连续应用重组人血小板生成素联合泼尼松治疗初治免疫性血小板减少症的临床研究

目的评价连续应用重组人血小板生成素(rh TPO)联合泼尼松治疗成人初治免疫性血小板减少症(ITP)的疗效及安全性。方法 119例初治ITP患者,男53例,女66例,随机分为试验组(59例)和对照组(60例)。对照组仅使用泼尼松治疗,泼尼松用法为起始剂量1 mg/kg/d。试验组在应用泼尼松基础上联合应用rhTPO 1.5万U/d×14 d;继之1.5万U,biw,用至90 d。比较两组患者的血小板水平、有效率及药物的不良反应。结果在第8、15,22、30、180 d,试验组血小板水平均高于对照组,检测结果分别为105±91×10~9/L对67±68×10~9/L(P=0.011);164±112×10~9/L对93±68×10~9/L(P=0.000);161±83×10~9/L对115±74×10~9/L(P=0.002);145±64×10~9/L对115±64×10~9/L(P=0.012)和124±54×10~9/L对101±66×10~9/L(P=0.040),差异有统计学意义。基线及第90 d,两组血小板水平的差异无统计学意义(P0.05)。试验组泼尼松使用剂量少于对照组且第15、22、30、90 d,试验组的空腹血糖水平低于对照组,两组的差异有统计学意义(P0.05)。结论连续应用rhTPO联合泼尼松治疗成人初治重症ITP患者,起效迅速,作用持久,不良反应少,可减少泼尼松的使用剂量。

A Clinical Study on Treatment of Newly Diagnosed Immune Thrombocytopenia by Continuously Using Recombinant Human Thrombopoietin Combined with Prednisone

Objective To evaluate the efficacy and safety of continuously using recombinant human thrombopoietin(rhTPO) combined with prednisone in treatment of newly diagnosed immune thrombocytopenia (ITP).Methods 53 male patients and 66 female patients with the newly diagnosed primary ITP in multicenter were randomized into trial(59 cases)or control group(60 cases).Control group was treated with prednisone only.Prednisone's starting dose was 1 mg/kg.After using 14 days,if the average platelet count ≥60 × 109/L,and if no bleeding or no risk factors for hemorrhage,then prednisone's dose was decreased and then stopped.In trial group,patients were treated with rhTPO combined with prednisone.rhTPO 15000 U/d,ih,d1 to d14,then,15 000 U,twice a week,until d90.Platelet count,the overall response rate,as well as adverse drug reactions,were strictly observed in the process.At the day 8,15,22,30 and 180 from the beginning of the treatment,the average platelet count in trial group [(105 ± 91) × 109/L,(164 ± 112) × 109/ L,(161 ± 83) × 109/L,(145 ± 64) × 109/L and (124 ± 54) × 109/L] were significantly higher than that in control group [(67 ± 68) × 109/L,(93 ±-68) × 109/L,(115 ± 74) × 109/L,(115 ± 64) × 109/L,(1 01 ± 66)× 109/L,P--0.011,0.000,0.002,0.012,0.040,respectively].At the day 15,22,30,90,the average fasting blood glucose in trial group[5.4 ± 1.1 mmol/L,5.5 ± 1.3 mmol/L,5.0 ± 1.4 mmol/L and 4.9 ± 1.5 mmol/L] were significantly lower than that in control group[5.9 ± 1.4 mmol/L,6.2 ± 2.0 mmol/L,5.9 ± 1.5 mmol/L and 5.6 ± 1.0 mmol/L,P =0.018,0.015,0.000,0.006,respectively].For patients with primary ITP,rhTPO combined with prednisone could rapidly increase the platelet count,prolonged the effect,indicating lower incidence of adverse events,and could decrease the total dose of prednisone.rhTPO combined with prednisone could be a beneficial treatment for patients with newly ITP.