Evidence map›Paper›PMID 33963478›Full record

ArticleChinese journal of integrative medicine2021

Landscape of Hepatobiliary Adverse Drug Reactions Related to Preparations Containing Psoraleae Fructus and Its Application in Pharmacovigilance.

Fei-Lin Ge, Ming Niu, Zi-Xin Han, Jun-Ling Cao, Jia-Bo Wang, Zhao-Fang Bai, Hai-Bo Song, Yu-Ming Guo, Xiao-He Xiao

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Article in Chinese journal of integrative medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.9field-weighted citation impact, top 16% 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

7 citing papers in PubMed, 15 citations in OpenAlex.

  1. Article
  2. Article
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  4. [A case of the syndrome of disappearing intrahepatic bile ducts caused by Polygonum multiflorum].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2024
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  6. Article
  7. Review
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

9 authors at 3 institutions in 1 country.

Fei-Lin GeSchool of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, 100029, China.
Ming NiuDepartment of Hepatology, Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.
Zi-Xin HanDepartment of Hepatology, Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.
Jun-Ling CaoDepartment of Pharmacy, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100078, China.
Jia-Bo WangDepartment of Hepatology, Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.
Zhao-Fang BaiDepartment of Hepatology, Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.
Hai-Bo SongCenter for Drug Reevaluation, National Medical Products Administration, Beijing, 100022, China. Songhaibo@cdr.gov.cn.
Yu-Ming GuoDepartment of Hepatology, Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. guoyuming_0520@126.com.
Xiao-He XiaoDepartment of Hepatology, Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.
Chinese PLA General Hospital · CNBeijing University of Chinese Medicine · CNNational Medical Products Administration · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo analyze clinical feature and information of medication to explore the risk signals of preparations containing Psoraleae Fructus (BGZP) related with hepatobiliary adverse drug reactions (ADR), in order to reinforce pharmacovigilance.

methodsA retrospective study was conducted based on hepatobiliary ADR related with BGZP from the China Adverse Drug Reaction Monitoring System in years from January 2012 to December 2016. Serious and general ADRs were analyzed and assessed.

resultsThere were 355 cases of hepatobiliary ADR related to BGZP. Both the amount of cases and the proportion of serious ADR showed an increasing growth by years (P<0.05). It was found that 10.43% of 355 cases may be involved with irrational drug use, including overdose, repeated medication, and combination of multiple drugs. There were 190 cases which used BGZP (non-combination), and they were mainly for common in diseases caused by abnormal immune activation (accounting for 40.53% of the total cases). Especially at the age group with the most cases with age of 41-50 years, the cases associated with immunological diseases of female were obviously more than that of male (P<0.05). The latency of hepatobiliary ADR related to BGZP ranged from 1 to 386 days, and the median latency was 27.5 days, along with the range of cumulative dose (0.45-520.02 g) as well as the daily dose (0.09-2.64 g/d) after the conversion.

conclusionsCases of hepatobiliary ADR related to BGZP showed significant individual differences, and there was no correlation between drug usage duration and dosage and the occurrence of hepatobiliary ADR. It may be similar with idiosyncratic drug-induced liver injury, and recommended that BGZP should be used with more caution under monitoring liver function, especially in female patients with immunological diseases.

Indexed as

Chemical and Drug Induced Liver InjuryDrug-Related Side Effects and Adverse ReactionsAdultAdverse Drug Reaction Reporting SystemsFemaleHumansMaleMiddle AgedPharmacovigilanceRetrospective Studiesdrug safetyhepatobiliary adverse drug reactionpharmacovigilancePsoraleae Fructus

Identifiers

PMID33963478
OpenAlexW3159955278

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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.