文章摘要
艾迪注射液联合卡瑞丽珠单抗治疗晚期非小细胞肺癌患者的临床疗效:一项前瞻性单中心随机对照试验
Clinical Efficacy of Aidi Injection Combined With Carrelizumab in the Treatment of Advanced Non-Small Cell Lung Cancer: A Prospective Single-Center Randomized Controlled Trial
投稿时间:2024-09-09  修订日期:2024-09-09
DOI:
中文关键词: 艾迪注射液  卡瑞丽珠单抗  晚期非小细胞肺癌  临床疗效
英文关键词: Aidi injection  Carrelizumab  Advanced non-small cell lung cancer  Clinical efficacy
基金项目:北京市科技计划课题(Z161100000216136)
作者单位邮编
马晟尧* 首都医科大学附属北京世纪坛医院 100038
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中文摘要:
      目的:基于前瞻性单中心随机对照试验,探讨艾迪注射液联合卡瑞丽珠单抗治疗晚期非小细胞肺癌(NSCLC)患者的临床疗效。方法:前瞻性选取2022年4月~2024年3月我院收治的82例晚期NSCLC患者,采用随机数字表法,将其分为对照组(n=41)和研究组(n=41)。对照组接受常规化疗治疗和卡瑞丽珠单抗治疗,研究组在对照组的基础上接受艾迪注射液治疗。对比两组客观缓解率(ORR)、疾病控制率(DCR)、血清肿瘤标志物[细胞角质蛋白19片段抗原21-1(CYFRA21-1)、鳞状细胞癌抗原(SCCA)、肿瘤特异性生长因子(TSGF)]、免疫指标[免疫球蛋白M(IgM)、免疫球蛋白A(IgA)、免疫球蛋白G(IgG)、树状突细胞(DC)、DC/单核巨噬细胞(PBMC)]、肿瘤侵袭转移指标[基质金属蛋白酶1(MMP-1)、基质金属蛋白酶2(MMP-2)、基质金属蛋白酶9(MMP-9)]及不良反应总发生率。结果:研究组ORR、DCR均高于对照组(P<0.05)。两组治疗后血清CYFRA21-1、TSGF、SCCA水平下降,且研究组血清CYFRA21-1、TSGF、SCCA水平均低于对照组(P<0.05)。两组治疗后IgM、IgA、IgG、DC、DC/PBMC均下降,且研究组IgM、IgA、IgG、DC、DC/PBMC均高于对照组(P<0.05)。两组治疗后血清MMP-1、MMP-9、MMP-2水平下降,且研究组血清MMP-1、MMP-9、MMP-2水平均低于对照组(P<0.05)。两组不良反应总发生率对比,差异无统计学意义(P>0.05)。结论:艾迪注射液联合卡瑞丽珠单抗治疗晚期NSCLC,可提高总体疗效,同时还可有效调节血清肿瘤标志物水平,减轻免疫抑制,阻止肿瘤侵袭转移,安全有效。
英文摘要:
      Objective: Based on prospective single-center randomized controlled trial, to investigate the clinical efficacy of aidi injection combined with carrelizumab in treatment of patients with advanced non-small cell lung cancer (NSCLC). Methods:A total of 82 patients with advanced NSCLC admitted to our hospital from April 2022 to March 2024 were prospectively selected and divided into control group ( n = 41 ) and study group ( n = 41 ) by random number table method. Control group received conventional chemotherapy and carrelizumab treatment, and study group received aidi injection on the basis of control group. The objective response rate (ORR), disease control rate (DCR), serum tumor markers [cytokeratin 19 fragment antigen 21-1 (CYFRA21-1), squamous cell carcinoma antigen (SCCA), tumor specific growth factor (TSGF)], immune indexes [immunoglobulin M (IgM), immunoglobulin A (IgA), immunoglobulin G (IgG), dendritic cells (DC), DC/mononuclear macrophages (PBMC)], tumor invasion and metastasis indexes [matrix metalloproteinase 1 (MMP-1), matrix metalloproteinase 2 (MMP-2), matrix metalloproteinase 9 (MMP-9)] and the total incidence of adverse reactions were compared between two groups. Results: The ORR and DCR in study group were higher than those in control group (P<0.05). The levels of serum CYFRA21-1, TSGF and SCCA in two groups decreased after treatment, and the levels of serum CYFRA21-1, TSGF and SCCA in study group were lower than those in control group (P<0.05). IgM, IgA, IgG, DC and DC/PBMC decreased in both groups after treatment, and IgM, IgA, IgG, DC and DC/PBMC in study group were higher than those in control group (P<0.05). The levels of serum MMP-1, MMP-9 and MMP-2 in two groups decreased after treatment, and the levels of serum MMP-1, MMP-9 and MMP-2 in study group were lower than those in control group (P<0.05). There was no difference in the total incidence of adverse reactions in two groups(P>0.05). Conclusion: Aidi injection combined with carrelizumab in the treatment of advanced NSCLC, which can improve the overall efficacy, effectively regulate the level of serum tumor markers, reduce immunosuppression, prevent tumor invasion and metastasis, and is safe and effective.
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