Abstract: This study was based on the experienced formula of Mao Rou’s mentor for many years in treating CITP, with the aim of exploring the clinical efficacy and immune efficacy mechanism of Yi Qi and Wen Yang method. In this study, there were 28 cases in the treatment group, and 4 cases (14.29%) had significant effect; 3 cases (10.74%) had good effect; the total effective rate was 42.86%. The mean Plt count in the treatment group before treatment was 23.02±13.69; the mean count after treatment was 46.18±50.47. The mean platelet count before and after treatment was tested by t-test, P<0.05, and there was a significant difference in platelet changes before and after treatment. The lymphocyte subpopulation study suggested that the downregulation of the ratio and functional defects of Treg cells and CD19+CD5+ B cells, as well as the hyperfunction of CTL cells, NKT cells, and CD3DR+ activated T cells in the immune disorder of CITP patients were important aspects of the pathogenesis. The pre- and post-treatment studies suggested that Yi Qi Wen Yang Tang helped to improve peripheral platelet levels by significantly decreasing the ratio of total T cells, NKT cells, and CD3DR+ activated T cells; and increasing the ratio of CD19+CD5+/CD19+, CD4+CD25+ Treg cells and Th2 cells, which played an immunomodulatory and immune tolerance role. Notably, the high expression of CTL cells and CD3+DR+ activated T cells in the treatment-naïve group did not decrease due to the therapeutic intervention, suggesting that Yi Qi Wen Yang Tang does not act through the CTL cell and CD3+DR+ activated T cell pathways, or suggesting that enhanced CTL and CD3+DR+ activated T cell functions may be associated with poor ITP treatment effects. Keywords: immune thrombocytopenia; Yi Qi Wen Yang method; T and B lymphocyte subsets; Immune thrombocytopenia (ITP) is called chronic ITP (cITP) if the disease lasts for more than 12 months. cITP is prone to recurrent attacks, difficult to treat, and has poor therapeutic effects. The characteristics of cITP are The mortality rate due to the disease itself and treatment-related factors is 4.2 times higher than that of the normal population. cITP is often treated with multiple regimens and platelets remain below the safe range, making treatment very difficult. monoclonal antibodies (rituxan, alemtuzumab), plasma exchange, immunosorbency, and other individual or combined measures, but the literature reports wide variation in efficacy. Most of these drugs have long treatment cycles, high relapse rates after drug discontinuation, and significant adverse effects. In this study, we investigated the clinical efficacy and immune mechanism of Yiqi and Wenyang method based on the empirical formula of Dr. Ma Rou, the chief physician, for many years in the treatment of CITP. I. Research methods 1. Diagnostic criteria Western medical diagnostic criteria refer to the diagnostic criteria of idiopathic thrombocytopenic purpura (ITP) developed in the Diagnostic and Efficacy Criteria for Blood Disorders, edited by Zhang Zhinan in 2007: Chinese medical evidence diagnostic criteria: refer to the revised program of the National Symposium on Acute Diseases in Traditional Chinese Medicine in August 1987, combined with the 2002 New Drugs in Traditional Chinese Medicine The diagnostic criteria of TCM symptoms: refer to the revised protocol of the National Symposium on Chinese Medicine in August 1987, combined with the 2002 Guidelines for Clinical Research on New Chinese Medicine. Spleen and kidney deficiency symptoms refer to the spleen and kidney yang deficiency type and qi and blood deficiency type symptoms criteria: ① main symptoms: basically no bleeding symptoms, or purpura pale red or dark and sparse, accompanied by tiredness and weakness, especially the weakness of both lower limbs is obvious, or awe of cold limbs, lumbar and knee weakness, like hot drinks, loose stools, polyuria; ② secondary symptoms: dizziness, palpitation, shortness of breath, diarrhea in the fifth shift. Tongue: light or light fat tongue, or tooth marks on the edge of the tongue, thin white coating; pulse: sunken and sluggish pulse or weak pulse. With 2 or more main symptoms; or 1 main symptom plus 1 or more secondary symptoms, plus tongue and pulse signs can be diagnosed. 2. Case selection criteria (1) meeting the diagnostic criteria of chronic ITP, with a disease duration >12 months; (2) having a mean platelet count <50×109/L on 2 consecutive occasions about one week apart, and not taking hormones or prednisone ≤10 mg; (3) meeting the TCM diagnosis of spleen and kidney deficiency; (4) aged between 14 and 75 years; (5) not participating in other clinical studies and voluntarily subjected to the study . 3. Drugs and observation methods The drugs in the treatment group consisted of 30 princely ginseng, 10 fried atractylodes, 10 poria, 10 roasted licorice, 10 cinnamon sticks, 10 peony, 20 locking yang, 10 spleen of Xian Ling spleen, 10 Chuan Dioscorea Z, 10 bacopa monniera, 15 bone marrow, 10 ginger, 10 jujube, which has the effect of strengthening the spleen, benefiting qi, warming the kidney and helping yang. The dosage form is soup. One dose a day, divided into 2 doses in the morning and evening, with appropriate addition or reduction each month according to the patient's symptoms. A total of 4 months were observed. 4. Observation indexes (1) Peripheral blood picture: platelet count, white blood cell count, hemoglobin content. (2) Peripheral blood T and B lymphocyte subpopulation examination The T and B lymphocyte subpopulations were detected by trichrome fluorescence direct immunoassay of BECKMAN COULTER, USA, mainly including CD3+CD4+T, CD3+CD8+T, CD4+/CD8+ ratio, CD3-CD16CD56+NK cells, NKT cells, CD3+ CD25+ , CD3+DR+ activated T cells, CD4+CD25+ Treg cells, CD19+ B cells and CD19+CD5+/CD19+ ratio to explore the immune disorder status and efficacy mechanism of CITP patients. 5. Criteria for judging the efficacy and statistical methods Western medicine efficacy criteria: refer to the ITP efficacy criteria of Diagnostic and Efficacy Criteria for Hematological Diseases, edited by Zhang Zhinan. SPSS statistics17.0 statistical software was applied for statistical analysis, and data were expressed as mean ± standard deviation ( ). t-test was applied for measurement data, and the significance of differences between groups was first tested by Levene's test for chi-square, and then independent sample or paired sample t-test, and the test results were selected according to the chi-square or not. II. RESULTS 1. Clinical efficacy study The treatment group took Yi Qi and Wen Yang formula for 4 months, with a 6-month follow-up period. The condition was stable during the observation period, and the cases with platelet fluctuation within 10,000 were considered invalid. The total number of cases in the treatment group was 28, with 4 cases of significant effect (14.29%); 3 cases of good effect (10.74%); 5 cases of improvement (17.86%); 16 cases of ineffectiveness (57.14%); 12 cases of total effectiveness; the total effective rate was 42.86%. In the treatment group, there were 5 cases of prednisone use during the observation period, all of them had been combined with long-term application at the time of enrollment, and the daily dose was less than 10 mg. 3 cases were reduced from 10 mg to 5 mg during the observation period, among which 1 case showed efficacy, 1 case improved, 1 case maintained the same platelet count; 1 case used 10 mg/day for the whole period, the platelet remained unchanged; 1 case used 5 mg/day for the whole period, the platelet count did not change. Table 1, Comparison of mean platelet count before and after treatment ( ) Group Pre-treatment Plt count Post-treatment Plt count Treatment group 23.02±13.69 46.18±50.47*