Drug-induced Adverse Events

Zinc Oxide Nanoparticles Blunt Potassium-Bromate-Induced Renal Toxicity by Reinforcing the Redox System
Molecules. 2023 Jun 29;28(13):5084. doi: 10.3390/molecules28135084.
ABSTRACT
Potassium bromate (PB) is a general food additive, a significant by-product during water disinfection, and a carcinogen (Class II B). The compound emits toxicity depending on the extent of its exposure and dose through consumable items. The current study targeted disclosing the ameliorative efficacy of zinc oxide nanoparticles (ZnO NPs) prepared by green technology in PB-exposed Swiss albino rats. The rats were separated into six treatment groups: control without any treatment (Group I), PB alone (Group II), ZnO alone (Group III), ZnO NP alone (Group IV), PB + ZnO (Group V), and PB + ZnO NPs (Group VI). The blood and kidney samples were retrieved from the animals after following the treatment plan and kept at -20 °C until further analysis. Contrary to the control (Group I), PB-treated rats (Group II) exhibited a prominent trend in alteration in the established kidney function markers and disturbed redox status. Further, the analysis of the tissue and nuclear DNA also reinforced the biochemical results of the same treatment group. Hitherto, Groups III and IV also showed moderate toxic insults. However, Group VI showed a significant improvement from the PB-induced toxic insults compared to Group II. Hence, the present study revealed the significant therapeutic potential of the NPs against PB-induced nephrotoxicity in vivo, pleading for their usage in medicines having nephrotoxicity as a side effect or in enhancing the safety of the industrial use of PB.
PMID:37446744 | PMC:PMC10343659 | DOI:10.3390/molecules28135084
Targeting Opioid Receptors in Addiction and Drug Withdrawal: Where Are We Going?
Int J Mol Sci. 2023 Jun 29;24(13):10888. doi: 10.3390/ijms241310888.
ABSTRACT
This review article offers an outlook on the use of opioids as therapeutics for treating several diseases, including cancer and non-cancer pain, and focuses the analysis on the opportunity to target opioid receptors for treating opioid use disorder (OUD), drug withdrawal, and addiction. Unfortunately, as has been well established, the use of opioids presents a plethora of side effects, such as tolerance and physical and physiological dependence. Accordingly, considering the great pharmacological potential in targeting opioid receptors, the identification of opioid receptor ligands devoid of most of the adverse effects exhibited by current therapeutic agents is highly necessary. To this end, herein, we analyze some interesting molecules that could potentially be useful for treating OUD, with an in-depth analysis regarding in vivo studies and clinical trials.
PMID:37446064 | PMC:PMC10341731 | DOI:10.3390/ijms241310888
In Vitro/In Vivo Hepatoprotective and Antioxidant Effects of Defatted Extract and a Phenolic Fraction Obtained from <em>Phlomis Tuberosa</em>
Int J Mol Sci. 2023 Jun 25;24(13):10631. doi: 10.3390/ijms241310631.
ABSTRACT
An in vitro/in vivo hepatotoxicity and hepatoprotection evaluation of a defatted extract and a phenolic fraction from Phlomis tuberosa, administered alone and in a carbon tetrachloride (CCl4)-induced metabolic bioactivation model, was performed. The extract and the phenolic fraction were analysed by high performance liquid chromatography (HPLC) to determine the total flavonoid content, to identify flavonoids and to quantify verbascoside. In addition, total polyphenolics in the samples were expressed as gallic acid equivalents. Applied alone, the extract and the fraction (5, 10 and 50 µg/mL) did not show a statistically significant hepatotoxic effect on isolated rat hepatocytes in vitro. In a CCl4-induced hepatotoxicity model, the samples exhibited a concentration-dependent, statistically significant hepatoprotective effect, which was most pronounced at 50 µg/mL for both. The phenolic fraction exhibited a more pronounced hepatoprotective effect compared to the extract. Data from the in vitro study on the effects of the extract were also confirmed in the in vivo experiment conducted in a CCl4-induced hepatotoxicity model in rats. A histopathological study showed that the animals treated with CCl4 and the extract had an unaltered histoarchitecture of the liver. The effects of the extract were the same as those of silymarin.
PMID:37445808 | PMC:PMC10341447 | DOI:10.3390/ijms241310631
Rosuvastatin-induced rhabdomyolysis: case report and call for proactive multifactorial risk assessment and preventive management of statin therapy in high-risk patients
Eur J Hosp Pharm. 2023 Jul 14:ejhpharm-2023-003765. doi: 10.1136/ejhpharm-2023-003765. Online ahead of print.
ABSTRACT
Cholesterol-lowering statins are frequently prescribed for primary and secondary prevention of ischaemic vascular events. Whereas most patients tolerate statins without problems, statin-associated myopathy is well documented, as are several risk factors. We present a case report of an 80-90-year-old man with coronary artery disease who rapidly developed severe rhabdomyolysis during treatment with rosuvastatin while in intensive care. He had several concomitant risk factors for statin-induced myopathy including high dosage, old age, renal and hepatic impairment, and a pharmacogenetic SLCO1B1*1 a/*5 variant. Single known risk factors have a low predictive value for statin-induced myopathy and may therefore be underestimated in clinical practice. However, adverse drug reactions frequently involve the joint action of a multitude of environmental and genetic component causes, and statin-induced myopathy should be regarded as a multicausal event. We therefore advocate a proactive multifactorial risk assessment to guide and individualise statin therapy in high-risk patients.
PMID:37451842 | DOI:10.1136/ejhpharm-2023-003765
Local anesthetic dosing and toxicity of adult truncal catheters: a narrative review of published practice
Reg Anesth Pain Med. 2023 Jul 14:rapm-2023-104667. doi: 10.1136/rapm-2023-104667. Online ahead of print.
ABSTRACT
BACKGROUND/IMPORTANCE: Anesthesiologists frequently use truncal catheters for postoperative pain control but with limited characterization of dosing and toxicity.
OBJECTIVE: We reviewed the published literature to characterize local anesthetic dosing and toxicity of paravertebral and transversus abdominis plane catheters in adults.
EVIDENCE REVIEW: We searched the literature for bupivacaine or ropivacaine infusions in the paravertebral or transversus abdominis space in humans dosed for 24 hours. We evaluated bolus dosing, infusion dosing and cumulative 24-hour dosing in adults. We also identified cases of local anesthetic systemic toxicity and toxic blood levels.
FINDINGS: Following screening, we extracted data from 121 and 108 papers for ropivacaine and bupivacaine respectively with a total of 6802 patients. For ropivacaine and bupivacaine, respectively, bolus dose was 1.4 mg/kg (95% CI 0.4 to 3.0, n=2978) and 1.0 mg/kg (95% CI 0.18 to 2.1, n=2724); infusion dose was 0.26 mg/kg/hour (95% CI 0.06 to 0.63, n=3579) and 0.2 mg/kg/hour (95% CI 0.06 to 0.5, n=3199); 24-hour dose was 7.75 mg/kg (95% CI 2.1 to 15.7, n=3579) and 6.0 mg/kg (95% CI 2.1 to 13.6, n=3223). Twenty-four hour doses exceeded the package insert recommended upper limit in 28% (range: 17%-40% based on maximum and minimum patient weights) of ropivacaine infusions and 51% (range: 45%-71%) of bupivacaine infusions. Toxicity occurred in 30 patients and was associated with high 24-hour dose, bilateral catheters, cardiac surgery, cytochrome P-450 inhibitors and hypoalbuminemia.
CONCLUSION: Practitioners frequently administer ropivacaine and bupivacaine above the package insert limits, at doses associated with toxicity. Patient safety would benefit from more specific recommendations to limit excessive dose and risk of toxicity.
PMID:37451826 | DOI:10.1136/rapm-2023-104667
Angiotensin-Converting Enzyme Inhibitor-Induced Angioedema: A Case Report With a Review of Management Options
Cureus. 2023 Jun 12;15(6):e40320. doi: 10.7759/cureus.40320. eCollection 2023 Jun.
ABSTRACT
Angiotensin-converting enzyme inhibitors (ACEIs) are widely used for heart failure, renal failure, diabetic nephropathy, stroke, arterial hypertension, and a number of other cardiovascular or related conditions. ACEI-induced angioedema is a rare entity but can result in life-threatening emergencies. It mainly occurs in patients starting on ACEI as an antihypertensive. We present a case of lisinopril-induced angioedema in an African American patient managed in the emergency department. After appropriate evaluation, the patient was declared safe to be observed in the emergency department. Intubation was not performed. Early identification of angioedema is paramount, and emergency physicians should maintain airways or intubate such patients if indicated. There should be a high level of suspicion of angioedema in patients taking ACEIs if they present with symptoms of respiratory compromise.
PMID:37448396 | PMC:PMC10337988 | DOI:10.7759/cureus.40320
Norethisterone-Induced Liver Injury and a Short Survey Among Gynecologists
Cureus. 2023 Jun 12;15(6):e40300. doi: 10.7759/cureus.40300. eCollection 2023 Jun.
ABSTRACT
Norethisterone, a commonly used oral contraceptive, and treatment for various gynecological disorders such as menorrhagia, abnormal uterine bleeding, and breast cancer, has been associated with multiple liver injuries. These injuries can manifest as hepatitis or cholestatic types of injury, benign neoplasms, peliosis hepatis, sinusoidal obstruction syndrome, and enlargement of existing hemangiomas. This report presents three cases in which liver enzyme levels were elevated due to norethisterone intake. Two of the cases were individuals undergoing evaluation as potential kidney donors in the nephrology department for their spouses, while the third case involved a patient with chronic kidney disease (CKD) stage-5 on maintenance hemodialysis. Regular follow-up of these patients, particularly due to the significance of two being kidney donors and one having advanced CKD, allowed for early detection of asymptomatic liver enzyme elevation and prompt discontinuation of norethisterone. Prescribing norethisterone is common in gynecological settings, including ours. To assess gynecologists' knowledge regarding norethisterone-related side effects, we conducted an online survey, the results of which are discussed in this report.
PMID:37448392 | PMC:PMC10337502 | DOI:10.7759/cureus.40300
Drug-Associated Gastropathy: Diagnostic Criteria
Diagnostics (Basel). 2023 Jun 29;13(13):2220. doi: 10.3390/diagnostics13132220.
ABSTRACT
Drugs are widely used to treat different diseases in modern medicine, but they are often associated with adverse events. Those located in the gastrointestinal tract are common and often mild, but they can be serious or life-threatening and determine the continuation of treatment. The stomach is often affected not only by drugs taken orally but also by those administered parenterally. Here, we review the mechanisms of damage, risk factors and specific endoscopic, histopathological and clinical features of those drugs more often involved in gastric damage, namely NSAIDs, aspirin, anticoagulants, glucocorticosteroids, anticancer drugs, oral iron preparations and proton pump inhibitors. NSAID- and aspirin-associated forms of gastric damage are widely studied and have specific features, although they are often hidden by the coexistence of Helicobacter pylori infection. However, the damaging effect of anticoagulants and corticosteroids or oral iron therapy on the gastric mucosa is controversial. At the same time, the increased use of new antineoplastic drugs, such as checkpoint inhibitors, has opened up a new area of gastrointestinal damage that will be seen more frequently in the near future. We conclude that there is a need to expand and understand drug-induced gastrointestinal damage to prevent and recognize drug-associated gastropathy in a timely manner.
PMID:37443618 | DOI:10.3390/diagnostics13132220
Efficacy and safety of Fufang Xueshuantong Capsules in combination with conventional drugs in the treatment of glaucoma: A meta-analysis and trial sequential analysis
Medicine (Baltimore). 2023 Jul 14;102(28):e34202. doi: 10.1097/MD.0000000000034202.
ABSTRACT
BACKGROUND: Glaucoma is the leading cause of irreversible blindness worldwide. The aim of this study was to evaluate the efficacy and safety of Fufang Xueshuantong Capsules (FFXST) in combination with conventional drugs in the treatment of glaucoma using meta-analysis and trial sequential analysis (TSA).
METHODS: Clinical trials of FFXST for glaucoma were identified in 8 databases until November 2022, and studies were included for meta-analysis and trial sequential analysis.
RESULTS: In terms of efficacy endpoints, meta-analysis showed that the combination group of FFXST significantly improved clinical effective rate (RR 1.29, 95% CI 1.20-1.39, P < .00001), visual function (MD 0.04, 95% CI 0.04-0.05, P < .00001), light sensitivity (MD 6.07, 95% CI 4.63-7.51, P < .00001), end-systolic blood flow velocity (MD 2.68, 95% CI 2.19-3.16, P < .00001) and end-diastolic blood flow velocity (MD 2.07, 95% CI 1.86-2.28, P < .00001), and significantly reduced total gray-scale value (MD -64.38, 95% CI -69.08 to -59.68, P < .00001) and defect of visual field (MD -3.40, 95% CI -4.11 to -2.69, P < .00001) compared with the conventional regimen group, while the pulsatility index and resistance index were comparable. The TSA indicated that these benefits were conclusive. In terms of safety endpoints, meta-analysis demonstrated that total drug-related adverse events in the combination group of FFXST were comparable to those in the conventional regimen group, with TSA showing that more studies are needed to validate the current results.
CONCLUSION: FFXST may be a safety and effective supplementary strategy for the treatment of glaucoma, which is worthy of further research.
PMID:37443494 | DOI:10.1097/MD.0000000000034202
Reply to: Marketing pitches of 'magic mushrooms' and 'psychedelics' mask that psychotomimetics use exposes those vulnerable to serious adverse effects
J Psychopharmacol. 2023 Jul;37(7):750-751. doi: 10.1177/02698811231169641a.
NO ABSTRACT
PMID:37439350 | DOI:10.1177/02698811231169641a
Construction and application of microneedle-mediated photothermal therapy and immunotherapy combined anti-tumor drug delivery system
Drug Deliv. 2023 Dec;30(1):2232950. doi: 10.1080/10717544.2023.2232950.
ABSTRACT
Conventional treatments for tumors were frequently accompanied by drawbacks and side effects. It might be useful to use the revolutionary microneedle technology which combines photothermal therapy with tumor immunotherapy. In this study, we created a microneedle drug delivery system with mercapto-modified gold nanorods and immune checkpoint blocker anti-PD-1 polypeptide. With good mechanical strength, the microneedle system can efficiently penetrate the skin and deliver drugs. When inserted into human skin, anti-PD-1 peptides and gold nanorods can be released, boosting the capacity of cytotoxic T lymphocytes to destroy tumor cells. Additionally, the elimination of the tumor is aided by the production of heat while being exposed to near-infrared light. This microneedle drug delivery system can enhance the immunological reaction and prolong the survival time of mice. Moreover, it has been demonstrated that the system has mild toxic and side effects on normal tissues and can effectively inhibit the growth of tumors, indicating a bright prospect for the treatment of cancers.
PMID:37439010 | DOI:10.1080/10717544.2023.2232950
A dual nociceptin and mu opioid receptor agonist exhibited robust antinociceptive effect with decreased side effects
Eur J Med Chem. 2023 Oct 5;258:115608. doi: 10.1016/j.ejmech.2023.115608. Epub 2023 Jul 1.
ABSTRACT
The compelling demand of a consummate analgesic medication without addiction is rising due to the clinical mistreatment. Additionally, the series of severe untoward effects usually deterred the utilization while coping with serious pain. As a possible turning point, we revealed that compound 14 is a dual agonist of mu opioid receptor (MOR) and nociceptin-orphanin FQ opioid peptide (NOP) receptor in this study. More importantly, compound 14 achieves pain relieving at very small doses, meanwhile, reduces several unwanted side effects such as constipation, reward, tolerance and withdrawal effects. Here, we evaluated the antinociception and side effects of this novel compound from wild type and humanized mice to further develop a safer prescription analgesic drug.
PMID:37437352 | DOI:10.1016/j.ejmech.2023.115608
Systemic Therapy in Older Patients With High-Risk Disease
Am Soc Clin Oncol Educ Book. 2023 Jun;43:e390456. doi: 10.1200/EDBK_390456.
ABSTRACT
Adjuvant systemic treatments for older patients with breast cancer require constant dose or schedule adjustments of standards established for younger ones. This is mainly due to frailty that increases according to age (40%-50% of signals in all comers after age 70 years) and remains difficult to spot or diagnose accurately and therefore is often overlooked. Older patients are at higher risk to develop side effects whether under chemotherapy, optimized endocrine treatment, or targeted therapies. Pharmacokinetic reflects poorly functional reserves that reduce with aging and is therefore misleading. The demonstration of significant long-term benefits provided by adjuvant treatments is challenged by life expectancy, driven by multimorbidity status that increases with age, competing with cancer outcome. When geriatric assessment is incorporated into the multidisciplinary team, treatment decision process shows 30%-50% changes, de-escalating initial age-agnostic treatment choices in two of three cases. Finally, expectations from treatment vary over the years: In older ones, although not being exclusive, there is a general shift of preference for protecting functionality, cognitive functions, and independence, as summarized in quality of life that many systemic adjuvant treatment may jeopardize. These provocative considerations show importance to pay more attention to expectations expressed by older patients to limit gaps between what is thought by health care professionals as right, often on the basis of dose intensity models strongly engrained in oncology and that older patients may assess counterintuitively differently. The most achieved molecular testing to identify high-risk luminal tumors should be combined with determinant geriatric factors to bring relevant global information in the adjuvant setting for older patients.
PMID:37437232 | DOI:10.1200/EDBK_390456
The synergistic impact of Spirulina and selenium nanoparticles mitigates the adverse effects of heat stress on the physiology of rabbits bucks
PLoS One. 2023 Jul 12;18(7):e0287644. doi: 10.1371/journal.pone.0287644. eCollection 2023.
ABSTRACT
Heat stress has a detrimental effect on animal fertility, particularly testicular functions, including reduced sperm output and quality, which causes an economic loss in the production of rabbits. The present trial investigated the efficacy of dietary Spirulina (SP) (Arthrospira platensis), selenium nanoparticles (SeNPs), and their combination (SP-SeNPs) on semen quality, haemato-biochemical, oxidative stress, immunity, and sperm quality of heat-stressed (HS) rabbit bucks. Sixty mature bucks (APRI line) were distributed into 6 groups of ten replicates under controlled conditions. Bucks in the 1st group (control-NC) were kept under normal conditions (11-22°C; 40-45% RH% = relative humidity), while the 2nd group (control-HS) was kept under heat stress conditions (32±0.50°C; 60-66% RH %). The control groups were fed a commercial pelleted diet and the other four heat-stressed groups were fed a commercial pelleted diet with 1 g SP, 25 mg SeNPs, 1 g SP+25 mg SeNPs, and 1 g SP+50 mg SeNPs per kg diet, respectively. The dietary inclusion of SP, SeNPs, and their combinations significantly increased hemoglobin, platelets, total serum protein, high-density lipoproteins, glutathione, glutathione peroxidase, superoxide dismutase, and seminal plasma testosterone while decreased triglycerides, total cholesterol, urea, creatinine, and malondialdehyde compared with the control-HS. Red blood cells, packed cell volume, serum albumin, and testosterone significantly increased, while SeNPs, SP+SeNPs25, and SP+SeNPs50 significantly decreased low-density lipoproteins, aspartate, and alanine amino transferees. Total antioxidant capacity substantially increased in serum and seminal plasma, while seminal plasma malondialdehyde decreased in 25 or 50 mg of SeNPs+SP/kg groups. All supplements significantly improved libido, sperm livability, concentration, intact acrosome, membrane integrity, total output in fresh semen, and sperm quality in cryopreserved semen. SP-SeNPs50 had higher synergistic effect than SP-SeNPs25 on most different variables studied. In conclusion, the dietary inclusion of SP plus SeNPs50 has a synergistic effect and is considered a suitable dietary supplement for improving reproductive efficiency, health, oxidative stress, and immunity of bucks in the breeding strategy under hot climates.
PMID:37437098 | DOI:10.1371/journal.pone.0287644
Standard RUTF vs. locally-made RUSF for acutely malnourished children: A quasi-experimental comparison of the impact on growth and compliance in a rural community of Pakistan
PLoS One. 2023 Jul 12;18(7):e0287962. doi: 10.1371/journal.pone.0287962. eCollection 2023.
ABSTRACT
BACKGROUND: The reduction in severe and moderate acute malnutrition (SAM and MAM) rates in Pakistan has been sub-optimal compared to other low-and middle-income countries (LMICs). Specially-formulated products have been designed globally to manage SAM and MAM, such as ready-to-use therapeutic food (RUTF) and ready-to-use supplementary food (RUSF), with variable efficacies. RUTF is primarily produced and patented in industrialized countries, raising supply challenges in resource-constrained regions with a high burden of acute malnutrition. RUSF minimizes costs by using locally-available ingredients while providing similar nutritional value. In this study, we compared the efficacy, side effects, and compliance of two months of supplementation with either RUTF or RUSF.
METHODS: Children aged nine months in the rural district of Matiari, Pakistan, with a weight-for-height z-score (WHZ) <-2 received either RUTF (500 kcal sachet) for two months in 2015 or RUSF (520 kcal sachet) for two months in 2018.
RESULTS: The RUSF group had a higher height gain and mid-upper arm circumferences (MUAC) score. Higher compliance was noted with lower side effects in the RUSF group. A higher compliance rate did correlate with the growth parameters in respective groups.
CONCLUSION: Our study found that both RUTF and RUSF partially improve the anthropometric status of acutely malnourished children, with neither being superior to the other.
PMID:37437065 | DOI:10.1371/journal.pone.0287962
Analysis of notified drug poisoning among children in Santa Catarina state, 2016-2020
Rev Paul Pediatr. 2023 Jul 10;42:e2022155. doi: 10.1590/1984-0462/2024/42/2022155. eCollection 2023.
ABSTRACT
OBJECTIVE: The aim of this study was to analyze the incidence of drug poisoning in children registered in the Santa Catarina Information and Toxicological Assistance Center between 2016 and 2020.
METHODS: This observational epidemiological study, with a historical cohort design, was carried out from reported cases of drug poisoning in children aged 0-12 years. Census sampling was used to collect data.
RESULTS: There were 4839 reported cases of drug poisoning among children in the State of Santa Catarina in the surveyed period, with an average annual incidence rate of 6 cases/1000 live births. The median age was 3 years. Most cases of poisoning occurred among girls aged 0-3 years by accidental ingestion of drugs at home. There was a predominance of signs and symptoms affecting the nervous system; only a small portion required hospitalization. Most cases were considered mild poisoning with a favorable outcome. No deaths were recorded. There was a tendency of increasing cases over time, however not significant. There is a predominance of incident cases in the Great West of the state, followed by the Midwest and Serra Catarinense regions.
CONCLUSIONS: Drug poisoning in children is predominant in early childhood, mainly caused by accidental ingestion of drugs at home. These findings highlight the importance of preventive and educational measures among family members and caregivers.
PMID:37436247 | PMC:PMC10332441 | DOI:10.1590/1984-0462/2024/42/2022155
Antibiotics for lower respiratory tract infection in children presenting in primary care: ARTIC-PC RCT
Health Technol Assess. 2023 Jun;27(9):1-90. doi: 10.3310/DGBV3199.
ABSTRACT
BACKGROUND: Antimicrobial resistance is a global health threat. Antibiotics are commonly prescribed for children with uncomplicated lower respiratory tract infections, but there is little randomised evidence to support the effectiveness of antibiotics in treating these infections, either overall or relating to key clinical subgroups in which antibiotic prescribing is common (chest signs; fever; physician rating of unwell; sputum/rattly chest; shortness of breath).
OBJECTIVES: To estimate the clinical effectiveness and cost-effectiveness of amoxicillin for uncomplicated lower respiratory tract infections in children both overall and in clinical subgroups.
DESIGN: Placebo-controlled trial with qualitative, observational and cost-effectiveness studies.
SETTING: UK general practices.
PARTICIPANTS: Children aged 1-12 years with acute uncomplicated lower respiratory tract infections.
OUTCOMES: The primary outcome was the duration in days of symptoms rated moderately bad or worse (measured using a validated diary). Secondary outcomes were symptom severity on days 2-4 (0 = no problem to 6 = as bad as it could be); symptom duration until very little/no problem; reconsultations for new or worsening symptoms; complications; side effects; and resource use.
METHODS: Children were randomised to receive 50 mg/kg/day of oral amoxicillin in divided doses for 7 days, or placebo using pre-prepared packs, using computer-generated random numbers by an independent statistician. Children who were not randomised could participate in a parallel observational study. Semistructured telephone interviews explored the views of 16 parents and 14 clinicians, and the data were analysed using thematic analysis. Throat swabs were analysed using multiplex polymerase chain reaction.
RESULTS: A total of 432 children were randomised (antibiotics, n = 221; placebo, n = 211). The primary analysis imputed missing data for 115 children. The duration of moderately bad symptoms was similar in the antibiotic and placebo groups overall (median of 5 and 6 days, respectively; hazard ratio 1.13, 95% confidence interval 0.90 to 1.42), with similar results for subgroups, and when including antibiotic prescription data from the 326 children in the observational study. Reconsultations for new or worsening symptoms (29.7% and 38.2%, respectively; risk ratio 0.80, 95% confidence interval 0.58 to 1.05), illness progression requiring hospital assessment or admission (2.4% vs. 2.0%) and side effects (38% vs. 34%) were similar in the two groups. Complete-case (n = 317) and per-protocol (n = 185) analyses were similar, and the presence of bacteria did not mediate antibiotic effectiveness. NHS costs per child were slightly higher (antibiotics, £29; placebo, £26), with no difference in non-NHS costs (antibiotics, £33; placebo, £33). A model predicting complications (with seven variables: baseline severity, difference in respiratory rate from normal for age, duration of prior illness, oxygen saturation, sputum/rattly chest, passing urine less often, and diarrhoea) had good discrimination (bootstrapped area under the receiver operator curve 0.83) and calibration. Parents found it difficult to interpret symptoms and signs, used the sounds of the child's cough to judge the severity of illness, and commonly consulted to receive a clinical examination and reassurance. Parents acknowledged that antibiotics should be used only when 'necessary', and clinicians noted a reduction in parents' expectations for antibiotics.
LIMITATIONS: The study was underpowered to detect small benefits in key subgroups.
CONCLUSION: Amoxicillin for uncomplicated lower respiratory tract infections in children is unlikely to be clinically effective or to reduce health or societal costs. Parents need better access to information, as well as clear communication about the self-management of their child's illness and safety-netting.
FUTURE WORK: The data can be incorporated in the Cochrane review and individual patient data meta-analysis.
TRIAL REGISTRATION: This trial is registered as ISRCTN79914298.
FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 9. See the NIHR Journals Library website for further project information.
PMID:37436003 | DOI:10.3310/DGBV3199
Model for Predicting Complications of Hemodialysis Patients Using Data From the Internet of Medical Things and Electronic Medical Records
IEEE J Transl Eng Health Med. 2023 Jan 5;11:375-383. doi: 10.1109/JTEHM.2023.3234207. eCollection 2023.
ABSTRACT
Intelligent models for predicting hemodialysis-related complications, i.e., hypotension and the deterioration of the quality or obstruction of the AV fistula, based on machine learning (ML) methods were established to offer early warnings to medical staff and give them enough time to provide pre-emptive treatment. A novel integration platform collected data from the Internet of Medical Things (IoMT) at a dialysis center and inspection results from electronic medical records (EMR) to train ML algorithms and build models. The selection of the feature parameters was implemented using Pearson's correlation method. Then, the eXtreme Gradient Boost (XGBoost) algorithm was chosen to create the predictive models and optimize the feature choice. 75% of collected data are used as a training dataset and the other 25% are used as a testing dataset. We adopted the prediction precision and recall rate of hypotension and AV fistula obstruction to measure the effectiveness of the predictive models. These rates were sufficiently high at approximately 71%-90%. In the context of hemodialysis, hypotension and the deterioration of the quality or obstruction of the arteriovenous (AV) fistula affect treatment quality and patient safety and may lead to a poor prognosis. Our prediction models with high accuracies can provide excellent references and signals for clinical healthcare service providers. Clinical and Translational Impact Statement-With the integrated dataset collected from IoMT and EMR, the superior predictive results of our models for complications of hemodialysis patients are demonstrated. We believe, after enough clinical tests are implemented as planned, these models can assist the healthcare team in making appropriate preparations in advance or adjusting the medical procedures to avoid these adverseevents.
PMID:37435541 | PMC:PMC10332468 | DOI:10.1109/JTEHM.2023.3234207
Y-site simulation compatibility study of 10% calcium salts with various injectable solutions during toxicological resuscitation
Eur J Hosp Pharm. 2023 Jul 12:ejhpharm-2023-003689. doi: 10.1136/ejhpharm-2023-003689. Online ahead of print.
ABSTRACT
PURPOSE: To determine the physical compatibility of 10% calcium chloride and 10% calcium gluconate in combination with injectable solutions, administered in the paediatric and adult intensive care unit setting during toxicological resuscitation involving calcium channel blockers and beta-blockers.
METHODS: Forty-eight combinations were prepared at room temperature, including the following products: calcium chloride, calcium gluconate, insulin, epinephrine, norepinephrine, highly concentrated dextrose solution, sodium chloride, Plasma-Lyte A and Ringer's lactate. A visual evaluation at times 0, 1, 4, 24, 48 and 72 hours and a particle count test with the LS-20 particle counter at times 0, 4, 24 and 72 hours were performed. The admixtures were considered incompatible if there was a precipitate, a colour change, turbidity, viscosity or a gas formation. The stability of calcium salts was also tested in empty IV bags and syringes by the particle count test.
RESULTS: All drug mixtures were found to be compatible by visual evaluation and using the particle counter based on United States Pharmacopoeia chapter 788 (USP<788>) specifications. Calcium salts were compatible with insulin and vasopressors in the tested combinations. The stability of 10% calcium salts in empty IV bags and polypropylene syringes was demonstrated for up to 48 hours at room temperature.
CONCLUSION: All the combinations tested were physically compatible for up to 72 hours at room temperature. Clinical use of calcium salt infusions, at an undiluted concentration, in combination with these injectable solutions in a toxicological resuscitation context is considered clinically acceptable.
PMID:37438091 | DOI:10.1136/ejhpharm-2023-003689
Safety update: NSAIDs in pregnancy
Drug Ther Bull. 2023 Jul 12:dtb-2023-000039. doi: 10.1136/dtb.2023.000039. Online ahead of print.
NO ABSTRACT
PMID:37438090 | DOI:10.1136/dtb.2023.000039