Sandborn W, McLeod R, Jewell D
Division of Gastroenterology, Department of Internal Medicine, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA.
Cochrane Database Syst Rev. 2000(2):CD001176. doi: 10.1002/14651858.CD001176.
To determine the effectiveness of medical therapy (including metronidazole, bismuth carbomer enemas, oral probiotic bacteria, butyrate suppositories, and glutamine suppositories) for inducing a response or maintaining remission in pouchitis.
Studies were selected using the MEDLINE data base (1966 - December 1997), abstracts from major gastrointestinal meetings and references from published articles and reviews. The Cochrane Controlled Trials Register and the Inflammatory Bowel Disease Review Group Trials Register were also searched.
Four randomized controlled trials of medical therapy in adult patients with pouchitis were identified: two placebo controlled trials in active chronic pouchitis; one maintenance of remission trial comparing two active agents in chronic pouchitis; and one placebo-controlled maintenance of remission trial for chronic pouchitis. A single patient "n-of-1" trial for active chronic pouchitis was excluded.
Data were extracted by three independent observers based on the intention to treat principle. Each study was given a quality score based on predetermined criteria. Extracted data were converted to 2X2 tables (response versus no response and medical therapy versus placebo or medical therapy versus medical therapy) and then synthesized in to a summary statistic using the pooled odds ratio and 95% confidence intervals as described by Cochran and Mantel and Haenszel (the "odds ratio" in MetaView).
The odds ratios of inducing a response using oral metronidazole or bismuth carbomer foam enemas compared with placebo in active chronic pouchitis were 26.67 (95% CI 2.31-308.01) and 1.00 (95% CI 0.29-3.48), respectively. The numbers needed to treat with these therapies to prevent an additional relapse was 2 for oral metronidazole, and undefined for bismuth carbomer foam enemas (due to equal efficacy between the enema and placebo). The odds ratio of maintaining remission in chronic pouchitis for oral probiotic bacteria (VSL-3) compared with placebo was 205.00 (95% CI 9.89-4247.71), while the number needed to treat to prevent one additional relapse was 2. After discontinuation of suppressive medical therapy for chronic pouchitis, there was no difference in the odds ratio of maintaining symptomatic remission with glutamine suppositories compared to butyrate suppositories, 3. 00 (95% CI 0.46-19.59). The numbers needed to treat with glutamine suppositories to prevent an additional relapse was 4.
REVIEWER'S CONCLUSIONS: The results presented in this review must be interpreted with extreme caution given the small numbers of trials and patients evaluated for any one comparison. Metronidazole appears to be an effective therapy for active chronic pouchitis. Bismuth carbomer foam enemas may not be an effective therapy for chronic active pouchitis. Oral probiotic therapy with VSL-3 appears to be an effective therapy for maintaining remission in patients with chronic pouchitis in remission. There is no evidence of a difference in the maintenance of symptomatic remission in patients with chronic pouchitis treated with glutamine versus butyrate suppositories, and it is unknown whether glutamine and butyrate are equally effective or ineffective. Additional randomized, double-blind, placebo-controlled, dose-ranging clinical trials are needed to determine the efficacy of empiric medical therapies currently being used in patients with pouchitis.
确定药物治疗（包括甲硝唑、卡波姆铋灌肠剂、口服益生菌、丁酸盐栓剂和谷氨酰胺栓剂）在诱导袋炎缓解或维持缓解方面的有效性。
使用MEDLINE数据库（1966年 - 1997年12月）、主要胃肠病学会议的摘要以及已发表文章和综述中的参考文献来选择研究。还检索了Cochrane对照试验注册库和炎症性肠病综述组试验注册库。
确定了四项针对成年袋炎患者的药物治疗随机对照试验：两项针对活动性慢性袋炎的安慰剂对照试验；一项在慢性袋炎中比较两种活性药物的缓解维持试验；以及一项针对慢性袋炎的安慰剂对照缓解维持试验。一项针对活动性慢性袋炎的单例患者“n-of-1”试验被排除。
由三名独立观察者根据意向性治疗原则提取数据。每项研究根据预定标准给予质量评分。提取的数据被转换为2×2表格（缓解与未缓解以及药物治疗与安慰剂或药物治疗与药物治疗），然后使用Cochran、Mantel和Haenszel描述的合并比值比和95%置信区间（MetaView中的“比值比”）将其综合为一个汇总统计量。
在活动性慢性袋炎中，与安慰剂相比，使用口服甲硝唑或卡波姆铋泡沫灌肠剂诱导缓解的比值比分别为26.67（95%CI 2.31 - 308.01）和1.00（95%CI 0.29 - 3.48）。用这些疗法预防额外复发所需治疗的人数，口服甲硝唑为2人，卡波姆铋泡沫灌肠剂未确定（因为灌肠剂与安慰剂疗效相同）。与安慰剂相比，口服益生菌（VSL-3）在慢性袋炎中维持缓解的比值比为205.00（95%CI 9.89 - 4247.71），预防一次额外复发所需治疗的人数为2人。在停止对慢性袋炎的抑制性药物治疗后，与丁酸盐栓剂相比，谷氨酰胺栓剂维持症状缓解的比值比无差异，为3.00（95%CI 0.46 - 19.59）。用谷氨酰胺栓剂预防额外复发所需治疗的人数为4人。
鉴于针对任何一项比较评估的试验和患者数量较少，本综述中呈现的结果必须极其谨慎地解读。甲硝唑似乎是活动性慢性袋炎的有效治疗方法。卡波姆铋泡沫灌肠剂可能不是慢性活动性袋炎的有效治疗方法。使用VSL-3进行口服益生菌治疗似乎是慢性袋炎缓解期患者维持缓解的有效治疗方法。没有证据表明用谷氨酰胺与丁酸盐栓剂治疗的慢性袋炎患者在维持症状缓解方面存在差异，并且谷氨酰胺和丁酸盐是同样有效还是无效尚不清楚。需要进行更多的随机、双盲、安慰剂对照、剂量范围临床试验，以确定目前用于袋炎患者的经验性药物治疗的疗效。
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