隧道式拖线术治疗单纯性肛瘘的临床研究

Clinical research of thread-dragging through fistula method in treating patients with simple anorectal fistula

目的:评价隧道式拖线术治疗单纯性肛瘘的疗效和安全性。方法:采用前瞻性、多中心、随机、对照的临床试验设计方案。244例高位和低位单纯性肛瘘患者分为治疗组和切开(挂线)法对照组。以愈合时间、治愈率、临床症状和生活质量积分等作为主要的观测指标;采用肛门直肠测压法进行安全性评价;并对两种手术方法的卫生经济学评价指标进行比较。结果:低位和高位单纯性肛瘘患者的治愈率在治疗组和对照组之间比较差异无统计学意义。低位单纯性肛瘘治疗组平均愈合时间为(22.26±8.67)d,对照组为(31.41±11.39)d;高位单纯性肛瘘治疗组平均愈合时间为(24.73±8.15)d,对照组为(32.20±12.60)d;两组比较均有统计学差异。低位和高位单纯性肛瘘治疗组患者临床症状积分除括约肌功能积分明显低于对照组外(P<0.05,P<0.01),其余各项症状积分和总积分两组比较均无统计学差异。低位单纯性肛瘘患者各项生活质量积分两组间比较均无明显差异;高位单纯性肛瘘治疗组生活质量括约肌功能积分和对治疗的信心积分均明显优于对照组(P<0.05),其余各项积分两组间比较则无统计学差异。卫生经济学评价结果显示,治疗组住院总费用要低于对照组(P<0.01)。低位和高位单纯性肛瘘治疗组肛管最大收缩压在治疗前后无明显变化;而对照组治疗后的肛管最大收缩压较治疗前有所降低,且较治疗组治疗后低,差异有统计学意义。结论:隧道式拖线术治疗单纯性肛瘘可以缩短病程、降低住院费用、提高患者生活质量,并能保护肛管括约肌的功能。

Objective, To evaluate the efficacy and safety of thread-dragging through fistula method in treating patients with simple anorectal fistula. Methods： In this multi-centered, prospective, and randomized controlled clinical trial, 244 patients with simple low or high anorectal fistula were randomly divided into study group （with the method of thread-dragging through fistula） and control group （with the method of incision or thread-drawing）. The healing time and curative rate of anorectal fistula, and the integral calculus of clinical symptom and life quality evaluations before and after treatment were all examined. The maximal anal canal squeeze pressure was measured to compare the therapeutic safety between these two groups. The health economical benefits were also assessed to determine which therapeutic method was more economical. Results： The curative rate of simple low and high anorectal fistula were of no significant differences between the study group and the control group. The healing time of simple low anorectal fistula in the study group and the control group were （22.26 ± 8.67） d and （31.41 ± 11.39） d respectively, while the healing time of simple high anorectal fistula in the study group and the control group were （24.73 ± 8.15） d and （32.20 ± 12.60） d respectively, and there revealed significant differences between these two groups. Each integral calculus of clinical symptom evaluation in the study group was not obviously different from those in the control group besides the integral calculus of anal sphincter function. The integral calculus of life quality between the study group and the control group of simple low anorectal fistula had no significant differences. The integral calculus of anal sphincter function and confidence in treatment in the study group of high anorectal fistula were better than those in the control group. The hospitalization expense of the study group was remarkably lower than that of the control group. The maximal anal canal squeeze pressure in the study group after treatment was not reduced obviously as compared with that in the same group before treatment, while it was decreased significantly in the control group after treatment as compared with those in the same group before treatment and in the study group after treatment. Conclusion： The method of thread-dragging through fistula in treating simple low and high anorectal fistula can shorten the course of the disease, save the hospitalization expenses, improve the life quality of the patients, and protect the anal sphincter function.