Effects of spleen-fortifying qi-tonifying blood-securing formula on immune thrombocytopenia and its mechanism*
2020, 43 (4):
Objective To explore the effect and mechanism of action of Jianpi Yiqi Shexue therapy (spleen-fortifying qi-tonifying blood-securing formula, or JYS formula) in treating immune thrombocytopenia (ITP). Methods A central, randomized, controlled, multi-center clinical trial design was used, and 272 ITP patients with spleen failing to contain blood were enrolled. Among them, 104 cases were treated with the investigational product, JYS formula, 103 cases received combination treatment of JYS formula and prednisone (combination group) and 65 cases were treated with prednisone only. The treatment lasted 21 days with 1 visit per week. Hemostasis, platelet count and TCM pattern (single symptom) efficacy; peripheral blood count, coagulation, immunity-retated blood neurotransmitters, platelet activation and NK cell molecular marker expression ratio of all subjects were evaluated and analyzed.Results Aftertreatment, the degree of bleeding was reduced in all groups, and the efficacy of the TCM experiment group and the combination group was earlier than that of the prednisone group. After treatment, the degree of thrombocytopenia in all groups decreased, and the efficacy in the combination group was greater than the other two mono-treatment groups. The total efficacy of TCM pattern in the JYS formula group and the combination group were better than prednisone group (P<0.05). Symptom relief in all three groups was observed compared with before treatment. On the score of abdominal bloating after eating, the curative effect of the JYS formula group and the combination group was earlier than that of predniso group. The average prothrombin time in prednisone group was shorter than that in the JYS formula group. Platelet count increased in all groups, and the counts in combination group and in prednisone group were higher than that in JYS formula group. β-endorphins were increased after treatment in both JYS formula group and combination group. All of the three groups showed different degrees of decline in vasoactive intestinal peptide after treatment. Conclusion Jianpi Yiqi Shexue formula could effectively relieve the bleeding symptoms of ITP patients due to “spleen failing to contain blood” and elevate the peripheral platelet count. Jianpi Yiqi Shexue formula can effectively improve TCM patterns and single symptoms in ITP patients. The therapeutic mechanism may be related to the regulating effect on peptide neurotransmitter in brain-gut axis.
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