慢性肛裂的治疗：Levorag® Emulgel 与地尔硫䓬凝胶 2 的可行性研究。

Treatment of chronic anal fissure: a feasibility study on Levorag® Emulgel versus Diltiazem gel 2.

机构信息

Digestive Disease Center K, Bispebjerg Hospital, University of Copenhagen, Bispebjerg Bakke 23, 2400, Copenhagen NV, Denmark.

Department of Surgery, Zealand University Hospital, Køge, Denmark.

出版信息

Int J Colorectal Dis. 2020 Apr;35(4):615-621. doi: 10.1007/s00384-020-03515-z. Epub 2020 Jan 24.

DOI:10.1007/s00384-020-03515-z

PMID:31980871

Abstract

PURPOSE

To compare the standard treatment, diltiazem gel 2%, with Levorag® Emulgel for chronic anal fissures.

METHODS

This was a single-blinded, randomised, controlled, clinical trial with a non-inferiority design. Patients with a chronic anal fissure were randomised to treatment with diltiazem or Levorag® Emulgel twice daily for 8 weeks. Primary endpoint was complete healing of the anal fissure after 12 weeks. Secondary endpoints included incidence of adverse events and efficacy on pain relief.

RESULTS

In total, 55 patients were included. Inclusion was terminated prematurely due to a slow inclusion rate. Complete fissure healing at 12 weeks follow-up was overall achieved in 31 of 55 (56%) patients, 18 of 29 (62%) in the diltiazem group compared with 13 of 26 (50%) in the Levorag® Emulgel group (P = 0.424). Pain relief was significantly better at day seven in patients treated with diltiazem (P = 0.040) compared with Levorag® Emulgel, whereas there were no differences in early (3 days) or late (12 weeks) pain relief. Three patients (10.3%) developed severe perianal exanthema during diltiazem treatment, whereas no side effects were observed in the Levorag® Emulgel group.

CONCLUSION

The study demonstrated statistical non-inferiority of Levorag® Emulgel compared with diltiazem in the treatment of chronic anal fissure. Diltiazem resulted in a more prompt pain relief and also in a substantial number of local allergic reactions. Levorag® Emulgel may therefore be an alternative in these patients.

TRIAL REGISTRATION

Clinicaltrials.gov no. NCT02158013.

摘要

目的

比较慢性肛裂的标准治疗药物地尔硫䓬凝胶 2%与 Levorag® Emulgel。

方法

这是一项单盲、随机、对照、非劣效性临床试验。将慢性肛裂患者随机分为地尔硫䓬或 Levorag® Emulgel 组，每日两次，治疗 8 周。主要终点为 12 周时肛裂完全愈合。次要终点包括不良事件发生率和止痛效果。

结果

共纳入 55 例患者。由于纳入速度较慢，提前终止了纳入。在 12 周的随访中，55 例患者中有 31 例（56%）完全愈合，29 例地尔硫䓬组中有 18 例（62%），26 例 Levorag® Emulgel 组中有 13 例（50%）（P=0.424）。地尔硫䓬组在第 7 天的止痛效果明显优于 Levorag® Emulgel（P=0.040），而在早期（3 天）或晚期（12 周）止痛效果方面无差异。3 例（10.3%）患者在使用地尔硫䓬治疗时出现严重的肛周皮疹，而 Levorag® Emulgel 组无不良反应。