The Clinical Observation Of The Therapeutic Effects And Reactions In Treating Newly-diagnosed Acute Promyelocytic Leukemia With Arsenic Trioxide

APL is one of the worst acute leukemias and its mortality rate is very high.Since arsentic was used to treat APL ,this situation has been changed.We has established a new way in the treatment of APL. The use of arsenic is a new method in treatment of APL.With the development of medicine and science ,arsenic has showed me a very remarkable effect. Objective: To assess the clinical effectiveness and side effect of As₂O₃ in previously untreated patients of APL. Methods:52 previously untreated patients of APL who were diagnosed as APL from January,2002 to January,2004 were chosen. The ages were 9-56 years old.The median age was 33 years old.28 patients are males and 24 patients are females.Except that 2 patients were dead because of the cerebral hemorrhage,the other 50 patiens had all finished one or more than one courses of the treatment with As₂O₃ without receiving the treatment with arsenic trioxide and the tradition Chinese medicine before.These patients had no severe visceral malfuntion.The female patients were not in the gestational period and lactational period.Induction therapy:The patients were given As₂O₃ until they had gotten CR.Consolidation therapy: The patients of Group A were given As₂O₃.The patients of Group B were given the treatment with the alternation of As₂O₃ and chemical therapy .In addition, the patients received the supportive care during the treatment period.We observed whether the patient had the side effect of headache,bone ache,mucosa dehydration,ulcer,bleeding,edema and examed the blood routine,bone marrow routine,blood coagulation routine,hepatic and renal funtion,ECG.They received the PML/RARαexamination before and after treatment during the period of induction therapy.And then they received the PML/RAR αexamination before the treatment of every course.We expressed the datas by the mean ±the standard deviation and analysed the differences between the two groups by t test and χ2 test. Results:1.Hematological remission:48 patients amond 52 patients had gotten CR by As2O3 alone.The median time of CR was 33.0 ±5.6 days(Range:24-48 days).2.Molecular biological remission:52 patients's fusion genes of PML/RAR αwere positive at the beginning of the treatments.28 patients (Group A:13 patients;Group B:15 patients)received the consolidation and maintenance therapies and received the PML/RAR αexminations. In January,2005, Group A:13 patients.9 patients'fusion genes of became negative. The mean course was 7.4±2.7 courses.Group B:15 patients,11patients'fusion genes of PML/RAR αbecame negative after one course of chemotherapy. 3patients'fusion genes of PML/RARαbecame negative after two courses of chemotherapy. 1 patients'fusion genes of PML/RAR αwas still positive after four courses of chemotherapy. The mean course was 4.7±1.3 .The rates of Group B were higher than that of Group A(P<0.05). The time of Group B was shorter than that of Group A(P<0.05). 3.Correlation factor analysis of bone marrow depression during the chemotherapy in Group B after CR:compare the bone marrow depression of the first chemotherapy between that after 2-4 courses As2O3(APL) and that after CR (M2).The lowest counts of WBC,Plt,Hb of Group APL is higher than that of Group M2,the time of WBC<10×109/L is shorter than that of Group M2,the time from the lowest counts of WBC and Plt to the normal is shorter than that of Group M2,the rate of infection and platelet transfusion and the time of using the antibiotics is lower than those of Group M2(P< 0.05 ) .4.DIC:There were 26.9% patients with blood coagulation disfunctions,9.6% patients who had been diagnosed as DIC,2 patients were dead in these early days of treatment because of cerebral hemorrhag.During the period of treatment by As2O3,the patients'blood coagulation disfunctions all became better,none of them was evoked DIC and with the elongation of the time of treatment ,the symptom of the patients of DIC was relieved. 5.CNSL:5 patients received the spinal fluid examinations .1patients was diagnosed as CNSL.6.Relapse and subsistence: The period of induction therapy:early mortality was 3.8%.The period ofconsolidation and maintenance therapy:the mortalities of Group A and B were 0%. The median time of the patients'treatments was 23 months (Range:12-36 months).The relapsed rate of Group A:0% in the 1st year,10.0% in the 2nd year;The relapsed rate of Group B:0%in the 1st year,0% in the 2nd year.There was no difference between that of Group A and B(P>0.05). 7.Side effect: (1)The influence of As2O3 on the hemogram :Induction remission:1)change of WBC: the percentage of the patients with WBC≥10×109/L and the average counts of WBC after the treatment are higher than that before treatment(P < 0.05),which can lead to the hyperleukocytosis.The incidence of the hyperleukocytosis is 48.9%;Consolidation:53.6% patients present the decrease of WBC and there is no difference of Hb and Plt between before treatment and after treatment(P>0.05).(2) The other side effect: The incidence of hepatic damage is 40.0%,The incidence of the nervous system symptom was 34.0%, the incidence of cardiovascular system symptom was 12.0%,the incidence of edema was 46.0%, the incidence of digestive tract symptom was 26.0%, the incidence of mucosal irritation was 28.0%,the incidence of skin symptom was 26.0%, None of these patients had renal injury.Conclusion:1.The As2O3 is a very effective treatment for the APL patients.In the period of induction therapy,the CR rate is high(92.3%) and the mortality is low(3.8%).In the period of consolidation and maintenance,the early relapsed rate is low(The relapsed rate of Group A:0% in the 1st year,10.0% in the 2nd year;The relapsed rate of Group B:0%in the 1st year,0% in the 2nd year) and the mortality is low(0% in Group A and B).2.Compared with the treatment with As2O3 alone ,the treatment with alternation of As2O3 and chemotherapy can elevate the rate of mocular biological remission and shorten the time of mocular biological remission.3.In the first course of chemotherapy ,bone marrow depression of the patients(APL) with the treatment of alternation of As2O3 and chemotherapy after 2-4 courses of As2O3 alone is lighter than the patients(M2) who acceptted the treatment with chemotherapy after CR. 4.The influence of As2O3 on blood routine:introduction remission :The WBC increased after the treatment and the hyperleukocytosis can be induced. Consolidation :The WBC decreased after the treatment. 5.In the clinical observion, we learned that the other main side effects of As2O3 at conventional dosage are edema,skin dehydration, dizziness, headache, hepatic damage etc.Most of the side effects are light and reversible. 6.We can prevent DIC by the use of As2O3 and low-dose heparin.The patiens almost avoided the DIC after the treatment by As2O3. 7.The questions that we need to explore:1)After the first course chemotherapy,we do not know whether the differences of bone marrow depression resulted from the difference of ANLL and the treatment in the period of induction remision or the occasion of chemotherapy between the patients(APL) with the treatment of alternation of As2O3 and chemotherapy after 2-4 courses of As2O3 alone and the patients(M2) who acceptted the treatment with...