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药物性龋齿:基于 VigiBase 数据的一项比例失调分析。

Drug-Induced Dental Caries: A Disproportionality Analysis Using Data from VigiBase.

机构信息

Service de Pharmacologie Médicale et Clinique, Centre Hospitalier Universitaire de Toulouse, 31000, Toulouse, France.

Laboratoire de Pharmacologie Médicale et Clinique, Faculté de Médecine, Université Paul Sabatier, 37 Allée Jules-Guesde, 31000, Toulouse, France.

出版信息

Drug Saf. 2017 Dec;40(12):1249-1258. doi: 10.1007/s40264-017-0575-5.

DOI:10.1007/s40264-017-0575-5
PMID:28744845
Abstract

INTRODUCTION

Dental caries is defined as a pathological breakdown of the tooth. It is an infectious phenomenon involving a multifactorial aetiology. The impact of drugs on cariogenic risk has been poorly investigated.

OBJECTIVES

In this study, we identified drugs suspected to induce dental caries as adverse drug reactions (ADRs) and then studied a possible pathogenic mechanism for each drug that had a statistically significant disproportionality.

METHODS

We extracted individual case safety reports of dental caries associated with drugs from VigiBase (the World Health Organization global individual case safety report database). We calculated disproportionality for each drug with a reporting odds ratio (ROR) and 99% confidence interval. We analysed the pharmacodynamics of each drug that had a statistically significant disproportionality.

RESULTS

In VigiBase, 5229 safety reports for dental caries concerning 733 drugs were identified. Among these drugs, 88 had a significant ROR, and for 65 of them (73.9%), no information about dental caries was found in the summaries of the product characteristics, the Micromedex DRUGDEX, or the Martindale databases. Regarding the pharmacological classes of drugs involved in dental caries, we identified bisphosphonates, atropinic drugs, antidepressants, corticoids, immunomodulating drugs, antipsychotics, antiepileptics, opioids and β-adrenoreceptor agonist drugs. Regarding possible pathogenic mechanisms for these drugs, we identified changes in salivary flow/composition for 54 drugs (61.4%), bone metabolism changes for 31 drugs (35.2%), hyperglycaemia for 32 drugs (36.4%) and/or immunosuppression for 23 drugs (26.1%). For nine drugs (10.2%), the mechanism was unclear.

CONCLUSION

We identified 88 drugs with a significant positive disproportionality for dental caries. Special attention has to be paid to bisphosphonates, atropinic drugs, immunosuppressants and drugs causing hyperglycaemia.

摘要

简介

龋齿被定义为牙齿的病理性破坏。它是一种涉及多因素病因的感染现象。药物对致龋风险的影响尚未得到充分研究。

目的

在这项研究中,我们确定了疑似引起龋齿的药物作为药物不良反应 (ADR),然后研究了每种药物的可能致病机制,这些药物具有统计学意义的不成比例性。

方法

我们从 VigiBase(世界卫生组织全球个体病例安全报告数据库)中提取了与药物相关的龋齿个体病例安全报告。我们使用报告比值比 (ROR) 和 99%置信区间计算了每种药物的不成比例性。我们分析了具有统计学意义的不成比例性的每种药物的药效学。

结果

在 VigiBase 中,确定了与 733 种药物相关的 5229 例龋齿安全报告。在这些药物中,有 88 种药物的 ROR 具有统计学意义,其中 65 种药物(73.9%)在产品特性摘要、Micromedex DRUGDEX 或 Martindale 数据库中未发现有关龋齿的信息。关于涉及龋齿的药物的药理学类别,我们确定了双膦酸盐、阿托品类药物、抗抑郁药、皮质激素、免疫调节药物、抗精神病药、抗癫痫药、阿片类药物和β-肾上腺素能受体激动剂药物。关于这些药物的可能致病机制,我们确定了 54 种药物(61.4%)改变唾液流量/成分、31 种药物(35.2%)改变骨代谢、32 种药物(36.4%)导致高血糖和/或 23 种药物(26.1%)免疫抑制。对于 9 种药物(10.2%),机制尚不清楚。

结论

我们确定了 88 种药物与龋齿有显著的正不成比例性。特别需要关注双膦酸盐、阿托品类药物、免疫抑制剂和引起高血糖的药物。

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