Clinical Study On Treatment Of Immune Thrombocytopenia With

Objective:To observe the changes of clinical symptoms (TCM syndrome) and hemostatic effect of Immune Thrombocytopenic Purpura (ITP) patients after treated with Jianpi Wenyang formula. To analyze whether these changes are caused by the past history of steroid hormone-dependent status and will lead to difference in therapeutic effect. To explore the possible mechanism of action of "To treat in the theory of spleen "method in Spleen Yang deficiency syndrome of ITP and provide a new way of thinking and data support for the clinical treatment of ITP.Method:Based on the principle of multi-center clinical trials, investigators of each clinical trial unit select ITP patients who met the inclusion criteria and gave Jianpi Wenyang granules (Components:Astragalus, Codonopsis, Poria, fried Atractylodes, Stove Subsoil, Agrimony, licorice),1 bag each time,2 times a day for a course of treatment of 21 days. The investigators visit the patients once a week after the initiation of the treatment to collet various relevant indicators, which include the indicators of efficacy and mechanisms such as clinical symptoms, bleeding symptom, peripheral blood film, clotting factors, immune function and medication safety indicators, and record them on the Case Report Form (CRF).â‘ To observe the changes of clinical symptoms and bleeding condition in patients after the treatment by compiling statistic and analyzing the collected research indicators with SAS 9.1 software. â‘¡Based on the concept of hormone-dependent status of ITP, the enrolled patients were divided into two groups (Group A:non-hormonal dependent group, Group B: hormone-dependent group). Comparison were made within the group to compile statistics, analyze and compare the differences of efficacy between the two groups after treatment.Results:This research includes 24 cases, which consists of 14 cases in Group A (non-steroid dependent group) and 10 cases in Group B (steroid dependent group). Both groups have balance baseline data which have comparability before the treatment.Part One (Overall evaluation of efficacy)1. Main Outcome Measures:â‘  In accordance with the standards of the efficacy of TCM syndromes, the overall total effective rate was 83.33%, total score of TCM syndromes were compared before and after the treatment within the group, and the differences have statistical significance (P<0.05).â‘¡ The efficacy of individual symptoms were compared before and after the treatment and symptoms of aversion of cold and cold extremities, shortness of breath and unwillingness to speak, abdominal cold and pain, loss of appetite, are improved (P< 0.05).â‘¢ Overall total effective rate of platelet efficacy is 45.83%, overall total effective rate of hemostatic effect is 66.67%. The platelet is compared before and after the treatment and the difference has statistical significance (P<0.05)2. Secondary outcomes:The changes of peripheral blood leukocytes and hemoglobin after the treatment have no statistical significance (P>0.05). The changes of coagulation function (includes prothrombin time, activated partial thromboplastin time, fibrinogen, thrombin time, D-D, etc.) have no statistical significance (P>0.05)3. Exploratory indicators:â‘ The changes of vasoactive intestinal peptide (VIP) before treatment and after treatment has statistical significance (P<0.05).â‘¡ The changes of T cell subsets and platelet associated antibodies before treatment and after treatment have no statistical significance (P> 0.05)Part Two (the comparison of efficacy between two groups):1. main outcome measures: The score of TCM syndromes were compared between two groups and have no statistical significance (P> 0.05). The hemostatic effect and platelet efficacy were compared between two groups and have no statistical significance (P>0.05).2. Secondary outcomes:The changes of peripheral blood film and coagulation function indicators were compared between two groups before and after treatment and the difference have no statistical significance (P> 0.05).3. Exploratory indicators:The exploratory indicators are compared within the group in both groups and the difference have no statistical significance (P>0.05)Conclusion: â‘ Jianpi Wenyang formula can effectively improve the TCM symptoms such as aversion of cold and cold extremities, shortness of breath and unwillingness to speak, abdominal cold and pain, loss of appetite, and increase the number of platelet and achieve the hemostatic effect. However there is no significant correlation with the past history of steroid-dependent status.â‘¡Jianpi Wenyang formula can increase the level of VIP. VIP level may be associated with the Spleen Yang Deficiency Syndrome of ITP.