透明质酸钠凝胶预防术后肠粘连的随机对照研究

A randomized controlled trial on sodium hyaluronate gel in prevention of postoperative intestinal adhesion

目的评价透明质酸钠凝胶对预防性肠造口术后预防粘连的有效性和安全性。方法采用前瞻性、多中心、随机和对照的方法,将来自6家医院的124例接受预防性肠造口术患者随机分配至透明质酸钠凝胶治疗组(59例)和空白对照组(65例)。比较两组在造口还纳手术时造口区域切口周围中、重度粘连发生率和安全性。结果研究组造口区域切口周围中、重度粘连发生率为6.3%,空白对照组为32.6%,研究组和空白对照组相比差异有统计学意义(P<0.05)。结论透明质酸钠凝胶可安全有效地减少术后中、重度肠粘连发生率。

Objective To evaluate the efficacy and safety of sodium hyaluronate gel in preventing adhesion after prophylactic enterostomy.Methods One hundred and twenty four patients from 6 hospitals were enrolled in this prospective multi-center randomized controlled trial.Patients were randomized into the study group(n=59)or the control group(n=65).All patients underwent prophylactic enterostomy.Patients of study group received odium hyaluronate gel for adhesion-prevention,while those in control group did not receive any adhesion-prevention treatment.The incidence of moderate to severe adhesion around the incision in the stoma area were evalutated during stoma reduction surgery.Results The incidence of moderate to severe adhesion around the incision in the stoma area was 6.3%in the study group,the difference was statistically significant(P<0.05)compared to that of the control group(32.6%).Conclusion Sodium hyaluronate gel can safely and effectively reduce the incidence of moderate and severe adhesions after abdominal surgery.