BACKGROUND Drug-induced interstitial lung disease (DI-ILD) is a heterogeneous subgroup of interstitial lung diseases (ILD). The number of molecules involved is increasing with time. Due to their low incidence, DI-ILDs may be detected only after a drug has been marketed, notably through Adverse Drug Reaction (ADR) reports to pharmacovigilance centres. The aim of our study was to describe drug-induced diffuse lung disease cases notified to and recorded by the French Pharmacovigilance Database (FPVD), reported clinical pictures and the potentially causal drugs. METHODS This retrospective study included cases registered in the FPVD from 1st January 1985 to 1st April 2022 which had ADR coded in MedDRA with a High Level Group Term "Lower respiratory tract disorders (excluding obstruction and infection)" involving patients aged 18 and over. RESULTS We analysed 7234 cases involving 13 059 suspect medications and 1112 specific molecules. Cases were categorised as serious in 96.7% and in 13.3% death ensued. Men accounted for 54.4% of the cases. Median age was 69 [18-103] years. The most prevalent ADRs were "ILD" (51.0%), "Pulmonary oedema" (acute/non-acute) (15.6%) and "Pulmonary fibrosis" (10.5%). "Anti-cancer drugs" (31.2%) and "Cardiovascular drugs" (29.1%) were the most prominent therapeutic classes involved, with amiodarone being the most commonly reported suspected drug (10.0%), followed by methotrexate (3.1%). CONCLUSION This study from a large nationwide dataset spanning 37 years is the largest known to date. Drug-induced diffuse lung diseases are serious with a potentially fatal outcome. Accurate diagnoses remain essential to identify it properly and discontinue the culprit drug urgently.

中文翻译：

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归因于药物的弥漫性肺病：一项使用法国药物警戒数据库进行的超过 37 年的全国性观察研究。


背景 药物诱导的间质性肺病 （DI-ILD） 是间质性肺病 （ILD） 的一个异质性亚组。所涉及的分子数量随着时间的推移而增加。由于 DI-ILD 的发生率低，只有在药物上市后才能检测到，特别是通过向药物警戒中心提交药物不良反应 （ADR） 报告。我们研究的目的是描述通知法国药物警戒数据库 （FPVD） 并由其记录的药物诱导的弥漫性肺病病例、报告的临床图片和潜在的致病药物。方法 本回顾性研究包括 1985 年 1 月 1 日至 2022 年 4 月 1 日在 FPVD 中登记的病例，这些病例在 MedDRA 中编码为 ADR，具有高级别组术语“下呼吸道疾病（不包括梗阻和感染）”，涉及 18 岁及以上的患者。结果 我们分析了 7234 例病例，涉及 13 059 种可疑药物和 1112 种特异性分子。96.7% 的病例被归类为严重病例，13.3% 的病例被归类为严重死亡。男性占病例的 54.4%。中位年龄为 69 [18-103] 岁。最普遍的 ADR 是“ILD”（51.0%）、“肺水肿”（急性/非急性）（15.6%）和“肺纤维化”（10.5%）。“抗癌药物”（31.2%） 和“心血管药物”（29.1%） 是涉及的最突出的治疗类别，其中胺碘酮是最常见的可疑药物 （10.0%），其次是甲氨蝶呤 （3.1%）。结论 这项研究来自一个跨越 37 年的大型全国数据集，是迄今为止已知的最大数据集。药物诱发的弥漫性肺病很严重，可能会致命。准确诊断对于正确识别它并紧急停用罪魁祸首药物仍然至关重要。