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一项比较结肠灌洗和口服抗生素治疗与 4%福尔马林应用治疗放射性直肠炎出血的随机对照试验。

A randomized controlled trial comparing colonic irrigation and oral antibiotics administration versus 4% formalin application for treatment of hemorrhagic radiation proctitis.

机构信息

Colorectal Division, Department of Surgery, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

出版信息

Dis Colon Rectum. 2012 Oct;55(10):1053-8. doi: 10.1097/DCR.0b013e318265720a.

DOI:10.1097/DCR.0b013e318265720a
PMID:22965404
Abstract

BACKGROUND

Several treatments have been described for hemorrhagic radiation proctitis. The treatment outcomes are variable. Colonic irrigation and oral antibiotics for hemorrhagic radiation proctitis have been recently reported to be a novel and promising therapeutic approach. However, a comparative study of this treatment has never been investigated.

OBJECTIVE

This study aimed to compare colonic irrigation and oral antibiotics (irrigation group) versus 4% formalin application (formalin group) for treatment of hemorrhagic radiation proctitis.

DESIGN

This was a randomized controlled trial.

SETTING

This study was conducted in a tertiary care/university-based hospital.

PATIENTS

Fifty patients with hemorrhagic radiation proctitis were randomly assigned to each treatment group (n = 25).

INTERVENTIONS

For individuals allocated to the irrigation group, daily self-administered colonic irrigation with 1 L of tap water and a 1-week period of oral antibiotics (ciprofloxacin and metronidazole) were prescribed. For individuals allocated to the formalin group, 4% formalin application for 3 minutes was performed.

MAIN OUTCOME MEASURES

Patients' symptoms and the endoscopic findings of each group were collected. Patient satisfaction was surveyed. The outcomes were evaluated at 8 weeks after the initiation of treatment.

RESULTS

There was a significant improvement in rectal bleeding and bowel frequency in both treatment groups, but significant improvement in urgency, diarrhea, and tenesmus was demonstrated only in the irrigation group. The comparative study between 2 treatments revealed greater improvement in rectal bleeding, urgency, and diarrhea in the irrigation group. Twenty of 24 patients in the irrigation group and 10 of 23 patients in the formalin group were satisfied with the treatment.

LIMITATIONS

This trial cannot illustrate whether the antibiotics and the irrigation were equally important because of the limitation of a 2-armed design.

CONCLUSIONS

The treatment with colonic irrigation and oral antibiotics appears to be more effective than 4% formalin application for hemorrhagic radiation proctitis treatment and achieves higher patient satisfaction.

摘要

背景

已经有几种治疗放射性直肠出血的方法。但治疗效果存在差异。最近有报道称,结肠灌洗和口服抗生素是治疗放射性直肠出血的一种新颖且有前途的治疗方法。然而,尚未对此治疗方法进行比较研究。

目的

本研究旨在比较结肠灌洗和口服抗生素(灌洗组)与 4%福尔马林应用(福尔马林组)治疗放射性直肠出血的效果。

设计

这是一项随机对照试验。

设置

本研究在三级保健/大学附属医院进行。

患者

50 例放射性直肠出血患者被随机分配至每个治疗组(n=25)。

干预措施

对于分配至灌洗组的患者,每天自行进行 1 升自来水的结肠灌洗,并口服抗生素(环丙沙星和甲硝唑) 1 周。对于分配至福尔马林组的患者,进行 4%福尔马林应用 3 分钟。

主要观察指标

收集每组患者的症状和内镜检查结果。调查患者满意度。在治疗开始后 8 周评估结局。

结果

两组患者的直肠出血和排便频率均有显著改善,但仅在灌洗组观察到尿急、腹泻和里急后重有显著改善。两种治疗方法的比较研究显示,灌洗组在直肠出血、尿急和腹泻方面的改善更为显著。灌洗组 24 例患者中有 20 例和福尔马林组 23 例患者中有 10 例对治疗满意。

局限性

由于采用 2 臂设计的局限性,本试验无法说明抗生素和灌洗是否同样重要。

结论

与 4%福尔马林应用相比,结肠灌洗和口服抗生素治疗放射性直肠出血的效果似乎更好,且患者满意度更高。

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