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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(P>0.05)。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(P<0.05)。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。
Objective To evaluate the efficacy and safety of continuous administration of recombinant human thrombopoietin (rh TPO) and prednisone in the treatment of newly diagnosed idiopathic thrombocytopenia (ITP) in adults. Methods 119 cases of newly diagnosed ITP patients, 53 males and 66 females, were randomly divided into experimental group (59 cases) and control group (60 cases). The control group was treated with prednisone only, prednisone was used as the initial dose of 1 mg / kg / d. The experimental group on the basis of the application of prednisone combined rhTPO 15,000 U / d × 14 d; followed by 15,000 U, biw, with 90 d. Compare the two groups of patients with platelet levels, efficiency and adverse drug reactions. Results On the 8th, 15th, 22th, 30th, and 180th days, the platelet levels in the experimental group were significantly higher than those in the control group (105 ± 91 × 10-9 / L vs. 67 ± 68 × 10-9 / L, P = (P = 0.000). The mean ± standard deviation of the control group was significantly higher than that of the control group (P <0.01) (P = 0.002); the average value of the control group was 145 ± 64 × 10-9 / L vs 115 ± 64 × 10-9 / L (P = 0.012) and 124 ± 54 × 10-9 / L vs 101 ± 66 × 10-9 / 0.040), the difference was statistically significant. At baseline and 90 days, there was no significant difference in platelet levels between the two groups (P> 0.05). The dosage of prednisone in the experimental group was less than that in the control group, and on the 15th, 22th, 30th and 90th days, the fasting blood glucose level in the experimental group was lower than that in the control group. The difference was statistically significant (P <0.05). Conclusion Continuous rhTPO plus prednisone treatment of adult patients with newly diagnosed severe ITP, rapid onset, long-lasting effect, fewer adverse reactions, can reduce the dose of prednisone.