Analysis Of Adverse Drug Reactions Of Pegaspargase In Chemotherapy Of Childhood Acute Lymphoblastic Leukemia

Objective The adverse drug reactions(ADR)of children with acute lymphoblastic leukemia(ALL)following PEG-Asp treatment in General Hospital of Ningxia were analyzed,and the types and characteristics of ADR were discussed to provide a theoretical basis for its safe use.Methods From December 2016 to January 2019,PEG-Asp was used 442 times in 64 patients with ALL in General Hospital of Ningxia.The types,time,severity and outcome of ADR after PEG-Asp treatment were retrospectively collected and analyzed with corresponding statistical methods.Results1.352 cases of ADR occurred in the study,including: 1)Clinical manifestations:hyperglycemia,gastrointestinal reaction,allergic reaction,thrombosis,bleeding,pancreatitis,with the incidence of 117 cases(26.47%),47 cases(10.63%),29 cases(6.56%),15 cases(3.39%),13 cases(2.94%),9 cases(2.04%),respectively.2)Laboratory examination:coagulation dysfunction: decreased FIB,prolonged APTT,prolonged PT,prolonged TT and increased INR,with the incidence of 209 cases(47.29%),123 cases(27.83%),66 cases(14.93%),22 cases(4.98%)and 7 cases(1.58%),respectively;Routine biochemical abnormalities: increased ALT,decreased ALB,increased T-BIL,increased AST,increased TG,and increased TC,with the incidence of 87 cases(19.68%),57 cases(12.90%),47 cases(10.63%),38 cases(8.60%),24 cases(5.43%)and 13 cases(2.94%),respectively.2.Potentially life threatening ADR which required urgent treatment or leading to death included 4 cases(0.90%)of allergic reactions in;1 case(0.23%)of pancreatitis;1 case(0.23%)of bleeding;16 cases(3.62%)of decreased FIB;3 cases(0.68%)of increased T-BIL.3.Time to the first onset of ADR after medication including: with t≤2 h in 15 cases(4.26%);2 h<t≤1 d in 87 cases(24.72%);1 d<t≤3 d in 196 cases(55.68%);3 d<t≤7 d in 38 cases(10.80%);7 d<t≤15 d in 13 cases(3.69%)and t >15 days in 3 cases(0.85%).4.The incidence of ADR in low-risk and high-risk group was higher than that in medium-risk group,and the difference was statistically significant(P<0.05).There was no significant difference in gender,age,morphological classification and immunological classification(P>0.05).Conclusion1.The main ADRs in children with ALL after PEG-Asp treatment were hyperglycemia,gastrointestinal reactions,allergic reactions,bleeding,thrombosis,pancreatitis,coagulation dysfunction,and biochemical abnormalities,most of which resolved after timely symptomatic and supportive treatment.2.Most ADRs in children with ALL after PEG-Asp treatment is mild,except allergic reactions,pancreatitis,FIB reduction,bleeding can also be life-threatening,which required urgent treatment.3.Time to the first onset of ADR in children with ALL after PEG-Asp treatment was most frequently seen within 3 days,after which the incidence decreased gradually.