Colón J I, Encarnación G, Ortiz Santini M R, Rodríguez Malavé M T, Santiago Delpín E A, Marchand A M
Department of Pathology, University of Puerto Rico Medical School, San Juan 00936-5067, USA.
P R Health Sci J. 1997 Mar;16(1):9-14.
A polyantigenic immunomodulator (PAI), previously known as polyantigenic vaccine, which consists of a mixture of antigens of inactivated bacteria with antigens of influenza virus in a peanut-oil-arlacel-A-aluminium monoesterate emulsion, increased tumor resistance and induced tumor regression in tumor bearing mice. This report presents clinical and laboratory data that demonstrate the effect of PAI in long term prolongation of disease free state in HIV positive patients. A total of 40 patients, 35 males and 5 females, with a mean age of 41.1 +/- 10.5 years, ranging from 28 to 68 years, HIV positive by (ELISA and Western Blot), with no restriction on the CD4 + T lymphocytes counts, were included in this open study. The PAI regimen was one subcutaneous injection per week for patients with < 400 CD4 + lymphocytes and one monthly injection for patients with CD4 + count > 400. All patients were monitored at different intervals for lymphocyte counts, clinical condition and treatment toxicity. After a follow up of eight years 81% of the patients were alive and 47% were free of disease. In patients without AIDS, the weight was 153.9 +/- 28 pounds pre-PAI and 164.6 +/- 27 (P = 1.2 x 10(-4); the CD4 + lymphocyte count was 795 +/- 421 pre-PAI and 585 +/- 279 post PAI (P = 0.08). In patients alive with AIDS, the weight was 159.5 +/- 32 pre-PAI and 163.9 +/- 32 pounds post-PAI (P = 0.8); the CD4 + lymphocyte counts was 491 +/- 255 pre-PAI and 298 +/- 142 post-PAI (P = 0.08); and five AIDS-related infections occurred in five patients. In patients who died the weight was 157.7 +/- 23 pre and 146.8 +/- 30 post (P = 0.10); and the CD4 count was 340.7 +/- 149 pre and 103.4 +/- 88 post (P = 0.0057). All died with infection. No toxicity with the use of PAI was reported. PAI improves disease free survival and quality of life in HIV + patients.
一种多抗原免疫调节剂（PAI），以前称为多抗原疫苗，它由灭活细菌抗原与流感病毒抗原在花生油-阿拉塞耳-A-单硬脂酸铝乳液中的混合物组成，可增强荷瘤小鼠的肿瘤抵抗力并诱导肿瘤消退。本报告展示了临床和实验室数据，这些数据证明了PAI在长期延长HIV阳性患者无病状态方面的作用。本开放性研究纳入了40例患者，其中男性35例，女性5例，平均年龄为41.1±10.5岁，年龄范围在28至68岁之间，经（酶联免疫吸附测定和蛋白质印迹法）检测为HIV阳性，对CD4 + T淋巴细胞计数无限制。对于CD4 +淋巴细胞<400的患者，PAI治疗方案为每周皮下注射一次；对于CD4 +计数>400的患者，为每月注射一次。所有患者在不同时间间隔接受淋巴细胞计数、临床状况和治疗毒性监测。经过八年的随访，81%的患者存活，47%的患者无疾病。在没有患艾滋病的患者中，PAI治疗前体重为153.9±28磅，治疗后为164.6±27磅（P = 1.2×10⁻⁴）；CD4 +淋巴细胞计数治疗前为795±421，治疗后为585±279（P = 0.08）。在存活的艾滋病患者中，PAI治疗前体重为159.5±32磅，治疗后为163.9±32磅（P = 0.8）；CD4 +淋巴细胞计数治疗前为491±255，治疗后为298±142（P = 0.08）；并且有5名患者发生了5次与艾滋病相关的感染。在死亡的患者中，治疗前体重为157.7±23磅，治疗后为146.8±30磅（P = 0.10）；CD4计数治疗前为340.7±149，治疗后为103.4±88（P = 0.0057）。所有患者均死于感染。未报告使用PAI产生的毒性。PAI可改善HIV +患者的无病生存期和生活质量。
