从拖线术治疗肛瘘方案设计探讨外科手术临床试验特点:前瞻性多中心随机对照临床试验  

Design characteristics of clinical surgery trial based on treatment program of tunnel thread-drawing method for anal fistula:a prospective randomized controlled multicenter trial

作　　者：何春梅[1] 陆金根[1] 曹永清[1] 姚一博[1] 

机构地区：[1]上海中医药大学龙华医院肛肠科,上海200032

出　　处：《中西医结合学报》2009年第12期1113-1118,共6页Journal of Chinese Integrative Medicine

基　　金：国家科技支撑计划资助项目(No.2007BAI20B04:No.2008BAI53B06)

摘　　要：背景:外科手术类干预措施在进行临床试验时.虽然方案设计的基本原则与药物临床试验类似,但在具体操作环节上,有许多自身特点需要引起关注和讨论。目的:通过隧道式拖线术治疗单纯性肛瘘临床试验实例,探讨手术疗法临床试验方案设计的特点。设计、场所、对象和干预措施:该临床方案为前瞻性、多中心、随机、开放、对照的试验设计。病例来源于上海中医药大学附属龙华医院和岳阳中西医结合医院肛以及江西中医学院附属医院。按高位和低位单纯性肛瘘的疾病亚型分层随机。采用全分析集进行病例分布和基线资料等的比较,采用符合方案集进行疗效和安全性评价。治疗方法为隧道式拖线术,以传统切挂法为对照。主要结局指标:以治愈时间、治愈率、生活质量等为疗效指标,并作安全性分析。结果:按优效性检验方法估算样本,共入组单纯性肛瘘244例,最终有效病例236例。冶疗组和对照组两类(低位和高位)单纯性肛瘘患者治愈率比较,差异均无统计学意义。低位单纯性肛瘘治疗组治愈时间为(22.26±8.67)d.对照组为(31.41±11.39)d;高位单纯性肛瘘治疗组治愈时间为(24.73±8.15)d,对照组为(32.20±12.60)d。两组比较,差异均有统计学意义(P<0.01)。经过治疗后,低位单纯性肛瘘患者各项生活质量积分在两组间的差异无统计学意义;高位单纯性肛瘘治疗组肛门括约功能积分和对治疗信心积分均明显优于对照组(P<0.05);两组其余各项积分比较,差异无统计学意义。安全性分析示两组均无不良事件发生,隧道式拖线组治疗前后肛管最大收缩压无明显变化。结论:隧道式拖线术治疗单纯性肛瘘可以明显缩短病程,提高患者生活质量,是一种安全的手术方法。临床治疗方案的培训是手术类临床试验质量保证的重要环节。盲法的实施几乎是不可能的,只能采用开放的方法,一般不能�Background： Basic principles of clinical trials of nonpharmacologic treatment are similar to those of pharmacologic treatment, but its some special characteristics should be discussed.Objective： To explore the design characteristics of clinical surgery trial through the example of tunnel thread- drawing therapy for simple anal fistula. Design, setting, participants and interventions： The clinical trial was designed as a prospective, controlled, randomized multicenter trial. The patients came from Longhua Hospital, Yueyang Hospital of Integrated Traditional Chinese and Western medicine, and Affiliated Hospital of Jianxi University of Traditional Chinese Medicine. Stratified random was performed according to the subtype of anal fistula including low and high anal fistula. Full analysis set was applied to analyze the baseline data, and per protocol set was used in efficacy and safety analysis. The intervention was tunnel thread-drawing method. Classical therapy of thread-drawing method was employed as positive control. Main outcome measures： The primary outcomes were course of recovery and cure rate. Quality of life score was used as secondary outcome and anal maximum constriction pressure was considered as safety outcome. Results： Optimal efficiency testing method was used to estimate sample size. A total of 244 subjects were recruited and 236 subjects completed the trial. There was no significant difference in the cure rate of the low and high anal fistula between the treatment group and control group. There was a significant difference in the course of recovery in the patients with low and high anal fistula between treatment group and control group （P〈0.01）. To the patients with low anal fistula, the course of recovery in the treatment group was （22.26±8.67） d, and the course of recovery in the control group was （31.41±11.39） d＇. To the patients with high anal fistula, the course of recovery in the treatment group was （24.73±8.15） d, and the course of recovery in the control group

关 键 词：临床方案 研究设计 隧道式拖线术 肛瘘 外科手术 前瞻性研究 多中心试验 随机对照试验 

分 类 号：R269[医药卫生—中西医结合]