| ObjectiveTo establish the safe and effective clinical methods of arsenic-containing Compound-Qinghuang Powder(Compound-QHP)in the treatment of myelodysplastic syndrome(MDS).Methods1.200 patients with MDS were treated with Compound-QHP(daily dose of 0.1 g realgar)for 2 courses,3 months for a course of treatment.The blood arsenic concentrations at different time points were detected by atomic fluore-scence spectrophotometry(HG-AFS)method.The efficacy and safety were eva-luated.2.After treatment for 1 month,the patients were randomly divided into group A and group B when the blood arsenic concentrations were less than 20 ?g/L.Daily dose of realgar was maintained in group A,while those was increased to that when the blood arsenic concentrations were more than 20 ?g/L in group B.The blood arsenic concentration,clinical efficacy and safety between the two groups were compared at the end of treatment with Compound-QHP.Results1.Overall result(1)163 cases were evaluated from 200 MDS patients enrolled(122 cases were treated with Compound-QHP and traditional Chinese medicine,while 41 patients were treated with comstanarazone for 2 to 4 mg/d).After 6 months of treatment,the effective rate was 89.6%,with the rate of hematologyimprovem ent of 31.3%.The hemoglobin content(Hb)increased from(79.03±25.61)g/L to(86.66±29.16)g/L(P<0.05),the absolute neutrophil cou-nt(ANC)increased from(1.19±0.61)×109/L to(1.37±0.75)×109/L(P<0.05),no significant change was observed in platelet count(P>0.05).(2)The monthly average amount of blood transfusion significantly reduced from(320.9±120.5)mL/month before treatment to(136.1±50.3)mL/month after treatment(P<0.05).(3)The blood arsenic concentrations were significantly increased after treatment for 1 month with(32.17±18.04)?g/L(P<0.05),3 months with(33.56±15.28)?g/L(P<0.05)and 6 months with(36.78±11.92)?g/L(P<0.05)respectively,when compared with those(4.08±2.11)p.g/L before treatment.There was no significant difference in blood arsenic concentration after treatment for 1 month,3 months and 6 months(P>0.05).(4)In the treatment of MDS,the adverse reactions were mainly mild abdominal pain and diarrhea,with the incidences of 8.6%for 1 month and 2.5%for 6 month respectively,all the reactions were mild and no patient was discontinued due to abdominal pain and diarrhea.Before treatment with Compound-QHP in patients enrolled,there were 19 cases with abnormal liver function,who had been privously administrated with male hormone.After treatment with Compound-QHP,there were 9 cases with fully recovered,10 cases with improved,and no new case with abnormal liver function,Before treatment with Compound-QHP in patients enrolled,there were 19 cases with abnormal myocardial enzymes.After treatment with Compound-QHP,there were 3 cases with fully recovered,16 cases with improved,and no new case with abnormal myocardial enzymes.There was no patient with abnormal renal function observed before and after treatment.2.Grouping results(1)There were 60 cases with the blood arsenic concentrations at less than 20?g/L after treatment with Compound-QHP for 1 month,these patients were randomly divided into group A and group B.48 cases were available evaluated at the end of study.(2)After the treatment,the average blood arsenic concentration of group B(44.43±10.54)?g/L was higher than those of group A(21.39±3.49)?g/L(P<0.05).(3)The rate of hematology improvement was significantly higher in group B(54.2%)than that in group A(29.2%,P<0.05).There was no significant difference of incidence rate of adverse reaction observed between group B(8.3%)and A(12.5%,P>0.05).The Hb,ANC,and PLT significantly increased in group B after treatment,with Hb from(75.59±24.9)g/L to(86.12±26.35)g/L(P<0.05),ANC from(1.02±0.37)×109/L to(1.28±0.60)×109/L(P<0.05),and PLT from(50.11±33.55)×109/L to(61.89±36.93)×109/L(P<0.05),respectively.While the numbers of Hb,ANC,and PLT were not significantly changed before and after treatment(P>0.05).(4)In both of group A and group B,the incidence rates of abdominal pain and diarrhea reactions of the patients were 8.3%and 4.2%respectively before and after the treatment.There were 3 cases with abnormal liver function in group A,after treatment with Compound-QHP,there were 1 cases with fully recovered,2 cases with improved,and no new case with abnormal liver function.There were 6 cases with abnormal liver function in group B,after the treatment,there were 2 cases with fully recovered,4 cases with improved.There were 5 cases with abnormal myocardial enzymes before the treatment,while after treatment with Compound-QHP,there were 1 cases with fully recovered,4 cases with improved.There were 4 cases with abnormal myocardial enzymes in group B,1 cases with fully recovered and 3 cases with improved after treatment.No patients in the two groups with abnormal renal function observed before and after treatment.ConclusionsMonitoring the blood arsenic concentration and adjusting the daily dose of realgar to increase the effective blood arsenic concentration,and then improving efficacy without increasing the clinical toxicity,is the safe and effective clinical methods of arsenic-containing Compound-QHP in the treatment of MDS. |
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