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仙连颗粒对激素依赖型ITP骨髓TPO、TGF-β1
水平的影响及临床研究

摘 要
目的：本研究所用采用的方剂仙连颗粒，系导师行医多年，经十余年悉心理论研究和临床经验总结所创。通过研究仙连颗粒对骨髓微环境中调节巨核细胞发育的正性因子血小板生成素( TPO) 与负性作用因子转化生长因子β1 ( TGF-β1 )水平变化的影响，以评价仙连颗粒对激素依赖型ITP的治疗效果及其作用机制，为临床应用提供更多依据。
方法：选取符合诊断标准的病例64例，按1:1的分配原则，运用单盲法随机分入治疗组与对照组，治疗组32例，给予仙连颗粒（装胶囊，每粒相当于 生药1.5g），每次10粒，一日三次，同时口服强的松片0.5mg/kg/d，待血小板恢复正常后，每两周减5mg，减至维持量5-10mg/d；对照组32例，给予安慰剂（糊精装胶囊），每次10粒，一日三次，同时口服强的松片0.5mg/kg/d，用法同治疗组，均以两个月为一疗程，观察两个疗程。观察两组患者治疗前后的临床症状（紫斑的分布与颜色、皮肤粘膜及内脏出血表现、发热、烦渴、五心烦热、口干、潮热盗汗、神疲乏力、气短以及舌象、脉象等）以及外周血象、骨髓象的改善情况。采用ELISA法测定治疗前后骨髓TPO、TGF-β1水平并与对照组作统计学比较。
结果：治疗后治疗组的有效率、显效率均明显高于对照组。治疗后治疗组在临床症状、血象、骨髓象的改善方面与对照组有非常显著性差异（P<0.01）。与疗前相比，治疗组、对照组均可以降低TPO、TGF-β1水平（P <0.01），但对照组在降低TPO、TGF-β1水平上不如仙连颗粒，进一步研究还发现仙连颗粒治疗阴虚血热型、气虚不摄型疗效较好，血热妄行型疗效较差。
结论：①该制剂能改善激素依赖型ITP患者的临床症状、血象、骨髓象，提示具有升高血小板功效的仙连颗粒在治疗ITP长期疗效方面优于强的松。②实验研究结果显示，该制剂能使血清骨髓TPO、TGF-β1的水平降低。③TPO、TGF-β1可为ITP 患者临床病情判断、预后估计、制定个体性治疗方案提供依据, 在ITP 的病理过程中发挥重要作用。
关键词：激素依赖型；特发性血小板减少性紫癜；仙连颗粒；临床疗效；TPO；TGF-β1
TPO 又称巨核细胞生长衍生因子(Megakaryocyte growth and development factor ,MGDF
转化生长因子(transforming growth factor, TGF-β1) 斑疹 rashes
烦 irritability
烦躁 irritability and restlessness
潮热 tidal fever or afternoon tidal fever
盗汗 night sweats

神疲 weariness

　　仙连颗粒对激素依赖型ITP骨髓TPO、TGF-β1
　　水平的影响及临床研究

　　摘 要
　　目的：本研究所用采用的方剂仙连颗粒，系导师行医多年，经十余年悉心理论研究和临床经验总结所创。通过研究仙连颗粒对骨髓微环境中调节巨核细胞发育的正性因子血小板生成素( TPO) 与负性作用因子转化生长因子β1 ( TGF-β1 )水平变化的影响，以评价仙连颗粒对激素依赖型ITP的治疗效果及其作用机制，为临床应用提供更多依据。
　　方法：选取符合诊断标准的病例64例，按1:1的分配原则，运用单盲法随机分入治疗组与对照组，治疗组32例，给予仙连颗粒（装胶囊，每粒相当于 生药1.5g），每次10粒，一日三次，同时口服强的松片0.5mg/kg/d，待血小板恢复正常后，每两周减5mg，减至维持量5-10mg/d；对照组32例，给予安慰剂（糊精装胶囊），每次10粒，一日三次，同时口服强的松片0.5mg/kg/d，用法同治疗组，均以两个月为一疗程，观察两个疗程。观察两组患者治疗前后的临床症状（紫斑的分布与颜色、皮肤粘膜及内脏出血表现、发热、烦渴、五心烦热、口干、潮热盗汗、神疲乏力、气短以及舌象、脉象等）以及外周血象、骨髓象的改善情况。采用ELISA法测定治疗前后骨髓TPO、TGF-β1水平并与对照组作统计学比较。
　　结果：治疗后治疗组的有效率、显效率均明显高于对照组。治疗后治疗组在临床症状、血象、骨髓象的改善方面与对照组有非常显著性差异（P<0.01）。与疗前相比，治疗组、对照组均可以降低TPO、TGF-β1水平（P <0.01），但对照组在降低TPO、TGF-β1水平上不如仙连颗粒，进一步研究还发现仙连颗粒治疗阴虚血热型、气虚不摄型疗效较好，血热妄行型疗效较差。
　　结论：①该制剂能改善激素依赖型ITP患者的临床症状、血象、骨髓象，提示具有升高血小板功效的仙连颗粒在治疗ITP长期疗效方面优于强的松。②实验研究结果显示，该制剂能使血清骨髓TPO、TGF-β1的水平降低。③TPO、TGF-β1可为ITP 患者临床病情判断、预后估计、制定个体性治疗方案提供依据, 在ITP 的病理过程中发挥重要作用。

　　Sally even particles of the steroid-dependent ITP bone marrow TPO, TGF-β1

　　Levels and clinical research

　　Abstract

　　Objective: The Institute of the prescription with the use of even particles cents, a tutor to practice for many years, by more than ten years of theoretical research and clinical care experience created. Sally even particles through research on the regulation of bone marrow micro-environment in the development of megakaryocyte factor is thrombopoietin (TPO) and the role of negative factors transforming growth factor β1 (TGF-β1) level of change to evaluate even the particles of the hormone cents ITP-dependent therapeutic effect and its mechanism, in order to provide more basis for clinical application.

　　Methods: The cases of diagnostic criteria in line with the 64 cases, the principle of distribution according to 1:1, the use of single-blind method were randomly divided into treatment group and control group, 32 cases of treatment group, even given cents particles (loaded capsules, each piece costs the equivalent of Pharmacognosy 1.5g), per 10 day three, while oral prednisone tablets 0.5mg/kg/d, to be returned to normal platelets every two weeks by 5mg, to maintain the amount of 5-10mg / d; the control group 32 patients given placebo (hardcover paste capsule), 10 each, three times a day, while oral prednisone tablets 0.5mg/kg/d, use the same treatment group, are a two-month course of treatment, observation of the two courses. Before and after treatment were observed in patients with clinical symptoms (purpura and the distribution of colors, mucocutaneous and visceral manifestations bleeding, fever, polydipsia, five upset hot, dry mouth, hot flashes sweating,神疲fatigue, shortness of breath, and Tongue, pulse, etc. ), as well as peripheral blood, bone marrow, as the improve the situation. ELISA method used before and after treatment of bone marrow TPO, TGF-β1 level and with the control group for statistical comparison.

　　Results: After treatment, the efficiency of the treatment group were significantly higher than the efficiency significantly. Treatment group after treatment in the clinical symptoms, blood, bone marrow as the improvement of the control group with a very significant difference (P <0.01). Compared with before treatment, treatment group and the control group may reduce TPO, TGF-β1 levels (P <0.01), but the control group in the reduction of TPO, TGF-β1 levels cents better than even the particles, a further study also found that even the particles cents Heat-treatment of blood deficiency and Qi deficiency-type effect is not well taken, blood-type effect妄行less heat.

　　CONCLUSION: ① the agents to improve the steroid-dependent ITP patients with clinical symptoms, blood, bone marrow, suggesting that the efficacy with increased platelet particles cents even long-term efficacy in the treatment of ITP is superior to prednisone. ② experimental results showed that the preparation of bone marrow serum can TPO, TGF-β1 down. ③ TPO, TGF-β1 can determine the clinical conditions of patients with ITP, the prognosis is estimated that the development of individual treatment programs based on the pathological process in ITP to play an important role.

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