Centre for Inflammatory Bowel Diseases, Department of Gastroenterology, Fremantle Hospital, Fremantle, Western Australia, Australia.
J Gastroenterol Hepatol. 2011 Jan;26(1):36-43. doi: 10.1111/j.1440-1746.2010.06497.x.
Rectally administered topical agents have demonstrated efficacy in the maintenance of distal colitis (DC) and proctitis and as they are rarely associated with significant blood drug levels, side effects are infrequent. The topical 5-aminosalicylic acid (5-ASA) suppositories and enemas target different regions of the distal colon and are effective for proctitis and DC, respectively. They demonstrate clinical results that are better than oral 5-ASAs and are preferred to topical steroids with better clinical, endoscopic and histological outcomes, without the risk of adrenal suppression. Disease resistant to topical agents, however, can be extremely difficult to manage. The addition of oral 5ASAs, steroids, immunosuppressants and the anti-tumor necrosis factor-α agents may be effective, but can result in significant side effects and not all patients will respond to the therapies. It is for these patients that new and novel therapies are required. Novel topical agents have been proposed for the management of resistant DC. These agents included butyrate, cyclosporine, and nicotine enemas, as well as tacrolimus suppositories, and tacrolimus, ecabet sodium, arsenic, lidocaine, bismuth, rebamipide and thromboxane enemas. While some of these agents appear to demonstrate impressive outcomes, the majority have only been examined in small open-labeled studies. There is thus a desperate need for more randomized double-blinded placebo controlled studies to investigate the clinical utility of these topical therapies. This review summarizes the efficacy of the established topical therapies, and explores the available data on the new and novel topical agents for the management of DC and proctitis.
直肠给予局部制剂已被证明对维持远端结肠炎(DC)和直肠炎有效,并且由于它们很少与显著的血液药物水平相关,因此副作用不常见。局部 5-氨基水杨酸(5-ASA)栓剂和灌肠剂针对远端结肠的不同区域,分别对直肠炎和 DC 有效。它们显示出优于口服 5-ASA 的临床效果,并且优于局部类固醇,具有更好的临床、内镜和组织学结果,而没有肾上腺抑制的风险。然而,对抗局部制剂的疾病可能极难治疗。添加口服 5-ASA、类固醇、免疫抑制剂和抗肿瘤坏死因子-α 制剂可能有效,但会导致严重的副作用,并非所有患者都会对这些治疗产生反应。正是这些患者需要新的和新颖的治疗方法。已经提出了一些新的局部制剂来治疗难治性 DC。这些制剂包括丁酸盐、环孢素和尼古丁灌肠剂,以及他克莫司栓剂、他克莫司、依卡倍特钠、砷、利多卡因、铋、瑞巴派特和血栓素灌肠剂。虽然其中一些制剂似乎显示出令人印象深刻的结果,但大多数仅在小型开放标签研究中进行了检查。因此,迫切需要更多的随机双盲安慰剂对照研究来研究这些局部治疗的临床实用性。本综述总结了既定局部治疗的疗效,并探讨了新的和新颖的局部制剂治疗 DC 和直肠炎的现有数据。