https://doi.org/10.1016/j.apsb.2022.04.019
This new article publication from Acta Pharmaceutica Sinica B, discusses the landscape of DILI-related adverse drug reaction on the Chinese Mainland.
Drug-induced liver injury (DILI) is a type of bizarre adverse drug reaction (ADR) damaging liver (L-ADR) which may lead to substantial hospitalizations and mortality. Due to the general low incidence, detection of L-ADR remains an unsolved public health challenge. The authors of this article used the data of 6.673 million of ADR reports from January 1st, 2012 to December 31st, 2016 in China National ADR Monitoring System to establish a new database of L-ADR reports for future investigation. Results showed that totally 114,357 ADR reports were retrieved by keywords searching of liver-related injuries from the original heterogeneous system.
By cleaning and standardizing the data fields by the dictionary of synonyms and English translation, 94,593 ADR records reported to liver injury were identified and then created a new database ready for computer mining. The reporting status of L-ADR showed a persistent 1.62-fold change over the past five years. The national population-adjusted reporting numbers of L-ADR manifested an upward trend with age increasing and more evident in men. The annual reporting rate of L-ADR in age group over 80 years old strikingly exceeded the annual DILI incidence rate in general population, despite known underreporting situation in spontaneous ADR reporting system. The percentage of herbal and traditional medicines (H/TM) L-ADR reports in the whole number was 4.5%, while 80.60% of the H/TM reports were new findings. There was great geographical disparity of reported agents, i.e. more cardiovascular and antineoplastic agents were reported in higher socio-demographic index (SDI) regions and more antimicrobials, especially antitubercular agents, were reported in lower SDI regions.
In conclusion, this study presents a large-scale, unbiased, unified, and computer-minable L-ADR database for further investigation. Age-, sex- and SDI-related risks of L-ADR incidence warrant to emphasize the precise pharmacovigilance policies within China or other regions in the world.
Keywords: Adverse drug reactions, Drug-induced liver injury, Spontaneous reporting system, Database, Socio-demographic index, Pharmacoepidemiology, Pharmacovigilance, Geographical disparity
Graphical Abstract: available at https://ars.els-cdn.com/content/image/1-s2.0-S2211383522002076-ga1_lrg.jpg
This study provides a whole epidemiological picture of L-ADR in mainland China and concluded that L-ADR has a persistent increase. This work provides a powerful tool to mine the potential hepatotoxic drugs in the future..
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The Journal of the Institute of Materia Medica, the Chinese Academy of Medical Sciences and the Chinese Pharmaceutical Association.
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CiteScore: 15.9
Impact Factor: 14.903
JIF without self-citation: 13.888
ISSN 2211-3835
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Article reference: Jiabo Wang, Haibo Song, Feilin Ge, Peng Xiong, Jing Jing, Tingting He, Yuming Guo, Zhuo Shi, Chao Zhou, Zixin Han, Yanzhong Han, Ming Niu, Zhaofang Bai, Guangbin Luo, Chuanyong Shen, Xiaohe Xiao, Landscape of DILI-related adverse drug reaction in China Mainland, Acta Pharmaceutica Sinica B, Volume 12, Issue 12, 2022, Pages 4424-4431, ISSN 2211-3835, https://doi.org/10.1016/j.apsb.2022.04.019