洛拉替尼治疗非小细胞肺癌的快速卫生技术评估

尚予淇; 郭浩; 王惠铎

doi:10.6039/j.issn.1001-0408.2024.15.03

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洛拉替尼治疗非小细胞肺癌的快速卫生技术评估

药事管理 | 更新时间：2024-08-11

- 洛拉替尼治疗非小细胞肺癌的快速卫生技术评估
- Rapid health technology assessment of lorlatinib in the treatment of non-small cell lung cancer
- 中国药房 2024年35卷第15期页码：1812-1817
- 作者机构：
  
  1.内蒙古科技大学包头医学院药学院，内蒙古包头　014040
  2.内蒙古自治区人民医院药学处，呼和浩特　010017
- 作者简介：
  
  硕士研究生。研究方向：临床药学。E-mail：shangyuqi0815@163.com
  副主任药师，硕士生导师，博士。研究方向：药品卫生技术评估。E-mail：guohao19870323@yeah.net
- 基金信息：
  
  内蒙古自治区自然科学基金项目(2018LH08011);内蒙古自治区人民医院院内基金项目(2020YN23)
- DOI：10.6039/j.issn.1001-0408.2024.15.03
  中图分类号： R979.1;R734.2
- 纸质出版日期：2024-08-15，
  
  收稿日期：2024-01-05，
  
  修回日期：2024-05-27，
- 稿件说明：
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尚予淇,郭浩,王惠铎.洛拉替尼治疗非小细胞肺癌的快速卫生技术评估 ^Δ[J].中国药房,2024,35(15):1812-1817.

SHANG Yuqi,GUO Hao,WANG Huiduo.Rapid health technology assessment of lorlatinib in the treatment of non-small cell lung cancer[J].ZHONGGUO YAOFANG,2024,35(15):1812-1817.
尚予淇,郭浩,王惠铎.洛拉替尼治疗非小细胞肺癌的快速卫生技术评估 ^Δ[J].中国药房,2024,35(15):1812-1817. DOI： 10.6039/j.issn.1001-0408.2024.15.03.

SHANG Yuqi,GUO Hao,WANG Huiduo.Rapid health technology assessment of lorlatinib in the treatment of non-small cell lung cancer[J].ZHONGGUO YAOFANG,2024,35(15):1812-1817. DOI： 10.6039/j.issn.1001-0408.2024.15.03.

摘要

目的

评价洛拉替尼治疗非小细胞肺癌（NSCLC）的有效性、安全性和经济性，为医院新药引进和临床用药决策提供循证参考。

方法

检索PubMed、Embase、Cochrane Library、Epistemonikos、中国知网、维普网、万方数据库、中国生物医学文献服务系统数据库以及国际卫生技术评估机构网络，经文献筛选、资料提取、质量评价后，对研究结果进行描述性分析。

结果

共纳入19篇文献，包括13篇系统评价（SR）/Meta分析、6篇药物经济学研究。与使用其他间变性淋巴瘤激酶（ALK）-酪氨酸激酶抑制剂（TKI）（如克唑替尼、布格替尼、阿来替尼、恩沙替尼和色瑞替尼等）的患者相比，使用洛拉替尼的患者具有最佳的无进展生存期（PFS）。但在亚洲人群中，与恩沙替尼、低剂量阿来替尼和布格替尼相比，洛拉替尼在延长PFS方面并没有表现出显著优势。在客观缓解率方面，洛拉替尼和低剂量阿来替尼较其他ALK-TKI表现出较大优势；同时，阿来替尼具有最佳的总生存期获益。在安全性方面，洛拉替尼安全性较差，3级及以上不良事件发生率较高。现有经济学研究显示，洛拉替尼在一线治疗ALK阳性晚期NSCLC患者带来健康获益的同时，治疗成本也更高。

结论

洛拉替尼治疗NSCLC有较好的有效性，但其安全性和经济性有待研究。

Abstract

OBJECTIVE

To evaluate the effectiveness， safety and economy of lorlatinib in the treatment of non-small cell lung cancer（NSCLC）， and provide evidence-based reference for the introduction of new drugs in hospitals and clinical medication decisions.

METHODS

Retrieved from PubMed， Embase， Cochrane Library， Epistemonikos， CNKI， VIP， Wanfang data， SinoMed databases and The International Network of Agencies for Health Technology Assessment （INAHTA）， the results of the included studies were descriptively analyzed after literature screening， data extraction and quality evaluation.

RESULTS

A total of 19 literature were included， involving 13 system assessment （SR）/meta-analyses and 6 pharmacoeconomic reviews. Compared with the patients who received other anaplastic lymphoma kinases （ALK）-tyrosine kinase inhibitor（TKI）（such as crizotinib， brigatinib， alectinib， ensartinib， and ceritinib）， those using lorlatinib obtained best progression-free survival （PFS）. However， in the Asian population， lorlatinib did not show a significant advantage in prolonging PFS， compared to ensartinib， low-dose alectinib， and brigatinib. In terms of objective remission rate， lorlatinib and low-dose alectinib showed significant advantages over other ALK-TKI. At the same time， alectinib had the best overall survival. In terms of safety， lorlatinib possessed a poor safety profile with a high incidence of grade 3 or higher adverse events. Existing economic studies showed that lorlatinib brought health benefits to first-line treatment of patients with ALK-positive advanced NSCLC at the same time as higher treatment costs.

CONCLUSIONS

Lorlatinib has good efficacy in the treatment of NSCLC， but its safety and economy need to be studied.

关键词

洛拉替尼非小细胞肺癌快速卫生技术评估有效性安全性经济性

Keywords

non-small cell lung cancerrapid health technology assessmenteffectivenesssafetyeconomy

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