盐酸安罗替尼不良反应分析

doi:10.19803/j.1672-8629.2022.07.17

摘要/Abstract

摘要： 目的总结盐酸安罗替尼导致药品不良反应的特点,为临床安全使用肿瘤靶向治疗药物提供参考。方法对2018年10月1日至2019年12月31日期间我院肿瘤内科36例使用安罗替尼靶向治疗后出现不良反应患者的性别、年龄、疾病种类、既往不良反应史、不良反应累及系统-器官、临床表现、发生时间、严重程度分级、转归与关联性评价等信息进行分析。结果 36例使用安罗替尼的患者共发生65例次不良反应,其中轻度不良反应49例次,重度不良反应16例次;不良反应主要表现为高血压、蛋白尿、手足综合征、乏力、口腔溃疡等。结论随着安罗替尼在临床应用的增多,注重疗效的同时,也要重视相关不良反应,提高用药安全性。

关键词: 安罗替尼, 药品不良反应, 恶性肿瘤

Abstract: Objective To summarize the characteristics of adverse reactions caused by anlotinib, and provide reference for clinically safe use of tumor targeted therapy drugs. Methods The clinical data on 36 patients who had developed adverse reactions after using anlotinib targeted therapy between October 1, 2018 and December 31, 2019 in the Department of Oncology of our hospital was analyzed in terms of gender, age, types of disease, previous adverse reactions, and system-organs involved. Clinical manifestations, time of occurrence, grades of severity, outcomes and correlations were analyzed. Results A total of 65 cases of adverse reactions occurred in 36 patients who had taken anlotinib, including 49 cases of mild adverse reactions and 16 cases of severe ones. The main adverse reactions were hypertension, proteinuria, hand-foot syndrome, fatigue, oral ulcers. Conclusion With the increasing use of anlotinib in clinic, both the efficacy and related adverse reactions deserve attention in order to make medication safer.

Key words: anlotinib, adverse drug reaction, malignant tumor

中图分类号:

R979.1

曹雅杰, 徐涵, 周宁宁, 钟春生. 盐酸安罗替尼不良反应分析[J]. 中国药物警戒, 2022, 19(7): 775-778.

CAO Yajie, XU Han, ZHOU Ningning, ZHONG Chunsheng. Adverse reactions induced by anlotinib hydrochloride[J]. Chinese Journal of Pharmacovigilance, 2022, 19(7): 775-778.

参考文献

[1] SYED YY.Anlotinib: first global approval[J]. Drugs, 2018,78(10): 1057-1062.
[2] LI HY, YANG CP, JIN HT.Research progress of target related toxicity of anti-tumor drugs[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2018, 15(3): 152-157.
[3] Chinese Medical Doctor Association Oncologist Branch, Chinese Society of Clinical Oncology Expert Committee of Vascular Targeted Therapy, Chinese Anti-Cancer Association Cancer Targeted Therapy Committee. Expert consensus on anlotinib hydrochloride in the treatment of advanced non-small cell lung cancer[J]. National Medical Journal of China(中华医学杂志), 2018, 98(44): 3561-3567.
[4] LIN HN, GU XY, ZHANG SW, et al.Analysis of the age of onset of global malignant tumor[J]. Chinese Journal of Oncology(中华肿瘤杂志), 2018, 40(7): 543-549.
[5] YU M, GAO Z, DAI X, et al.Population pharmacokinetic and covariate analysis of apatinib, an oral tyrosine kinase inhibitor, in healthy volunteers and patients with solid tumors[J]. Clinical Pharmacokinetics, 2017, 56(1): 65-76.
[6] JAYSON GC, KERBEL R, ELLIS LM, et al.Antiangiogenic therapy in oncology: current status and future directions[J]. Lancet, 2016, 18(3): 321-323.
[7] ROVIELLO G, RAVELLI A, POLOM K, et al.Apatinib: a novel receptor tyrosine kinase inhibitor for the treatment of gastric cancer[J]. Cancer Lett, 2016, 372(2): 187-191.
[8] SCOTT AJ, MESSERSMITH WA, JIMENO A.Apatinib: a promising oral antiangiogenic agent in the treatment of multiple solid tumors[J]. Drugs Today (Barc), 2015, 51(4): 223-229.
[9] LIN B, SONG X, YANG D, et al.Anlotinib inhibits angiogenesis via suppressing the activation of VEGFR2, PDGFRβ and FGFR1[J]. Gene, 2018, 654: 77-86.
[10] XIE C, WAN X, QUAN H, et al.Preclinical characterization of anlotinib, a highly potent and selective vascular endothelial growth factor receptor-2 inhibitor[J]. Cancer Sci, 2018, 109(4): 1207-1219.
[11] ZHONG CC, CHEN F, YANG JL, et al.Pharmacokinetics and disposition of anlotinib, an oral tyrosine kinase inhibitor, in experimental animal species[J]. Acta Pharmacol Sin, 2018, 39(6): 1048-1063.
[12] SHI XL, DONG QM, YU Y, et al.Antitumor effects of anlotinib in thyroid cancer[J]. Endocr Relat Cancer, 2019, 26(1): 153-164.
[13] CHOUEIRI TK, HALABI S, SANFORD BL, et al.Cabozantinib versus sunitinib as initial targeted therapy for patients with metastatic renal cell carcinoma of poor or intermediate risk: the Alliance A031203 CABOSUN trial[J]. J Clin Oncol, 2017, 35(6): 591-597.
[14] CHI YHBL, WANG JW.Efficacy and safety of anlotinib hydrochloride in mCRC patients from a single-arm, phase Ⅱ trial in China[C]. Proceedings of CSCO 2018, Xiamen, 2018.
[15] SUN Y, NIU W, DU F, et al.Safety, pharmacokinetics, and antitumor properties of anlotinib, an oral multi-target tyrosine kinase inhibitor, in patients with advanced refractory solid tumors[J]. Journal of Hematology & Oncology, 2016, 9(1): 105.
[16] HAN B, LI K, WANG Q, et al.Effect of anlotinib as a third-line or further treatment on overall survival of patients with advanced non-small cell lung cancer: the alter 0303 phase 3 randomized clinical trial[J]. JAMA Oncol, 2018, 4(11): 1569-1575.
[17] HUANG AM, WANG WM, QIAN H, et al.Analysis of the short-term efficacy and safety of Anlotinib in advanced non-small cell lung cancer[J]. Anti-tumor Pharmacy(肿瘤药学), 2019, 9(5): 793-797, 808.
[18] LACAL PM, GRAZIANI G.Therapentic implication of vascular endothelial growth factor receptor-1(VEGFR-1) targeting in cancer cells and tumor microenvironment by competitive and noncompetitive inhibitors[J]. Pharmacol Res, 2018, 136: 97-107.
[19] LEE JH, CHUNG YH, KIM JA, et al.Genetic predisposition of hand-foot skin reaction after sorafenib therapy in patients with hepatocellular carcinoma[J]. Cancer, 2013, 119(1): 136-142.
[20] HU LOWE DD, LOU HY, GRAZZINI ML, et al.Nonclinical antinagiogenesis and antitumor activities of axitinib (AG013736), an oval, potent, and selective inhibitor of vascular endothelial growth factor receptor tyrosine kinases 1, 2, 3[J]. Clin Cancer Res, 2008, 14(22): 7272-7283.
[21] MA XQ, CHENG Y, CHEN YX.Research progress on proteinuria related to VEGF signaling pathway inhibitor[J]. Chinese Clinical Oncology(临床肿瘤学杂志), 2015, 20(4): 357-362.
[22] FELIU J, SALUD A, SAFONT MJ, et al.Correlation of hypertension and protrinuria with outcome in elderly bevacizumab-treated patients with metastatic colorectal cancer[J]. Plos One, 2015, 10(1): e0116527.
[23] SANTONI M, EONTI A, MASSAVI F, et al.Treatment-related fatigue with sorafenib, sunitinib and pazo panib in patients with advanced solid tumors: an up-to-date review and meta-anbalysis of clinical trials[J]. Int J Cancer, 2015, 136(1): 1-10.
[24] ZHANG YH, QIN ZS, YANG J, et al.Traditional Chinese and western medicine prevention and treatment of adverse skin reactions related to targeted drugs[J]. Modern Chinese Clinical Medicine(现代中医临床), 2018, 25(6): 52-56.
[25] LIU MZ, HAN F.Research progress of oral mucositis related to tumor treatment[J]. Chinese Journal of Radiation Oncology(中华放射学肿瘤杂志), 2018, 27(9): 869-872.