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目的比较门冬酰胺酶(L-ASP)和培门冬酶(PEG-ASP)治疗儿童ALL过程中的不良反应,以便及时有效地监测与防范,提高化疗安全。方法回顾性观察诱导缓解和早期巩固治疗期,随机接受ASP或PEG-ASP治疗的135例ALL患儿的临床表现及实验室检查,采用χ2检验及t检验进行分析。结果 ASP、PEG-ASP对ALL患儿的骨髓增殖均有抑制作用,白细胞、中性粒细胞、Hb、血小板及骨髓抑制恢复时间诱导缓解治疗期:ASP组分别为(18.00±5.91)d、(19.70±6.00)d、(21.74±6.97)d、(18.51±8.66)d、(24.04±6.02)d;PEG-ASP组分别为(26.80±6.23)d、(26.40±6.06)d、(30.40±7.31)d、(17.50±8.30)d、(30.30±5.52)d。早期巩固治疗期:ASP组分别为(15.55±3.32)d、(16.68±6.00)d、(2.84±6.58)d、(6.73±8.89)d、(16.61±5.02)d;PEG-ASP组分别为(23.13±13.65)d、(23.78±10.95)d、(11.82±12.61)d、(2.82±7.30)d、(28.12±6.47)d。纤维蛋白原、活化部分凝血活酶时间、抗凝血酶Ⅲ恢复时间,诱导缓解治疗期:ASP组分别为(14.57±7.13)d、(12.15±7.91)d、(12.38±8.15)d。PEG-ASP组分别为(29.70±5.36)d、(24.60±11.37)d、(29.30±8.41)d。早期巩固治疗期:ASP组分别为(11.24±2.90)d、(11.64±2.01)d、(7.13±3.71)d;PEG-ASP组分别为(29.46±7.25)d、(19.05±9.26)d、(30.26±8.56)d。变态反应、总蛋白降低、清蛋白降低发生率,诱导缓解治疗期:ASP组分别为3.77%、56.60%、22.64%;PEG-ASP组分别为0.00%、100.00%、60.00%;早期巩固治疗期:ASP组分别为21.21%、57.58%、30.30%;PEG-ASP组分别为2.56%、84.61%、64.10%。结论 ASP、PEG-ASP均对ALL患儿的骨髓增殖具有抑制作用,其抑制的程度临床相似;PEG-ASP治疗时,骨髓抑制、血常规、血凝恢复正常时间长,蛋白质抑制作用强,变态反应发生率低,余不良反应发生率与ASP相似。
Objective To compare the adverse reactions of asparaginase (L-ASP) and pegaspargase (PEG-ASP) in the treatment of children with ALL in order to monitor and prevent them in a timely manner and improve the safety of chemotherapy. Methods The clinical manifestations and laboratory tests of 135 ALL patients randomized to receive ASP or PEG-ASP were retrospectively reviewed. Chi-square test and t-test were used to analyze the results. Results ASP and PEG-ASP inhibited the proliferation of all children with ALL. The recovery time of leukocyte, neutrophil, Hb, platelet and myelosuppression were all significantly decreased in the ASP group (18.00 ± 5.91) d and ( (26.80 ± 6.26) d and (30.40 ± 6.06) days respectively in the PEG-ASP group were significantly higher than those in the PEG-ASP group (19.70 ± 6.00 d, 21.74 ± 6.97 d and 18.04 ± 6.06 d, respectively 7.31) d, (17.50 ± 8.30) d, (30.30 ± 5.52) d. The initial consolidation period was (15.55 ± 3.32) d in ASP group (16.68 ± 6.00) d, (2.84 ± 6.58) d, (6.73 ± 8.89) d and (16.61 ± 5.02) d in PEG group and (23.13 ± 13.65) d, (23.78 ± 10.95) d, (11.82 ± 12.61) d, (2.82 ± 7.30) d and (28.12 ± 6.47) d respectively. Fibrinogen, activated partial thromboplastin time, antithrombin Ⅲ recovery time, induced remission treatment period: ASP group were (14.57 ± 7.13) d, (12.15 ± 7.91) d, (12.38 ± 8.15) d. PEG-ASP group was (29.70 ± 5.36) d, (24.60 ± 11.37) d, (29.30 ± 8.41) d respectively. The early consolidation period was (11.24 ± 2.90) d in the ASP group (11.64 ± 2.01) days and (7.13 ± 3.71) days in the ASP group, and (29.46 ± 7.25) days in the PEG-ASP group and (19.05 ± 9.26) (30.26 ± 8.56) d. Allergic reaction, total protein, albumin, and induction of remission were 3.77%, 56.60% and 22.64% respectively in the ASP group and 0.00%, 100.00% and 60.00% in the PEG-ASP group, respectively : 21.21%, 57.58% and 30.30% in ASP group and 2.56%, 84.61% and 64.10% in PEG-ASP group respectively. Conclusion Both ASP and PEG-ASP can inhibit the proliferation of myeloid leukemia in children with ALL, and the degree of inhibition is clinically similar. In the treatment of PEG-ASP, myelosuppression, blood routine, blood clotting, normal blood clotting, The incidence of reaction is low, the incidence of adverse reactions and ASP similar.