Bioequivalence evaluation of two capsule formulations of amoxicillin in healthy adult male bangladeshi volunteers: A single-dose, randomized, open-label, two-period crossover study

Background: Amoxicillin, a semisynthetic penicillin antibiotic, is widely prescribed in Bangladesh due to its extended spectrum and its rapid and extensive oral absorption with good tolerability. Although a number of generic oral formulations of amoxicillin are available in Bangladesh, a study of the bioequivalence and pharmacokinetic properties of these formulations has not yet been conducted in a Bangladeshi population.Objective: The aim of this study was to assess the pharmacokinetic properties and bioequivalence of 2 formulations of amoxicillin 500-mg capsules (test, SK-mox^®; reference, Amoxil-Bencard^®) using serum data.Methods: This single-dose, randomized, open-label, 2-period crossover study was conducted in healthy male subjects in compliance with the Declaration of Helsinki and International Conference on Harmonisation guidelines. Subjects were assigned to receive the test or the reference drug as a single-dose, 500-mg capsule under fasting conditions after a 1-week washout period. After oral administration, blood samples were collected and analyzed for amoxicillin concentration using a validated high-performance liquid chromatography method. The pharmacokinetic parameters were determined using a noncompartmental method. The formulations were considered bioequivalent if the natural log-transformed ratios of pharmacokinetic parameters were within the predetermined equivalence range of 80% to 125%, according to the US Food and Drug Administration (FDA) requirement.Results: Twenty-four healthy adult male Bangladeshi volunteers (mean [SD] age, 26.92 [3.37] years; age range, 23–34 years; mean [SD] body mass index, 23.O9 [1.58] kg/m²) participated in the study. Using serum data, the values obtained for the test and reference formulations, respectively, were as follows: C_max, 9.85 (2.73) and 10.63 (2.12) μg/mL; T_max, 1.29 (0.58) and 1.33 (0.49) hours; and AUC_0–12, 27.09 (7.62) and 28.56 (6.30) μg/mL · h⁻¹. No period, sequence, or formulation effects were observed; however, significant variation was found among subjects with regard to AUC_0–12 (P < 0.001), AUC_0−∞ (P = 0.002), area under the moment curve (AUMC) from 0 to 12 hours (P < 0.001), and AUMC_0−∞ (P = 0.017). All CIs for the parameters measured were within the FDA-accepted limits of 80% to 125%.Conclusion: The present study suggests that the test 500-mg amoxicillin capsule was bioequivalent to the reference 500-mg capsule according to the FDA regulatory definition, in this population of healthy adult male Bangladeshi volunteers.     

Estrogen and urinary incontinence in women

Objective: The purpose of this study was to review the efficacy of estrogen therapy for urinary incontinence by examining published trials and to review the epidemiologic and physiologic evidence for its action. Data Sources: Controlled and uncontrolled trials of estrogen therapy in the English literature were collected. Eight controlled and 14 uncontrolled trials were identified. Methods of Study Selection: Trials were selected if they were prospective. All types of estrogen treatment were included. All types of outcome measurements were included. Data Extraction and Synthesis: Trials were categorized by type of estrogen used; outcome variables (subjective improvement vs. objective urodynamic data); and cure/improvement rates. Conclusions: Published trials do not support estrogen replacement as efficacious therapy for stress urinary incontinence. It may be useful for incontinence associated with urgency and frequency. Adequately large controlled trials that evaluate estrogen replacement regimens used in the USA remain to be done.     

Prospective evaluation of the International Study Group for Liver Surgery definition of post hepatectomy liver failure after liver resection: an international multicentre study

Background

The International Study Group for Liver Surgery (ISGLS) definition of post hepatectomy liver failure (PHLF) was developed to be consistent, widely applicable, and to include severity stratification. This international multicentre collaborative study aimed to prospectively validate the ISGLS definition of PHLF.

Effects of age and race on skin condition and bacterial counts on hands of neonatal ICU nurses

OBJECTIVE: The purpose of this study was to assess the relationship between demographic factors such as age and race and skin condition and bacterial counts on hands of nurses. METHODS: Nurses (n = 111) working in 1 of 2 neonatal ICUs in New York City were surveyed regarding reported hand care practices and demographics, the condition of their hands was assessed by a trained observer and by themselves using validated instruments, and a hand culture was obtained. RESULTS: There were no significant differences in any skin care practices by race, but nurses who wore powder-free gloves were significantly younger than those who did not (P =.004). There were no significant differences in bacterial counts on hands of black or white nurses (mean log colony-forming units 3.49 and 3.61 respectively, P =.63) and no significant correlation between age and microbial counts (r = 0.04, P =.72). In a logistic regression analysis, race, but not age, was a significant predictor of skin health. By both observer (P =.02) and self-assessment (P =.004) black nurses had healthier skin. CONCLUSION: Physiochemical differences in skin associated with demographic factors such as age and race may be exacerbated among those in disciplines such as nursing, for whom the skin of the hands is continually stressed by occupational practices such as frequent hand hygiene. Such demographic factors need be considered when assessing skin condition and when advocating for appropriate strategies to maximize skin health. The recommendations of the new CDC Hand Hygiene Guideline for Healthcare Settings(23) regarding maintaining skin health and providing moisturizers and products that are milder to the skin are timely and should be followed.     

Toll-like receptor 4 polymorphisms in dengue virus-infected children

Differential viral recognition by cells bearing Toll-like receptor 4 (TLR4) polymorphisms Asp299Gly and Thr399Ile may influence susceptibility and severity of dengue virus infection. In central Java, Indonesia, we investigated 201 children with dengue hemorrhagic fever (DHF) and 179 healthy controls. Patients and controls were mostly ethnic Javanese. A nearly complete cosegregation of the two mutations was observed. The TLR4 299/399 genotype was found in five patients and four controls. Prevalence of the TLR4 299/399 genotype did not differ significantly between controls and DHF patients or between patients with different severities of DHF. Also, vascular leakage in patients with different TLR4 genotypes did not differ. Thus, the 299/399 TLR4 haplotype has only minor influence on susceptibility and severity of complicated dengue virus infection.     

Growth and Investigation of Annealing Effects on Ternary Cd1−xMgxO Nanocomposit Thin Films

Thin films of Cd_1−xMg_xO (CdMgO) (0 ≤ x ≤ 1) were investigated by depositing the films on glass substrates using the co-evaporation technique. The structural, surface morphological, optical, and electrical characteristics of these films were studied as a function of Mg content after annealing at 350 °C. The XRD analysis showed that the deposited films had an amorphous nature. The grain size of the films reduced as the Mg concentration increased, as evidenced by the surface morphology, and EDAX supported the existence of Mg content. It was observed that as the films were annealed, the transmittance of the CdMgO films saw an increase of up to 85%. The blue shift of the absorption edge was observed by the increase of Mg content, which was useful for enhancing the efficiency of solar cells. The optical band gap increased from 2.45 to 6.02 eV as the Mg content increased. With increased Mg content, the refractive index reduced from 2.49 to 1.735, and electrical resistivity increased from 535 Ω cm to 1.57 × 10⁶ Ω cm.     

Thymic retention of CD4+CD25+FoxP3+ T regulatory cells is associated with their peripheral deficiency and thrombocytopenia in a murine model of immune thrombocytopenia

Immune thrombocytopenia (ITP) is a bleeding disorder in which antibodies and/or T cells lead to enhanced peripheral platelet destruction and reduced bone marrow platelet production. Several reports have observed that ITP is associated with a peripheral deficiency of tolerance-inducing CD4(+)CD25(+)FoxP3(+) T regulatory cells (Tregs). Using a murine model of ITP, we analyzed Tregs in the spleen and thymus. CD61 knockout mice were immunized against wild-type (CD61(+)) platelets, and their splenocytes were transferred into severe combined immunodeficient (SCID) mice. Compared with SCID mice receiving naive splenocytes, within 2 weeks after transfer, the ITP SCID mice became thrombocytopenic (< 200 × 10(9) platelets/L) and had increased serum anti-CD61 antibodies. The quantity of thymic Tregs by 2 weeks after transfer was significantly elevated, whereas Tregs in the spleens were significantly reduced. Treatment of the ITP mice with 2 g/kg intravenous immunoglobulin raised the platelet counts, reduced antibody production, and normalized the thymic and splenic Treg populations. Compared with thymocytes from ITP mice treated with intravenous immunoglobulin, thymocytes from untreated ITP mice delayed the onset of ITP when administered before engraftment with immune splenocytes. These results suggest that ITP in mice is associated with a peripheral Treg deficiency because of thymic retention and therapy normalizes the Tregs.