收藏切换
Signal mining and analysis of adverse drug events of raltegravir and dolutegravir based on the FAERS database
收藏切换
Jia-hui GU1, 2, 3, Jian-qun ZHAO2, 3, Qing-yu CHEN1, 2, 3, Yan-li CAO2, 3, Yin-ling MA1, 2, 3, *
Chinese Journal of New Drugs | 2026, 35(11) : 1222 - 1232
Less
收藏切换
Chinese Journal of New Drugs | 2026, 35(11): 1222-1232
Signal mining and analysis of adverse drug events of raltegravir and dolutegravir based on the FAERS database
Full
Jia-hui GU1, 2, 3, Jian-qun ZHAO2, 3, Qing-yu CHEN1, 2, 3, Yan-li CAO2, 3, Yin-ling MA1, 2, 3, *
Affiliations
  • 1School of Pharmacy, Hebei Medical University, Shijiazhuang 050017, China
  • 2Department of Pharmacy, Hebei General Hospital, Shijiazhuang 050051, China
  • 3Hebei Key Laboratory of Clinical Pharmacy, Shijiazhuang 050051, China
Published: 2026-06-15 doi: 10.20251/j.cnki.1003-3734.2026.11.013
Outline
收藏切换
Objective:

To mine the adverse drug event (ADE) signals of raltegravir and dolutegravir based on the FDA adverse event reporting system (FAERS) database, and provide references for clinical medication safety and rational drug selection.

Methods:

All ADE reports of raltegravir from the fourth quarter of 2007 to the fourth quarter of 2024 and dolutegravir from the third quarter of 2013 to the fourth quarter of 2024 in the FAERS database were mined using reporting odds ratio (ROR) and proportional report ratio (PRR).

Results:

After excluding all kinds of injuries, poisoning, and operation complications, as well as other unrelated signals such as all kinds of operations and medical operations, product problems and social problems, there were 4 136 ADE reports related to raltegravir, 288 effective signals were obtained, and the signals involved 23 system organs; there were 2 119 cases of dolutegravir-related ADE reports, 165 effective signals were mined, and 22 system organs were involved. The related ADE signals with significant differences between raltegravir and dolutegravir were mainly concentrated in nervous system disorders, psychiatric disorders, infections and infestations, blood and lymphatic system diseases, pregnancy, puerperium and perinatal conditions, congenital, familial and genetic diseases, and eye diseases, etc. Dolutegravir had a higher risk of ADEs in nervous system disorders and psychiatric disorders, while raltegravir had a higher risk in other disease-related ADEs.

Conclusion:

The study found that there is a significant difference in the risk of adverse events between raltegravir and dolutegravir in the treatment of acquired immunodeficiency syndrome, which can provide references for individualized clinical treatment.

raltegravir  /  dolutegravir  /  acquired immune deficiency syndrome  /  FDA adverse event reporting system  /  adverse drug event  /  signal mining
谷佳慧, 赵建群, 陈晴宇, 曹艳丽, 马银玲. 基于FAERS数据库对拉替拉韦和多替拉韦的药物不良事件信号挖掘与分析. 中国新药杂志, 2026 , 35 (11) : 1222 -1232 . DOI: 10.20251/j.cnki.1003-3734.2026.11.013
Jia-hui GU, Jian-qun ZHAO, Qing-yu CHEN, Yan-li CAO, Yin-ling MA. Signal mining and analysis of adverse drug events of raltegravir and dolutegravir based on the FAERS database[J]. Chinese Journal of New Drugs, 2026 , 35 (11) : 1222 -1232 . DOI: 10.20251/j.cnki.1003-3734.2026.11.013
Year 2026 volume 35 Issue 11
53
8
Cite this Article
BibTeX
Article Info
doi: 10.20251/j.cnki.1003-3734.2026.11.013
  • Online Date:2026-10-26
  • Published:2026-06-15
Article Data
Affiliations
History
  • Accepted:2025-06-29
Funding
Affiliations
    1School of Pharmacy, Hebei Medical University, Shijiazhuang 050017, China
    2Department of Pharmacy, Hebei General Hospital, Shijiazhuang 050051, China
    3Hebei Key Laboratory of Clinical Pharmacy, Shijiazhuang 050051, China
References
Share
https://castjournals.cast.org.cn/joweb/zgxyzz/EN/10.20251/j.cnki.1003-3734.2026.11.013
Share to
QR

Scan QR to access full text

Cite this article
BibTeX
Citations
表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
关闭全屏
  • BibTeX
  • EndNote
  • RefWorks
  • TxT