Tarantino Michael D, Fogarty Patrick F, Shah Palvi, Brainsky Andrés
Department of Pediatric Hematology/Oncology, The Bleeding and Clotting Disorders Institute, University of Illinois College of Medicine-Peoria , IL , USA .
Platelets. 2015;26(1):93-6. doi: 10.3109/09537104.2013.870333. Epub 2014 Jan 16.
Primary immune thrombocytopenia (ITP) is an autoimmune disease characterized by chronically low peripheral blood platelet counts. Eltrombopag is an oral, non-peptide, thrombopoietin-receptor agonist that increases platelet production. This report examines peri-procedural platelet counts and bleeding complications among chronic ITP patients requiring dental procedures while participating in clinical studies with eltrombopag. A total of 494 patients participated in five clinical studies of eltrombopag in chronic ITP. Information about dental procedures was collected prospectively in four studies and retrospectively in one study. Twenty-four patients (22 eltrombopag, 2 placebo) underwent 32 dental procedures (dental cleaning, tooth repair, artificial crown, dental prosthesis, tooth extraction, dental or wisdom teeth extraction, dental root extraction, and endodontic procedures, among others) during study treatment or up to 10 days later. Supplemental ITP therapy (e.g., corticosteroids, platelet transfusions) was given before the dental procedure to increase platelet counts in three eltrombopag-treated patients and both placebo-treated patients. The mean pre-procedure platelet count ± standard deviation for all procedures in the overall population of patients, eltrombopag group, and placebo group prior to undergoing dental procedures was 96 000 ± 81 069/µl,103 517 ± 81 522/µl, and 23 333 ± 9291/µl, respectively. Two patients in each group had platelet counts below 30 000/µl before the procedure. No patient who had a dental procedure experienced a bleeding adverse event. Among patients with chronic ITP who required a dental procedure during clinical studies of eltrombopag, supplemental ITP treatment was required for both patients who received placebo but was not required for most patients who received eltrombopag. No bleeding complications were reported. These data imply that patients with chronic ITP who receive eltrombopag and experience increases in platelet counts fulfill current pre-procedural platelet count recommendations to undergo invasive dental procedures, and may have a lower risk of bleeding complications and a reduced need for supplemental ITP treatment.
原发性免疫性血小板减少症（ITP）是一种自身免疫性疾病，其特征为外周血血小板计数长期偏低。艾曲泊帕是一种口服非肽类血小板生成素受体激动剂，可增加血小板生成。本报告探讨了在参与艾曲泊帕临床研究的慢性ITP患者中，进行牙科手术期间的围手术期血小板计数及出血并发症情况。共有494例患者参与了五项关于艾曲泊帕治疗慢性ITP的临床研究。四项研究前瞻性收集了牙科手术相关信息，一项研究为回顾性收集。24例患者（22例接受艾曲泊帕治疗，2例接受安慰剂治疗）在研究治疗期间或之后长达10天内接受了32项牙科手术（包括洗牙、补牙、镶牙、安装假牙、拔牙、拔除恒牙或智齿、拔除牙根以及牙髓治疗等）。在牙科手术前，对3例接受艾曲泊帕治疗的患者和2例接受安慰剂治疗的患者给予了补充性ITP治疗（如皮质类固醇、血小板输注）以提高血小板计数。在接受牙科手术的所有患者总体人群、艾曲泊帕组和安慰剂组中，术前血小板计数的平均值±标准差分别为96000±81069/µl、103517±81522/µl和23333±9291/µl。每组各有2例患者术前血小板计数低于30000/µl。接受牙科手术的患者均未发生出血不良事件。在艾曲泊帕临床研究期间需要进行牙科手术的慢性ITP患者中，接受安慰剂治疗的患者均需要补充性ITP治疗，而接受艾曲泊帕治疗的大多数患者则无需补充。未报告出血并发症。这些数据表明，接受艾曲泊帕治疗且血小板计数增加的慢性ITP患者符合目前进行侵入性牙科手术的术前血小板计数建议，并且出血并发症风险可能较低，对补充性ITP治疗的需求也减少。
