Momen Mohamed Ibrahim, Bisher Sawaf, Noheir Ashraf Ibrahem Fathy Hassan, Momen Hassan Moussa, Mayar Ibrahim, Karam R Motawea, Muhammed Elhadi, Yaseen Alastal
{"title":"霉酚酸酯与硫唑嘌呤治疗自身免疫性肝炎的疗效比较:系统回顾和荟萃分析。","authors":"Momen Mohamed Ibrahim, Bisher Sawaf, Noheir Ashraf Ibrahem Fathy Hassan, Momen Hassan Moussa, Mayar Ibrahim, Karam R Motawea, Muhammed Elhadi, Yaseen Alastal","doi":"10.1159/000548140","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Azathioprine (AZA) is the standard treatment for both induction and maintenance of response in autoimmune hepatitis (AIH). However, lifelong administration is often required, and the combination therapy of prednisolone and azathioprine raises significant concerns regarding efficacy and tolerability, especially given the high relapse rates following AZA cessation. Consequently, there is a need to explore alternative treatment options. This systematic review and meta-analysis compared the efficacy and safety of mycophenolate mofetil (MMF) versus AZA, combined with prednisolone, for treating AIH.</p><p><strong>Methods: </strong>PubMed, Cochrane, Scopus, and Web of Science were searched to identify randomized clinical trials and cohort studies comparing AZA and MMF for treating AIH. Four studies compared steroid withdrawal and complete biochemical response (CBR) between the MMF and AZA groups. Subgroup analyses were performed based on age (above and below 50 years) and IgG levels (above and below 2400 mg/dL). RevMan (version 5.4) software was used for meta-analysis.</p><p><strong>Results: </strong>Four studies (three cohort studies and one RCT) comprising 505 patients were included in the final analysis. The pooled analysis showed a statistically significant association between the MMF group and increased CBR compared with the AZA group (RR = 1.44, 95% CI = 1.03 to 2.01, p-value = 0.03), with no significant difference between the two groups regarding steroid withdrawal. Subgroup analysis by age revealed a significant association between the MMF group and increased CBR in patients over 50 years (RR = 1.63, 95% CI = 1.00-2.64, p-value = 0.05). IgG subgroup analysis revealed a significant association between the MMF group and increased biochemical remission compared with the AZA group in patients with IgG levels of less than 2400 mg/dL (RR = 1.63, 95% CI = 1.00-2.64, p-value = 0.05).</p><p><strong>Conclusion: </strong>The use of MMF was significantly associated with increased CBR compared to AZA in patients with AIH. Additionally, there was no significant association between the two groups regarding steroid withdrawal. Further research is needed to fully elucidate the optimal treatment strategy for AIH patients across different subpopulations.</p>","PeriodicalId":11315,"journal":{"name":"Digestion","volume":" ","pages":"1-14"},"PeriodicalIF":3.6000,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparative Efficacy of Mycophenolate Mofetil vs. Azathioprine in Autoimmune Hepatitis: A Systematic Review and Meta-Analysis.\",\"authors\":\"Momen Mohamed Ibrahim, Bisher Sawaf, Noheir Ashraf Ibrahem Fathy Hassan, Momen Hassan Moussa, Mayar Ibrahim, Karam R Motawea, Muhammed Elhadi, Yaseen Alastal\",\"doi\":\"10.1159/000548140\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Azathioprine (AZA) is the standard treatment for both induction and maintenance of response in autoimmune hepatitis (AIH). However, lifelong administration is often required, and the combination therapy of prednisolone and azathioprine raises significant concerns regarding efficacy and tolerability, especially given the high relapse rates following AZA cessation. Consequently, there is a need to explore alternative treatment options. This systematic review and meta-analysis compared the efficacy and safety of mycophenolate mofetil (MMF) versus AZA, combined with prednisolone, for treating AIH.</p><p><strong>Methods: </strong>PubMed, Cochrane, Scopus, and Web of Science were searched to identify randomized clinical trials and cohort studies comparing AZA and MMF for treating AIH. Four studies compared steroid withdrawal and complete biochemical response (CBR) between the MMF and AZA groups. Subgroup analyses were performed based on age (above and below 50 years) and IgG levels (above and below 2400 mg/dL). RevMan (version 5.4) software was used for meta-analysis.</p><p><strong>Results: </strong>Four studies (three cohort studies and one RCT) comprising 505 patients were included in the final analysis. The pooled analysis showed a statistically significant association between the MMF group and increased CBR compared with the AZA group (RR = 1.44, 95% CI = 1.03 to 2.01, p-value = 0.03), with no significant difference between the two groups regarding steroid withdrawal. Subgroup analysis by age revealed a significant association between the MMF group and increased CBR in patients over 50 years (RR = 1.63, 95% CI = 1.00-2.64, p-value = 0.05). IgG subgroup analysis revealed a significant association between the MMF group and increased biochemical remission compared with the AZA group in patients with IgG levels of less than 2400 mg/dL (RR = 1.63, 95% CI = 1.00-2.64, p-value = 0.05).</p><p><strong>Conclusion: </strong>The use of MMF was significantly associated with increased CBR compared to AZA in patients with AIH. Additionally, there was no significant association between the two groups regarding steroid withdrawal. 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引用次数: 0
摘要
背景:硫唑嘌呤(AZA)是诱导和维持自身免疫性肝炎(AIH)反应的标准治疗方法。然而,通常需要终身给药,强的松龙和硫唑嘌呤联合治疗引起了对疗效和耐受性的重大关注,特别是考虑到停用AZA后的高复发率。因此,有必要探索替代治疗方案。本系统综述和荟萃分析比较了霉酚酸酯(MMF)与AZA联合强的松龙治疗AIH的疗效和安全性。方法:检索PubMed、Cochrane、Scopus和Web of Science,以确定比较AZA和MMF治疗AIH的随机临床试验和队列研究。四项研究比较了MMF组和AZA组的类固醇停药和完全生化反应(CBR)。根据年龄(50岁以上及以下)和IgG水平(2400 mg/dL以上及以下)进行亚组分析。采用RevMan (version 5.4)软件进行meta分析。结果:4项研究(3项队列研究和1项随机对照试验)共505例患者纳入最终分析。合并分析显示,与AZA组相比,MMF组与CBR增加有统计学意义(RR = 1.44, 95% CI = 1.03 ~ 2.01, p值= 0.03),两组在类固醇停药方面无显著差异。年龄亚组分析显示,MMF组与50岁以上患者CBR增加之间存在显著相关性(RR = 1.63, 95% CI = 1.00-2.64, p值= 0.05)。IgG亚组分析显示,在IgG水平低于2400 mg/dL的患者中,与AZA组相比,MMF组与生化缓解增加之间存在显著相关性(RR = 1.63, 95% CI = 1.00-2.64, p值= 0.05)。结论:与AZA相比,MMF的使用与AIH患者CBR的增加显著相关。此外,两组在类固醇戒断方面没有显著的相关性。需要进一步的研究来充分阐明不同亚群AIH患者的最佳治疗策略。
Comparative Efficacy of Mycophenolate Mofetil vs. Azathioprine in Autoimmune Hepatitis: A Systematic Review and Meta-Analysis.
Background: Azathioprine (AZA) is the standard treatment for both induction and maintenance of response in autoimmune hepatitis (AIH). However, lifelong administration is often required, and the combination therapy of prednisolone and azathioprine raises significant concerns regarding efficacy and tolerability, especially given the high relapse rates following AZA cessation. Consequently, there is a need to explore alternative treatment options. This systematic review and meta-analysis compared the efficacy and safety of mycophenolate mofetil (MMF) versus AZA, combined with prednisolone, for treating AIH.
Methods: PubMed, Cochrane, Scopus, and Web of Science were searched to identify randomized clinical trials and cohort studies comparing AZA and MMF for treating AIH. Four studies compared steroid withdrawal and complete biochemical response (CBR) between the MMF and AZA groups. Subgroup analyses were performed based on age (above and below 50 years) and IgG levels (above and below 2400 mg/dL). RevMan (version 5.4) software was used for meta-analysis.
Results: Four studies (three cohort studies and one RCT) comprising 505 patients were included in the final analysis. The pooled analysis showed a statistically significant association between the MMF group and increased CBR compared with the AZA group (RR = 1.44, 95% CI = 1.03 to 2.01, p-value = 0.03), with no significant difference between the two groups regarding steroid withdrawal. Subgroup analysis by age revealed a significant association between the MMF group and increased CBR in patients over 50 years (RR = 1.63, 95% CI = 1.00-2.64, p-value = 0.05). IgG subgroup analysis revealed a significant association between the MMF group and increased biochemical remission compared with the AZA group in patients with IgG levels of less than 2400 mg/dL (RR = 1.63, 95% CI = 1.00-2.64, p-value = 0.05).
Conclusion: The use of MMF was significantly associated with increased CBR compared to AZA in patients with AIH. Additionally, there was no significant association between the two groups regarding steroid withdrawal. Further research is needed to fully elucidate the optimal treatment strategy for AIH patients across different subpopulations.
期刊介绍:
''Digestion'' concentrates on clinical research reports: in addition to editorials and reviews, the journal features sections on Stomach/Esophagus, Bowel, Neuro-Gastroenterology, Liver/Bile, Pancreas, Metabolism/Nutrition and Gastrointestinal Oncology. Papers cover physiology in humans, metabolic studies and clinical work on the etiology, diagnosis, and therapy of human diseases. It is thus especially cut out for gastroenterologists employed in hospitals and outpatient units. Moreover, the journal''s coverage of studies on the metabolism and effects of therapeutic drugs carries considerable value for clinicians and investigators beyond the immediate field of gastroenterology.