宁血升板汤联合泼尼松治疗特发性血小板减少性紫癜与泼尼松等效性多中心随机平行对照研究

Ningxueshengban Tang(宁血升板汤) combined with Prednisone vs Prednisone in Treatment of Idiopathic Thrombocytopenic Purpura: a Equivalent, Multicenter, Randomized Parallel Controlled Study

[目的]观察宁血升板汤联合泼尼松治疗特发性血小板减少性紫癜与泼尼松等效性。[方法]使用多中心等效性随机平行对照方法,将60例门诊患者按就诊顺序号简单随机分为两组。对照组30例泼尼松0.25mg^0.5mg/kg·d-1。治疗组30例宁血升板汤(水牛角30g,生地、赤芍、丹皮、女贞子、旱莲草、卷柏、连翘、生侧柏、生地榆、仙鹤草各15g,三七1.5g),1剂/d,水煎200m L,2次/d;泼尼松治疗同对照组。连续治疗8周为1疗程。观测临床症状、血小板、细胞因子、不良反应。连续治疗1疗程,判定疗效。[结果]治疗组显效6例,良效9例,进步10例,无效5例,总有效率83.33%。对照组显效4例,良效8例,进步12例,无效6例,总有效率80.00%。临床疗效两组间无明显差异(P>0.05)。细胞因子分泌水平两组均明显降低(P<0.05),IL-10降低幅度治疗组小于对照组(P<0.05),TNF-α降低治疗组大于对照组(P<0.05)。[结论]宁血升板汤联合泼尼松治疗特发性血小板减少性紫癜,疗效满意,与泼尼松具有等效性,无严重不良反应,值得推广。

[Objective] To observe the equivalence of Ningxue Shengban decoction combined with prednisone vs prednisone in treatment of Idiopathic thrombocytopenic purpura（ITP）. [Methods] Muhicenter and randomized parallel controlled trial was designed for comparative study of 60 patients with ITP. The patients were randomly divided into two groups according to the drawing lots of visiting sequence. A control group of 30 cases were treated with prednisone, 0.25 mg-0.5 mg/kg ~ d-1, and the treatment group of 30 cases were treated with Ningxue Shengban decoction （Shuiniujiao 30 g, Shengdihuang, Chishao, Danpi, Nuzhenzi, Hanliancao, Juanbai, Lianqiao, Shengcebai, Shengdiyu, Xianhecao 15 g, Sanqi 1.5 g）, decoction 200 ml, 1 a/d, 2 times/d, with the same western medicine treatment of control group. 8 weeks for a course of continuous treatment.Observation of clinical symptoms, platelet count, secretion of cytokines, adverse reactions. One course of treatment, to determine the efficacy. [Results] In the treatment group, 6 cases were curative effect, 9 cases were good effect, 10 cases were progressive, 5 cases were invalid, total effective rate was 83.33%. In the control group, 4 cases were curative effect, 8 cases were good effect, 12 cases were progressive, 6 cases were invalid, total effective rate was 80.00%. There was no significant difference at total effective rate between the two groups （P〉0.05）. The secretion of cytokine in both groups was going down markedly after the treatment. Comparing the two groups, the decreasing range of IL-10 in treatment group is smaller than control group （P〈0.05）, whereas the decreasing range of TNF- ct in treatment group is larger than control group （P〈0.05）. [Conclusion] There is a good effect of treating ITP with Ningxue Shengban decoction combined with prednisone. The treatment had equivalence comparing with prednisone, without severe adverse reactions, and it is worthy to promote in clinic.