Huang Xiaoshan, Tong Yi, Zhou Feng, Zhao Yunshuang, Li Qingqing, Chen Siyu, Xiao Lan, Zeng Zhaofeng
College of Pharmacy, Changsha Health Vocational College Changsha 410000, Hunan, China.
College of Clinical Medicine, Changsha Health Vocational College Changsha 410000, Hunan, China.
Am J Transl Res. 2024 Jul 15;16(7):2931-2939. doi: 10.62347/CQGK2579. eCollection 2024.
To compare the efficacy and safety of different asparaginase formulations in the treatment of acute lymphoblastic leukemia (ALL) based on nano-magnetic bead immunoassay.
Retrospective analysis of adult ALL patients' clinical data who admitted to The Affiliated Hospital of Changsha Health Vocational College from August 2020 to August 2023. Finally, 65 adult ALL patients were included in this study, including the polyethylene glycol conjugated asparaginase (PEG-ASNase) group (n = 32) and the L-asparaginase (L-ASNase) group (n = 33). Enzyme-linked immunosorbent assay (ELISA) based on magnetic nanoparticles was used to determine the activity of ASNase in both groups. The levels of asparagine or glutamine in two groups were detected by automatic biochemical analyzer during induction therapy, and the adverse events of the two groups were observed during the treatment.
PEG-ASNase demonstrated a slower decrease in enzyme activity, longer action duration, and higher safety profile compared to L-ASNase. PEG-ASNase group and L-ASNase group demonstrated a similar complete remission rate (71.88% vs. 60.61%). Event-free survival was higher in patients receiving PEG-ASNase than those receiving L-ASNase (42.4% and 18.7%). The observed adverse reactions included allergic reactions, pancreatic lesions, gastrointestinal reactions and liver function damage. The incidence of gastrointestinal reactions and liver function damage was higher in the L-ASNase group than that in PEG-ASNase group (45.45% and 33.33%).
This study provides valuable insights into the asparaginase treatments in clinical, highlighting the importance of PEG-ASNase for improving treatment protocols in adult ALL patients.
基于纳米磁珠免疫测定法比较不同天冬酰胺酶制剂治疗急性淋巴细胞白血病(ALL)的疗效和安全性。
回顾性分析2020年8月至2023年8月在长沙卫生职业学院附属医院住院的成年ALL患者的临床资料。最终,本研究纳入65例成年ALL患者,包括聚乙二醇缀合天冬酰胺酶(PEG-ASNase)组(n = 32)和L-天冬酰胺酶(L-ASNase)组(n = 33)。采用基于磁性纳米颗粒的酶联免疫吸附测定法(ELISA)测定两组中天冬酰胺酶的活性。在诱导治疗期间,用自动生化分析仪检测两组中天冬酰胺或谷氨酰胺的水平,并观察两组治疗期间的不良事件。
与L-ASNase相比,PEG-ASNase的酶活性下降较慢,作用持续时间更长,安全性更高。PEG-ASNase组和L-ASNase组的完全缓解率相似(71.88%对60.61%)。接受PEG-ASNase治疗的患者无事件生存率高于接受L-ASNase治疗的患者(42.4%和18.7%)。观察到的不良反应包括过敏反应、胰腺病变、胃肠道反应和肝功能损害。L-ASNase组胃肠道反应和肝功能损害的发生率高于PEG-ASNase组(45.45%和33.33%)。
本研究为临床上天冬酰胺酶治疗提供了有价值的见解,突出了PEG-ASNase对改善成年ALL患者治疗方案的重要性。