Early corticosteroid avoidance in kidney transplant recipients receiving ATG-F induction: 5-year actual results of a prospective and randomized study.

One hundred ninety-seven patients received anti-T-lymphocyte globulins Fresenius, mycophenolate mofetil and delayed cyclosporine, and were randomized to ≥6-month corticosteroids (+CS; n=99) or no CS (-CS; n=98). One- and five-year actual graft survival (censored for death) was 93.2% and 86.4% in the +CS group versus 94.9% and 89.8% in the -CS group (5-year follow-up, p=0.487). Freedom from clinical rejection was 86.9% and 81.8% versus 74.5% and 74.5% (p=0.144), respectively, at 1 and 5 years; 5-year freedom from biopsy-proven rejection was 88.9% versus 83.7% (p=0.227). More late first rejections occurred in the +CS group. Significantly lower 5-year graft survival in patients experiencing rejection was observed for +CS (55.6% vs. 92.0%; p=0.005) with 8/18 versus 2/25 graft losses. Renal function at 5 years was stable and comparable (median serum creatinine, 159 vs. 145 µmol/L; creatinine clearance, 53.5 vs. 56.6 mL/min). More +CS patients developed diabetes, dyslipidemia and malignancies. Rejections in -CS patients occurred early after transplantation and did not impair long-term renal function. In patients receiving CS, rejections occurred later and with a higher risk for subsequent graft failure. A similar and not inferior 5-year efficacy profile and a reduced morbidity were observed in CS-free patients compared to patients who received CS for at least 6 months.

Energy expenditure: components and evaluation methods.

INTRODUCTION: The determination of energy expenditure, considering the physical activity level and health status, is very important to adjust the individuals' nutritional supply. Energy expenditure can be determined by using indirect calorimetry, bioelectrical impedance, doubly labeled water, predictive equations, among others. All these methods have been used in clinical and research areas. However, considering the inconsistence in several research results, there is no consensus yet about the applicability of many of these methods. OBJECTIVES: The aim of this review is to describe the components of energy expenditure and the methods for its determination and estimation, summarizing their main advantages and limitations. RESULTS AND DISCUSSION: Indirect calorimetry and doubly labeled water are considered more accurate methods, but expensive. On the other hand, even though other methods present limitations, they are convenient and less expensive, and can be used with some caution.

Impact of different protein sources in the glycemic and insulinemic responses.

OBJECTIVE: The maintenance of normal blood glucose concentrations is a crucial factor to the achievement of a good health status throughout life. However, the occurrence of abnormalities in this parameter has become increasingly common, which can result in several non-transmissible diseases, such as type 2 diabetes and cardiovascular diseases. Therefore, the purpose of this study was to discuss the role of protein sources in the glycemic and insulinemic responses. METHODS: In this review paper, we critically analyzed recently published studies that discussed the role of different protein sources in the glycemic and insulinemic responses in healthy individuals and in those who have cardiovascular diseases or type 2 diabetes. RESULTS: The results of some of these studies suggest that the daily ingestion of at least one high protein meal containing low to moderate amounts of carbohydrate increases insulin secretion and glucose uptake, improving insulin sensitivity. Furthermore, the results indicate that these effects are particularly associated with the consumption of animal protein (p.e. hydrolyzed whey protein), which has a high content of branched-chain amino acids such as leucine, valine and others such as arginine, which leads to improvements in insulin secretion and uptake glucose, since it increases insulin sensitivity. However, there is still no consensus in the literature about the quantity and quality of protein capable of reducing or maintaining blood-glucose concentrations at the desirable range, without causing adverse effects. The difference in the results of the studies may be associated to methodological problems presented by these studies. CONCLUSIONS: Well designed studies should be conducted to identify the quantity and quality of protein that can lead to the improvement on blood glucose concentrations, without negative effects to health. These studies should also identify the mechanisms and the magnitude by which protein may affect glycemic response.

Glycemia and insulinemia evaluation after high-sucrose and high-fat diets in lean and overweight/obese women.

The study investigates the effect of weight-maintaining high-sucrose (HSD) and high-fat (HFD) diets on plasma glucose and insulin concentrations in lean and obese women, and verifies the correlation between insulin profile and body composition. Lean (G1 group, n=6, BMI= 21.4 (20.2-22.8) kg/m2) and overweight/obese (G2 group, n=6, BMI 28.6 (25.1-32.1) kg/m2) women participated in the study. HSD (59% total carbohydrate with 23% sucrose; 28% lipid) or HFD (42% total carbohydrate with 1.3% sucrose; 45% lipid) diets were consumed under free-living conditions for 14 days. Anthropometry and body composition were assessed before and after HSD and HFD diets following-up. Fasting and postprandial (at 30, 60, 180 and 240 min) glucose and insulin were determined. HOMA-IR and QUICK index were also calculated. Fasting and postprandial glucose and insulin concentration did not differ significantly between groups or diets. However, there was a positive and significant correlation between plasma fasting and postprandial insulin concentrations and BMI, percentage of total body fat (% TBF) and HOMA-IR index. In addition, carbohydrate and sucrose intake presented a positive and significant correlation with insulin concentration and HOMA-IR at 180 min postprandial, after adjusting for energy intake and % TBF (p<0.05). These results suggest that altering the profile of the macronutrients in the diet can modify glycemia and insulinemia homeostasis, regardless of energy intake and adiposity. On the other hand, the overweight/obese women can maintain a stable metabolic profile with the habitual diet.

O perfil de macronutrientes influencia a termogênese induzida pela dieta e a ingestão calórica / Macronutrient profile affects diet-induced thermogenesis and energy intake

The diet composition can interfere directly in the energy homeostase. In the energy metabolism, the oxidation pathway and diet-induced thermogenesis are differentiated by diet macronutrients proportion. In this respect, the high-proteindiet is the most thermogenic, compared to high-carbohydrate and high-lipid diets, while high-carbohydrate diet appears to increase the thermogenic effect more than high-lipid diet, but the studies arecontroversies. Towards energy intake, it can stimulate or inhibit the energy intake, according to the foods palatability, satiation and satiety degree, related to diet carbohydrate, protein and lipid content. A hierarchy has been observed for the satiating efficacies of the macronutrients protein, carbohydrate and fat, with protein as most satiating and fat as least satiating. In general, there are discrepancies between studies about the regulatory role of macronutrients in the components of energy expenditure and intake, due the methodological differences in the subjects, exposition time for diet, energy density, and total energy content. The present work seeks to analyze the more consistent scientific evidences toward the modulator role of diet composition on the diet induced thermogenesis and energy intake, for better understanding of obesity prevention and control by dietetic intervention.

A composição da dieta pode interferir diretamente na homeostase energética. No metabolismo energético, a via de oxidação e a termogênese induzida pela dieta são diferenciadas pela proporção de macronutrientes da dieta. Neste sentido, a dieta hiperprotéica émais termogênica que as dietas hiperglicídicas e hiperlipídicas, enquanto que as dietas ricas em carboidrato parecem ser mais termogênicas que as ricas em lipídio, mas os resultados ainda são controversos. Em relação à ingestão calórica, a composição da dieta pode estimular ou inibir a mesma, de acordo com a palatabilidade dos alimentos e o grau de saciação e saciedade, relacionadas às quantidades de carboidrato, proteína e lipídio da mesma. Uma hierarquia tem sido relatada para a capacidade dos macronutrientes em induzir saciedade em que a proteína é o mais sacietógeno ao contrário dos lipidios, que são os menos sacietógenos. De modo geral, ainda há discrepâncias entre os estudos, em relação ao papel regulador dos macronutrientes em componentes do gasto energético e na ingestão calórica, devido às diferenças metodológicas como amostra, tempo de exposição à dieta, densidade calórica e conteúdo calórico total da mesma. Desta forma, o presente trabalho tem como objetivo analisar as evidências científicas mais consistentes a respeito do papel modulador da composição da dieta na termogênese induzida pela dieta e na ingestão calórica, para melhor entendimento da prevenção e controle da obesidade pela intervenção dietética.

[Effect of high sucrose- and high-fat diets ingested under free-living conditions in insulin resistance in normal weight and overweight women]. / Efecto de dietas ricas en sacarosa y en lípidos ingeridas en condiciones de vida libre sobre la resistencia insulínica en mujeres con peso normal y exceso de peso.

OBJECTIVE: The purpose of this study was to investigate the effect of high sucrose diet (HD) and high fat diet (RFD) ingested under free-living conditions, on insulin homeostasis, verifies the association between insulin resistance and body composition as well. RESEARCH METHODS AND PROCEDURES: 20 healthy women, 13 normal-weight (22.5 +/- 2.1 years of age; BMI 22.2 +/- 1.9 kg/m2) and 7 over-weight (21.8 +/- 2.8 years of age; BMI 28.4 +/- 3.2 kg/m2), included in 2 groups G1 and G2 respectively, they were randomized to intake HD diets (59% carbohydrate including 23.0% of sucrose; 28.0% lipid; 13.0% protein; 20.2 g fiber) or HDF (42.0% carbohydrates including 1.3% of sucrose; 45.0% lipid; 13.0% protein; 22.2 g fiber) after initial assessment (BD). It was taken anthropometric measures, body composition and blood samples were obtained for fasting and post-prandial glucose and insulin determinations. RESULTS: Glycemia, insulinemia and HOMA-IR did not differ between groups (p > 0.05). Although on BD, HOMA-IR correlates positively with weight (r = 0.750), BMI (r = 0.929), waist circumference (WC) (r = 0.750) and percentage body fat (r = 0.857) for G2 group. The values of fasting HOMA-IR on BD were significantly greater than HFD for G1 group (p < 0.05). On HD the total carbohydrates amount and sucrose are greater than BD and HFD. CONCLUSION: The results confirm direct correlation between HOMA-IR, abdominal obesity and body fat. Therefore diet can modulate the insulinemic action.

[Tyrothricin powder in the treatment of cutaneous lesions]. / Tyrothricin-Puder bei Hautverletzungen. Reduktion des Wundradius bei infizierten und infektionsgefährdeten Wunden--Eine randomisierte, placebokontrollierte Doppelblind-Studie.

BACKGROUND AND OBJECTIVES: The efficacy and tolerance of an antiseptic wound powder based on the antibiotic tyrothricin was investigated in a prospective, randomized multicenter trial in patients with posttraumatic and surgical cutaneous lesions. PATIENTS AND METHODS: In 5 centers, 131 male and female patients from 18-85 years were included with posttraumatic or surgical cutaneous lesions with infection or in danger of infection (area > or = 200 mm2). In a double-blind study, tyrothricin (n = 62; 0.1 g tyrothricin per 100 g of vehicle) or placebo powder (n = 69) was applied to the wound twice daily for 9 days. The primary aim was to evaluate the average daily reduction of the radius from the lesion area between the start and end of the randomized treatment (alpha = 0.025; one-sided). Secondly, a wound index (range 0-15) was calculated from the assessments of rubor, crusting, exudation, pain and functional impairment. RESULTS: The treatment groups were comparable at baseline. During randomized treatment, the radius of the lesions was reduced at an average of 0.55 +/- 0.31 mm/day (mean +/- SD) for tyrothricin and 0.47 +/- 0.30 mm/day for placebo (p = 0.016; one-sided; intention-to-treat data set). The wound index decreased at an average of 4.2 +/- 1.7 and 3.3 +/- 1.9 points for tyrothricin and placebo, respectively (p = 0.0048; one-sided). 4 adverse events occurred in each group. A causal relationship with the investigational drug could not be excluded in 3 of the placebo group. CONCLUSION: The results confirm the tendency to an acceleration of wound healing by tyrothricin powder (Tyrosur Powder) in case of infection or danger of infection. A superior efficacy compared to placebo was demonstrated. Due to its good tolerability and the absence of a systemic effects tyrothricin powder is appropriate for the treatment of superficial skin lesions.

[Tolerability of Icelandic moss lozenges in upper respiratory tract diseases - multicentric drug monitoring study with 3,143 children]. / Verträglichkeit von Isländisch-Moos-Pastillen bei Erkrankungen der oberen Atemwege - multizentrische Anwendungsbeobachtung mit 3143 Kindern.

BACKGROUND AND OBJECTIVE: Icelandic moss is a medical herb with therapeutic efficacy in inflammatory airway diseases. Although preparations based on the extract of this lichen have been marketed since the 19th century, their tolerability has not yet been investigated systematically. PATIENTS AND METHODS: The tolerability of Isla-Moos and Isla-Mint lozenges and the changes of clinical symptoms during treatment were investigated in a post-marketing surveillance study performed in 300 predominantly pediatric practices in Germany. The preparations contained 80 and 100 mg, respectively, of an aqueous Icelandic moss extract. 3,143 children between 4 and 12 years of age who suffered from upper respiratory tract diseases received Isla-Moos (n = 1,848) or Isla-Mint (n = 1,295) over a period of 1-2 weeks; 61% of the children received 4-6 lozenges per day. Tolerability was evaluated by assessing adverse drug reactions (ADRs). Treatment success was assessed globally by the investigators and the patients' parents. The parents were also asked to rate their children's symptoms before and after treatment. RESULTS: During the period of observation, 73 adverse events, most of which were related to the basic disease, were reported in 57 children (1.8%). In 6 children (0.2%) and 7 events (2x itching, 2x nausea, 1x abdominal pain, 1x heartburn, 1x burning in the mouth) a causal relationship with Icelandic moss extract could not be excluded, so that they were evaluated as ADRs. All ADRs subsided spontaneously during the period of observation. The incidence of ADRs was 1 event in 3,008 (95% confidence interval: 1,504-7,019) treatment days. As regards clinical symptoms, 39% of the children were fully recovered and another 55% were improved by the end of the period of observation. CONCLUSIONS: During treatment of 4- to 12-year-old children with Isla-Moos and Isla-Mint lozenges only isolated, trivial, and transient adverse drug reactions were observed. The results thus confirm the good tolerability of both drugs and support a favorable risk-benefit assessment.

Efficacy of dry extract of ivy leaves in children with bronchial asthma--a review of randomized controlled trials.

OBJECTIVES: To investigate if extracts from dried ivy leaves (Hedera helix L.) are effective in the treatment of chronic airway obstruction in children suffering from bronchial asthma. DESIGN: Systematic review of trials documented in the literature with re-analysis of original data. TRIALS: 5 randomized controlled trials investigating the efficacy of ivy leaf extract preparations in chronic bronchitis, 3 of which were conducted in children and met our selection criteria. One compared ivy leaf extract cough drops to placebo, one compared suppositories to drops and one tested syrup against drops. MAIN OUTCOME MEASURES: Body-plethysmographic and spirometric measures. RESULTS: Drops were significantly superior to placebo in reducing airway resistance (primary outcome measure; p = 0.04 two-sided) and descriptively superior in all other 'objective' measures. For syrup and suppositories, at least 54%, resp. 35% of the effect against placebo were preserved. CONCLUSIONS: The trials included in this review indicate that ivy leaf extract preparations have effects with respect to an improvement of respiratory functions of children with chronic bronchial asthma, but more far-reaching conclusions can hardly be drawn because of a meagre database, including the fact that only one primary trial included a placebo control. Further research, particularly into the long-term efficacy of the herbal extract, is needed.

[Benign prostatic hyperplasia--treatment with sabal fruit extract. A treatment study of 1,334 patients]. / Benigne Prostatahyperplasie--Behandlung mit Sabalfrucht-Extrakt. Eine Anwendungsbeobachtung an 1,334 Patienten.

METHOD: In a drug monitoring study, 1,334 outpatients with benign prostatic hyperplasia (BPH) were treated for 12 weeks with an extract from the fruits of Sabal serrulata. RESULTS: Under this treatment, the volume of residual urine decreased by 50%, pollakisuria decreased on average by 37%, and nocturia by 54%. The percentage of patients with dysuric pain decreased from 75% to 37%. The efficacy of the drug was rated good to excellent in more than 80% of the cases, and good to excellent tolerability was reported by more than 95% of the patients. CONCLUSION: The improvement in the irritative symptoms may be considered relevant in terms of improvement in the quality of the life of the patients, and justifies this form of treatment.

[Analysis of antibodies against human immunodeficiency virus on a voluntary basis in healthy persons in Amsterdam 1988 and 1989]. / Onderzoek op antistoffen tegen humaan immunodeficiëntievirus op vrijwillige basis bij gezonde personen te Amsterdam in 1988 en 1989.

At the Municipal Health Service of Amsterdam it is possible to be tested for HIV antibodies after signing an informed consent. In 1988, 1247 persons were tested (797 men, 450 women) and in 1989, 1400 persons (869 men, 531 women). Fifty-eight persons were identified as HIV-seropositive for the first time (1988: 24 men, 3 women; 1989: 28 men, 3 women). All but one woman belonged to a risk group or had had sexual contact with a person from a known risk group. In 1989 no increase in the percentage of HIV-seropositive persons was seen. In our (selected) group of persons in 1988 and 1989 we saw no transmission of HIV outside the known risk groups.