Methods. TF was extracted from buffy-coats of blood donors or produced in vitro using lymphoblastoid cell lines and, in this case, it was specific for one of the following: HSV, hepatitis B virus, candida albicans, HPV, HHV-6, varicella-zoster, HIV. In most cases, TF was the only treatment. However in several cancer and SIDS patients it was included, in a strategy of immune-modulation, as an adjuvant of chemotherapy (Burkitt´s lymphoma), surgery and radiotherapy (NPC, lung carcicoma, GIT, ovary, uterus, breast, breast, glioblastoma), hormone therapy (metastatic carcinima, GIT, ovary, uterus, breast, glioblastoma), hormone therapy (metastatic prostate cancer), trans-urethral resection and complement-fixing anti-tumour antibodies, interlukin-2 (IL-2)a nd interferon-alpha-2ª (a-IFN) instillation in the urinary bladder for the immunoprophalaxis of TCCB, IL-2 and a_IFN for metastatic renal cancer, and antiretroviral therapy for AIDS. The duration of the treatment ranged from 6 to 127 months. TF was administered i.m. or orally. In 279 patients with recurrent ocular disease (139 herpes keratitis, 47 kerato-uveitis, and 93 uveitis) HSV-specific TF was orally administered for at least 3 months with a mean duration of 687 days, whereas the entire follow-up period was 365913 before and 191772 days after the TF treatment.
Results. A statistically significant increase of survival and decrease of the frequency of tumor relapses compared to the control groups was observed in cancer patients (P<0.001). Improvement of the liver biopsies and of many biochemical serological parameters was observed in hepatitis B patients at the end of a 6 months treatment. The cell mediated immune response against the viral antigens was significantly increased (assessed by the lymphocyte stimulation and leukocyte migration tests) (P<0.001) in the TF-receiving
herpes sufferers. Furthermore, in these patients the number of relapses was significantly decreased, dropping from 1247 before to 235 after the beginning of TF treatment, whereas
the correlated cumulative Relapse Index (RI=100xN episodes/months of follow-up) dropped from 10.23 to 3.68 (P<0.0001). The patients with retinitis pigmentosa experienced a slower progression during treatment. Complete or partial regression of the penile plaques were observed in 4 of 16 patients with Lapeyronie´s disease after 8-27 months of TF therapy.
Conclusion. In 1/3 of the patients the observation period exceeds 20 years. Thus the results confirm not only that specific TF treatment is effective in several pathologies, and it lacks acute but also chronic toxicity. Indeed, side effects were never observed in any of our patients thus corroborating the already established consensus of the complete safety of TF administration.