Background Antimicrobial agents are among the most commonly prescribed drugs in pregnancy due to the increased susceptibility to infections during pregnancy. Antimicrobials can contribute to different maternal complications. Therefore, it is important to study their patterns in prescription and utilization. The data regarding this issue is scarce in Saudi Arabia. Therefore, the aim of this study is to generate data on the antimicrobial agents that are most commonly prescribed during pregnancy as well as their indications and safety. Methods This is a retrospective study focusing on pregnant women with a known antimicrobial use at Johns Hopkins Aramco Healthcare (JHAH). The sample included 344 pregnant women with a total of 688 antimicrobial agents prescribed. Data was collected on the proportion of pregnant women who received antimicrobial agents and on the drug safety during pregnancy using the risk categorization system of the U.S. Food and Drug Administration (FDA). Results The results showed that urinary tract infections (UTIs) were the most reported (59%) infectious diseases. Around 48% of pregnant women received antimicrobial medications at some point during pregnancy. The top two antimicrobial agents based on prescription frequency were B-lactams (44.6%) and azole anti-fungals (30%). The prescribed drugs in the study were found to be from classes B, C and D under the FDA risk classification system. Conclusion The study revealed a high proportion of antimicrobials prescribed during pregnancy that might pose risks to mothers and their fetuses. Future multicenter studies are warranted to evaluate the rational prescription of antimicrobial medications during pregnancy.
Background: Coronavirus 2019 (COVID-19) patients are at risk of thrombosis. Literature that compares the effectiveness of enoxaparin to unfractionated heparin (UFH) in COVID-19 patients is scarce. Objective: We aimed to evaluate the effectiveness and safety of enoxaparin compared with UFH when used at their standard/intermediate dosing in COVID-19 patients. Methods: This was a retrospective study conducted at a large COVID-19 center located in Eastern Province, Saudi Arabia. Confirmed COVID-19 cases (≥18 years old) admitted between January and December 2020 were randomly screened for inclusion. Exclusion criteria were patients receiving therapeutic anticoagulation, on chronic anticoagulation, had active bleeding, a platelet count <25 × 109/L, or an incomplete electronic file. The primary endpoint was the occurrence of any thrombotic event (pulmonary embolism, deep venous thrombosis, stroke, or myocardial infarction) or mortality. Secondary endpoints were major or minor bleeding. We applied inverse propensity score weighting (IPTW) with survival analysis to analyze the primary endpoint. Logistic regression was used for the secondary endpoint. Results: A total of 980 patients were included (enoxaparin, n = 470 and UFH, n = 510) with a mean age (±SD) of 47.7 (± 12.3) for the enoxaparin arm and 52 (±13.9) for the UFH arm. There was a statistically significant difference in the primary endpoint with an adjusted hazard ratio (aHR) of 0.46 (95%CI: 0.22 to 0.96, P = 0.039) in favor of the enoxaparin arm. There was no statistically significant difference in major or minor bleeding rates between the two arms. Conclusion and Relevance: When compared with UFH, enoxaparin was associated with a significant reduction in thrombotic events or mortality among COVID-19 patients. The results need confirmation from randomized controlled trials.
Background Antimicrobial agents are considered among the most commonly prescribed drugs in pregnancy given the increased susceptibility of infections during pregnancy. Antimicrobials can contribute to different maternal complications. Therefore, it is important to study their prescribing and utilization pattern. Such type of data regarding this issue is scarce in Saudi Arabia and this encouraged us to conduct this research. The aim of this study is to generate data about the most commonly prescribed antimicrobial agents during pregnancy, as well as their indicators and safety. Methods This is a retrospective study focusing on pregnant women with a known antimicrobial consumption at Johns Hopkins Aramco Healthcare (JHAH). The sample size was 344 pregnant women with 688 antimicrobial prescriptions. Data was collected about prevalence of infections and antimicrobial prescriptions in addition to drug safety during pregnancy using FDA risk categorization system. Results The results showed that Urinary Tract Infections (UTIs) were the most reported (59%) infectious diseases. Around 48% of pregnant women received antimicrobial medications at some point during their pregnancy. The top two antimicrobial agents based on prescription frequency were B-lactams (44.6%) and azole anti-fungals (30%). The prescribed drugs in the study were found to be from B, C and D classes according to the FDA risk classification system. Conclusion Overall antimicrobial prescribing practices were appropriate. The study revealed a high prevalence of antimicrobials prescribing during pregnancy that might pose risks to mothers and their fetuses. Future multi center studies are warranted to evaluate the rational prescribing of antimicrobial medications during pregnancy.
Background relevance: A plethora of literature is available regarding the clinical trials for natural products however; no information is available for critical assessments of the quality of these clinical trials. Aim of study: This is a first time report to critically evaluate the efficacy, safety and large scale applications of up-to-date clinical trials for diabetes, based on the three scales of Jadad, Delphi, and Cochrane. Methodology: An in-depth and extensive literature review was performed using various databases, journals, and books. The keywords searched included, “clinical trials,” “clinical trial in diabetes,” “diabetes,” “natural products in diabetes,” “ethnopharmacological relevance of natural products in diabetes,” etc. Results: Based on eligibility criteria, 16 plants with 74 clinical trials were found and evaluated. Major drawbacks observed were; “non-randomization and blindness of the studies,” “non-blindness of patients/healthcare/outcome assessors,” “lack of patient compliance and co-intervention reports,” “missing information regarding drop-out/withdrawal procedures,” and “inappropriate baseline characteristics.” Principal component analysis and Pearson correlation revealed four components with %variability; PC1: 23.12, PC2: 15.83, PC3: 13.11, and PC4: 11.38 ( P ≤ .000). According to descriptive statistics, “non-blinding of outcome assessors” was the major drawback (82%) whereas, “not mentioning the timing of outcome assessment” was observed lowest (6.8%). An in-house quality grading (scale 0–24) classified these clinical trials as; poor (67.6%), acceptable (19.9%), and good quality trials (13.5%). Conclusion: Proper measures in terms of more strict regulations with pharmacovigilance of plants are utmost needed in order to achieve quality compliance of clinical trials.
Currently, the whole world is facing a life-threatening novel coronavirus 2019 (COVID-19) pandemic. Natural products are well-known for their potential role against viral disease, and some anti-viral agents have been developed to combat these diseases. Herein, the authors investigated the possible effects of this Holy plant Nigella sativaL. (NS), against coronavirus, using evidence-based and mechanistic approaches to conclude the immune-boosting and alleviation of respiratory systemeffects of NS. The pharmacological studies established a prominent role in treating various respiratory, immune systems, cardiovascular, skin, and gastrointestinal disorders. Literature supported the significant anti-viral role and showed an inhibitory role for NS against MHV-A59 CoV (mouse-hepatitis virus–A59) infected Hela, i.e., HeLaCEACAM1a (HeLa-epithelial carcinoembryonic antigen-related cell adhesion molecule 1a) cell. NS is a safe herbal product or dietary supplement and could be an effective and affordable community adjuvant treatment for coronavirus in the current scenario.
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