Shirazi Mehdi, Khezri Abdolaziz, Samani Soleiman Mohammadi, Monabbati Ahmad, Kojoori Javad, Hassanpour Abbas
Department of Surgery, Division of Urology, Shiraz University of Medical Sciences, Faghihi Hospital, Zand Avenue, 71345-51154 Shiraz, Iran.
Int J Urol. 2007 Mar;14(3):203-8. doi: 10.1111/j.1442-2042.2007.01693.x.
The purpose of this study is to evaluate the effect of intraurethral captopril gel as an antifibrotic agent on patients with urethral stricture.
In the first phase of clinical trial, 13 rabbits were included and local side-effects of captopril gel were evaluated. In the second phase, 56 patients were enrolled from April 2004 to January 2006. After internal urethrotomy the patients were classified into three patient groups: (i) received placebo gel (group I); (ii) received 0.1% captopril gel (group II); and (iii) instilled 0.5% captopril gel intraurethrally (group III).
In phase I, no significant local side-effects were seen in the urethra of rabbits. In phase II, the mean age of the patients was 39.5 and the mean follow-up duration was 16 months. The most common etiology of the urethral stricture in the patients was iatrogenic (35.7%), most of their strictures had a depth of 0.5 cm or less (67.8%), and the length of most strictures was between 1 and 2 cm (41.1%). The patients' maximum urine flow increased more in groups II and III, than in group I (P < 0.04, P < 0.05, respectively). The recurrence rate was less in groups II and III than in group I (P < 0.05). In terms of the maximal urine flow and recurrence rate, no significant difference was seen between group II and group III (P = 0.13, P = 0.21, respectively).
Captopril gel is a safe, effective and non-toxic agent for decreasing the recurrence rate of the urethral stricture after internal urethrotomy. However, more studies, including more cases and a longer follow up, are needed to prove the effect of captopril gel on patients' urethra.
本研究旨在评估尿道内应用卡托普利凝胶作为抗纤维化药物对尿道狭窄患者的疗效。
在临床试验的第一阶段，纳入13只兔子，评估卡托普利凝胶的局部副作用。在第二阶段，从2004年4月至2006年1月纳入56例患者。经尿道内切开术后，将患者分为三组：（i）接受安慰剂凝胶（第一组）；（ii）接受0.1%卡托普利凝胶（第二组）；（iii）经尿道内注入0.5%卡托普利凝胶（第三组）。
在第一阶段，兔子尿道未观察到明显的局部副作用。在第二阶段，患者的平均年龄为39.5岁，平均随访时间为16个月。患者尿道狭窄最常见的病因是医源性（35.7%），大多数狭窄深度为0.5 cm或更浅（67.8%），大多数狭窄长度在1至2 cm之间（41.1%）。第二组和第三组患者的最大尿流增加量比第一组更多（分别为P < 0.04，P < 0.05）。第二组和第三组的复发率低于第一组（P < 0.05）。在最大尿流和复发率方面，第二组和第三组之间未观察到显著差异（分别为P = 0.13，P = 0.21）。
卡托普利凝胶是一种安全、有效且无毒的药物，可降低经尿道内切开术后尿道狭窄的复发率。然而，需要更多的研究，包括更多病例和更长时间的随访，以证实卡托普利凝胶对患者尿道的疗效。
