Tacrolimus interaction with oral oestrogen in kidney transplant recipients: A case-control study.

WHAT IS KNOWN AND OBJECTIVE: Oestrogens could inhibit the metabolism of drugs, such as calcineurin inhibitors, that are substrates for cytochrome P-450 microsomal enzymes. This study assessed the potential tacrolimus interaction with oral conjugated oestrogen in kidney transplant recipients who received conjugated oestrogen as prophylaxis against bleeding, before kidney biopsy. METHODS: In this case-control study, 13 kidney transplant recipients who received oral conjugated oestrogen as prophylaxis against uraemic bleeding before allograft biopsy were considered as cases. Thirteen matched kidney transplant recipients with similar immunosuppressive regimen served as controls. In this study, comparisons were made between the groups regarding daily dose, blood trough concentrations and calculated concentration corrected for dose of tacrolimus at three time points of the study. RESULTS AND DISCUSSION: All patients in the case group received conjugated oestrogen at a dose of 3.75 mg/day for 4.78 ± 0.83 days. Without any change in tacrolimus dose, the blood concentration of tacrolimus increased during concomitant administration of conjugated oestrogen (from 8.10 ± 2.85 to 12.35 ± 4.62 ng/mL; P = .11) and decreased after cessation of conjugated oestrogen (6.07 ± 2.18 ng/mL; P = .015). The calculated concentration corrected for dose of tacrolimus increased from 127.04 ± 79.23 to 211.40 ± 146.38 ngmLmgkg/d after conjugated oestrogen administration (P = .036). Thereafter, it decreased to 108.55 ± 78.61 ngmLmgkg/d after cessation of oestrogen (P = .003). Only one patient experienced nausea while taking oestrogen without any change in her liver enzymes. WHAT IS NEW AND CONCLUSION: Concomitant administration of oral oestrogen increased tacrolimus blood concentration. Hence, it is necessary to monitor tacrolimus blood levels during concomitant oestrogen therapy and for several days after oestrogen withdrawal.

The effect of alpha-lipoic acid (ALA) supplementation on cardiovascular risk factors in men with chronic spinal cord injury: a clinical trial.

STUDY DESIGN: A randomized, double-blind, placebo-controlled clinical trial. OBJECTIVE: To assess the effect of alpha-lipoic acid (ALA) supplementation on IL-6, hs-CRP, FBS, anthropometric indices, food intake and blood pressure in male patients with chronic spinal cord injury (SCI). SETTING: Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran. METHODS: Fifty-eight men with chronic SCI participated in the study. Participants were divided in two groups: one group received 600 mg of supplemental ALA (n=28) and the other group received placebo (n=30) for 12 weeks. At the beginning and end of the study, biochemical parameters, anthropometric indices, blood pressure and dietary intakes were measured. Dietary intake was measured using N4 software, and statistical analyses were carried out using SPSS16. RESULTS: No significant reduction was found in IL-6 (P=0.97) and hs-CRP levels (P=0.23). There was significant reduction in fasting blood sugar (P=0.001), body weight (P=0.001), BMI (P=0.001), waist circumference (P=0.001) and blood pressure (P=0.001). Dietary intake was significantly reduced, including fat (P=0.001), carbohydrate (P=0.001), protein (P=0.002) and energy intakes (P=0.001). CONCLUSION: Lipoic acid supplementation had no significant effect on the measured inflammatory markers but it reduces fasting blood sugar, anthropometric parameters, food intake and blood pressure in men with chronic SCI.

Effect of Coenzyme Q10 supplementation on antioxidant enzymes activity and oxidative stress of seminal plasma: a double-blind randomised clinical trial.

Low seminal plasma concentrations of coenzyme Q10 (CoQ10) have been correlated with impaired sperm parameters, but the exact mechanism remains of dominating interest. This randomised, placebo-controlled study examined the effect of CoQ10 on catalase, superoxide dismutase (SOD) and F2 -isoprostanes in seminal plasma in infertile men and their relation with CoQ10 concentration. Sixty infertile men with idiopathic oligoasthenoteratozoospermia (OAT) were randomised to receive 200 mg d(-1) of CoQ10 or placebo for 3 months. 47 persons of them completed the study. Semen analysis, anthropometric measurements, diet and physical activity assessment were performed for subjects before and after treatment. Independent and paired t-test, chi-square test and ancova were compared outcomes of supplementation between two groups. CoQ10 levels increased from 44.74 ± 36.47 to 68.17 ± 42.41 ng ml(-1) following supplementation in CoQ10 (P < 0.001). CoQ10 group had higher catalase and SOD activity than the placebo group. There was a significant positive correlation between CoQ10 concentration and normal sperm morphology (P = 0.037), catalase (P = 0.041) and SOD (P < 0.001). Significant difference was shown between the mean of changes in seminal plasma 8-isoprostane in two groups (P = 0.003) after supplementation. Three-month supplementation with CoQ10 in OAT infertile men can attenuate oxidative stress in seminal plasma and improve semen parameters and antioxidant enzymes activity.

Coenzyme Q10 improves seminal oxidative defense but does not affect on semen parameters in idiopathic oligoasthenoteratozoospermia: a randomized double-blind, placebo controlled trial.

BACKGROUND: Several lines of evidence show the implication of oxidative stress in the etiology of male infertility. Recently, the role of coenzyme Q10 (CoQ10) in the prevention and treatment of disease has been intensively probed. However, definitive efficacy studies in oligoasthenoteratozoospermia (OAT) have not been completed yet. AIM: To evaluate the effect of CoQ10 supplementation on semen parameters in idiopathic OAT (iOAT). MATERIAL/SUBJECTS AND METHODS: A double-blind placebo controlled clinical trial was carried out. A total of 47 infertile men with iOAT were randomly assigned to receive 200 mg CoQ10 daily or placebo during a 12- week period. Semen parameters were determined using microscopic evaluation according to World Health Organization guidelines. Lipid peroxidation was assessed by measuring the concentration of plasma malondialdehyde. We evaluated the total antioxidant capacity of seminal plasma. To compare variables between and within the 2 groups we used independent t-test and Paired t-test. RESULTS: The trial showed non-significant changes in semen parameters of CoQ10 group. However, concentrations of thiobarbituric acid-reactive substances were significantly (p<0.05) reduced in serum of treated groups compared with the control. Furthermore, total antioxidant capacity of seminal plasma significantly increased in the CoQ10 group (p<0.05). CONCLUSION: Our results provide further evidence suggesting that CoQ10 supplementation is associated with alleviating oxidative stress, although it does not show any significant effects on sperm concentration, motility and morphology. It may be suggested that CoQ10 could be taken as an adjunct therapy in cases of OAT. Further studies are needed to draw a final conclusion.

Tacrolimus Dose Requirement in Iranian Kidney Transplant Recipients within the First Three Weeks after Transplantation.

BACKGROUND: Tacrolimus is the main immunosuppressive agent in many kidney transplant protocols with an initial recommended daily dose of 0.2 mg/kg of ideal body weight (IBW). However, due to the high inter- and intra-patient variability in its pharmacokinetics, the required tacrolimus doses may differ markedly from patient to patient. OBJECTIVE: To assess the required tacrolimus dose to achieve the desired whole blood concentration within the first three weeks after kidney transplantation among Iranian patients. METHODS: This cross-sectional study was performed at kidney transplantation ward of Imam Khomeini Hospital Complex where almost all patients receive thymoglobulin induction therapy and a calcineurin inhibitor, mainly tacrolimus, plus mycophenolate, and prednisolone as maintenance immnosuppressive drugs with the target tacrolimus whole blood concentration of 8-12 ng/mL for the first month after transplantation. RESULTS: The mean±SD administered daily dose of tacrolimus during the first three weeks after transplantation was 0.085±0.024 mg/kg of IBW that resulted in a mean±SD whole blood concentration of 10.34±5.44 ng/mL. The required mean±SD dose of the drug to achieve the desired whole blood level of 8-10 ng/mL was 0.08±0.02 mg/kg. Only 27.4% of the assessed tacrolimus blood levels were within the desired range. Compared with males, females needed 19% more daily dose of tacrolimus to reach similar whole blood levels. Tacrolimus blood levels were significantly correlated with daily tacrolimus doses (r=0.307, p=0.001) and patients' age (r=0.283, p=0.003). CONCLUSION: It seems that Iranian kidney transplant recipients need lower daily doses of tacrolimus to achieve the desired whole blood levels; compared with males, females need a higher dose.

Effect of lullaby and classical music on physiologic stability of hospitalized preterm infants: a randomized trial.

BACKGROUND: Music is considered a subset of developmental supportive care. It may act as a suitable auditory stimulant in preterm infants. Also, it may reduce stress responses in autonomic, motor and state systems. OBJECTIVE: To assess and compare the influence of lullaby and classical music on physiologic parameters. METHOD: This is a randomized clinical trial with cross-over design. A total of 25 stable preterm infants with birth weight of 1000-2500 grams were studied for six consecutive days. Each infant was exposed to three phases: lullaby music, classical music, and no music (control) for two days each. The sequence of these phases was assigned randomly to each subject. Babies were continuously monitored for heart rate, respiratory rate, and oxygen saturation and changes between phases were analyzed. RESULT: Lullaby reduced heart rate (p < 0.001) and respiratory rate (p = 0.004). These effects extended in the period after the exposure (p < .001 and p = 0.001, respectively). Classical music reduced heart rate (p = 0.018). The effects of classical music disappeared once the music stopped. Oxygen saturation did not change during intervention. CONCLUSION: Music can affect vital signs of preterm infants; this effect can possibly be related to the reduction of stress during hospitalization. The implications of these findings on clinical and developmental outcomes need further study.

Trace enrichment and determination of silver by immobilized DDTC microcolumn and flow injection atomic absorption spectrometry.

Flow injection (FI) system incorporating a microcolumn of immobilized diethyldithiocarbamate (DDTC) on surfactant-coated alumina was combined with atomic absorption spectrometry for on-line trace enrichment and determination of silver in different matrices. Silver was deposited on the microcolumn by processing a standard or solution of analyte at pH 3-4 on the column. Injection of 250mul of ethanol then served to elute the retained species to atomic absorption spectrometry (AAS). A sample volume of 20ml resulted in a pre-concentration factor of 125, and precision at the 20mugl(-1) was 4% (R.S.D.). The procedure was applied to tap water, well water, rain water, sea water, radiology film, and lead concentrate samples. The accuracy was assessed through recovery experiments, independent analysis by furnace-AAS, and analysis of certified reference material.

Intestinal malrotation beyond the neonatal period.

Of 162 children with intestinal malrotation treated during a 13-year period, only 20 were first seen and treated outside the neonatal period. These presented with symptoms that were largely non-specific and there was a delay between the initial consultation and the making of the correct diagnosis of up to 5-years. The clinical features, radiologic findings and management are discussed, the importance of the history and radiographic findings stressed.

Coronary heart disease and urinary albumin excretion rate in type 2 (non-insulin-dependent) diabetic patients.

Associations between overnight urinary albumin excretion rate and prevalent coronary heart disease and its major risk factors were examined in a cross-sectional study of 141 Type 2 (non-insulin-dependent) diabetic patients. Mean albumin excretion rate was higher in men (geometric mean 13.5 micrograms/min; 95% confidence interval 10.3-17.6) than women (7.5 micrograms/min; 5.7-9.8, p less than 0.01). In diabetic men and women mean albumin excretion rate was higher in those with electrocardiographic and/or symptomatic evidence of coronary heart disease than in those without (men, 23.1 micrograms/min; 95% confidence interval 13.7-39.0 versus 10.6 micrograms/min; 7.9-14.2, p less than 0.01, women, 13.7 micrograms/min; 8.0-23.5 versus 5.4 micrograms/min; 4.2-6.8, p less than 0.01). Multiple logistic regression analysis was used to allow for confounding between variables. In the diabetic group as a whole, raised albumin excretion rate (p less than 0.001), gender (p less than 0.05) and systolic blood pressure (p = 0.06) entered the "best" model for coronary heart disease prediction. In women, albumin excretion rate alone (p less than 0.01) and in men albumin excretion rate (p less than 0.01) and age (p = 0.05) entered the "best" models. We conclude that albumin excretion rate is significantly associated with coronary heart disease morbidity after taking into account the confounding effects of raised blood pressure and other cardiovascular risk factors.