and hemagglutination routine were detected and compared before(d_0) and after treatment(d_8). Results The difference of adverse reaction incidences in different chemotherapy stages between two groups was not statistically significant(P>0.05). The incidence rate of hypersensitivity in PEG-ASP group(0.00%) was lower than that in L-ASP group(7.41%, P<0.05). The falling values of the total protein(TP) in the PEG-ASP group and L-ASP group were(7.33±5.54) g/L and(5.60±4.39) g/L respectively, and the falling values of albumen(ALB) were(5.21±4.53) g/L and(3.90±3.73) g/L respectively. The comparison between two groups showed that the TG and ALB in PEG-ASP group were decreased more than those in L-ASP group(P<0.05). The differences in the incidence rates and degree of the other indexes of the liver function and hemagglutination routine between the two groups were not statistically significant(P>0.05). Conclusion In clinical application of PEG-ASP and L-ASP, the hypersensitivity incidence of PEG-ASP is lower than L-ASP, while the degree of protein synthesis inhibition of PEG-ASP is higher than that of L-ASP, so the incidence of hypoproteinemia is higher, which should arouse more attention.