Analysis Of The Clinical Efficacy And Safety Of Domestic Imatinib And Imported Imatinib In The Treatment Of Newly Treated CML

Objective: Chronic myelogenous leukemia(CML)is a hematological malignant tumor originating from multifunctional hematopoietic stem cells.The incidence rate in my country is 0.639-0.99 per 100,000 people.It can be affected at all ages.Middle-aged and elderly people are at high risk.The median age of onset is 45-50 years old.There are more men than women.Ph chromosome positive or BCR-ABL gene positive is the basis for diagnosis.Targeted therapy is currently the main clinical treatment method.Since the advent of imatinib,the effect has been significant,but because of its high price,many patients cannot afford it.The domestic imatinib has a lower price,but it is currently relatively cheap for domestic imatinib.Whether there is a difference in efficacy between imatinib and imported imatinib is still the focus of clinical research.In this study,we observed the use of domestic imatinib(Gunicor)in chronic phase patients with Ph+ chromosome positive(Ph+)chronic myeloid leukemia.Or Xinwei)and imported imatinib(Gleevec)after the treatment of hematological remission rate,molecular remission rate,best response,conversion treatment ratio and adverse reactions,to evaluate domestic imatinib and imported imatinib The clinical efficacy and safety of martinib.Methods: This study is a retrospective study.The clinical data of 171 newly diagnosed CML-CP patients who received imatinib treatment from January 2015 to December 2019 in the Department of Hematology of the Second Hospital of Hebei Medical University were collected.All are Ph+chromosome and BCR/ABL fusion gene positive and long-term use of imatinib mesylate(400mg/d),of which 46 patients took domestic imatinib and imported imatinib(Gleevec)According to the Sokal score,the collected clinical data of the two groups were divided into risk stratification,according to the hematological remission rate,the best response effect,the molecular remission rate and the response rate after 3,6,and 12 months of treatment.The ratio of the two groups of imatinib converted to second-generation TKI or other drugs is used to evaluate the initial efficacy of the two.According to whether the original imatinib is converted to domestic imatinib,the original efficacy is maintained to evaluate whether the two have similar efficacy.The safety of the two groups of data was evaluated according to indicators such as hematological toxicity and non-hematological toxicity during treatment.Adverse reactions were graded and recorded according to NCI/NIH Common Toxicity Standard Version 3.0 and retrospectively analyzed.SPSS23.0statistical software was used to perform statistical analysis on the data,the classification count data was described in percentage,and the chi-square test was used to compare the differences between the groups.Results:1.Epidemiology: The median age of onset was 48 years old,with middle-aged and elderly people as the high-risk population.2.The domestic imatinib group and the imported imatinib group were treated for 3 months(P=0.337 x2=0.923),6 months(P=0.700 x2=0.148),12months(P=0.734 x2)=0.116)There was no statistically significant difference in the best response and efficacy afterwards(P>0.05).3.There is no statistical difference between the domestic group and the imported group after 3 months(P=0.747),6 months(P=0.564),and 12 months(P=0.492)to achieve MR3.0data(P> 0.05);There was no statistical difference in the comparison of data reaching MR4.0 at 3 months(P=0.767),6 months(P=0.804),and 12 months(P=0.526)(all P>0.05).3.There were 10 cases in the domestic imatinib group who switched their treatment plans due to drug resistance or adverse reactions,accounting for21.7%.There were 33 cases in the original imatinib group who switched the treatment plan due to drug resistance or adverse reactions,accounting for26.4%.There was no statistical difference between the two groups(P>0.05).4.In follow-up,a total of 32 patients in the original imatinib group were converted to domestic imatinib,and one patient reached MR3.0 in March.After switching to domestic imatinib,it reached MR4.0 after 6 months and has maintained this effect.The remaining 31 people reached MR4.0 at least 1 year later.After switching to domestic imatinib,the original effect can be maintained.The condition is progressing.5.There was no significant difference in adverse reactions between domestic imatinib and imported imatinib(P>0.05).In the two groups of non-hematological adverse reactions,edema 24%vs33.6%(P=0.225),muscle pain 13.0%vs12.0%(P=0.854),skin rash 8.7%vs10.4%(P=0.966),nausea and vomiting 19.6%vs17.6%(P=0.767),bone and joint pain accounted for10.9% vs8.0%(P=0.777),diarrhea 6.5%vs5.6%(P=1.000),and leukopenia in hematological adverse reactions was 17.4%vs19.2%(P=0.788),Anemia was 13.0%vs11.2%(P=0.729),thrombocytopenia was 8.7%vs5.6%(P=0.704),there were no serious grade III-IV adverse reactions,and no drug toxicity mortality.Conclusion:1.The median age of onset of chronic myelogenous leukemia in this article is 48 years,which is lower than that of European and American countries.2.The results of the study show that domestic imatinib and imported imatinib have good efficacy and safety for newly-treated CML,and there is no significant difference in clinical efficacy and safety between the two.However,the price of domestic imatinib is cheap and the patient’s economic burden is small,which is more conducive to clinical application.3.Dynamic monitoring of the transcription level of the BCR/ABL fusion gene can better help us evaluate the response to drug treatment,discover disease progression and drug resistance,and is of great significance for the diagnosis,treatment and prognosis of chronic myeloid leukemia.4.Domestic imatinib and imported imatinib have similar drug resistance in the treatment of chronic myelogenous leukemia.