重组人白细胞介素-11联合地塞米松治疗重症原发免疫性血小板减少症的疗效分析

Efficacy of High-dose Dexamethasone in Combination with Recombinant Human Interleukin-11 in Adult Patients with Severe Primary Immune Thrombocytopenia

目的:评价重组人白细胞介素-11(recombinant human interleukin-11,rhIL-11)联合单疗程大剂量地塞米松治疗成人重症原发免疫性血小板减少症(immune thrombocytopenia,ITP)的近期疗效和安全性。方法:采用历史对照研究方法,分析26例接受rhIL-11联合大剂量地塞米松治疗的的重症ITP患者(联合治疗组)以及19例仅接受大剂量地塞米松治疗的重症ITP患者(地塞米松治疗组)的临床资料,比较两组治疗总有效率、完全反应率、起效时间、血小板峰值、不良反应等,并分析可能影响rhIL-11疗效的相关因素。结果:联合治疗组治疗总有效率和完全反应率分别为80.8%和57.7%,而地塞米松治疗组的总有效率和完全反应率分别为47.4%和26.3%,差异均有统计学意义(P<0.05);联合治疗组血小板峰值高于地塞米松治疗组[分别为(129.6±58.4)×109/L和(97.2±45.2)×109/L;P=0.05];但两组之间起效时间并无显著差异(P>0.05)。联合治疗组在治疗起始14 d内血小板计数处于安全范围的天数为(9.0±3.5)d,地塞米松治疗组则为(5.5±4.5)d,两组差异有统计学意义(P<0.01)。联合治疗组经rhIL-11治疗后患者的血小板峰值与骨髓巨核细胞数、年龄、性别等均无显著相关性,患者对rhIL-11耐受性良好。结论:rhIL-11可以提高大剂量地塞米松治疗重症ITP的疗效。

Objective：To evaluate the short-term efficacy and safety of a single cycle of high dose dexamethasone （HD-DXM） combined with recombinant human interleukin-11 （rhlL 11 ） in adult patients with severe primary immune thrombocytopenia （ITP）. Methods：Two groups of patients with severe ITP received HD-DXM therapy in combination with rhII.-11 （n = 26） or not in combination with rhlL-11（n = 19） . The overall response rates （OR）, complete response rates （CR）, time to initial re- sponse, peak platelet counts and side effects between the two groups were compared. Clinical characteristics possibly correlated with the efficacy of rhIL-11 was also analyzed. Results： The OR and CR in patients treated with HI-DXM combined with rhIL- 11 were 80.8%and 57.7%, and those were 47.4% and 26.3% in patients treated with HD-DXM （P all 〈0.05）. The peak platelet counts were （129.6 ± 58.4） × 109/L in patients received HFYDXM combined with rhlI.-11 and （97.2 ＋ 45.2） ~ 109/L in patients received HI〉DXM （P = 0.05）,and there was no statistical significant difference in the onset time between the two groups （P〉0.05）. There was significant difference in the duration of safety range between the two groups（P〈0.01 ）. No sig nificant correlation was found between the peak platelet counts after rhlI. 11 treatment and megakaryocyte counts, age, or gen der in patients received HD-DXM combined with rhIL-1/. （P〉0.05）. Patients tolerated rhlL-11 well. Conclusions： RhIl.-11 can improve the efficacy of HDDXM in treating severe ITP.