硝酸甘油软膏治疗肛裂的多中心随机对照研究

目的评价硝酸甘油软膏治疗肛裂的临床疗效和安全性。方法采用多中心、随机、双盲、安慰剂平行对照的临床试验方法，从7个临床中心入组240例慢性肛裂患者，按随机数字表法随机分为试验组（硝酸甘油软膏，120例）和对照组（凡士林软膏，120例），疗程为8周。比较两组肛裂愈合率、肛裂疼痛强度VAS评分、肛管静息压的变化及不良反应事件发生率。结果共有221例（92．1％）完成了试验，其中试验组114例，对照组107例。治疗终点（56d），试验组和对照组肛裂愈合率分别为78．9％（90／114）和29．0％（31／107），排粪后肛裂疼痛VAS评分下降率分别为（94．8±15．7）％和（61．2±35．7）％，差异均有统计学意义（均P〈0．01）。试验组和对照组分别有12例和6例患者接受了肛门直肠测压，首次用药前后肛管静息压下降值试验组为（20．2±18．5）mmHg，对照组为（7．1±14．7）mmHg，但两组差异并无统计学意义（P=0．152）。试验组不良反应事件发生率明显高于对照组42．1％（48／114）比913％（10／107），P〈0．05]，但不良反应事件主要为轻度的头痛、头胀，可自行缓解。结论硝酸甘油软膏可有效缓解肛裂疼痛，促进肛裂愈合，且使用安全、耐受性好。

A multi-center, randomized, double-blind, placebo-controlled trial of glyceryl trinitrate ointment in the treatment of anal fissure

Objective To evaluate the clinical efficacy and safety of glyceryl trinitrate （GTN） ointment in the treatment of anal fissure. Methods In this multi-center, randomized, double-blind and placebo-controlled trial, 240 chronic anal fissure patients from 7 clinical centers were randomized to receive eight-week treatment with GTN ointment （treatment group） or vaseline ointment （control group） respectively. Healing rate, visual analogue score （VAS）, maximum anal resting pressure （MARP） and adverse reactions were recorded and compared. Results A total of 221 patients （92.1%） finished the trial, including 114 patients in treatment group （95.0%, 114/120） and 107 in control group （89.2%, 107/120）. At the endpoint of treatment（56 d）, 90 patients in treatment group （78.9%,90/114） healed completely compared to 31 patients in control group（29.0%,31/107）, and decrease rates of VAS in the two groups were （94.8±15.7）% and （61.2±35.7）% respectively, both differences were statistically significant （P〈0.01 ）. MARP after first administration was （ 20.2 ± 18.5 ） mm Hg in treatment group （n = 12 ）and （7.1 ± 14.7 ） mm Hg in control group （n=6）, which was not significantly different （P=0.152）. Adverse reaction incidence was higher in treatment group （42.1% vs. 9.3%, P〈0.05）, while these adverse reactions were mainly headache and fullness in head, which were self-limiting. Conclusion GTN ointment can effectively promote healing and relieve pain in anal fissure with safety and tolerance.