Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA; Gastroenterology Unit, Amiens University and Hospital, Université de Picardie Jules Verne, Amiens, France.
Lancet Gastroenterol Hepatol. 2018 Nov;3(11):742-753. doi: 10.1016/S2468-1253(18)30231-0. Epub 2018 Aug 17.
The majority of patients with ulcerative colitis have mildly to moderately active disease. To inform the management of patients with left-sided or extensive mildly to moderately active ulcerative colitis, we assessed the comparative efficacy and tolerability of different therapies.
In this systematic review and network meta-analysis, we searched Epub, MEDLINE In-Process & Other Non-Indexed Citations, MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Scopus, and Web of Science from inception to Dec 14, 2015, and updated on MEDLINE on March 1, 2018, for randomised controlled trials in adults (age ≥17 years) with left-sided or extensive mild to moderate ulcerative colitis. Studies were included if patients were treated with oral sulfasalazine, diazo-bonded 5-aminosalicylates (5-ASAs), mesalazine (low dose <2 g/day, standard dose 2-3 g/day, or high dose >3 g/day), controlled ileal-release budesonide, or budesonide multimatrix, alone or in combination with rectal 5-ASA therapy, and were compared with each other or placebo for induction or maintenance of clinical remission. The minimum duration of therapy was 4 weeks for trials of induction and 24 weeks for trials of maintenance therapy. We did pairwise and random-effects network meta-analysis using a frequentist approach, and calculated odds ratios (ORs) and 95% CIs; agents were ranked using surface under the cumulative ranking (SUCRA) probabilities. We used Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria to appraise quality of evidence. We examined heterogeneity with the I statistic.
Our search identified 1316 unique studies, from which 75 randomised trials with 12 215 patients were eligible for analysis. Based on 48 induction randomised trials (8020 participants) that met inclusion criteria, combined oral and rectal 5-ASAs (SUCRA 0·99) and high-dose mesalazine (>3 g/day; SUCRA 0·82) were ranked highest for induction of remission. Both interventions were superior to standard-dose mesalazine (2-3 g/day; failure to induce remission with combined oral and rectal 5-ASAs OR 0·41, 95% CI 0·22-0·77; high-dose mesalazine 0·78, 0·66-0·93) with moderate confidence in estimates. On the basis of 28 randomised trials (4218 participants) that met inclusion criteria, all interventions were superior to placebo for maintenance of remission; however, neither combined oral and rectal 5-ASAs nor high-dose mesalazine were superior to standard-dose mesalazine.
In patients with mildly to moderately active left-sided or extensive ulcerative colitis, combined oral and topical mesalazine therapy and high-dose mesalazine are superior to standard-dose mesalazine for induction of remission, but not maintenance of remission. Standard-dose mesalazine might be preferred for maintenance in most patients.
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大多数溃疡性结肠炎患者的疾病处于轻度至中度活动期。为了为左半结肠炎或广泛性轻度至中度溃疡性结肠炎患者的治疗提供信息，我们评估了不同治疗方法的疗效和耐受性。
在这项系统评价和网络荟萃分析中，我们从建库到 2015 年 12 月 14 日检索了 Epub、MEDLINE In-Process & 其他非索引引文、MEDLINE、Embase、Cochrane 对照试验注册中心、Cochrane 系统评价数据库、Scopus 和 Web of Science，并于 2018 年 3 月 1 日在 MEDLINE 上进行了更新，以纳入成年（年龄≥17 岁）左半结肠炎或广泛性轻度至中度溃疡性结肠炎的随机对照试验。如果患者接受了口服柳氮磺胺吡啶、偶氮键合 5-氨基水杨酸（5-ASA）、美沙拉嗪（低剂量＜2g/天、标准剂量 2-3g/天或高剂量＞3g/天）、受控回肠释放布地奈德或布地奈德多基质治疗，并且与其他治疗或安慰剂进行比较，用于诱导或维持临床缓解，则将其纳入研究。治疗的最短疗程为诱导治疗 4 周，维持治疗 24 周。我们采用了贝叶斯网络荟萃分析，使用了似然比检验，计算了比值比（OR）和 95%置信区间（CI）；使用累积排序曲线下面积（SUCRA）概率对药物进行了排名。我们使用推荐分级的评估、制定与评价（GRADE）标准来评估证据质量。我们用 I ² 检验来评估异质性。
我们的搜索共识别出 1316 项独特的研究，其中 75 项随机试验（12215 例患者）符合纳入分析的标准。基于 48 项诱导随机试验（8020 例患者），联合口服和直肠 5-ASA（SUCRA 0.99）和高剂量美沙拉嗪（＞3g/天；SUCRA 0.82）在诱导缓解方面排名最高。这两种干预措施均优于标准剂量美沙拉嗪（2-3g/天；联合口服和直肠 5-ASA 诱导缓解失败的 OR 0.41，95%CI 0.22-0.77；高剂量美沙拉嗪 0.78，0.66-0.93），其估计值有中度可信度。基于 28 项符合纳入标准的随机试验（4218 例患者），所有干预措施均优于安慰剂维持缓解；然而，联合口服和直肠 5-ASA 或高剂量美沙拉嗪均不如标准剂量美沙拉嗪。
对于轻度至中度活动期左半结肠炎或广泛性溃疡性结肠炎患者，联合口服和局部美沙拉嗪治疗以及高剂量美沙拉嗪在诱导缓解方面优于标准剂量美沙拉嗪，但在维持缓解方面无优势。在大多数患者中，标准剂量美沙拉嗪可能更适合维持治疗。
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