痔上黏膜结扎疗法和RPH术治疗Ⅱ~Ⅲ度脱垂性痔病的随机对照研究

Ligation for prolapsed hemorrhoids versus Ruiyun procedure for hemorrhoids for gradeⅡtoⅢprolapsed hemorrhoids:a randomized controlled trial

目的观察痔上黏膜结扎疗法和RPH术治疗Ⅱ~Ⅲ度脱垂性痔病的临床疗效。方法选择2018年5月至2021年6月上海中医药大学附属普陀医院肛肠科住院治疗的67例Ⅱ~Ⅲ度脱垂性痔病患者为研究对象。按照随机数字表法分为研究组(n=34,予痔上黏膜结扎疗法治疗)和对照组(n=33,予RPH术治疗)。其中研究组有1例患者失访,不纳入分析,最终研究组纳入33例患者。比较两组的疗效、手术时间、住院时间、结扎或套扎数目、痔症状评分(术前、术后1个月、3个月和6个月)、Wexner肛门失禁评分(术前、术后1个月、3个月和6个月)、VAS疼痛评分(手术当天、术后第1、第3、第7、第14天)、术后并发症评分(术后第1、第7、第14、第21天和1个月)及安全性评价。结果研究组的治愈率为90.9%,高于对照组的57.6%,手术时间长于对照组,结扎或套扎数目多于对照组,差异均有统计学意义(均P<0.05)。两组痔症状评分(术后1个月、3个月及6个月)、Wexner肛门失禁评分(术后3个月、6个月)均较术前降低(均P<0.05)。两组VAS疼痛评分(术后第1、第3、第7、第14天)均较手术当天降低(均P<0.05),研究组的VAS疼痛评分(术后第7天)较对照组低(均P<0.05)。两组术后并发症评分(术后第14、第21天和1个月)均较术后第1天降低(均P<0.05)。研究组术后无胶圈早期脱落病例。对照组术后有4例出现胶圈早期脱落和肛周血肿/血栓,胶圈早期脱落率达12.1%。结论痔上黏膜结扎疗法治疗Ⅱ~Ⅲ度脱垂性痔病的临床疗效优于RPH术,术后疼痛缓解更早,安全性更高。

Objectives To compare the effectiveness of ligation for prolapsed hemorrhoids versus Ruiyun procedure for hemor⁃rhoids(RPH)for gradeⅡtoⅢprolapsed hemorrhoids.Methods Sixty-seven patients with gradeⅡtoⅢprolapsed hemor⁃rhoids treated at the Department of Anorectal Diseases,Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,were recruited between May 2018 and June 2021.Using a random number table,patients were assigned to treatment group(n=34,receiving ligation for prolapsed hemorrhoids)and control group(n=33,receiving RPH).One patient in the treatment group was lost during follow-up and was not included in the final analyses.The followings were compared between the two groups:effectiveness,duration of surgery,duration of hospitalization,the number of ligations,scores of hemorrhoids symptoms(be⁃fore surgery,1 month,3 months,and 6 months after surgery),Wexner anal incontinence score(before surgery,1 month,3 months,and 6 months after surgery),pain visual analog scale(VAS)scores(the day of surgery,1 day,3 days,7 days,and 14 days after surgery),scores of postoperative complications(1 day,7 days,14 days,21 days,and 1 month after surgery),and safe⁃ty.Results Cure rate was 90.9%in the treatment group,which was significantly higher than that in the control group(57.6%,P<0.05).Duration of surgery was significantly longer,and the number of ligations was significantly larger in the treatment group than in the control group(P<0.05).Scores of hemorrhoids symptoms(1,3,and 6 months after surgery)and Wexner anal inconti⁃nence scores(3 and 6 months after surgery)decreased significantly after surgery(P<0.05),and pain VAS scores(1 day,3 days,7 days,14 days after surgery)decreased significantly after surgery in both groups(P<0.05).pain VAS scores at 7 days after sur⁃gery were significantly lower in the treatment group than in the control group(P<0.05).In both groups,scores of complications(14 days,21 days,and 1 month after surgery)decreased significantly from the score at 1 day after surgery(P<0.05).No rubber band shedding occurred in the treatment group.In contrast,four patients in the control group experienced early rubber band shedding and perianal hematoma/thrombosis,with a rate of early rubber band shedding of 12.1%.Conclusion Ligation for pro⁃lapsed hemorrhoids for gradeⅡtoⅢprolapsed hemorrhoids is more effective than RPH.It is associated with early postoperative pain relief and better safety profile.