Objective: 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).
Methods: 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.
Results: 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.
Conclusion: 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.
目的: 评价大剂量地塞米松联合重组人血小板生成素(rhTPO)治疗成人初治重症原发免疫性血小板减少症(ITP)的有效性及安全性。
方法: 48例初治重症ITP患者，男26例，女22例，中位年龄45(20~69)岁，随机分为观察组(23例)和对照组(25例)，分别给予大剂量地塞米松(40 mg/d×4 d)联合rhTPO(15 000 U/d×14 d)方案及大剂量地塞米松单药治疗。比较两组患者治疗后血小板计数、血小板增幅以及总有效率，观察药物的不良反应。
结果: 治疗第3、7、14、30天，观察组血小板计数及增幅均高于对照组(P<0.05)。治疗第3、7天，两组总有效率差异无统计学意义(34.8％对36.0%，χ2=0.008，P=0.930；56.5％对48.0%，χ2=0.349，P=0.555)；治疗第14、30天，观察组总有效率均高于对照组(91.3％对68.0%，χ2=3.945，P=0.047; 82.6％对52.0%，χ2=5.050，P=0.025)。观察组出现肌肉酸痛不适1例，停药后自行好转。
结论: 与大剂量地塞米松单药比较，大剂量地塞米松联合rhTPO治疗成人初治重症ITP起效快速、血小板计数增幅较大、疗效持久，具有良好的安全性。