Raise E, Guerra L, Viza D, Pizza G, De Vinci C, Schiattone M L, Rocaccio L, Cicognani M, Gritti F
Dept. of Infectious Diseases, Maggiore Hospital, Bologna, Italy.
Biotherapy. 1996;9(1-3):49-54. doi: 10.1007/BF02628656.
The efficiency of HIV-1 specific transfer factor (TF) administration, combined with Zidovudine (ZDV), in asymptomatic persistent generalised lymphadenopaty, or AIDS related complex (ARC) patients was evaluated. Twenty patients were randomly assigned to receive only ZDV (1st group) or ZDV together with HIV-1-specific TF (2nd group). HIV-1-specific TF was administered orally at 2 x 10(7) cell equivalent daily for 15 days, and thereafter once a week for up to 6 months. There were no significant differences between the two groups in clinical evolution, red blood cells, haemoglobin, lymphocytes, CD20 subset, transaminases, beta-2-microglobulin, p24 antigen. White blood cells, CD8 lymphocytes as well as IL-2 levels increased in the second group, while the CD4 subset increased in the first group. The combination treatment with ZDV and TF appeared to be safe and well tolerated. Furthermore, levels of serum cytokines were investigated in 10 patients (8 asymptomatic and 2 ARC) treated with ZDV, and compared with 5 patients of the 2nd group (3 asymptomatic and 2 ARC) treated with ZDV plus HIV-1-specific TF. Peripheral lymphocytes, CD4, CD8 subsets, IL-2, TNF alpha, IL-6, p24 antigen, IL-2 soluble lymphocyte receptors (sR), CD4sR, CD8sR and beta-2-microglobulin were evaluated at the baseline and at the 3rd month. The CD4 subset was not significantly different in the two groups, whilst IL-2 increased in the 2nd group receiving ZDV plus TF, suggesting an activation of the Th1 secretion pattern.
评估了在无症状持续性全身性淋巴结病或艾滋病相关综合征（ARC）患者中，将HIV-1特异性转移因子（TF）与齐多夫定（ZDV）联合使用的疗效。20名患者被随机分配，仅接受ZDV治疗（第1组）或接受ZDV联合HIV-1特异性TF治疗（第2组）。HIV-1特异性TF口服给药，每日2×10⁷细胞当量，持续15天，此后每周一次，持续6个月。两组在临床进展、红细胞、血红蛋白、淋巴细胞、CD20亚群、转氨酶、β2-微球蛋白、p24抗原方面无显著差异。第2组白细胞、CD8淋巴细胞以及IL-2水平升高，而第1组CD4亚群升高。ZDV与TF的联合治疗似乎安全且耐受性良好。此外，对10名接受ZDV治疗的患者（8名无症状患者和2名ARC患者）的血清细胞因子水平进行了研究，并与第2组中5名接受ZDV加HIV-1特异性TF治疗的患者（3名无症状患者和2名ARC患者）进行了比较。在基线和第3个月时评估外周淋巴细胞、CD4、CD8亚群、IL-2、TNFα、IL-6、p24抗原、IL-2可溶性淋巴细胞受体（sR）、CD4sR、CD8sR和β2-微球蛋白。两组的CD4亚群无显著差异，而在接受ZDV加TF的第2组中IL-2升高，提示Th1分泌模式被激活。
