Background Although many patients with venous thromboembolism require extended treatment, it is uncertain whether it is better to use full- or lower-intensity anticoagulation therapy or aspirin. Methods In this randomized, double-blind, phase 3 study, we assigned 3396 patients with venous thromboembolism to receive either once-daily rivaroxaban (at doses of 20 mg or 10 mg) or 100 mg of aspirin. All the study patients had completed 6 to 12 months of anticoagulation therapy and were in equipoise regarding the need for continued anticoagulation. Study drugs were administered for up to 12 months. The primary efficacy outcome was symptomatic recurrent fatal or nonfatal venous thromboembolism, and the principal safety outcome was major bleeding. Results A total of 3365 patients were included in the intention-to-treat analyses (median treatment duration, 351 days). The primary efficacy outcome occurred in 17 of 1107 patients (1.5%) receiving 20 mg of rivaroxaban and in 13 of 1127 patients (1.2%) receiving 10 mg of rivaroxaban, as compared with 50 of 1131 patients (4.4%) receiving aspirin (hazard ratio for 20 mg of rivaroxaban vs. aspirin, 0.34; 95% confidence interval [CI], 0.20 to 0.59; hazard ratio for 10 mg of rivaroxaban vs. aspirin, 0.26; 95% CI, 0.14 to 0.47; P<0.001 for both comparisons). Rates of major bleeding were 0.5% in the group receiving 20 mg of rivaroxaban, 0.4% in the group receiving 10 mg of rivaroxaban, and 0.3% in the aspirin group; the rates of clinically relevant nonmajor bleeding were 2.7%, 2.0%, and 1.8%, respectively. The incidence of adverse events was similar in all three groups. Conclusions Among patients with venous thromboembolism in equipoise for continued anticoagulation, the risk of a recurrent event was significantly lower with rivaroxaban at either a treatment dose (20 mg) or a prophylactic dose (10 mg) than with aspirin, without a significant increase in bleeding rates. (Funded by Bayer Pharmaceuticals; EINSTEIN CHOICE ClinicalTrials.gov number, NCT02064439 .).
Abstract Background: The accuracy of the Contour(®) Plus (Bayer HealthCare LLC, Diabetes Care, Whippany, NJ) blood glucose monitoring system (BGMS) was evaluated in two separate studies. Materials and Methods: In the laboratory study, fingerstick samples from 100 subjects were tested in duplicate using three test strip lots and assessed per International Organization for Standardization (ISO) 15197:2003, Section 7 (≥95% of results within ±15 mg/dL or ±20% of the reference result for samples with glucose concentrations <75 and ≥75 mg/dL, respectively) and ISO 15197:2013, Section 6.3 (≥95% of results within ±15 mg/dL or ±15% of the reference result for samples with glucose concentrations <100 and ≥100 mg/dL, respectively) accuracy criteria. In the clinical trial, 220 subjects with diabetes, naive to the BGMS, tested capillary glucose from fingertip and palm blood samples and completed an ease-of-use questionnaire. BGMS and YSI glucose analyzer results were compared. Results: In the laboratory study, 100% of results met ISO 15197:2003 and ISO 15197:2013 accuracy criteria. In the clinical trial, 100% and 99.1% of subject fingerstick results and 98.1% and 96.7% of subject palm results met ISO 15197:2003 and ISO 15197:2013 accuracy criteria, respectively. By Parkes Consensus Error Grid analysis, 100% of subject fingerstick results and 98.1% of subject palm results were within Zone A (remainder within Zone B). Questionnaire results showed most subjects found the BGMS easy to use. Conclusions: The Contour Plus BGMS meets ISO 15197:2003 and ISO 15197:2013 accuracy criteria in the laboratory and when used by untrained individuals.
Stimulus-responsive zinc oxide-functionalized macromolecular humic acid nanocarrier for enhancement of antibacterial activity of ciprofloxacin hydrochloride
- International journal of biological macromolecules
- Published 2 months ago
Macromolecular of naturally occurring humic acid (HA) have garnered interest in the chemical, biological and medicine industry owing to their unique behavior, i.e., strong adsorptive and non-toxic nature. Here, we investigated the functionalization of organic (HA) with inorganic (ZnO) hybrid nanoparticles for topical and site-targeted delivery of ciprofloxacin by simple emulsification techniques. Ciprofloxacin (CIPRO)-encapsulated hybrid nanocarrier constitute an attractive novel drug delivery vehicle for sustained release of antibiotics to bacterial infection sites in an extended and controlled manner. The analytical characteristics of the designed system were thoroughly investigated by FTIR, XRD, SEM/EDAX, and TEM. The drug release of ciprofloxacin over 24 h was 87.5%, 98.03%, 97.44%, and 97.24% for pH 2.5, 5.5, 6.8, and 8.0, respectively. The antibacterial activities results confirmed that the CIPRO-encapsulated hybrid nanocarrier showed excellent growth inhibition against microorganisms. This hybrid nanocarrier loaded with antibiotics represents a promising approach for targeted and controlled drug delivery to infected sites.
Two laboratory experiments (Studies 1 and 2) were conducted to confirm the efficacy of an imidacloprid and permethrin combination (Advantix® Spot-on, Bayer) to repel and kill Phlebotomus (Larroussius) perniciosus sand flies when applied once a month topically to dogs.
Hysterosalpingo-foam sonography (HyFoSy) has been suggested to be a possible less invasive alternative to hysterosalpingography (HSG), which is the reference standard for confirmation of tubal occlusion after Essure (Bayer AG, Leverkusen, Germany) hysteroscopic sterilization. The purpose of our study was to evaluate the accuracy of HyFoSy compared to HSG for confirmation of tubal occlusion after Essure hysteroscopic sterilization.
Antibiotic residue in meat is a serious public health concern due to its harmful effects on consumer health. This study aimed at estimating the residue levels of four commonly used antibiotics in meat samples using three analytical methods (ELISA, TLC and HPLC). A total of 150 samples of raw meat from sales points were analysed for ciprofloxacin, streptomycin, tetracycline, and sulphanilamide residues. Overall, ELISA analysis showed that 56, 34, 18, and 25.3% of the samples tested positive for ciprofloxacin, streptomycin, sulphanilamide and tetracycline residues respectively while TLC and HPLC detected 21.4, 29.4, 92.5, and 14.6%, and 8.3, 41.1, 88.8, and 14.6% of the samples as containing the residues, with ciprofloxacin and sulphanilamide having the lowest and highest occurrence, respectively. Furthermore, the concentrations of antibiotic residues were in the ranges of 19.8-92.8, 26.6-489.1, 14.2-1280.8, and 42.6-355.6 μg/kg with ELISA, while HPLC detected concentration ranges of 20.7-82.1, 41.8-320.8, 65.2-952.2 and 32.8-95.6 μg/kg for sulphanilamide, tetracycline, streptomycin, and ciprofloxacin, respectively. Mean ciprofloxacin and streptomycin residue levels were above the Codex/SA MRL recommended limit, while 3% of the samples contained multidrug residues. Although some of the mean residues levels were below the permissible limits, the co-occurrence of multidrug residues in some of the samples calls for concern.
The sodium-modified form of fluorohectorite nanoclay (NaFh) is introduced as a potential drug carrier, demonstrating its ability for the controlled release of the broad-spectrum antibiotic Ciprofloxacin through in vitro tests. The new clay-drug composite is designed to target the local infections in the large intestine, where it delivers most of the incorporated drug thanks to its pH-sensitive behavior. The composite has been conceived to avoid the use of coating technology and to decrease the side-effects commonly associated to the burst-release of the ciprofloxacin at the stomach level. NaFh was obtained from lithium-fluorohectorite by ion exchange, and its lack of toxicity was demonstrated by in vivo studies. Ciprofloxacin hydrochloride (Cipro) was encapsulated into the clay at different values of the pH, drug initial concentration, temperature and time. Systematic studies by X-ray diffraction (XRD), infrared and visible spectrophotometry (FT-IR and UV-vis), and thermal analysis (TGA) indicated that the NaFh host exhibits a high encapsulation efficiency for Cipro, which reaches a 90% of the initial Cipro in solution at 65 oC, with initial concentration of drug in solution of 1.36 x 10-2 mol L-1 at acid pH. XRD revealed that a true intercalation of Cipro takes place between clay layers. TG showed an increased thermal stability of the drug when intercalated into the clay, as compared to the “free” Cipro. IR suggested a strong clay-Cipro interaction via ketone group, as well as the establishment of hydrogen bonds between the two materials. In vitro drug release tests revealed that NaFh is a potentially efficient carrier to deliver Cipro in the large intestine, where the release process is mediated by more than just one mechanism.
We report here the draft genome sequences of 15 ciprofloxacin-resistant Salmonella enterica strains with resistance to multiple other antibiotics, including aminoglycosides, β-lactams, sulfonamides, tetracycline, and trimethoprim, isolated from different imported foods. Three strains (NCTR75, NCTR281, and NCTR350) showed a high level of ciprofloxacin resistance compared to that of the other isolates. The whole-genome sequencing data provide a better understanding of the antibiotic resistance mechanisms and virulence properties of these isolates.
Premise and Objective: Elective laparoscopic cholecystectomy (LC) has low risk for post-operative infectious complications; still most clinicians use persistent post-operative prophylactic antibiotics out of habit, tradition, or simply as defensive practice due to evolving medicolegal implications of a large number of surgeries being showcased as daycare or next day discharge procedures. This randomised prospective trial was done to test the need for such prophylaxis in cases of elective LC in a rural/semi-urban setting.
The emergence of antibiotics and their active metabolites in aquatic ecosystem has motivated the development of sensitive and reliable sensors to monitor traces of antibiotics and metabolites in drinking water sources (i.e. surface water). The surface enhanced Raman scattering (SERS) technique, which is widely recognized as a high sensitivity method for molecular vibrational detection, is potentially a powerful tool for trace environmental contamination analysis. The main goal of this work is to demonstrate pharmaceutical and metabolite multiplexing detection using the SERS approach. Periodic metallic nanostructures were fabricated using laser interference lithography (LIL) and used as SERS substrates (platform that supports the SERS effect). The LIL method allowed excellent substrate-to-substrate geometric parameters variations; for instance, the variations in periodicity were determined to be less than 1%. A common fluoroquinolone (FQ) parent-and-metabolite pair, enrofloxacin (ENRO) and ciprofloxacin (CIPRO), was targeted for multiplexing detection on the relative uniform substrates fabricated by LIL. The quantifications of the analytes mixtures were achieved by chemometric analysis (i.e. non-negative matrix factorization with alternating least square algorithm (NMF-ALS)). The limit of the quantification (LOQ) of the present method is in the ppm-level with less than 10% spatial variation in the SERS signal.