Background Low bioavailability steroids, including beclomethasone dipropionate (BDP) and budesonide MMX, have been developed to ensure colonic targeting and low systemic activity than systematic corticosteroids in treating patients with ulcerative colitis (UC). Objectives This systematic review and meta-analysis evaluated the efficacy and safety of BDP and budesonide MMX® compared with 5-aminosalicylic acid (5-ASAs) or placebo, in patients with mild-to-moderate UC. Design Systematic review and meta-analysis. Methods We searched MEDLINE, EMBASE, and the Cochrane central register of controlled trials from inception to December 2021. We included all available randomized controlled trials (RCTs) comparing oral BDP or budesonide MMX with 5-ASAs or with placebo in induction of remission of mild-to-moderate UC. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. Results We identified two RCTs comparing BDP 5 mg with 5-ASA, one RCTs comparing BDP 10 mg with 5-ASA, two RCTs BDP 5 mg versus placebo, one RCT BDP 10 mg versus placebo, two RCTs budesonide MMX 9 mg versus 5-ASA, and six RCTs budesonide MMX 9 mg versus placebo. In terms of achieving clinical remission or improvement, BDP 5 mg, BDP 10 mg, and budesonide MMX 9 mg were more effective than placebo (OR 2.36, 95% CI 1.37-4.08; OR 2.23, 95% CI 1.02-4.87; and OR 2.03, 95% CI 1.45-2.85, respectively). The drugs were also more effective than placebo in achieving endoscopic remission. Regarding the comparisons with 5-ASA, we found no differences between 5-ASA and BDP 5 mg or BDP 10 mg or budesonide MMX 9 mg in achieving clinical remission or improvement (OR 0.90, 95% CI 0.51-1.57; OR 1.54, 95% CI 0.42-5.64; and OR 1.17, 95% CI 0.82-1.66). However, 5-ASA was more effective than budesonide MMX 9 mg in achieving histological remission (OR 0.33, 95% CI 0.16-0.70). Overall, all the drugs were safe and well tolerated. Conclusion Low bioavailability steroids were more effective than placebo in achieving clinical remission, clinical and endoscopic remission, and histological remission. No differences were found between 5-ASA and BDP or budesonide MMX. Surely, more RCTs, also comparing BDP and budesonide MMX, are mandatory to confirm or not these results.

中文翻译：

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口服二丙酸倍氯米松和布地奈德 MMX 与 5-氨基水杨酸盐​​或安慰剂治疗溃疡性结肠炎的疗效和安全性：系统评价和荟萃分析。

背景 低生物利用度类固醇，包括二丙酸倍氯米松 (BDP) 和布地奈德 MMX，在治疗溃疡性结肠炎 (UC) 患者时，是为了确保结肠靶向性和比系统性皮质类固醇低的全身活性。目的 这项系统评价和荟萃分析评估了 BDP 和布地奈德 MMX® 与 5-氨基水杨酸 (5-ASA) 或安慰剂相比，在轻至中度 UC 患者中的疗效和安全性。设计系统回顾和荟萃分析。方法 我们检索了 MEDLINE、EMBASE 和 Cochrane 对照试验中央注册库。我们纳入了所有可用的随机对照试验 (RCT)，这些试验比较口服 BDP 或布地奈德 MMX 与 5-ASA 或安慰剂在诱导轻度症状缓解方面的作用。 - 至中度 UC。计算优势比 (OR) 和 95% 置信区间 (CI)。结果 我们确定了两项比较 BDP 5 mg 与 5-ASA 的随机对照试验、一项比较 BDP 10 mg 与 5-ASA 的随机对照试验、两项 BDP 5 mg 与安慰剂的随机对照试验、一项 BDP 10 mg 与安慰剂的随机对照试验、两项布地奈德 MMX 9 mg 与 5-ASA 的随机对照试验。 ASA 和 6 项随机对照试验：布地奈德 MMX 9 mg 与安慰剂相比。在实现临床缓解或改善方面，BDP 5 mg、BDP 10 mg 和布地奈德 MMX 9 mg 比安慰剂更有效（OR 2.36，95% CI 1.37-4.08；OR 2.23，95% CI 1.02-4.87；OR 2.23，95% CI 1.02-4.87；OR 2.03，95% CI 分别为 1.45-2.85）。这些药物在实现内镜缓解方面也比安慰剂更有效。关于与 5-ASA 的比较，我们发现 5-ASA 与 BDP 5 mg 或 BDP 10 mg 或布地奈德 MMX 9 mg 在实现临床缓解或改善方面没有差异（OR 0.90，95% CI 0.51-1.57；OR 1.54，95） % CI 0.42-5.64；OR 1.17，95% CI 0.82-1.66）。然而，5-ASA 在实现组织学缓解方面比布地奈德 MMX 9 mg 更有效（OR 0.33，95% CI 0.16-0.70）。总体而言，所有药物都是安全且耐受性良好的。结论 低生物利用度类固醇在实现临床缓解、临床和内镜缓解以及组织学缓解方面比安慰剂更有效。5-ASA 和 BDP 或布地奈德 MMX 之间没有发现差异。当然，必须进行更多的随机对照试验（同时比较 BDP 和布地奈德 MMX）来确认或否定这些结果。