Evidence map›Paper›PMID 35470602›Full record

ArticleJournal of Korean medical science2022

Analysis of Adverse Drug Reactions to First-Line Anti-Tuberculosis Drugs Using the Korea Adverse Event Reporting System.

Soo Jie Chung, Sun-Ju Byeon, Jeong-Hee Choi

Open access · goldAbstract read
In one paragraph

Article in Journal of Korean medical science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
5.1field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

Soo Jie Chung *Department of Pulmonology and Allergy, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.ORCID https://orcid.org/0000-0002-7717-1188
Sun-Ju Byeon *Department of Pathology, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.ORCID https://orcid.org/0000-0002-9599-4970
Jeong-Hee ChoiDepartment of Pulmonology and Allergy, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea.ORCID https://orcid.org/0000-0002-0599-875X
Hallym University · KRHallym University Dongtan Sacred Heart Hospital · KR

Funding

Ministry of Food and Drug Safety
6 · The paper itself

Abstract

backgroundAdverse drug reactions (ADRs) to first-line anti-tuberculosis (TB) drugs are common; however, there have been few reports of nationwide epidemiologic studies on ADRs to anti-TB drugs in Korea. This study aimed to investigate the clinical characteristics of various ADRs to first-line anti-TB drugs using a nationwide database of ADRs.

methodsWe used the Korea Adverse Event Reporting System (KAERS) database (2009-2018). The study subjects were selected using the Korean Standard Classification of Diseases codes for pulmonary and extrapulmonary TB and electronic data interchange codes for isoniazid (INH), rifampicin (RIF), ethambutol (ETB), and pyrazinamide (PZA). The causality assessment of "possible," "probable," or "certain" by World Health Organization-Uppsala Monitoring Center System causality category was selected.

resultsA total of 1,562,024 ADRs were reported in the KIDS-KAERS database from 2009 to 2018, where ADRs to first-line anti-TB drugs were 17,843 cases (1.14%). The most common causative drugs were RIF (28.7%), INH (24.0%), ETB (23.4%), and PZA (23.9%) in that order. 48.5% of cases were reported in the older patients (≥ 60 years). According to organ system, gastro-intestinal system disorder was most common (32.0%), followed by skin and appendage (25.9%), liver and biliary system (14.2%). Nausea was the most common ADR (14.6%), followed by hepatic enzyme elevation (14.2%), rash (11.7%), pruritus (9.1%), vomiting (8.9%), and urticaria (4.2%). Most ADRs appeared within 1 month, but ADRs such as neuropathy, paresthesia, hematologic abnormalities, renal function abnormalities and liver enzyme abnormality were also often reported after 2 months.

conclusionOur data are clinically informative for recognizing and coping with ADRs of anti-TB drugs.

Indexed as

Antitubercular AgentsDrug-Related Side Effects and Adverse ReactionsEthambutolHumansIsoniazidPyrazinamideRepublic of KoreaRifampinAntitubercular AgentsEthambutolIsoniazidPyrazinamideRifampinAdverse Drug ReactionsBig DataKIDS KAERS Database (KIDS-KD)Tuberculosis

Identifiers

PMID35470602
PMCPMC9039191
OpenAlexW4224923222

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.