不可逆电穿孔联合免疫治疗对不可切除胰腺癌有效性和安全性的Meta分析

叶舰; 杨峻峰; 杜丽文; 刘建生

doi:10.12449/JCH241122

不可逆电穿孔联合免疫治疗对不可切除胰腺癌有效性和安全性的Meta分析

DOI: 10.12449/JCH241122

叶舰¹,
杨峻峰¹,
杜丽文¹,
刘建生^2, , ,

1.
山西医科大学第一临床医学院，太原 030001
2.
山西医科大学第一医院肝胆胰外科，太原 030001

利益冲突声明：本文不存在任何利益冲突。

作者贡献声明：叶舰负责研究设计，数据整理，统计学分析和论文撰写；杨峻峰、杜丽文负责数据整理和统计学分析；刘建生负责研究设计，论文指导和论文修改。

详细信息

通信作者:
刘建生， 147542533@qq.com （ORCID： 0000-0002-6038-2560）

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出版历程
- 收稿日期: 2024-03-07
- 录用日期: 2024-04-16
- 出版日期: 2024-11-25

Efficacy and safety of irreversible electroporation combined with immunotherapy in treatment of unresectable pancreatic cancer： A Meta-analysis

1.
The First Clinical Medical College of Shanxi Medical University，Taiyuan 030000，China
2.
Department of Hepatobiliary and Pancreatic Surgery，The First Hospital of Shanxi Medical University，Taiyuan 030000，China

More Information

Corresponding author: LIU Jiansheng， 147542533@qq.com （ORCID： 0000-0002-6038-2560）

摘要

摘要: 目的系统评价不可逆电穿孔（IRE）联合免疫治疗对于不可切除胰腺癌患者的安全性和有效性。方法本研究根据PRISMA指南完成，PROSPERO注册号：CRD42024531984。检索PubMed、Embase、Cochrane Library、Web of Science、中国知网、万方和维普等数据库从建库至2024年2月发表的关于IRE联合免疫治疗不可切除胰腺癌的相关文献。按照设定的纳入和排除标准筛选文献并提取数据，评估文献质量。采用Review Manager 5.3和Stata 17.0软件进行Meta分析。结果最终纳入6篇研究，其中3篇前瞻性研究，2篇回顾性研究，1篇随机对照试验。共计376例不可切除胰腺癌患者，其中IRE治疗组222例，IRE联合免疫治疗组154例。Meta分析结果显示，IRE联合免疫治疗相较于IRE治疗组，能够明显提高患者的无进展生存期（HR=0.82，95%CI：0.72～0.92，P=0.001），延长总生存期（HR=0.86，95%CI：0.80～0.93，P=0.000 1），以及增加患者体内T淋巴细胞计数（MD=217.93，95%CI：192.87～242.99，P<0.000 01），提高患者机体免疫功能。但是在降低患者不良事件发生率（OR=1.43，95%CI：0.76～2.72，P=0.27）及提高患者疾病客观缓解率（OR=1.49，95%CI：0.87～2.56，P=0.15）方面差异均无统计学意义。结论 IRE联合免疫治疗安全有效，可以明显提高不可切除胰腺癌患者总生存期与无进展生存期，增强患者免疫功能。
- 胰腺肿瘤 /
- 消融技术 /
- 免疫抑制法 /
- Meta分析
Abstract: Objective To systematically review the safety and efficacy of irreversible electroporation （IRE） combined with immunotherapy in patients with unresectable pancreatic cancer. Methods This study was conducted according to the PRISMA guideline， with a PROSPERO registration unmber of CRD42024531984. Datebases including PubMed， Embase the Cochrane Library， Web of Science， CNKI， Wanfang Data， and VIP were searched for related articles on IRE combined with immunotherapy for unresectable pancreatic cancer published up to February 2024. The articles were screened and related data were extracted according to the established inclusion and exclusion criteria， and the quality of the articles was assessed. Review Manager 5.3 and Stata 17.0 software were used to perform the meta-analysis. Results Six studies were finally included， with three prospective studies， two retrospective studies， and one randomized controlled trial. There were 376 patients with unresectable pancreatic cancer in total， among whom there were 222 patients in the IRE group and 154 patients in the IRE+immunotherapy group. The meta-analysis showed that compared with IRE alone， IRE combined with immunotherapy significantly prolonged progression-free survival （hazard ratio ［HR］=0.82， 95% confidence interval ［CI］： 0.72 ‍—‍ 0.92， P=0.001） and overall survival （HR=0.86， 95%CI： 0.80 ‍—‍ 0.93， P=0.000 1）， increased T lymphocyte count in the patients （mean difference=217.93， 95%CI： 192.87 ‍—‍ 242.99， P<0.000 01）， and improved the immune function of patients. However， there were no significant differences between the two groups in reducing the incidence rate of adverse events （odds ratio ［OR］=1.43， 95%CI： 0.76 ‍—‍ 2.72， P=0.27） and improving the objective remission rate of patients （OR=1.49， 95%CI： 0.87 ‍—‍ 2.56， P=0.15）. Conclusion IRE combined with immunotherapy is safe and effective in patients with unresectable pancreatic cancer and can significantly improve overall survival and progression-free survival and enhance immune function， with little effect on objective remission rate and the incidence rate of adverse events.
- Pancreatic Neoplasms /
- Ablation Techniquesl /
- Immunosuppression /
- Meta-Analysis

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图 1 文献筛选流程图

Figure 1. Flow chart of literature screening

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图 2 两组患者OS的Meta分析结果

Figure 2. Meta analysis results of OS in two groups

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图 3 两组患者PFS的Meta分析结果

Figure 3. Meta analysis of PFS in two groups

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图 4 两组患者ORR的Meta分析结果

Figure 4. Meta analysis results of orr in two groups of patients

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图 5 两组患者T淋巴细胞计数的Meta分析结果

Figure 5. Meta analysis results of T lymphocyte count in two groups of patients

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图 6 两组患者不良事件发生率的Meta分析结果

Figure 6. Meta analysis of the incidence of adverse events in the two groups

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表 1 纳入研究的6篇文献基本特征

Table 1. Basic characteristics of the six included studies

作者	发表时间（年）	国家	例数	治疗方案	质量评分（分）	研究类型
Lin^［12］	2017	中国	71	IRE+NK细胞	NOS评分：7	前瞻性研究
Lin^［13］	2017	中国	40	IRE+NK细胞	NOS评分：7	前瞻性研究
Lin^［14］	2020	中国	62	IRE+γδ2 T淋巴细胞	Jadad评分：4	随机对照试验
Pan^［15］	2020	中国	92	IRE+NK细胞	NOS评分：8	前瞻性研究
He^［16］	2021	中国	85	IRE+toripalimab	NOS评分：7	回顾性研究
Zhang^［17］	2023	中国	26	IRE+PD-1抑制剂	NOS评分：8	回顾性研究

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