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

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.