摘要
目的:探索DC-CIK细胞应用于临床的质量控制及对恶性肿瘤的疗效。方法:选取陕西省友谊医院肿瘤生物诊疗科中晚期恶性肿瘤患者33例(恶性黑色素瘤3例,肠癌4例,肺癌5例,胃癌3例,食管癌4例,宫颈癌7例,肾癌7例)。采集患者外周血分离PBMC,诱导DC-CIK细胞,并扩增培养。质控检测细胞数量和活细胞比例、细胞毒活性、感染源、流式细胞术检测免疫表型。将检测合格后的DC-CIK细胞分5次静脉回输入患者体内,每2天回输一次,每疗程5次,共2个疗程,观察治疗效果和不良反应。结果:经诱导后的DC-CIK细胞符合预期免疫活性细胞质控的各项要求。33例患者经治疗后,完全缓解3例,部分缓解17例,稳定9例,进展4例。总有效率60.6%,临床受益率87.8%。治疗后患者外周血CD3+、CD4+、CD8+、CD3+CD56+T细胞比例分别为(60.25±7.75)%、(29.76±3.85)%、(30.25±4.35)%和(18.20±4.30)%,较治疗前均明显增高(P均<0.05)。生活质量KPS评分较治疗前明显上升(P<0.01)[(75.3±7.6)分vs(58.5±6.2)分]。无严重不良反应和化验指标异常。结论:DC-CIK细胞制剂质量控制指标切实可行,对恶性肿瘤有较好的临床疗效,并能有效增强患者的免疫功能。
Objective：To study the clinical quality control and therapeutic effects against malignant tumors of DC - CIK cells,which mixed culture from DC and CIK ceils. Methods： Thirty - three patients with advanced malignant tumor were from Friendship Hospital of Shaanxi Province. Peripheral blood mononuclear cells （PBMC） were isolated from the patients. To induce CIK cell and DC ceil respectively and then to mix culture with mature DC and CIK ceils to induce DC - CIK cells. Quality control indices including quantity, viability, cytotoxicity, endotoxin contaminant and infection source of DC - CIK ceils were examined, and the immunophenotypes were studied by flow cytometry. The qualified DC -CIK ceils were gathered and infused back to the tumor patients intravenously, once every two days, each episode included 5 times,with a total of 2 courses. Therapeutic effects and adverse reactions were observed, and the effective and clinical beneficial rates were calculated. Results ：The prepared DC -CIK cells met the quality stand- ard of the expected immune activated ceils. The rations of CD3＋ T, CD4＋ T, CD8＋ T and CD3＋ CD56＋ ceils in the pe- ripheral blood were （60.25 ± 7.75 ） %, （29.76 ± 3.85 ） %, （30.25 ± 4.35 ） % and （ 18.20±4.30 ） % respectively after treatment with DC - CIK ceils, which were significantly higher than those before treatment （ all P 〈 0.05 ）. There were 3 cases CR,17 cases PR,9 cases SD ,4 eases progression in 33 patients,the total effective rate was 60.6% ,and the clinical beneficial rate was 87.8%. KPS score before treatment and after treatment was （75.3±7.6） and （58.5 ± 6.2） respectively,which increased significantly than those before treatment （P 〈 0.01 ）. There were no abnormal changes of the related chemical induces or toxicity reaction. Conclusion： Our quality control measure for prepared DC - CIK cells is feasible and they have definite therapeutic effects against malignant tumor and can efiqciently improve the immune function of tumor patients.
出处
《现代肿瘤医学》
CAS
2013年第10期2194-2197,共4页
Journal of Modern Oncology
基金
陕西省自然科学基础研究项目(编号:2007C260)
