Evidence map›Paper›PMID 31032272›Full record

ArticleAnnals of translational medicine2019

A real-world study on adverse drug reactions to Xuebijing injection: hospital intensive monitoring based on 93 hospitals (31,913 cases).

Rui Zheng, Hui Wang, Zhi Liu, Xiaohui Wang, Jing Li, Xiang Lei, Yilin Fan, Si Liu, Zhiqiao Feng, Hongcai Shang

Open access · diamondAbstract read
In one paragraph

Article in Annals of translational medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 6 pooled it
4.1field-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

23 citing papers in PubMed, 6 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
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  6. Efficacy and safety of eight typesFrontiers in pharmacology · 2022
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  10. Safflower yellow inChinese herbal medicines · 2026
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  17. Frontiers in bioengineering and biotechnology · 2022
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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

10 authors at 3 institutions in 1 country.

Rui ZhengKey Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.
Hui WangEvidence-based Medicine Center, Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.
Zhi LiuEvidence-based Medicine Center, Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.
Xiaohui WangTianjin Taicheng Yaozhong Biomedical Technology Co. LTD, Tianjin 300110, China.
Jing LiTianjin Taicheng Yaozhong Biomedical Technology Co. LTD, Tianjin 300110, China.
Xiang LeiTianjin Taicheng Yaozhong Biomedical Technology Co. LTD, Tianjin 300110, China.
Yilin FanTianjin CLINDA Medical Technology Co. LTD, Tianjin 300384, China.
Si LiuTianjin Chase Sun Pharmaceutical Co. LTD, Tianjin 300170, China.
Zhiqiao FengTianjin Chase Sun Pharmaceutical Co. LTD, Tianjin 300170, China.
Hongcai ShangKey Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.
Tianjin University of Traditional Chinese Medicine · CNBeijing University of Chinese Medicine · CNGuangzhou Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough we have made tremendous medical advances in recent decades in modern antibiotics and supportive therapies, the treatment of sepsis has not experienced such rapid advancement. Xuebijing injection (XBJ) is a Chinese prescription consisting of

methodsFrom the clinical application of XBJ in a real-world setting, patients in 93 hospitals using XBJ were monitored between August 2013 and August 2016. There was no limit on the treatment course and dosage. From data obtained in interviews or telephone follow-ups with hospitalized patients, the circumstances of patients' adverse events (AEs) during the course of drug treatment and during the 7 days after drug withdrawal were recorded and encoded by MedDRA18.0. The likelihood of ADRs was determined by the criteria of the Uppsala Monitoring Centre. Statistical analyses were performed by SAS9.2 software.

resultsIn total, 31,913 participants enrolled, and none were lost to follow-up. AEs (suspected ADRs) occurred in 234 participants. ADRs occurred in 96 participants, and the incidence was 0.3%. The ADRs with the top three frequencies were skin pruritus (0.116%), erythra (0.066%) and chest tightness (0.044%). There was no significant relationship between ADRs and solvents (P=0.149), route of administration (P=0.640), unhealthy addiction (P=0.069), allergy (P=0.535), first use of XBJ (P=0.161) or dosage (P=0.743). There was a significant relationship between ADRs and irrigating syringe (P<0.0001) and fluid dripping too quickly (P=0.019).

conclusionsThis large-scale survey of hospitalized patients found that the incidence of ADRs was occasional (0.3%), while most of the ADRs were relatively mild or non-serious. XBJ should be administered rationally and according to its instructions to prevent the occurrence of ADRs.

Indexed as

Adverse drug reaction (ADR)hospital intensive monitoring (HIM)real-world studyXuebijing injection (XBJ)

Identifiers

PMID31032272
PMCPMC6465439
OpenAlexW2893637699

What Socratic holds

Textmetadata
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.