Mevorach Robert A, Hulbert William C, Rabinowitz Ronald, Kennedy William A, Kogan Barry A, Kryger John V, Caldamone Anthony, Clark William R, Kaplan George W, Durkee Charles T, Elder Jack S
University of Rochester, Rochester, New York, USA.
J Urol. 2006 Jan;175(1):288-91. doi: 10.1016/S0022-5347(05)00013-3.
With no FDA approved material available for endoscopic treatment of vesicoureteral reflux, in 2001 we began a prospective multicenter trial of synthetic calcium hydroxyapatite as a subureteral bulking agent in children with traditional indications for surgical repair.
A total of 98 patients (155 ureters) with grades II to IV reflux were enrolled at 10 sites in the United States to obtain 86 patients with completed protocol end points at 3 months. Of the 86 patients 74 underwent renal and bladder ultrasonography, blood count and serum chemistry analysis, and VCUG at 1 year. A total of 46 patients (47%) completed 2-year study end points, including VCUG.
At 1 and 2 years 24 of the 74 patients (32%) were cured. Ureteral cure rates were 46% and 40% at 1 and 2 years, respectively. With 35 patients treated and 85% compliance with the required 2-year VCUG the primary center achieved 2-year cure rates of 66% of patients and 72% of ureters.
Synthetic calcium hydroxyapatite is a safe, durable and effective material for endoscopic treatment of VUR. Increased experience with the injection of synthetic calcium hydroxyapatite yields improved results.
由于尚无美国食品药品监督管理局（FDA）批准用于内镜治疗膀胱输尿管反流的材料，2001年我们启动了一项前瞻性多中心试验，研究合成羟基磷灰石作为输尿管下注射填充剂用于有传统手术修复指征的儿童患者。
美国10个地点共纳入98例（155条输尿管）Ⅱ至Ⅳ级反流患者，以获得86例在3个月时达到方案终点的患者。86例患者中，74例在1年时接受了肾脏和膀胱超声检查、血细胞计数和血清化学分析以及排尿性膀胱尿道造影（VCUG）。共有46例患者（47%）完成了2年的研究终点，包括VCUG。
在1年和2年时，74例患者中有24例（32%）治愈。输尿管治愈率在1年和2年时分别为46%和40%。主要中心治疗了35例患者，其中85%的患者完成了所需的2年VCUG，患者的2年治愈率为66%，输尿管的2年治愈率为72%。
合成羟基磷灰石是一种用于内镜治疗膀胱输尿管反流的安全、持久且有效的材料。增加合成羟基磷灰石注射的经验可取得更好的效果。
