重组人血小板生成素治疗老年慢性免疫性血小板减少性紫癜的疗效观察

Clinical Study on Recombinant Humanized Thrombopoietin in the Treatment of Elderly Patients with Chronic Immune Thrombocytopenia

目的:评价重组人血小板生成素(recombinant humanized thrombopoietin,rhTPO)治疗老年慢性免疫性血小板减少性紫癜(immune thrombocytopenia,ITP)的临床疗效和不良反应。方法:对2008年1月—2012年12月收治的25例慢性ITP老年患者,皮下注射rhTPO 300 U/(kg.d),每天1次,共14 d或至血小板计数≥100×109/L时,停止给药。停药后继续观察14 d。依据成人ITP诊治中国专家共识(修订版)的标准进行临床疗效和安全性分析和评估。结果:经rhTPO治疗后,完全反应7例,有效13例,总有效率为80.0%(20/25)。用药后血小板计数最高值平均达到(146.18±83.96)×109/L,停药后血小板计数缓慢下降,治疗后第28天血小板计数回落至(85.40±39.53)×109/L,均显著高于治疗前的血小板计数(15.30±7.97)×109/L(P<0.01),但白细胞计数和血红蛋白含量在治疗前后差异无统计学意义(P>0.05)。rhTPO对凝血酶原时间、活化的部分凝血活酶时间和纤维蛋白原无显著影响(P>0.05)。治疗过程中出现的不良反应主要有嗜睡、头晕和乏力,分别为4例、3例、3例,腹泻和皮疹各1例。结论:rhTPO是治疗老年慢性ITP有效而且耐受性较好的治疗药物。

Objective：To evaluate the efficacy and toxicity of recombinant humanized thrombopoietin（rhTPO） in the treatment of elderly patients with chronic immune thrombocytopenia（ITP）.Methods：A total of 25 elderly patients with chronic ITP were enrolled from January 2008 to December 2012 and administrated subcutaneously with rhTPO 300 U/kg once per day for 14 days or until platelet count rose to no less than 100×109/L.Afterwards,all patients continued to be observed for 14 days.Clinical efficacy and safety of rhTPO have been further analyzed and evaluated according to Chinese experts＇ common views on diagnosis and therapy of adult ITP.Results： After treatment with rhTPO,seven patients achieved complete response while thirteen cases reached response,and the overall response rate was 80.0%（20/25）.After exposure to rhTPO,the mean platelet count increased to the highest level of（146.18±83.96）×109/L.After stopping treatment of rhTPO,the mean platelet count gradually decreased to（85.40±39.53）×109/L on 28th day of post-treatment.However,both of these platelet counts were significantly higher than mean platelet count before treatment（15.30±7.97）×109/L,P0.01.However,no significant differences were found in white blood cell counts and haemoglobin before and after treatment（P0.05）.It was shown that rhTPO exert little influences on PT,APTT and fibrinogen levels（P0.05）.The major adverse effects of rhTPO including 4 cases of mild doss,3 cases of dizziness,3 cases of fatigue,1 case of diarrhea and 1 case of skin rash,which can be relieved or eased after symptomatic treatment.Conclusions： rhTPO is an effective and well-tolerated therapeutic drug for elderly patients with chronic ITP.