药线疗法治疗肛门直肠周围脓肿的临床规范化研究

目的评价药线疗法治疗肛门直肠周围脓肿的有效性与安全性。方法采用前瞻性、多中心、平行、随机、对照的临床研究方法,以凡士林油纱条引流法为对照组,以创面愈合率、愈合时间为主要疗效指标,以术后换药疼痛指数、出血积分、复发率为次要疗效指标,以不良事件为安全性指标,评价药线疗法治疗肛门直肠周围脓肿的有效性与安全性。结果本研究共入组113例病例,其中试验组55例,对照组58例,试验组和对照组各剔除1例,共有111例病例完成观察和随访。试验组术后14天脓腔愈合率（56.15%）高于对照组（48.17%）（P〈0.05）,但组间脓腔愈合时间差异无统计学意义（P〉0.05）。试验组术后2天、术后10天、术后14天疼痛积分低于对照组（P〈0.05）,术后当天、术后2天、术后7天、术后10天出血程度低于对照组（P〈0.05）。观察期间,两组均未出现严重的不良反应,术后3个月时各有1例复发（P〉0.05）。结论药线疗法用于治疗肛门直肠周围脓肿,其优势不仅在于提高愈合率,而且能够减轻创口疼痛及较严重的出血等术后常见症状。

Clinical standardization research of medicated thread therapy in the treatment of perianal abscess

Objective To evaluate the effectiveness and safety of medicated thread therapy in the treatment of perianal abscess.Methods The clinical trial was designed as prospective,controlled,randomized multicenter trial.Vaseline sliver drainage was employed as control group.The primary therapeutic indexes include cure rate,course of recovery.Scores of postoperative pain and bleeding,recurrence rate were used as secondary therapeutic indexes.Adverse event was considered as safety index.Results A total of 113 subjects were recruited.Fifty-five subjects were in the treatment group and 58 in the control group.One hundred and eleven subjects were observed and followed up.There was a significant difference in the cure rate of postoperative fourteenth day between treatment group（56.15%） and control group（48.17%）（P0.05）,and no significant difference was found in the course of recovery between the two groups（P0.05）.There was significant differences in the scores of postoperative pain at 2nd,10th and 14th day between two groups（P0.05）.Postoperative bleeding in the treatment group was lower than that of the controls at the 1st,2nd,7th,10th day（P0.05）.In the 3 month follow-up,one subject was recurred respectively in two groups,and no adverse event in the two groups（P0.05）.Conclusion The medicated thread therapy can boost the cure rate for perianal abscess,relieve postoperative pain and bleeding.