Efficacy and safety of cyclosporine in colitis: An updated meta-analysis of randomized control trials (1998 to 2024).

IF 5.3 2区医学 Q2 IMMUNOLOGY

Inflammopharmacology Pub Date : 2025-10-09 DOI:10.1007/s10787-025-01988-4

Aqsa Mehreen, Faiza Batool, Uzma Azeem Awan, Shaista Aslam, Adnan Haider, Muneeb Ullah, Jin-Wook Yoo, Rida Fatima Saeed, Muhammad Naeem

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引用次数: 0

Abstract

Background: Ulcerative colitis (UC) is a chronic inflammatory condition affecting the large intestine that can progress to colorectal cancer if left untreated. Different therapeutic approaches are used for its treatment and cyclosporine is one of them. It has been investigated as a rescue treatment option in cases when patients are unresponsive to steroidal therapy. However, its efficacy and safety remain uncertain. This study aims to conduct a comprehensive analysis of clinical evidence on cyclosporine safety and efficacy for the treatment of UC.

Methods: Electronic databases, Cochrane Library, and PubMed were searched from 1998 till December 2024 to screen the relevant studies. A systematic approach was followed to pool and analyze the studies following the PICOS framework (population, intervention, comparison, outcome, and study design). Data was extracted systematically and analyzed using Comprehensive Meta-analysis software (CMA version 3), with the risk of bias evaluated using the RoB-2 tool, heterogeneity measured using I² statistic, and Publication bias was evaluated using funnel plots and Egger's test.

Results: Out of 27 studies initially identified, 6 studies meeting the eligibility criteria were included in the final analysis. The risk of bias was high in four studies for all the outcomes except for colectomy rates. Heterogeneity between studies was not significant for all outcomes. Analysis results demonstrated that there was no statistically significant difference between the clinical response (OR = 1.290, 95%CI 0.552-3.012, P = 0.557), colectomy rates (OR = 1.171, 95%CI 0.776-1.767, P = 0.452), and serious adverse events (OR = 0.592, 95%CI 0.313-1.120, P = 0.107) of cyclosporine in comparison with control group.

Conclusion: There is no statistically significant difference between cyclosporine compared to the control group in improving clinical outcomes for patients with ulcerative colitis. Future studies with larger sample sizes can explore its role with combination therapy in targeted patient sub-groups.

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环孢素治疗结肠炎的疗效和安全性：1998年至2024年随机对照试验的最新荟萃分析。

背景：溃疡性结肠炎（UC）是一种影响大肠的慢性炎症性疾病，如果不及时治疗，可发展为结直肠癌。不同的治疗方法用于治疗，环孢素是其中之一。当患者对类固醇治疗无反应时，它已被研究作为一种抢救治疗选择。然而，其有效性和安全性仍不确定。本研究旨在对环孢素治疗UC的安全性和有效性的临床证据进行综合分析。方法：检索1998年至2024年12月的电子数据库、Cochrane图书馆和PubMed，筛选相关研究。采用系统方法汇总和分析PICOS框架下的研究（人群、干预、比较、结果和研究设计）。采用综合meta分析软件（CMA version 3）对数据进行系统提取和分析，偏倚风险采用rob2工具评估，异质性采用I2统计量测量，发表偏倚采用漏斗图和Egger检验评估。结果：在最初确定的27项研究中，6项符合资格标准的研究被纳入最终分析。除结肠切除术率外，4项研究的所有结果的偏倚风险都很高。研究间的异质性在所有结果中并不显著。分析结果显示，环孢素的临床疗效（OR = 1.290, 95%CI 0.552 ~ 3.012, P = 0.557）、结肠切除术发生率（OR = 1.171, 95%CI 0.776 ~ 1.767, P = 0.452）、严重不良事件（OR = 0.592, 95%CI 0.313 ~ 1.120, P = 0.107）与对照组比较，差异均无统计学意义。结论：与对照组相比，环孢素在改善溃疡性结肠炎患者临床预后方面无统计学差异。未来更大样本量的研究可以探索其在靶向亚组患者联合治疗中的作用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Inflammopharmacology IMMUNOLOGYTOXICOLOGY-TOXICOLOGY

CiteScore

8.00

自引率

3.40%

发文量

200

期刊介绍： Inflammopharmacology is the official publication of the Gastrointestinal Section of the International Union of Basic and Clinical Pharmacology (IUPHAR) and the Hungarian Experimental and Clinical Pharmacology Society (HECPS). Inflammopharmacology publishes papers on all aspects of inflammation and its pharmacological control emphasizing comparisons of (a) different inflammatory states, and (b) the actions, therapeutic efficacy and safety of drugs employed in the treatment of inflammatory conditions. The comparative aspects of the types of inflammatory conditions include gastrointestinal disease (e.g. ulcerative colitis, Crohn''s disease), parasitic diseases, toxicological manifestations of the effects of drugs and environmental agents, arthritic conditions, and inflammatory effects of injury or aging on skeletal muscle. The journal has seven main interest areas: -Drug-Disease Interactions - Conditional Pharmacology - i.e. where the condition (disease or stress state) influences the therapeutic response and side (adverse) effects from anti-inflammatory drugs. Mechanisms of drug-disease and drug disease interactions and the role of different stress states -Rheumatology - particular emphasis on methods of measurement of clinical response effects of new agents, adverse effects from anti-rheumatic drugs -Gastroenterology - with particular emphasis on animal and human models, mechanisms of mucosal inflammation and ulceration and effects of novel and established anti-ulcer, anti-inflammatory agents, or antiparasitic agents -Neuro-Inflammation and Pain - model systems, pharmacology of new analgesic agents and mechanisms of neuro-inflammation and pain -Novel drugs, natural products and nutraceuticals - and their effects on inflammatory processes, especially where there are indications of novel modes action compared with conventional drugs e.g. NSAIDs -Muscle-immune interactions during inflammation [...]