| Background:Myelodysplastic syndromes(MDS)is a group of abnormal clonal diseases originated from hematopoietic stem-cells,which is characterized by abnormal differentiation and maturation of myeloid cells,ineffective hematopiesis,hematopoietic function failure and high risk of translating to acute leukemia because of the genetic instability.MDS has been named SuiDuLao in traditional Chinese medicine(TCM).Our previous clinical works indicated that Qinghuang Powder(QHP)had a obvious effectiveness in treating MDS.It was found that there were still some patients with different degree of adverse reactions in the long-term clinical treatment with QHP,such as stomachache,diarrhea,eyelids and lower extremities dedma,numbness of the limbs.Chief physician Hu Xiaomei was distinctive in the treatment of MDS with QHP.Based on the common reactions of QHP,chief physician Hu created the Compound-QingHuang Powder(Compound-QHP)upgraded from the QHP.In this work,the clinical safty and efficacy of Compound-QHP were analized and summarized in the treatment of MDS.Objective:1.To inveatigate the clinical safety of Compound-QHP in the treatment of MDS by comparison of the adverse reactions between the patients treated with Compound-QHP and QHP.2.To investigate the clinical efficacy of Compound-QHP in the treatment of MDS by comparison of the therapeutic outcomes between the patients treated with Compound-QHP and QHP.Methods:1.(1)121 patients with MDS were collected.60 cases out of them were treated with QHP(QHP group)and 61 of them with Compound-QHP(Compound-Qinghuang Powder group).(2)20 patients with MDS were treated at first with QHP(at first Qinghuang Powder group)and follow-up with Compound-QHP(follow-up Compound-Qinghuang Powder group).The treatment time of 3 months was as one course,and all the patients were treated for more than two course.The incidence of adverse reactions were recorded during the treatment and the differences of adverse reactions between the treatment groups were compared and analized.2.(1)121 patients with MDS were collected.60 cases out of them were treated with QHP(Qinghuang Powder group)and 61 of them with Compound-QHP(Compound-Qinghuang Powder group).(2)20 patients with MDS were treated at first with QHP(at first Qinghuang Powder group)and follow-up with Compound-QHP(follow-up Compound-Qinghuang Powder group).The treatment time of 3 months was as one course,and all the patients were treated for more than two course,then the efficacy were evaluated.Results:1.(1)The overall incidence of adverse reactions in Compound-QHP group was lower than that in QHP group,with a significant difference between them(P<0.05).The incidences of adverse symptoms in Compound-OHP group were lower than those in QHP group,especially,the incidence of lower limb swelling,epigastric discomfort and abdominal pain and diarrhea(P<0.05).(2)The overall incidence of adverse reactions in follow-up Compound-QHP group was lower than that in at first QHP group(P<0.05),especially,the incidence of facial swelling,leg swelling and abdominal pain and d iarrhea(P<0.05).No patient had the liver or kidney dysfunction after treatment with QHP or Compound-QHP.2.(1)The overall effective rate of Co.mpound-QHP group was higher than that in QHP group in treating MDS,and with a significant difference between them(P<0.05).The blood transfusion was significantly decreased in Compound-QHP than that in QHP group(P<0.05).After the treatment,the hemoglobin content was improved obviously in Compound-QHP group than that in QHP group(P<0.05).The overall effective rates of RA/RCMD type and RAEB type treated with Compound-QHP were significantly increased than that in QHP group(P<0.05).The effective rates of patients with normal chromosome/trisomy 8(+8)and the other abnormal karyotypes in Compound-QHP group was significantly increased than that in QHP group(P<0.05).The effective rates of patients with moderate risk Ⅱ/high risk group in Compound-QHP group was significantly increased than that in QHP group(P<0.05).The effective rates of patients treated with both of 2 courses and 3 courses in Compound-QHP group were significantly increased than that in QHP group(P<0.05),based on the therapeutic courses.The median survival time of patients with poor prognosis and high risk degree treated with Compound-QHP was somewhat longer than that QHP group.(2)The rate of hematologic improvement of patients in follow-up Compound-QHP group was significantly higher than that in at first QHP group(P<0.05).The white blood cell(WBC),hemoglobin(Hb),and platelet(PLT)in peripheral blood were improved obviously in follow-up Compound-QHP group than that in QHP group.Conclusion:1.Compared with QHP,the incidence of adverse reaction was significantly decreased in patients treated with Compound-QHP,which suggested that Compound-QHP is more safe than QHP in the treatment of MDS.2.Compared with QHP,the effective rate was significantly increased in patients treated with Compound-QHP,which suggested that Compound-QHP is more effective than QHP in the treatment of MDS. |
