大剂量地塞米松联合重组人血小板生成素治疗重症免疫性血小板减少症的临床疗效研究

目的 比较大剂量地塞米松联合重组人血小板生成素(rhTPO)与单纯使用大剂量地塞米松冲击治疗重症免疫性血小板减少症(ITP)的疗效.方法 选择2013年1月至2015年3月于济宁市第一人民医院血液内科住院治疗的75例重症ITP患者为研究对象,采用随机数字表法将其随机分为治疗组(n=38)和对照组(n=37).两组患者年龄、性别构成比等一般情况比较,差异无统计学意义(P＞0.05).治疗组给予静脉滴注地塞米松40mg/次×1次/d×4 d+皮下注射rhTPO 15 000 U/次×1次/d×14 d,若血小板计数＜10×109/L,则给予输注新鲜单采血小板1个治疗量.对照组仅给予静脉滴注地塞米松40 mg/次×1次/d×4d,余辅助治疗同治疗组.治疗14 d后,对两组患者的临床疗效和不良反应发生率进行统计学分析.本研究遵循的程序符合济宁市第一人民医院人体试验委员会所制定的伦理学标准,得到该委员会批准,分组征得受试对象本人的知情同意,并与之签署临床研究知情同意书.结果 两组患者治疗有效率(77.3％比47.8％)、达有效时间(6.9±1.4)d比(10.2±2.1)d]、血小板升高值(155.2±101.2)×109/L比(55.7±33.3)×109/L]比较,差异均有统计学差异(x2=5.01,U=2.46、3.15;P＜0.05).两组患者血小板输注率、药物不良反应发生率比较,差异无统计学意义(P＞0.05).结论 大剂量地塞米松联合rhTPO治疗重症ITP患者安全有效,较单纯使用大剂量地塞米松能有效缩短血小板起效时间,并且能明显提高血小板水平.

High dose of dexamethasone combined with recombinant human thrombopoietin in treatment of severe immunologic thrombocytopenia

Objective To compare the clinical effects of high-dose dexamethasone only and high-dose dexamethasone combined with recombinant human thrombocytopenia (rhTPO) in treatment of severe immunologic thrombocytopenia(ITP).Methods From January 2013 to March 2015,a total of 75 patients with severe ITP were included in the study.They were randomly divided into research group (n=38) and control group (n=37).There were no significant differences in general condition such as age,gender ratio between two groups (P ＞ 0.05).Combination therapy of high-dose dexamethasone (40 mg/time × 1 time/d× 4 d) and rhTPO (15 000 U/time× 1 time/d× 14 d) were given to ITP patients in research group.Meanwhile high-dose dexamethasone (40 mg/time × 1 time/d × 4 d) only was given to ITP patients in control group.And the adjuvant therapy was the same in both groups.The clinical effects and incidence of adverse reactions were compared between two groups by statistical methods.The study protocol was approved by the Ethical Review Board of Investigation in Human Being of First People's Hospital of Jining city.Informed consent was obtained from each participants.Results There were significant differences in objective response rate(77.3 ％ vs 47.8 ％),effective time (6.9 ± 1.4) d vs (10.2 ± 2.1) d] and increased platelet amounts(155.2± 101.2) × 109/L vs (55.7± 33.3) × 109/L] between two groups(x2 =5.01,U=2.46,3.15;P＜0.05).No significant difference were found in platelet transfusion rate and drug adverse reactions between two groups (P ＞ 0.05).Conclusions The high-dose dexamethasone combined with rhTPO in the treatment of severe ITP is better than high-dose dexamethasone only,with shorter median time and higher increased platelet amounts.