Stenberg A, Läckgren G
Department of Pediatric Surgery, University Children's Hospital, Uppsala, Sweden.
J Urol. 1995 Aug;154(2 Pt 2):800-3. doi: 10.1097/00005392-199508000-00127.
We investigated the safety and clinical effects of a new biocompatible, biodegradable treatment, the Deflux system (dextranomer microspheres in sodium hyaluronan solution), for the endoscopic treatment of grades III and IV vesicoureteral reflux. In preclinical safety studies in pigs histopathological examination demonstrated excellent tolerance. Two weeks after submucous implantation in the pig bladder early ingrowth of fibroblasts and recently generated collagen were noted at the implantation sites. At 14 weeks of followup this ingrowth had slightly increased. Long-term followup in rats showed that the volume of subcutaneous implants was slightly reduced (23%) 1 year after implantation. In a clinical study we investigated the implantation technique and the short (3 months) and long-term (1 year) effects of Deflux implantation in 75 children (101 ureters) with grades III and IV vesicoureteral reflux. We report data from up to 3 months of followup. Implant volumes of 0.4 to 1.0 ml. were sufficient to create distinct boluses and crescent-like ureteral orifices. Although viscous, due to its viscoelastic properties the substance was easy to inject in a well controlled manner. At cystography 3 months later reflux had resolved in 68% of implants, was reduced to grades I and II in 13% of implants and was unchanged in 19% of treated ureters (grades III and IV reflux). No signs of ureteral obstruction or adverse reactions were noted. Results from 1 year of followup will be reported later. Our results indicate that the dextranomer microspheres act as micro-carriers that promote ingrowth of fibroblasts and generate new collagen. We conclude that the Deflux system may represent a new, safe, simple alternative to endoscopic treatment of vesicoureteral reflux in children.
我们研究了一种新型生物相容性、可生物降解的治疗方法——Deflux系统（透明质酸钠溶液中的葡聚糖微球）用于内镜治疗III级和IV级膀胱输尿管反流的安全性和临床效果。在猪的临床前安全性研究中，组织病理学检查显示耐受性良好。在猪膀胱黏膜下植入两周后，植入部位可见成纤维细胞早期长入和新生成的胶原。随访14周时，这种长入略有增加。大鼠的长期随访显示，皮下植入物的体积在植入1年后略有减少（23%）。在一项临床研究中，我们调查了75例患有III级和IV级膀胱输尿管反流的儿童（101条输尿管）的Deflux植入技术以及短期（3个月）和长期（1年）效果。我们报告了长达3个月的随访数据。0.4至1.0毫升的植入体积足以形成明显的团块和新月形输尿管口。尽管该物质具有粘性，但由于其粘弹性，易于以良好控制的方式注射。3个月后的膀胱造影显示，68%的植入物反流消失，13%的植入物流体反流减少至I级和II级，19%的治疗输尿管（III级和IV级反流）反流无变化。未发现输尿管梗阻迹象或不良反应。1年随访结果将在以后报告。我们的结果表明，葡聚糖微球起到微载体的作用，促进成纤维细胞长入并生成新的胶原。我们得出结论，Deflux系统可能是儿童膀胱输尿管反流内镜治疗的一种新的、安全、简单的替代方法。
