Comparison Of Clinical Effects And Adverse Reactions Between Domestic And Imported Imatinib In The Chronic Phase Of Chronic Myelogenous Leukemia

Background and Objective:Chronic myeloid leukemia(CML)is an abnormally proliferative blood disease of mature bone marrow.It is characterized by the Philadelphia chromosome Ph and forms the BCR-ABL fusion gene.The treatment of CML has undergone radiotherapy,chemotherapy,interferon and Targeted drug,before imatinib mesylate(TK1)did not appear,the 8-year survival rate of CML patients was 10-20%,and now CML has become a controllable chronic disease,tyrosine kinase inhibitor(TKIs)Imatinib mesylate has become the first-line treatment for patients with Ph-positive CML.The international randomized study of interferon combined with low-dose cytarabine(IRIS trial)confirmed the higher clinical efficacy and lower incidence of adverse reactions of imatinib A number of international studies have shown the efficacy of TKI in the treatment of CML,which can make 80%of patients live a normal life.It can be said that the appearance of TKI is a milestone,but long-term life-long medication,the price of expensive drugs is not affordable to all patients,and economic pressure is The main problem for patients is that domestic pharmaceutical manufacturers have produced domestic drugs Xinwei according to the structure of imatinib.The price is lower than imported,which can greatly reduce the economic burden on patients.However,whether the efficacy and safety of generic drugs and imported drugs are Consistently,There are no relevant literature reports in China.Objective:Comparing the clinical effects and adverse reactions of domestic imatinib Xinwei and imported Gleevec in the treatment of chronic myeloid leukemia in the chronic phaseMaterials and Methods:The outpatient clinic collected 253 patients with chronic myeloid leukemia from the period of July 2016 to July 2019 in First Affiliated Hospital of Zhengzhou University.The patients took medication regularly and were included in the study.For example,for follow-up in outpatient clinics.Retrospective analysis of hematological and molecular responses of domestic imatinib Xinwei and imported imatinib Gleevec(Xinwei group and Gleevec group)for 3 months,6 months and 12 months,Cytogenetic response,adverse drug reactions and 5-year overall survival rate,event-free survival rate and disease progression-free survival rate,to evaluate the clinical efficacy and drug safety of the two drugs in the treatment of CML.Results:The clinical effects and adverse reactions of the two drugs were not statistically significant(both P>0.05),Xinwei group vs Gleevec group,3 months complete hematologic response rate(CHR)92.5%vs 95.1%(P=0.468),complete cytogenetic response rate(CCyR)10.1%vs 12.2%(P=0.89),major molecular response rate(MMR)5.1%vs 4.3%(P=0.408).After 6 months of treatment,CHR was 96,7%vs 100%(P=0.062),CCyR was 58.6%vs 44.9%(P=0.315),and MMR was 20.5%vs 19.2%(P=0.102).After 12 months of treatment,CHR was 99.1%vs 95(P=0.067),CCyR was 80.6%vs 85.9%(P=0.110)in both groups,and MMR was 52.6%vs 61.4%(P=0.101)in both groups.It shows that the two drugs have similar effects on the chronic phase CP of CML.Among the hematological adverse reactions,simple white blood cells decreased by 5.1%vs 7.8%(P=0.357),anemia 8.7%vs 4.3%(P=0.118),and simple platelets decreased by 9.4%vs 5.2%(P=0.105).Non-hematological adverse reactions between the two groups,skin itching 18.8%vs 38.7%(P=0.065),edema 55%53.9%(P=0.854),bone pain 30.4%vs 24.3%(P=0.281),muscle pain 21.7%vs20%(P=0.735),diarrhea 4.3%vs6.1%(P=0.533),alanine aminotransferase increased 6.5%vs9.6%(P=0.372),total bilirubin increased 8.0%vs7.80%(P=0.966),panic chest tightness 2.1%vs 3.5%(P=0.529),fatigue 36.2%35.6%(P=0.924).There was no statistically significant difference in the 5-year overall survival OS between the Xinwei group and the Gleevec group(P=0.78),and there was no statistically significant difference in the 5-year event-free survival EFS between the two groups(P=0.259)Conclusion:1.The clinical effect of domestic imatinib Xinwei in the treatment of CML is not statistically different from that of Gleevec in the treatment of CML,which can achieve the clinical effect of Gleevec in the treatment of CML.2.The incidence of adverse reactions of domestic imatinib in the treatment of CML is lower and the safety is better.There is no statistically significant difference in the incidence of adverse reactions with Gleevec in the treatment of CML.3.The short-term survival rate of patients treated with domestic imatinib Xinwei was not statistically different from that of imported imatinib Gleevec.4.Compared with imported Gleevec,the price of domestic imatinib Xinwei is relatively low,which is accepted by more patients.