Evidence map›Paper›PMID 30326892›Full record

ArticleBMC complementary and alternative medicine2018

Post-marketing safety surveillance and re-evaluation of Xueshuantong injection.

Chunxiao Li, Tao Xu, Peng Zhou, Junhua Zhang, Ge Guan, Hui Zhang, Xiao Ling, Weixia Li, Fei Meng, Guanping Liu and 4 more

Open access · goldAbstract read
In one paragraph

Article in BMC complementary and alternative medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 3 pooled it
1.0field-weighted citation impact, top 24% 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

11 citing papers in PubMed, 3 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. The use ofFrontiers in pharmacology · 2024
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  4. Article
  5. Review
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  9. Evidence-based complementary and alternative medicine : eCAM · 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

14 authors at 2 institutions in 1 country.

Chunxiao LiThe First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450000, People's Republic of China.
Tao XuThe First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450000, People's Republic of China.
Peng ZhouThe First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450000, People's Republic of China.
Junhua ZhangEvidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin, 300000, People's Republic of China.
Ge GuanThe First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450000, People's Republic of China.
Hui ZhangThe First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450000, People's Republic of China.
Xiao LingThe First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450000, People's Republic of China.
Weixia LiThe First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450000, People's Republic of China.
Fei MengThe First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450000, People's Republic of China.
Guanping LiuGuangxi Wuzhou Pharmaceutical (group) Co., Ltd, Wuzhou, 543000, People's Republic of China.
Linyan LvGuangxi Wuzhou Pharmaceutical (group) Co., Ltd, Wuzhou, 543000, People's Republic of China.
Jun YuanShanghai Yongzheng Medical Science and Technology Co., Ltd, Shanghai, 200000, People's Republic of China.
Xuelin LiThe First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450000, People's Republic of China. lixuelin450000@163.com.
Mingjun ZhuThe First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450000, People's Republic of China. zhumingjun317@163.com.
First Affiliated Hospital of Henan University · CNTianjin University of Traditional Chinese Medicine · CN

Funding

Major New Drugs Innovation and Development 2012ZX09101201
6 · The paper itself

Abstract

backgroundTraditional Chinese medicine injections (TCMIs) have been widely used to treat severe and acute diseases due to their high bioavailability, accurate curative effect, and rapid effect. However, incidence rates of adverse drug reactions (ADRs) of TCMIs have also increased in recent years. Xueshuantong injection (XSTI) is a commonly-used TCMI comprised of Panax notoginseng total sapiens for the treatment of stroke hemiplegia, chest pain, and central retinal vein occlusion. Its safety remains uncelar. Therefore, post-marketing safety of XSTI was studied in this research.

methodsIn present study, post-marketing safety surveillance and re-evaluation of XSTI were reported. Thirty thousand eight hundred eighty-four patients in 33 hospitals from 7 provinces participated in this study. Incidence rate, most common clinical manifestations, types, severity, occurrence time, and disposal of ADRs were calculated.

resultsIncidence rate of ADR of XSTI was 4.14‰ and the most common clinical manifestations were skin and its appendages damage. Type A accounts for 95.49% of ADRs of XSTI and most of them (41.41%) were occurred within 24 h after receiving XSTI treatment. Severities of most ADRs of XSTI were moderate reactions (86.72%). Main disposition of ADRs of XSTI was drug withdrawal and symptomatic treatment (54.69%).

conclusionsOur data provide basis for improvement of instructions of XSTI and clinical safety of XSTI. Post-marketing surveillance of TCMIs in this study is a powerful tool to identify types and manifestations of ADRs to improve safety and effectiveness of drugs in clinical applications.

trial registrationThis protocol has international registration in China clinical trial registration center ( ChiCTR~OPC~ 14,005,718 ) at December 22, 2014.

Indexed as

ChinaClinical Trials as TopicCohort StudiesDrug-Related Side Effects and Adverse ReactionsDrugs, Chinese HerbalHumansIncidenceInjectionsProduct Surveillance, PostmarketingDrugs, Chinese HerbalPanax notoginseng extractADRs/ADEsPost-marketingTraditional Chinese medicine injectionsXueshuantong injection

Identifiers

PMID30326892
PMCPMC6192149
OpenAlexW2896494386

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.