Gu Shi-yang, Zhuang Jing-li, Zou Shan-hua, Li Feng, Wang Zhi-mei, Cheng Yun-feng, Wang Wei-guang, Cheng Zhi-xiang, Yuan Ling, Cheng Lu-ya, Wei Zheng
Department of Hematology, Zhong Shan Hospital of Shanghai Medical College, Fudan University, Shanghai 200032, China.
Zhonghua Xue Ye Xue Za Zhi. 2013 Oct;34(10):883-6. doi: 10.3760/cma.j.issn.0253-2727.2013.10.012.
To evaluate the efficacy and safety of recombinant human thrombopoietin (rhTPO) combined with glucocorticoid in treatment of severe newly diagnosed primary immune thrombocytopenia (ITP).
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.
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.
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.
评估重组人血小板生成素（rhTPO）联合糖皮质激素治疗新诊断的重度原发性免疫性血小板减少症（ITP）的疗效和安全性。
2009年6月至2012年12月，我院诊断为重度原发性ITP的24例男性患者和38例女性患者被随机分为试验组（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。
治疗开始后第3天、第7天和第14天，试验组的平均血小板计数（APC）[(35.5±24.9)×10⁹/L、(135.2±94.9)×10⁹/L和(192.0±109.1)×10⁹/L]显著高于对照组[(24.5±15.6)×10⁹/L、(78.2±121.9)×10⁹/L和(95.8±60.5)×10⁹/L，P分别为0.022、0.009和0.001]。治疗后第28天和第90天两组的APC无显著差异[(147.8±59.1)×10⁹/L对(105.1±56.9)×10⁹/L，P = 0.243；(137.4±52.3)×10⁹/L对(104.3±59.8)×10⁹/L，P = 0.568]。在第7天、第14天和第28天，试验组的完全缓解率分别为61.3%、87.1%和80.6%，也显著高于对照组（16.1%、29.0%和48.3%，P分别为0.000、0.000和0.004）。试验组的中位起效时间为3天，而对照组为5天；试验组的完全缓解中位持续时间为76天，而对照组为54天。试验组有4例接受血小板输注治疗，而对照组有11例。
对于重度原发性ITP患者，与单用糖皮质激素相比，rhTPO联合糖皮质激素可迅速提高血小板计数，显著提高完全缓解率并延长疗效，且可耐受的不良事件发生率较低。rhTPO联合糖皮质激素可为这些患者提供一种新的治疗选择。
