聚乙二醇干扰素-α治疗原发性血小板增多症的疗效和安全性分析

Analysis of the efficacy and safety of Peg-IFN-αin the treatment of essential thrombocythemia

目的:评价聚乙二醇干扰素-α(Peg-IFN-α)治疗原发性血小板增多症(essential thrombocythemia,ET)的临床疗效及安全性。方法:纳入50例ET患者,均接受12个月以上Peg-IFN-α治疗,180μg皮下注射,以每2周1次作为起始剂量,后续根据血常规调整治疗间隔,并分析其临床疗效及不良反应。结果:Peg-IFN-α治疗ET患者的血液学反应发生较快,3个月后较初诊时血小板明显降低(508.56±120.75 vs.931.44±209.13,P=0.000),12个月时血液学完全缓解率和总缓解率分别为70%、98%;Peg-IFN-α治疗ET患者的JAK2-V617F突变负荷在治疗6个月时较初诊时明显降低(0.2541±0.1228 vs.0.3153±0.1332,P<0.0001),12个月时的分子生物学完全缓解率为12.5%,总缓解率为31.75%。患者的MPN-SAF-TSS积分在Peg-IFN-α治疗6月内下降明显(P<0.001),但12月时积分较治疗6月时变化不大(P>0.05);患者的血液学不良反应少见,均为1-2级不良反应,非血液学不良反应以流感样症状为主,绝大部分患者为1-2级,偶有≥3级的不良反应,但延长用药间隔或对症处理后患者可耐受,没有患者因不良反应而终止治疗。结论:Peg-IFN-α治疗ET有效且安全。

AIM:To evaluate the clinical efficacy and safety of pegylated interferon-alpha(Peg-IFN-α)in the treatment of essential thrombocythemia(ET).METHODS:A total of 50 ET patients were treated with Peg-IFN-αfor more than 12 months.180μg was injected subcutaneously once every two weeks as the initial dose,and then the treatment interval was adjusted according to blood routine.The clinical efficacy and adverse reactions were analyzed.RESULTS:The hematologic response of ET patients treated with Peg-IFN-αoccurred quickly,and the platelet decreased significantly after 3 months(508.56±120.75 vs.931.44±209.13,P=0.000).Hematologic complete remission rate and overall remission rate at 12 months were 70%and 98%,respectively.The JAK2-V617F mutation burden of ET patients treated with Peg-IFN-αwas significantly lower at 6 months of treatment than at initial diagnosis(0.2541±0.1228 vs.0.3153±0.1332,P<0.0001).The 1-year molecular biology complete remission rate was 12.5%,and overall remission rate was 31.75%.MPN-SAF-TSS scores decreased significantly within 6 months after Peg-IFN-αtreatment(P<0.001),but there was no significant change in the score at 12 months compared with 6 months(P>0.05).Hematological adverse reactions were rare,and all of them were grade 1-2 adverse reactions.Non-hematological adverse reactions were mainly influenza-like symptoms.Most of the patients were grade 1-2,and occasionally had grade≥3 adverse reactions.All adverse reactions could be tolerated after extending medication interval or symptomatic treatment,and no patient terminated treatment because of adverse reactions.CONCLUSION:Peg-IFN-αis effective and safe in the treatment of ET.