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Case Reports 2002; 23(5-6): 387-390 PubMed PMID: 12500158 Citation  Keywords:  Analgesics, Non-Narcotic:therapeutic use, Anti-Anxiety Agents:therapeutic use, Anticonvulsants:therapeutic use, Antioxidants:therapeutic use, Benzodiazepines, Child, Preschool, Consanguinity, Disease Progression, Dronabinol:therapeutic use, Electroencepha.   

GOAL: The casuistic of a child suffering from late infantile neuronal ceroid lipofuscinosis (NCL) of the type Jansky-Bielschowsky aims to provide a description of possible therapeutic options for the severe spastic and the debilitating myocloni that occur within the context of this disorder. Moreover, it also should include a discussion of potential indications for the application of delta 9-Tetrahydrocannabinol (THC) (Dronabinol, Marinol) in childhood....

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Case Reports 2002; 23(4): 370-372 PubMed PMID: 12195243 Citation  Keywords:  Aged, Aged, 80 and over, Female, Fluorescein Angiography, Humans, Macular Degeneration:diagnosis, Photochemotherapy, Photosensitizing Agents:administration & dosage, Porphyrins:administration & dosage,.   

: Our controlled case describes the drug possibility to stabilize the exudative form of Age-related Macular Degeneration. The new approach of selective destruction of choroidal neovascularization (CNV) can be applied in patients with subfoveal lesions. Photodynamic therapy (PDT) is based on the reaction of photoactivable drug with the light of low-energy laser beam. So far only verteporfin [Visudyne, Novartis] as sensitizer is marketed and laser with wavelength of 689 nm is used. But it is questionable whether to apply this very costly treatment to extremely old people. An example of treatment of 90-year old woman with AMD with classic form of CNV is presented. Her BCVA was 0.05 OD. She underwent four session of PDT. At the last visit (eighteen months after initial and ten months after last session of PDT) the BCVA remained 0.05 OD. The patient is using a special magnifying lens for reading achieving near vision of 0.32. The presented example indicates the necessity of detailed study of every case to promote the therapeutic decisions for the benefit of progress in the field....

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Clinical Trial 2002; 23(4): 365-368 PubMed PMID: 12195242 Citation  Keywords:  Adolescent, Adult, Aged, Animals, Electric Conductivity, Electroretinography, Humans, Middle Aged, Oligopeptides:administration & dosage, Pineal Gland:drug effects, Rats, Rats, Inbred Strains, Retina:pathology, Retinitis Pigmentosa:drug therapy,.   

: We have studied the effect of tetrapeptide Epitalon (Ala-Glu-Asp-Gly) on the course of congenital pigmented degeneration of the retina. The application of Epitalon in Campbell rats is found to intensify the bioelectric and functional activity of the retina due to the preservation of its morphological structure. Epitalon therapy in patients with degenerative retinal lesions results in a positive clinical effect in 90% of the cases. The analysis of Epitalon effects suggests that the tetrapeptide participates in the mechanisms of transcription common for the epiphysis and retina....

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Clinical Trial 2002; 23(4): 341-344 PubMed PMID: 12195238 Citation  Keywords:  Adjuvants, Immunologic:administration & dosage, Aged, Antineoplastic Agents:administration & dosage, Carcinoma, Neuroendocrine:drug therapy, Carcinoma, Renal Cell:drug therapy, Digestive System Neoplasms:drug therapy, Female, Humans, Injections, Subcutane.   

OBJECTIVES: The preliminary applications of the psychoneuroimmunological knowledges to the treatment of human diseases have confirmed the possibility to amplify IL-2-dependent anticancer immunity by the pineal hormone melatonin (MLT) or by opioid antagonist, such as naltrexone (NTX), which act by activating TH1 lymphocytes or suppressing TH2 lymphocytes, respectively. At present, however, there are no data about the immunobiological effects of a concomitant administration of both MLT and NTX on IL-2-induced anticancer immunity. This preliminary study was carried out to evaluate whether the association of NTX may further enhance the lymphocytosis induced by the neuroimmunotherapy with IL-2 plus MLT.

MATERIALS & METHODS: The study included 14 consecutive untreatable metastatic solid tumor patients. According to a cross-over randomized study, the patients were treated during two consecutive immunotherapeutic cycles at 21-day intervals with IL-2 plus MLT alone or with IL-2 plus MLT plus NTX. IL-2 was injected subcutaneously at 3 MIU/day for 6 days/week for 4 weeks, MLT was given orally at 20 mg /day in the evening every day, and NTX was given orally at 100 mg in the morning every next day. For the immune evaluation, venous blood samples were drawn before the onset of treatment and at weekly intervals.

RESULTS: Lymphocyte mean number significantly increased after both IL-2 plus MLT and IL-2 plus MLT plus NTX. However, the concomitant administration of NTX induced a significantly higher increase in lymphocyte mean number with respect to that achieved with IL-2 plus MLT alone. In contrast, the increase in eosinophil mean number was significantly higher on IL-2 plus MLT alone.

CONCLUSIONS: This preliminary study shows that the association of NTX further amplifies the lymphocytosis obtained by IL-2 plus MLT. Since the lymphocytosis represents the most important favourable prognostic variable predicting the anticancer efficacy of IL-2 immunotherapy, it is probable that a cancer neuroimmunotherapy with IL-2 plus both MLT and NTX to activate TH1 and suppress TH2 cells respectively, may deserve more promising results in the treatment of human neoplasms according to the psychoneuroimnunological knowledge....

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Clinical Trial 2002; 23(4): 309-313 PubMed PMID: 12195232 Citation  Keywords:  Adolescent, Adrenocortical Hyperfunction:drug therapy, Adult, Androgen Antagonists:administration & dosage, Cyproterone Acetate:administration & dosage, Drug Therapy, Combination, Estradiol Congeners:administration & dosage, Ethinyl Estradiol:administrati.   

OBJECTIVES: To investigate melatonin production in hyperandrogenic women before and during treatment with cyproterone acetate and ethinyl estradiol (Diane 35).

MATERIAL AND METHODS: We studied 10 women with late onset adrenal hyperplasia due to 21-hydroxylase deficiency (LOCAH) and 10 women with idiopathic hirsutism (IH). Patients were treated with Diane 35 for four months. Fasting blood samples for the determination of luteinizing hormone (LH), follicle-stimulating hormone (FSH), testosterone and dihydroepiandrosterone sulfate (DHEAS) and 24-hour urine collections for the determination of 6-sulfatoxymelatonin (aMT6s) excretion were obtained from all patients at baseline and after 4 months of treatment. Results were compared with those obtained in 15 control women.

RESULTS: At baseline, women with LOCAH had significantly higher serum testosterone, 17-hydroxyprogesterone (17OHP) and ACTH stimulated 17OHP values than IH and control women. Their aMT6s values (51.0+/-20.5 mg/24h) were significantly higher than the values in IH (34.3+/-7.1) and control women (30.5+/-6.5) (p< 0.001). Diane 35 treatment significantly decreased serum LH, FSH and testosterone levels and aMT6s values in LOCAH patients (29.8+/-16.6 mg/24h) (p<0.0001) in LOCAH patients.

CONCLUSIONS: These results indicate that hyperandrogenic women with LOCAH have increased melatonin production. The normalization of aMT6s and testosterone values during cyproterone acetate-ethinyl estradiol treatment, suggest that sex steroids either directly or through the suppression of gonadotropin, modulate melatonin secretion in these patients....

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Journal Article 2002; 23(Suppl 2): 37-42 PubMed PMID: 12163846 Citation  Keywords:  Aging:metabolism, Animals, Estrogen Replacement Therapy, Estrogens, Non-Steroidal:therapeutic use, Female, Homeostasis:physiology, Humans, Isoflavones, Menopause:physiology, Neurosecretory Systems:metabolism, Phytoestrogens, Plant Preparations, Receptors,.   

: Endocrine modulation by natural and synthetic chemicals and the eventually resulting beneficial or adverse effects for human and animal health are controversially debated not only among scientists but particularly in the public. Most information is available on so-called environmental estrogens, however the amount of information on substances interfering with other hormonal axes steadily increases, particularly on those exhibiting (anti)androgenic activities. The aim of this paper is to summarize existing data and to give an overview on the potential pathways leading to interferences of environmental hormones with homeostasis and eventually resulting health effects. Experimental evidence suggests the hypothesis that fetal and neonatal organisms may be at risk if exposed to environmental estrogens. In contrary, it appears as if phytoestrogens, particularly those with selective estrogen receptor modulator- (SERM-)like activities have the potential to be useful in medical application, both as dietary means and as pharmaceuticals. Lacking valid information about the detailed analysis of the molecular mode of action for environmental estrogens, the possibility for an ultimate classification of environmental estrogens in "dangerous endocrine disruptors" and phytoestrogens in "useful pharmaceuticals" cannot be supported conclusively. Nevertheless both activities are likely....

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Clinical Trial 2002; 23(3): 255-258 PubMed PMID: 12080288 Citation  Keywords:  Aged, Antineoplastic Agents:administration & dosage, Carcinoma, Renal Cell:drug therapy, Drug Therapy, Combination, Female, Humans, Injections, Subcutaneous, Interleukin-2:administration & dosage, Kidney Neoplasms:drug therapy, Lymphocyte Count, Male, Mid.   

OBJECTIVES: Recent advances in knowledge of Psychoneuroimmunology have shown that several neuroactive substances, including neurohormones and neuropeptides, may exert immunomodulatory effects. However, despite the great variety of potential neuroimmune interactions, at present we may recognize two major neuroendocrine systems exerting a physiological neuroimmunomodulatory function, consisting of the pineal gland and the brain opioid system, provided by immunostimulatory and immunosuppressive effects, respectively. Recent in human studies have demonstrated the possibility to amplify the biological activity of IL-2, the major anticancer cytokine, by pineal indoles.

MATERIALS & METHODS: The present study was carried out to draw some preliminary in human results on the possible immunomodulatory effects of the inhibition of the brain opioid activity by a long-acting opioid antagonist, naltrexone (NTX). The study was performed in 10 metastatic renal cell cancer patients, who had progressed on a previous immunotherapeutic cycle with IL-2 alone. Patients were treated with the same doses of IL-2 (6 million lU/day subcutaneously for 6 days/week for 4 weeks) plus an oral administration of NTX at a dose of 100 mg every 2 days.

RESULTS: The clinical response consisted of a partial response in 1 and a stable disease in 5 patients, whereas the other 4 patients progressed. Therefore, the percent of non-progressive disease was 6/10 (60%). Moreover, mean lymphocyte increase achieved during IL-2 plus NTX was significantly higher (P<0.05) than that obtained during the previous treatment with IL-2 alone.

CONCLUSIONS: This study shows that a blockade of the brain opioid system, which plays a physiological immunosuppressive role, may improve the anticancer effects of IL-2 in humans....

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Comparative Study 2002; 23(3): 249-254 PubMed PMID: 12080287 Citation  Keywords:  Animals, Body Temperature, Brain Ischemia:pathology, Infarction, Middle Cerebral Artery:drug therapy, Male, Neuropeptides:pharmacology, Neuroprotective Agents:pharmacology, Pituitary Adenylate Cyclase-Activating Polypeptide, Rats, Rats, Wistar, Vasoactive.   

OBJECTIVES: Pituitary adenylate cyclase activating polypeptide (PACAP) and vasoactive intestinal polypeptide (VIP) belong to the same peptide family, and both neuropeptides have been shown to exert in vitro and in vivo neurotrophic and neuroprotective effects. The aim of the present study was to investigate and compare the protective effects of PACAP and VIP in permanent focal cerebral ischemia in rats. The effect on the progression of the cerebral infarct was also studied.

METHOD: Male rats were injected 450 pmol PACAP or VIP dissolved in physiological saline intracerebroventricularly, preceding the occlusion of the middle cerebral artery. Control animals received vehicle treatment. Permanent focal ischemia was induced by the intraluminal filament occlusion of the middle cerebral artery. Animals were sacrificed 12 or 24 hours after the onset of ischemia, and infarcted brain areas were determined by staining bran sections with triphenyl-tetrazolium chloride.

RESULTS: Twelve hours after ischemia, the infarcted brain volume resulted to be 14.8% in the control group, 15.3% in the VIP-treated group and 5.8% in the PACAP-treated animals. Twenty-four hours after middle cerebral artery occlusion, the infarcted brain volumes were 21.5%, 20.7% and 14.3% in the control, VIP and PACAP-treated animals, respectively.

CONCLUSION: Our results provide further evidence for the neuroprotective effects of PACAP38 as given in form of a preischemic bolus. It slows down the progression of the evolution of the infarct and reduces the final infarct size. In contrast, a related peptide, VIP, does not have neuroprotective effects under the same experimental conditions....

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