使用基于亚甲蓝和硝酸甘油的乳膏治疗慢性肛裂：来自一家转诊结直肠病科单位的II期随机试点试验。

The use of a methylene blue and glyceryl trinitrate-based cream for the treatment of chronic anal fissures: a phase II randomized pilot trial from a referral coloproctological unit.

作者信息

Lobascio P, Tomasicchio G, Cassetta N, Altomare D F, Gallo G, Pezzolla A, Laforgia R

机构信息

Department of Precision and Regenerative Medicine and Jonic Area (DiMePRe-J), Section of Surgery, General Surgery Unit - Hospital University of Bari, Piazza Giulio Cesare 11, 70124, Bari, SE, Italy.

Farmacia Santelia, Via Antonio Santelia Architetto, N. 135, 70033, Corato - Bari, SE, Italy.

出版信息

Tech Coloproctol. 2025 Jan 3;29(1):39. doi: 10.1007/s10151-024-03029-8.

DOI:10.1007/s10151-024-03029-8

PMID:39751710

Abstract

BACKGROUND

Chronic anal fissures (CAFs) are the second most common anorectal disease. Non-surgical treatment includes several options with controversial efficacy. The aim of this study was to evaluate the efficacy and safety of a new ointment based on methylene blue in addition to glyceryl trinitrate.

METHODS

A phase II randomized single-centre triple-blinded study was carried out in a tertiary proctology unit on patients with CAF. The enrollment started after local ethics committee approval (study n. 6461, protocol approval n. 0045085). Eligible consecutive patients were randomized to one of three different groups, each receiving a different ointment. The efficacy of the treatment was evaluated with the REALISE score.

RESULTS

Nine patients were treated with cream A (median age 47 years, IQR 40-56, 22% female), nine with cream B (median age 52 years, IQR 49-57, 33% female), and nine with cream C (median age 58 years, IQR 46-62, 55% female). In group A, REALISE scores decreased significantly from a median of 22 (IQR 12-25) to 6 (IQR 4-8) (p < 0.05) after 40 days. In group B, REALISE scores improved significantly from a median of 20 (IQR 17-22) to 5 (IQR 4-9) (p < 0.05). In group C, REALISE scores decreased significantly from a median of 19 (IQR 19-20) to 4 (4-5) (p < 0.05). No statistically differences were recorded. The healing rate was 77% with creams A and C, while it was 44% with cream B.

CONCLUSION

Methylene blue-based ointments could be a new and innovative treatment for the non-operative management and healing of CAFs.

摘要

背景

慢性肛裂是第二常见的肛肠疾病。非手术治疗有多种选择，但其疗效存在争议。本研究旨在评估一种基于亚甲蓝加硝酸甘油的新型软膏的疗效和安全性。

方法

在一家三级直肠病科对慢性肛裂患者进行了一项II期随机单中心三盲研究。在获得当地伦理委员会批准后开始入组（研究编号6461，方案批准编号0045085）。符合条件的连续患者被随机分为三个不同组，每组接受不同的软膏治疗。采用REALISE评分评估治疗效果。

结果

9例患者接受A组乳膏治疗（中位年龄47岁，四分位间距40 - 56，女性占22%），9例接受B组乳膏治疗（中位年龄52岁，四分位间距49 - 57，女性占33%），9例接受C组乳膏治疗（中位年龄58岁，四分位间距46 - 62，女性占55%）。A组中，40天后REALISE评分从中位数22（四分位间距12 - 25）显著降至6（四分位间距4 - 8）（p < 0.05）。B组中，REALISE评分从中位数20（四分位间距17 - 22）显著改善至5（四分位间距4 - 9）（p < 0.05）。C组中，REALISE评分从中位数19（四分位间距19 - 20）显著降至4（4 - 5）（p < 0.05）。未记录到统计学差异。A组和C组乳膏的愈合率为77%，而B组乳膏的愈合率为44%。