Evidence map›Paper›PMID 26159784›Full record

ArticleEuropean journal of clinical pharmacology2015

Detecting drug-herbal interaction using a spontaneous reporting system database: an example with benzylpenicillin and qingkailing injection.

Haona Li, Jianxiong Deng, Zhihua Yue, Yiexiang Zhang, He Sun

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Article in European journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 28% 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 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

5 authors at 3 institutions in 1 country.

Haona LiSchool of Pharmaceutical Science and Technology, Tianjin University, No. 92 Weijin Road, Nankai district, Tianjin, 300072, China.
Jianxiong Deng
Zhihua Yue
Yiexiang Zhang
He Sun
Guangdong Province Environmental Monitoring Center · CNTianjin University · CNFosun Pharma (China) · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe study aims to quantify anaphylaxis signal for combined exposure of benzylpenicilin and qingkailing injection (QI) compared with individual exposure of the two drugs and the background risk based on all other exposures in SRS database.

methodsData used in this study were collected during 2003-2014 from China Guangdong Provincial Center of ADR Monitoring. We studied the suspected ADR reports using a case/non-case design. The cases were defined as the reactions coded by WHO-preferred terms of anaphylactic shock or anaphylactoid reaction. Reporting odds ratios (RORs) were used as a measure of disproportionality and were adjusted for age and gender to reduce confounding effects. An observed-to-expected ratio Ω was also used for interaction detection.

resultsThe crude RORs (95 % CIs) for anaphylaxis in patients who used only benzylpenicillin or QI and those who used the two drugs concomitantly compared with patients who used neither of the two drugs were 2.50 (2.34-2.68), 1.59 (1.46-1.73), and 6.22 (3.34-11.58), respectively. The adjusted RORs (95 % CIs) were 2.48 (2.31-2.65), 1.54 (1.41-1.67), and 6.01 (3.22-11.20), respectively, after being adjusted for age and gender. The measured Ω, Ω0, Ω025, and Ω975 was 1.03, 1.09, 0.14, and 1.71, respectively.

conclusionsCase reports in the database are suggestive of a safety signal which indicates that an interaction between benzylpenicillin and QI resulting in excess risk of anaphylaxis may occur. SRS databases have a potential for signaling unknown drug-herbal interactions. More effort is needed to expand this potential.

Indexed as

Adverse Drug Reaction Reporting SystemsDatabases, FactualHerb-Drug InteractionsAdolescentAdultAgedAnaphylaxisAnti-Bacterial AgentsChildChild, PreschoolChinaDrugs, Chinese HerbalFemaleHumansInfantInjectionsAnti-Bacterial AgentsDrugs, Chinese HerbalPenicillin GQingkailing

Identifiers

PMID26159784
OpenAlexW815615363

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Registered trials

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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.