Barberio Brigida, Marsilio Ilaria, Buda Andrea, Bertin Luisa, Semprucci Gianluca, Zanini Annalisa, Crepaldi Martina, Zingone Fabiana, Savarino Edoardo
Division of Gastroenterology, Department of Surgery, Oncology and Gastroenterology, University of Padua, Via Giustiniani N.2, Padua 35122, Italy.
Division of Gastroenterology, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.
Therap Adv Gastroenterol. 2023 Aug 1;16:17562848231188549. doi: 10.1177/17562848231188549. eCollection 2023.
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).
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.
Systematic review and meta-analysis.
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.
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 placebo, one RCT BDP 10 mg placebo, two RCTs budesonide MMX 9 mg 5-ASA, and six RCTs budesonide MMX 9 mg 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.
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.
已研发出生物利用度低的类固醇药物，包括二丙酸倍氯米松（BDP）和布地奈德多微粒体（budesonide MMX），以确保在治疗溃疡性结肠炎（UC）患者时实现结肠靶向作用且全身活性低于系统性皮质类固醇。
本系统评价和荟萃分析评估了BDP和布地奈德多微粒体与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。
系统评价和荟萃分析。
我们检索了从数据库建立至2021年12月的MEDLINE、EMBASE和Cochrane对照试验中央注册库。我们纳入了所有比较口服BDP或布地奈德多微粒体与5-ASA或安慰剂用于诱导轻至中度UC缓解的随机对照试验（RCT）。计算比值比（OR）和95%置信区间（CI）。
我们确定了两项比较5mg BDP与5-ASA的RCT、一项比较10mg BDP与5-ASA的RCT、两项BDP 5mg与安慰剂比较的RCT、一项BDP 10mg与安慰剂比较的RCT、两项布地奈德多微粒体9mg与5-ASA比较的RCT以及六项布地奈德多微粒体9mg与安慰剂比较的RCT。在实现临床缓解或改善方面，5mg BDP、10mg BDP和9mg布地奈德多微粒体比安慰剂更有效（OR分别为2.36，95%CI 1.37 - 4.08；OR 2.23，95%CI 1.02 - 4.87；以及OR 2.03，95%CI 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，我们发现在实现临床缓解或改善方面，5-ASA与5mg BDP或10mg BDP或9mg布地奈德多微粒体之间没有差异（OR分别为0.90，95%CI 0.51 - 1.57；OR 1.54，95%CI 0.42 - 5.64；以及OR 1.17，95%CI 0.82 - 1.66）。然而，5-ASA在实现组织学缓解方面比9mg布地奈德多微粒体更有效（OR 0.33，95%CI 0.16 - 0.70）。总体而言，所有药物均安全且耐受性良好。
生物利用度低的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与BDP或布地奈德多微粒体之间未发现差异。当然，还需要更多的RCT（也包括比较BDP和布地奈德多微粒体的试验）来证实或否定这些结果。
