| Background and Objective:Acute Myeloid Leukemia is a malignant tumor of the blood system that can occur in all ages,the prognosis of acute promyelocytic leukemia(AML-M3)is the best of all,other types are still can not be cured except hematopoietic stem cell transplantation,and the main purpose of treatment is to control recurrence.Therefore,it is very important to explore effective treatment to reduce recurrence.The aim of this paper is to observe the clinical efficacy of recombinant human interleukin-2 in the consolidation chemotherapy,maintenance treatment of acute myeloid leukemia by Prospective observations,retrospective analysis and Meta analysis,and to provide the basis for clinical treatment.Methods:1.Prospective observation:data derived from randomized,parallel,ulticenter clinical studies of the efficacy and safety of histamine dihydrochloride injection combined with IL-2 as a maintenance therapy for AML.The data collected from the center were analyzed and compared.After randomized grouping,19 patients were included in the study center,and were randomly divided into two groups,group A and group B,group A is paitents use rhIL-2 duringmaintenance therapy,a total of 12patients,group B were treated with rhIL-2 and histamine dihydrochloride in maintenance therapy,7 patients were included in group B;bone marrow morphology,bone marrow microresidual lesions,routine blood urine routine,blood biochemistry,electrocardiogram,and electrocardiogram(ECG)were reexamined regularly during the course of medication.The adverse reactions in the course of medication were observed and recorded,and the leukemia free survival time and Overall survival of leukaemia free patients were compared.2.Retrospective analysis:32 patients with AML diagnosed in our hospital(first affiliated hospital of Nanchang University)from July 2012 to May 2016 were selected.Two groups were divided into two groups.Group meth was treated with rhIL-2during the course of consolidation chemotherapy after obtaining CR1,group eth did not use rhIL-2 or HDCduring maintenance therapy or consolidation therapy,there were 20 patients in group eth.The results of bone marrow related examination,blood cell analysis,blood biochemistry,electrocardiogram were collected in group meth and group eth during the course of consolidation chemotherapy.A comparison was made in the course of consolidation treatment and the duration of complete remission.3.The relevant studies on the use of rhIL-2 in the maintenance therapy of AML were searched in databases such as Pubmed,Wanfang,ChinaNet and Chinese Biomedical Literature Database,and form Meta analysis to further confirm the clinical effect of rhIL-2.Results:1.There was no significant difference in baseline situation among foure groups.2.Prospective study:the LFS of group B was slightly better than that of group A,but the difference was not statistically significant(Log Rank P=0.921).There was no significant difference in the results of the three coefficientsof blood routine,the proportion of the original cells of the bone marrow,the residual disease of the bone marrow during the course of the maintenance therapy and the duration of continuous remissionin of the patients Group A and group B.But the proportion of bone marrow primordial cells,bone marrow residual lesions is lower and the duration of continuous remission is longer in group B than those in group A.3.Retrospective analysis:There was no significant difference in the the three coefficients of blood routine,proportion of bone marrow primordial cells and duration of complete remission in patients with group meth and group eth during consolidation therapy.4.Clinical comprehensive analysis of patients in prospective observation group and retrospective analysis group:the survival curve of group A with rhIL-2 was significantly higher than that of group eth.The difference of disease-free survival time was statistically significant in group A than in group eth.The 1-year CR rate,2-year CR rate,3-year CR rate and 3-year CR rate of the patients with rhIL-2(including group A and group meth)were significantly higher than those in the group eth,patients who never used rhIL-2(P<0.05).5.In this study,the total amount of cytarabine was above or below 30g/m~2 in the patients treated with rhIL-2 during maintenance therapy,the curative effect was similar.However,the total amount above 30g/m~2 was slightly better than that of below 30g/m~2 in patients who had not used rhIL-2 during the consolidation therapy.6.Adverse reactions:all had injection site reactions(sclerosis,redness,pain),fever,headache,dizziness,etc are appeared in different degrees,some of the patients had mild hemocytopenia,Eosinophils increase in most patient,abnormal transaminase and elevated uric acid were found in some cases.The adverse reactions in group B were similar to those in group A(1-2 grade).The symptoms of the two groups could be disappeared after observation or treatment,and the adverse reactions of the patients were not significantly increased by combined use of drugs.Conclusion1.The LFS with rhIL-2 combined with HDC was slightly better than that with rhIL-2 alone in maintenance therapy,but the difference was not statistically significant.2.The curative effect of the patients treated with rhIL-2 in the consolidation therapy was similar to that of the patients without rhIL-2,but the LFS of the patients was prolonged by using rhIL-2 in the maintenance therapy.3.In this study,the total amount of cytarabine was above or below 30g/m~2 in the patients treated with rhIL-2 during maintenance therapy,and the curative effect was similar.However,the total amount of cytarabine above 30g/m~2was slightly better than that of below 30g/m~2 in patients who had not used rhIL-2 during the consolidation therapy.4.Patients with AML included in this study were better able to tolerate low doses of rhIL-2. |
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