Mínguez M, Melo F, Espí A, García-Granero E, Mora F, Lledó S, Benages A
Department of Gastroenterology, Clinic Hospital, University of Valencia, Spain.
Dis Colon Rectum. 1999 Aug;42(8):1016-21. doi: 10.1007/BF02236694.
The aim of this study was to evaluate the clinical and manometric results of three different doses of botulinum toxin and two methods of injection for the treatment of chronic idiopathic anal fissure.
Sixty-nine patients with chronic anal fissure were included in a non-randomized, prospective trial of intrasphincteric injection of botulinum toxin. All patients reported postdefecatory anal pain lasting more than two months. Scoring systems were developed for anal pain, bleeding, and defecatory difficulty. Maximum resting and squeeze anal pressures were determined before and one month after treatment. Twenty-three patients undergoing a 5-U injection of diluted botulinum toxin A (BOTOX) on each side of the anal sphincter (total dose, 10 U) constituted the first group. In a second group 27 patients were injected as previously described, with an additional 5-U injection below the fissure (total dose, 15 U). The 19 patients constituting the third group received a 7-U injection on each side of the anus and below the fissure (total dose, 21 U). All patients were followed up for at least six months.
Pain relief one month after treatment was more evident in the second and the third group (48 percent of patients in the first group, 74 percent in the second group, and 100 percent in the third group). A significant reduction of the mean resting pressure was demonstrated only in Groups II and III (P < 0.05), whereas the mean squeeze pressure significantly decreased in the three groups (P < 0.01 in Group I and P < 0.001 in Groups II and III). Fifty-two percent of the patients in the first group, 30 percent in the second group, and 37 percent in the third group were reinjected during the follow-up period, because of persistence of symptomatology or early relapse. The need for surgery was similar in the first and the second group (17 and 19 percent, respectively) and clearly lower in the last group (5 percent). No serious complications or incontinence attributable to this therapeutic modality developed in any patient.
Intrasphincteric injection of botulinum toxin is a reliable new option in the treatment of uncomplicated chronic anal fissure. The healing rate is related to the dose and probably to the number of puncture sites. No permanent damage to the continence mechanism was detected in these patients.
本研究旨在评估三种不同剂量的肉毒杆菌毒素及两种注射方法治疗慢性特发性肛裂的临床和测压结果。
69例慢性肛裂患者纳入一项非随机前瞻性肉毒杆菌毒素括约肌内注射试验。所有患者均报告排便后肛门疼痛持续超过两个月。制定了肛门疼痛、出血和排便困难的评分系统。在治疗前及治疗后1个月测定静息和用力时的最大肛管压力。23例患者在肛门括约肌两侧各注射5单位稀释的A型肉毒杆菌毒素（保妥适）（总剂量10单位），构成第一组。第二组27例患者按上述方法注射，在肛裂下方额外注射5单位（总剂量15单位）。第三组19例患者在肛门两侧及肛裂下方各注射7单位（总剂量21单位）。所有患者至少随访6个月。
治疗后1个月，第二组和第三组的疼痛缓解更明显（第一组48%的患者，第二组74%，第三组100%）。仅在第二组和第三组观察到平均静息压力显著降低（P<0.05），而三组的平均用力压力均显著降低（第一组P<0.01，第二组和第三组P<0.001）。随访期间，第一组52%的患者、第二组30%的患者和第三组37%的患者因症状持续或早期复发而再次注射。第一组和第二组的手术需求相似（分别为17%和19%），最后一组明显较低（5%）。所有患者均未出现归因于该治疗方式的严重并发症或失禁。
括约肌内注射肉毒杆菌毒素是治疗单纯性慢性肛裂的一种可靠新选择。愈合率与剂量及可能的穿刺部位数量有关。在这些患者中未检测到对控便机制的永久性损害。
