Comparison of drug safety data obtained from the monitoring system, literature, and social media: An empirical proof from a Chinese patent medicine

Autor: Ruyu Xia, Xun Li, Nan-qi Zhao, Bao-Yong Lai, Su Golder, Li-Qiong Wang, Rui-Xue Hu, Sai-Nan Fang, Di Wang, Guoyan Yang, Yutong Fei, Jianping Liu
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Chinese patent medicine
Physiology
Databases
Pharmaceutical
Gastrointestinal Diseases
Psychological intervention
Social Sciences
030204 cardiovascular system & hematology
Cochrane Library
Pathology and Laboratory Medicine
law.invention
0302 clinical medicine
Randomized controlled trial
Sociology
law
Medicine and Health Sciences
030212 general & internal medicine
Multidisciplinary
Publications
Social Communication
Nausea
Research Assessment
Checklist
Systematic review
Social Networks
Research Design
Observational Studies
Medicine
Network Analysis
Research Article
Diarrhea
medicine.medical_specialty
Computer and Information Sciences
Drug Research and Development
Systematic Reviews
Drug-Related Side Effects and Adverse Reactions
Vomiting
Science
MEDLINE
Gastroenterology and Hepatology
Research and Analysis Methods
03 medical and health sciences
Signs and Symptoms
Adverse Reactions
Drug Safety
Diagnostic Medicine
medicine
Adverse Drug Reaction Reporting Systems
Humans
Social media
Pharmacology
business.industry
Biology and Life Sciences
Communications
Family medicine
Cordyceps
business
Physiological Processes
Social Media
Drugs
Chinese Herbal
Zdroj: PLoS ONE
PLoS ONE, Vol 14, Iss 11, p e0222077 (2019)
ISSN: 1932-6203
Popis: Objectives To investigate the consistency of adverse events (AEs) and adverse drug reactions (ADRs) reported in the literature, monitoring and social media data. Methods Using one Chinese patent medicine-Cordyceps sinensis extracts (CSE) as an example, we obtained safety data from the national monitoring system (July 2002 to February 2016), literature (up to November 2016) and social media (May 2019). For literature data, we searched the Chinese National Knowledge Infrastructure Database (CNKI), WanFang database, Chinese Science and Technology Periodical Database (VIP), Chinese Biomedical Literature Database (SinoMed), PubMed, Embase and the Cochrane Library. Social media data was from the Baidu post bar and Sina micro-blog. Two authors independently screened the literature and extracted data by PRISMA Harms checklist was followed. AEs and ADRs were coded using the World Health Organization Adverse Reaction Terminology (WHO-ART). AEs and ADRs were grouped into thirty-one organ-system classes for comparisons. Frequencies, relative frequencies and rank were used as metrics. Radar chart was used to manifest the features of the distributions and proportions. Results 610 AEs reported in CFDA monitoring data were associated with CSE, of which 537 (88.03%) were suspected ADRs (10.49% certain). 5568 AEs were identified from 172 papers (63% RCTs, 37% other types of studies including case series, case reports, ADR monitoring reports and reviews), in which 86 (1.54%) were ADRs (1.54% certain). 15 AEs (0 certain ADR) were identified from social media. AEs, ADRs and their affected system-organ classes, looked largely similar, but different in every aspect when looking at details. Data from RCTs demonstrated the most disparity. Conclusions In our study, the most prevalent AEs and ADRs, mainly gastro-intestinal system disorders including nausea, diarrhea and vomiting, in monitoring system were largely similar with those in literature and social media. But data from different sources varied if looked at details. Multiple data sources (the monitoring system, literature and social media) should be integrated to collect safety information of interventions. The distributions of AEs and ADRs from RCTs were least similar with the data from other sources. Our empirical proof is consistent with other similar studies.
Databáze: OpenAIRE
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