Department of Biomedical Sciences, Humanitas University, Milan, Italy.
IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Center, Milan, Italy.
Br J Clin Pharmacol. 2019 Oct;85(10):2244-2254. doi: 10.1111/bcp.14051. Epub 2019 Jul 31.
The comparative efficacy, safety and tolerability of budesonide-MMX and oral mesalamine in active, mild-to-moderate ulcerative colitis (UC) are unclear. We conducted a network meta-analysis to fill this evidence gap.
We searched PubMed, Scopus, Embase, the Cochrane Library, clinical trial registries, regulatory agencies' websites and international conference proceedings, up to July 2018, to identify randomized controlled trials of adult patients with active, mild-to-moderate UC, comparing budesonide-MMX or mesalamine against placebo, or against each other, or different dosing strategies, for induction of remission. Two reviewers independently abstracted study data and outcomes, and assessed each trial's risk-of-bias.
We identified and synthesized evidence from 15 eligible trials including 4083 participants. Budesonide-MMX 9 mg/day and mesalamine >2.4 g/day had similar efficacy for induction of clinical and endoscopic remission (OR = 0.97; 0.59-1.60), both showing superiority over placebo (OR = 2.68; 1.75-4.10, and OR = 2.75; 1.94-3.90, respectively). Furthermore, mesalamine >2.4 g/day was more efficacious than mesalamine 1.6-2.4 g/day (odds ratio = 1.27; 1.03-1.56). Secondary analyses showed that mesalamine >2.4 g/day ranks at the top among comparator treatments regarding safety (serious adverse events; surface under the cumulative ranking area [SUCRA] 79.2%) and tolerability (treatment discontinuations or withdrawals from the study due to adverse events; SUCRA 96.7%). There was no evidence of inconsistency, while heterogeneity between studies and risk of publication bias were low.
Budesonide-MMX and mesalamine >2.4 g/day had similar efficacy for induction of clinical and endoscopic remission in active, mild-to-moderate UC; however, mesalamine >2.4 g/day showed better tolerability. Further high-quality research is warranted.
布地奈德 MMX 与口服美沙拉嗪治疗活动期轻度至中度溃疡性结肠炎（UC）的疗效、安全性和耐受性比较尚不明确。我们开展了一项网状荟萃分析以填补这一证据空白。
我们检索了 PubMed、Scopus、Embase、Cochrane 图书馆、临床试验注册数据库、监管机构网站和国际会议论文集，检索时限截至 2018 年 7 月，以确定比较成人活动期轻度至中度 UC 患者接受布地奈德 MMX 或美沙拉嗪与安慰剂，或彼此之间，或不同剂量方案治疗诱导缓解的随机对照试验。两名审查员独立提取研究数据和结局，并评估了每个试验的偏倚风险。
我们纳入了 15 项符合条件的试验并进行了证据综合，共纳入了 4083 名参与者。布地奈德 MMX 9mg/天和＞2.4g/天的美沙拉嗪治疗诱导临床和内镜缓解的疗效相似（OR=0.97；0.59-1.60），两者均优于安慰剂（OR=2.68；1.75-4.10 和 OR=2.75；1.94-3.90）。此外，＞2.4g/天的美沙拉嗪优于 1.6-2.4g/天的美沙拉嗪（比值比=1.27；1.03-1.56）。二次分析显示，在安全性（严重不良事件；累积排序概率曲线下面积 [SUCRA] 79.2%）和耐受性（因不良事件退出或终止研究；SUCRA 96.7%）方面，＞2.4g/天的美沙拉嗪在比较治疗方法中排名最高。没有证据表明存在不一致性，且研究间异质性和发表偏倚风险较低。
布地奈德 MMX 与＞2.4g/天的美沙拉嗪治疗活动期轻度至中度 UC 的临床和内镜缓解效果相似，但＞2.4g/天的美沙拉嗪具有更好的耐受性。需要进一步开展高质量的研究。
