健脾益气摄血颗粒治疗免疫性血小板减少症临床疗效观察

Clinical curative effect observation on treatment of immune thrombocytopenia treated with Jianpi Yiqi Shexue Granules

目的:观察健脾益气摄血颗粒改善"脾不统血证(脾气虚)"型免疫性血小板减少症(ITP)患者症状及止血疗效。方法:应用中央随机对照、多中心临床试验方法,将符合病例入选标准的ITP患者按3∶3∶2分为中药组(健脾益气摄血组)、联合组(健脾益气摄血联合强的松组)、西药组(强的松)。治疗21d,每周访视1次,采集症状与出血等数据,最后进行统计学处理。结果:临床症状疗效中药组(104例)、联合组(103例)在临床证候显效率与有效率明显优于西药组(P<0.05),治疗7d后出血程度较入组时明显减轻(P<0.05),中药组的血小板均值及增长趋势始终低于其他两组(P<0.05)。结论:健脾益气摄血颗粒在改善"脾不统血"ITP患者的脾(气)虚症状及出血症状上,疗效优于并早于单用强的松;联合用药优势更加明显,并且对强的松可能潜在的不良反应有一定的缓解作用。

Objective:To observe the improvement of symptoms and hemostatic effect of Jianpi Yiqi Shexue Granules in patients with spleen failing to control blood (deficiency of spleen qi)type immune thrombocytopenia (ITP).Methods:A central randomized,multicenter clinical trial was applied with the ITP patients on TCM syndrome of spleen failing to control blood (spleen qi deficiency).Patients are divided cases into Chinese medicine group (invigorating spleen and replenishing qi and control blood group),90 cases into combination group (invigorating spleen and replenishing qi and control blood combined with prednisone group ),and 60 cases into western medicine group (prednisone group).After 21 days of treatment and followed-up once a week,the data of symptoms and bleeding was collected and statistically analyzed.Results:The Chinese medicine group and the combination group were more effective than the prednisone group in the efficiency of the syndromes (P<0.05),and the level of bleeding began to decrease (P<0.05) after 7days of treatment.The Chinese medicine group had lower growth trends than the other 2 groups (P<0.05). Conclusion:The Jianpi Yiqi Shexue Granules can improve ITP patients'spleen deficiency symptoms and bleeding symptoms who caused by spleen fairing to control blood,and its curative effect is better and earlier than prednisone alone,the advantages of drug combination are more obvious,and there are some mitigating effects on the potential sideeffects of prednisone.