Richard C S, Gregoire R, Plewes E A, Silverman R, Burul C, Buie D, Reznick R, Ross T, Burnstein M, O'Connor B I, Mukraj D, McLeod R S
Department of Surgery, University of Montreal, Quebec, Canada.
Dis Colon Rectum. 2000 Aug;43(8):1048-57; discussion 1057-8. doi: 10.1007/BF02236548.
This was a multicenter, randomized, controlled trial to compare the effectiveness of topical nitroglycerin with internal sphincterotomy in the treatment of chronic anal fissure.
Patients with symptomatic chronic anal fissures were randomly assigned to 0.25 percent nitroglycerin tid or internal sphincterotomy. Both groups received stool softeners and fiber supplements and were assessed at six weeks and six months.
Ninety patients were accrued, but 8 were excluded from the analysis because they refused internal sphincterotomy after randomization (6), the fissure healed before surgery (1), or a fissure was not observed at surgery (1). There were 38 patients in the internal sphincterotomy group (22 males; mean age, 40.3 years) and 44 patients in the nitroglycerin group (15 males; mean age, 38.7 years). At six weeks 34 patients (89.5 percent) in the internal sphincterotomy group compared with 13 patients (29.5 percent) in the nitroglycerin group had complete healing of the fissure (P = 5x10(-8)). Five of the 13 patients in the nitroglycerin group relapsed, whereas none in the internal sphincterotomy group did. At six months fissures in 35 (92.1 percent) patients in the internal sphincterotomy group compared with 12 (27.2 percent) patients in the nitroglycerin group had healed (P = 3x10(-9)). One (2.6 percent) patient in the internal sphincterotomy group required further surgery for a superficial fistula compared with 20 (45.4 percent) patients in the nitroglycerin group who required an internal sphincterotomy (P = 9x10(-6)). Eleven (28.9 percent) patients in the internal sphincterotomy group developed side effects compared with 37 (84 percent) patients in the nitroglycerin group (P<0.0001). Nine (20.5 percent) patients discontinued the nitroglycerin because of headaches (8) or a severe syncopal attack (1).
Internal sphincterotomy is superior to topical nitroglycerin 0.25 percent in the treatment of chronic anal fissure, with a high rate of healing, few side effects, and low risk of early incontinence. Thus, internal sphincterotomy remains the treatment of choice for chronic anal fissure.
这是一项多中心、随机、对照试验，旨在比较局部应用硝酸甘油与内括约肌切开术治疗慢性肛裂的疗效。
有症状的慢性肛裂患者被随机分为每日三次使用0.25%硝酸甘油组或内括约肌切开术组。两组均接受软化大便药物和纤维补充剂治疗，并在六周和六个月时进行评估。
共纳入90例患者，但8例被排除在分析之外，原因是随机分组后拒绝接受内括约肌切开术（6例）、肛裂在手术前愈合（1例）或手术时未观察到肛裂（1例）。内括约肌切开术组有38例患者（22例男性；平均年龄40.3岁），硝酸甘油组有44例患者（15例男性；平均年龄38.7岁）。六周时，内括约肌切开术组34例患者（89.5%）肛裂完全愈合，而硝酸甘油组为13例患者（29.5%）（P = 5×10⁻⁸）。硝酸甘油组13例患者中有5例复发，而内括约肌切开术组无复发。六个月时，内括约肌切开术组35例患者（92.1%）肛裂愈合，硝酸甘油组为12例患者（27.2%）（P = 3×10⁻⁹）。内括约肌切开术组1例（2.6%）患者因浅表肛瘘需要进一步手术，而硝酸甘油组20例（45.4%）患者需要行内括约肌切开术（P = 9×10⁻⁶）。内括约肌切开术组11例（28.9%）患者出现副作用，硝酸甘油组为37例（84%）患者（P<0.0001）。9例（20.5%）患者因头痛（8例）或严重晕厥发作（1例）停用硝酸甘油。
在内括约肌切开术治疗慢性肛裂方面优于局部应用0.25%硝酸甘油，愈合率高、副作用少且早期失禁风险低。因此，内括约肌切开术仍然是慢性肛裂的首选治疗方法。
