Evidence map›Paper›PMID 31593579›Full record

ArticlePloS one2019

Analysis of drug-induced hearing loss by using a spontaneous reporting system database.

Mizuki Tanaka, Shiori Hasegawa, Satoshi Nakao, Kazuyo Shimada, Ririka Mukai, Kiyoka Matsumoto, Mitsuhiro Nakamura

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 9% 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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  15. Evaluation of anti-infective-relatedInternational journal of medical sciences · 2020
    Article
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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

7 authors at 1 institution in 1 country.

Mizuki TanakaLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu-shi, Gifu, Japan.
Shiori HasegawaLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu-shi, Gifu, Japan.
Satoshi NakaoLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu-shi, Gifu, Japan.
Kazuyo ShimadaLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu-shi, Gifu, Japan.
Ririka MukaiLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu-shi, Gifu, Japan.
Kiyoka MatsumotoLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu-shi, Gifu, Japan.
Mitsuhiro NakamuraLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu-shi, Gifu, Japan.ORCID 0000-0002-5062-5522
Gifu Pharmaceutical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Many drugs can cause hearing loss, leading to sensorineural deafness. The aim of this study was to evaluate the risk of drug-induced hearing loss (DIHL) by using the Japanese Adverse Drug Event Report (JADER) database and to obtain profiles of DIHL onset in clinical settings. We relied on the Medical Dictionary for Regulatory Activities preferred terms and standardized queries, and calculated the reporting odds ratios (RORs). Furthermore, we applied multivariate logistic regression analysis, association rule mining, and time-to-onset analysis using Weibull proportional hazard models. Of 534688 reports recorded in the JADER database from April 2004 to June 2018, adverse event signals were detected for platinum compounds, sulfonamides (plain) (loop diuretics), interferons, ribavirin, other aminoglycosides, papillomavirus vaccines, drugs used in erectile dysfunction, vancomycin, erythromycin, and pancuronium by determining RORs. The RORs of other aminoglycosides, other quaternary ammonium compounds, drugs used in erectile dysfunction, and sulfonamides (plain) were 29.4 (22.4-38.6), 18.5 (11.2-30.6), 15.4 (10.6-22.5), and 12.6 (10.0-16.0), respectively. High lift score was observed for patients with congenital diaphragmatic hernia treated with pancuronium using association rule mining. The median durations (interquartile range) for DIHL due to platinum compounds, sulfonamides (plain), interferons, antivirals for treatment of hepatitis C virus (HCV) infections, other aminoglycosides, carboxamide derivatives, macrolides, and pneumococcal vaccines were 25.5 (7.5-111.3), 80.5 (4.5-143.0), 64.0 (14.0-132.0), 53.0 (9.0-121.0), 11.0 (3.0-26.8), 1.5 (0.3-11.5), 3.5 (1.3-6.8), and 2.0 (1.0-4.5), respectively. Our results demonstrated potential risks associated with several drugs based on their RORs. We recommend to closely monitor patients treated with aminoglycosides for DIHL for at least two weeks. Moreover, individuals receiving platinum compounds, sulfonamides (plain), interferons, and antivirals for HCV infection therapy should be carefully observed for DIHL for at least several months.

Indexed as

Adverse Drug Reaction Reporting SystemsDatabases, FactualSelf ReportAdolescentAdultAgedAged, 80 and overChildFemaleHearing LossHumansMaleMiddle Aged

Identifiers

PMID31593579
PMCPMC6782099
OpenAlexW2979931405

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.