一项比较硝苯地平和硝酸异山梨酯治疗慢性肛裂有效性和安全性的双盲随机试验。

A Double-Blind Randomized Trial Comparing the Effectiveness and Safety of Nifedipine and Isosorbide Dinitrate in Chronic Anal Fissure.

作者信息

Khaledifar Borzoo, Mahmoudi Mehran Yousefi Ahmad, Mobasheri Mahmoud

机构信息

Department of Cardiology, Shahrekord University of Medical Sciences, Shahrekord, Iran.

General Practitioner, Shahrekord University of Medical Sciences, Shahrekord, Iran.

出版信息

Malays J Med Sci. 2015 Sep;22(5):42-49.

PMID:28239267

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5295740/

Abstract

BACKGROUND

Chronic anal fissure is a common disease that is accompanied with pain and bleeding during defecation. Various surgical and non-surgical methods have been offered for the treatment of this condition. The aim of this randomised clinical study was to compare the effectiveness and safety of nifedipine and isosorbide dinitrate (ISDN) in the treatment of chronic anal fissure.

METHODS

This double-blind clinical trial study was performed on patients aged 20 to 60 years old in 2012 to 2013. The samples with a primary diagnosis of chronic anal fissure were enrolled from the patients admitted to public treatment at the educational Imam Ali Clinic, Shahrekord, Iran by researchers and general surgery specialists. The patients were randomised into two groups: nifedipine 0.3% (n = 35) or ISDN 0.2% (n = 35) applied three times a day for three weeks. The patients were examined on the 7th, 14th, and 21st days of treatment, and the symptoms including bleeding, pain, and healing status, as well as the side effects of the drugs, were assessed. Pain was evaluated using a visual analogue scale (VAS).

RESULTS

After 21 days of follow-up, complete healing was achieved in 77.1% (n = 27) of patients in the nifedipine group and 51.4% (n = 18) in the ISDN group ( 0.05). The mean VAS of the pain on day 21 was 0.91 (SD 0.01) in the ISDN group and 0.45±0.78 in the nifedipine group, with a statistically significant difference ( 0.038). The bleeding was similar in the two groups (P = 0.498).

CONCLUSION

In view of the findings on healing status and pain in the patients, nifedipine may be significantly more effective in the treatment of chronic anal fissure than ISDN.

摘要

背景

慢性肛裂是一种常见疾病，排便时伴有疼痛和出血。针对这种病症，已提供了各种手术和非手术治疗方法。这项随机临床研究的目的是比较硝苯地平和硝酸异山梨酯（ISDN）治疗慢性肛裂的有效性和安全性。

方法

这项双盲临床试验于2012年至2013年对20至60岁的患者进行。研究人员和普通外科专家从伊朗沙赫鲁德教育伊玛目阿里诊所接受公共治疗的患者中招募了初步诊断为慢性肛裂的样本。患者被随机分为两组：0.3%硝苯地平组（n = 35）或0.2% ISDN组（n = 35），每天涂抹三次，持续三周。在治疗的第7天、14天和21天对患者进行检查，评估包括出血、疼痛和愈合状况等症状以及药物的副作用。使用视觉模拟量表（VAS）评估疼痛。

结果

随访21天后，硝苯地平组77.1%（n = 27）的患者实现完全愈合，ISDN组为51.4%（n = 18）（P<0.05）。ISDN组第21天疼痛的平均VAS为0.91（标准差0.01），硝苯地平组为0.45±0.78，差异有统计学意义（P = 0.038）。两组出血情况相似（P = 0.498）。