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硝苯地平口服治疗与局部应用治疗肛裂的随机对照初步研究。

Randomized controlled pilot trial of nifedipine as oral therapy vs. topical application in the treatment of fissure-in-ano.

机构信息

Department of Surgery, University College of Medical Sciences and Guru Teg Bahadur Hospital, University of Delhi, Dilshad Garden, New Delhi 110095, India.

出版信息

Am J Surg. 2013 Nov;206(5):748-51. doi: 10.1016/j.amjsurg.2013.05.003. Epub 2013 Sep 12.

DOI:10.1016/j.amjsurg.2013.05.003
PMID:24035211
Abstract

BACKGROUND

Fissure-in-ano is a common condition that leads to pain and affects quality of life. Sphincterotomy remains the gold standard, but it may lead to troublesome incontinence in some patients. To overcome this problem, numerous pharmacologic therapies have been tested with varying outcomes. The investigators compared the effect of the addition of oral and topical nifedipine to conservative measures in the treatment of patients with fissure-in-ano.

METHODS

Ninety patients with fissure-in-ano, randomized into 3 groups of 30 each, were included in the study. Group I received conventional treatment, group II received oral nifedipine and conventional treatment, and group III received topical nifedipine along with conventional treatment. Patients were followed for 8 weeks for pain relief (assessed using a visual analogue scale) and healing to evaluate the effect of treatment.

RESULTS

Pain relief was significantly better in the group III at 3 weeks and 2 months compared with group I (P < .05). Groups II and III were comparable in terms of pain relief. Healing rates were significantly better in group II (P = .03) and group III (P = .00) compared with group I, but groups II and III were found to be comparable. Adverse effects were most commonly reported by group II patients, but these were not significantly higher than in other 2 groups.

CONCLUSIONS

We recommend the addition of either oral or topical nifedipine to conservative measures to significantly improve pain relief and healing rates in patients with fissure-in-ano.

摘要

背景

肛门裂是一种常见的疾病,会导致疼痛,影响生活质量。括约肌切开术仍然是金标准,但它可能会导致一些患者出现麻烦的失禁。为了解决这个问题,已经测试了许多药物治疗方法,但结果各不相同。研究人员比较了在肛门裂患者的保守治疗中加入口服和局部硝苯地平的效果。

方法

90 名肛门裂患者被随机分为 3 组,每组 30 名。第 I 组接受常规治疗,第 II 组接受口服硝苯地平加常规治疗,第 III 组接受局部硝苯地平加常规治疗。患者接受 8 周的随访,以评估疼痛缓解(使用视觉模拟评分)和愈合情况,从而评估治疗效果。

结果

第 III 组在 3 周和 2 个月时的疼痛缓解明显优于第 I 组(P <.05)。第 II 组和第 III 组在疼痛缓解方面相当。第 II 组(P =.03)和第 III 组(P =.00)的愈合率明显优于第 I 组,但第 II 组和第 III 组之间没有差异。第 II 组患者最常报告不良反应,但与其他两组相比,并无显著增加。

结论

我们建议在保守治疗中加入口服或局部硝苯地平,以显著提高肛门裂患者的疼痛缓解率和愈合率。

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