Altomare D F, Rinaldi M, Milito G, Arcanà F, Spinelli F, Nardelli N, Scardigno D, Pulvirenti-D'Urso A, Bottini C, Pescatori M, Lovreglio R
Dipartimento di Emergenza e Trapianti d'Organo, Università di Bari, Italy.
Dis Colon Rectum. 2000 Feb;43(2):174-9; discussion 179-81. doi: 10.1007/BF02236977.
Internal anal sphincterotomy for treating chronic anal fissure can irreversibly damage anal continence. Reversible chemical sphincterotomy may be achieved by anal application of glyceryl trinitrate ointment (nitric oxide donor), which has been reported to heal the majority of patients with anal fissure by inducing sphincter relaxation and improving anodermal blood flow. This trial aimed to further clarify the role of glyceryl trinitrate in the treatment of chronic anal fissure.
A total of 132 consecutive patients from nine centers were randomly assigned to receive 0.2 percent glyceryl trinitrate ointment or placebo twice daily for at least four weeks. The severity of pain and maximum anal resting pressure were measured before and after one week of treatment. Anodermal blood flow was measured before and after application of glyceryl trinitrate or placebo in ten patients.
The study was completed by 119 patients (59 glyceryl trinitrate and 60 placebo), matched for gender, age, duration of symptoms, duration of treatment, site of fissure, previous attempts to treat, pain score, and maximum anal resting pressure. Twenty-nine patients (49.2 percent) healed after glyceryl trinitrate and 31 patients (51.7 percent) healed after placebo (P = not significant). Pain score fell significantly in both groups, in addition to maximum anal resting pressure. Anodermal blood flow improved significantly in seven patients receiving glyceryl trinitrate, but not in the three receiving placebo. Twenty-three patients (33.8 percent) experienced headache and 4 (5.9 percent), orthostatic hypotension after glyceryl trinitrate.
This trial fails to demonstrate any superiority of topical 0.2 percent glyceryl trinitrate treatment vs. a placebo, although the effects of glyceryl trinitrate on anodermal blood flow and sphincter pressure are confirmed. This finding, together with the high incidence of side-effects, should discourage the use of this treatment as a substitute for surgery in chronic anal fissure.
内括约肌切开术治疗慢性肛裂会不可逆转地损害肛门节制功能。通过在肛门局部应用硝酸甘油软膏（一氧化氮供体）可实现可逆性化学性括约肌切开术，据报道，该方法可通过诱导括约肌松弛和改善肛管皮肤血流治愈大多数肛裂患者。本试验旨在进一步阐明硝酸甘油在慢性肛裂治疗中的作用。
来自9个中心的132例连续患者被随机分配，每天两次接受0.2%硝酸甘油软膏或安慰剂治疗，至少治疗4周。在治疗1周前后测量疼痛严重程度和最大肛门静息压。对10例患者在应用硝酸甘油或安慰剂前后测量肛管皮肤血流。
119例患者（59例硝酸甘油组和60例安慰剂组）完成了研究，两组在性别、年龄、症状持续时间、治疗持续时间、肛裂部位、既往治疗尝试、疼痛评分和最大肛门静息压方面相匹配。硝酸甘油组29例患者（49.2%）愈合，安慰剂组31例患者（51.7%）愈合（P值无统计学意义）。两组的疼痛评分和最大肛门静息压均显著下降。7例接受硝酸甘油治疗的患者肛管皮肤血流显著改善，而3例接受安慰剂治疗的患者未改善。硝酸甘油治疗后，23例患者（33.8%）出现头痛，4例患者（5.9%）出现体位性低血压。
本试验未能证明局部应用0.2%硝酸甘油治疗相对于安慰剂有任何优势，尽管硝酸甘油对肛管皮肤血流和括约肌压力的影响得到了证实。这一发现，连同高发生率的副作用，应不鼓励将该治疗方法作为慢性肛裂手术的替代方法使用。
