Evidence map›Paper›PMID 42525694›Full record

ArticlePloS one2026

Real‑world analysis of Macular Oedema associated with Paclitaxel Formulations using the Japanese Adverse Drug Event Report database.

Koki Takeda, Toshinori Hirai, Ayu Sugioka, Rinka Okamura, Asako Nishimura, Nobuhito Shibata

Abstract read
In one paragraph

Article in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

6 authors.

Koki TakedaLaboratory of Medical Pharmaceutics, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe, Kyoto, Japan.ORCID https://orcid.org/0009-0004-7712-5714
Toshinori HiraiDepartment of Pharmacy, Institute of Science Tokyo Hospital, Bunkyo-ku, Tokyo, Japan.
Ayu SugiokaLaboratory of Medical Pharmaceutics, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe, Kyoto, Japan.
Rinka OkamuraLaboratory of Medical Pharmaceutics, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe, Kyoto, Japan.
Asako NishimuraLaboratory of Medical Pharmaceutics, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe, Kyoto, Japan.
Nobuhito ShibataLaboratory of Medical Pharmaceutics, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts, Kyotanabe, Kyoto, Japan.ORCID https://orcid.org/0000-0002-4476-1237

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThis study explored the potential association between paclitaxel (PTX) and macular oedema (ME), a rare adverse event, through pharmacovigilance analysis using a large-scale spontaneous reporting database.

methodsDisproportionality analysis of ME associated with PTX formulations, including nanoparticle albumin-bound PTX (nab‑PTX) was conducted using the Japanese Adverse Drug Event Report database on data collected during April 2004-June 2025. Multivariable logistic regression analysis was used to estimate adjusted reporting odds ratios (RORs) for ME. A positive signal was defined as a lower 95% confidence interval (CI) for the ROR exceeding 1.0 with at least three ME cases.

resultsAmong 585,738 reports, 123 involved ME. A significant signal was observed for overall PTX (adjusted ROR: 19.5; 95% CI: 13.5-28.3). By formulation, significant signals were identified for conventional PTX (adjusted ROR: 9.4; 95% CI: 5.5-16.1) and nab‑PTX (adjusted ROR: 47.0; 95% CI: 30.4-72.8). Multivariable logistic regression indicated significant signals for diabetes mellitus (adjusted ROR: 1.8; 95% CI: 1.2-2.9) and co-administration of prostaglandin analogue eye drops (adjusted ROR: 19.9; 95% CI: 8.6-45.7).

conclusionPTX formulations were associated with an increased reporting signal of ME. Notably, patients with diabetes mellitus and those using prostaglandin analogue eye drops may require closer ophthalmologic monitoring during PTX therapy.

Indexed as

Adverse Drug Reaction Reporting SystemsAntineoplastic Agents, PhytogenicMacular EdemaPaclitaxelDatabases, FactualFemaleHumansJapanMaleMiddle AgedPharmacovigilanceAntineoplastic Agents, PhytogenicPaclitaxel

Identifiers

PMID42525694
PMCPMC13419171

What Socratic 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 Socratic graph.