Risk signals mining for Fluocinolone acetonide intravitreal implants based on Hainan Province Franchised Drug Monitoring System and FAERS

MIAO Huiqing; LIN Kai; YAO Minghong; LIN Lijun

doi:10.6039/j.issn.1001-0408.2024.12.16

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Risk signals mining for Fluocinolone acetonide intravitreal implants based on Hainan Province Franchised Drug Monitoring System and FAERS

更新时间：2024-06-25

- Risk signals mining for Fluocinolone acetonide intravitreal implants based on Hainan Province Franchised Drug Monitoring System and FAERS
- ZHONGGUO YAOFANG Vol. 35, Issue 12, Pages: 1505-1510(2024)
- 作者机构：
  
  1.海南省药物警戒中心，海口　570216
  2.海南省药品和医疗器械审评服务中心，海口　570216
  3.四川大学华西医院中国循证医学中心，成都　610041
  4.海口市药物警戒中心，海口　570100
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.12.16
  CLC： R979.5
- Published：30 June 2024，
  
  Received：22 December 2023，
  
  Revised：19 February 2024，
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苗会青,林凯,姚明宏等.基于海南省特许药品监测系统和FAERS的氟轻松玻璃体植入剂的风险信号挖掘 ^Δ[J].中国药房,2024,35(12):1505-1510.

MIAO Huiqing,LIN Kai,YAO Minghong,et al.Risk signals mining for Fluocinolone acetonide intravitreal implants based on Hainan Province Franchised Drug Monitoring System and FAERS[J].ZHONGGUO YAOFANG,2024,35(12):1505-1510.
苗会青,林凯,姚明宏等.基于海南省特许药品监测系统和FAERS的氟轻松玻璃体植入剂的风险信号挖掘 ^Δ[J].中国药房,2024,35(12):1505-1510. DOI： 10.6039/j.issn.1001-0408.2024.12.16.

MIAO Huiqing,LIN Kai,YAO Minghong,et al.Risk signals mining for Fluocinolone acetonide intravitreal implants based on Hainan Province Franchised Drug Monitoring System and FAERS[J].ZHONGGUO YAOFANG,2024,35(12):1505-1510. DOI： 10.6039/j.issn.1001-0408.2024.12.16.

摘要

目的

挖掘氟轻松玻璃体植入剂的风险信号，促进患者安全合理用药。

方法

基于海南省特许药品不良反应监测子系统（以下简称“特许药品监测系统”）数据及FDA不良事件报告系统（FAERS）数据，采用系统器官分类及首选术语对氟轻松玻璃体植入剂的药品不良反应（ADR）/不良事件（ADE）报告进行编码，统计相关患者的信息，采用报告比值比（ROR）法及英国药品和保健产品管理局（MHRA）综合标准法（以下简称“MHRA”法）进行风险信号挖掘。

结果

特许药品监测系统收到的72份氟轻松玻璃体植入剂ADR/ADE报告中，患者男女比例为1∶1.4，患者年龄主要分布在18～64岁；ADR/ADE共累及5个系统器官，眼器官疾病占比87.7%；新的一般的ADR报告9份（占12.5%），严重的ADR报告4份（占5.6%）；ROR法及MHRA法均挖掘出白内障、青光眼、高眼压3个风险信号。FAERS数据库收到的244份报告中，患者男女比例为1∶1.5；ADR/ADE共累及10个系统器官，各类损伤、中毒及操作并发症占46.1%，产品问题占32.0%；严重的ADR报告20份（占8.2%）；ROR法及MHRA法均挖掘出植入并发症、给药系统问题等19个风险信号。

结论

临床使用氟轻松玻璃体植入剂时除了关注高眼压、白内障、青光眼等眼部ADR/ADE外，也应警惕产品质量及不合理使用方面的ADE所引发的潜在风险。

Abstract

OBJECTIVE

To explore the risk signals of Fluocinolone acetonide intravitreal implants and promote safe and rational drug use for patients.

METHODS

Based on the data from the Hainan Province Franchised Drug Adverse Reaction Monitoring Subsystem （hereinafter referred to as the “Franchised Drug Monitoring System”） and the FDA Adverse Event Reporting System （FAERS）， the adverse drug reaction （ADR）/adverse drug event （ADE） reports of Fluocinolone acetonide intravitreal implants were coded by using system organ classification and preferred terminology， and relevant patient information was collected. Risk signal mining was carried out by using the reporting odds ratio （ROR） method and the comprehensive standards method of the UK Medicines and Healthcare Products Regulatory Agency （hereinafter referred to as the “MHRA method”）.

RESULTS

Among the 72 reports of Fluocinolone acetonide intravitreal implants received by the Franchised Drug Monitoring System， the ratio of male to female was 1∶1.4， the patient’s age was mainly distributed between 18 and 64 years old； ADR/ADE affected 5 systemic organs， with eye organ diseases accounting for 87.7%； among them， there were 9 new and general ADR reports （12.5%） and 4 severe ADR reports （5.6%）； ROR method and MHRA method both identified three risk signals： cataracts， glaucoma， and high intraocular pressure. Among the 244 reports received by the FAERS database， the ratio of male to female was 1∶1.5； ADR/ADE damage affected 10 systemic organs， with 46.1% suffering from various injuries， poisoning， and operational complications， and 32.0% suffering from product problems； there were 20 severe ADR reports （8.2%）； ROR method and MHRA method both identified 19 risk signals， including implantation complications， medication system issues， etc.

CONCLUSIONS

When using Fluocinolone acetonide intravitreal implants in clinical practice， in addition to paying attention to eye ADR/ADE such as high intraocular pressure， cataracts， and glaucoma， attention should also be paid to the potential risks caused by ADE due to product quality and unreasonable use.

关键词

氟轻松玻璃体植入剂葡萄膜炎不良反应不良事件风险信号报告比值比英国药品和保健产品管理局

Keywords

uveitisadverse reactionadverse eventrisk signalsreporting odds ratioUK Medicines and Healthcare Products Regulatory Agency

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