Kumar Aditi, Hiner George, Brookes Matthew J, Segal Jonathan P
Department of Gastroenterology, The Royal Wolverhampton NHS Trust, Wolverhampton Road, Wolverhampton, West Midlands wv10 0qp, UK.
Department of Gastroenterology, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, UK.
Therap Adv Gastroenterol. 2023 Feb 24;16:17562848231154319. doi: 10.1177/17562848231154319. eCollection 2023.
The mainstay of treatment for microscopic colitis (MC) is budesonide. However, the optimal formulation and dosage of budesonide to induce and maintain remission has not yet been clearly demonstrated.
To compare the data for efficacy and safety of treatments to induce and maintain remission for MC.
We conducted a meta-analysis of randomised controlled trials (RCTs) comparing treatment with each other or placebo for induction and maintenance of clinical and histological remission in MC.
We searched MEDLINE (1946 to May 2021), EMBASE and EMBASE Classis (1947 to May 2021), the Cochrane central register of controlled trials (Issue 2, May 2021) and conference proceedings between 2006 and 2020. Results were reported as pooled relative risks (RRs) with 95% confidence intervals (CIs) to summarise the effect of each comparison tested, with treatments ranked according to p score.
We identified 15 RCTs in total for the treatment of MC. Entocort 9 mg ranked first for clinical (RR: 4.89, CI: 2.43-9.83; p score: 0.86) and histological (RR: 13.39, CI: 1.92-93.44; p score 0.94) induction of remission, whilst VSL#3 ranked second for clinical induction (RR: 5.30, CI: 0.68-41.39; p score 0.81). Budenofalk 6 mg/3 mg alternate day dosing ranked first for clinical maintenance of remission (RR: 3.68, CI: 0.08-159.92, p-score 0.65). Entocort and Budenofalk were associated with the greatest adverse events for induction and maintenance of clinical remission, respectively, although the overall withdrawal numbers for treatment placebo groups were 10.9% (22/201) and 10.5% (20/190), respectively.
Entocort 9 mg/day ranked first among the treatment options in inducing remission and Budenofalk 6 mg/3 mg alternate day dosing for maintaining remission in the treatment of MC. Moving forward, mechanistic studies exploring the differences between Entocort and Budenofalk would be valuable whilst future RCT studies are needed in non-corticosteroidal maintenance, particularly looking into immunomodulators, biologics and probiotics.
显微镜下结肠炎（MC）的主要治疗药物是布地奈德。然而，布地奈德诱导和维持缓解的最佳剂型和剂量尚未明确。
比较MC诱导和维持缓解治疗的疗效和安全性数据。
我们对随机对照试验（RCT）进行了荟萃分析，比较了MC诱导和维持临床及组织学缓解的相互治疗或与安慰剂治疗。
我们检索了MEDLINE（1946年至2021年5月）、EMBASE和EMBASE经典数据库（1947年至2021年5月）、Cochrane对照试验中央注册库（2021年第2期）以及2006年至2020年的会议记录。结果以合并相对风险（RRs）和95%置信区间（CIs）报告，以总结每个测试比较的效果，并根据p值对治疗进行排名。
我们共确定了15项治疗MC的RCT。在临床（RR：4.89，CI：2.43 - 9.83；p值：0.86）和组织学（RR：13.39，CI：1.92 - 93.44；p值0.94）诱导缓解方面，9毫克的Entocort排名第一，而在临床诱导方面，VSL#3排名第二（RR：5.30，CI：0.68 - 41.39；p值0.81）。布地奈德6毫克/3毫克隔日给药在临床维持缓解方面排名第一（RR：3.68，CI：0.08 - 159.92，p值0.65）。Entocort和布地奈德分别在诱导和维持临床缓解方面与最大的不良事件相关，尽管治疗组与安慰剂组的总体退出率分别为10.9%（22/201）和10.5%（20/190）。
在MC治疗中，9毫克/天的Entocort在诱导缓解的治疗选择中排名第一，布地奈德6毫克/3毫克隔日给药在维持缓解方面排名第一。展望未来，探索Entocort和布地奈德之间差异的机制研究将很有价值，同时在非皮质类固醇维持治疗方面，特别是免疫调节剂、生物制剂和益生菌方面，未来还需要进行RCT研究。
