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Objective: The 13 C-urea breath test (UBT) is the most widely used non-invasive diagnostic test for Helicobacter pylori. Debate continues to surround the possible interference of antacid intake on its result. This study aims to confirm the non-interference of almagate in the determination of H. pylori by UBT., Patients and Methods: Observational, multicentre study in adult patients treated with almagate in whom a UBT (TAUKIT®) was indicated. When the UBT result was negative, use of almagate was stopped for 30 days and the UBT was repeated. When the result was positive, no further determinations were made. The primary endpoint was the percentage of patients who, having had a negative result in the first breath test, were positive in the second after having stopped taking almagate (UBT false negatives, possibly attributable to almagate)., Results: Of the 167 evaluable patients, 59% were female, average age was 49 and 97% had gastrointestinal symptoms. The result of the first UBT was negative in 71% of cases. Of these, in the second UBT test after stopping the almagate, the negative result was confirmed in 97.5%. Out of the total number of cases evaluated, the rate of false negatives was 1.8%., Conclusions: Taking almagate has minimal or no interference in the result of UBT for the diagnosis of H. pylori infection. It can therefore be used in the weeks prior to a UBT., (Copyright © 2021 The Authors. Publicado por Elsevier España, S.L.U. All rights reserved.)

The widespread use of engineered nanomaterials (ENMs) in consumer products and the overwhelming uncertainties in their ecological and human health risks have raised concerns regarding their safety among industries and regulators. There has been an ongoing debate over the past few decades on ways to overcome the challenges in assessing and mitigating nano-related risks, which has reached a phase of general consensus that nanotechnology innovation should be accompanied by the application of the precautionary principle and best practice risk management, even if the risk assessment uncertainties are large. We propose a quantitative methodology for selecting the optimal risk control strategy based on information about human health and ecological risks, efficacy of risk mitigation measures, cost and other contextual factors. The risk control (RC) methodology was developed in the European FP7 research project SUN and successfully demonstrated in two case studies involving real industrial nano-enabled products (NEPs): nano-scale copper oxide (CuO) and basic copper carbonate (Cu 2 (OH) 2 CO 3 ) used as antimicrobial and antifungal coatings and impregnations for the preservation of treated wood, and two nanoscale pigments used for colouring plastic automotive parts (i.e. red organic pigment and carbon black). The application of RC for human health risks showed that although nano-related risks could easily be controlled in automotive plastics case study with modifications in production technology or specific type of engineering controls, nano-related risks due to sanding and sawing copper oxide painted wood were non-acceptable in the use lifecycle stage and would need the identification of a more effective risk control strategy., (Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.)

In this work, we evaluate the tissue response and tolerance to a designed 3D porous scaffold composed of nanocrystalline carbonate-hydroxyapatite and agarose as a preliminary step in bone repair and regeneration. These scaffolds were subcutaneously implanted into rats, which were sacrificed at different times. CD4+, CD8+ and ED1+ cells were evaluated as measurements of inflammatory reaction and tolerance. We observed some inflammatory response early after subcutaneous implantation. The 3D interconnected porosity increased scaffold integration via the formation of granulation tissue and the generation of a fibrous capsule around the scaffold. The capsule is initially formed by collagen which progressively invades the scaffold, creating a network that supports the settlement of connective tissue and generating a compact structure. The timing of the appearance of CD4+ and CD8+ cell populations is in agreement with the resolved inflammatory response. The appearance of macrophage activity evidences a slow and gradual degradation activity. Degradation started with the agarose component of the scaffold, but the nano-apatite was kept intact for up to 30 days. Therefore, this apatite/agarose scaffold showed a high capacity for integration by a connective network that stabilizes the scaffold and results in slow nano-apatite degradation. The fundamental properties of the scaffold would provide mechanical support and facilitate bone mobilization, which is of great importance in the masticatory system or large bones.

Environmental pollution by alkaline salts, such as Na 2 CO 3 , is a permanent problem in agriculture. Here, we examined the putative role of jasmonic acid (JA) in improving Na 2 CO 3 -stress tolerance in maize seedlings. Pretreatment of maize seedlings with JA was found to significantly mitigate the toxic effects of excessive Na 2 CO 3 on photosynthesis- and plant growth-related parameters. The JA-induced improved tolerance could be attributed to decreased Na uptake and Na 2 CO 3 -induced oxidative damage by lowering the accumulation of reactive oxygen species and malondialdehyde. JA counteracted the salt-induced increase in proline and glutathione content, and significantly improved ascorbic acid content and redox status. The major antioxidant enzyme activities were largely stimulated by JA pretreatment in maize plants exposed to excessive alkaline salts. Additionally, increased activities of glyoxalases I and II were correlated with reduced levels of methylglyoxal in JA-pretreated alkaline-stressed maize plants. These results indicated that modifying the endogenous Na + and K + contents by JA pretreatment improved alkaline tolerance in maize plants by inhibiting Na uptake and regulating the antioxidant and glyoxalase systems, thereby demonstrating the important role of JA in mitigating heavy metal toxicity. Our findings may be useful in the development of alkali stress tolerant crops by genetic engineering of JA biosynthesis.

Phenotypic plasticity has the potential to allow organisms to respond rapidly to global environmental change, but the range and effectiveness of these responses are poorly understood across taxa and growth strategies. Colonial organisms might be particularly resilient to environmental stressors, as organizational modularity and successive asexual generations can allow for distinctively flexible responses in the aggregate form. We performed laboratory experiments to examine the effects of increasing dissolved carbon dioxide (CO 2 ) (i.e. ocean acidification) on the colonial bryozoan Celleporella cornuta sampled from two source populations within a coastal upwelling region of the northern California coast. Bryozoan colonies were remarkably plastic under these CO 2 treatments. Colonies raised under high CO 2 grew more quickly, investing less in reproduction and producing lighter skeletons when compared with genetically identical clones raised under current surface atmosphere CO 2 values. Bryozoans held under high CO 2 conditions also changed the Mg/Ca ratio of skeletal calcite and increased the expression of organic coverings in new growth, which may serve as protection against acidified water. We also observed strong differences between source populations in reproductive investment and organic covering reaction norms, consistent with adaptive responses to persistent spatial variation in local oceanographic conditions. Our results demonstrate that phenotypic plasticity and energetic trade-offs can mediate biological responses to global environmental change, and highlight the broad range of strategies available to colonial organisms., Competing Interests: Competing interestsThe authors declare no competing or financial interests., (© 2017. Published by The Company of Biologists Ltd.)

Background: The present study tested whether replacement of the leavening agent ammonium carbonate by sodium hydrogen carbonate in combination with calcium cation and acidifying agent will synergically decrease acrylamide (AA) content in gingerbread., Results: The type of leavening agent and the presence of Ca 2+ and citric acid accounted for 33.6%, 13.2% and 53.2% of the explained variability of the AA content, respectively (P < 0.01). The AA content in gingerbread produced with (NH 4 ) 2 CO 3 alone was 186.5 µg kg -1 . Irrespective of other tested additives, NaHCO 3 decreased (P < 0.05) AA content to 42% compared to (NH 4 ) 2 CO 3 . Combination of NaHCO 3 + CaCl 2 + citric acid in dough reduced (P < 0.05) AA content below the limit of detection (25 µg kg -1 ). The AA content in gingerbread (y; µg kg -1 ) decreased with an increasing number of additives used (x) according to the equation y = 158.8 - 47.94x (r 2 = 0.42; P < 0.0001). A comprehensive sensory analysis did not indicate any significant deterioration (P > 0.05) in the organoleptic quality of gingerbread produced using calcium cation and citric acid., Conclusion: The present study demonstrates that the combination of additives NaHCO 3 /Ca 2+ /citric acid synergically decreases AA content in gingerbread without compromising the sensory quality. © 2016 Society of Chemical Industry., (© 2016 Society of Chemical Industry.)

Objective: To describe the use of sodium carbonate and apomorphine in a historical cohort of dogs, compare the occurrence of emesis and report any adverse effects recorded., Methods: This historical, observational study included information from medical records of dogs that received an emetic agent. The occurrence of emesis with apomorphine or sodium carbonate was calculated and the association between emesis and agent was explored, with the odds ratio and 95% confidence interval (CI) reported. A non-inferiority analysis of the occurrence of emesis for sodium carbonate was performed against an equivalence range of ±7% of the estimated occurrence of emesis with apomorphine. Owners were emailed a short survey about their dog's health after their visit to the hospital for induced emesis., Results: Records for 787 dogs seen from January 2007 to December 2013 were included. For apomorphine, 382/392 dogs showed emesis (97%, 95% CI 95-100%). For sodium carbonate, 320/395 dogs showed emesis (81%, 95% CI 77-85%), which fell below the equivalence range for apomorphine (97 ± 7%, 90-100%) and was considered inferior. The odds ratio of emesis with apomorphine to sodium carbonate was 9.0 (95% CI 4.6-17.6). Of 18 responses to the survey, 5 reported abnormalities after emesis (3 with sodium carbonate, 2 with apomorphine)., Conclusion: The occurrence of emesis with sodium carbonate was high but inferior to apomorphine. However, the advantages of sodium carbonate, including less expense and ease of accession compared with apomorphine, make it a viable choice in emergency medicine., (© 2016 Australian Veterinary Association.)

The extrinsic sources for erosion-causing acids are primarily acidic beverages and foodstuffs. Effervescent tablets also contain organic acids (e.g. citric, tartaric, malic) in order to form carbon dioxide by contact with water – with the help of the carbonate salts of the tablets. To adequately inform patients about the possible erosive potential of effervescent tablets, this study was undertaken in order to investigate the erosive potential of effervescent tablets (ET), containing either a combination of vitamins and minerals or vitamins only, commercially available in Switzerland. One hundred and ninety-two bovine enamel samples were prepared and allocated to 16 groups (A–H and 1–8; n = 12/group). Samples were eroded (120 s/erosive cycle) in freshly prepared solutions (200 ml/12 samples) comprised of tap water and a supplement as follows: none (control groups, A and 1); vitamin+mineral ET: Qualite and Prix (B), Optisana (C), Well and Active (D), Actilife All in One (E), Berocca (F), Isostar (G) and Qualite and Prix Mg + Vit C (H); vitamin ET: Actilife-Multivitamin (2), Sunlife Vitamin C (3), Optisana Vitamin C (4), Optisana Multivitamin (5), Well and Active Multivitamin (6), Kneipp Vitamin C+Zink (7) and Sunlife Multivitamin (8). Enamel loss was measured using profilometry after 10 and 20 erosive cycles. For the vitamin+mineral ET, no loss was observed in groups B–E. Significantly highest enamel loss (mean ± SD) after 20 cycles was observed for Isostar (5.26 ± 0.76 µm) and Qualite and Prix Mg + Vit C (5.12 ± 0.67 µm). All vitamine ET showed erosive enamel loss. Significantly highest loss was observed for Sunlife Multivitamin (8.45 ± 1.08 µm), while the lowest loss was observed for Actilife-Multivitamin (5.61 ± 1.08 µm) after 20 cycles. Some of the tested effervescent tablets showed a considerable erosive potential and patients should be informed accordingly.

Ichthyophthirius multifiliis is a recurring problem in Australian rainbow trout Oncorhynchus mykiss farms and requires strategically timed, repeat treatments for effective management. Sodium percarbonate (SPC) is permitted for use in Australia, with host safety margins based on the toxicity of acute exposures to hydrogen peroxide (HP), the active product released when SPC is added to water. The effects of exposure to HP released by SPC, of repeated doses and of doses exceeding 100 mg l-1 on rainbow trout are unknown. We exposed juvenile rainbow trout (mean weight: 30.5 ± 9 g) to repeated doses of 50, 150 and 250 mg l-1 SPC for 1 h on Days 1, 2, 7 and 8 of a treatment regime. The effect of SPC was assessed by histological evaluation of structural changes in gill tissue. Survival was 100% in all groups, but some fish exposed to 250 mg l-1 SPC displayed impaired swimming performance, and on Day 9 after the final treatment, oedema was present in 9.8% of lamella, which was significantly higher than the mean occurrence of 1.7, 4.2 and 1.3% in fish treated with 0, 50 and 150 mg l-1 SPC, respectively. These changes resolved within 24 h of the cessation of treatment. We conclude that SPC is safe to use on rainbow trout in doses of ≤150 mg l-1 at 17°C, however caution is advised at doses approaching 250 mg l-1. Water temperature, fish age, fish size and maturity, intensity of parasite infection and stocking density could alter the sensitivity of rainbow trout to SPC treatments.

Saline-alkaline stress is characterized by high salinity and high alkalinity (high pH); alkaline stress has been shown to be the primary factor inhibiting rice seedling growth. In this study, we investigated the potential priming effect of abscisic acid (ABA) on tolerance of rice seedlings to alkaline stress simulated by Na2CO3. Seedlings were pretreated with ABA at concentrations of 0 (control), 10, and 50 μM by root-drench for 24 h and then transferred to a Na2CO3 solution that did not contain ABA. Compared to control treatment, pretreatment with ABA substantially improved the survival rate of rice seedlings and increased biomass accumulation after 7 days under the alkaline condition. ABA application at 10 μM also alleviated the inhibitory effects of alkaline stress on the total root length and root surface area. Physiologically, ABA increased relative water content (RWC) and decreased cell membrane injury degree (MI) and Na(+)/K(+) ratios. In contrast, fluridone (an ABA biosynthesis inhibitor) decreased the RWC and increased MI in shoots under the alkaline conditions. These data suggest that ABA has a potent priming effect on the adaptive response to alkaline stress in rice and may be useful for improving rice growth in saline-alkaline paddy fields., (Copyright © 2015 Elsevier Masson SAS. All rights reserved.)

A female in her forties with advanced incurable rectal cancer presented to our emergency department after loss of consciousness followed by brief myoclonic jerks in her legs. A cerebral MRI was normal. Her electrocardiogram showed a prolonged QTc interval of 596 milliseconds and hypokalemia was present. She had no family history of congenital long QT syndrome or of cardiovascular disease. She was not on any medication apart from having ingested 100 g caesium carbonate over the previous 11 days as an alternative cancer treatment. Caesium chloride is postulated to increase pH and thereby induce apoptosis in cancer cells. In treatment doses caesium competes with potassium for membrane transport proteins in the cardiac cell membrane and in the reabsorption tubuli of the kidneys. A result is hypokalemia shortly after depolarization during the cardiomyocytes' repolarisation phase or delayed post-depolarisation. Torsade de pointes ventricular arrhythmias, ventricular tachycardia, pump failure and death can follow. A few case reports of adverse effects from caesium ingestion have been published, as well as reports on how caesium is used in animal models to induce ventricular tachycardia, but the hazards of caesium ingestion and its long half-life are not well known in the medical care profession or among patients. As this patient's QTc interval normalised slowly to 413 milliseconds 60 days after stopping caesium ingestion, we consider caesium intoxication and convulsive syncope from a self-terminating ventricular tachycardia as the most probable aetiology. The main message from this case is that alternative medicine can have life-threatening side effects.

Objectives: Copper (Cu) is widely used in industry for the manufacture of a vast range of goods including Cu-intrauterine devices (IUDs), electronic products, agrochemicals, and many others. It is also one of the trace elements essential to human health in the right measure and is used as a parenteral supplement in patients unable to ingest food. Elevated Cu levels have been found in the plasma of women using Cu-IUDs and in farmers working with Cu-based pesticides. However, possible alterations due to Cu overload in the brain have been poorly studied. Therefore, the aim of this study was to investigate the effects of Cu administration on rat brain in Cu-sufficient and Cu-deficient animals fed on semi-synthetic diets with different doses of Cu (7 or 35 ppm)., Methods: We aimed to investigate the effects of Cu administration using two routes of administration: oral and intraperitoneal (IP). Male Wistar rats were feeding (one month) a complete (7 ppm) or a deficient (traces) Cu diets subdivided into three categories oral-, intraperitoneal- (or both) supplemented with copper carbonate (7 to 35 ppm). Cu content in plasma, brain zones (cortex and hippocampus), antioxidant enzyme activities, and protease systems involved in programmed cell death were determined., Results: The results show that Cu levels and the concentration of Cu in plasma and brain were dose-dependent and administration route-dependent and demonstrated a prooxidative effect in plasma and brain homogenates. Oxidative stress biomarkers and antioxidative enzyme activity both increased under Cu overload, these effects being more noticeable when Cu was administered IP. Concomitantly, brain lipids from cortex and hippocampus were strongly modified, reflecting Cu-induced prooxidative damage. A significant increase in the activities of calpain (milli- and micro-) and caspase-3 activity also was observed as a function of dose and administration route., Conclusion: The findings of this study could be important in evaluating the role of Cu in brain metabolism and neuronal survival., (Copyright © 2014 Elsevier Inc. All rights reserved.)

What Is Known and Objective: Complementary medicines are commonly used by many patients. Caesium, a complementary therapy said to be of benefit for cancer treatment, has been associated with cardiac arrhythmias in the literature. We report a case of caesium-induced torsades de pointes and provide an evidence review., Case Summary: A 46-year-old woman with syncope experienced torsades de pointes and cardiac arrest. Upon admission her QTc was 620 ms. The patient had taken caesium carbonate 10 g daily for 1 month prior to admission. The patient was successfully resuscitated and discharged home after 35 days in hospital., What Is New and Conclusion: Ten cases of caesium-induced cardiac arrhythmias have previously been reported in the literature. Treatment strategies differed significantly among the cases. However, all patients recovered from the event. Complementary and alternative medicines should not be overlooked as a potential cause of serious adverse events., (© 2013 Blackwell Publishing Ltd.)

Unlabelled: Lodenafil carbonate is a new phosphodiesterase Type 5 (PDE5) inhibitor used in treatment of erectile dysfunction., Objective: The present study was conducted to evaluate the safety, tolerability, and pharmacokinetics of lodenafil carbonate after administering ascending (1 - 100 mg) single oral doses to healthy male volunteers (n = 33)., Methods: The study was an open label, dose-escalation, Phase I clinical trial involving the administration of single oral doses of lodenafil carbonate. Lodenafil carbonate was administered sequentially, escalating in single doses of 1 mg - 100 mg with a washout period of at least 1 week between each dose. The progression to the next dose was allowed after clinical and laboratory exams, Ambulatory Monitoring of Arterial Pressure (AMAP) without relevant clinical modifications and adverse events without clinical relevancy. Blood samples were collected at pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 14, 16, 20 and 24 h post-dosing. Plasma samples for measurement of lodenafil carbonate and lodenafil were analyzed by liquid chromatography coupled to tandem mass spectrometry., Results: No serious adverse events were observed, and none of the subjects discontinued the study due to intolerance. The AMAP measurements, clinical and laboratory exams and ECG revealed no significant changes even at higher doses. Lodenafil carbonate was not detected in any samples, indicating that it acts as a prodrug. The mean lodenafil pharmacokinetic parameters for tmax and t1/2 were 1.6 ( ± 0.4) h and 3.3 ( ± 1.1) h, respectively. This study demonstrated that lodenafil carbonate was well tolerated and showed a good safety profile in healthy male volunteers.

Objectives: To compare the fracture resistance of bovine teeth after intracoronal bleaching with sodium percarbonate (SPC) or sodium perborate (SP) mixed with water or 20% hydrogen peroxide (HP)., Materials and Methods: Fifty extracted bovine teeth were divided into four experimental groups (G1-G4) and one control (n = 10) after endodontic treatment. Following root canal obturation, a glass ionomer barrier was placed at the cemento-enamel junction. After that, the pulp chambers were filled with: G1 - SP with water; G2 - SP with 20% HP; G3 - SPC with water; and G4 - SPC with 20% HP. No bleaching agent was used in the control group. Coronal access cavities were sealed with glass ionomer and specimens were immersed in artificial saliva. The bleaching agents were replaced after 7 days, and teeth were kept in artificial saliva for an additional 7 days, after which the pastes were removed and the coronal access cavities were restored with glass ionomer. Crowns were subjected to compressive load at a cross head speed of 0.5 mm min(-1) applied at 135° to the long axis of the root by an EMIC DL2000 testing machine, until coronal fracture. Data were statistically analysed by anova and Tukey test., Results: No differences in fracture resistance were observed between the experimental groups (P > 0.05). However, all experimental groups presented lower fracture resistance than the control group (P < 0.05)., Conclusion:  SPC and SP led to equal reduction on fracture resistance of dental crowns, regardless of being mixed with water or 20% HP., (© 2011 John Wiley & Sons A/S.)

Effects of sodium carbonate (Na2CO3) and sodium bicarbonate (NaHCO3) on yield and characteristics of Pacific white shrimp (Litopenaeus vannamei) were studied. Shrimp soaked in 2.5% NaCl containing both compounds at different levels of pH (5.5, 7, 8.5, 10 and 11.5) showed an increase in the weight gain and cooking yield and a reduced cooking loss as pH of solutions increased (p<0.05). Increases in pH and salt content in soaked shrimp muscle were obtained with increasing pH (p<0.05). Higher pH of soaking solution partially solubilized proteins in the muscle as well as carotenoproteins. pH of solutions above 8.5 led to the pronounced leaching of pigments, associated with the lowered redness of cooked shrimp. Shear force of raw and cooked shrimp continuously decreased as pH of solution increased (p<0.05). Solution containing 2.5% NaCl and 2.0% NaHCO3 (pH 8.5) was recommended for treatment of white shrimp as a promising alternative for phosphates to increase the yield and to lower cooking loss without any negative effect on sensory properties.

We report on a scrub typhus patient who contracted meningoencephalitis during doxycycline administration. This is the first case of scrub typhus in which doxycycline concentrations were measured in serum and cerebrospinal fluid. Clinicians should be alerted to the possibility that meningoencephalitis can occur because of inadequate maintenance of serum doxycycline level caused by antacids administered along with doxycycline., (Copyright © 2011 Elsevier Inc. All rights reserved.)

The role of zinc in the nervous system is receiving increased attention. At a time when dietary fortification and supplementation have increased the amount of zinc being consumed, little work has been done on the effects of enhanced zinc on behavior. Both zinc and copper are essential trace minerals that are acquired from the diet; under normal conditions the body protects against zinc overload, but at excessive dosages, copper deficiency has been seen. In order to examine the effect of enhanced metal administration on learning and memory, Sprague Dawley rats were given water supplemented with 10ppm Zn, 10ppm Zn+0.25ppm Cu, or normal lab water, during pre- and post-natal development. Fear conditioning tests at 4months showed significantly higher freezing rates during contextual retention and extinction and cued extinction for rats drinking water supplemented with zinc, suggesting increased anxiety compared to controls raised on lab water. During the MWM task at 9months, zinc-enhanced rats had significantly longer latencies to reach the platform compared to controls. The addition of copper to the zinc supplemented water brought freezing and latency levels closer to that of controls. These data demonstrate the importance of maintaining appropriate intake of both metals simultaneously, and show that long-term supplementation with zinc may cause alterations in memory., (Copyright 2010 Elsevier Inc. All rights reserved.)

Introduction: This is a phase III, prospective, randomized, double-blind, placebo-controlled clinical trial on lodenafil carbonate (LC), a novel phosphodiesterase 5 inhibitor developed in Brazil., Aim: Expanding information on LC efficacy and safety., Main Outcome Measures: International Index of Erectile Function (IIEF) erectile domain, positive answers to the sexual encounter profile (SEP)-2 and SEP-3 questions and incidence of adverse events (AEs)., Methods: A total of 350 men with erectile dysfunction (ED) of all degrees were randomized to placebo, LC 40 mg or LC 80 mg and followed for 4 weeks. They completed the IIEF and answered the SEP questions 2 and 3 after each intercourse without and with the use of LC., Results: IIEF Erectile Domain scores without and with the use of medication were the following (mean [M] +/- standard deviation [SD]): placebo = 13.9 +/- 5.2 and 14.8 +/- 7.8; LC 40 mg = 13.6 +/- 5.3 and 18.6 +/- 8.0; LC 80 mg = 13.4 +/- 4.9 and 20.6 +/- 7.7 (analysis of variance [ANOVA] P < 0.01). Positive answers to SEP-2 without and with the use of medication were the following (M +/- SD): placebo = 55.3 +/- 43.2% and 52.1 +/- 41.4%; LC 40 mg = 46.4 +/- 44.3% and 63.5 +/- 42.0%; LC 80 mg = 50.2 +/- 40.9% and 80.8 +/- 32.3% (ANOVA P < 0.01). Positive answers to SEP-3 were the following: placebo = 20.2 +/- 32.3% and 29.7 +/- 38.1%; LC 40 mg = 19.6 +/- 34.3% and 50.8 +/- 44.4%; LC 80 mg = 20.8 +/- 33.2% and 66.0 +/- 39.3% (ANOVA P < 0.01). The patients with at least one AE were placebo = 28.7%, LC 40 mg = 40.9%, and LC 80 mg = 49.5%. AEs whose incidence was significantly higher with LC than with placebo included rhinitis, headache, flushing, visual disorder, and dizziness., Conclusions: LC showed a satisfactory efficacy-safety profile for oral therapy of ED.

Background and Objectives: This phase II study tested the safety and efficacy of fermagate, a calcium-free iron and magnesium hydroxycarbonate binder, for treating hyperphosphatemia in hemodialysis patients., Design, Setting, Participants, & Measurements: A randomized, double-blind, three-arm, parallel-group study compared two doses of fermagate (1 g three times daily or 2 g three times daily with placebo). Sixty-three patients who had been on a stable hemodialysis regimen for > or =3 mo were randomized to the treatment phase. Study medication was administered three times daily just before meals for 21 d. The primary endpoint was reduction in serum phosphate over this period., Results: In the intention-to-treat analysis, mean baseline serum phosphate was 2.16 mmol/L. The fermagate 1- and 2-g three-times-daily treatment arms were associated with statistical reductions in mean serum phosphate to 1.71 and 1.47 mmol/L, respectively. Adverse event (AE) incidence in the 1-g fermagate arm was statistically comparable to the placebo group. The 2-g arm was associated with a statistically higher number of patients reporting AEs than the 1-g arm, particularly gastrointestinal AEs, as well as a higher number of discontinuations, complicating interpretation of this dose's efficacy. Both doses were associated with elevations of prehemodialysis serum magnesium levels., Conclusions: The efficacy and tolerability of fermagate were dose dependent. Fermagate showed promising efficacy in the treatment of hyperphosphatemia in chronic hemodialysis patients as compared with placebo in this initial phase II study. The optimal balance between efficacy and tolerability needs to be determined from future dose-titration studies, or fixed-dose comparisons of more doses.

Excessive fluoride ingestion predominantly comes from drinking water sources. However, prevalence and severity of dental and skeletal fluorosis in northern Tanzania have been reported to be higher than would be expected from ingestion of fluoride through drinking water alone. This study aimed at investigating the contribution of "trona" (also locally known as magadi) a food additive, to the prevalence and severity of fluorosis in northern Tanzania. The study was carried out in four villages (Embaseni, Kitefu and Ngurdoto) in Maji ya Chai ward; and Nkoanekoli in Poli ward, in Arusha region, Tanzania. Analysis of fluoride concentrations was carried out in drinking water sources as well as in magadi samples. Assessment of the prevalence of dental fluorosis using Dean's Index Method was carried out for a population of 2217 pupils in four primary schools located in the case study area. Fluoride concentration in drinking water sources was found to range from 1.7 to 11.3 mg/l, while the concentration in magadi samples in case study villages were in the range of 0.21 to 0.9 mg/g. Total fluoride ingestion through magadi and water were established to be 11.74 mg/person/day in Embaseni, 36.1 mg/person/day in Ngurdoto, 10.88 mg/person/day in Kitefu and 5.7 mg/person/day in Nkoanekoli villages. Levels of total fluoride ingestion were directly correlated with Community Fluorosis Index (CFI) values, which were found to be 3.32 (in Embaseni), 3.67 (in Ngurdoto), 2.2 (in Kitefu) and 1.47 (in Nkoanekoli). The village with the highest fluoride consumption rate showed the highest CFI as well. High levels of fluoride concentrations in magadi suggest that excessive fluorosis in northern Tanzania may be due to the use of magadi in food preparations.

An epidemiological health study compared the health status of residents of a town exposed to an accidental Catacarb chemical release from an adjacent oil refinery, with the health status of demographically similar residents of an unexposed town in the region. Few studies of Catacarb's effects on humans exist; however, animal studies have shown it to be a respiratory, gastro-intestinal, dermatological and visual irritant. As part of the study, health questionnaires assessing pre- and post exposure symptoms, illnesses and medication use were mailed to residents in both towns. Medication use is sometimes reported to be a more objective and reliable measure of health outcomes. The current paper compared medication use of exposed and unexposed residents. Significant increases after exposure were found in the use of the following medications: antacid, asthma medication, cough and cold medication, eye medication, headache medication and sleep medication. These increases were consistent with reported symptoms, albeit of greater magnitude; no increase in medication use for other illnesses was reported. Medication use in this sample was consistent with patients' report of symptoms and may be a better measure of outcome.

Objectives: To identify risk factors for dental fluorosis that cannot be explained by drinking water fluoride concentration alone., Methods: Two hundred eighty-four Tanzanian children ages 9 to 19 (mean 14.0+/-SD 1.69), who were lifetime residents at differing altitudes (Chanika, 100 m; Rundugai, 840 m; and Kibosho, 1,463 m; Sites 1, 2, and 3 respectively) were examined for dental fluorosis and caries. They were interviewed about their food habits, environmental characteristics and use of a fluoride-containing food tenderizer known locally as magadi. Meal, urine, water and magadi samples supplied by the participants were analyzed for fluoride content. Urine samples were also analyzed for creatinine concentration. Four magadi samples from Sites 1 and 3 were analyzed for complete element composition., Results: Of the 13 water samples from Site 2, 10 contained > or =4 mg/L F, ranging from 1.26 to 12.36 mg/L with a mean+/-SD of 5.72+/-4.71 mg/L. Sites 1 and 3 had negligible water fluoride of 0.05+/-0.05 and 0.18+/-0.32 mg/L respectively. Mean TFI fluorosis scores (range 0-9) for Site 2 were high: 4.44+/-1.68. In Sites 1 and 3, which both had negligible water fluoride, fluorosis scores varied dramatically: Site 1 mean maximum TFI was 0.01+/-0.07 and Site 3 TFI was 4.39+/-1.52. Mean DMFS was 1.39+/-2.45, 0.15+/-0.73 and 0.19+/-0.61 at Sites 1, 2, and 3, respectively. There were no restorations present. Urinary fluoride values were 0.52+/-0.70, 4.34+/-7.62, and 1.43+/-1.80 mg/L F at Sites 1, 2, and 3, respectively. Mean urinary fluoride values at Site 3 were within the normal urinary fluoride reference value range in spite of pervasive severe pitting fluorosis. Meal and magadi analyses revealed widely varied fluoride concentrations. Concentrations ranged from 0.01 to 22.04 mg/L F for meals and from 189 to 83211 mg/L F for magadi. Complete element analysis revealed the presence of aluminum, iron, magnesium, manganese, strontium and titanium in four magadi samples. There were much higher concentrations of these elements in samples from Site 3, which was at the highest altitude and had severe enamel disturbances in spite of negligible water fluoride concentration. An analysis of covariance model supported the research hypothesis that the three communities differed significantly in mean fluorosis scores (P<0.0001). Controlling for urinary fluoride concentration and urinary fluoride:urinary creatinine ratio, location appeared to significantly affect fluorosis severity. Urinary fluoride:urinary creatinine ratio had a stronger correlation than urinary fluoride concentration with mean TFI fluorosis scores (r=0.43 vs r= 0.25)., Conclusions: The severity of enamel disturbances at Site 3 (1463 m) was not consistent with the low fluoride concentration in drinking water, and was more severe than would be expected from the subjects' normal urinary fluoride values. Location, fluoride in magadi, other elements found in magadi, and malnutrition are variables which may be contributing to the severity of dental enamel disturbances occurring in Site 3. Altitude was a variable which differentiated the locations.

Lead exposure was assessed in a random cohort of 70 male papier mâché workers and compared with 35 age and sex matched controls. Blood-lead levels in workers were significantly higher than in controls (Mean 68.07 +/- 44.64 ug/dl vs 25.52 +/- 16.56 ug/dl respectively; P < 0.001). Urinary lead was also higher in workers (128.53 +/- 52.61 ug/l) compared to controls (91.18 +/- 27.06, P < 0.001), but excretion of urinary coproporphyrin in the two groups was not significantly different (102.78 +/- 153.42 vs 70.03 +/- 27.06 ug/l, P > 0.05). Blood levels bore a significant correlation with age but did not bear any correlation with the duration of exposure. Various modes of exposure to lead included hand mixing of paints, skin application of the paint to match shades and making point of the brush using lips and the tongue.

We describe a 2 1/2-yr-old Chinese boy who ingested potassium carbonate solution and presented with gastric outlet obstruction. He underwent successful antral resection. A severe fibroproliferative process of the antral submucosa obliterating the lumen was found to be the cause of this gastric outlet obstruction. To the best of our knowledge, this is the first report describing such a fibroproliferative process of the stomach.

Alkali burns of the eye can result in permanent visual impairment and are therefore potentially devastating. Immedicate diagnosis and treatment are essential to a good prognosis. The authors report the case of a 52-year-old woman who suffered alkali keratitis as the result of the activation of an automobile air bag. This type of injury will be seen more frequently as more cars are equipped with air bags and should be suspected in drivers and passengers involved in accidents in which air bags have been activated.

Objective: To study experimentally possible adverse effects of bicarbonate on cytoplasmic pH., Design: Open, randomized control trial of white blood cells from human volunteers., Setting: Experimental laboratory in a large university hospital., Subjects: Lymphocytes prepared from human blood., Interventions: The fluorescent intracellular probe 2',7'-bis-(carboxyethyl)-5,6-carboxyfluorescein acetoxymethyl ester (BCECF-AM) was used to study the influence on cytoplasmic pH after the addition of different alkaline buffers to lymphocytes with normal as well as decreased initial intracellular pH., Measurements and Main Results: In normal lymphocytes, sodium bicarbonate caused a marked, dose-dependent acidification of the cytoplasm followed by a slow, often unpredictable increase. Ringer's acetate solution decreased the intracellular pH dose-dependently this acidification effect continued throughout the measurements. In contrast, trometamol (tris) and Carbicarb both caused a pronounced dose-dependent and lasting alkalinization of the cytoplasm. Tris buffer mixture (Tribonate) produced a slight initial dose-dependent acidification, followed by a slow increase in cytoplasmic pH to values above those recorded during control measurements. Lymphocytes that were preincubated in acetate showed similar results after addition of tris buffer mixture or sodium bicarbonate. Lymphocytes with intracellular acidosis due to preincubation in an acid buffer demonstrated a more pronounced and dose-dependent decrease of cytoplasmic pH immediately after addition of the bicarbonate-containing buffers (sodium bicarbonate and tris buffer mixture). The decrease was only partly compensated for over the next 10 mins. Only the buffers that were not producing CO2 could fully compensate for the severe extra- and intracellular acidosis imposed on the lymphocytes by preincubation in an acid medium., Conclusion: Use of bicarbonate-containing buffers often results in an initial decrease of cytoplasmic pH.

Two pilot studies were performed to determine whether aluminium-containing antacids may have a place in the treatment of Helicobacter pylori infection. The urease activity of H. pylori is cytopathic to gastric epithelium, and inhibition of this enzyme may have therapeutic potential. In the first study 24 subjects, 12 of which were infected with H. pylori, were given 1 tablet of chewable aluminium hydroxide-containing antacids 10 min before a 14C-urea breath test. Gastric urease activity was suppressed by 33.3% (p = 0.02) in the H. pylori-positive subjects (none became negative) within 40 min after administration of the tablet. Gastric H. pylori infection can be effectively eradicated by triple regimens containing bismuth salts, tetracycline, and metronidazole. Owing to adverse effects of this treatment and concern for possible neurotoxicity of bismuth, a bismuth substitute is warranted. Hence, in the second study, 20 subjects infected with H. pylori were treated with 1 antacid tablet 4 times daily between meals, plus 500 mg oxytetracycline and 200 mg metronidazole 4 times daily with meals for 2 weeks. Individual H. pylori status was assessed by the 14C-urea breath test. Four weeks after cessation of treatment, H. pylori was eradicated in 45% (9 of 20) of the subjects (95% confidence interval, 23.1-68.5%). Thirty per cent (6 of 20) observed one or more adverse effect regarded as moderate or severe, of which loose stools and headache were the most common.(ABSTRACT TRUNCATED AT 250 WORDS)

Nutritional and environmental factors are now known to affect the blood pressure and pulse rate of man. The present study investigated the effect of nicotiana tabacum on these parameters. Thirty-three male Nigerians (20-68 years) living in Calabar, Nigeria were used for this study. The subjects were treated at three different periods with snuff containing varied concentrations of Natron (0.5g and 10g/100g of snuff) and their systolic and diastolic pressures as well as pulse rate were measured at intervals of 30 minutes up to a maximum of 90 minutes. Each subject served as his own control. There were significant and time-dependent increases in the parameters measured. In addition, the increases were more marked in the absence of Natron than in its presence.

Objective: To determine the occurrence of upper gastrointestinal hemorrhage in critically ill children, and the efficacy of prophylaxis with almagate (antacid), ranitidine, and sucralfate., Design: Prospective, randomized, controlled trial., Setting: Pediatric ICU of a tertiary care pediatric hospital., Patients: During a 2-yr study period, 165 patients with one or more upper gastrointestinal hemorrhage risk factors were randomized into one of four groups. Twenty-five patients were excluded because of protocol violations. A total of 140 patients completed the study, with 35 patients in each group., Interventions: Patients received no treatment in the control group. The antacid group received almagate 0.25 to 0.5 mL/kg every 2 hrs by nasogastric tube. The ranitidine group received 1.5 mg/kg every 6 hrs iv. The sucralfate group received 0.5 to 1 g every 6 hrs by nasogastric tube., Methods: Gastric pH and macroscopic bleeding were determined every 2 hrs in all patients until the end of the study. Macroscopic bleeding was classified as nonhemorrhage, slight, or important. Microscopic gastric bleeding was researched with guaiac testing in 72 patients (680 samples). The severity of illness was evaluated by using the Therapeutic Intervention Scoring System, Physiologic Stability Index, and the Multiorgan System Failure scores. The risk of upper gastrointestinal hemorrhage was evaluated by the Zinner and Tryba indices, and was modified for children., Measurements and Main Results: The occurrence rate of important upper gastrointestinal hemorrhage was higher (by 20%) in the control group than in the rest of the groups (5.7%), p less than .01. There were no differences between the other groups (almagate 5.7%, ranitidine 8.5%, and sucralfate 2.8%). There was a statistically significant correlation between the occurrence rate of important upper gastrointestinal hemorrhage, the scores of severity of illness indices (Therapeutic Intervention Scoring System, Physiologic Stability Index, and the Multiorgan System Failure scoring system), the risk of upper gastrointestinal hemorrhage indices (Zinner and Tryba), and mortality rate. The Zinner index better classified the patients in relation to the onset of important upper gastrointestinal hemorrhage (sensitivity 76.9%, specificity 85.8%)., Conclusions: Upper gastrointestinal hemorrhage is an important complication in critically ill children. Prophylaxis with almagate, ranitidine, or sucralfate reduces the occurrence rate of clinically important gastrointestinal hemorrhage.