N-acetylcysteine for non-paracetamol drug-induced liver injury: a systematic review protocolReport as inadecuate




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Systematic Reviews

, 4:84

First Online: 12 June 2015Received: 24 November 2014Accepted: 05 June 2015DOI: 10.1186-s13643-015-0075-6

Cite this article as: Chughlay, M.F., Kramer, N., Werfalli, M. et al. Syst Rev 2015 4: 84. doi:10.1186-s13643-015-0075-6

Abstract

BackgroundDrug-induced liver injury DILI refers to acute or chronic liver injury that may occur as a consequence of using drugs and herbal or dietary supplements. Specific therapies for DILI are limited. There is considerable evidence for efficacy and safety of N-acetylcysteine NAC in management of paracetamol-induced liver injury. More recently, research has explored the use of NAC in non-paracetamol drug-induced liver injury. It is important to summarise the evidence of NAC for non-paracetamol DILI to determine if NAC may be considered a therapeutic option in this condition.

Methods-designWe will conduct a systematic review of the benefit and harm of NAC in non-paracetamol drug-induced liver injury. Primary and secondary outcomes of interest are pre-specified. Primary outcomes include all-cause mortality, mortality due to DILI, time to normalisation of liver biochemistry e.g. return of alanine transaminase to <100 U-l and-or international normalized ratio INR <1.5 and adverse events. Secondary outcomes include transplantation rate, time to transplantation, transplant-free survival and duration of hospitalisation. We will include randomized controlled trials RCTs and prospective cohort studies. RCTs will contribute to the evaluation of safety and efficacy of NAC, whereas, the cohort studies will contribute exclusively to the evaluation of safety. We will search several bibliographic databases including PubMed, Scopus, CINAHL, CENTRAL, grey literature sources, conference proceedings and ongoing trials. Following data extraction and assessment of the risk of bias, we will conduct a meta-analysis if feasible, as well as subgroup analyses. We will assess and explore clinical and statistical heterogeneity.

DiscussionThe aim of this review is to provide evidence on the effectiveness and safety of NAC in non-paracetamol DILI. We anticipate that the results could aid health care practitioners, researchers and policymakers in the decision-making regarding the use of NAC in patients with non-paracetamol DILI.

Systematic review registrationPROSPERO CRD42014008771

KeywordsN-acetylcysteine Acetylcysteine Drug-induced Hepatitis Liver Liver failure Non-paracetamol Non-acetaminophen AbbreviationsALTalanine aminotransferase

DDWDigestive Diseases Week

DILIdrug-induced liver injury

EASLEuropean Association for the Study of Liver

ICTRPInternational Clinical Trials Registry Platform

INRinternational normalized ratio

NACN-acetylcysteine

NAPQIN-acetyl-p-benzoquinone imine

PACTRPan African National Clinical Trials Registry

RCTrandomized controlled trial

RevManReview Manager

WHOWorld Health Organization

Electronic supplementary materialThe online version of this article doi:10.1186-s13643-015-0075-6 contains supplementary material, which is available to authorized users.

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Author: Mohamed Farouk Chughlay - Nicole Kramer - Mahmoud Werfalli - Wendy Spearman - Mark Emmanuel Engel - Karen Cohen

Source: https://link.springer.com/







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