University of Alberta, Faculty of Medicine, Edmonton, AB, Canada.
Department of Surgery, Division of Otolaryngology-Head and Neck Surgery, University of Alberta, Edmonton, AB, Canada.
J Otolaryngol Head Neck Surg. 2018 Jan 8;47(1):3. doi: 10.1186/s40463-017-0248-5.
Epistaxis is the most common emergent consultation to otolaryngology-head & neck surgery (OHNS) and with 60% of the population having experienced an episode and 1.6 in 10,000 requiring hospitalization in their lifetime. In preliminary studies Floseal® (Baxter, USA) Hemostatic Matrix has shown efficacy in up to 80% of persistent anterior epistaxis. We sought to evaluate the clinical efficacy and cost-effectiveness of Floseal® (Baxter, USA) compared to traditional nasal packing for persistent epistaxis.
A prospective, randomized controlled trial was conducted on all adult patients consulted to the OHNS service at the tertiary referral centers of the University of Alberta Hospital and Royal Alexandra Hospital for persistent epistaxis. Patients were randomized to the Floseal® (Baxter, USA) or traditional packing study arms. Our main clinical outcome measures were: 1) Hemostasis directly following treatment and at 48 h post-treatment, and 2) self-reported patient comfort at 48 h post-treatment. Further, trial data was used for a formal cost-effectiveness analysis to determine incremental cost-effectiveness ratio (ICER). Univariate sensitivity analysis and uncertainty analysis were performed.
There were no significant differences between groups for initial hemostasis (76.9% vs. 84.6%, p = 1.000) or, hemostasis at 48 h (76.9% vs. 69.2%, p = 1.000), requirement for admission (15.4% vs. 46.1%, p = 0.2016) or 30-day re-presentation rates (15.4% vs. 46.1%, p = 0.2016). Floseal® (Baxter, USA) was superior for decreased pain during placement (2.42 vs. 7.77, p = 0.0022), treatment (0.50 vs. 4.46, p = 0.0007) and removal (0 vs. 3.85, p = 0.0021). Floseal® (Baxter, USA) provides an average $1567.61 per patient savings from the single-payer system point of view and has an ICER of - $11,891 per re-bleed prevented (95% CI: -$37,658 to +$473). Uncertainty analysis shows that Floseal® has >90% chance of not only being cost-effective, but the dominant (preferred) treatment.
Floseal® (Baxter, USA) was demonstrated to be an effective, comfortable and cost-effective alternative treatment of persistent epistaxis when compared to traditional packing methods for patients referred to OHNS with a normal coagulation profile.
Trial registration number: NCT02488135 . Date registered: June 26, 2015.
鼻出血是耳鼻喉头颈外科（OHNS）最常见的急诊情况，60%的人群经历过鼻出血，其中 1.6/10000 人在其一生中需要住院治疗。在初步研究中，Floseal®（百特，美国）止血基质在多达 80%的持续性前鼻出血患者中显示出疗效。我们旨在评估 Floseal®（百特，美国）与传统鼻腔填塞治疗持续性鼻出血的临床疗效和成本效益。
对所有在艾伯塔大学医院和皇家亚历山德拉医院三级转诊中心就诊的 OHNS 服务持续性鼻出血患者进行前瞻性、随机对照试验。患者随机分为 Floseal®（百特，美国）或传统填塞研究组。我们的主要临床结局指标是：1）治疗后即刻和治疗后 48 小时的止血情况，2）治疗后 48 小时患者的自我报告舒适度。此外，试验数据用于正式的成本效益分析，以确定增量成本效益比（ICER）。进行了单变量敏感性分析和不确定性分析。
两组在初始止血方面（76.9% vs. 84.6%，p=1.000）或 48 小时止血方面（76.9% vs. 69.2%，p=1.000）、住院需求（15.4% vs. 46.1%，p=0.2016）或 30 天再就诊率（15.4% vs. 46.1%，p=0.2016）方面无显著差异。Floseal®（百特，美国）在放置时（2.42 分 vs. 7.77 分，p=0.0022）、治疗时（0.50 分 vs. 4.46 分，p=0.0007）和移除时（0 分 vs. 3.85 分，p=0.0021）疼痛减轻方面具有优势。从单一支付者系统的角度来看，Floseal®（百特，美国）可为每位患者节省 1567.61 加元，并且每防止一次再出血的增量成本效益比为-11891 加元（95%CI：-37658 至 +473）。不确定性分析表明，Floseal®（百特，美国）不仅具有成本效益，而且具有 90%以上的可能性成为首选治疗方法。
与传统填塞方法相比，Floseal®（百特，美国）对于凝血功能正常的 OHNS 就诊患者的持续性鼻出血是一种有效、舒适且具有成本效益的替代治疗方法。
试验注册号：NCT02488135。登记日期：2015 年 6 月 26 日。
