Impact of magnesium supplementation on clinical outcome and disease progression of patients with diabetic nephropathy: a prospective randomized trial.

Background: Magnesium (Mg) deficiency is closely linked with proteinuria. Objectives: To assess the impact of oral Mg citrate supplementation on the clinical outcome of diabetic nephropathy (DN) patients. Design: This was a prospective, randomized, controlled, open-label study. Methods: Sixty DN patients were recruited from Nephrology and Endocrinology departments, Ain Shams University Hospitals, Cairo, Egypt. Patients were assigned by stratified randomization based on their Mg status, to either Mg citrate group, (n = 30), who received the standard regimen + oral Mg citrate 2.25 g/day or Control group, (n = 30), who received the standard regimen only. The primary endpoint was a change in urinary albumin to creatinine ratio (UACR) after 12 weeks. Secondary outcomes were insulin resistance, glycemic control, lipid profile, serum osteocalcin, quality of life (QoL) and Mg tolerability. Results: Out of a total of 60 patients enrolled, only 54 patients (26 in Mg citrate group and 28 in the control group) completed the study. Groups were comparable at baseline. The UACR median percent reduction was significantly higher in the Mg citrate group (-6.87%) versus (-0.9%) in the Control group, p = 0.001. After 12 weeks, the estimated glomerular filtration rate significantly improved in the Mg citrate group versus Control group (p = 0.001). Comparable change was observed in glycemic indices. Lipid profile significantly improved in the Mg citrate group versus Control group (p = 0.001). Serum osteocalcin levels significantly declined in the Mg citrate group (p = 0.001) versus control group. Regarding QoL, the total score and all domains significantly improved in the Mg citrate group compared to control. The Mg supplement was tolerable with only mild reported side effects that required no intervention. Conclusion: Oral Mg citrate supplementation improved microalbuminuria in DN patients. It also had favorable effects on serum osteocalcin, lipid profile and QoL with no reported major side effects. Trial registration: ClinicalTrials.gov identifier: NCT03824379.

COVID-19 vaccine hesitancy in Egypt: a cross-sectional study.

INTRODUCTION: Coronavirus disease 2019 (COVID-19) vaccine hesitancy is a major problem. This study aimed to determine the factors associated with COVID-19 vaccine acceptance. METHODOLOGY: A cross-sectional survey-based study was conducted on a sample of the Egyptian population using an online survey distributed through social media platforms, including Facebook, WhatsApp, and LinkedIn. The questionnaire was composed of five parts: part I describing the research questionnaire and its aim, part II assessing the demographic data, part III assessing knowledge and attitude towards COVID-19 infection, and part IV and V evaluating knowledge regarding COVID-19 vaccines, factors affecting vaccine acceptance and participants' attitude toward vaccination. Regression models were used to assess factors associated with vaccine acceptability. RESULTS: A total of 24376 responses were included in the statistical analysis. Females represented more than two-thirds of the study sample (70.5%,) and 18-24 years was the most commonly reported age group. Around one-third of the sample were healthcare professionals (HCPs). Only 14.3% of the participants received or registered to receive the vaccine, while 47% refused to be vaccinated. Regression analysis revealed that male gender, secondary education, older age, married or divorced status, presence of comorbidities, and higher level of knowledge regarding the vaccine were significantly associated with high vaccine acceptance. The most important vaccine attributes influencing vaccine selection in the current work were efficacy and safety. CONCLUSIONS: Vaccine hesitancy is currently a major challenge. Governments should design educational campaigns that provide trusted data related to vaccine efficacy and safety to encourage vaccination and enhance awareness.

Synthesis and Characterization of the Mixed Metal Oxide of ZnO-TiO2 Decorated by Polyaniline as a Protective Film for Acidic Steel Corrosion: Experimental, and Computational Inspections.

In this work, the preparation, characterization, and evaluation of a novel nanocomposite using polyaniline (PANi) functionalized bi-metal oxide ZnO-TiO2 (ZnTiO@PANi) as shielding film for carbon steel (CS)-alloy in acidic chloride solution at 298 K was studied. Different spectroscopic characterization techniques, such as UV-visible spectroscopy, dynamic light scattering (DLS), X-ray photoelectron spectroscopy (XPS), and Fourier transform infrared spectroscopy (FTIR) approaches, as well as other physicochemical methods, such as X-ray diffraction (XRD), high-resolution transmission electron microscopy (HR-TEM), and field emission scanning electron microscope (FESEM), were used to describe the produced nanocomposites. The significance of these films lies in the ZnO-TiO2 nanoparticle's functionalization by polyaniline, a material with high conductivity and electrochemical stability in acidic solutions. The mechanistic findings of the corrosion inhibition method were obtained by the use of electrochemical methods including open-circuit potentials (OCP) vs. time, potentiodynamic polarization (PDP), and electrochemical impedance spectroscopy (EIS). The results indicate that the synthesized ZnTiO@PANi is a powerful acidic corrosion inhibitor, and its inhibition effectiveness is 98.86% in the presence of 100 ppm. Additionally, the charge transfer resistance (Rp) value augmented from 51.8 to 432.7, and 963.7 Ω cm2 when the dose of PANi, and ZnTiO@PANi reached 100 ppm, respectively. The improvement in Rp and inhibition capacity values with an increase in nanocomposite dose is produced by the nanocomposite additives covering a larger portion of the surface, resulting in a decrease in alloy corrosion. By identifying the probable regions for molecule adsorption on the steel substrate, theoretical and computational studies provided significant details regarding the corrosion mitigation mechanism. The possibility of substituting old poisonous small substances with inexpensive and non-hazardous polymeric materials as shielding layers for utilization in the oilfield sectors is an important suggestion made by this research.

Advanced Protective Films Based on Binary ZnO-NiO@polyaniline Nanocomposite for Acidic Chloride Steel Corrosion: An Integrated Study of Theoretical and Practical Investigations.

Due to their thermal stability characteristics, polymer/composite materials have typically been employed as corrosion inhibitors in a variety of industries, including the maritime, oil, and engineering sectors. Herein, protective films based on binary ZnO-NiO@polyaniline (ZnNiO@PANE) nanocomposite were intended with a respectable yield. The produced nanocomposite was described using a variety of spectroscopic characterization methods, including dynamic light scattering (DLS), ultraviolet-visible spectroscopy (UV-Vis), Fourier-transform infrared spectroscopy (FTIR), and X-ray photoelectron spectroscopy (XPS) approaches, in addition to other physicochemical methods, including X-ray powder diffraction (XRD), transmission Electron Microscopy (TEM), field emission scanning electron microscopy (FESEM), and selected area electron diffraction (SAED). By using open-circuit potentials (OCP) vs. time, electrochemical impedance spectroscopic (EIS), and potentiodynamic polarization (PDP) methods, the inhibitory effects of individual PANE and ZnNiO@PANE on the mild steel alloy corrosion in HCl/NaCl solution were assessed. The ZnNiO@PANE composite performed as mixed-type inhibitors, according to PDP findings. PANE polymer and ZnNiO@PANE composite at an optimal dose of 200 mg/L each produced protective abilities of 84.64% and 97.89%, respectively. The Langmuir isotherm model is used to explain the adsorption of ZnNiO@PANE onto MS alloy. DFT calculations showed that the prepared materials' efficiency accurately reflects their ability to contribute electrons, whereas Monte Carlo (MC) simulations showed that the suitability and extent of adsorption of the ZnNiO@PANE molecule at the metal interface determine the materials' corrosion protection process.

The impact of clinical pharmacist implemented education on the incidence of prescribing errors in COVID-19 patients.

Background: Clinical pharmacists have a vital role during COVID-19 pandemic in mitigating medication errors, particularly prescribing errors in hospitals. That is owing to the fact that prescribing errors during the COVID-19 pandemic has increased. Aim: This study aimed to evaluate the impact of the clinical pharmacist on the rate of prescribing errors on COVID-19 patients in a governmental hospital. Methods: The study was a pre-post study conducted from March 2020 till September 2020. It included the pre-education phase P0; a retrospective phase where all the prescriptions for COVID-19 patients were revised by the clinical pharmacy team and prescription errors were extracted. Followed by a one-month period; the clinical pharmacy team prepared educational materials in the form of posters and flyers covering all prescribing errors detected to be delivered to physicians. Then, the post-education phase P1; all prescriptions were monitored by the clinical pharmacy team to assess the rate and types of prescribing errors and the data extracted was compared to that from pre-education phase. Results: The number of prescribing errors in P0 phase was 1054 while it was only 148 in P1 Phase. The clinical pharmacy team implemented education phase helped to significantly reduce the prescribing errors from 14.7/1000 patient-days in the P0 phase to 2.56/1000 patient-days in the P1 phase (p-value <0.001). Conclusion: The clinical pharmacist significantly reduced the rate of prescribing errors in patients with COVID-19 which emphasizes the great role of clinical pharmacists' interventions in the optimization of prescribing in these stressful conditions.

The Impact of Clinical Pharmacist Implemented Protocol on Albumin Utilization and Cost in an Intensive Care Unit in Egypt.

Introduction: Albumin is an expensive non-blood plasma substitutes with limited availability that has been reported to be inappropriately used in healthcare settings. Hence, interventions are recommended to control its misuse. Objective: To evaluate the impact of clinical pharmacist implemented dispensing protocol on optimization of albumin use in an intensive care unit (ICU). Design: A retrospective prospective 3-phase interventional study was conducted in an ICU in a tertiary Egyptian hospital over a period of 2 years. Methods: The study included three phases; a preparation phase where a local albumin dispensing protocol and a restriction dispensing form were prepared by clinical pharmacists and was approved by the local Drugs and Therapeutics Committee, a retrospective pre-implementation phase in which the medical records of all ICU patients receiving albumin were evaluated for appropriateness of albumin use according to the developed protocol, and a prospective implementation phase where the dispensing protocol and restriction dispensing form were applied. The pattern of albumin consumption and cost were recorded and compared between the retrospective and prospective phases. Results: In the retrospective phase, 190 ICU patients received albumin of whom 83.6% was considered inappropriate indications for albumin compared to only 44 patients in the prospective phase of whom 16% was considered inappropriate (p-value <0.001). Clinical pharmacists' interventions significantly decreased the inappropriate albumin consumption from 4.7 vials/patient in the retrospective phase to 2.7 vials/patient in the prospective phase (p-value <0.001) with a total cost savings of 313,900 Egyptian Pounds (19,930 US Dollars). Conclusion: The current study showed that clinical pharmacists' interventions led to a significant control on albumin use and consequently reduced the cost associated with its consumption.

Corrigendum to ``Protective Role of Sarpogrelate in Combination with Bromocriptine and Cabergoline for Treatment of Diabetes in Alloxan-induced Diabetic Rats'' [Current Therapeutic Research Volume 95, 2021, 100647].

[This corrects the article DOI: 10.1016/j.curtheres.2021.100647.].

Protective Role of Sarpogrelate in Combination with Bromocriptine and Cabergoline for Treatment of Diabetes in Alloxan-induced Diabetic Rats.

BACKGROUND: Although dopamine D2 receptor agonists, bromocriptine and cabergoline, are notable medications in the treatment of Parkinsonism, hyperprolactinemia, and hyperglycemia, there is an identified relationship between the utilization of D2-like R agonists and the progress of myocardial injury, especially in the early phase of therapy. OBJECTIVE: This investigation aimed to examine the potential activity of sarpogrelate (a 5-hydroxytryptamine 2A [5-HT2A] receptor blocker) in reducing myocardial injury prompted by extended haul utilization of D2 receptor agonists in a model of diabetic rats. METHODS: In the in vivo studies, both bromocriptine and cabergoline were managed independently and combined with sarpogrelate for about a month in diabetic nephropathy rats. Blood glucose level and other myocardial biochemical parameters were estimated. The probable mechanism for insulin secretagogue action was evaluated through in vitro isolated islets study. Sodium/potassium-adenosine triphosphatase activity was assayed in an isolated microsomal fraction of the renal cortex. Isolated perfused rat hearts were treated with different doses of dopamine before and after being subjected to the tested drugs, dose response of heart rate, and heart contractility were recorded. RESULTS: Bromocriptine and cabergoline created a significant reduction in blood glucose level without any action on insulin secretagogues. Bromocriptine prevented the loss of sodium/potassium-adenosine triphosphatase activity in the cortex of an ischemic kidney. Treatment of bromocriptine or cabergoline with sarpogrelate altogether decreased the levels of the elevated myocardial biomarkers in serum. Administration of different doses of dopamine in presence of bromocriptine or capergoline resulted in significantly rising in the heart rate percentage comparing to dopamine alone. A mix of bromocriptine or cabergoline with sarpogrelate diminished both heart rate and contractility, respectively. CONCLUSIONS: The examination demonstrated that the combined use of sarpogrelate with bromocriptine or cabergoline decreased the potential adverse effects of these 2 drugs on myocardial tissues.

Efficacy and Safety of Metformin Use in Rheumatoid Arthritis: A Randomized Controlled Study.

Objective: To evaluate the efficacy and safety of metformin use in rheumatoid arthritis (RA) patients receiving conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs). Methods: A prospective, randomized, controlled, single blinded, study was carried on 66 RA patients with moderate and high disease activity state, receiving csDMARDs. Patients were simply randomized to receive either metformin 850 mg twice daily (Metformin group, n = 33), or placebo twice daily (Control group, n = 33) in addition to their stable anti-rheumatic regimen and followed up for 6 months. Serum C-reactive protein (CRP), disease activity of 28 joints based on CRP (DAS-28-CRP), and quality of life (QOL) were evaluated at baseline and then every 3 months. Moreover, serum adiponectin was assessed at baseline and after 6 months. Results: Sixty patients completed the study. Drop out was due to intolerance to metformin side effects (n = 3) and non-compliance (n = 3). Metformin significantly decreased CRP levels and DAS-28-CRP after 6 months compared to the control group (p-value <0.001). A significant improvement in QOL of metformin group was observed as early as after 3 months (p-value = 0.006) with a continued improvement observed at 6 months (p-value <0.001) compared to the control group. Despite the significantly higher serum adiponectin in the metformin group at baseline, it was significantly reduced after 6 months in the metformin group with median percent change of -63.49% compared to the significant increase in the control group with median percent change of 92.40%. Conclusion: Metformin significantly improved inflammation, disease severity, and QOL in RA patients with high safety profile. Clinical Trial Registration: Clinical-Trials.gov, identifier [NCT08363405].

Therapeutic activity of sarpogrelate and dopamine D2 receptor agonists on cardiovascular and renal systems in rats with alloxan-induced diabetes.

BACKGROUND: Dopamine D2 receptor agonists, bromocriptine and cabergoline, are notable medications in the treatment of Parkinsonism, hyperprolactinemia, and hyperglycemia. An affiliation was found between the initiation of myocardial injury ailment and long term treatment with dopamine D2 agonist drugs identified with the partial activation of 5-hydroxytryptamine receptor 2 A (5-HT2A). The investigation aimed to examine the activity of sarpogrelate (a 5-HT2A receptor blocker) in reducing myocardial injury prompted by extended haul utilisation of D2 receptor agonists in rats with alloxan-induced diabetes. METHODS: Both bromocriptine and cabergoline were managed independently and combined with sarpogrelate for about a month in diabetic nephropathy rats. Both tail-cuff blood pressure and the BGL were recorded weekly. For all animals, the kidney hypertrophy index, serum creatinine, blood urea nitrogen, alanine transaminase, and aspartate transaminase levels were measured after one month of treatment. The severity of the cardiac injury was assessed by the estimation of lactate dehydrogenase-1 (LDH-1), cardiac troponin I, and tumor necrosis factor alpha 1 (TNF1). The triphenyltetrazolium chloride (TTC) staining method was used to determine the experimental myocardial infarction (MI) size. RESULTS: Bromocriptine and cabergoline created a significant reduction in BGL, BP, and kidney hypertrophy index in diabetic nephropathy rats. Administration of bromocriptine and cabergoline, alone, or in combination with sarpogrelate fundamentally diminished the blood concentrations of alkaline phosphatase (ALP), Aspartate aminotransferase (AST), urea, and creatinine. Bromocriptine and cabergoline alone showed a noteworthy increase in the LDH-1, Troponin I, and TNF1 levels in the serum (p < 0.05). Paradoxically, utilising bromocriptine or cabergoline with sarpogrelate treatment altogether decreased the levels of the myocardial biomarkers in the serum. A mix of bromocriptine or cabergoline with sarpogrelate diminished the level of the myocardial infarct size in the heart assessed through the TTC staining method. CONCLUSIONS: The examination demonstrated that the combined use of sarpogrelate with bromocriptine or cabergoline decreased the potential adverse effects of these two drugs on the myocardial tissues.

Comparative single-dose mRNA and ChAdOx1 vaccine effectiveness against SARS-CoV-2, including early variants of concern: a test-negative design, British Columbia, Canada

IntroductionIn randomized controlled trials, single-dose efficacy against SARS-CoV-2 illness exceeded 90% for mRNA vaccines (BNT162b2 and mRNA-1273), and 75% for ChAdOx1. In British Columbia (BC), Canada second doses were deferred up to 16 weeks and ChAdOx1 was only initially recommended for adults 55 years of age and older. We compared single-dose vaccine effectiveness (VE) during the spring 2021 wave in BC when Alpha and Gamma variants of concern (VOC) predominated. MethodsVE was estimated against infection and hospitalization by test-negative design: cases were RT-PCR test-positive for SARS-CoV-2 and controls were test-negative. Adults 50-69 years old with specimen collection between April 4 and May 22 (weeks 14-20) were included. Variant-specific VE was estimated between weeks 17-20 when genetic characterization of all case viruses was performed, primarily through whole genome sequencing. ResultsVE analyses included 7,116 (10%) cases and 60,958 controls. Three-quarters of vaccinated participants received mRNA vaccine (60% BNT162b2, 15% mRNA-1273) and 25% received ChAdOx1. Half of genetically characterized viruses were Alpha, with 38% Gamma, 4% Delta and 8% non-VOCs. Single-dose VE against any infection was 75% (95%CI: 72-78) for BNT162b2, 82% (95%CI: 76-87) for mRNA-1273 and 61% (95%CI: 54-66) for ChAdOx1. VE against hospitalization was 83% (95%CI: 76-89), 85% (95%CI: 63-94) and 96% (95%CI: 86-99), respectively. VE against Alpha vs. Gamma infections did not differ among mRNA (78%;95%CI: 73-82 and 80%;95%CI: 74-85) or ChAdOx1 (66%;95%CI: 57-74 and 60%;95%CI: 48-69) recipients. ConclusionsA single dose of mRNA vaccine reduced the SARS-CoV-2 infection risk by at least 75%, including infections due to early VOC. Although effectiveness of a single dose of ChAdOx1 was lower at 60% against infection, just one dose of any vaccine reduced the hospitalization risk by more than 80%. In the context of constrained vaccine supplies, these findings have implications for global vaccine deployment to reduce the overall burden of infections and hospitalizations due to SARS-CoV-2.

Pharmacovigilance education to healthcare professionals: Will it affect their performance in reporting adverse drug reactions?

AIM: To assess impact of pharmacovigilance (PV) educational program on knowledge, attitude and practice (KAP) of healthcare professionals (HCPs). METHODS: a prospective study was conducted on HCPs at an Egyptian hospital. The study included: pre-education phase; where KAP questionnaire was administered by HCPs to obtain baseline data, intervention phase; where educational sessions were held by clinical pharmacists and Egyptian PV centre, and post-education phase; where the questionnaire was re-administered by participants 9 months post-receiving educational sessions. The questionnaire comprised five sections: participants' demographics, knowledge, attitude and practice sections and two multiple choice questions asking about the importance of establishment of ADRs monitoring centre, and factors hindering ADRs reporting. Pre-education and post-education data were compared. RESULTS: From 221 HCPs invited to participate, only 153 filled the pre-education and post-education questionnaires. At baseline, the median (range) of the total KAP score were 1 (0-7), 1 (0-4) and 4 (0-14) for physicians, nurses and pharmacists, respectively. All KAP scores were low for all HCPs at baseline with the pharmacists having significantly higher knowledge and attitude scores compared with physicians, and nurses (P < .001). After education, all scores significantly increased and 13 ADRs were reported by HCPs compared with only 2 at baseline. CONCLUSION: It was concluded that educational program had a significant impact on enhancing KAP of HCPs towards PV and ADRs reporting.

Promising drug repurposing approach targeted for cytokine storm implicated in SARS-CoV-2 complications.

A global threat has emerged in 2019 due to the rapid spread of Coronavirus disease (COVID-19). As of January 2021, the number of cases worldwide reached 103 million cases and 2.22 million deaths which were confirmed as the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This global pandemic galvanized the scientific community to study the causative virus (SARS-CoV2) pathogenesis, transmission, and clinical symptoms. Remarkably, the most common complication associated with this disease is the cytokine storm which is responsible for COVID-19 mortality. Thus, targeting the cytokine storm with new medications is needed to hamper COVID-19 complications where the most prominent strategy for the treatment is drug repurposing. Through this strategy, several steps are skipped especially those required for testing drug safety and thus may help in reducing the dissemination of this pandemic. Accordingly, the aim of this review is to outline the pathogenesis, clinical features, and immune complications of SARS-CoV2 in addition to suggesting several repurposed drugs with their plausible mechanism of action for possible management of severe COVID-19 cases.

The effect of itraconazole on the clinical outcomes of patients with advanced non-small cell lung cancer receiving platinum-based chemotherapy: a randomized controlled study.

Itraconazole is an oral antifungal that has a been reported to have anticancer effect in non-small cell lung cancer (NSCLC) through inhibition of angiogenesis. The aim is to evaluate the effect of using itraconazole on the clinical outcome of metastatic NSCLC. This was a prospective randomized controlled open-label study conducted on 60 chemotherapy-naive metastatic NSCLC. Patients were simply randomized to either Control group who received platinum-based chemotherapy for a maximum of six cycles or Itraconazole group who received the same chemotherapy regimen in addition to itraconazole 200 mg daily for 21 days starting from day 1 in each cycle. Primary outcome was 1-year progression-free survival (PFS) while secondary outcomes included overall response rate (ORR), 1-year overall survival (OS) and tolerability. The two groups were comparable at baseline with no significant difference between groups regarding demographics and clinical characteristics. The ORR in Control group was 66.7% versus 90% in Itraconazole group (p value 0.028). There was a significant difference between groups regarding PFS where the mean 1-year PFS was 5.415 months in Control group versus 6.556 months in Itraconazole group (p value = 0.002). However, there was no significant difference between groups with respect to 1-year OS. All adverse effects reported were tolerable except for one patient who developed grade 2 cardiotoxicity in Itraconazole group requiring itraconazole discontinuation. Itraconazole use was beneficial in NSCLC in terms of 1-year PFS and ORR which was not reflected by improvement in 1-year OS.Clinical trial.gov registration number: NCT03664115, date of registration: September 10, 2018.

Prevalence and Prognostic Value of HPV among Tunisian Patients with Laryngeal Cancer and Relationship between DNA HPV and p16, IGF-1R, Survivin, p53 Expressions.

OBJECTIVES: Tobacco and alcohol are the main etiological factors common to laryngeal cancers. However, the Human Papilloma Virus (HPV) constitutes an alternative risk factor according to several studies. In Tunisia, despite the annual increasing incidence of laryngeal squamous cell carcinoma (LSCC), the prevalence and prognostic significance of HPV have never been explored.In this study, we sought to highlight HPV DNA in 70 biopsies of laryngeal cancer, and to analyze the status of HPV infection in association with p53, p16, survivin, and IGF-1R expressions. METHODS: HPV high risk (HPV HR) DNA was detected in tumors by in situ hybridization. However, the expression of p53, p16, survivin and IGF-1R were stained by immunohistochemistry test. The correlations of HPV status with clinicopathological parameters, overall survival, disease-free survival and proteins expressions were statistically evaluated. RESULTS: HPV HR DNA was detected in 39 out of 70 (55.71%) laryngeal tumors. HPV+ patients have a better overall survival (P = .081) and long disease-free-survival (P = .016) with a low rate of recurrence (P = .006) than HPV- patients. No significant correlations were found between HPV HR status and clinicopathological parameters (all P > .005). Moreover, HPV+ tumors were not associated with expression of p53, p16 and survivin. However, HPV HR status correlates with weak to moderate IGF-1R expression (P = .043). CONCLUSION: The substantial detection of HPV HR in LSCC tumors suggest that this virus plays an important part in laryngeal cancer in Tunisia. It is a good prognostic factor. In addition, HPV infection could act to block the pathway of IGF-1R expression.

Early predictors of neonatal hyperbilirubinemia in full term newborn.

BACKGROUND: Reliable predictive markers enabling physicians to identify which newborns will develop significant hyperbilirubinemia have become mandatory for prevention of severe hyperbilirunemia. We aimed at determining the critical cord serum bilirubin and albumin levels and bilirubin/albumin ratio early as reliable markers. STUDY DESIGN: This prospective study included 175 full-term neonates. Measurement of cord bilirubin, albumin and bilirubin/albumin ratio was done to predict significant hyperbilirubinemia in healthy term newborns based on serum bilirubin measurements made within 5 days of life. RESULTS: Most cases that developed significant neonatal hyperbilirubinemia (67.9%) had cord albumin level ≤ 2.8 gm/dl. Cord Bilirubin/albumin ratio cut off value > 0.61 had a good predictive value with a sensitivity of 100% and specificity of 88.4%, and cord serum albumin cut off value ≤ 3.0 mg/dl also had a good predictive value with a sensitivity of 85.7% and specificity of 67.3%. ROC curve analysis of cord total bilirubin demonstrated that a cut off value of ≥1.84 mg/dl had a good predictive value with a sensitivity of 100.0% and specificity of 87.1%. CONCLUSION: Cord bilirubin/albumin ratio, serum bilirubin and albumin could be early predictors for neonatal hyperbilirubinemia.

Effect of Hypericum humifusum aqueous and methanolic leaf extracts on biochemical and histological parameters in adult rats.

Hypericum genus is traditionally known for its medicinal use and its therapeutic and antioxidant effects. However, the toxic effect of this plant has not been much explored. Our study aimed at investigating the effect of Hypericum humifusum (Hh) leaf extracts on oxidative stress parameters in male rats. For it, we first focused on the phytochemical analysis of the aqueous and methanolic extracts of Hh leaves. Hence, Wistar rats were treated per gavage for 30 days and divided into Control (1 mL/rat, distilled water), A200 group (200 mg/kg body weight (bw) aqueous extract), A400 group (400 mg/kg bw aqueous extract), M10 group (10 mg/kg bw methanolic extract), M20 group (20 mg/kg bw methanolic extract). The phytochemical analysis revealed the presence of tannins, flavonoids, steroids, carbohydrates, and phenolic compounds. Biochemical and histological investigations were performed in plasma and liver tissue. Liver tissue homogenates were used for the measurement of malondialdehyde (MDA), catalase (CAT) and superoxide dismutase (SOD) levels. At the same time, alanine transaminase (ALT), aspartate transaminase (AST) and lactate dehydrogenase (LDH) were assayed in plasma samples. Histological study was also conducted in liver. We showed that Hh extracts reduced relative liver weight and increased ALT, AST, LDH activities in treated groups compared to control group. These results were associated with an increase of MDA levels and a decrease of antioxidant enzyme activities (CAT and SOD) in liver tissues of treated rats. Histology of liver demonstrated several alterations showing necrosis, altered hepatocytes and lymphocyte migration mainly in A200 group and dilated sinusoids, foamy appearance of hepatocytes and lymphocyte accumulation in the other treated groups. This original work indicated that chronic consumption of Hh leaf extracts has no antioxidant effect but instead it induces oxidative stress and enhances markers of cell damage which was confirmed by histological study of liver rats.

Hearing loss among high-risk newborns admitted to a tertiary Neonatal Intensive Care Unit.

PURPOSE: The aim of this work is to identify the most significant risk factors for hearing impairment in high risk neonates hospitalized at our Neonatal Intensive Care Unit (NICU) and to assess the sensitivity of hearing screening tests. METHODS: This study involved 260 neonates admitted to a tertiary NICU; they were classified into two groups; 150 preterm and 110 full terms with risk factors for hearing loss. The hearing screening tests performed were transient evoked otoacoustic emissions (TEOAEs) and the automated auditory brainstem response (AABR). RESULTS: Forty-eight preterm neonates (32%) and 30 full term neonates (27.3%) had pathological AABR. In preterm group, mechanical ventilation more than five days, sepsis, usage of aminoglycosides, loop diuretics, vancomycin alone or in combination with aminoglycosides and prolonged duration of admission were considered risk factors of hearing affection whereas in full term group mechanical ventilation more than five days was the risk factor of hearing affection (p<.05). CONCLUSIONS: The prevalence of hearing loss is highest among high risk neonates and TEOAE and AABR were found to be reliable screening tools. Use of ototoxic drugs and mechanical ventilation for more than five days were significant risk factors for hearing loss in our study population.

Chronic consumption of Hypericum humifusum leaf extracts impairs epididymis spermatozoa characters in association with oxidative stress in adult male Wistar rats.

Recently, there has been increasing interest in Hypericum (Hypericaceae) genus. The first part of the present study focused on the phytochemical analysis of the methanolic and aqueous extracts of Hypericum humifusum leaves. The second part of the study investigated the effect of Hypericum humifusum leaf extracts on male reproductive parameters. 30 male rats were grouped into control (1mL/rat, distilled water), treated by 200mg/kg body weight (bw) aqueous extract (A200), 400mg/kg bw aqueous extract (A400), 10mg/kg bw methanolic extract (M10) and 20mg/kg bw methanolic extract (M20) groups. The phytochemical analysis revealed the presence of tannins, flavonoids, steroids, carbohydrates, and phenolic compounds. After thirty-day treatment, body and reproductive organs were weighed. Testes in all rat groups were processed for biochemical assays and histopathological examinations. Epididymis sperm analyses were also performed. Testicular tissue homogenate samples were used for Malondialdehyde (MDA), catalase and superoxide dismutase (SOD) measurements. We showed that Hh extracts induced a severe seminiferous tubular damage with an increase in the percentage of empty seminiferous tubules. Epididymis sperm analysis revealed a significant reduction in density and viability of sperm with alteration of spermatozoa morphology. Also, we found that Hh leaf extracts decreased plasma total cholesterol, HDL-cholesterol and triglycerides levels. These results were associated with an increase of MDA levels and a decrease of catalase and SOD activities in testis tissues. Our finding revealed that chronic consumption of Hh extracts induces disruption of normal spermatogenesis by alteration of sperm density, viability, and morphology. This action may be due to an inhibition of the antioxidant-defense system.

A prospective randomized controlled study of cisplatin versus carboplatin-based regimen in advanced squamous nonsmall cell lung cancer.

BACKGROUND: The use of cisplatin (Cis) versus carboplatin (Carb) in the treatment of advanced nonsmall cell lung cancer (NSCLC) is controversial. The aim of the study was to compare the safety and efficacy of Cis versus Carb in squamous NSCLC. PATIENTS AND METHODS: A prospective, randomized, controlled, open-label study was conducted on advanced squamous NSCLC patients who were randomly assigned to receive Cis (40 mg/m 2 [day 1 and day 8]) or Carb (area under the curve = 5 [day 1]) combined with gemcitabine [Gem] (1000 mg/m 2 [day 1 and day 8]) of a 3-week schedule for six cycles. Study objectives were a radiological response after three cycles and six cycles, 1-year progression-free survival (PFS), 1-year overall survival (OS), and quality of life (QOL) assessment using functional assessment of cancer therapy-lung at baseline, after three cycles, and after six cycles. STATISTICAL ANALYSIS: Statistical analysis was done using Statistical Package for Social Science version 15. A P < 0.05 was considered statistically significant. RESULTS: Seventy-one patients were enrolled (Gem/Cis group [n = 36], Gem/Carb group [n = 35]). Response rates were comparable in both arms. Nonsignificant differences were found regarding 1-year PFS (P = 0.308) and 1-year OS (P = 0.929) between the two groups. Neutropenia was significantly higher in Gem/Carb group, while vomiting and ototoxicity were significantly higher in Gem/Cis group. The effect on QOL was similar in both groups. CONCLUSION: Cis and Carb have similar efficacy, tolerability, and effect on QOL and both can be used as a first-line treatment of squamous NSCLC.