Jianpiyiqi Photo Clinical Research Spleen Qi Deficiency Immune Thrombocytopenia Treatment Of Blood

Objective:Through standardized clinical trials to test different interventions(the methods of JianpiYiqi,JianpiYiqi combined with prednisone,prednisone) in improving clinical symptoms(syndromes) and hemostatic efficacy in patients with immune thrombocytopenia of spleen qi deficiency,observe the security in clinical application,explore immune thrombocytopenia’s efficacy mechanism of treatment from the spleen, compare the efficacy advantages and characteristics in order to provide support for the clinical application.Methods:Apply the method of center randomized controlled, multi-center clinical trials.By using central randomization,investigators of each clinical trial unit selected ITP patients who met the case criteria, then respectively assigned them to the group of JianpiYiqi Granules,JianpiYiqi Granules combined with prednisolone or prednisolone only therapy.JianpiYiqi Granules (Components:Astragalus,Codonopsis,Poria,Atractylodes,gelatin,madder,licorice),one bag each time, two times a day;The initial dose of prednisone is1-1.5mg/(kg-d),as early as8:00Dayton clothing;dosage reduced if effect shows during the treatment;the group of JianpiYiqi combined with prednisone use the same amount.The treatment lasted21days in each group.The investigators visit patients weekly after the start of the treatment.They collected various test data available for the efficacy, safety assessment and mechanism, including:clinical symptoms(syndromes),bleeding symptoms,peripheral blood,5-hydroxytryptamine,P-endorphin,vasoactive intestinal peptide.peripheral blood T cells and their subsets and safety monitoring indicators, and record them on the CRF.Results:Main outcome measures:①Efficacy of TCM syndromes:There are significant differences among the three groups; three groups are not completely same,P<0.05. There are significant differences between the prednisone group and the combination group,P=0.017;There are no significant differences when the JianpiYiqi group is compared with the prednisone group and the combination group,P>0.05.②The three groups are tested by using the TCM syndromes total score and comparing with the data before each time point by paired t test.The results show that at first week,the JianpiYiqi group and the combination group have significant differences compared with before treatment,P<0.05;the prednisone group has no significant differences compared with before treatment, P>0.05.In the second and third week,three groups have significant differences compared with before treatment, P<0.05.③The comparison of the individual symptoms efficacy,including body tired and fatigue,tired of shen and words,loss of appetite, abdominal distention after eating,the three group are all valid.There are significant differences in efficacy of body tired and fatigue among the three groups, P<0.05; using rank test to test the two of the three groups, taking a=0.025,there are significant differences between the prednisone group and the combination group, and between the JianpiYiqi group and the prednisone group,P<0.025.There are no significant differences between the JianpiYiqi group and the combination group, P>0.025.The three groups are all effective about tired of shen and words,loss of appetite, abdominal distention after eating,but there are no significant differences in efficacy, P>0.05.④At hemostasis aspect,three groups are all effective,and there are significant differences among the three groups in hemostatic efficacy,P<0.05,using rank test to test the two of the three groups, takeing a=0.025,there are significant differences between the the prednisone group and JianpiYiqi group, and between the combination group and JianpiYiqi group,P<0.025;There are no significant differences between the prednisone group and the combination group,P>0.025.⑤In terms of enhancing platelets,the three groups are all effective.There are no significant differences in platelet effect among the three groups, P>0.05.⑥The three group are tested for the platelet count by comparing with before treatment at each time point using paired t test.The results show that the prednisone group has significant differences compared with before treatment at each time point,P<0.05; the JianpiYiqi group and the combination group have no significant differences compared with before treatment at each time point,P>0.05.Secondary outcomes:After the treatment,the three groups are tested for peripheral blood leukocytes, erythrocytes, hemoglobin compared with before treatment using paired t test. The results show that the combination group has significant differences in hemoglobin,P<0.05,but the JianpiYiqi group and the prednisone group show no significant differences,P>0.05;the three groups have no significant differences in leukocytes,erythrocytes,.P>0.05.Exploratory indicators:①Before treatment and after treatment,each index of T cell subsets shows no significant differences in the three groups,P>0.05.②Before treatment and after treatment,5-HT and (3-endorphin show no significant differences in the three groups,P>0.05.③Before treatment and after treatment,the JianpiYiqi group and the combination group have significant differences in vasoactive intestinal peptide,P<0.05.Conclusion:According to the results of the current clinical study, we can get the following conclusions:①JianpiYiqi can effectively improve the clinical symptoms and relieve bleeding;②The efficacy mechanism of JianpiYiqi treatment for the ITP patients with type of spleen deficiency may be related to the improvement of immune function and elevation of peptide neurotransmitters——vasoactive intestinal peptide.