本文選題：壓力性尿失禁 + 無張力尿失禁懸吊系統(tǒng)�。� 參考：《河北醫(yī)科大學(xué)》2016年碩士論文

【摘要】：目的:評價深圳邁普再生醫(yī)學(xué)科技有限公司開發(fā)的無張力尿失禁懸吊系統(tǒng)用于治療女性SUI的安全性和有效性。方法:本研究為隨機(jī)、單盲、陽性平行對照臨床試驗。符合入排標(biāo)準(zhǔn)的女性壓力性尿失禁患者18例,所有患者均由同一醫(yī)生進(jìn)行TVT-O手術(shù),兩組所用手術(shù)器械不同,其中試驗組9例,應(yīng)用深圳邁普再生醫(yī)學(xué)科技有限公司開發(fā)的無張力尿失禁懸吊系統(tǒng)(商品名:Regen Sling);對照組9例,應(yīng)用Ethicon SARL生產(chǎn)的經(jīng)閉孔經(jīng)陰道前壁尿道懸吊器(商品名:TVT-O)。比較兩組手術(shù)時間、手術(shù)出血量、術(shù)后疼痛VAS評分、術(shù)后留置尿管時間、術(shù)后殘余尿、術(shù)后血常規(guī)、術(shù)后住院時間、生活質(zhì)量(尿失禁影響問卷簡版IIQ-7)評分、性生活質(zhì)量(盆腔臟器脫垂/尿失禁性功能問卷PISQ-12)評分及是否有侵蝕等并發(fā)癥,明確兩組療效是否存在差異以評價實驗組產(chǎn)品療效。結(jié)果:RS組與ES組患者的年齡、漏尿時間、術(shù)前WBC、1小時尿墊試驗、生活質(zhì)量評分、性生活質(zhì)量評分、既往腹部及盆底手術(shù)史等基本情況差異無統(tǒng)計學(xué)意義{53.33歲(37-64歲)與54.78歲(43-64歲),P0.05;6.18年(2-20年)與9.22年(2-27年),P0.05;6.65*109/L(5.09-9.80*109/L)與6.28*109/L(5.15-8.58*109/L),P0.05;54.32g(9.8-170.4g)與38.94g(3.4-140.7g),P0.05;18.67分(9-27分)與15.33分(9-25分),P0.05;40.67分(30-49分)與42.67分(32-53分),P0.05;66.67%(6/9)與33.33%(3/9),P0.05};RS組與ES組手術(shù)時間、手術(shù)出血量、術(shù)中并發(fā)癥發(fā)生率、術(shù)后疼痛VAS評分、尿管留置時間、術(shù)后殘余尿、術(shù)后血常規(guī)、術(shù)后住院天數(shù)等臨床資料差異無統(tǒng)計學(xué)意義{43.67分鐘(30-70分鐘)與43.67分鐘(30-170分鐘),P0.05;5.78ml(1-20ml)與4.67ml(1-6ml),P0.05;0與11.11%,P0.05;3.78分(2-6分)與4.67分(2-7分),P0.05;1.11d(1-2d)與2.00d(1-6d),P0.05;59.00ml(0-298ml)與138.78ml(0-630ml),P0.05;10.58*109/L(6.43-16.75*109/L)與9.72*109/L(5.92-12.59*109/L),P0.05;2.22d(1-4d)與2.78d(2-7d),P0.05};RS組與ES組術(shù)后3月隨訪生活質(zhì)量評分、并發(fā)癥發(fā)生率差異無統(tǒng)計學(xué)意義{8.73分(7-56分)與7.56分(7-12分),P0.05;66.67%與66.67%,P0.05};RS組與ES組術(shù)后6月隨訪生活質(zhì)量評分、性生活質(zhì)量評分、并發(fā)癥發(fā)生率差異無統(tǒng)計學(xué)意義{7.67分(7-13分)與7.00分(7-7分),P0.05;43.67分(36-58分)與41.22分(36-50分),P0.05;22.22%與33.33%,P0.05};RS組與ES組術(shù)后9月隨訪生活質(zhì)量評分、性生活質(zhì)量評分、并發(fā)癥發(fā)生率差異無統(tǒng)計學(xué)意義{7.00分(7-7分)與7.00分(7-7分);40.00分(36-58分)與39.67分(36-52分),P0.05;22.22%與33.33%,P0.05};治愈率:RS組與ES組差異無統(tǒng)計學(xué)差異{88.89%(8/9)與77.78%(7/9),P0.05};改善率:RS組與ES組差異無統(tǒng)計學(xué)差異{100%(9/9)與88.89%(8/9),P0.05};失敗率:RS組與ES組差異無統(tǒng)計學(xué)差異{0%(0/9)與11.11%(1/9),P0.05};有效率:RS組與ES組差異無統(tǒng)計學(xué)差異{100%(9/9)與88.89%(8/9),P0.05};不良事件發(fā)生率:RS組與ES組差異無統(tǒng)計學(xué)差異{66.67%(6/9)與66.67%(6/9),P0.05}。結(jié)論:1深圳邁普再生醫(yī)學(xué)科技有限公司開發(fā)的無張力尿失禁懸吊系統(tǒng)Regen Sling用于治療女性SUI安全、有效。2 TVT-O手術(shù)用于治療女性SUI有效率高,但不良事件發(fā)生率也高,手術(shù)醫(yī)生需慎重選擇適應(yīng)癥病人進(jìn)行治療,治療前需向患者詳細(xì)交代手術(shù)療效與風(fēng)險。
[Abstract]:Objective: To evaluate the development of recycled Shenzhen Maipu Medical Technology Co Ltd tension-free incontinence suspension system is safe and effective for the treatment of female SUI. Methods: This study was a randomized, single blind, positive parallel controlled clinical trial. With female stress urinary incontinence patients discharge standard in 18 cases, all patients were TVT-O operation by the same doctor, two groups with different surgical instruments, 9 cases in test group, application of Shenzhen development of medical science and Technology Co Ltd Maipu regeneration tension-free incontinence suspension system (trade name: Regen Sling); the control group of 9 cases, using Ethicon SARL production of transobturator urethral suspension anterior vaginal wall (trade name: TVT-O). Between the two groups in operation time, bleeding volume, postoperative pain VAS score, postoperative indwelling catheter time, residual urine after operation, postoperative blood routine, hospitalization time after operation, the quality of life (incontinence impact questionnaire short version of I IQ-7)璇勫垎,鎬х敓媧昏川閲，

本文編號：1735814