Page 108 - 《中国药房》2025年4期

信迪利单抗联合化疗用于胆管癌的安全性评价
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钟 豪 ，林 航 ，卢娅欣 ，麦海燕 （1.中山大学附属第三医院药学部，广州 510630；2.中山大学附属第三
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医院大数据人工智能中心，广州 510630）
中图分类号 R969.3；R979.1；R735.8 文献标志码 A 文章编号 1001-0408（2025）04-0482-04
DOI 10.6039/j.issn.1001-0408.2025.04.16

摘 要 目的 评价信迪利单抗联合化疗用于胆管癌的安全性。方法 收集2021年1月1日－2022年12月31日于我院化疗的胆
管癌患者资料，根据用药方案的不同分为对照组（29例）和观察组（18例）。对照组患者予以注射用盐酸吉西他滨+注射用顺铂或
注射用奥沙利铂，观察组患者在此基础上加用信迪利单抗注射液。两组患者于每个治疗周期开始前及结束后均检查血常规、肝肾
功能、生化指标等，并观察不良反应发生情况。采用Naranjo’s评估量表评价不良反应与使用药物的相关性。结果 血液毒性反应
与两组使用药物的相关性均为“很可能”，但观察组的评分更高、相关性更强；肝毒性反应与对照组使用药物的相关性为“可疑”，与
观察组使用药物的相关性为“很可能”；胃肠道症状与两组使用药物的相关性均为“有可能”；全身症状、皮肤毒性、肌肉骨骼毒性、
内分泌毒性、肾毒性的相关性均为“可疑”。观察组患者血液毒性总发生率显著高于对照组（P＝0.014）。两组患者的肝毒性、胃肠
道症状、全身症状、皮肤毒性、肌肉骨骼毒性、内分泌毒性及肾毒性的总发生率以及≥3级血液毒性、肝毒性发生率比较，差异均无统
计学意义（P＞0.05）。发生不良反应的患者经停药或对症支持治疗后，症状均有所缓解。治疗期间未有患者死亡。结论 信迪利单
抗联合化疗可能会增加胆管癌患者血液毒性反应的发生风险，尤其是血小板减少，但不良反应在可控范围内，总体安全性良好。
关键词 信迪利单抗；化疗；胆管癌；安全性评价；血小板减少

Safety evaluation of sintilimab in combination with chemotherapy for the treatment of cholangiocarcinoma
ZHONG Hao ，LIN Hang ，LU Yaxin ，MAI Haiyan（1. Dept. of Pharmacy， the Third Affiliated Hospital of Sun
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Yat-sen University， Guangzhou 510630， China；2. Big Data and Artificial Intelligence Center， the Third
Affiliated Hospital of Sun Yat-sen University， Guangzhou 510630， China）
ABSTRACT OBJECTIVE To assess the safety profile of sintilimab in combination with chemotherapy for the treatment of
cholangiocarcinoma. METHODS The data of patients with cholangiocarcinoma from January 1st， 2021 to December 31st， 2022
were collected and divided into control group （29 cases） and observation group （18 cases） based on different medication regimens.
Patients in the control group were treated with Gemcitabine hydrochloride for injection+Cisplatin for injection or Oxaliplatin for
injection， the observation group was treated with Sintilimab injection based on the control group. Patients in each group underwent
blood routine， liver and kidney function， biochemical and other examinations before and after each treatment cycle to observe the
occurrence of adverse drug reactions. The correlation of adverse drug reactions with drugs was evaluated with Naranjo’s scale.
RESULTS The correlation between blood toxicity and drug use was deemed “probable” in both groups； however， the observation
group exhibited a significantly higher score， indicating a stronger correlation. In the control group， hepatotoxic reactions were
classified as “suspicious” whereas in the observation group， they were categorized as “probable”. The correlation of gastrointestinal
symptoms between the two groups was considered “possible”. Systemic symptoms， skin toxicity， musculoskeletal toxicity，
endocrine toxicity and renal toxicity were all classified as having a “suspicious” correlation with drug use. The total incidence of
blood toxicity in the observation group was significantly higher than control group （P＝0.014）. There was no statistically significant
difference in the total incidences of hepatotoxic， gastrointestinal symptoms， systemic symptoms， skin toxicity， musculoskeletal
toxicity， endocrine toxicity， renal toxicity， or the incidence of grade 3 or higher blood toxicity， hepatotoxic between the two
groups （P＞0.05）. For the patients experiencing adverse drug reactions， the symptoms were alleviated following drug
discontinuation or symptomatic supportive treatment. No fatalities occurred during the treatment period. CONCLUSIONS Sintilimab
combined with chemotherapy may significantly increase the risk of blood toxicity in patients with cholangiocarcinoma， especially
thrombocytopenia， but the adverse reactions are within a controllable range， and the overall safety is good.
KEYWORDS sintilimab； chemotherapy； cholangiocarcinoma； safety evaluation； thrombocytopenia

Δ 基金项目 广东省药学会肿瘤领域超说明用药评价研究基金项 我国自主研发的信迪利单抗是一种靶向免疫检查
目（No.2023ZLCS38） 点蛋白程序性死亡受体1（programmed death-1，PD-1）的
＊第一作者 主管药师，硕士。研究方向：临床药学。E-mail：
全人源化免疫球蛋白G4单克隆抗体，其可阻断 PD-1 与
17770425825@163.com
# 通信作者 副 主 任 药 师 。 研 究 方 向 ：临 床 药 学 。 E-mail： 程序性死亡受体配体 1 （programmed death-ligand 1，
maihy@mail.sysu.edu.cn PD-L1）和PD-L2相互作用介导的免疫抑制反应，从而增

· 482 · China Pharmacy 2025 Vol. 36 No. 4 中国药房 2025年第36卷第4期