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吗替麦考酚酯单药治疗与联合用药在自身免疫性肝炎缓解期的疗效相当。

Azathioprine Monotherapy Is Equivalent to Dual Therapy in Maintaining Remission in Autoimmune Hepatitis.

机构信息

Arizona College of Osteopathic Medicine, Midwestern University, 19555 N. 59th Ave, Glendale, AZ, 85308, USA.

Division of Gastroenterology and Hepatology, Mayo Clinic in Arizona, 5777 E. Mayo Blvd, Phoenix, AZ, 85054, USA.

出版信息

Dig Dis Sci. 2021 May;66(5):1715-1719. doi: 10.1007/s10620-020-06347-7. Epub 2020 May 20.

DOI:10.1007/s10620-020-06347-7
PMID:32436124
Abstract

BACKGROUND

Standard of care treatment for AIH includes prednisone monotherapy or dual therapy prednisone-azathioprine. However, many hepatologists alternatively use azathioprine monotherapy to avoid side effects of long-term corticosteroids.

AIMS

To determine whether azathioprine monotherapy is comparable to dual prednisone-azathioprine for maintenance of remission in AIH.

METHODS

A retrospective chart review of 260 individuals with AIH from a single institution was performed; 45 individuals were included. Exclusion criteria included concomitant PBC or PSC, use of alternative treatment regimen, and/or failure to reach remission. Treatment regimen received was guided by clinician standard of practice, not patients' clinical factors. Initial remission was defined as normalization of serum ALT for at least two consecutive blood draws. Data were analyzed for 5 years post-remission, recording outcome and dose of prednisone and/or azathioprine.

RESULTS

83% of individuals were female, and average age was 65 years. Median dose of prednisone and azathioprine for the dual-therapy group was 5 mg and 100 mg, respectively, while median azathioprine dose for the monotherapy group was 75 mg. Considering overall outcome, 93% of all patients maintained remission. 80% of the dual-therapy group, and 95% of the azathioprine monotherapy group maintained remission. Using Chi-square analysis to compare the maintenance of remission between dual therapy and azathioprine monotherapy, a p value of 0.28 was calculated.

CONCLUSIONS

AASLD guidelines recommend dual prednisone-azathioprine as standard of care for maintenance of remission in AIH. Our results suggest that azathioprine monotherapy is equivalent to prednisone-azathioprine. Azathioprine monotherapy offers a significant advantage in mitigating risks of long-term corticosteroid therapy.

摘要

背景

AIH 的标准治疗包括泼尼松单药治疗或泼尼松-硫唑嘌呤联合治疗。然而,许多肝病学家选择使用硫唑嘌呤单药治疗来避免长期使用皮质类固醇的副作用。

目的

确定硫唑嘌呤单药治疗是否与泼尼松-硫唑嘌呤联合治疗在 AIH 缓解维持方面具有可比性。

方法

对一家单机构的 260 名 AIH 患者进行回顾性图表审查,其中 45 名患者符合纳入标准。排除标准包括同时患有 PBC 或 PSC、使用替代治疗方案以及/或未达到缓解。治疗方案是根据临床医生的标准实践而非患者的临床因素来指导的。初始缓解定义为血清 ALT 至少连续两次恢复正常。在缓解后 5 年内分析数据,记录泼尼松和/或硫唑嘌呤的剂量和结局。

结果

83%的患者为女性,平均年龄为 65 岁。联合治疗组泼尼松和硫唑嘌呤的中位剂量分别为 5mg 和 100mg,而单药治疗组硫唑嘌呤的中位剂量为 75mg。考虑到整体结局,93%的患者缓解持续。联合治疗组 80%和单药治疗组 95%的患者缓解持续。使用卡方分析比较联合治疗和硫唑嘌呤单药治疗的缓解维持情况,计算出的 p 值为 0.28。

结论

AASLD 指南建议泼尼松-硫唑嘌呤联合治疗作为 AIH 缓解维持的标准治疗。我们的结果表明,硫唑嘌呤单药治疗与泼尼松-硫唑嘌呤等效。硫唑嘌呤单药治疗在减轻长期皮质类固醇治疗的风险方面具有显著优势。

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