Background. Vitiligo is a common skin disorder characterized by macular depigmentation of the skin. The etiopathogenesis of the disease is still unclear, but there is evidence that autoimmunity and endocrine disfunction may be involved. Objective. The aim of this study was to determine whether vitiligo is statistically associated with thyroid autoimmunity. Method. In a prospective case-control study, we compared the frequency of thyroid autoantibodies (thyroglobulin antibody, anti-Tg and thyroid peroxidase antibody, and anti-TPO) in 33 patients with vitiligo and in 33 healthy volunteers. Thyroid autoantibodies and thyroid hormones (thyroxine (T4), triiodothyronine (T3), and thyroid stimulating hormone (TSH) were measured in all subjects. Results. Thyroid functional abnormalities were found in 6 (18.18%) patients. Anti-Tg and anti-TPO were positive in 9 (27.27%) and 8 (24.24%) patients, respectively. In control group, only one subject (3.03%) had abnormalities in thyroid hormonal status, and two subjects had positive thyroid autoantibodies. Compared with the control group, the frequency of both anti-Tg and anti-TPO was significantly higher in those with vitiligo (P < .05). Conclusion. This study shows a significant association between vitiligo and thyroid autoimmunity, and that tests to detect thyroid autoantibodies are relevant in patients with vitiligo.

The aim of this trial was to examine the effects of antihypertensive fixed combination of lisinopril plus hydrochlorothiazide (Lopril H, Bosnalijek dd, Bosnia and Herzegovina) on regression of left ventricular hypertrophy in patients with essential arterial hypertension. We included 297 patients in our trial, aged 54.65+/-9.6 years, with treated or untreated hypertension and with high risk of cardiac events, in an opened trial of therapy based on lisinopril plus hydrochlorothiazide. Patients from five European countries were followed up for a period of 12 weeks. Duration of treatment was 12 weeks. We adjusted daily doses of lisinopril plus hydrochlorothiazide after every clinical examination and recorded adverse effects of drugs. In the beginning and after 12 weeks of treatment, 277 patients (93.2%) underwent 2-dimensional echocardiography and there were 186 patients evaluated for efficacy of treatment on left ventricular hypertrophy (LVH). We recorded a regression of index mass LVH (168.56 vs 161.51 g/m2, P<0.0001), and regression was something more in women vs men. We recorded average reduction of left ventricular mass index for patients with LVH (N=186) by 7.05 g/m2 (4.18%) in all patients, by 6.73 g/m2 (3.93%) in men and 7.27 g/m2 (4,37%) in women. The proportion of patients who attained a regression of left ventricular mass tended to be greater in men (54.55% vs 53.21%). This research has proved regression of LVH in more than 53% patients after using fixed combination of lisinopril plus hydrochlorothiazide.

Endogen phospholipids play a major role in determining the structure and nature of cell membranes. A deficiency of phospholipids in cellular membranes makes it almost impossible for the cell membrane to perform its function as a selective barrier between what passes in and out of the cell. Polyenylphosphatidylcholine chemical structure corresponds to that of endogen phospholipids, but it possesses functional superiority because of its content of unsaturated fatty acids. Polyenylphosphatidylcholine integrates in the cell membrane and organelle systems while becoming their constitutive elements. A healthy cell membrane leads to healthy cells and then healthy tissue and then to healthy organs or body systems and finally, healthy bodies and minds. For a long time, polyenylphosphatidylcholine in combination with vitamins has been used in the treatment of numerous health problems such as liver diseases, dyslipoproteinaemias and different intoxications with consequent liver failure. The main aim of toxicology studies is evaluation of the toxic potential and risks of human exposition to the substance. According to the Organization for Economic Cooperation and Development (OECD) acute oral toxicity refers to those adverse effects occurring following oral administration of a single dose of a substance or multiple doses given within 24 hours. LD50 (median lethal dose), oral, is a statistically derived single dose of a substance that can be expected to cause death in 50 per cent of animals when administered by the oral route. Our acute toxicity study was performed on albino Wistar rats. Animals were randomised in three experimental and one control group, each of 5 males and 5 females. Study was based on the administration of a single oral dose of the test substance (polyenylphosphatidylcholine) to each experimental animal. There were three dose-levels of the test substance: 300, 500 and 1000 mg/kg. Test substance administration day was the first day of the observation period that lasted 14 days. Control animals were given milk vehicle. At the end of the study, no statistically significant differences between experimental and control animals were observed concerning the recorded parameters: body weight, respiratory rate, tremor, faeces and phonation quality, indicating the absence of the test substance acute toxicity.

Body weight variations during toxicological testing can be one of the indicators of the test substance toxic effects. Data on food and water consumption are true indicators of the rate of growth of experimental animals (Stevens & Gallo, 1989). Daily recording of the food and water consumption was done during the acute toxicity testing of HEPALIP FORTE. The study was performed on Wistar rats. The active component of HEPALIP FORTE is EPL substance--essential phospholipids, a natural substance present in every living cell. Essential phospholipids in combination with vitamins have been used in the treatment of liver diseases, dyslipoproteinaemias and intoxications accompanied with liver failure. Statistical analysis of the body weight variations was performed separately, for males and females. The analysis failed to show any significant difference between the groups. There was a significant difference in water consumption between the male group 2M and female groups 3F and 2F in comparison with control groups. Statistical analysis of the variations of food consumption showed a significant difference in all male groups in comparison with control groups, and only in the 3F female group in comparison with a control group. Considering the absence of lethality and the lack of significant influence of the test substance on animal body weights, we concluded that the test substance was not acutely toxic in rats, if applied orally, in single doses of 300 mg/kg, 500 mg/kg and 1000 mg/kg. Significant differences found in food and water consumption suggest a need of their during the future chronic toxicity testing.

The main active component of preparation HEPALIP FORTE is EPL--essential phospholipids. Their chemical structure corresponds to that of endogen phospholipids, but they have functional superiority because of the content of unsaturated fatty acids. Essential phospholipids in combination with the vitamins have been used in the treatment of liver diseases, dyslipoproteinaemias and intoxications with consequent liver failure. Acute toxicity study on HEPALIP FORTE was performed on Wistar rats. The main aim of toxicology studies for the drug registration process is evaluation of the toxic potential and risks of human exposition to the substance (Gelbke et al., 1999). Acute toxicity is an orientation point of the test substance toxicity and represents a starting test for the toxicological evaluation. Study included one oral dose of the substance, applied with oesophageal intubations. There were three dose-levels: 300, 500 and 1000 mg/kg. No lethality was recorded and statistical analysis of body weight variations failed to show any significant difference between the groups. Reversible tremor was more frequently recorded in females and was not present in control animals. After the planed sacrifice, no changes related to the test substance were recorded. We noticed a statistically significant difference in the liver weights between males of 3M and 2M groups in comparison to the control. Similar (not significant) tendency was noticed in females. Significant differences in organ weights might be suggestive of a toxic effect that experimental animal managed to recover from in partial manner. The histopathological analysis detected no changes in the structure and morphology of liver parenchyma.