Boyer Holly, Fernandes Patricia, Le Chap, Yueh Bevan
Department of Otolaryngology - Head and Neck Surgery, University of Minnesota Medical School, University of Minnesota, Minneapolis, MN.
Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.
Int Forum Allergy Rhinol. 2015 May;5(5):435-40. doi: 10.1002/alr.21484. Epub 2015 Feb 2.
Our previous studies have demonstrated the tolerability and low side-effect profile of office-based sclerotherapy with sodium tetradecyl sulfate (STS) for treating recurrent epistaxis due to hereditary hemorrhagic telangiectasia (HHT). The objective of this study was to use a prospective randomized trial to determine the effectiveness of sclerotherapy with STS vs standard treatment.
This prospective randomized trial (conducted from November 1, 2011, through January 31, 2014) involved 17 patients with recurrent epistaxis due to HHT. We defined standard treatment as continuation of any treatment that the patient had previously undergone, such as moisturization, packing, and cautery. We used a crossover design, so study participants were randomized to either sclerotherapy or standard treatment during the first time period, and then to the other during the second period. The primary outcome measure was frequency and severity of epistaxis, as measured by the epistaxis severity score (ESS). The ESS is a 10-point scale, with higher scores corresponding to more bleeding.
After controlling for treatment order, bleeding was substantially better controlled after sclerotherapy; the ESS after sclerotherapy was nearly one point lower than after standard treatment (-0.95, 1-sided p = 0.027). Treatment order, baseline ESS, the number of lesions, moisturization practices, and a history of previous blood transfusions did not significantly affect the results.
This trial demonstrated that sclerotherapy with STS (vs standard treatment) significantly reduced epistaxis due to HHT.
我们之前的研究已经证明,使用十四烷基硫酸钠(STS)进行门诊硬化治疗对遗传性出血性毛细血管扩张症(HHT)所致复发性鼻出血具有耐受性且副作用小。本研究的目的是通过一项前瞻性随机试验来确定STS硬化治疗与标准治疗的有效性。
这项前瞻性随机试验(于2011年11月1日至2014年1月31日进行)纳入了17例因HHT导致复发性鼻出血的患者。我们将标准治疗定义为患者先前接受过的任何治疗的延续,如保湿、填塞和烧灼。我们采用交叉设计,因此研究参与者在第一个时间段被随机分配接受硬化治疗或标准治疗,然后在第二个时间段接受另一种治疗。主要结局指标是鼻出血的频率和严重程度,通过鼻出血严重程度评分(ESS)来衡量。ESS是一个10分制量表,分数越高表示出血越多。
在控制治疗顺序后,硬化治疗后出血得到了更好的控制;硬化治疗后的ESS比标准治疗后低近1分(-0.95,单侧p = 0.027)。治疗顺序、基线ESS、病变数量、保湿措施和既往输血史对结果没有显著影响。
该试验表明,与标准治疗相比,STS硬化治疗显著减少了HHT所致的鼻出血。