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干细胞疗法治疗克罗恩病的安全性和有效性:系统评价的伞状综述

Safety and efficacy of stem cell therapy for Crohn's disease: an umbrella review of systematic reviews.

作者信息

Thangavelu Lakshmi, Mohan Syam, Alfaifi Hassan A, Farasani Abdullah, Menon Soumya V, Bansal Pooja, Choudhary Chhavi, Kumar M Ravi, Vashishth Raghav, Al-Rihaymee Afrah M A, Rustagi Sarvesh, Malhotra Anil K, Shabil Muhammed, Khatib Mahalaqua N, Zahiruddin Quazi S, Abdelwahab Siddig I, Bushi Ganesh, Almasabi Saleh H A, Alrasheed Hayam A, Rabaan Ali A

机构信息

Center for Global health Research, Saveetha Medical College and Hospitals, Saveetha Institute of Medical and Technical Sciences, Saveetha University, India.

Substance Abuse and Toxicology Research Centre, Jazan University, Jazan, Saudi Arabia.

出版信息

Int J Surg. 2024 Dec 1;110(12):7495-7507. doi: 10.1097/JS9.0000000000002104.

DOI:10.1097/JS9.0000000000002104
PMID:39352128
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11634090/
Abstract

BACKGROUND

Crohn's disease is a chronic, relapsing form of inflammatory bowel disease marked by severe gastrointestinal inflammation and a broad range of debilitating symptoms. Despite advances in medical treatments, achieving sustained remission remains challenging for many patients. This umbrella review aims to consolidate evidence from various systematic reviews to evaluate the efficacy and safety of stem cell therapies in treating Crohn's disease.

METHODS

This review followed the Joanna Briggs Institute methodology and adhered to PRISMA guidelines. A literature search of PubMed, Web of Science, Embase, and the Cochrane Library covered records up to 20 April 2024. Only systematic reviews and meta-analyses on stem cell therapy for Crohn's disease were considered. Data were extracted and analyzed for clinical efficacy indicators like remission induction and safety metrics, including adverse events and mortality rates.

RESULTS

Sixteen systematic reviews were included, spanning studies conducted between 2009 and 2023. Stem cell therapy showed a pooled risk ratio (RR) of 1.299 (95% CI: 1.192-1.420) for clinical remission, indicating a 29.9% increased likelihood of remission compared to controls. The pooled RR for healing perianal Crohn's disease was 1.358 (95% CI: 1.13-1.631), suggesting a 35.8% increased likelihood of healing. A pooled RR of 1.481 (95% CI: 1.036-2.116) shows a 48.1% higher immediate fistula closure rate with stem cell therapy. For long-term outcomes, a RR of 1.422 (95% CI: 1.091-1.854) indicates a 42.2% increased likelihood of maintaining closure. However, stem cell therapy did not significantly impact Crohn's Disease Activity Index (CDAI) (RR: 1.154, 95% CI: 0.193-6.883) and Perianal Disease Activity Index (PDAI) scores (mean difference at 12 weeks: -0.505, 95% CI: -2.481 to 1.471; mean difference at 24 weeks: -0.338, 95% CI: -1.638 to 0.963). The safety profile was comparable to conventional therapies, with a pooled RR of 0.972 (95% CI: 0.739-1.278) for adverse events and 1.136 (95% CI: 0.821-1.572) for serious adverse events.

CONCLUSION

Stem cell therapy offers significant progress in treating Crohn's disease, particularly in complex cases, by improving fistula closure rates and suggesting potential as a supplementary therapy. Its safety profile aligns with conventional treatments, yet ongoing clinical trials are crucial to optimize its use. Continual research will enable healthcare providers to tailor more effective treatment strategies for this challenging condition.

摘要

背景

克罗恩病是一种慢性复发性炎症性肠病,其特征为严重的胃肠道炎症和一系列使人衰弱的症状。尽管医学治疗取得了进展,但对许多患者来说,实现持续缓解仍然具有挑战性。本伞状综述旨在整合来自各种系统评价的证据,以评估干细胞疗法治疗克罗恩病的疗效和安全性。

方法

本综述遵循乔安娜·布里格斯研究所的方法,并遵守PRISMA指南。对PubMed、科学网、Embase和考科蓝图书馆进行文献检索,涵盖截至2024年4月20日的记录。仅考虑关于干细胞疗法治疗克罗恩病的系统评价和荟萃分析。提取并分析数据,以获取临床疗效指标,如诱导缓解和安全指标,包括不良事件和死亡率。

结果

纳入了16项系统评价,涵盖2009年至2023年进行的研究。干细胞疗法的临床缓解合并风险比(RR)为1.299(95%CI:1.192 - 1.420),表明与对照组相比,缓解可能性增加了29.9%。肛周克罗恩病愈合的合并RR为1.358(95%CI:1.13 - 1.631),表明愈合可能性增加了35.8%。干细胞疗法的即时瘘管闭合率合并RR为1.481(95%CI:1.036 - 2.116),表明瘘管闭合率高出48.1%。对于长期结局,RR为1.422(95%CI:1.091 - 1.854)表明维持闭合的可能性增加了42.2%。然而,干细胞疗法对克罗恩病活动指数(CDAI)(RR:1.154,95%CI:0.193 - 6.883)和肛周疾病活动指数(PDAI)评分没有显著影响(12周时平均差异:-0.505,95%CI:-2.481至1.471;24周时平均差异:-0.338,95%CI:-1.638至0.963)。安全性与传统疗法相当,不良事件合并RR为0.972(95%CI:0.739 - 1.278),严重不良事件合并RR为1.136(95%CI:0.821 - 1.572)。

结论

干细胞疗法在治疗克罗恩病方面取得了显著进展,特别是在复杂病例中,通过提高瘘管闭合率并显示出作为辅助疗法的潜力。其安全性与传统治疗方法一致,但正在进行的临床试验对于优化其使用至关重要。持续的研究将使医疗保健提供者能够为这种具有挑战性的疾病制定更有效的治疗策略。

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