| Purpose:To observe the clinical efficacy and safety of the Bushentianjing Recipe in the treatment of chronic aplastic anemia(CAA),and to analyze its impact on improving patients.quality of life,and provide a practical basis for clinical application.Method:According to the diagnostic criteria for chronic aplastic anemia(CAA)in Zhang Zhinan,s“Diagnostic and Efficacy Standards for Blood Diseases",50 patients with CAA who were admitted to the Department of Hematology,Jiangsu Provincial Hospital of Traditional Chinese Medicine from June 2016 to June 2018 were enrolled.On the basis of maintaining the original western medicine treatment,the research group will be treated with the prescription of Bushentianjing,3 months for a course of treatment,taking at least 4 courses.The blood routines were recorded,before and 3?6?9 and 12 months after treatment;Patients were assisted to fill out the symptom classification quantification table and the SF-36 health survey scale to assess the changes in TCM syndrome total scores and health-related quality of life(HRQoL)scores before treatment and 12 months after treatment;The observation indicators also included liver and kidney function,adverse reaction assessment,in order to comprehensively evaluate the clinical efficacy,safety and cyclosporine withdrawal rate of Bushentianjing Prescription.Statistical description and analysis were performed using SPSS 25.0,and the difference was statistically significant at P<0.05.Result:1.After 12 months of treatment with Bushentianjing Recipe,the total effective rate was 76.0%(38/50 cases),of which 12 cases were cured,15 cases were relieved,11 cases were significantly improved,12 cases were ineffective.Among them,18 cases of severe aplastic anemia(SAA),the total effective rate was 55.6%(10/18 cases),32 cases of non-heavy aplastic anemia(NSAA),and the effective rate was 87.5%(28/32 cases),suggesting that patients of NSAA have better efficacy than SAA(P<0.05).2.In this group of patients,the peripheral blood neutrophil counts(ANC),hemoglobin(Hb),and platelet(PLT)counts were increased 3 months after treatment with Bushentianjing Recipe.However,there was no difference compared with before treatment(P>0.05).After 12 months of treatment,ANC count:before treatment(1.78±1.42)x10g/L vs after treatment(4.35±1.53)x109g/L(P<0.05);Hb count:before treatment(83.58±27.9)g/L vs after treatment(101.53±25.75)g/L(P<0.05);PLT count:before treatment(39.15±42.19)x109/L vs after treatment(61.93±50.46)×109/L(P<0.05).The course of treatment for blood routine indicators was significantly different between the groups.The Hb value was significantly different after 9 months(P=0.005),while the PLT count was after 12 months(P=0.034),and the rest had no significant difference(P>0.05).3.After 12 months of treatment with Bushentianjing Recipe,the percentage of peripheral blood neutrophils was(49.95±13.25)%,which was higher than before,and the percentage of lymphocytes was(42.76±13.59)%decreased compared with before,and the N/L ratio was 1.50±1.15,which was statistically significant compared with before treatment 1.50±1.15(P<0.05),but the difference was not obvious between courses(P>0.05).4.Before the treatment of Bushentianjing Prescription,the total score of TCM syndrome was 21.56±5.20.The total score decreased significantly to 15.20±3.01 after 12 months of treatment(P<0.05).In the comparison of the efficacy of TCM syndromes,the effective rate was 95.5%(21/22)in the kidney yang deficiency group,88.9%(16/18)in the kidney yin deficiency group,and the effective rate of the kidney yin and yang was 80.0%(8/10)?the difference between the different subgroups was not statistically significant(P>0.05).5.After 12 months of treatment,the SF-36 scale indicated that the health-related quality of life was all significantly increased at the Physical Function?Role-physical Function?General Healths Vitality?Role-emotional and Mental Health(P<0.05).The scores were 74.414.96?71.6±19.1?66.08±5.35?71.6±6.93?78.63±24.35?65.4±11.02 after treatment,respectively before treatment were 67.4±5.99?40.6±20.32?47.7±9.76?50.3±12.65?45.96±19.94?50.36±13.04.6.Safety evaluation:This group of patients were well tolerated by Bushentianjing Prescription.During the course of medication,none of the patients discontinued or retired due to adverse reactions of traditional Chinese medicine.The main adverse reaction was diarrhea,and the incidence rate was 2.0%(1/50).7.Cyclosporine withdrawal rate:42 patients of CAA who were taking cyclosporine before treatment,including 6 patients with cyclosporine alone,28 patients with cyclosporine?androgen,7 patients with cyclosporine+androgen+glucocorticoid,l patient with cyclosporine+glucocorticoids,and 7 patients were used Chinese medicines.16 patients with complete withdrawal of cyclosporine and 1 1 patients were withdrawing at 12 months after treatment,and the cyclosporine withdrawal rate was 64.3%(27/42).Conclusion:The Bushentianjing Decoction has a significant clinical effect in the treatment of CAA.It can effectively be better in the treatment of NSAA than SAA.After 3 months of treatment,it can effectively improve the absolute value of peripheral blood neutrophils,hemoglobin and platelet count,and reverse the the imbalance of peripheral blood neutrophils and lymphocytes.The hemoglobin count increased significantly in the third course after treatment,and the platelet count was significantly increased in forth course.Although the peripheral blood of some patients did not improve significantly,the symptoms of dizziness,fatigue,pale lips,bleeding and other TCM symptoms were significantly alleviated.The health-related quality of life was improved compared with before treatment,and it can effectively assist the withdrawal of cyclosporine.Bushentianjing Prescription is safe and reliable,and the incidence of adverse reactions is low,which is worthy of clinical application. |
PDF Full Text Request