德國殷格翰2019年7月10日 /美通社/ -- 勃林格殷格翰公司在澳大利亞墨爾本舉行的2019年國際血栓與止血學(xué)會（ISTH）年會上，對外公布了兩項使用達(dá)比加群治療兒童疾病的研究結(jié)果。[1],[2]
研究數(shù)據(jù)顯示，在治療兒童急性靜脈血栓栓塞（VTE）時，達(dá)比加群與目前的標(biāo)準(zhǔn)療法（SOC）擁有相似的療效與安全性。[1]另一項研究同樣證實了達(dá)比加群良好的安全性，這項研究首次評估了采用直接口服抗凝劑（DOAC）在存在持續(xù)性VTE風(fēng)險因素的兒童中預(yù)防復(fù)發(fā)性VTE的效果。[2]
目前，用于治療與預(yù)防兒童復(fù)發(fā)性VTE的標(biāo)準(zhǔn)療法存在一定的局限性，包括需要頻繁監(jiān)測與非口服給藥等。[2]上述針對達(dá)比加群的全新研究旨在為對VTE患兒及存在VTE復(fù)發(fā)風(fēng)險的兒童采用抗凝治療提供更多的洞見與專業(yè)知識。
勃林格殷格翰公司副總裁、心血管代謝領(lǐng)域臨床開發(fā)負(fù)責(zé)人Martina Bruckmann教授說：“多年來，VTE的診斷率與發(fā)病率都在急劇上升，兒童VTE的發(fā)病率很高。盡管目前我們擁有治療VTE的相關(guān)療法，但兒童患者仍需獲得有效、安全與更加便捷的治療選擇。因此，我們旨在研究達(dá)比加群在成人VTE患者中被證實的安全性與療效是否同樣適用于兒童患者。令人鼓舞的是，這些研究表明達(dá)比加群在兒童復(fù)發(fā)性VTE的潛在治療與預(yù)防上具有相似的安全性與療效?！?/p>
達(dá)比加群（泰畢全，Pradaxa）尚未在任何國家獲批用于治療VTE患兒。上述研究反映了勃林格殷格翰公司始終致力于拓展血栓疾病治療領(lǐng)域的科學(xué)知識。廣泛的RE-VOLUTION®臨床試驗項目已充分證實達(dá)比加群在成人患者中的安全性與療效，并擁有大量臨床試驗數(shù)據(jù)。[3]-[4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25]
參考文獻(xiàn)
[1] Albisetti M. et al. Efficacy and Safety of Dabigatran Etexilate for Treatment of Venous Thromboembolism in Paediatric Patients - Results of the DIVERSITY Trial. Abstract number: OC 57.3. Special Issue: Abstracts of the XXVII Congress of the International Society on Thrombosis and Haemostasis. 2019;03(S1):139-140.
[2] Brandao L. et al. Safety of Dabigatran Etexilate for Secondary Prevention of Venous Thromboembolism in Paediatric Patient. Abstract number: OC 57.1. Special Issue: Abstracts of the XXVII Congress of the International Society on Thrombosis and Haemostasis. 2019;03(S1):138-139.
[3] Connolly SJ. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51.
[4] Connolly SJ. et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875-76.
[5] Connolly SJ. et al. Additional Events in the RE-LY Trial. N Engl J Med. 2014;371:1464–5.
[6] Connolly SJ. et al. The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study. Circulation. 2013;128:237–43.
[7] Ezekowitz MD. et al. Long-term evaluation of dabigatran 150 vs. 110 mg twice a day in patients with non-valvular atrial fibrillation. Europace. 2016;18:973–8.
[8] Cannon CP. et al. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. N Engl J Med. 2017;377:1513–24.
[9] Calkins H. et al. Uninterrupted Dabigatran versus Warfarin for Ablation in Atrial Fibrillation. N Engl J Med. 2017;376:1627–36.
[10] Pollack CV. et al. Idarucizumab for Dabigatran Reversal - Full Cohort Analysis. N Engl J Med. 2017;377:431–41.
[11] Pollack CV. et al. Idarucizumab for Dabigatran Reversal. N Engl J Med. 2015;373:511–20.
[12] Eriksson BI. et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thomb Haemost. 2007;5:2178–85.
[13] RE-MOBILIZE Writing Committee. et al. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Arthroplasty. 2009;24:1–9.
[14] Eriksson BI. et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007;370:949–56.
[15] Eriksson BI. et al. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II*). A randomised, double-blind, non-inferiority trial. Thromb Haemost. 2011;105:721–9.
[16] Schulman S. et al. Dabigatran versus Warfarin in the Treatment of Acute Venous Thromboembolism. N Engl J Med. 2009;361:2342–52.
[17] Schulman S. et al. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014;129:764–72.
[18] Schulman S. et al. Extended Use of Dabigatran, Warfarin, or Placebo in Venous Thromboembolism. N Engl J Med. 2013;368:709–18.
[19] Eikelboom JW. et al. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013;369:1206–14.
[20] Diener HC. et al. Design of Randomized, double-blind, Evaluation in secondary Stroke Prevention comparing the EfficaCy and safety of the oral Thrombin inhibitor dabigatran etexilate vs. acetylsalicylic acid in patients with Embolic Stroke of Undetermined Source (RE-SPECT ESUS). Int J Stroke. 2015;10:1309–12.
[21] Ferro. JM. et al. Randomized evaluation of the safety and efficacy of dabigatran etexilate versus dose adjusted warfarin in patients with cerebral venous thrombosis (RE-SPECT CVT). Presented on Tuesday 10 May at the 2nd European Stroke Organisation Conference 2016, Barcelona, Spain.
[22] Ageno W. et al. RE-COVERY DVT/PE: Rationale and design of a prospective observational study of acute venous thromboembolism with a focus on dabigatran etexilate. Thromb Haemost. 2017;117:415–21.
[23] Huisman MV. et al. The Changing Landscape for Stroke Prevention in AF: Findings From the GLORIA-AF Registry Phase 2. J Am Coll Cardiol. 2017;69:777–85.
[24] Huisman MV. et al. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation.
Am Heart J.2014;167:329–34.
[25] RE-VECTO Surveillance Program: Evaluating the use of idarucizumab in a real-world setting. Available at: https://www.re-vecto.com/
