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采用 Dysport(®)注射肉毒毒素治疗慢性肛裂:剂量发现研究。

Chronic anal fissures treated with botulinum toxin injections: a dose-finding study with Dysport(®).

机构信息

Department of Neurology and Clininical Neurophysiology, Deutsche Klinik für Diagnostik, Wiesbaden, Germany.

出版信息

Colorectal Dis. 1999 Jan;1(1):26-8. doi: 10.1046/j.1463-1318.1999.00006.x.

DOI:10.1046/j.1463-1318.1999.00006.x
PMID:23577680
Abstract

Botox(®) injection of the anal sphincter muscle cures chronic uncomplicated anal fissures in up to 80% of patients. This study examines the therapeutic efficacy and side effect profile of the British botulinum product Dysport(®) . Fifty patients (29 women) were recruited to participate in this randomized dose-finding study, their mean age being 32.9 years. The low dose group A was treated with a total dose of 20 U injected in two sites each lateral to the fissure, the high dose group B was treated with 40 U. Eighty-two percent of patients were pain-free within a week following the injections. The fissure was healed in 78% of treated patients after 3 months. Three patients relapsed within 6 months. The most common adverse side effect was transient incontinence (n = 4). Clinical outcome was not significantly different between the two treatment groups. The low dose can therefore be regarded sufficient for the treatment of anal fissure. Therapeutic efficacy was equivalent to published data on Botox treatment. Both Dysport(®) and Botox(®) can therefore be used to treat chronic uncomplicated anal fissures. Both Dysport(®) and Botox(®) therapy are well tolerated, can be performed on an out-patient basis and avoid the risk of permanent faecal incontinence which complicates surgical treatment of anal fissures.

摘要

肉毒杆菌毒素(®)肛门括约肌注射可治愈高达 80%的慢性非复杂性肛裂患者。本研究探讨了英国肉毒杆菌产品 Dysport(®)的治疗效果和副作用特征。50 名患者(29 名女性)参与了这项随机剂量发现研究,平均年龄为 32.9 岁。低剂量组 A 在肛裂两侧的两个部位注射 20 个单位,高剂量组 B 注射 40 个单位。注射后一周内,82%的患者疼痛消失。治疗 3 个月后,78%的患者肛裂愈合。3 名患者在 6 个月内复发。最常见的不良反应是短暂性失禁(n=4)。两组治疗的临床结果无显著差异。因此,低剂量可被视为治疗肛裂的足够剂量。治疗效果与肉毒杆菌毒素治疗的已发表数据相当。Dysport(®)和 Botox(®)均可用于治疗慢性非复杂性肛裂。Dysport(®)和 Botox(®)治疗均耐受良好,可在门诊进行,避免了肛裂手术治疗中常见的永久性粪便失禁的风险。

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