Glucocorticosteroids for viral hepatitis C

 

Abstract

Background

Hepatitis C virus may cause liver inflammation and fibrosis. It is not known whether glucocorticosteroids are beneficial or harmful for patients with hepatitis C infection.

Objectives

The objectives were to evaluate the beneficial and harmful effects of glucocorticosteroids for patients with acute or chronic hepatitis C infection with or without hepatitis C related autoimmune disorders.

Search methods

Searches of The Cochrane Hepato-Biliary Controlled Trials Register, The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and reference lists of relevant articles and hand searches of relevant journals were performed in July 2003. Principal authors of clinical trials were approached.

Selection criteria

Randomised clinical trials dealing with glucocorticosteroids for viral hepatitis C - acute or chronic with or without autoimmune disorders.

Data collection and analysis

Data were extracted by one reviewer and validated by another. Further information was sought by correspondence with the principal investigator of the trial in case the relevant data were not published. Disagreements were solved by discussion before the meta-analysis.

Main results

Eight trials randomised 384 patients with chronic hepatitis C to glucocorticosteroids plus interferon versus interferon plus placebo/no intervention, glucocorticosteroids versus interferon, or glucocorticosteroids versus placebo. Glucocorticosteroids treatment given as short pre-treatment followed by interferon or as long-term parallel treatment combined with interferon versus interferon monotherapy had no significant effect on mortality (no deaths occurred; 342 patients), virological response at six months follow-up (RR 0.85; 95% CI 0.52 to 1.38; 38 patients), or biochemical response at six months follow-up (RR 0.95; 95% CI 0.84 to 1.06; 307 patients). There was no significant difference in serious adverse events between combination therapy versus interferon monotherapy (RR 4.76; 95% CI 0.24 to 93.19; 342 patients). Glucocorticosteroids versus interferon had no significant effect on mortality (RR 2.33; 95% CI 0.27 to 17.80; 13 patients) or virological response at follow-up (RR 1.17; 95% CI 0.86 to 1.58; 13 patients). We found no trials on glucocorticosteroids for acute hepatitis C.

Authors' conclusions

There is insufficient evidence neither to confirm nor exclude both beneficial and harmful effects of glucocorticosteroids for chronic hepatitis C with or without autoimmune disorders. This Review is not able to rule out potential serious adverse effects of glucocorticosteroids. Therefore, this Review cannot establish whether glucocorticosteroids treatment can be safely administrated for indications requiring glucocorticosteroids without analysing for hepatitis C virus. The effect of glucocorticosteroids for acute hepatitis C has not been examined in randomised trials.

 

Plain language summary

No evidence to support or refute glucocorticosteroids for viral hepatitis C

Acute infection with viral hepatitis C manifests most commonly no symptoms, but frequently results in chronic infection. Chronic hepatitis C is in most cases benign, but may progress to severe illness and liver-related death. This review found no significant effect of glucocorticosteroids on chronic hepatitis, but the amount of data is sparse. Accordingly there is insufficient evidence to neither confirm nor exclude beneficial and harmful effects of glucocorticosteroids for hepatitis C. Further, the evidence is unclear as to whether glucocorticosteroids treatment can be safely administered for other diseases in patients with concomitant hepatitis C. The authors were unable to identify randomised clinical trials on glucocorticosteroids for acute hepatitis C.

 

摘要

背景

使用腎上腺糖皮質類固醇於C型肝炎病人

C型肝炎病毒病毒會引起肝炎和肝纖維化。我們不知道腎上腺糖皮質類固醇對C型肝炎病毒感染的病人之利弊。

目標

目標是評估急、慢性C型肝炎病毒感染病人，本身有或無C型肝炎病毒相關自體免疫疾病者，使用腎上腺糖皮質類固醇的利弊。

搜尋策略

搜尋2003年7月之前的The Cochrane HepatoBiliary Controlled Trials Register、 The Cochrane Central Register of Controlled Trials (CENTRAL)、MEDLINE、EMBASE以及相關文章的參考文獻清單，手動搜索相關期刊。聯繫主要臨床試驗的作者。

選擇標準

急、慢性C型肝炎病毒感染病人，本身有或無C型肝炎病毒相關自體免疫疾病者，使用腎上腺糖皮質類固醇的隨機臨床試驗。

資料收集與分析

一位回顧作者摘錄數據，另外一位回顧作者校對。如果相關資料還未發表，通過聯繫實驗的主要研究人員，獲取更多的資訊。在實施統合分析前，事先討論以解決爭議點。

主要結論

共有8個隨機試驗，共384位慢性C型肝炎病人，(1)比較腎上腺糖皮質類固醇加干擾素、干擾素加安慰劑/無干預法、(2)比較腎上腺糖皮質類固醇和干擾素或者(3)比較腎上腺糖皮質類固醇和安慰劑。與干擾素單一療法相比較，在干擾素治療前作為短期預治療的腎上腺糖皮質類固醇，或者結合干擾素一起使用作為長期平行治療的腎上腺糖皮質類固醇，在死亡率(無死亡事件; 342 位病人), 6個月後續追蹤中的病毒學反應(RR 0.85; 95% CI 0.52 – 1.38; 38位 病人)，或6個月後續追蹤中的生化反應(RR 0.95; 95% CI 0.84 – 1.06; 307 位病人)等方面，沒有顯著差異。複合療法對照干擾素單一療法，在嚴重不良事件方面沒有顯著差異(RR 4.76; 95% CI 0.24 – 93.19; 342 位病人)。 和干擾素相比，腎上腺糖皮質類固醇在死亡率(RR 2.33; 95% CI 0.27 – 17.80; 13 位病人)或後續追蹤的病毒學反應(RR 1.17; 95% CI 0.86 – 1.58; 13 位元病人)等方面並無明顯差異。我們找不到在急性C型肝炎病毒期使用腎上腺糖皮質類固醇的試驗。

作者結論

慢性C型肝炎患者，不論本身是否有自體免疫疾病，並無證據支持或否定使用腎上腺糖皮質類固醇的利弊。但本文獻回顧亦無法排除腎上腺糖皮質類固醇引起嚴重不良反應的可能。因此本文獻回顧不能確立當病人符合腎上腺糖皮質類固醇適應症時，未了解是否有C型肝炎感染，就給予類固醇的安全性。此外亦無隨機試驗檢視，對急性C型肝炎病毒病人給予腎上腺糖皮質類固醇的結果。

翻譯人

本摘要由臺中榮民總醫院黃芳亮翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

沒有證據支持或反對，對急性C型肝炎病毒使用腎上腺糖皮質類固醇。C型肝炎病毒多數情況下沒有症狀，但是經常會導致慢性感染。慢性C型肝炎多表現為為良性, 但也可能發展為嚴重疾病，導致和肝臟有關的死亡。本文獻回顧無法證實腎上腺糖皮質類固醇對慢性肝炎有明顯療效，但也是因為數據不多的關係。因此，沒有足夠的證據支持或排除對C型肝炎病毒使用腎上腺糖皮質類固醇的利弊。另外，沒有明確的證據指出，合併C型肝炎病毒病人以腎上腺糖皮質類固醇治療其他疾病的安全性。作者沒有發現針對急性C型肝炎病毒使用腎上腺糖皮質類固醇的隨機臨床試驗。