首页|基于真实世界数据的西妥昔单抗临床综合评价

基于真实世界数据的西妥昔单抗临床综合评价

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目的 基于真实世界数据对西妥昔单抗开展临床综合评价,拟为临床合理使用及药品相关决策提供依据。方法 参考药品临床综合评价相关指南,基于真实世界数据,从安全性、有效性、经济性、创新性、适宜性、可及性6 个维度对西妥昔单抗进行评价。结果 安全性,西妥昔单抗的多数不良反应与贝伐珠单抗、传统化疗方案无显著性差异,但皮疹发生率显著高于其他两种方案;有效性,西妥昔单抗与贝伐珠单抗无显著性差异,但 5%的缓解率远低于临床试验结果;经济性,进行倾向值得分匹配后,应用西妥昔单抗与应用贝伐珠单抗方案的总费用无显著性差异,但显著高于传统化疗方案总费用;创新性,西妥昔单抗可用于头颈部鳞癌,填补了该领域临床治疗空白,满足了临床需求,具有一定的创新性;适宜性,非劣性;可及性,当前在山东地区的可获得性和可负担性相对较差。结论 与贝伐珠单抗相比较,西妥昔单抗在安全性、有效性、经济性、适宜性无显著性差异,创新性有优势,可及性略差。
Clinical application evaluation of cetuximab based on real-world data
Objective To conduct a clinical application evaluation of cetuximab based on real-world data,explore the content and methods of the clinical comprehensive evaluation of antitumor drugs,and provide a basis for rational clinical use and drug-related decision-making.Methods According to the guidelines of clinical application evaluation,cetuximab was evaluated in six dimensions based on real-world data.Results The evaluation results of various dimensions showed that most adverse reactions of cetuximab were not significantly different from bevacizumab and common chemotherapy regimens,but the incidence of rash was significantly higher than the others.In terms of efficacy,there is no significant difference be-tween cetuximab and bevacizumab,but the remission rate of 5%is much lower than the clinical trial results.After propensity score matching,there was no significant difference in the total cost of the bevacizumab regimen,but it was significantly high-er than the total cost of the common chemotherapy regimen.Cetuximab can be used for head and neck squamous cell carci-noma which can fill the clinical treatment gap and meet the clinical requirements.It is analogous to other similar anti-tumor drugs and has no obvious advantages over the current suitability,but availability and affordability of cetuximab in Shandong is relatively poor.Conclusion Compared with bevacizumab,cetuximab has no significant difference in safety,efficacy,e-conomy,and suitability,and has advantages in innovation and slightly poor accessibility.

Clinical application evaluationColorectal cancerCetuximabReal-world data

栾亚丽、王元明、高田田、王晓君

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山东第一医科大学附属省立医院药学部,山东 济南 250012

山东省药师协会,山东 济南 250101

药品临床综合评价 结直肠癌 西妥昔单抗 真实世界数据

山东省医学会临床药学应用研究项目山东省第一批药品临床综合评价项目

YXH2019ZX0092021YZ012

2024

药学研究
山东省药品检验所 山东省药学会

药学研究

CSTPCD
影响因子:0.653
ISSN:2095-5375
年,卷(期):2024.43(4)
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