← 返回前沿论文

中药注射剂联合化疗治疗晚期非小细胞肺癌的疗效和安全性比较:一项贝叶斯网络 meta 分析

英文原题:Comparative efficacy and safety of traditional Chinese medicine injections combined with chemotherapy for advanced non-small cell lung cancer: a Bayesian network meta-analysis.

PubMed 2026/08/19(内容时间) Front Immunol Q1 · IF 7(JCR 2025)

研究概要

TCMIs联合化疗可能与晚期NSCLC患者临床反应、免疫相关指标、肿瘤相关标志物及治疗耐受性的改善相关。然而,鉴于证据确定性有限、异质性较大以及纳入研究的方法学局限性,这些发现应谨慎解读,并需通过高质量的前瞻性研究加以证实。

研究思路结论见上方概要

非小细胞肺癌(NSCLC)仍是全球癌症相关死亡的主要原因。尽管化疗是晚期NSCLC的重要治疗策略,但其疗效受到治疗耐药和不良事件的限制。中药注射剂(TCMIs)被广泛用作辅助治疗;然而,不同基于TCMI方案的比较疗效和安全性仍不明确。本研究旨在采用贝叶斯网络荟萃分析比较各种TCMIs联合化疗的疗效和安全性。

从中国知网、万方、维普、中国生物医学文献数据库等中文数据库,以及PubMed、Web of Science、Cochrane Library等英文数据库中检索关于TCMIs联合化疗治疗NSCLC的RCTs。检索时间为2021年1月1日至2026年5月1日。采用Cochrane风险偏倚工具评估纳入研究的方法学质量,并使用网络Meta分析置信度(CINeMA)框架评估网络证据的确定性。使用Stata和R软件进行网络Meta分析。

共纳入71项RCT,涉及6,386例患者。网络Meta分析结果显示,康莱特注射液联合化疗在客观缓解率(ORR)、CD8及皮肤不良反应方面排名相对较优;康艾注射液联合化疗在血红蛋白降低相关不良反应方面排名相对较优;参芪扶正注射液在NK 细胞(NK细胞)、免疫球蛋白G(IgG)、神经元特异性烯醇化酶(NSE)及糖类抗原19-9(CA19-9)方面排名相对较优;艾迪注射液在免疫球蛋白A(IgA)、免疫球蛋白M(IgM)及骨髓抑制相关不良反应方面排名相对较优;复方苦参注射液在癌胚抗原(CEA)、血管内皮生长因子(VEGF)及白细胞减少、肝肾功能损害、胃肠道症状等不良反应方面排名相对较优;参麦注射液联合化疗在糖类抗原125(CA125)方面排名相对较优;鸦胆子油乳注射液联合化疗在鳞状细胞癌抗原(SCC)方面排名相对较优;消癌平注射液在分化簇4阳性T淋巴细胞(CD4+ T细胞)/分化簇8阳性T淋巴细胞(CD8+ T细胞)方面排名相对较优;人参多糖注射液在疾病控制率(DCR)、分化簇3阳性T淋巴细胞(CD3+ T细胞)、分化簇4阳性T淋巴细胞(CD4+ T细胞)及细胞角蛋白19片段(CYFRA21-1)方面排名相对较优;黄芪多糖注射液联合化疗在血小板减少相关不良反应方面排名相对较优。Meta回归分析发现,年龄与CYFRA21-1、SCC、VEGF及IgM的效应估计值之间存在统计学关联;然而,这些发现应解释为探索性关联,而非因果解释。CYFRA21-1的亚组分析提示年龄相关亚组之间可能存在差异,尚需进一步验证。

展开英文摘要原文

BACKGROUND: Non-small cell lung cancer (NSCLC) remains a leading cause of cancer-related mortality worldwide. Although chemotherapy is an important treatment strategy for advanced NSCLC, its efficacy is limited by treatment resistance and adverse events. Traditional Chinese medicine injections (TCMIs) are widely used as adjunctive therapies; however, the comparative efficacy and safety of different TCMI-based regimens remain unclear. This study aimed to compare the efficacy and safety of various TCMIs combined with chemotherapy using Bayesian network meta-analysis. METHODS: RCTs on TCMIs combined with chemotherapy for NSCLC were retrieved from Chinese databases including CNKI, Wanfang, VIP, and Chinese Biomedical Literature Database, as well as English databases including PubMed, Web of Science, and Cochrane Library. The retrieval period was from January 1, 2021 to May 1, 2026. The Cochrane risk-of-bias tool was used to assess the methodological quality of the included studies, and the certainty of network evidence was evaluated using the Confidence in Network Meta-Analysis (CINeMA) framework. Stata and R software were used to perform network meta-analysis. RESULTS: A total of 71 RCTs involving 6,386 patients were included. The results of the network meta-analysis showed that Kanglaite Injection combined with chemotherapy showed a relatively favorable ranking for objective response rate (ORR), CD8, and skin adverse reactions; Kang'ai Injection combined with chemotherapy for hemoglobin reduction-related adverse reactions; Shenqi Fuzheng Injection for natural killer cells (NK cells), immunoglobulin G (IgG), neuron-specific enolase (NSE), and carbohydrate antigen 19-9 (CA19-9); Aidi Injection for immunoglobulin A (IgA), immunoglobulin M (IgM), and bone marrow suppression-related adverse reactions; Fufang Kushen Injection for carcinoembryonic antigen (CEA), vascular endothelial growth factor (VEGF), and adverse reactions such as leukopenia, liver and kidney function damage, and gastrointestinal symptoms; Shenmai Injection combined with chemotherapy for carbohydrate antigen 125 (CA125); Yadanzi Youru injection combined with chemotherapy for squamous cell carcinoma antigen (SCC); Xiao'aiping Injection for cluster of differentiation 4 positive T lymphocyte (CD4 + T Cell)/cluster of differentiation 8 positive T lymphocyte (CD8 + T Cell); Renshen duotang injection for disease control rate (DCR), cluster of differentiation 3 positive T lymphocyte (CD3 + T Cell), cluster of differentiation 4 positive T lymphocyte (CD4 + T Cell), and cytokeratin 19 fragment (CYFRA21-1); Huangqi Duotang injection combined with chemotherapy for thrombocytopenia-related adverse reactions. Meta-regression analyses identified statistical associations between age and effect estimates of CYFRA21-1, SCC, VEGF, and IgM; however, these findings should be interpreted as exploratory associations rather than causal explanations. Subgroup analysis of CYFRA21-1 suggested potential differences across age-related subgroups, which require further validation. CONCLUSION: TCMIs combined with chemotherapy maybe associated with improvements in clinical response, immune-related indicators, tumor-associated markers, and treatment tolerability in patients with advanced NSCLC. However,given the limited certainty of evidence, substantial heterogeneity, and methodological limitations of included studies, these findings should be interpreted cautiously and require confirmation through high-quality prospectivestudies. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/, identifier CRD420261392216.

论文信息

作者
Ma ZZ、Wei YM、Yu SC、Liu MH、Cheng YF、Wang BY、Sun RG
第一作者单位
Department of Integrated Traditional Chinese and Western Medicine, Liaoning University of Traditional Chinese Medicine Xinglin College, Shenyang, China.China
通讯作者单位
Integrated Traditional Chinese and Western Medicine Oncology Department, Shenyang Fifth People Hospital, Shenyang, China.China
文献类型
网状荟萃分析 · 对照研究 · 系统综述
期刊
Frontiers in immunology2026
原文标识
PubMed 42688223 · DOI 10.3389/fimmu.2026.1901595