Li Yan, Huang Qin, Wang Chao, An Li, Wang Xiaomin
Zhonghua Xue Ye Xue Za Zhi. 2016 Feb;37(2):134-7. doi: 10.3760/cma.j.issn.0253-2727.2016.02.010.
To evaluate the efficacy and safety of high dose dexamethasone combined with recombinant human thrombopoietin (rhTPO) in adults with severe newly diagnosed immune thrombocytopenia (ITP).
Forty-eight adult patients with severe ITP were randomized into two groups, experimental group and control group. The patients in experimental group were given high-dose dexamethasone combined with rhTPO treatment, the patients in control group were given single high-dose dexamethasone treatment. Platelet count, platelet increase, as well as the overall response rate were strictly observed in the process. At the same time, the patient's drug tolerance and any adverse drug reactions were observed.
The platelet counts and platelet increase of the patients in experimental group were significantly higher than that in control group (P<0.05) at day 3, 7, 14, 30. There was no significant difference in overall response rates between the two groups (34.8% vs 36.0%, 56.5% vs 48.0%, P>0.05) at day 3, 7. The overall response rates of experimental group at day 14, 30 were significantly higher than that of control group (91.3% vs 68.0%, 82.6% vs 52.0%, P<0.05). The muscle aches occurred in one patient in experimental group which was self-recovery without special treatment.
rhTPO combined with high-dose dexamethasone could rapidly increase the platelet count, reduce the risk of bleeding, and prolonge the effect with a low incidence of tolerable adverse events compared to single high-dose dexamethasone. rhTPO combined with high-dose dexamethasone could be a new therapeutic choice for severe primary ITP.
评估大剂量地塞米松联合重组人血小板生成素(rhTPO)治疗成人新诊断的重度免疫性血小板减少症(ITP)的疗效和安全性。
48例成人重度ITP患者随机分为两组,即实验组和对照组。实验组患者给予大剂量地塞米松联合rhTPO治疗,对照组患者给予单次大剂量地塞米松治疗。在此过程中严格观察血小板计数、血小板增加情况以及总体缓解率。同时,观察患者的药物耐受性及任何药物不良反应。
实验组患者在第3、7、14、30天的血小板计数和血小板增加量均显著高于对照组(P<0.05)。两组在第3、7天的总体缓解率无显著差异(34.8% 对36.0%,56.5% 对48.0%,P>0.05)。实验组在第14、30天的总体缓解率显著高于对照组(91.3% 对68.0%,82.6% 对52.0%,P<0.05)。实验组有1例患者出现肌肉酸痛,自行恢复,未进行特殊治疗。
与单次大剂量地塞米松相比,rhTPO联合大剂量地塞米松可快速提高血小板计数,降低出血风险,延长疗效,且可耐受的不良事件发生率较低。rhTPO联合大剂量地塞米松可为重度原发性ITP提供一种新的治疗选择。