镍钛形状记忆合金编织管状支架X射线与膀胱镜下前列腺置入与宿主的生物相容性特点

Endourethral Ni-Ti alloy stenting under X-ray or cystoscope for prostatic hyperplasia: Biocompatibility to host

背景：前列腺增生治疗的金标准目前仍是经尿道前列腺电切术，但并非所有的患者都适合采用该种手术方式。前列腺支架作为一种暂时或者永久解除前列腺段尿路梗阻的方法是泌尿外科领域一种相对较新的方法，由于具有受患者身体状况影响小、操作简单、疗效确切等优点被各国泌尿外科前列腺治疗指南列为可选择的治疗手段之一。目的：分析镍钛合金支架置入治疗合并心脑血管疾病等高危前列腺增生的效果及其不同技术操作与其生物相容性特点。设计、时间及地点：回顾性分析2002-10/2006-04昆明医学院第一附属医院泌尿外科的病例资料。对象：选择在局部麻醉状态下行前列腺镍钛合金支架置入治疗合并心脑血管等高危疾病的前列腺增生老年患者41例。平均年龄（81.7±7.4）岁。方法：采用南京微创医学科技有限公司生产的MTN型镍钛形状记忆合金编织管状支架，配备膀胱镜或X射线定位置入器。其中27例为透视尿道造影条件下置入，14例为膀胱镜下置入。主要观察指标：①两种方法支架置入后与宿主生物相容性的反应。②支架置入前后前列腺症状评分、残余尿量和最大尿流率。结果：41例中2例放置失败，38例接受随访6-36个月。①27例X射线透视尿道造影条件下一次置入成功。2例术后3个月内反复尿路感染，经治疗痊愈。1例术后发生较严重血尿，置入后约1个月尿道黏膜覆盖支架后自然消失。3例不能正常排尿予以留置14F气囊导尿管，并予口服α受体阻滞剂拔除尿管后小便能自解。1例终身膀胱造瘘。②14例膀胱镜下置入病例中2例发生前列腺支架脱落入膀胱，其中1例经手术后取出并同时行前列腺绿激光气化术，1例行开放手术并同时行前列腺摘除术。4例术后反复尿路感染。1例术后发生较严重的血尿，置入后约1个月尿道黏膜覆盖支架后自然消失。5例不能正常排尿予以留置14F气囊导尿管，并予口服α受体阻滞剂，3d后拔除尿管。1例始终不能正常排尿，改行终生膀胱造瘘。③支架置入后IPSS评分由（27.19±3.56）分减少到（8.34±4.54）分，差异有显著性意义（P〈0.01），最大尿流率从0mL/s增加到（12.48±3.36）mL/s，差异有显著性意义（P〈0.01）。结论：镍钛合金网状支架置入组织相容性好、治疗效果好、严重并发症少。X射线定位置入法优于膀胱镜置入法。

BACKGROUND： Transurethral resection of prostate is the golden standard for hyperplasia of prostate gland, but this therapy is not suitable for some patients, Prostate scaffold as a novel temporary or permanent therapy in urinary surgery for obstruction in prostate gland has been regarded as one option for prostate gland treatment because its simple operation, not rigorously limition by patient physical condition and precise treatment effect. OBJECTIVE： To evaluate the curative effect, biocompatibility and technology of endourethral Ni-Ti alloy stent in treating high risk patients with hyperplasia of prostate gland. DESIGN, TIME AND SETTING： We retrospectively analyzed the data of patients in Department of Urinary Surgery, First Affiliated Hospital of Kunming Medical College from October 2002 to April 2006. PARTICIPANTS： Forty-one elderly patients with hyperplasia of prostate gland complicated by cardio-cerebrovascular disease, who underwent endourethral Ni-Ti alloy stenting （Micro-tech, Nanjing） under local anesthesia, were selected, with an average age of （81.7±7.4） years. METHODS： MTN endourethral Ni-Ti alloy stenting was implanted in 41 patients assisted by cystoscope or X-ray. Twenty-seven underwent surgery under urethrography and 14 patients under cystoscope. MAIN OUTCOME MEASURES： （1）Biocompatibility of scaffold with host by two implantation methods; （2）Prostate gland scoring, residual urine volume and maximum urine flow rate. RESULTS： Among 41 cases, 2 failed to implant, and 38 were followed up for 6-36 months. Twenty-seven undergoing surgery under urethrography was one-off successful. Two patients developed urinary tract infection within 3 months and cured completely; one developed severe blood urine, and disappeared about 1 month later after urinary mucosa covering on the scaffold; three cases sustained abnormal urination, and treated by 14F balloon urethral catheter and α receptor block agent; one developed permanent abnormal urination and treated by bladder stoma. Of the 14 patients undergoing endourethral Ni-Ti alloy stenting under cystoscope, the scaffolds of 2 cases shed in bladder： 1 was taken out by surgery and treated by prostate green laser gasification, and 1 was treated by open surgery and prostatectomy; 4 developed repetitive urinary tract infection; 1 developed severe blood urine, and disappeared about 1 month later after urinary mucosa covering on the scaffold; 5 sustained abnormal urination, and treated by 14F balloon urethral catheter and α receptor block agent; 1 developed permanent abnormal urination and treated by bladder stoma. The scores in IPSS was significantly decreased from （27.19±3.56） to （8.34±4.54） after stent implantation （P 〈 0.01）, and the maximum urine flow rate significantly increased from 0 mL/s to （12.48±3.36） mL/s （P 〈 0.01）. CONCLUSION： Eendourethral Ni-Ti alloy stent in treating high risk patients with prostatic hyperplasia is effective, with a good histocompatibility and rare severe complications. In addition, X-ray location is superior to cystoscope.