[A clinical comparative study on treatment of severe newly diagnosed immune thrombocytopenia by recombinant human thrombopoietin combined with glucocorticoid].
[A clinical comparative study on treatment of severe newly diagnosed immune thrombocytopenia by recombinant human thrombopoietin combined with glucocorticoid].
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DOI：
10.3760/cma.j.issn.0253-2727.2013.10.012
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发表时间：
2013-10-01
影响因子：
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通讯作者：
Wei, Zheng
中科院分区：
文献类型：
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作者：
Gu, Shi-yang;Zhuang, Jing-li;Wei, Zheng
目的：评价重组人血小板生成素（rhTPO）联合糖皮质激素治疗初诊重症原发性免疫性血小板减少症（ITP）的疗效和安全性。方法：2009年6月至2012年12月，我院诊断为重症原发性ITP患者24例，男性24例，女性38例，随机分为试验组（31例）和对照组（31例），中位年龄为 50岁（范围：21-84岁）。试验组采用rhTPO联合糖皮质激素治疗，对照组仅采用糖皮质激素治疗。 结果：治疗第3、7、14天，试验组平均血小板计数（APC）[（35.5±24.9）*10⁹/L、（135.2±94.9）*10⁹/L， (192.0±109.1)*10⁹/L]显着较高 低于对照组[分别为(24.5±15.6)*10⁹/L、(78.2±121.9)*10⁹/L和(95.8±60.5)*10⁹/L, P=0.022、0.009和0.001]。治疗后第28天、第90天两组APC差异无统计学意义[（147.8±59.1）*10⁹/L vs（105.1±56.9）*10⁹/L，P=0.243； (137.4±52.3)*10⁹/L vs (104.3±59.8)*10⁹/L, P=0.568]。第7、14和28天，试验组的完全缓解率分别为61.3%、87.1%和80.6%，也显着高于对照组（分别为16.1%、29.0%和48.3%，P=0.000、0.000和0.004）。试验组的中位缓解时间为 3 天，而对照组为 5 天；试验组完全缓解的中位持续时间为 76 天，而对照组为 54 天。试验组有4例接受血小板输注，对照组有11例。结论：对于重度原发性ITP患者，与单用糖皮质激素相比，rhTPO联合糖皮质激素可快速增加血小板计数，显着提高完全缓解率，延长疗效，且可耐受不良事件发生率低。 rhTPO联合糖皮质激素可能成为这些患者的新治疗选择。
OBJECTIVE: To evaluate the efficacy and safety of recombinant human thrombopoietin (rhTPO) combined with glucocorticoid in treatment of severe newly diagnosed primary immune thrombocytopenia (ITP).METHODS: From June 2009 to December 2012, 24 male patients and 38 female patients with the diagnosis of severe primary ITP in our hospital were randomized into trial group (31 cases) or control group (31 cases), the median age was 50 years (range: 21-84 years). Trial group was treated with rhTPO combined with glucocorticoid, and control group was treated with glucocorticoid only.RESULTS: At the day 3, 7 and 14 from the beginning of treatment, the average platelet count (APC) in trial group[(35.5±24.9)*10⁹/L, (135.2±94.9)*10⁹/L and (192.0±109.1)*10⁹/L]were significantly higher than that in control group[(24.5±15.6)*10⁹/L, (78.2±121.9)*10⁹/L and (95.8±60.5)*10⁹/L, P=0.022, 0.009 and 0.001, respectively]. There was no significant difference in APC between the two groups at day 28 and 90 after treatment[(147.8±59.1)*10⁹/L vs (105.1±56.9)*10⁹/L, P=0.243; (137.4±52.3)*10⁹/L vs (104.3±59.8)*10⁹/L, P=0.568, respectively]. At the day 7, 14 and 28, the complete response rates in trial group were 61.3%, 87.1% and 80.6%, which were also significantly higher than that in control group (16.1%, 29.0% and 48.3%, P=0.000, 0.000 and 0.004, respectively). The median time to response in trial group was 3 days while in the control group was 5 days; the median duration of complete response in trial group was 76 days while in the control group was 54 days. In trial group, there were 4 cases treated with platelet transfusion, while in control group there were 11 cases, respectively.CONCLUSION: For patients with severe primary ITP, rhTPO combined with glucocorticoid could rapidly increase the platelet count, significantly improve the complete response rate and prolonged the effect with a low incidence of tolerable adverse events compared to single use of glucocorticoid. rhTPO combined with glucocorticoid could be a new therapeutic choice to those patients.