Kobelt Gisela, Canning Douglas A, Hensle Terry W, Läckgren Göran
HDI France, Spéracèdes, France.
J Urol. 2003 Apr;169(4):1480-4; discdussion 1484-5. doi: 10.1097/01.ju.0000056638.75652.54.
Vesicoureteral reflux is a risk factor for progressive renal damage associated with urinary tract infection. Mild to moderate reflux is routinely treated with long-term antibiotic prophylaxis to prevent recurrent infections and open surgical reimplantation for breakthrough infections despite antibiotic therapy. Endoscopic subureteral injection of implant material is a therapeutic alternative to long-term prophylaxis and open surgery but its widespread use in the United States has been prevented by the lack of a stable implant material. Dextranomer/hyaluronic acid copolymer has been shown to be a safe, effective and durable implant material and was recently approved in the United States. We estimate the effect on costs and cure rates of introducing endoscopic injection with dextranomer/hyaluronic acid copolymer as a treatment alternative in the United States.
We constructed a model that mimics current clinical practice of vesicoureteral reflux treatment for 6 years, and incorporates spontaneous resolution and surgical intervention rates obtained from 2 long-term followup studies. The treatment algorithm was established using medical data from the literature, and clinical management practices from a Delphi survey of 27 pediatric urologists and nephrologists across the United States. Endoscopic injection was introduced into the model as replacement to surgery or alternative to long-term antibiotic prophylaxis. The effectiveness of dextranomer/hyaluronic acid copolymer was calculated from 140 patients (208 ureters) with grade III reflux treated in a clinical study of 221 children in Sweden.
With current practice, the average cost per patient in 6 years was 6,640 US dollars and 23.5% of patients continued to have reflux. Replacing open surgery with endoscopic injection led to similar cure rates (22.2% failures) but costs were reduced to 5,522 US dollars. When injection was performed after 1 year of antibiotic therapy failure rates were reduced to 8.5% but costs increased to 7,644 US dollars.
Our results show that a persistent approach to endoscopic surgery can be expected to result in overall success that equals or exceeds open surgery at a lower cost. This finding is particularly true if open reimplant is reserved for patients with high grade or persistent vesicoureteral reflux.
膀胱输尿管反流是与尿路感染相关的进行性肾损害的危险因素。轻度至中度反流通常采用长期抗生素预防治疗，以防止反复感染；对于尽管进行了抗生素治疗仍出现突破性感染的情况，则采用开放性手术再植术。内镜下输尿管下注射植入材料是长期预防和开放手术的一种治疗替代方法，但由于缺乏稳定的植入材料，其在美国尚未得到广泛应用。葡聚糖omer/透明质酸共聚物已被证明是一种安全、有效且持久的植入材料，最近在美国获得批准。我们估计了在美国将葡聚糖omer/透明质酸共聚物内镜注射作为一种治疗选择引入后对成本和治愈率的影响。
我们构建了一个模拟膀胱输尿管反流治疗当前临床实践6年的模型，并纳入了从2项长期随访研究中获得的自然缓解率和手术干预率。治疗算法是根据文献中的医学数据以及对美国27名儿科泌尿科医生和肾病学家进行的德尔菲调查中的临床管理实践建立的。内镜注射被引入模型，以替代手术或作为长期抗生素预防的替代方法。葡聚糖omer/透明质酸共聚物的有效性是根据瑞典一项对221名儿童进行的临床研究中治疗的140例III级反流患者（208条输尿管）计算得出的。
按照当前的治疗方法，6年内每位患者的平均成本为6640美元，23.5%的患者仍有反流。用内镜注射替代开放性手术可获得相似的治愈率（失败率为22.2%），但成本降至5522美元。在抗生素治疗1年后进行注射，失败率降至8.5%，但成本增至7644美元。
我们的结果表明，持续采用内镜手术有望以较低成本取得等于或超过开放性手术的总体成功率。如果将开放性再植术保留给高级别或持续性膀胱输尿管反流患者，这一发现尤其正确。
