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本研究评价含胸腺肽增强免疫的自体细胞因子诱导的杀伤细胞(CIK)输注联合小剂量IL-2方案治疗老年人B细胞性慢性淋巴细胞白血病(B-CLL)的安全性及疗效。以胸腺肽α1作为增强免疫方案,用法为1.6 mg/d,皮下注射,14 d为1个周期。采集5例B-CLL老年患者外周血单个核细胞,每周采集1次,分别在应用胸腺肽α1前和应用1个周期后各采集3次,在体外经干扰素-γ(IFN-γ)、白介素-2(IL-2)及抗CD3单克隆抗体诱导成CIK细胞,观察对比应用胸腺肽α1前后CIK细胞在扩增数量、效应细胞扩增倍数、淋巴细胞亚群比例及体外杀瘤活性的变化。5例患者在接受胸腺肽α1治疗后开始进行自体CIK细胞联合小剂量IL-2方案免疫治疗,具体为:胸腺肽α1 1.6 mg/d,皮下注射,隔日1次;每次回输CIK细胞数为(4-6)×109个,回输后应用IL-2 1 mU/d,皮下注射,第1-10天。28 d为1个疗程,动态观察CIK细胞治疗前后细胞免疫功能、肿瘤相关生物学指标、疾病缓解情况及感染频次、程度的变化。结果表明:胸腺肽α1增强免疫治疗后体外诱导CIK细胞在扩增数量、效应细胞扩增倍数、比例及体外杀瘤活性4个方面均明显高于胸腺肽α1治疗前(P<0.05)。5例患者共接受46个疗程的CIK细胞联合IL-2治疗,未观察到明显不良反应。治疗后5例患者一般情况得到不同程度改善,CD3+、CD3+CD8+、CD3+CD56+细胞比例明显升高(P<0.05),血清β2微球蛋白水平显著下降(P<0.05),感染频次减少,程度减轻(P<0.05);3例由部分缓解(PR)达到完全缓解,1例由疾病稳定(SD)达到PR,1例由疾病进展达到SD。结论:含胸腺肽增强免疫的自体CIK细胞联合小剂量IL-2方案治疗老年人B-CLL安全有效。
This study evaluated the safety and efficacy of thymosin-enhanced immune-derived cytokine-induced killer (CIK) infusion in combination with low-dose IL-2 in the treatment of B-cell chronic lymphocytic leukemia (B-CLL) in the elderly. To thymosin α1 as booster solution, the use of 1.6 mg / d, subcutaneous injection, 14 d for a cycle. Peripheral blood mononuclear cells were collected from 5 elderly B-CLL patients and collected once a week. The mononuclear cells were harvested three times before and one cycle after administration of thymosin α1, respectively. IFN-γ, IL-2 and anti-CD3 monoclonal antibodies were induced into CIK cells. The changes of CIK cells before and after thymosin α1 were compared in terms of number of expansion, multiples of effector cells, lymphocyte subsets and in vitro cytotoxic activity . Five patients received immunotherapy with autologous CIK cells combined with low-dose IL-2 after thymosin α1 treatment: thymosin α1 1.6 mg / d subcutaneously every other day; -6) × 109, and IL-2 1 mU / d after transfusion was injected subcutaneously on day 1-10. 28 d for a course of treatment, dynamic observation of CIK cell immune function before and after treatment, tumor-related biological indicators, disease response and frequency of infection, the degree of change. The results showed that the number of CIK cells induced by thymosin α1 enhanced immunotherapy in vitro was significantly higher than that of thymosin α1 (P <0.05) in four aspects: the number of expansion, the ratio of multiplication of effector cells and the antitumor activity in vitro. Five patients received a total of 46 courses of CIK cells combined with IL-2 treatment, no significant adverse reactions were observed. After treatment, the general situation of 5 patients was improved to some extent. The proportion of CD3 +, CD3 +, CD8 + and CD3 + CD56 + cells was significantly increased (P <0.05), serum β2 microglobulin level was significantly decreased (P <0.05) (P <0.05). Three patients achieved complete remission by partial response (PR), one patient achieved stable disease (SD) and one patient achieved disease progression by SD. Conclusion: It is safe and effective to treat B-CLL in the elderly with autologous CIK cells with thymosin enhanced immunity combined with low-dose IL-2 regimen.