线管分期引流法治疗复杂性肛瘘的多中心随机对照临床研究

Clinical Observation of Stage Drainage Method onComplex Anal Fistula:a Multicenter Randomized Controlled Trial

目的:客观评价线管分期引流法治疗复杂性肛瘘的有效性和安全性,以形成技术规范和推广应用方案。方法:将来自4个研究中心的180例复杂性肛瘘(高位和低位)患者随机分为治疗组和对照组,每组90例。采用全分析集(full analysis set,FAS)进行病例分布和基线资料的比较,采用符合方案集(per pro-tocol set,PPS)进行疗效和安全性评价。治疗组中,高位复杂性肛瘘采用高位旷置加线管分期引流术,低位复杂性肛瘘采用线管分期引流术;对照组中,高位复杂性肛瘘采用切开挂线术,低位复杂性肛瘘采用切开术。观察并比较两组患者的住院时间、治愈时间、住院费用,同时评价两组患者的生存质量及安全性。结果:纳入的180例患者,最终有效179例,剔除1例。治疗组的住院时间、治愈时间较对照组均明显缩短(P<0.05),住院费用较对照组亦明显减少(P<0.05);治疗后治疗组和对照组患者的生存质量较治疗前均明显提高(P<0.05),两组间生存质量差异不具有统计学意义(P>0.05)。结论:线管分期引流法治疗复杂性肛瘘安全、有效,具有极大的临床推广和应用价值。

Objective： To evaluate the efficacy and safety of stage drainage method in treating complex anal fistula,and form the treatment standard and popularization plan.Methods： One hundred and eighty patients with complex anal fistula from four centers were randomly divided into treatment group and control group,with ninety cases in each group.Full analysis set（FAS） was applied to analyze the baseline data and per protocol set（PPS） was used to evaluate the safety and efficacy.In treatment group,the patients with high complex anal fistula were treated by stage drainage plus lay-open therapy,and the patients with low complex anal fistula were treated by stage drainage therapy;in control group,the high complex anal fistula patients were treated by thread-drawing therapy,and the low complex anal fistula patients were treated by incision therapy.The hospitalization time and fee,and the cure time were compared,and the quality of life and safety were evaluated.Results： A total of 180 cases were recruited and 179 cases completed the trial.Compared with control group,the hospitalization time and cure time in treatment group were significantly shortened（P0.05）,and the hospitalization fee of treatment group was obviously reduced（P0.05）;after treatment,the quality of life of patients in both two groups was enhanced compared with before treatment,while there was no statistical difference in the quality of life between two groups（P0.05）.Conclusion： The stage drainage method is safe and effective in treating complex anal fistula,and worthy of popularization and application in clinics.