Ptushkin V V, Vinogradova O Yu, Pankrashkina M M, Chernikov M V, Arshanskaya E G, Tkachenko N E
The City Clinical Hospital named after S.P. Botkin Moscow Department of Health, Moscow, Russia.
National Medical Research Center of Children's Hematology, Oncology and Immunology named after Dmitry Rogachev of the Russian Federation Ministry of Health, Moscow, Russia.
Ter Arkh. 2018 Aug 17;90(7):70-76. doi: 10.26442/terarkh201890770-76.
To analyze the long-term efficacy and safety of ATR in adult patients with primary resistant ITP in real-world clinical practice.
The article contains long-term results analysis of ATR application under real clinical practice conditions in 138 patients (40 men and 98 women) whose median age at the beginning of therapy was 59 (18-86) years. Two ATR medicines-romiplostim (100 patients) and eltrombopag (38 patients) were used.
During the first month of therapy, the median platelet count in the romiplostim group increased from 17·109 / L to 60·109 / L (9-600·109 / L), and the elethrombopag from 16.109 / L to 56.109 / L (9-400·109 / L). The minimal response (reaching platelet counts over 30·109 / L) was achieved in 92% of cases in both groups. Partial response (achievement of platelet count more than 50·109 / L) was achieved in 91 and 84% of patients in the rhombostim and eltrombopag groups, respectively. The frequency of complete response (an increase in platelet counts above 100·109 / L) was noted somewhat more often in the rhy- ploistim group-69% compared to 47% in the eltrombopag group (P = NS). Most patients demonstrated a long-term stable effect in the form of an increase in blood platelet count to a safe level during months and years of ATR treatment. The achievement of at least partial remission for 3 months or more was 70 and 71% in romiplostim and elthrombopag groups, respectively. Patients who started ATR- therapy are currently continuing treatment: 51% - in romiplostim group and in eltrombopag group-39%. The main reason of discontinuation the initially effective therapy were the loss of platelet response, toxicity, withdrawal from treatment (withdrawal with preservation of remission) and patients death. The tolerability of drugs with long-term admission was satisfactory. The most common AE were headache, bone pain, thrombosis, increased blood pressure and petechial hemorrhagic eruptions. The overall incidence of complications did not differ significantly between the romiplostim and eltrombopag groups -15.6 and 15.8%, respectively.
Long-term ATR-therapy using in patients with resistant chronic ITP is an effective and largely safe treatment option.
分析在实际临床实践中，艾曲泊帕乙醇胺片（ATR）治疗成人原发性难治性免疫性血小板减少症（ITP）的长期疗效和安全性。
本文包含在实际临床实践条件下对138例患者（40例男性和98例女性）应用ATR的长期结果分析，这些患者治疗开始时的中位年龄为59岁（18 - 86岁）。使用了两种ATR药物——罗米司亭（100例患者）和艾曲泊帕（38例患者）。
在治疗的第一个月，罗米司亭组的血小板计数中位数从17×10⁹ /L增加到60×10⁹ /L（9 - 600×10⁹ /L），艾曲泊帕组从16×10⁹ /L增加到56×10⁹ /L（9 - 400×10⁹ /L）。两组92%的病例达到最小反应（血小板计数超过30×10⁹ /L）。罗米司亭组和艾曲泊帕组分别有91%和84%的患者达到部分反应（血小板计数超过50×10⁹ /L）。完全反应（血小板计数增加至100×10⁹ /L以上）的发生率在罗米司亭组略高，为69%，而艾曲泊帕组为47%（P = 无显著性差异）。在数月至数年的ATR治疗期间，大多数患者表现出以血小板计数增加至安全水平形式的长期稳定效果。罗米司亭组和艾曲泊帕组至少部分缓解3个月或更长时间的比例分别为70%和71%。开始ATR治疗的患者目前仍在继续治疗：罗米司亭组为51%，艾曲泊帕组为39%。停止初始有效治疗的主要原因是血小板反应丧失、毒性、退出治疗（保留缓解状态退出）和患者死亡。长期用药的耐受性良好。最常见的不良事件是头痛、骨痛、血栓形成、血压升高和瘀点性出血疹。罗米司亭组和艾曲泊帕组并发症的总体发生率无显著差异，分别为15.6%和15.8%。
对难治性慢性ITP患者使用ATR进行长期治疗是一种有效且基本安全的治疗选择。
