Paper Details 
Original Abstract of the Article :
<b>Objective:</b> To mine the signals of adverse drug reaction (ADR) of entecavir and tenofovir by using the US FDA Adverse Event Reporting System (FAERS) database, so as to provide reference for the safe clinical use of these two drugs. <b>Methods:</b> Reporting odds ratio (ROR) and proportion of ...See full text at original site
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引用元:
https://doi.org/10.3760/cma.j.cn501113-20200117-00020

データ提供:米国国立医学図書館(NLM)

Mining Signals of Adverse Drug Reactions: A Journey Through the FAERS Database

The field of [pharmacovigilance] is crucial to ensure the safety of drugs and identify potential adverse effects. This study delves into the vast landscape of the [US FDA Adverse Event Reporting System (FAERS)] database, a repository of invaluable information on drug safety. The researchers employed the [Reporting odds ratio (ROR) and proportion of report ratio (PRR)] methods to analyze [26 quarterly reports] of the FAERS database, spanning from the fourth quarter of 2012 to the first quarter of 2019. Their goal was to uncover [signals of adverse drug reaction (ADR)] for [entecavir and tenofovir], two medications commonly used to treat [Hepatitis B virus (HBV)]. The study revealed [104 and 187 signals of ADR] for entecavir and tenofovir dipivoxil, respectively, highlighting the importance of vigilant monitoring and careful consideration of these medications' potential effects. The authors emphasize that [the mining signals of adverse drug reaction of entecavir and tenofovir dipivoxil indicate that these two drugs can cause female reproductive system damage, fetal abnormalities, neonatal and infant abnormalities, and male reproductive system damage]. However, in addition to the above-mentioned ADR, the ADR instruction manual excludes entecavir and tenofovir dipivoxil primarily for respiratory and visual system damage, and the tenofovir disoproxil primarily for skin and appendage damage, and hearing and vestibular function damage. Therefore, in clinical medication management, it is suggested to pay close attention to the choice of drugs for special population infected with HBV, monitor possible ADR during medication course, and provide pharmacological monitoring to achieve personalized medication.

Uncovering the Hidden Landscape of Drug Effects: A Treasure Hunt in the FAERS Database

This study's findings underscore the crucial role of [pharmacovigilance] in safeguarding patient health. By meticulously sifting through the vast [FAERS] database, the researchers identified [a significant number of ADR signals] for [entecavir and tenofovir], revealing potential risks associated with these medications. The study highlights the need for careful monitoring of patients taking these drugs and emphasizes the importance of [personalized medication] strategies, considering individual patient characteristics and potential vulnerabilities. The researchers' work serves as a reminder that even widely used medications can have unexpected consequences, and ongoing surveillance is vital to ensure patient safety.

Navigating the Sands of Drug Safety: A Guide for Clinicians and Patients

This research provides valuable insights for both clinicians and patients. Doctors should be aware of the potential [ADR] associated with [entecavir and tenofovir] and consider the [risks and benefits] for each patient. Furthermore, patients should be informed about the potential side effects of these medications and encouraged to report any unusual symptoms to their healthcare providers. Open communication between healthcare providers and patients is essential to ensure safe and effective medication use.

Dr. Camel's Conclusion

Just like a camel navigates the vast desert, the researchers in this study navigated the immense FAERS database, uncovering hidden signals of potential drug reactions. This exploration reminds us that even familiar drugs can have hidden consequences, and staying vigilant about their effects is crucial. This study emphasizes the importance of a collaborative approach between doctors and patients to ensure medication safety and promote well-being.

Date :
  1. Date Completed 2021-10-14
  2. Date Revised 2021-10-14
Further Info :

Pubmed ID

34638200

DOI: Digital Object Identifier

10.3760/cma.j.cn501113-20200117-00020

Related Literature

SNS
PICO Info
in preparation
Languages

Chinese

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