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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
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          尚予淇 ,郭 浩 ,王惠铎(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
                                    1
          民医院药学处,呼和浩特 010017)
          中图分类号  R979.1;R734.2      文献标志码  A      文章编号  1001-0408(2024)15-1812-06
          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。
          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

          Rapid health technology assessment of lorlatinib in the treatment of non-small cell lung cancer
          SHANG Yuqi ,GUO Hao ,WANG Huiduo(1.  School  of  Pharmacy,  Baotou  Medical  College,  Inner  Mongolia
                      1
                                 2
                                                1
          University  of  Science  and  Technology,  Inner  Mongolia  Baotou  014040,  China;2.  Dept.  of  Pharmacy,  Inner
          Mongolia Autonomous Region People’s Hospital, Hohhot 010017,China)
          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.
          KEYWORDS     lorlatinib; non-small cell lung cancer; rapid health technology assessment; effectiveness; safety; economy


              在全世界范围内,肺癌是十分常见且致命的恶性肿                          约占肺癌的85%~90%       [1―2] 。NSCLC在分子水平上是一
          瘤之一。肺癌从组织学上分为小细胞肺癌和非小细胞                             组异质性疾病。间变性淋巴瘤激酶(anaplastic lym‐
          肺癌(non-small cell lung cancer,NSCLC),其中 NSCLC       phoma kinase,ALK)与 5′-末端棘皮动物微管结合蛋白
                                                             (echinoderm  microtubule  associated  protein-like  4,
              Δ 基金项目 内蒙古自治区自然科学基金项目(No.2018LH08011);          EML4)重排形成的EML4-ALK融合基因是NSCLC的致
          内蒙古自治区人民医院院内基金项目(No.2020YN23)                       癌驱动基因,也是 ALK 重排最常见的融合基因 。因
                                                                                                        [3]
             * 第一作者 硕 士 研 究 生 。 研 究 方 向 :临 床 药 学 。 E-mail:
                                                              此,EML4-ALK 融合基因是 NSCLC 具有前景的治疗靶
          shangyuqi0815@163.com
                                                              点。克唑替尼(crizotinib)为第一代 ALK-酪氨酸激酶抑
              # 通信作者 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                 制剂 (tyrosine kinase inhibitor,TKI),第二代 ALK-TKI

          · 1812 ·    China Pharmacy  2024 Vol. 35  No. 15                            中国药房  2024年第35卷第15期
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