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目的:探讨粒巨细胞集落刺激因子(GM-CSF)联合异体肿瘤细胞疫苗的安全性和有效性。方法:收录病理明确的IV期癌症患者60例,其中恶性黑色素瘤11例,卵巢癌10例,肾癌15例,胃/结直肠癌14例,乳腺癌10例。每周皮下注射肿瘤细胞和GM-CSF分泌细胞混合物1ml;共6次。在第1,5次注射同时,进行DTH接种试验。治疗前后取外周血样进行淋巴细胞亚型及细胞因子检测。治疗完成1个月后进行影像学检查。结果:所有病人对治疗耐受良好,无脱组患者。主要不良反应为,注射局部红肿疼痛,硬结,瘙痒和发热。4例治疗后有影像学好转但未达到部分缓解,40例稳定,16例进展。DTH阳性率68%(41/60)。流式细胞仪检测治疗后CD8+T细胞(CTL)明显增加(P<0.05),CD4+CD25+CD127-T细胞(Treg)降低(P<0.05)。ELISA检测IFN-γ治疗前后的变化无统计学意义,但有升高趋势。结论:异体GM-CSF联合肿瘤细胞疫苗治疗安全,耐受良好,能改善患者的机体免疫状态。
Objective: To investigate the safety and efficacy of granulocyte colony-stimulating factor (GM-CSF) combined with allogeneic tumor cell vaccine. Methods: Sixty patients with pathologically confirmed stage IV cancer were enrolled, including 11 cases of malignant melanoma, 10 cases of ovarian cancer, 15 cases of kidney cancer, 14 cases of stomach / colorectal cancer and 10 cases of breast cancer. 1 ml of tumor cell and GM-CSF secreting cell mixture was injected subcutaneously every week for a total of 6 times. At the same time as the first injection, the DTH inoculation was performed. Peripheral blood samples were taken before and after treatment for detection of lymphocyte subtypes and cytokines. One month after the completion of treatment, imaging was performed. Results: All patients were well tolerated for treatment and no patients were excluded. The main adverse reactions were local injection of painful redness, induration, itching and fever. 4 cases of imaging improved but did not achieve partial remission, 40 cases of stable, 16 cases of progress. The positive rate of DTH was 68% (41/60). CD8 + T cells (CTL) were significantly increased (P <0.05) and CD4 + CD25 + CD127-T cells (Tregs) were decreased by flow cytometry (P <0.05). The change of IFN-γ before and after treatment by ELISA was not statistically significant, but there was an increasing trend. Conclusion: Allogeneic GM-CSF combined with tumor cell vaccine is safe and well tolerated and can improve the immune status of patients.