Analysis of 121 Reports of Adverse Drug Reactions to PD-1/PD-L1 Inhibitors

doi:10.19803/j.1672-8629.20250928

Abstract

Abstract: Objective To investigate the characteristics and influencing factors of adverse drug reactions (ADRs) induced by PD-1/PD-L1 inhibitors in order to contribute to rational medication. Methods ADR reports related to PD-1/PD-L1 inhibitors and collected by a tertiary hospital in Anhui Province in 2024-2025 were analyzed in terms of the patients' gender, age, weight, underlying diseases, systems and organs involved in ADRs, and clinical manifestations. Results A total of 121 ADR reports were included, involving 86 males (71.07%) and 35 females (28.93%). Most of the patients were aged 51 to 80 (110 cases, 90.91%), and weighed 41 to 80 kg (113 cases, 93.39%). The underlying diseases included stomach, esophagus, lung and liver malignancies. The systems involved were damage to hematological and lymphatic systems (53 cases, 39.85%), the skin and its appendages (27 cases, 20.30%), and the endocrine system (10 cases, 7.52%). The clinical manifestations included leukopenia, neutropenia, thrombocytopenia, bone marrow suppression, rash, and abnormal thyroid and adrenal functions. Damage to hematological and lymphatic systems induced by PD-1/PD-L1 inhibitors was significantly associated with age (>70 years) and underlying diseases (gastric, esophageal and cardia digestive system tumors) (P<0.05). Conclusion During the treatment of tumor patients with PD-1/PD-L1 inhibitors, the prevalence of ADRs varies by gender, age, body weight, and underlying disease. Clinicians should be better informed of PD-1/PD-L1 inhibitors, and look out for risk indicators to prevent and reduce the occurrence of severe ADRs.

Key words: PD-1/PD-L1 Inhibitors, Antineoplastic Drugs, Hematologic and Lymphatic System Damage, Skin and Appendage Damage, Endocrine System Damage, Adverse Drug Reaction

CLC Number:

DU Yan, YANG Chunlan, SUN Xuqun, FANG Ling. Analysis of 121 Reports of Adverse Drug Reactions to PD-1/PD-L1 Inhibitors[J]. Chinese Journal of Pharmacovigilance, 2026, 23(5): 553-557.

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URL: https://zgywjj.magtechjournal.com/EN/10.19803/j.1672-8629.20250928

https://zgywjj.magtechjournal.com/EN/Y2026/V23/I5/553

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