Clin Mol Hepatol > Volume 26(2); 2020 > Article |
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No | Study | Country/region | Causality assessment for DILI | Time periods | Publication type (report, journal article, abstract) | Hospital-/registrybased | Drug classification type (single agent or class) | Total number of DILI records | Included acetaminophen |
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Studies from the West | |||||||||
1 | Andrade et al. [5] (2005) | Spain | CIOMS/RUCAM | Apr 1994 to Aug-04 | Prospective | Prospective Regional registry | Both | 461 | Yes 13 cases |
Clinical judgement, CIOMS by 3 independent experts | |||||||||
2 | Bessone et al. [14] (2016) | Latin America | CIOMS/RUCAM | 2011 to 2014 | Prospective | Latin American registry | Single | 206 | Yes but 0 cases |
3 | Björnsson et al. [4] (2013) | Iceland | CIOMS/RUCAM | Mar 2010 to Feb 2012 | Prospective | National | Both | 96 | No (specifically excluded) |
4 | Chalasani et al. [15] (2015) | USA | DILIN methods | Sep 2004 to May 2013 | Observational longitudinal | National | Both | 899 | No (specifically excluded) |
5 | Sgro et al. [3] (2002) | France | Global imputability score I | Nov 1997 to Nov 2000 | Population based | Regional | Both | 34 | Yes (1 died: prolonged acetaminophen) |
6 | De Valle et al. [16] (2006) | Swedish outpatient clinic | CIOMS | 1995 to 2005 | Retrospective review of case records | 1 university hospital outpatients urban area | Both | 77 | Not mentioned |
7 | de Abajo et al. [17] (2004) | UK | Description like RUCAM but not specifically stated | 1994 to 1999 | Population based case control (5,000 controls) | GP research database in the UK | Both | 128 | Yes: 12 from acetaminophen |
8 | Ibáñez et al. [18] (2002) | Spain | Description like RUCAM but not specifically stated | 1992 to 1998 | Population based prospective | 12 hospitals collaborating network | Both | 107 | Yes: 12 from acetaminophen |
9 | Carey et al. [19] (2008) | US Mayo (inpatients) | CIOMS | 1998 to 2006 | Retrospective search with codes | Inpatient visits at Mayo Hospital | Both | 40 | Yes: 40 had DILI, 27 from acetaminophen |
11 | Hussaini et al. [20] (2007) | Cornwall England | CIOMS | 1998 to 2004 | Retrospective analysis | Rural population | Both | 28 | Not mentioned |
12 | Meier et al. [21] (2005) | Switzerland | CIOMS | Jan 1996 to Dec 2000 | Medical records review | Pharmacoepidemiological databases | Both | 88 | Yes |
13 | Sabaté et al. [22] (2007) | Barcelona Spain 12 hospitals | Jaundice, ALT AST | Jan 1993 to Dec 1999 | Multi centre prospective case control | 12 hospitals | Drugs | 126 | Yes |
2,700,000 | |||||||||
14 | Sistanizad Peterson. [23] (2013) | Tasmania Australia | CIOMS | Jun 2008 to July 2009 | Retrospective | 1 major hospital serving 250,000 people | Drugs | 17 | Yes |
15 | Galan et al. [24] (2005) | US | Description like RUCAM but not specifically stated | 1993 to 2002 | Retrospective review of records | 1 tertiary care hospital | Both | 32 | Yes but 0 cases |
16 | Vega et al. [25] (2017) | Delaware, US | CIOMS | 2014 | Prospective | DILN | Both | 23 | Yes |
Studies from the East | |||||||||
17 | Suk et al. [6] (2012) | Korea | RUCAM | May 2005 to May 2007 | Prospective | 17 referral hospitals (nationwide) | Class | 371 | Yes |
18 | Kwon et al. [26] (2012) | Korea | WHO-UMC | Jan 2007 to Dec 2008 | Retrospective-registry of spontaneous reports of adverse drug reactions | 9 regional pharmacovigilence centres in Korea (nationwide) | Both | 567 | Yes |
19 | Zhou et al. [27] (2013) | China | Various | 1994 to 2011 | Retrospective review of electronic and manual searches | Multiple centres | Class | 24,112 | Yes |
20 | Ou et al. [28] (2015) | China | CIOMS | Jan 2011 to Dec 2014 | Retrospective review of inpatient records | Inpatients - 1 hospital | Both | 361 | Yes |
21 | Lee et al. [29] (2012) | Taiwan | ICD–9 code (case cross over comparison of diagnosis) | 1997 to 2004 | Retrospective | Population based database (insurance) | Both | 4,857 | Unclear |
22 | Takikawa et al. [30] (2009) | Japan | DDW-J 2004 | Jan 1997 to Dec 2006 | Retrospective | 29 facilities (nationwide) | Class | 1,676 | Yes |
23 | Huang et al. [31] (2013) (abstract) | Taiwan | RUCAM | Unclear | Retrospective | 6 medical centres across Taiwan | Class | 1,099 | Yes |
24 | Sobhonslidsuk et al. [32] (2016) | Thailand | ICD-10 (toxic liver disease) | 2009 to 2013 | Retrospective | Population based database (nationwide) (DILN Taiwan) | Single | 589 | Yes |
25 | Rathi et al. [33] (2016) | India | RUCAM | 2014 to 2015 | Prospective | 1 tertiary care hospital in metropolitan India | Class | 82 | Unclear |
26 | Bektas et al. [34] (2008) (abstract) | Turkey | Various | Unclear | Retrospective | Single centre | Class | 170 | Unclear |
27 | Jaiprakash et al. [35] (2012) | India | AST/ALT | Jul 2006 to Jul 2007 | Retrospective | 1 tertiary care hospital in rural South India | Class | 65 | Unclear |
28 | Devarbhavi et al. [36] (2010) | India | RUCAM | 1997 to 2008 | Retrospective | Inpatients - 1 hospital | Both | 244 | Yes |
DILI, drug induced liver injury; CIOMS, Council for International Organizations of Medical Sciences; RUCAM, Roussel Uclaf Causality Assessment Method; GP, general practice; ALT, alanine aminotransferase; AST, aspartate transferase; WHO-UMC, World Health Organisation-Uppsala Monitoring Center; ICD, International Classification of Diseases; DDW-J, The Digestive Disease Week Japan.
Seng Gee Lim
https://orcid.org/0000-0003-0994-4932