| Object:By observating the remission rate in hematologic and molecular biology,of Ph chromosome positive(Ph+)in chronic myelogenous leukemia(CML)patients with use of domestic imatinib(Genike or Xinwei)or import of imatinib(Gleevec),Eevaluation the initial clinical efficacy and safety of domestic and imported drugs.Methods:The retrospective methodology includes in this study.59 newly diagnosed CML patients(Ph chromosome and BCR/ABL fusion gene was positive)in chronic phase,were all from the hematology department of the first affiliated hospital of Nanchang University during July 2014 to November 2016.All of them were treated with long-term use of imatinib mesylate(400mg/d).through the treatment of blood count,bone marrow image analysis,molecular genetics after treating for 3,6,12,18 months and body temperature,joint pain,rash and other indicators during the treatment period,to evaluate the early efficacy and safety of drugs.The application of SPSS18.0 statistical software for statistical analysis of the data,classification and enumeration data were described by the percentage,and the chi square test was used to compare the differences between groups.The rank sum test was used to compare the decline level of the fusion gene Results:1.Epidemiological features: the median age of onset was 45 years old,with a high incidence of middle and old aged people.2.The accumulation of blood domestic imatinib group and imported imatinib group obtained complete remission(CHR)rate,respectively 100% and 100%,the cumulative complete molecular remission rate(CMR)were 74.1% and 54.8%(P=0.128>0.05).3.In the two groups treated for 3 months,6 months,12 months and 18 months after the molecular remission rate compared to no significant difference,the declining transcription level of BCR-ABL fusion gene compare with those at intial onset time:P=0.288,P=0.036,P=0.012,P=0.064.4.The adverse reactions of domestic drugs and imported drugs had no significant difference(P>0.05).In domestic imatinib grop,cumulative CHR was 100%,CMR was 74.1%,and no serious IV grade adverse reactions,including edema was 66.7%,nausea and vomiting was 33.3%,44.4% forJoint pain,The rash was 25.9%,the diarrhea was 25.9%,the white blood cell decrease was 37%,the thrombocytopenia was 29.6%,the grade I / II anemia was 33.3%,there was no severe grade IV adverse reaction,and there was no drug toxicity death rate.5.The resistance rates of domestic and imported drugs were 7.4% and 9.7%,respectively.Compared with no statistical difference,the overall resistance rate was8.6%.Conclusions:1.The median age of onset of chronic myeloid leukemia is 45 years old.Compared with most literatures abroad,the age is younger.2.Domestic imatinib in the early curative effect and adverse reactions in the treatment of chronic myeloid leukemia incidence and spectrum is similar to import drugs,and domestic imatinib does not increase serious adverse reactions or other safetycompare to imports.However,domestic drug prices was lower,the domestic medicine can be benefit to more patients.3.Dynamic monitoring of transcription levels of BCR/ABL fusion genes is important in the diagnosis,treatment,and prognosis of chronic myeloid leukemia,with better response to drug therapy,disease progression,and detection of drug resistance.4.Domestic and imported drugs have similar resistance in the treatment of chronic myeloid leukemia. |
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