硝酸甘油软膏治疗慢性肛裂的临床研究

Clinical study of nitroglycerin ointment in treating chronic anal fissure

目的研究硝酸甘油软膏治疗慢性肛裂的有效性和安全性。方法选取南京中医药大学无锡附属医院2012年7月—2014年5月收治的慢性肛裂患者240例,随机分为试验组和对照组,各120例。试验组给予硝酸甘油软膏治疗,对照组采用不含药物成分的安慰剂治疗,连续用药8周。观察两组患者主要疗效、次要疗效指标以及不良反应发生情况。结果试验组肛裂愈合率高于对照组(P<0.05);试验组视觉模拟(VAS)评分、便血评分、肛门溃疡评分以及肛管静息压均低于对照组(P<0.05);试验组不良事件发生率和不良反应发生率均高于对照组(P<0.05);两组患者头痛程度比较,差异有统计学意义(P<0.05);头痛持续时间比较,差异无统计学意义(P>0.05)。结论硝酸甘油软膏治疗慢性肛裂疗效确切,可明显缓解肛门疼痛、便血、肛门溃疡等症状,降低肛管静息压。

Objective To evaluate the efficacy and safety of nitroglycerin ointment in the treatment of chronic anal fissure. Methods A total of 240 patients With with chronic anal fissure were selected from July 2012 to May 2014 in Wuxi Affiliated Hospital of Nanjing Chinese Medicine University,which were randomly divided into the experiment group and the control group,120 cases in each group. The experiment group was given nitroglycerin ointment,the control group was given placebo without any drug ingredients,the two groups were all treated for 8 weeks. The anal fissure healing situation,treatment efficacy and the adverse reactions were observed. Results The anal fissure healing rate of experiment group was higher than control group( P < 0. 05); the scores of anal VAS,hemafecia,anal ulcer and anal canal resting pressure of experiment group were significantly lower than those in control group( P < 0. 05). The incidence of adverse events and the incidence of adverse reactions of experiment group were higher than those in control group( P < 0. 05),there were significant differences of headache intensity between two groups( P < 0. 05),there was no differences of headache duration between two groups( P > 0. 05). Conclusion Nitroglycerin ointment has an excellent efficacy in the treatment of chronic anal fissure,can relieve symptoms such as anal pain,hemafecia,anal ulce,and reduce the anal canal resting pressure.