特瑞普利单抗注射液临床合理应用分析与评价

Evaluation and Analysis on Rational Clinical Application of Toripalimab Injection

摘要

目的 分析特瑞普利单抗注射液临床使用情况，评价临床用药合理性和安全性。方法 选取 2024 年 1 月至 2024 年 12 月于南通大学附属肿瘤医院住院并使用特瑞普利单抗注射液的 240 例患者资料，统计病例资料和临床用药情况，对特瑞普利单抗注射液临床用药合理性和安全性进行评价。结果 临床应用中，9.58% 的患者存在超适应证用药情况；14.17% 的患者用药剂量与药品说明书推荐用法用量不符。≥ 3 级不良事件占 22.60%。年龄 ≥ 65 岁、治疗疗程 ≥ 3 个月、接受联合治疗、单次给药剂量不符合药品说明书用法用量的患者，药物不良事件发生率更高（P< 0.05）。结论 临床用药中存在特瑞普利单抗注射液用药不合理情况，使用免疫检查点抑制剂应严格遵循循证医学的指导原则，药学部应加强对处方的审核和点评，确保患者用药的安全性和有效性。

Abstract

Objective To analyze the clinical application of toripalimab injection and evaluate its medication rationality and safety. Methods Clinical data of 240 patients who were hospitalized in the Affiliated Tumor Hospital of Nantong University from January 2024 to December 2024 and administered toripalimab injection were collected, and the patient case data and clinical medication were counted to evaluate the rationality and safety of clinical medication of toripalimab injection. Results In clinical application, cases of off-label use accounted for 9.58%. Meanwhile, cases with dosage deviating from the labeled instructions accounted for 14.17%. Adverse reactions of grade ≥ 3 accounted for 22.60%. The incidence of adverse drug events was higher in patients aged ≥ 65 years, with a treatment duration of ≥ 3 months, receiving combination therapy, and with a single dose inconsistent with the package insert (P< 0.05).Conclusion There is irrational use of toripalimab injection in clinical medication. The use of immune checkpoint inhibitors should strictly follow the guiding principles of evidence-based medicine, and the pharmacy department should strengthen the review and comment on prescriptions to ensure the safety and effectiveness of patients' medication.

关键词

特瑞普利单抗注射液 / 超适应证用药 / 临床用药 / 用药分析

Key words

toripalimab injection / off-label use / clinical medication / medication analysis

参考文献

[1] Aliazis K, Christofides A, Shah R,et al. The tumor microenvironment's role in the response to immune checkpoint blockade[J].Nat Cancer, 2025, 6(6): 924-937.

[2] 林行广, 吴延昇. 特瑞普利单抗联合卡培他滨同步容积调强放疗治疗局部晚期或晚期食管鳞状细胞癌的效果及安全性分析[J].免疫学杂志, 2026, 42(2): 133-138.

[3] Zhong J, Fei K, Wu L,et al. Toripalimab plus chemotherapy for first line treatment of advanced non-small cell lung cancer (CHOICE-01): final OS and biomarker exploration of a randomized, double-blind, phase 3 trial[J].Signal Transduct Target Ther, 2024, 9(1): 369.

[4] 粟麟, 许巧, 万士豪, 等. 特瑞普利单抗在膀胱肿瘤综合治疗中的疗效和安全性分析[J].重庆医科大学学报, 2024, 49(6): 740-744.

[5] 刘东阳, 蔡梦娇, 何丽,等. 特瑞普利单抗联合放化疗对鼻咽癌颈部淋巴结转移及免疫功能的影响[J].实用临床医药杂志, 2025, 29(14): 23-27+33.

[6] Rajasekaran N, Wang X, Ravindranathan S,et al. Toripalimab, a therapeutic monoclonal anti-PD-1 antibody with high binding affinity to PD-1 and enhanced potency to activate human T cells[J].Cancer Immunol Immunother, 2024, 73(3): 60.

[7] 刘宇伟, 杨卫, 勾小华, 等. 安罗替尼与特瑞普利单抗联合治疗驱动基因阴性晚期非小细胞肺癌的疗效及安全性分析[J].世界临床药物, 2026, 47(5): 495-501.

[8] 国家药品监督管理局药品审评中心. 特瑞普利单抗注射液上市药品信息[EB/OL]. (2024-06-24) [2026-07-31].https://www.cde.org.cn/main/xxgk/postmarketpage?acceptidCODE=545d82b07f1b5e3ee6a3190a7db41a48.

[9] Eisenhauer E A, Therasse P, Bogaerts J,et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)[J].Eur J Cancer, 2009, 45(2): 228-247.

[10] Naranjo C A, Busto U, Sellers E M,et al. A method for estimating the probability of adverse drug reactions[J].Clin Pharmacol Ther, 1981, 30(2): 239-245.

[11] Lin J, Chen L, Chen L,et al. Efficacy and safety of DNV3 (a lymphocyte-activation gene 3 - blocking antibody) combined with toripalimab and chemotherapy in advanced melanoma: an open-label, single-arm clinical trial[J].MedComm, 2026, 7(3): e70648.

[12] Mai H Q, Chen Q Y, Chen D,et al. Toripalimab plus chemotherapy for recurrent or metastatic nasopharyngeal carcinoma: the JUPITER-02 randomized clinical trial[J].JAMA, 2023, 330(20): 1961-1970.

[13] Lian B, Li Z, Wu N,et al. Phase II clinical trial of neoadjuvant anti-PD-1 (toripalimab) combined with axitinib in resectable mucosal melanoma[J].Ann Oncol, 2024, 35(2): 211-220.

[14] Yu X, Cui R, Guo P. Evaluation of the efficacy and safety of toripalimab combination therapy for treatment of advanced gastric cancer: a meta-analysis[J].Int J Clin Exp Pathol, 2025, 18(3): 96-109.

[15] Cheng Y, Zhang P, Lu M,et al. Efficacy and safety of surufatinib plus toripalimab in treatment-naive, PD-L1-positive, advanced or metastatic non-small-cell lung cancer and previously treated small-cell lung cancer: an open-label, single-arm, multicenter, multi-cohort phase II trial[J].Cancer Immunol Immunother, 2025, 74(3): 83.

[16] Chen J, Li C, Cao Y,et al. Toripalimab combined with concurrent platinum-based Chemoradiotherapy in patients with locally advanced cervical Cancer: an open-label, single-arm, phase II trial[J].BMC Cancer, 2022, 22(1): 793.

[17] 魏小丽, 任超, 王风华, 等. 抗PD-1抗体特瑞普利单抗治疗难治性恶性实体瘤的I期研究[J].癌症, 2021, 40(10): 426-435.

[18] 岳艳, 江彤. 免疫检查点抑制剂相关甲状腺功能异常的研究进展[J].山东医药, 2021, 26(1): 102-105.

[19] Li C, Liu S, He Y,et al. Toripalimab combined with bevacizumab plus chemotherapy as first-line treatment for refractory recurrent or metastatic cervical cancer: a single-arm, open-label, phase II study (JS001-ISS-CO₂14) [J].J Gynecol Oncol, 2025, 36(3): e44.

[20] Li X, Qu L X, Ren Y M,et al. Case report: a case report and literature review on severe bullous skin reaction induced by anti-PD-1 immunotherapy in a cervical cancer patient[J].Front Pharmacol, 2021, 12: 707967.

[21] 余敏, 李歆. 528 例卡瑞利珠单抗治疗的免疫相关不良反应及风险因素分析[J].中国药物警戒, 2023, 20(10): 1134-1140.

[22] 焦盼盼, 薛丽娟, 詹娟. 免疫检查点抑制剂相关不良反应的危险因素与预测因素[J].国际肿瘤学杂志, 2023, 50(12): 739-744.

基金资助

江苏省药学会科研项目(Q202236)