薬物誘発性歯周病:FDA有害事象報告システム (FAERS) のデータベース分析からの洞察
Shun Mao1, Fei Ma1, Chang Zeng1
1School of Stomatology, Hunan University of Chinese Medicine, Changsha, China; Department of General Dentistry, Changsha Stomatological Hospital, Changsha, China.
European journal of pharmacology
|August 29, 2025
まとめ
この研究では 歯周病を引き起こす薬物を特定するために FDAのデータを分析しました 83の薬は骨粗鬆症と心臓血管薬を含むリスクシグナルを示し,診断に医療提供者を助けました.
科学分野:
- 薬用警戒について
- 歯科 医学
- 薬物安全性
背景:
- 薬剤による歯周病は 重要な臨床的課題です
- 薬と歯茎の健康との関連を理解することは 患者のケアにとって極めて重要です
研究 の 目的:
- FDAの有害事象報告システム (FAERS) データベースを使用して,歯周病との潜在的な薬物関連性を特定する.
- 歯周腺の有害事象に関連した薬の安全性信号を検出する.
主な方法:
- 2004Q1から2024Q3までのFAERSデータの分析
- 不均衡分析 (ROR,PRR,BCPNN,MGPS) を適用して,有害事象の信号を検出する.
- 患者の人口統計と報告情報源の記述的統計分析
主要な成果:
- 薬剤誘発性歯周病に関連する有害事象は34,354件報告された.
- 抗骨粗鬆症薬 (ゾレドロン酸,デノスマブ,アレンドロン酸) と心臓血管薬 (アムロディピン,リバロキサバン) を含む83の薬剤が陽性なリスクシグナルを示した.
- 女性と高齢者はより頻繁に影響を受け,消費者は主な報告者でした.
結論:
- FAERSデータベースの分析では,歯周病のリスクの増加に関連する特定の薬剤が特定されました.
- 発見は,特定の薬の歯周リスクの潜在的文書化不足を強調しています.
- 薬剤による歯周病の認識と管理の能力が向上します
関連する概念動画
FDA Approved Drugs: Changes to Approved Drugs
66
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
66
Pharmacovigilance
1.3K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.3K
Drug Regulation
2.3K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
2.3K
Assessment of the Gastrointestinal System I: Subjective Data
414
Assessing the gastrointestinal (GI) system is a complex process that begins with collecting subjective data. This data, collected through patient interviews, provides crucial insights into the patient's health history, perception patterns, and lifestyle habits, all contributing significantly to GI health.
Health History
The initial step in assessing the GI system is obtaining a comprehensive health history. This includes inquiring about the patient's history or presence of problems...
Health History
The initial step in assessing the GI system is obtaining a comprehensive health history. This includes inquiring about the patient's history or presence of problems...
414
Oral Hypoglycemic Agents: Biguanides and Glitazones
416
Biguanides, particularly metformin (Glucophage), are insulin sensitizers that enhance glucose uptake, thereby reducing insulin resistance. Unlike sulfonylureas, metformin doesn't prompt insulin secretion, which helps to curb hypoglycemia risk. Metformin is beneficial in treating conditions like polycystic ovary syndrome due to its insulin-resistance reduction capability. The drug's primary action involves curtailing hepatic gluconeogenesis, a significant contributor to high blood...
416


