Obes Surg. 2023 Feb 14. doi: 10.1007/s11695-023-06502-9. Online ahead of print.

ABSTRACT

PURPOSE: μ-receptor opioids are associated with unwanted gastrointestinal side effects and respiratory depression. A long-acting non-μ-receptor parenteral opioid is not currently available for management of acute and chronic postsurgical pain (CPSP). This double-blind clinical trial tested an extended-release κ-receptor agonist, sebacoyl dinalbuphine ester (SDE, Naldebain®) for management of surgical pain after laparoscopic bariatric surgery.

MATERIALS AND METHODS: Patients were randomly assigned to receive a single intramuscular injection of SDE (150 mg, n = 30) or vehicle solution (n = 30) at > 12 h before surgery. All patients received standard perioperative multimodal analgesia (MMA). The primary endpoint was the pain intensity in the beginning 7 days after operation. The secondary endpoints were adverse reactions up to 7 days and incidence of CPSP at 3 months after surgery.

RESULTS: Compared with placebos, the area under curves of visual analog scale (VAS) for 0-48 h after operation were significantly reduced in SDE group (143.3 ± 65.4 and 105.9 ± 36.3, P = 0.025). There were significantly fewer patients in the SDE group who had moderate-to-severe pain (VAS ≥ 4) (16.7% vs 50%; P = 0.012) at postoperative 48 h. Pain intensities were similar between the two groups at 72 h and 7 days postoperatively. The incidence of CPSP at 3 months was not different. SDE did not increase drug-related systemic adverse events.

CONCLUSION: In addition to the standard perioperative MMA, a single-dose injection of long-acting κ-receptor agonist SDE provides significantly better pain management for 48 h following laparoscopic bariatric surgery. A long-acting κ-receptor agonist opioid could improve in-hospital pain management and potentiate early discharge after operation without increasing drug-related systemic complications.

PMID:36787017 | DOI:10.1007/s11695-023-06502-9

Clin Infect Dis. 2023 Feb 14:ciad070. doi: 10.1093/cid/ciad070. Online ahead of print.

ABSTRACT

BACKGROUND: The optimal duration of antimicrobial therapy for urinary tract infections in men remains controversial.

METHODS: To compare 7 days to 14 days total antibiotic treatment for febrile urinary tract infections in men, this multicenter randomized, double-blind placebo-controlled non-inferiority trial enrolled 282 men from 27 centers in France. Men were eligible if they had a febrile urinary tract infection and urine culture showing a single uropathogen.Participants were treated with ofloxacin or third generation cephalosporin at day 1, then randomized at day 3-4 to either continue ofloxacin for 14 days total treatment, or for 7 days followed by placebo until day 14.The primary endpoint was treatment success, defined as a negative urine culture, the absence of fever and of subsequent antibiotic treatment between the end of treatment and 6 weeks after day 1. Secondary endpoints included recurrent urinary tract infection within weeks 6 and 12 after day 1, rectal carriage of antimicrobial-resistant Enterobacterales and drug-related events.

RESULTS: Two hundred and forty participants were randomly assigned to receive antibiotic therapy for 7 (115 participants) or 14 days (125 participants). In the ITT analysis, treatment success occurred in 64 participants (55.7%) in the 7-day group and in 97 participants (77.6%) in the 14-day group (risk difference-21.9 (-33.3 to -10.1)), demonstrating inferiority. Adverse events during antibiotic therapy were reported in four participants in the 7-day arm and seven in the 14-day arm. Rectal carriage of resistant Enterobacterales did not differ between both groups.

CONCLUSION: A treatment with ofloxacin for 7 days was inferior to 14 days for febrile UTI in men and should therefore not be recommended.

PMID:36785526 | DOI:10.1093/cid/ciad070

J Pediatr Pharmacol Ther. 2023;28(1):78-83. doi: 10.5863/1551-6776-28.1.78. Epub 2023 Feb 3.

ABSTRACT

OBJECTIVE: Acetaminophen is a commonly administered analgesic and antipyretic medication that is generally well-tolerated. Recent studies in critically ill adults and subsets of pediatric patients with underlying cardiac disease identify an association between adverse hemodynamic effects with intravenous (IV) acetaminophen. However, the data may not be generalizable to a broader population of critically ill children. The objective of this study was to determine the incidence of hemodynamic changes associated with IV acetaminophen administration in critically ill pediatric medical-surgical patients.

METHODS: This was a retrospective observational study of all patients 18 years of age and younger who received at least 1 dose of IV acetaminophen in a pediatric intensive care unit at a quaternary care medical center, between July and December 2018. The primary outcome was the incidence of hypotension, defined as a decrease in mean arterial pressure (MAP) by at least 15% from baseline. Potential risk factors for IV acetaminophen-associated hypotension were assessed.

RESULTS: A total of 212 patients received 492 doses of IV acetaminophen. The primary endpoint of hypotension occurred following 24% of doses. An intervention for hypotension, primarily fluid resuscitation, was required for 11.9% of the dose-associated hypotension events. Patients receiving vasoactive infusions had more frequent dose-associated hypotension events than those not receiving infusions; however, no other potential risk factors were identified.

CONCLUSIONS: The incidence of hypotension observed in critically ill pediatric patients after IV acetaminophen administration is clinically relevant. Large placebo-controlled trial and further study of the risk factors and mechanism of this hemodynamic change are warranted.

PMID:36777989 | PMC:PMC9901319 | DOI:10.5863/1551-6776-28.1.78

Crohns Colitis 360. 2022 Mar 15;4(2):otac008. doi: 10.1093/crocol/otac008. eCollection 2022 Apr.

ABSTRACT

BACKGROUND: Microscopic colitis (MC) is suspected to result from increased immune activity in gut mucosa. Immune checkpoint inhibitors (ICIs) treat cancer by activating the immune system, and further investigation is needed regarding their role in the development of MC.

METHODS: A retrospective case series investigated cases of endoscopically and histologically confirmed MC developing after administration of ICIs. Clinical notes and medication administration records were reviewed for demographics, symptom duration, and treatment response.

RESULTS: Nineteen cases of de novo MC were identified, with 95% of cases requiring steroid treatment, 53% presenting with hospitalization, and colitis-related mortality in 1 individual. Symptom onset occurred a median of 160 days after initiation of ICI therapy and 53 days after their most recent dose of therapy. Patients had a median of 125 days of symptoms, and ICI therapy was held in 70% of individuals due for treatment.

CONCLUSIONS: MC can develop after ICI administration, and presents with severe symptoms, often requiring hospitalization and steroid treatment. In certain individuals this can require a prolonged treatment course of steroid therapy or immunomodulators. Individuals developing diarrhea after ICI therapy warrant thorough workup including endoscopy and rapid treatment initiation given the disease severity observed in this series.

PMID:36777041 | PMC:PMC9802423 | DOI:10.1093/crocol/otac008

Open Forum Infect Dis. 2023 Feb 8;10(2):ofad025. doi: 10.1093/ofid/ofad025. eCollection 2023 Feb.

NO ABSTRACT

PMID:36776775 | PMC:PMC9905358 | DOI:10.1093/ofid/ofad025

Medicina (B Aires). 2023;83(1):158-162.

ABSTRACT

Adverse reaction reporting is essential to understand the actual safety of marketed medicines. There are cases of patients with multidrug intolerance syndrome, an under-reported entity, which can occur when adverse reactions to more than two pharmacologically unrelated drugs occur in the same patient. We describe the case of a woman diagnosed with multisensitive Staphylococcus aureus endocarditis who experienced adverse reactions to five structurally unrelated antibiotics with different mechanisms of action in two consecutive hospitalisations. The reactions were secondary to cefazolin (tricytopenia), vancomycin (renal injury), daptomycin (elevated creatine phosphokinase) and linezolid (hepatotoxicity) in the first hospitalization, and to cotrimoxazole (thrombocytopenia) in the second. Transient damage to different organ systems was observed in all cases. Finally, hospital discharge was granted with clindamycin without further intercurrences until treatment was completed. This case could correspond to the aforementioned syndrome or to an as yet uncharacterized entity.

PMID:36774615

Eur J Pharmacol. 2023 Feb 10:175587. doi: 10.1016/j.ejphar.2023.175587. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: Pharmacological treatments available for substance use disorder (SUD) focus on pharmacodynamics, agonizing or antagonizing the drug of abuse (DOA) on receptor level. Drawbacks of this approach include the reliance on long-term patient compliance, on-target off-site effects, perpetuation of addiction and unavailability for many DOAs. Newer, pharmacokinetic approaches are needed that restrict DOA's access to the brain or disrupt DOA-instated brain changes maintaining addiction. Biotechnology might be able to provide the right biopharmaceutical tools to deliver a fine-tuned solution with less side effects compared to currently available treatments.

METHODS: This review examines the available literature on biopharmaceuticals developed to treat SUD.

RESULTS: Active and passive immunization, metabolic enhancers that augment DOA metabolism and clearance, as well as genetic/epigenetic modulation are promising next generation SUD treatments. Active immunization relies on production of antidrug antibodies by means of vaccination, while passive immunization constitutes of exogenous administration of such antibodies. Metabolic enhancers include drug-specific metabolizing enzymes that can be administered or secreted by modified skin grafts, as well as catalytic antibodies that hasten DOA metabolism. Nanotechnological advances can also allow for brain delivery of siRNAs, mRNAs or DNA in order to modulate central, common in all addictions, genetic or epigenetic targets attenuating drug seeking behavior and reversing drug-induced brain changes.

CONCLUSIONS: and Scientific Significance: Biopharmaceuticals can in the future complement or even replace traditional pharmacodynamics approaches in SUD treatment. While passive and active immunization biopharmaceuticals have entered human clinical trials, metabolic enhancers and genetic approaches are at the preclinical level.

PMID:36775113 | DOI:10.1016/j.ejphar.2023.175587

Saudi Med J. 2023 Feb;44(2):194-201. doi: 10.15537/smj.2023.44.2.20220680.

ABSTRACT

OBJECTIVES: To assess the different side effects of COVID-19 vaccines at different scenarios in Saudi Arabia.

METHODS: This cross-sectional study sought to investigate the side effects of COVID-19 vaccines through an online survey of 2,718 participants in Saudi Arabia.

RESULTS: People can manage their expectations about vaccine side effects and deal with symptoms better by knowing beforehand that they are likely to experience mild side effects for a short period, symptoms that are manifested regardless of age, and infection before or after vaccination. There are certain uncommon side effects that affect more people who got infected, and not before vaccination; there are side effects that disproportionately impact women, and also the side effects that wane after the second dose.

CONCLUSION: These findings can assist in evaluating the concerns regarding vaccine acceptance. The public should be made aware that they are likely to experience at least one side effect, with temporary post-injection inflammation, musculoskeletal pain, fever, and headache as the most commonly reported side effects across the board. However, the common symptoms are mild to moderate, and the side effects last for a short period for most people.

PMID:36773975 | DOI:10.15537/smj.2023.44.2.20220680

Int J Mol Sci. 2023 Feb 3;24(3):3013. doi: 10.3390/ijms24033013.

ABSTRACT

Sphingolipids are exceptionally diverse, comprising hundreds of unique species. The bulk of circulating sphingolipids are synthesized in the liver, thereby plasma sphingolipid profiles represent reliable surrogates of hepatic sphingolipid metabolism and content. As changes in plasma sphingolipid content have been associated to exposure to drugs inducing hepatotoxicity both in vitro and in rodents, in the present study the translatability of the preclinical data was assessed by analyzing the plasma of patients with suspected drug-induced liver injury (DILI) and control subjects. DILI patients, whether intrinsic or idiosyncratic cases, had no alterations in total sphingoid base levels and profile composition compared to controls, whereby cardiovascular disease (CVD) was a confounding factor. Upon exclusion of CVD individuals, elevation of 1-deoxysphingosine (1-deoxySO) in the DILI group emerged. Notably, 1-deoxySO values did not correlate with ALT values. While 1-deoxySO was elevated in all DILI cases, only intrinsic DILI cases concomitantly displayed reduction of select shorter chain sphingoid bases. Significant perturbation of the sphingolipid metabolism observed in this small exploratory clinical study is discussed and put into context, in the consideration that sphingolipids might contribute to the onset and progression of DILI, and that circulating sphingoid bases may function as mechanistic markers to study DILI pathophysiology.

PMID:36769329 | PMC:PMC9917723 | DOI:10.3390/ijms24033013

Int J Mol Sci. 2023 Feb 3;24(3):2957. doi: 10.3390/ijms24032957.

ABSTRACT

SARS-CoV-2 is the virus that causes the infectious disease known as Corona Virus Disease 2019 (COVID-19). The severe impact of the virus on humans is undeniable, which is why effective vaccines were highly anticipated. As of 12 January 2022, nine vaccines have obtained Emergency Use Listing by the World Health Organization (WHO), and four of these are approved or authorized by the Centers for Disease Control and Prevention (CDC) in the United States. The initial clinical trials studying COVID-19 vaccine efficacy excluded pregnant and lactating individuals, meaning that data on the effects of the vaccine on breast milk were lacking. Until today, none of the authorized vaccines have been approved for use in individuals under six months. During the first months of life, babies do not produce their own antibodies; therefore, antibodies contained in their mothers' breastmilk are a critical protective mechanism. Several studies have shown the presence of SARS-CoV-2 antibodies in the breast milk of women who have been vaccinated or had been naturally infected. However, whether these are protective is still unclear. Additionally, research on the BNT162b2 mRNA vaccine developed by Pfizer-BioNTech and the mRNA-1273 vaccine developed by Moderna suggests that these vaccines do not release significant amounts, if any, of mRNA into breast milk. Hence, there is no evidence that vaccination of the mother poses any risk to the breastfed infant, while the antibodies present in breast milk may offer protection against the virus. The primary objective of this systematic review is to summarize the current understanding of the presence of immunoglobulins in human milk that are elicited by SARS-CoV-2 vaccines and to evaluate their ability to neutralize the virus. Additionally, we aim to quantify the side effects experienced by lactating mothers who have been vaccinated, as well as the potential for adverse effects in their infants. This study is critical because it can help inform decision-making by examining the current understanding of antibody secretion in breastmilk. This is particularly important because, although the virus tends to be less severe in younger individuals, infants who contract the disease are at a higher risk of requiring hospitalization compared to older children.

PMID:36769279 | PMC:PMC9917673 | DOI:10.3390/ijms24032957

Int J Mol Sci. 2023 Feb 2;24(3):2856. doi: 10.3390/ijms24032856.

ABSTRACT

The kidney functions not only as a metabolite elimination organ but also plays an important role in pharmacotherapy. The kidney tubule epithelia cells express membrane carriers and transporters, which play an important role in drug elimination, and can determine drug nephrotoxicity and drug-drug interactions, as well as constituting direct drug targets. The above aspects of kidney transport proteins are discussed in the review.

PMID:36769175 | PMC:PMC9917665 | DOI:10.3390/ijms24032856

Int J Mol Sci. 2023 Feb 1;24(3):2769. doi: 10.3390/ijms24032769.

ABSTRACT

Immune checkpoint inhibitors (ICIs) have changed how we think about tumor management. Combinations of anti-programmed death ligand-1 (PD-L1) immunotherapy have become the standard of care in many advanced-stage cancers, including as a first-line therapy. Aside from improved anti-tumor immunity, the mechanism of action of immune checkpoint inhibitors (ICIs) exposes a new toxicity profile known as immune-related adverse effects (irAEs). This novel toxicity can damage any organ, but the skin, digestive and endocrine systems are the most frequently afflicted. Most ICI-attributed toxicity symptoms are mild, but some are severe and necessitate multidisciplinary side effect management. Obtaining knowledge on the various forms of immune-related toxicities and swiftly changing treatment techniques to lower the probability of experiencing severe irAEs has become a priority in oncological care. In recent years, there has been a growing understanding of an intriguing link between the gut microbiome and ICI outcomes. Multiple studies have demonstrated a connection between microbial metagenomic and metatranscriptomic patterns and ICI efficacy in malignant melanoma, lung and colorectal cancer. The immunomodulatory effect of the gut microbiome can have a real effect on the biological background of irAEs as well. Furthermore, specific microbial signatures and metabolites might be associated with the onset and severity of toxicity symptoms. By identifying these biological factors, novel biomarkers can be used in clinical practice to predict and manage potential irAEs. This comprehensive review aims to summarize the clinical aspects and biological background of ICI-related irAEs and their potential association with the gut microbiome and metabolome. We aim to explore the current state of knowledge on the most important and reliable irAE-related biomarkers of microbial origin and discuss the intriguing connection between ICI efficacy and toxicity.

PMID:36769093 | PMC:PMC9916922 | DOI:10.3390/ijms24032769

Int J Mol Sci. 2023 Feb 1;24(3):2720. doi: 10.3390/ijms24032720.

ABSTRACT

The gut microbiota is involved in the development of the immune system and can modulate the risk for immune-mediated disorders such as multiple sclerosis (MS). Dysbiosis has been demonstrated in MS patients and its restoration by disease-modifying treatments (DMTs) is hypothesized. We aimed to study the changes in gut microbiota composition during the first 6 months of treatment with dimethyl fumarate (DMF), an oral DMT, and to identify the microorganisms associated with DMF side effects. We collected and analyzed the gut microbiota of 19 MS patients at baseline and after 1, 3, and 6 months of DMF treatment. We then cross-sectionally compared gut microbiota composition according to the presence of gastrointestinal (GI) symptoms and flushing. Overall, the gut microbiota biodiversity showed no changes over the 6-month follow-up. At the genus level, DMF was associated with decreased Clostridium abundance after 6 months. In subjects reporting side effects, a higher abundance of Streptococcus, Haemophilus, Clostridium, Lachnospira, Blautia, Subdoligranulum, and Tenericutes and lower of Bacteroidetes, Barnesiella, Odoribacter, Akkermansia, and some Proteobacteria families were detected. Our results suggest that gut microbiota may be involved in therapeutic action and side effects of DMF, representing a potential target for improving disease course and DMT tolerability.

PMID:36769041 | PMC:PMC9917003 | DOI:10.3390/ijms24032720

Int J Environ Res Public Health. 2023 Feb 2;20(3):2690. doi: 10.3390/ijerph20032690.

ABSTRACT

In this study, we aimed to investigate radiation risk perception, mental health, and interest in tritiated water among evacuees from and returnees to Tomioka town, Japan, as well as to evaluate the intention to return (ITR) among evacuees living inside and outside Fukushima Prefecture. Of the 1728 respondents, 318 (18.4%) and 1203 (69.6%) participants reported living outside and inside Fukushima Prefecture, and 207 (12.0%) reported living in Tomioka. The ITR was not significantly different between those who lived inside and outside the prefecture among the evacuees. Similarly, there were no significant differences in radiation risk perception, mental health, and interest in tritiated water. However, the evacuees were independently associated with a motivation to learn about tritiated water (OR = 1.242, 95%Cl: 1.041-1.438, p = 0.016), reluctance to consume food from Tomioka (OR = 1.635, 95%Cl: 1.372-1.948, p < 0.001), and concern that adverse health effects would occur because of the Fukushima Daiichi Nuclear Power Plant accident (OR = 1.279, 95%Cl: 1.055-1.550, p = 0.012) compared to returnees, according to logistic regression analysis. Interestingly, the returnees were found to have better mental health but lower life satisfaction than the evacuees. These findings suggest the importance of ongoing risk communication about radiation exposure and tritiated water among residents regardless of their place of residency.

PMID:36768061 | PMC:PMC9915426 | DOI:10.3390/ijerph20032690

Int J Environ Res Public Health. 2023 Jan 26;20(3):2228. doi: 10.3390/ijerph20032228.

ABSTRACT

Wound care is an important public health challenge that is present in all areas of the healthcare system, whether in hospitals, long term care institutions or in the community. We aimed to quantify the number of skin wounds reported after and during the COVID-19 pandemic. This descriptive longitudinal retrospective study compared of wound records in patients hospitalized in the internal medicine service during the first year of the COVID-19 pandemic (from 1 March 2020, to 28 February 2021) and previous-year to the outbreak (from 1 January 2019, to 31 December 2019). A sample of 1979 episodes was collected corresponding to 932 inpatients, 434 from the pre-pandemic year and 498 from the first year of COVID-19 pandemic; 147 inpatients were diagnosed with SARS-CoV-2 infection (3.2%). The percentage of wound episodes in the first year of the COVID-19 pandemic was higher than the pre-pandemic year, 17.9% (1092/6090) versus 15% (887/5906), with a significant increase in the months with the highest incidence of COVID cases. This study shows an increase in the burden of wound care during the COVID-19 pandemic, and it could be attributable to the increase in the number of patients hospitalized for SARS-CoV-2 infection in internal medicine units.

PMID:36767595 | PMC:PMC9916326 | DOI:10.3390/ijerph20032228

Int J Environ Res Public Health. 2023 Jan 17;20(3):1708. doi: 10.3390/ijerph20031708.

ABSTRACT

Cancer disease is a world problem which is increasing in its prevalence. Oncology patients have a multitude of symptoms derived from the treatments and from the disease itself that affect their quality of life to a greater or lesser extent. The aim of this study has been to discover the physical and psychological symptoms related to chemotherapy treatment in Spanish cancer patients in order to improve their quality of life. Symptoms from the previous week were taken into account and the Memorial Symptom Assessment Scale was used to measure the frequency, severity and associated distress of 32 symptoms. A total of 246 chemotherapy patients at the University Day Hospital in Salamanca completed the scale once while receiving chemotherapy treatment. A 95% confidence interval was considered. The most prevalent symptoms were a lack of energy (76.4%), anxiety (66.7%) and a dry mouth (60.6%). Lung cancer was the most prevalent cancer in men (26%) and breast cancer was the most prevalent cancer in women (72%). There is no consensus on which is the most prevalent symptom in this population and more studies will need to be carried out to determine the best treatment protocols. Symptom's prevalence knowledge could improve the patients' care to prevent or avoid complications and to improve the cancer patients' quality of life.

PMID:36767073 | PMC:PMC9914572 | DOI:10.3390/ijerph20031708

Molecules. 2023 Jan 26;28(3):1210. doi: 10.3390/molecules28031210.

ABSTRACT

Heat shock protein 90 (HSP90) facilitates folding and stability and prevents the degradation of multiple client proteins. One of these HSP90 clients is BCR-ABL, the oncoprotein characteristic of chronic myeloid leukemia (CML) and the target of tyrosine kinase inhibitors, such as imatinib. Alvespimycin is an HSP90 inhibitor with better pharmacokinetic properties and fewer side effects than other similar drugs, but its role in overcoming imatinib resistance is not yet clarified. This work studied the therapeutic potential of alvespimycin in imatinib-sensitive (K562) and imatinib-resistant (K562-RC and K562-RD) CML cell lines. Metabolic activity was determined by the resazurin assay. Cell death, caspase activity, mitochondrial membrane potential, and cell cycle were evaluated by means of flow cytometry. Cell death was also analyzed by optical microscopy. HSPs expression levels were assessed by western blotting. Alvespimycin reduced metabolic activity in a time-, dose-, and cell line-dependent manner. Resistant cells were more sensitive to alvespimycin with an IC50 of 31 nM for K562-RC and 44 nM for K562-RD, compared to 50 nM for K562. This drug induced apoptosis via the mitochondrial pathway. In K562 cells, alvespimycin induced cell cycle arrest in G0/G1. As a marker of HSP90 inhibition, a significant increase in HSP70 expression was observed. Our results suggest that alvespimycin might be a new therapeutic approach to CML treatment, even in cases of resistance to imatinib.

PMID:36770876 | DOI:10.3390/molecules28031210

Int J Mol Sci. 2023 Feb 2;24(3):2945. doi: 10.3390/ijms24032945.

ABSTRACT

As the clinical complications induced by microbial infections are known to have life-threatening side effects, conventional anti-infective therapy is necessary, but not sufficient to overcome these issues. Some of their limitations are connected to drug-related inefficiency or resistance and pathogen-related adaptive modifications. Therefore, there is an urgent need for advanced antimicrobials and antimicrobial devices. A challenging, yet successful route has been the development of new biostatic or biocide agents and biomaterials by considering the indisputable advantages of biopolymers. Polymers are attractive materials due to their physical and chemical properties, such as compositional and structural versatility, tunable reactivity, solubility and degradability, and mechanical and chemical tunability, together with their intrinsic biocompatibility and bioactivity, thus enabling the fabrication of effective pharmacologically active antimicrobial formulations. Besides representing protective or potentiating carriers for conventional drugs, biopolymers possess an impressive ability for conjugation or functionalization. These aspects are key for avoiding malicious side effects or providing targeted and triggered drug delivery (specific and selective cellular targeting), and generally to define their pharmacological efficacy. Moreover, biopolymers can be processed in different forms (particles, fibers, films, membranes, or scaffolds), which prove excellent candidates for modern anti-infective applications. This review contains an overview of antimicrobial polyester-based formulations, centered around the effect of the dimensionality over the properties of the material and the effect of the production route or post-processing actions.

PMID:36769266 | DOI:10.3390/ijms24032945

Br J Dermatol. 2023 Feb 10;188(2):247-258. doi: 10.1093/bjd/ljac074.

ABSTRACT

BACKGROUND: In 2015, a major achievement in vitiligo research was the development of an internationally agreed upon core outcome domain set for randomized clinical trials (RCTs). Three outcomes were identified as being essential: repigmentation, side-effects/harms and maintenance of gained repigmentation. Four items were further recommended for inclusion. The following recommendations then followed: repigmentation should be assessed by measuring the percentage of repigmentation in quartiles (0-25%, 26-50%, 51-79%, 80-100%) and cosmetic acceptability of the results should be assessed using the Vitiligo Noticeability Scale.

OBJECTIVES: The primary objective of this study was to assess uptake of the core outcome domain set for RCTs in vitiligo. Secondary objectives were to update the systematic review on outcomes reported in vitiligo RCTs, and to assess whether repigmentation and cosmetic acceptability of the results were measured using the above-mentioned recommended scales.

METHODS: We searched PubMed, Cochrane Library (CENTRAL and Systematic Reviews) and ClinicalTrials.gov for vitiligo RCTs between November 2009 and March 2021. Screening and data extraction were independently performed on title and summary by two researchers. All outcomes and outcome measures reported in eligible RCTs were retrieved and collated.

RESULTS: In total, 174 RCTs were identified: 62 were published between 2009 and 2015, and 112 were published between 2016 and 2021.Thirty-eight different outcomes were reported. Repigmentation was the primary outcome in 89% of trials (150 of 169). Forty-nine different tools were used to measure repigmentation. Side-effects and harms were reported in 78% of trials (136 of 174). Maintenance of gained repigmentation was reported in only 11% of trials (20 of 174) and duration of follow-up varied greatly from 1 to 14 months. Cosmetic acceptability of the results and cessation of disease activity were assessed in only 2% of trials (four of 174). Quality of life of patients with vitiligo was assessed in 13% of trials (22 of 174). Finally, only 11 of 112 RCTs (10%) published between 2016 and 2021 reported all three essential core outcome domains (repigmentation, side-effects and maintenance of gained repigmentation) and none of the trials reported both essential and recommended core outcome domains.

CONCLUSIONS: Efforts are still needed to close the gap between set recommendations and RCT outcome reporting.

PMID:36763863 | DOI:10.1093/bjd/ljac074

Front Immunol. 2023 Jan 25;14:1106472. doi: 10.3389/fimmu.2023.1106472. eCollection 2023.

ABSTRACT

INTRODUCTION: Concern of a correlation between disease relapse in patients with acquired demyelinating disorders of central nervous system (CNS) and SARS-CoV2 vaccines has been raised. In this single center study, we retrospectively evaluated safety of SARS-CoV2 vaccination and COVID-19 short-term outcome in pediatric acquired demyelinating disorders of CNS.

MATERIALS AND METHODS: Patients with multiple sclerosis (MS), myelin oligodendrocyte glycoprotein antibody associated disease (MOGAD) and neuromyelitis optica spectrum disorder (NMOSD) with disease onset before 18 years of age were included. Demographic and clinical data, and information regarding previous SARS-CoV-2 infection and vaccination were collected.

RESULTS: We included nine patients with MOGAD. Six patients received SARS-CoV2 vaccination and complained pain at injection site while only one had fever and fatigue. Median follow-up was 28 weeks (range 20-48). Seven patients had COVID-19 occurring with mild flu-like symptoms and median follow-up was 28 weeks (range 24-34). Nobody had disease relapse. Five patients with NMOSD were included. All patients received SARS-CoV2 vaccination (BNT162b2-Pfizer-BioNTech). The median follow-up was 20 weeks (range 14-24) and only two patients complained pain at injection site, fever and fatigue. Three patients had also COVID-19 with mild flu-like symptoms, despite two of them being under immunosuppressive treatment. Lastly, forty-three patients with MS were included. 35 out of 43 received SARS-CoV2 vaccination with a median follow-up of 24 weeks (range 8-36). Fourteen patients had no side effects, while 21 complained mild side effects (mainly pain at injection site) and one experienced a disease relapse with complete recovery after steroid therapy. At vaccination, all but one were under treatment. Sixteen patients had COVID-19 occurring with mild symptoms.

DISCUSSION: COVID-19 outcome was good although many patients were under immunosuppressive treatment. Vaccine-related side effects were frequent but were mild and self-limited. Only one MS patient had a post-vaccination relapse with complete recovery after steroid therapy. In conclusion, our data support the safety of SARS-CoV-2 vaccines in pediatric MS, MOGAD and NMOSD.

PMID:36761740 | PMC:PMC9905148 | DOI:10.3389/fimmu.2023.1106472