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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 incidence and severity of common adverse reactions in the treatment of acute lymphoblastic leukemia (ALL) in children with pepsin-like enzyme (PEG-ASP) and L-asparaginase (L-ASP) in accordance with. Methods 38 patients with ALL who received PEG-ASP or L-ASP were enrolled in the study (162 cases of chemotherapy). The incidence of adverse reactions and its severity were observed according to the different formulations of ASP used in the PEG-ASP group (81 cases) and L-ASP group (81 cases). The levels of pre-chemotherapy (d_0) After (d_8) of liver function and blood coagulation routine data. Results There was no significant difference in clinical adverse reactions between the two groups (P> 0.05). The incidence of allergic reactions (0.00%) in PEG-ASP group was significantly lower than that in L-ASP (7.31 ± 5.54) g / L and (5.60 ± 4.39) g / L respectively in PEG-ASP group and L-ASP group compared with pre-chemotherapy group (7.41%, P <0.05) (5.21 ± 4.53) g / L and (3.90 ± 3.73) g / L, respectively. Compared between two groups, the decrease of total protein and albumin in PEG-ASP group was more obvious than that in L-ASP group (P <0.05). There was no significant difference between the two groups in the incidence and severity of other common adverse reactions and various experimental indicators (P> 0.05). Conclusion The incidence of anaphylactic reactions in PEGASP is lower than that of L-ASP in clinical application, but its inhibitory effect on protein synthesis is higher than that of L-ASP. It is more prone to hypoproteinemia and deserves clinical attention.