Nelson Richard L, Thomas Kathryn, Morgan Jenna, Jones Abigail
Department of General Surgery, Northern General Hospital, Sheffield, UK.
Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003431. doi: 10.1002/14651858.CD003431.pub3.
Because of the disability associated with surgery for anal fissure and the risk of incontinence, medical alternatives for surgery have been sought. Most recently, pharmacologic methods that relax the anal smooth muscle, to accomplish reversibly what occurs in surgery, have been used to obtain fissure healing.
To assess the efficacy and morbidity of various medical therapies for anal fissure.
Search terms include "anal fissure randomized". Timing from 1966 to August 2010. Further details of the search below.
Studies in which participants were randomized to a non-surgical therapy for anal fissure. Comparison groups may include an operative procedure, an alternate medical therapy or placebo. Chronic fissure, acute fissure and fissure in children are included in the review. Atypical fissures associated with inflammatory bowel disease or cancer or anal infection are excluded.
Data were abstracted from published reports and meeting abstracts, assessing method of randomization, blinding, "intention to treat" and drop-outs, therapies, supportive measures (applied to both groups), dosing and frequency and cross-overs. Dichotomous outcome measures included Non-healing of the fissure (a combination of persistence and recurrence), and Adverse events (including incontinence, headache, infection, anaphylaxis). Continuous outcome measures included measures of pain relief and anorectal manometry.
In this update 23 studies including 1236 participants is added to the 54 studies and 3904 participants in the 2008 publication, however 2 studies were from the last version reclassified as un included, so the final number of participants is 5031.49 different comparisons of the ability of medical therapies to heal anal fissure have been reported in 75 RCTs. Seventeen agents were used (nitroglycerin ointment (GTN), isosorbide mono & dinitrate, Botulinum toxin (Botox), diltiazem, nifedipine (Calcium channel blockers or CCBs), hydrocortisone, lignocaine, bran, minoxidil, indoramin, clove oil, L-arginine, sitz baths, sildenafil, "healer cream" and placebo) as well as Sitz baths, anal dilators and surgical sphincterotomy. GTN was found to be marginally but significantly better than placebo in healing anal fissure (48.9% vs. 35.5%, p < 0.0009), but late recurrence of fissure was common, in the range of 50% of those initially cured. Botox and CCBs were equivalent to GTN in efficacy with fewer adverse events. No medical therapy came close to the efficacy of surgical sphincterotomy, though none of the medical therapies in these RCTs were associated with the risk of incontinence.
AUTHORS' CONCLUSIONS: Medical therapy for chronic anal fissure, currently consisting of topical glyceryl trinitrate, botulinum toxin injection or the topical calcium channel blockers nifedipine or diltiazem in acute and chronic fissure and fissure in children may be applied with a chance of cure that is marginally better than placebo. For chronic fissure in adults all medical therapies are far less effective than surgery. A few of the newer agents investigated show promise based only upon single studies (clove oil, sildenifil and a "healer cream") but lack comparison to more established medications.
由于肛裂手术会导致残疾以及存在大便失禁的风险，人们一直在寻找手术的替代医学方法。最近，已采用能松弛肛门平滑肌的药理学方法来实现手术中可逆发生的情况，以促进肛裂愈合。
评估各种肛裂医学疗法的疗效和发病率。
检索词包括“肛裂随机对照试验”。检索时间为1966年至2010年8月。以下是检索的更多详细信息。
研究中参与者被随机分配接受肛裂的非手术治疗。比较组可能包括手术操作、替代医学疗法或安慰剂。本综述纳入慢性肛裂、急性肛裂和儿童肛裂。排除与炎症性肠病、癌症或肛门感染相关的非典型肛裂。
数据从已发表的报告和会议摘要中提取，评估随机化方法、盲法、“意向性治疗”和失访情况、治疗方法、支持措施（应用于两组）、给药剂量和频率以及交叉情况。二分法结局指标包括肛裂未愈合（持续性和复发性的综合情况）以及不良事件（包括大便失禁、头痛、感染、过敏反应）。连续性结局指标包括疼痛缓解程度和肛肠测压。
本次更新在2008年发表的54项研究和3904名参与者的基础上增加了23项研究和1236名参与者，不过有2项研究从上次版本重新分类为未纳入，所以最终参与者数量为5031名。75项随机对照试验报告了49种不同医学疗法治愈肛裂能力的比较。使用了17种药物（硝酸甘油软膏（GTN）、单硝酸异山梨酯和二硝酸异山梨酯、肉毒杆菌毒素（肉毒素）、地尔硫卓、硝苯地平（钙通道阻滞剂或CCBs）、氢化可的松、利多卡因、麸皮、米诺地尔、吲哚拉明、丁香油、L - 精氨酸、坐浴、西地那非、“愈合乳膏”和安慰剂）以及坐浴、肛门扩张器和手术括约肌切开术。发现GTN在愈合肛裂方面略优于安慰剂，但差异有统计学意义（48.9%对35.5%，p < 0.0009），不过肛裂后期复发很常见，在最初治愈者中复发率达50%左右。肉毒素和CCBs在疗效上与GTN相当，但不良事件较少。没有任何医学疗法能接近手术括约肌切开术的疗效，不过这些随机对照试验中的任何医学疗法都与大便失禁风险无关。
慢性肛裂目前的医学治疗方法，包括急性和慢性肛裂以及儿童肛裂中使用的局部硝酸甘油、肉毒杆菌毒素注射或局部钙通道阻滞剂硝苯地平或地尔硫卓，治愈几率可能略高于安慰剂。对于成人慢性肛裂，所有医学疗法的效果都远不如手术。一些新研究的药物仅基于单项研究显示出前景（丁香油、西地那非和一种“愈合乳膏”），但缺乏与更成熟药物的比较。
