| Objective:Intend to explore the treatment and partial mechanism of compound Zaofan pills in the treatment of hematological toxicity in patients with chronic granule induced by imatinib.Methods:In August 2018-January 2021 clinic in North Sichuan Medical College affiliated hospital blood internal medicine,taking imatinib and hematology toxicity chronic-phase chronic myeloid leukemia,were randomly divided into treatment group and control group,two groups of patients,according to the level of blood picture to give dynamic observation,adjust the dose of imatinib,transfusion of blood products and treatment with recombinant human granulocyte colony stimulating factor support,treatment group on the basis of this combined with compound Zaofan pills.The time for the blood cell level to reach the standard dose of imatinib(400mgqd)was compared between the two groups,rh G-CSF was added to support the treatment the number of recurrent hematological toxicity,the proportion of discontinuation of imatinib,the blood cells count of the 15th day,1st month,3rd month,6th month,and the 3rd month,6th month,12th month molecular reaction in the two groups were collected respectively.The concentrations of CSF,EPO,TPO and TNF-α in the two groups were detected by enzyme-linked immunosorbent assay(ELISA),and T cells,B cells and NK cells were detected by flow cytometry.Results:Analysis of clinical data:(1)The time it took for the blood cell level to reach the standard dose of imatinib was significantly shorter in the treatment group than in the control group(34.5 days vs62.5 days),the difference being statistically significant(P=0.001).(2)Comparison of the frequency of repeated hematological toxicity during follow-up:the number of hematological toxicity ≥2 times in the treatment group was lower than that in the control group(41.4%vs68.3%),with statistical significance(P=0.009).(3)Comparison of the proportion of discontinuation and reduction of imatinib:the proportion of discontinuation of imatinib in the treatment group was lower than that in the control group(25.9%vs47.6%),the difference was statistically significant(P=0.013).The proportion of imatinib reduction in the treatment group was lower than that in the control group(20.7%vs38.1%),and the difference was statistically significant(P=0.005).(4)The use of rh G-CSF supporting treatment:the treatment group was lower than the control group(2000μg vs 2500μg),and the difference was statistically significant(P=0.000).(5)Blood cells change over time:the changes of leukocytes and neutrophils in the treatment group were higher than those in the control group at the 15th day,1st and 3rd month,and the overall level in the treatment group was higher than that in the control group.There was significant difference between the two groups(P<0.05).The change of platelet in the treatment group was higher than those in the control group at the 1st and 3rd month,and the difference was statistically significant(P<0.05).The change of hemoglobin in the treatment group was higher than those in the control group at the 3rd month,and the difference was statistically significant(P<0.05).(6)Molecular remission:The molecular remission rate of the treatment group was higher than that of the control group at 12 months,the difference was statistically significant(P=0.011).The remission rate of MMR4 or above at the 12th month was higher than that of the control group,with statistical significance(P=0.028).Analysis of experimental study:(1)At the 6th month,CD8+cells,CD8+CD28+cells and CD8+CD28-cells in the treatment group were significantly lower than those in the control group(20.93±14.09 vs 33.22±9.86,9.25±3.78 vs 10.70±3.53,8.58±4.67 vs 19.03±9.39),the difference was statistically significant(P=0.000,0.049,0.000).In addition,the total T lymphocytes,CD3+ cells,CD4+cells,NK cells and CD4/CD8 in the treatment group were significantly higher than those in the control group(67.86±13.01 vs 60.18±13.24,65.28±14.31vs 57.18±15.05,29.75±14.09vs 20.80±13.42,1.97±0.91 vs 1.07±0.66),the difference was statistically significant(P=0.004,0.007,0.003,0.000).(2)At the 6th month,the concentration of CSF,EPO and TPO in the treatment group was significantly higher than that in the control group(102.62±73.55 vs 48.01±53.71,3.68±2.06 vs 2.11±1.91,35.03±23.47 vs 19.03±16.63),the difference was statistically significant(P=0.004,0.008,0.009).Besides,the concentration of TNF-α in the treatment group was lower than that in the control group(22.71±6.18 vs 29.15±10.24),the difference was statistically significant(P=0.013).Conclusion:1.Compound Zaofan pills can improve the hematological toxicity of imatinib in patients with chronic myelogenous leukemia and the resulting drug with drawal,so that patients with hematological toxicity can get faster and deeper hematological and molecular remission.2.By promoting the positive hematopoietic regulator CSF,EPO and TPO,and inhibiting the negative hematopoietic regulator TNF-α,Compound Zaofan pills can promote the formation and release of blood cells.In addition,it can reduce the destruction of blood cells by regulating the proportion of T lymphocytes,which may be the mechanism of its improvement of hematopoietic toxicity. |
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