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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;
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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
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*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 ·