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·循证药学·


          斯鲁利单抗一线治疗小细胞肺癌的快速卫生技术评估
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          侯奕冰 ,康 朔 ,公 元 ,王晓晖 ,聂 颖 ,刘焕龙 (1.河北医科大学第二医院药学部,石家庄 050000;
                                                   3
          2.河北医科大学第二医院医保办,石家庄 050000;3.河北医科大学药学院,石家庄 050017)
          中图分类号  R969.3;R956      文献标志码  A      文章编号  1001-0408(2025)11-1405-06
          DOI  10.6039/j.issn.1001-0408.2025.11.21
          摘  要  目的  评价斯鲁利单抗一线治疗小细胞肺癌(SCLC)的有效性、安全性和经济性,为医疗机构药物遴选提供循证依据。方
          法  采用快速卫生技术评估方法,系统检索PubMed、Cochrane Library、Embase、中国知网、万方数据、维普网以及国内外卫生技术
          评估机构官方网站,检索时限为建库开始至2024年10月,由2名评价者根据纳入和排除标准独立筛选文献并评估文献质量后,进
          行定性分析。结果  共纳入13篇系统评价/Meta分析和9篇经济学研究,文献质量总体良好。有效性方面,与单纯化疗相比,斯鲁
          利单抗联合化疗可显著改善 SCLC 患者的无进展生存期、总生存期和客观缓解率。安全性方面,斯鲁利单抗联合化疗方案治疗
          SCLC导致的3级及以上不良事件发生率与单纯化疗相比无明显差异,显示出良好的安全性;与其他免疫抑制剂的联合疗法相比,
          其不良事件的发生率也较低。经济性方面,相比于单纯化疗方案,斯鲁利单抗联合化疗方案不具有经济性,可能与斯鲁利单抗价
          格过高有关。结论  斯鲁利单抗一线治疗SCLC的有效性、安全性较好,但经济性无明显优势。
          关键词  斯鲁利单抗;小细胞肺癌;有效性;安全性;经济性;快速卫生技术评估

          Rapid health technology assessment of serplulimab in the first-line treatment of small-cell lung cancer
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          HOU Yibing ,KANG Shuo ,GONG Yuan ,WANG Xiaohui ,NIE Ying ,LIU Huanlong(1.  Dept.  of  Pharmacy,
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          the Second Hospital of Hebei Medical University, Shijiazhuang 050000, China;2. Medical Insurance Office, the
          Second  Hospital  of  Hebei  Medical  University,  Shijiazhuang  050000,  China;3.  School  of  Pharmacy,  Hebei
          Medical University, Shijiazhuang 050017, China)
          ABSTRACT   OBJECTIVE To evaluate the efficacy, safety and cost-effectiveness of serplulimab as a first-line treatment of small-
          cell lung cancer (SCLC), and provide an evidence-based basis for drug selection in hospitals. METHODS Rapid health technology
          assessment   was  adopted;  PubMed,  Cochrane  Library,  Embase,  CNKI,  Wanfang,  VIP  and  official  websites  of  domestic  and
          international  health  technology  assessment  agencies  were  systematically  searched  from  the  inception  to  Oct.  2024.  Two  reviewers
          independently  screened  the  literature,  assessed  the  quality  of  included  studies  and  carried  out  the  qualitative  analysis  according  to
          the  inclusion  and  exclusion  criteria.  RESULTS  A  total  of  13  systematic  reviews/meta-analyses  and  9  economic  studies  were
          included, and the literature quality was generally good. In terms of effectiveness, compared with chemotherapy alone, serplulimab
          combined  with  chemotherapy  significantly  improved  progression-free  survival,  overall  survival,  and  objective  response  rate  in
          patients with SCLC. In terms of safety, serplulimab combined with chemotherapy showed no significant difference in the incidence
          of  ≥3  grade  adverse  events  compared  with  chemotherapy  alone  in  the  treatment  of  SCLC,  indicating  a  good  safety  profile;
          compared  with  combination  therapies  involving  other  immunosuppressive  agents,  the  incidence  rate  of  adverse  events  was  also
          lower.  In  terms  of  cost-effectiveness,  compared  with  chemotherapy  alone,  serplulimab  combined  with  chemotherapy  is  not  cost-
          effective,  which  may  be  related  to  the  high  price  of  serplulimab.  CONCLUSIONS  Serplulimab  is  effective  and  safe  in  the
          treatment of SCLC, but has no obvious advantage in terms of cost-effectiveness.
          KEYWORDS    serplulimab; small-cell lung cancer; effectiveness; safety; cost-effectiveness; rapid health technology assessment



                                                                 癌症是严重危害人类健康的重大慢性疾病,是全球
             Δ 基金项目 河北省自然科学基金(No.H2021206300);河北省高           重大健康威胁之一。国家癌症中心的数据显示,我国癌
          等教育教学改革研究与实践项目(No.2021GJJG145)                     症发病率近年来持续上升 。据统计,2020 年中国癌症
                                                                                    [1]
             *第一作者 硕士研究生。研究方向:药物经济学。E-mail:hyb_
                                                             新发病例和死亡病例分别约占全球新发病例和死亡病
          0119@163.com                                                     [2]
             # 通信作者 主任药师,硕士生导师,博士。研究方向:药物经济                  例的23%和30% 。肺癌是全球范围内发病率和病死率
          学。E-mail:lhlong1026@163.com                        均较高的恶性肿瘤之一,其中小细胞肺癌(small-cell


          中国药房  2025年第36卷第11期                                              China Pharmacy  2025 Vol. 36  No. 11    · 1405 ·
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