基于血液神经递质变化从脾论治免疫性血小板减少症临床研究

Clinical study on the mechanism of immune thrombocytopenia by treating from the spleen based on the changes of blood neurotransmitter

目的基于脑肠轴平衡学说,从血液神经递质角度探讨从脾论治免疫性血小板减少症(ITP)的机制。方法采用中央随机对照、多中心临床试验方法,将272例符合脾不统血证的ITP患者随机分健脾益气摄血组(A组)90例、健脾益气摄血联合强的松组(B组)90例、强的松组(C组)60例。A组给予健脾益气摄血配方颗粒口服,每次1袋,每日2次;C组强的松首次剂量按1~1.5 mg/(kg·d),早8点顿服;B组配方颗粒、强的松用量、用法同A、C组。3组均以21天为一疗程。结果 3组治疗后外周血小板分度评分值组间比较,差异均有统计学意义(P<0.05);A组与B组比较,差异有统计学意义(P<0.05);A组与C组比较,差异有统计学意义(P<0.05)。第7天与第1天出血分度评分值组内比较,A组、B组差异均有统计学意义(P<0.05);第14、第21天出血分度评分值分别与第1天比较,3组差异均有统计学意义(P<0.05)。A、B组治疗前后β-内啡肽(β-EP)测定值比较,差异均有统计学意义(P<0.05)。3组治疗前后血管活性肠肽(VIP)测定值比较,差异有统计学意义(P<0.05);治疗后A、B 2组分别和C组两两比较,差异均有统计学意义(P<0.05)。结论健脾益气摄血方可能通过调控血液神经递质激活机体止血机制。

Objective Based on the theory of brain-gut axis balance,to explore the underlying mechanism of the theory ＂treating from the spleen＂ for immune thrombocytopenia（ITP） from the angle of blood neurotransmitters expression levels.Methods Central random control and multi-centered clinical trials were used to randomly divide 272 ITP subjects into Jianpi Yiqi Shexue group（group A） of 90 cases,Jianpi Yiqi Shexue plus Prednisone group（group B） of 90 cases,and Prednisone group（group C） of 60 cases.Group A were given Jianpi Yiqi Shexue Granules（the formula for tonifying spleen,invigorating qi and controlling blood）1 bag each time,twice a day;group C received Prednisone with the dose of 1-1.5 mg/（kg·d） at the first time at 8 am everyday;group B received combined therapies of Jianpi Yiqi Shexue Granules plus Prednisone with the same methods as group A and C.The treatment course of all three groups was 21 days.Results Statistically significant differences were found among three groups in peripheral thrombocytes scorings（P〈0.05）.Moreover,statistically significant differences were found between A and B（P〈0.05）,as well as between A and C（P〈0.05）.In group A and B,remarkable differences were found in bleeding grade scouring on Day 7,14,21,compared with Day 1（P〈0.05）.In group A and B,remarkable differences were found in β-EP levels between pre-and post–treatment（P〈0.05）.In all three groups,remarkable differences were found in VIP levels between pre-and post-treatment（P〈0.05）.Post-treatment VIP levels in group A and B were significantly different from that in group C（P〈0.05）.Conclusion Jianpi Yiqi Shexue Formula could stimulate hemostasis mechanism via the regulation on the blood neurotransmitters.