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接受免疫检查点抑制剂治疗的患者发生硬化性苔藓和扁平苔藓的风险。

Risk of Lichen Sclerosus and Lichen Planus in Patients Receiving Immune Checkpoint Inhibitors.

机构信息

Department of Clinical Pharmacy, College of Pharmacy, Umm Al-Qura University, Makkah 24382, Saudi Arabia.

Qassim Health Cluster, Ministry of Health, Buraidah 52385, Saudi Arabia.

出版信息

Int J Environ Res Public Health. 2022 Dec 29;20(1):580. doi: 10.3390/ijerph20010580.

Abstract

INTRODUCTION

Immune checkpoint inhibitors (ICIs) are recommended for various types of cancer. On the other hand, these ICIs may cause immune-related adverse events (irAEs). Lichen sclerosus (LS) and lichen planus (LP) are two distinct phenotypes of irAEs that occur in a subset of patients treated with ICIs. These adverse effects have a detrimental effect on the patient's quality of life and treatment phases; however, the clinical evaluation and assessment of LS and LP remain uncertain. This study aims to assess and evaluate the risk of LS and LP associated with the use of ICIs via a systematic review of the literature and the USA FDA Adverse Events FAERS database.

METHOD

The study searched electronic databases such as PubMed, Medline, Cochrane, and Google Scholar for case reports on immune-checkpoint-inhibitor-associated lichen sclerosus and lichen planus published in English between inception and 31 December 2021. The FDA's adverse event reporting system (FAERS) database was also analyzed.

RESULTS

Thirty-eight case reports and two retrospective studies with a total of 101 patients, in addition to the FAERS data, were evaluated. More cases involved lichen planus (78.9%) than lichen sclerosis (21%). Nivolumab and pembrolizumab were most frequently reported with LS and LP, among other ICIs. Thirty-six out of thirty-eight patients with LS or LP experienced complete remission, while two patients experienced partial remission. Most of the cases had an excellent response to corticosteroids (92.1%), while the remainder had moderate (5.2%) and poor (2.6%) responses. Additionally, the reporting odds ratio (ROR) of the FAERS database indicated a favorable association for ICIs, the risk of LP, and LS. A stronger association was uniquely found between nivolumab and pembrolizumab.

CONCLUSION

There have been published case reports for these adverse events. Healthcare providers should be aware of the possibility of lichen sclerosis and lichen planus developing in patients receiving ICIs which could necessitate hospitalization or discontinuation. Regulatory agencies are advised to monitor the risks as a potential safety signal.

摘要

简介

免疫检查点抑制剂(ICIs)被推荐用于各种类型的癌症。另一方面,这些 ICIs 可能会引起免疫相关的不良反应(irAEs)。硬化性苔藓(LS)和扁平苔藓(LP)是一组接受 ICIs 治疗的患者中发生的两种不同的 irAEs 表型。这些不良反应对患者的生活质量和治疗阶段产生不利影响;然而,LS 和 LP 的临床评估仍不确定。本研究旨在通过对文献的系统回顾和美国 FDA 不良事件 FAERS 数据库评估,评估和评估与使用 ICIs 相关的 LS 和 LP 的风险。

方法

该研究通过电子数据库(如 PubMed、Medline、Cochrane 和 Google Scholar)搜索了自成立以来至 2021 年 12 月 31 日以英文发表的与免疫检查点抑制剂相关的硬化性苔藓和扁平苔藓的病例报告。还分析了 FDA 的不良事件报告系统(FAERS)数据库。

结果

评估了 38 份病例报告和 2 份回顾性研究,共 101 例患者,以及 FAERS 数据。涉及 LP 的病例多于 LS(78.9%对 21%)。除了其他 ICIs 之外,nivolumab 和 pembrolizumab 与 LS 和 LP 最常被报道。38 例 LS 或 LP 患者中有 36 例完全缓解,2 例部分缓解。大多数病例对皮质类固醇有极好的反应(92.1%),其余病例有中度(5.2%)和差(2.6%)反应。此外,FAERS 数据库的报告比值比(ROR)表明,ICIs、LP 和 LS 的风险有利。nivolumab 和 pembrolizumab 之间发现了更强的关联。

结论

这些不良反应已经有病例报告。医护人员应该意识到接受 ICIs 治疗的患者可能会出现硬化性苔藓和扁平苔藓,并可能需要住院或停药。建议监管机构监测风险,作为潜在的安全信号。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c6bb/9819784/557ec1ff7673/ijerph-20-00580-g001.jpg

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