| Objective:To observe the clinical efficacy and effect on IL-6,IL-17 of Shenyubuxue prescription combined with CsA in the treatment of spleen-kidney yang deficiency chronic aplastic anemia?CAA?,and to observe its safety and clinical value.Methods:A total of 76 cases were patients with CAA from haematology Department of the First Affiliated Hospital,Chaity branch of Guangxi university of TCM,Ruikang oncology and haematology Department of Guangxi university of TCM from Oct.1,2015 to Aug.31,2017,who were randomly divided into treatment group?38 cases?and control group?38cases?.The control group was treated with CsA(3-5mg/kg-1·d-1,d1-180),Stanozolol?2mg Tid?,while the treatment group was treated with Shenyubuxue prescription?150ml boiling water,morning and evening hours service?combined with CsA and Stanozolol.The two groups were treated for 6 months,and evaluated trimonthly.Two groups of patients are observed before and after treatment 3 months,6 months effect of ORR,TCM therapeutic effect,TCM symptom score,count of HGB,PLT,ANC,RET,bone marrow hyperplasity,horizontal differentiation of serum IL-6 and IL-17,the times and type of serious infections occurred,within half a year blood transfusion volume and interval score,life quality score,and adverse events.Results:Totally 76 cases were enrolled in this study,and 6 cases were dropped in the course of treatment,the treatment group were enrolled 2cases?gave up treatment?,the control group were enrolled 4 cases?2 patients were untreated and 2 patients gave up treatment?,and 70 cases were finally included in the statistical analysis.Among them,36 cases in treatment group and 34 cases in control group.?1?The objective response rate?ORR?of treatment group was 86.11%while control group was 67.64%,there was no statistical significance between two groups?P>0.05?,but the combined effect of the treatment group was better than that of the control group by rank test?P<0.05?;?2?Comparison of TCM therapeutic effect:the total efficiency of treatment group was 88.89%while control group was 70.59%,there was no statistical significance between two groups?P>0.05?,but the combined effect of the treatment group was better than that of the control group by rank test?P<0.05?;?3?TCM symptom score:after 6 months of treatment,TCM symptom score was significantly lower than prior treatment?P<0.05?.?4?Comparison of peripheral blood:After treatment,HGB,PLT,ANC and RET were all increased in both groups?P<0.05?,and that treatment group was superior to the control group?P<0.05?.?5?Bone marrow hyperplasity:after treatment,bone marrow hyperplasia was increased in both groups?P<0.05?,and treatment group was superior to control group?P<0.05?.?6?Level of serum IL-6 and IL-17:after treatment,serum IL-6 and IL-17 were both lower than previous group?P<0.05?,and the decrease of treatment group was significantly lower than control group?P<0.05?.?7?The times of febrile neutropenia occurred:the incidence of febrile neutropenia in treatment group was significantly lower than control group within half a year?P<0.05?.?8?Evaluation of infection type:the infection of lung,digestive,urinary and blood line in treatment group were all lower than the control group?P<0.05?,and no blood line infection occurred in the treatment group.?9?Evaluation of blood transfusion volume:after 6 months of treatment,the blood transfusion volume in treatment group was significantly lower than control group?P<0.05?.?10?Evaluation ofblood transfusion interval:after 6 months of treatment,the blood transfusion interval in treatment group was longer than control group?P<0.05?.?11?Life quality score:the improvement of life quality in treatment group was better than control group?P<0.05?.?12?Adverse reaction:in control group,there were 5 patients with mild elevation of AST,and no abnormal liver and kidney function and ECG in other patients.Conclusions:1.The clinical curative effect of the Shenyubuxue prescription combined CsA in the treatment of spleen-kidney yang deficiency syndrome CAA is higher than that of the western medicine group.2.This prescription can improve the count of HGB,PLT,ANC and RET,improve bone marrow hyperplasia and promote marrow hematopoiesis;reduce the times of infections,improve the life quality of patients,reduce effectively blood transfusion volume and prolong the interval of blood transfusion;safe and reliable,not increase the adverse reaction.3.This prescription reduced significantly serum IL-6 and IL-17 levels in patients and improved the immune function of patients. |
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