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Journal Article 2001; 22(1): 53-73 PubMed PMID: 11393163 Citation  Keywords:  Adrenal Glands:physiology, Animals, Biological Clocks, Blood Pressure:physiology, Chronobiology Disorders:physiopathology, Chronobiology Phenomena, Chronotherapy, Circadian Rhythm:physiology, Drug Administration Schedule, Genomics, Homeostasis, Humans, Pi.   

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Journal Article 2012; 33(8): 773-781 PubMed PMID: 23391973 Citation  Keywords:  Adolescent, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Hormonal:administration & dosage, Antineoplastic Combined Chemotherapy Protocols:administration & dosage, Antioxidants:administration & dosage, Female, Hormones:administration & dosage, Hu.   

OBJECTIVES: Lymphomas are the main form of haematological neoplasms, representing 55.6% of all tumours of the blood. Overall, they account for 5.3% of all malignant tumours (excluding basal and squamous cell skin cancer) in Italy with a prevalence constantly increasing at a rate of 3% per year. From a histological point of view, they represent a vast heterogeneous group of haematological diseases, their staging being based on defined cyto-morphological and anatomo-pathological criteria. Although the combined use of standard approaches can provide good response rates, recurrence is particularly frequent in patients undergoing traditional treatment, with critical and often irreversible side effects such as myelosuppression and a high frequency of opportunistic infections and sterility. Numerous epidemiological studies and preclinical data have for some time now reported the anticancer effects of molecules such as Melatonin, Retinoids, Vitamins E, D3, and C, Somatostatin and prolactin inhibitors in neoplastic diseases. There are, however, very few publications on the combined effects of these substances in vivo.

METHODS: We report an observational study carried out on 55 patients affected by various forms of lymphoma, treated with the biological therapy known as the Di Bella Method (DBM). The 1, 3 and 5-year survival rates are reported, together with any signs of toxicity.

RESULTS: The DBM treatment achieved partial or complete objective responses in a shorter time and in greater percentages if administered as first-line therapy. The adjuvant treatment increased survival time and improved quality of life with respect to the data reported in the literature for the same types and stages of lymphoma.

CONCLUSION: Overall, the treatment was well tolerated, with minor and transient side effects. The patients were able to continue the treatment at home, carrying out their normal activities without problems....

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Clinical Trial 2012; 33(7): 722-726 PubMed PMID: 23391885 Citation  Keywords:  Abdomen:surgery, Adult, Analgesics, Opioid:administration & dosage, Biomarkers:blood, Drug Monitoring:methods, Elective Surgical Procedures, Female, Humans, Hysterectomy:methods, Infusions, Subcutaneous:methods, Middle Aged, Morphine:administration & dosa.   

OBJECTIVES: Systemic β-endorphin, an endogenous opioid and stress hormone, has been demonstrated to correlate with the postoperative pain intensity, however its putative role as a postoperative pain biomarker has not been cleared.

METHODS: Thirty patients scheduled for elective hysterectomy were included into the study. Postoperative pain was assessed by a numeric rating scale from 0 to 10. Plasma morphine concentrations were determined using high performance liquid chromatography with UV detection. Plasma β-endorphin concentrations were measured by a radioimmunoassay.

RESULTS: Administration of morphine in intravenous infusion turned out to be a markedly better method of morphine administration up to 4th hour postoperatively regarding both drug concentration and pain rating. A significant correlation between systemic β-endorphin concentration and pain rating at the 4th postoperative hour was found. No association between morphine and β-endorphin concentrations was detected.

CONCLUSION: Systemic β-endorphin is not an appropriate pain marker in postoperative gynaecologic patients....

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Journal Article 2012; 33(7): 697-702 PubMed PMID: 23391877 Citation  Keywords:  Adolescent, Adult, Chemoradiotherapy:adverse effects, Contraceptive Agents, Female:administration & dosage, Drug Combinations, Dydrogesterone:administration & dosage, Estradiol:administration & dosage, Estriol:administration & dosage, Female, Follicle Sti.   

OBJECTIVES: Premature ovarian failure (POF) is a consequence of gonadotoxic chemoradiotherapy given in antyneoplasia treatment. In young women it will correlate with menopausal symptoms which tend to appear due to depleted ovarian follicle reserve.

DESIGN: It was a case series study that included women 18-50 years old who were treated for malignancy with gonadotoxic chemioradiotherapy. We have measured blood hormonal levels of follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2) and progesterone within one month of various hormone replacement therapy (HRT).

RESULTS: We have observed different kind of hormonal reaction according to FSH, LH, estradiol and progesterone levels due to various hormonal replacement therapy. The administration of various HRT regimens presented with a decrease in the blood concentration of estradiol E2 and progesterone and a concomitant increase of FSH and LH. These findings demonstrate a shift to physiological ranges and a simultaneous improvement of symptoms associated with CI-POF.

CONCLUSIONS: The most appropriate therapy needs to be selected according to the patient's alleviation of symptoms and correction of blood hormone levels....

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Clinical Trial 2012; 33(7): 680-683 PubMed PMID: 23391874 Citation  Keywords:  Aged, Arginine Vasopressin:blood, Carbidopa:adverse effects, Catechols:adverse effects, Dopamine Agonists:administration & dosage, Dose-Response Relationship, Drug, Drug Combinations, Drug Therapy, Combination, Female, Humans, Inappropriate ADH Syndrome:c.   

OBJECTIVES: Several cases of syndrome of inappropriate antidiuresis induced by anti-Parkinson agents have been reported. Our previous study demonstrated that pergolide and pramipexole stimulated elevation of plasma arginine vasopressin (AVP) levels in some patients with Parkinson's disease (PD), but that levodopa/carbidopa (300/30 mg/day) did not affect plasma AVP levels in treatment-naïve PD patients. On the basis of the binding profile of ropinirole to monoamine receptors, we hypothesized that ropinirole does not stimulate AVP secretion. The aim of this study was to test this hypothesis.

METHODS: Inclusion criteria were patients with probable PD suffering from a wearing-off phenomenon and who had been treated using levodopa/carbidopa with or without entacapone, but not with other classes of anti-Parkinson agents. Patients were excluded if they had at least one condition that could be associated with high AVP levels. Ropinirole was initiated at 0.5 mg 3 times daily, and daily dosages were increased by 1.5 mg/day on a biweekly basis up to 6 mg/day. Plasma AVP levels were determined every two weeks. Effects of escalating ropinirole dosage on plasma AVP levels were evaluated using a one-way analysis of variance for repeated measures, an a priori Dunnett multiple comparison test, and a regression analysis.

RESULTS: Of 16 patients enrolled, 11 patients (four males and seven females) completed the study. There was no statistically significant dose-response relationship between the ropinirole dosage and plasma AVP levels.

CONCLUSION: A minimal therapeutic dosage of ropinirole did not affect plasma AVP levels in patients with PD taking levodopa....

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Clinical Trial 2012; 33(Suppl 2): 98-101 PubMed PMID: 23183519 Citation  Keywords:  Aged, Cardiovascular Diseases:drug therapy, Drug Therapy, Combination, Female, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors:administration & dosage, Male, Middle Aged, Muscle Weakness:chemically induced, Musculoskeletal Pain:chemically induced, .   

OBJECTIVES: Statins significantly reduce CV morbidity and mortality. Unfortunately, one of the side effects of statins is myopathy, for which statins cannot be administered in sufficient doses or administered at all. The aim of this study was to demonstrate the effect of coenzyme Q10 in patients with statin myopathy.

DESIGN/SETTING: Twenty eight patients aged 60.6±10.7 years were monitored (18 women and 10 men) and treated with different types and doses of statin. Muscle weakness and pain was monitored using a scale of one to ten, on which patients expressed the degree of their inconvenience. Examination of muscle problems was performed prior to administration of CQ10 and after 3 and 6 months of dosing. Statistical analysis was performed using Friedman test, Annova and Students t-test.

RESULTS: Pain decreased on average by 53.8% (p<0.0001), muscle weakness by 44.4% (p<0.0001). The CQ10 levels were increased by more than 194% (from 0,903 μg/ml to 2.66 μg/ml; p<0.0001).

CONCLUSION: After a six-month administration of coenzyme Q10, muscle pain and sensitivity statistically significantly decreased....

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Controlled Clinical Trial 2012; 33(Suppl 2): 87-92 PubMed PMID: 23183517 Citation  Keywords:  Adult, Aged, Atherosclerosis:drug therapy, Drug Therapy, Combination, Dyslipidemias:drug therapy, Fatty Acids, Omega-3:administration & dosage, Female, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors:administration & dosage, Hypertriglyceridemia:dr.   

BACKGROUND: Atherogenic dyslipidemia contributes substantially to the residual cardiovascular risk. The aim of this study was to examine the effects of therapeutic doses of n-3 polyunsaturated fatty acids on the three major lipid abnormalities of atherogenic dyslipidemia, i.e. hypertriacylglycerolemia, low HDL cholesterol, and increased levels of small dense LDL particles, as well as on some new risk factors.

MATERIALS AND METHODS: A total of 60 hypertriacylglycerolemic patients were included in the study. Group S consisted of 36 patients who were already treated with statins, Group N of 24 patients not yet treated. Each patient was examined after six weeks on placebo and six weeks of treatment with n-3 PUFA (eicosapentaenoic and docosahexaenoic acid ethyl esters, 3.0 g/d).

RESULTS: Treatment with n-3 PUFA caused a decrease in plasma triacylglycerols (28%, p<0.001), and VLDL (-27%, p<0.001), an increase in HDL-C (+4%, p<0.01), and a decrease in sdLDL cholesterol (-16%, p<0.05). These changes were accompanied by a decrease in microalbuminuria (-30%, p<0.05), as well as in several parameters of oxidative stress. Analysis of the fatty acids composition of plasma phospholipids showed a significant increase in all n-3 PUFAs examined, accompanied by a decrease in n-6 PUFAs, as well as in monounsaturated acids. No significant differences in the effects of n-3 PUFA were found between the Groups S and N.

CONCLUSION: Our results support the opinion that hypertriacylglycerolemic patients benefit from the treatment with n-3 PUFA which improves several important metabolic factors of cardiovascular risk....

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Journal Article 2012; 33(Suppl 2): 73-77 PubMed PMID: 23183514 Citation  Keywords:  Adult, Antigens, CD11a:metabolism, Antigens, CD14:metabolism, Antigens, CD18:metabolism, Cross-Over Studies, Diabetes Mellitus, Type 2:drug therapy, Dyslipidemias:drug therapy, Female, Fenofibrate:administration & dosage, Humans, Hypolipidemic Agents:admi.   

BACKGROUND: Mixed hyperlipidemia is often associated with type 2 diabetes mellitus and contributes to atherosclerosis progression in diabetes patients. Leukocyte activation plays an important role in atherogenesis. Both statins and fibrates are used in the treatment of mixed dyslipidemia, but their specific effect on leukocyte function remains to be elucidated. We have therefore compared the effect of simvastatin and fenofibrate on several leukocyte activation markers in diabetes patients.

METHODS: Twenty patients with type 2 diabetes and mixed hyperlipidemia were sequentially treated with simvastatin (20 mg/day) and fenofibrate (200 mg/day) in a randomized cross-over study (12 weeks each treatment). We measured adhesion molecules LFA-1, VLA-4 and CD18; in addition, lipopolysaccharide receptor CD14 on monocytes was analyzed as a marker of innate immunity. Leukocyte expression of these molecules was quantified using flow cytometry. Laboratory examinations were done at baseline and at the end of each treatment. Baseline values were compared to those of 29 healthy controls.

RESULTS: Expression of integrin CD18 (in all leukocyte populations), lipopolysaccharide receptor and VLA-4 (on lymphocytes only) was significantly higher in patients than in controls. Both treatments resulted in significant decrease in CD18 and CD14 expression; LFA-1 and VLA-4 were not influenced.

CONCLUSIONS: Both simvastatin and fenofibrate had similar favorable effect on leukocyte activation markers. This result supports the use of both statins and fibrates for the treatment of mixed hyperlipidemia in patients with type 2 diabetes mellitus....

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