Evidence map›Paper›PMID 33893351›Full record

ArticleScientific reports2021

Safety of traditional Chinese medicine injection based on spontaneous reporting system from 2014 to 2019 in Hubei Province, China.

Rui Huang, Yuanxuan Cai, Linhui Yang, Xiaofang Shangguan, Bishwajit Ghose, Shangfeng Tang

Open access · goldAbstract read
In one paragraph

Article in Scientific reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
3.6field-weighted citation impact, top 6% 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, 3 syntheses or guidelines pooled it, 28 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

6 authors at 1 institution in 1 country.

Rui HuangTongji Medical College, School of Pharmacy, Huazhong University of Science and Technology, Wuhan, 430030, Hubei, People's Republic of China.
Yuanxuan CaiTongji Medical College, School of Pharmacy, Huazhong University of Science and Technology, Wuhan, 430030, Hubei, People's Republic of China.
Linhui Yang *Tongji Medical College, School of Pharmacy, Huazhong University of Science and Technology, Wuhan, 430030, Hubei, People's Republic of China.
Xiaofang Shangguan *Tongji Medical College, School of Pharmacy, Huazhong University of Science and Technology, Wuhan, 430030, Hubei, People's Republic of China.
Bishwajit GhoseTongji Medical College, School of Pharmacy, Huazhong University of Science and Technology, Wuhan, 430030, Hubei, People's Republic of China. brammaputram@gmail.com.
Shangfeng TangTongji Medical College, School of Medicine and Health Management, Huazhong University of Science and Technology, Wuhan, 430030, Hubei, People's Republic of China. sftang2018@hust.edu.cn.
Huazhong University of Science and Technology · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Traditional Chinese medicine (TCM) injection is widely used in clinical settings, but its adverse drug reactions (ADRs) can be a serious public health concern. The objective is to study the safety of TCM injection and provide suggestions for clinical use. ADR reports collected by the Hubei Adverse Drug Reaction Monitoring Center from 2014 to 2019 were analysed. The safety of TCM injections was described by descriptive analysis and three signal mining methods, including the reporting odd ratio (ROR), proportional reporting ratio (PRR) and comprehensive standard method (MHRA). The findings indicate that the age groups of 0-10 and 41-80 years had the highest rates of reporting ADRs. A total of 96.41% of the ADRs occurred within one week, mostly on the same day that the injection was administered. Among the 60 TCM injections, Shenmai, Xiangdan, Salvia, Shengmai, Astragalus and Xuebijing injection had an above average ratio of severe ADRs (12.63%). A total of 99.24% of the cases improved after treatment. There were 9 deaths whose ADRs were mainly anaphylactic shock, dyspnoea and anaphylactoid reaction. In signal mining, the three methods produced 19 signals that were the same, and 14 of them were off-label ADRs. The frequency of TCM injections in children and elderly patients should be reduced and monitored strictly. Close observation is necessary during the first seven days after receiving the injection. The clinical use of Shenmai, Xiangdan, Salvia, Shengmai, Astragalus and Xuebijing injections should be investigated. Signal mining and more research are needed on TCM injections.

Indexed as

Adverse Drug Reaction Reporting SystemsAdultAgedAged, 80 and overChildChild, PreschoolChinaDrug-Related Side Effects and Adverse ReactionsDrugs, Chinese HerbalFemaleHumansIncidenceInfantMaleMedicine, Chinese TraditionalMiddle AgedDrugs, Chinese Herbal

Identifiers

PMID33893351
PMCPMC8065117
OpenAlexW3154790930

What OpenQuestion holds

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LicenceCC BY
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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.