外用硝苯地平与外用硝酸甘油治疗慢性肛裂的比较。

Topical nifedipine vs. topical glyceryl trinitrate for treatment of chronic anal fissure.

作者信息

Ezri Tiberiu, Susmallian Sergio

机构信息

Department of Anesthesia, Edith Wolfson Medical Center, Holon, Israel.

出版信息

Dis Colon Rectum. 2003 Jun;46(6):805-8. doi: 10.1007/s10350-004-6660-8.

DOI:10.1007/s10350-004-6660-8

PMID:12794583

Abstract

PURPOSE

Nifedipine (administered orally or applied topically) has been effective for nonsurgical treatment of anal fissure. We compared the efficacy of nifedipine vs. glyceryl trinitrate for chemical sphincterotomy of anal fissure.

METHODS

In a prospective, double-blind trial, 52 patients suffering from chronic anal fissure were randomly and equally allocated to receive either glyceryl trinitrate or nifedipine, both applied topically to the perianal region. The end point of the study was healing within a predetermined period (6 months). Variables assessed included demographic data (age, gender), symptoms associated with the fissure, duration of treatment, percentage of healing, untoward effects of treatment, pain scores, duration of follow-up, recurrence, and need for complementary means of treatment. Descriptive data are presented as mean +/- standard deviation and quantal data as percentage. Inference analysis was performed using the Student's t-test for the descriptive data and the chi-squared or Fisher's exact test for nominal variables.

RESULTS

No significant differences were recorded with regard to age, gender, symptoms associated with the fissure, or duration of treatment. Healing rate was higher (P < 0.04) with nifedipine (89 percent) as compared with glyceryl trinitrate (58 percent). Treatment side effects (headache, flushing) were more frequent (P < 0.01) with glyceryl trinitrate (40 percent) as compared with nifedipine (5 percent). Pain scores were significantly lower (P < 0.03) on completion of treatment in both groups (3.2 in glyceryl trinitrate and 3.4 in nifedipine vs. 6.2 and 6.1, respectively), but did not differ between the two groups. Recurrence occurred in 31 percent of patients treated with glyceryl trinitrate and 42 percent of those treated with nifedipine after a mean period of 18 +/- 3 weeks and 12 +/- 4 weeks, respectively.

CONCLUSION

Topical application of nifedipine for management of chronic anal fissure was more effective and had fewer side effects than topical glyceryl trinitrate. Recurrence was frequent with both drugs.

摘要

目的

硝苯地平（口服或局部应用）已被证实对肛裂的非手术治疗有效。我们比较了硝苯地平和硝酸甘油用于肛裂化学性括约肌切开术的疗效。

方法

在一项前瞻性双盲试验中，52例慢性肛裂患者被随机均分为两组，分别接受硝酸甘油或硝苯地平治疗，均局部应用于肛周区域。研究的终点是在预定时期（6个月）内愈合。评估的变量包括人口统计学数据（年龄、性别）、与肛裂相关的症状、治疗持续时间、愈合百分比、治疗的不良反应、疼痛评分、随访持续时间、复发情况以及是否需要辅助治疗手段。描述性数据以均值±标准差表示，定量数据以百分比表示。对描述性数据采用学生t检验进行推断分析，对名义变量采用卡方检验或Fisher精确检验。

结果

在年龄、性别、与肛裂相关的症状或治疗持续时间方面，未记录到显著差异。硝苯地平组的愈合率（89%）高于硝酸甘油组（58%）（P < 0.04）。硝酸甘油组的治疗副作用（头痛、脸红）发生率（40%）高于硝苯地平组（5%）（P < 0.01）。两组治疗结束时疼痛评分均显著降低（P < 0.03）（硝酸甘油组为3.2，硝苯地平组为3.4，治疗前分别为6.2和6.1），但两组之间无差异。硝酸甘油组和硝苯地平组分别在平均18±3周和12±4周后，复发率分别为31%和42%。