| Objective:To compare the efficacy of double-center immunosuppression(IST)and IST combined with Shenqi Xianbu Decoction in the treatment of aplastic anemia,and explore the efficacy and safety of traditional Chinese medicine.Methods:Sixty-one patients diagnosed as extremely severe aplastic anemia or transfusion-dependent non-severe aplastic anemia in the Department of Hematology of the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine and Xiangya Hospital of Central South University from January 1,2017 to December 31,2021 were collected and treated with IST combined with Shenqixian Decoction or IST alone,They were divided into Chinese and western medicine group and western medicine group according to whether they took Chinese medicine orally or not.Then,according to different IST sources,it was divided into pALG and rATG treatment to compare and discuss the baseline level of the two groups before treatment,compare the effective rate of the two groups,and compare the values of Ret,WBC,ANC,HGB,PLT,LYM,the recovery rate of bone marrow hematopoiesis and the safety of drugs at the 3rd and 6th months after treatment,and make statistical analysis by SPSS25.0.Results:1.Characteristics of case baseline:From January 1,2017 to December 31,2021,a total of 61 patients met the inclusion and exclusion criteria,and there was no significant difference in case baseline data.2.Efficacy statistics:In the third month of pALG treatment,the total effective rates of the two groups were 50.0%in the non-exposure group(Western medicine group)and 90.5%in the exposure group(Chinese and Western medicine group),and there was a difference in stratified efficacy(p=0.032);in rATG treatment,the total effective rates of the two groups were 50.0%and 85.7%,respectively,and there was a difference in stratified efficacy(p=0.031).At the 6th month,the total effective rates of pALG and rATG were 64.3%and 85.7%,respectively,with a difference in stratified efficacy(p=0.044),and 66.7%and 92.8%,respectively,with a difference in stratified efficacy(p=0.040).3.Blood cell count:There were differences in Ret and LYM between the two groups in the 3rd month(p=0.010,0.012),and differences in Ret and HGB in the 6th month(p=0.005,0.034),and no difference in WBC,ANC,pALG and LYM.In the treatment of rATG,there were differences in Ret and LYM between the two groups at the 3rd month(p=0.004,0.011)and differences in Ret and HGB at the 6th month(p=0.000,0.021),and there was no difference in WBC,ANC,PLT and LYM.4.Bone marrow smear and biopsy:At the 3rd month,the recovery rate of bone marrow hematopoiesis was different between the two groups,and the P values of pALG and rATG were 0.031 and 0.038 respectively;at the 6th month,the recovery rate of bone marrow hematopoiesis was different between the two groups,and the P values of pALG and rATG were 0.011 and 0.026 respectively.5.Safety analysis:serum sickness,liver function damage,kidney function damage and digestive tract reaction p>0.05,there was no significant difference between the two groups,and IST combined with Shenqixianbu decoction did not increase the incidence of common adverse reactions.Conclusion:1.Compared with IST,Shenqi Xianbu Decoction combined with IST can improve the curative effect of IST in the treatment of aplastic anemia,mainly by improving the total effective rate,CR and PR rates and the recovery rate of bone marrow hematopoiesis.2.Shenxianbu Decoction combined with IST can accelerate the growth of reticulocyte and hemoglobin in 3-6 months after treatment.In the first 3 months after treatment,Shenqixianbu Decoction can significantly reduce the number of lymphocytes,and has an immunomodulatory effect.3.The combination of Shenqi Xianbu Decoction and immunosuppression did not increase the incidence of common adverse reactions. |