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清热祛湿法治疗 PD-1/PD-L1 抑制剂所致 2~3 级皮疹的临床体会:一项单中心回顾性研究。

Clinical Experience of External Application of Clearing Heat and Removing Dampness in Relieving Grade 2 to 3 Rash Caused by Programed Cell Death Protein 1 (PD-1)/Programed Cell Death Ligand 1 (PD-L1) Inhibitors: A Single-Center Retrospective Study.

机构信息

Department of Oncology, The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, Zhejiang, China.

The First Clinical College of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.

出版信息

Integr Cancer Ther. 2024 Jan-Dec;23:15347354231226108. doi: 10.1177/15347354231226108.

Abstract

OBJECTIVE

In China, grade 2 to 3 immune-related rash will probably lead to the interruption of immunotherapy. Corticosteroid (CS) is the main treatment, but not always effective. The external application of clearing heat and removing dampness, which is represented by Qing-Re-Li-Shi Formula (QRLSF), has been used in our hospital to treat immune-related cutaneous adverse events (ircAEs) for the last 5 years. The purpose of this study was to discuss its efficacy and safety in the treatment of grade 2 to 3 rash.

METHODS

A retrospective study of patients with grade 2 to 3 immune-related rash in our hospital from December 2019 to December 2022 was conducted. These patients received QRLSF treatment. Clinical characteristics, treatment outcome, and health-related quality of life (HrQoL) were analyzed.

RESULTS

Thirty patients with grade 2 to 3 rash (median onset time: 64.5 days) were included. The skin lesions of 24 cases (80%) returned to grade 1 with a median time of 8 days. The accompanying symptoms were also improved with median time of 3 to 4 days. The addition of antihistamine (AH) drug didn't increase the efficacy of QRLSF (AH + QRLSF: 75.00% vs QRLSF: 83.33%,  = .66). No significant difference was observed in the efficacy of QRLSF treatment regardless of whether patients had previously received CS therapy (untreated population: 88.24% vs treated population: 69.23%,  = .36). During 1-month follow-up, 2 cases (8.33%) underwent relapses. In terms of HrQoL, QRLSF treatment could significantly reduce the median scores of all domains of Skindex-16, including symptoms (39.58 vs 8.33,  < .0001), emotions (58.33 vs 15.48,  < .0001), functioning (46.67 vs 13.33,  < .0001) and composite (52.60 vs 14.06,  < .0001).

CONCLUSION

External application of clearing heat and removing dampness was proven to be an effective and safe treatment for such patients. In the future, high-quality trials are required to determine its clinical application in the field of ircAEs.

摘要

目的

在中国,2 级到 3 级免疫相关性皮疹可能导致免疫治疗中断。皮质类固醇(CS)是主要治疗药物,但并非总是有效。清热利湿法(QRLSF)是一种外治法,已在我院用于治疗免疫相关性皮肤不良事件(ircAEs)达 5 年。本研究旨在探讨其治疗 2 级到 3 级皮疹的疗效和安全性。

方法

对 2019 年 12 月至 2022 年 12 月我院收治的 2 级到 3 级免疫相关性皮疹患者进行回顾性研究。这些患者接受 QRLSF 治疗。分析临床特征、治疗结局和健康相关生活质量(HrQoL)。

结果

共纳入 30 例 2 级到 3 级皮疹患者(中位发病时间:64.5 天)。24 例(80%)患者皮损恢复至 1 级,中位时间为 8 天。伴随症状也得到改善,中位时间为 3 到 4 天。加用抗组胺药(AH)并未增加 QRLSF 的疗效(AH+QRLSF:75.00% vs QRLSF:83.33%, = .66)。无论患者是否接受过 CS 治疗,QRLSF 治疗的疗效均无显著差异(未治疗人群:88.24% vs 治疗人群:69.23%, = .36)。在 1 个月随访期间,2 例(8.33%)出现复发。在 HrQoL 方面,QRLSF 治疗可显著降低 Skindex-16 所有领域的中位数评分,包括症状(39.58 分比 8.33 分, < .0001)、情绪(58.33 分比 15.48 分, < .0001)、功能(46.67 分比 13.33 分, < .0001)和综合(52.60 分比 14.06 分, < .0001)。

结论

清热利湿法外治法被证明对这类患者是一种有效且安全的治疗方法。未来需要高质量的试验来确定其在 ircAEs 领域的临床应用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/20c4/10799584/7acdddf35cb8/10.1177_15347354231226108-fig1.jpg

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