肛裂切除黏膜下移术治疗陈旧性肛裂的前瞻性多中心随机对照试验  

Mucosa advancement flap anoplasty in treatment of chronic anal fissures:a prospective,multicenter,randomized controlled trial

作　　者：王振宜[1] 刘华[1] 孙建华[1] 毛旭明[2] 徐伟祥[3] 吴迎鸽[1] 张海岩[1] 朱丽娟[3] 金炜[1] 吴炯[1] 李盈[1] 吴闯[1] 姜在龙[1] 石丽[1] 李琰[2] 董维[2] 

机构地区：[1]上海中医药大学岳阳中西医结合医院肛肠科,上海200437 [2]上海交通大学医学院第九人民医院肛肠科,上海200011 [3]上海中医药大学上海市中医医院肛肠科,上海200071

出　　处：《中西医结合学报》2011年第4期402-409,共8页Journal of Chinese Integrative Medicine

基　　金：上海市卫生局中医药科研基金课题(No.30304113249)

摘　　要：背景:肛裂是常见肛肠科疾病之一,约10%陈旧性肛裂患者最终需要手术治疗。如何通过技术改良减轻手术痛苦和预防功能损伤是肛肠外科医师关注的热点。目的:评价肛裂切除黏膜下移术治疗陈旧性肛裂的疗效和安全性。设计、场所、对象和干预措施:采用前瞻性、多中心、随机、对照临床试验设计方案,纳入2009年1月～2010年4月来自上海中医药大学附属岳阳中西医结合医院和上海市中医医院、上海交通大学医学院附属第九人民医院肛肠科住院的陈旧性肛裂患者120例,采用各分中心随机分层,随机分为试验组(肛裂切除黏膜下移术)和对照组(肛裂切除术)各60例。两组均采取手术治疗,术后观察期为2周,短期随访6周。主要结局指标:以治愈率、创面愈合时间和临床症状为主要观察指标,观察术后并发症以及手术前后肛管张力变化进行安全性评价。结果:3例患者(试验组1例,对照组2例)因术后1周内提早出院而退出试验。术后第6周,试验组疗效优于对照组(P<0.05)。试验组创面愈合时间为(17.22±4.41)d,对照组为(21.24±7.44)d,两组比较差异有统计学意义(P<0.05)。术后第3天、第14天和第6周时试验组肛门疼痛程度轻于对照组(P<0.05);术后第3天和第14天,试验组肛门出血情况优于对照组(P<0.05),术后6周试验组与对照组出血情况比较,差异无统计学意义(P=0.051)。术后两组肛管张力比较,差异无统计学意义(P>0.05)。术后2周内两组患者并发症(排尿障碍、创缘水肿、术后发热、术后感染、肛门失禁、肛门变形)比较,差异无统计学意义(P>0.05)。两组均随访6周,所有随访患者未见术后并发症,未见复发。结论:陈旧性肛裂患者采用肛裂切除黏膜下移术能提高手术疗效,缩短疗程,改善患者术后痛苦,同时具有较好的安全性。Background：Anal fissure is one of the most common anal-rectum diseases,and approximately 10 percent patients with chronic anal fissure ultimately receive surgery.Relieving postoperative pain and protecting functions of the sphincter are central issues for coloproctologists.Objective：To evaluate the efficacy and safety of anoplasty in the treatment of chronic anal fissures.Design,setting,participants and interventions：In this prospective,multicenter,randomized controlled trial,120 adult patients with chronic anal fissure were referred from Department of Coloproctology of Yueyang Hospital of Integrated Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai Ninth People＇s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and Shanghai Municipal Hospital of Traditional Chinese Medicine.The patients were enrolled from January 2009 to April 2010 and randomly divided into study（mucosa advancement flap anoplasty,abbreviated as anoplasty） group and control（fissurectomy） group.The two groups were assessed separately,and the main outcome measures were observed for 2 weeks,with a short-term follow-up for 6 weeks.Main outcome measures：Degree of pain,haemorrhage and anal canal pressure were observed and recorded preoperatively,and on the third day,the fourteenth day and the sixth week postoperatively.The wound healing time was also recorded.Surgical complications of the two groups were recorded and compared on the third day and the sixth week postoperatively.The curative effects associated with the surgery were analyzed on the fourteenth day and the sixth week after surgery and the therapeutic results were evaluated.Results：Three patients were dropped out due to the early discharge from hospital and losing connection（1 in study group and 2 in control group）.Overall the surgery showed that the anoplasty group had better results than the fissurectomy group in the curative effect on the sixth week after operation（P0.05）.Time of wound

关 键 词：陈旧性肛裂 肛裂 肛裂切除黏膜下移术 多中心研究 随机对照试验 前瞻性研究 

分 类 号：R657.1[医药卫生—外科学]