德舒妥与胜舒两件式结肠造口袋安全性有效性的探索性随机对照研究  

Efficacy and Safety of DeShuTuo Versus Sensura Two-Piece Ostomy Appliance in Colostomy:A Randomized,Open-Label,Parallel,Positive-Controlled,Multicenter,Non-Inferiority Clinical Trial

作　　者：许文婷[1] 谌永毅[2] 谢玲女[3] 郑美春[4] 张洁 叶新梅[6] 高艳秋[7] XU Wen-ting;CHEN Yong-yi;XIE Ling-nv;ZHENG Mei-chun;ZHANG Jie;YE Xin-mei;GAO Yan-qiu(The Second Affiliated Hospital of Suzhou University,Jiangsu Suzhou 215000;Hunan Cancer Hospital,Hunan Changsha 410000;Zhejiang Cancer Hospital,Zhejiang Hangzhou 310000;Sun Yat-sen University Cancer Center,Guangdong Guangzhou 510000;Shaanxi Cancer Hospital,Shaanxi Xi’an 710000;The Sixth Affiliated Hospital of Sun Yat-sen University,Guangdong Guangzhou 510000;Shandong Provincial Hospital,Shandong Jinan 250000)

机构地区：[1]苏州大学附属第二医院,江苏苏州215000 [2]湖南省肿瘤医院,湖南长沙410000 [3]浙江省肿瘤医院,浙江杭州310000 [4]中山大学肿瘤防治中心,广东广州510000 [5]陕西省肿瘤医院,陕西西安710000 [6]中山大学附属第六医院,广东广州510000 [7]山东省立医院,山东济南250000

出　　处：《中国医疗器械信息》2024年第19期139-143,共5页China Medical Device Information

摘　　要：目的:评价德舒妥两件式造口袋在结肠造口患者中的有效性、安全性,以及其是否非劣效于胜舒两件式造口袋。方法:随机、开放、平行、阳性对照、多中心、非劣效性临床试验。纳入73名肠造口患者,随机使用德舒妥或胜舒两件式造口袋。主要观察指标为造口周围皮炎未发生率,次要观察指标包括底盘渗漏程度、造口底盘平均使用时间、患者满意度。结果:观察组造口周围未发生皮炎的比例为69.4%(95%CI,51.9%~83.7%),对照组造口周围未发生皮炎的比例为66.7%(95%CI,49.0%~81.4%),两组间无统计学差异(P=0.8219)。两组间在底盘渗漏评分、造口底盘使用时间、受试者满意度、不良事件方面均无统计学差异。结论:与胜舒两件式造口袋相比,德舒妥两件式造口袋在造口周围皮炎、底盘渗漏程度、造口底盘使用时间以及患者满意度方面具有非劣效性。Objective:To evaluate the efficacy and safety of DeShuTuo two-piece ostomy appliance in patients with colostomies and whether they are non-inferior to Sensura two-piece ostomy appliance.Methods:A randomized,open,parallel,positive-controlled,multicenter,noninferiority trial was conducted in 73 patients with colostomies who were randomized to the use of either a DeShuTuo or a Sensura two-piece ostomy bag.The primary outcome was the absence of peristomal dermatitis,and the secondary outcomes included the degree of leakage,the average duration of stoma base use,and patient satisfaction.Results:The percentage of no peristomal dermatitis was 69.4%(95%CI,51.9%-83.7%)in the DeShuTuo group and 66.7%(95%CI,49.0%-81.4%)in the Sensura group,with no statistical difference between the two groups(P=0.8219).There was no statistical difference between the two groups in terms of leakage score,duration of stoma base use,participant satisfaction,or adverse events.Conclusion:Compared with the Sensura two-piece ostomy bag,the DeShuTuo two-piece ostomy bag was non-inferior in terms of peristomal dermatitis,degree of leakage,duration of stoma base use,and participant satisfaction.

关 键 词：结肠造口 造口袋 造口周围皮炎 

分 类 号：TH779[机械工程—仪器科学与技术]