5%米诺地尔局部治疗与 0.2%硝酸甘油局部治疗慢性肛裂的随机临床试验。

Topical 5% minoxidil versus topical 0.2% glyceryl trinitrate in treatment of chronic anal fissure: A randomized clinical trial.

机构信息

Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt.

出版信息

Int J Surg. 2020 Mar;75:152-158. doi: 10.1016/j.ijsu.2020.01.143. Epub 2020 Feb 4.

DOI:10.1016/j.ijsu.2020.01.143

PMID:32028023

Abstract

BACKGROUND

Chronic anal fissure (CAF) is a common painful anal condition. Medical treatment of CAF involves the use of agents that induce chemical sphincterotomy. The present trial aimed to compare the efficacy and safety of topical minoxidil and glyceryl trinitrate (GTN) preparations in treatment of CAF.

METHODS

Adult patients with CAF were randomly assigned to one of two equal groups; group I received topical 5% minoxidil gel and group II received topical 0.2% GTN cream. The main outcome measures were healing of anal fissure, duration to healing, relief of symptoms, and adverse effects.

RESULTS

62 patients (36 female and 26 male) were included to the study. Group I comprised 30 patients and group II comprised 32 patients. Healing of anal fissure was achieved in 23 (76.7%) patients in group I and 15 (46.9%) patients in group II (p = 0.03). The average duration to healing in group I was significantly shorter than group II (4.1 ± 1.9 vs 5.3 ± 2.7 weeks, p = 0.048). Adverse effects were recorded in 2 (6.6%) patients in group I and 13 (40.6%) patients in group II. The post-treatment pain score in the GTN group was significantly lower than the Minoxidil group.

CONCLUSION

Topical 5% minoxidil gel achieved greater and quicker healing of CAF and fewer adverse effects than topical 0.2% GTN cream. Post-treatment pain scores after GTN were significantly lower than minoxidil.

TRIAL REGISTRATION NUMBER

NCT03528772.

摘要

背景

慢性肛裂（CAF）是一种常见的肛门疼痛病症。CAF 的医学治疗包括使用诱导化学括约肌切开术的药物。本试验旨在比较局部应用米诺地尔和硝化甘油（GTN）制剂治疗 CAF 的疗效和安全性。

方法

将 CAF 成年患者随机分配到两组，每组各 31 例；组 I 接受局部 5%米诺地尔凝胶治疗，组 II 接受局部 0.2%GTN 乳膏治疗。主要结局指标为肛裂愈合、愈合时间、症状缓解和不良反应。

结果

共有 62 例患者（36 例女性和 26 例男性）纳入研究。组 I 有 30 例，组 II 有 32 例。组 I 中有 23 例（76.7%）患者肛裂愈合，组 II 中有 15 例（46.9%）患者（p=0.03）。组 I 的平均愈合时间明显短于组 II（4.1±1.9 与 5.3±2.7 周，p=0.048）。组 I 中有 2 例（6.6%）患者和组 II 中有 13 例（40.6%）患者出现不良反应。GTN 组治疗后的疼痛评分明显低于米诺地尔组。