Pediatr Rev. 2023 Mar 1;44(3):153-164. doi: 10.1542/pir.2021-005456.

ABSTRACT

Musculoskeletal complaints are common among children in the primary care setting. Joint pain can be categorized as either inflammatory or noninflammatory (also known as mechanical), and differentiating between these 2 categories affects a physician's differential diagnosis and plan for evaluation. Patients with inflammatory arthritis will frequently present to the primary care physician with musculoskeletal complaints. Specific features in the history and physical examination distinguish juvenile idiopathic arthritis (JIA) from other musculoskeletal etiologies. (1)JIA is the most common cause of inflammatory joint pain in children younger than 16 years, with a variable worldwide incidence; in Europe and North America, the incidence is approximately 7.8 to 8.3 per 1,000, with prevalence rates between 12.8 and 45 per 100,000. (2) It is thought that as many as 8 million children in the world have chronic arthritis. (2) Given its prevalence, it is important for the primary care physician to be able to appropriately recognize this condition and in doing so prevent a delay in diagnosis and management. Arthritis is a common cause of disability in children, and complications of JIA can be severe. Many therapies used in JIA have adverse effects and contraindications (specifically vaccinations and teratogen exposure) that require recognition by the primary care physician. This article discusses the differences between inflammatory and noninflammatory joint pain, the diagnosis and various categories of JIA, long-term outcomes and complications associated with JIA, and the general management of JIA with special emphasis on adverse effects and contraindications of therapies.

PMID:36854831 | DOI:10.1542/pir.2021-005456

Anticancer Res. 2023 Mar;43(3):1341-1349. doi: 10.21873/anticanres.16282.

ABSTRACT

BACKGROUND/AIM: Azoles are widely used for prophylaxis in patients with haematologic malignancies and are well known as selective cytochrome P450 isoenzyme 3A4 inhibitors. Although the interaction between bortezomib and azoles has been reported, most previous studies were case reports or small clinical studies. Hence, we conducted a pharmacoepidemiological study to elucidate the impact of azoles on bortezomib-related adverse reactions, using the Japanese adverse drug event report database (JADER).

PATIENTS AND METHODS: We extracted 19,567 reports on patients prescribed bortezomib and/or azoles. We classified cases into three groups, namely bortezomib, bortezomib and azoles, and azoles groups. We estimated the odds ratios (OR) for the impact of concomitant azole use on five bortezomib-related adverse drug reactions (peripheral neuropathy, thrombocytopenia, neutropenia, leukopenia, and interstitial lung disease) using logistic regression.

RESULTS: The OR for peripheral neuropathy in the 'bortezomib and azoles' group was higher than that in the bortezomib group [OR=2.02, 95% confidence interval (CI)=1.32-3.08]. The magnitude of the interaction was stronger with itraconazole than that with fluconazole (itraconazole, OR=3.22, 95% CI=1.78-5.70; fluconazole, OR=1.56, 95% CI=0.86-2.72).

CONCLUSION: We found an association between concomitant administration of azoles with bortezomib and peripheral neuropathy. Azoles may enhance bortezomib-induced peripheral neuropathy based on their pharmacokinetic properties.

PMID:36854533 | DOI:10.21873/anticanres.16282

Anticancer Res. 2023 Mar;43(3):983-991. doi: 10.21873/anticanres.16242.

ABSTRACT

The treatment of advanced renal cell carcinoma has been substantially improved by the introduction of targeted and immune therapies and their respective combinations. Unleashing the activity of the immune system opened a new and successful front in the fight against cancers. Despite the benefits, drug resistance phenomena and adverse side effects can compromise efficacy. The development of new modalities of drugs and therapies with properties and mechanisms of action that break away from conventional medicines was expanded in recent years. This perspective discusses the prospects of these innovative and highly potent novel treatments in overcoming much of the current issues surrounding the resistance to approved renal cell carcinoma treatments and the challenges facing their introduction.

PMID:36854518 | DOI:10.21873/anticanres.16242

J Infus Nurs. 2023 Mar-Apr 01;46(2):107-115. doi: 10.1097/NAN.0000000000000496.

ABSTRACT

This study aimed to analyze the factors associated with local adverse effects resulting from hypodermoclysis in older adult patients in palliative care. The study involved 127 older adults undergoing palliative care at a hospital in southeastern Brazil. Data collection was performed from August to November 2019. Patients aged 60 years or older, with a prescription for hypodermoclysis at the time of admission and who were not receiving hypodermoclysis at the time of admission, were included. Data collected included sociodemographic, clinical, pharmacotherapeutic, and adverse effects of hypodermoclysis administration. Most participants were women (59.0%), with a mean age of 78.5 years. Frailty was the most prevalent diagnosis (26.8%), and 80.2% of patients were in the end-of-life stage. There was an incidence of 24.0% of adverse events, with catheter obstruction and swelling in the surrounding area of the hypodermoclysis site being the most frequent at 11.3% and 8.5%, respectively. Ondansetron administration by hypodermoclysis was 3 times more likely to have an adverse effect compared to not using this drug. In contrast, a protective factor was evident with the administration of 0.9% sodium chloride, which contributed to the reduction of complications. The occurrence of adverse effects from hypodermoclysis in the study population of older adults in palliative care was low.

PMID:36853873 | DOI:10.1097/NAN.0000000000000496

Asian Pac J Cancer Prev. 2023 Feb 1;24(2):389-400. doi: 10.31557/APJCP.2023.24.2.389.

ABSTRACT

BACKGROUND: Tacrolimus is a powerful macrolide calcineurin inhibitor that has low adverse effects which lead to a rapid response in the control of signs and symptoms in comparison to that of corticosteroids in Oral Lichen Planus(OLP). There have been increasing number of studies establishing the use of topical tacrolimus in oral lichen planus. Still, there is a need to find evidence of the successful use of tacrolimus in comparison to other drugs used in the treatment of OLP, by means of a systematic review and meta-analysis, so that an informed and accurate approach can be utilized.

METHODS: A comprehensive literature review was performed, including PubMed, the Cochrane Library, published up to and including December 2021. There were no restrictions on date of publication. Articles available in English language were included. Using the Cochrane Collaboration tool, we assessed the risk of bias for randomized controlled trials. A meta-analysis was performed on the relevant studies.

RESULTS: A total of 11 RCTs evaluating the effects of tacrolimus were included in this study after application of inclusion and exclusion criteria. Seven studies revealed a low bias risk, three presented a moderate risk and one had a high risk of bias. The results revealed no significant difference in clinical resolution and adverse effects between tacrolimus and corticosteroids. The pooled data from our meta-analysis shows that there is not sufficient evidence to prove that Tacrolimus is better in efficacy than other topical corticosteroids.

CONCLUSION: According to the current systematic study and meta-analysis, there is not sufficient evidence to prove that Tacrolimus is better in efficacy than other drugs. Uniform trials are required with larger sample sizes and standardized methodology are required for a better analysis.

PMID:36853285 | DOI:10.31557/APJCP.2023.24.2.389

Int J Tuberc Lung Dis. 2023 Jan 1;27(1):7-12. doi: 10.5588/ijtld.22.0249.

ABSTRACT

The need to address the impact of air pollution on health is reinforced by recent scientific evidence and the 2021 WHO Air Quality Guidelines (AQG). Air pollution is an avoidable risk factor causing a high burden for society with elevated deaths, health disorders, disabilities and huge socio-economic costs, especially in low- and middle-income countries. We have evaluated recent evidence from international reports, systematic reviews and official websites of international agencies. Growing evidence shows a causal relationship between air pollution exposure and acute lower respiratory infections, chronic obstructive pulmonary disease, asthma and lung cancer. Exposure to air pollution in both the short- and long-term has a serious impact on respiratory health. Harmful effects occur even at very low pollutant concentration levels, and there are no detectable thresholds below which exposure may be considered safe. The adverse respiratory health effects of air pollutants, even at low levels, are confirmed by recent epidemiological studies. Scientific respiratory societies and patient associations, along with other stakeholders in the health sector, should increase their engagement and advocacy to raise awareness of clean air policies and the latest WHO AQG.

PMID:36853127 | DOI:10.5588/ijtld.22.0249

J Int Med Res. 2023 Feb;51(2):3000605231156761. doi: 10.1177/03000605231156761.

ABSTRACT

Oral vancomycin is mainly used to treat and prevent active Clostridium difficile infection. Because it is widely believed that there is a very low absorption rate via the gastrointestinal tract, reports of adverse reactions following oral vancomycin administration are rare. This case report describes for the first time a case of antibiotic-associated diarrhoea in a 2-month-old infant treated with oral vancomycin. After oral vancomycin treatment, the number of eosinophils increased significantly and the levels gradually recovered after drug withdrawal. A review and analysis of the previously reported adverse reactions caused by oral vancomycin and eosinophilia caused by vancomycin confirm the need for physicians to pay close attention to vancomycin-related adverse reactions, to monitor the required concentration and to measure eosinophil counts in patients with rash-related adverse reactions. Patients with concomitant diseases and children should be monitored for adverse events as it is possible that they have increased gastrointestinal absorption of vancomycin following oral administration. When vancomycin causes eosinophilia, fever and rash, physicians should be alert to the possibility of organ damage.

PMID:36852821 | DOI:10.1177/03000605231156761

Sensors (Basel). 2023 Feb 20;23(4):2351. doi: 10.3390/s23042351.

ABSTRACT

The article's subject is the investigation of electromagnetic fields (EMF) of the microwave frequency band in a typical human living environment, especially in shielded areas. The point of view of electromagnetic field presence in the environment with the rapid increase in the level of the electromagnetic background is currently an essential point concerning population protection against the potential adverse effects of such EMFs. The authors focus on actual measurements, especially in shielded spaces frequently used in everyday life, such as elevator cabins and cars. The goal is a quantitative evaluation of the distribution of specific vector quantities of the EM field and a comparison with the currently valid hygiene standards. Measured values in shielded spaces show elevated levels in contrast to the open space. However, the values do not exceed limits set by considering the thermal effect on living tissues.

PMID:36850949 | PMC:PMC9961501 | DOI:10.3390/s23042351

Sensors (Basel). 2023 Feb 8;23(4):1918. doi: 10.3390/s23041918.

ABSTRACT

Mitigation or even elimination of adverse effects caused by ionizing radiation is the main scope of the radiation protection discipline. The interaction of radiation with living matter is quantified and correlated with biological effects by dose. The Sievert is the most well-known quantity, and it is used with the equivalent and effective dose to minimize stochastic effects. However, Gray is the reference quantity for sizing tissue reactions that could occur under high-exposure conditions such as in a radiation emergency. The topics addressed in this review are the choice to move from Sievert to Gray, how the operational quantities for environmental and individual monitoring of the detectors should consider such a change of units, and why reference levels substitute dose levels in emergency exposure.

PMID:36850517 | PMC:PMC9959072 | DOI:10.3390/s23041918

Anticancer Res. 2023 Mar;43(3):1377-1384. doi: 10.21873/anticanres.16286.

ABSTRACT

BACKGROUND/AIM: This study aimed to assess the clinical impact of lenvatinib after disease progression on atezolizumab plus bevacizumab in patients with advanced hepatocellular carcinoma (HCC).

PATIENTS AND METHODS: A total of 14 patients who received lenvatinib after failure of atezolizumab plus bevacizumab and all patients were classified as having a Barcelona Clinic Liver Cancer stage C. Six patients had macrovascular invasion, and a liver occupation rate of >50% was reported in seven patients. The Kaplan-Meier method was performed to analyze the cumulative survival, while log-rank test was used to detect the differences. The dose of lenvatinib was determined based on body weight.

RESULTS: The participants' responses to lenvatinib treatment were as follows: 21.4% achieved partial response (PR), while 35.7% had a stable disease, with a disease control rate of 57.1%. The median progression-free survival (PFS) and overall survival (OS) were 4.2 months and 8.3 months, respectively; the median PFS and OS were 6.7 months and 10.5 months in the PR group. No significant difference was observed in the median PFS and OS between patients with and without macrovascular invasion or liver occupation rate of >50%. Most of the adverse events (AEs) were categorized as grade 1-2; all patients tolerated the AEs, and no drug-related mortality was reported. Additionally, half of the population underwent subsequent therapy after progression on lenvatinib treatment.

CONCLUSION: Lenvatinib is effective and can be safely used as second-line systemic therapy after progression on atezolizumab plus bevacizumab in patients with advanced HCC in real-world clinical practice.

PMID:36854513 | DOI:10.21873/anticanres.16286

J Cancer Res Clin Oncol. 2023 Feb 28. doi: 10.1007/s00432-023-04630-4. Online ahead of print.

ABSTRACT

PURPOSE: Clinical pharmacy can reduce drug-related iatrogenesis by improving the management of adverse effects of drugs, limiting drug-drug interactions, and improving patient adherence. Given the vulnerability of cancer patients and the toxicity of injectable anticancer drugs, clinical pharmacy service (CPS) could provide a significant clinical benefit in cancer care. This review aims to synthesize existing evidence on clinical pharmacy's impact on patients treated with intravenous anticancer drugs.

METHODS: A comprehensive search was performed in the PubMed/Medline database from January 2000 to December 2021, associating the keywords: clinical pharmacy, pharmaceutical care, pharmacist, oncology, and chemotherapy. To be eligible for inclusion, studies have to report clinical pharmaceutical services for patients treated with intravenous chemotherapy with a clinical and/or economic impact.

RESULTS: Forty-one studies met the selection criteria. Various CPS were reported: medication reconciliation, medication review, and pharmaceutical interview with patient. There was a lack of randomized study (n = 3; 7.3%). In one randomized controlled trial, pharmaceutical intervention significantly improved quality of life of patients receiving pharmaceutical care during injectable anticancer drugs courses. Economical results appear to show positive impact of clinical pharmacy with cost savings reported from 3112.87$ to 249 844€. Although most studies were non-comparative, they highlighted that clinical pharmacy tend to limit chemotherapy side effects and drug-related problems, improve quality of life and satisfaction of patients and healthcare professional, and a positive economic impact.

CONCLUSION: Clinical pharmacy can reduce adverse drug events in cancer patients. More robust and economic evaluations are still required to support its development in everyday practice.

PMID:36853384 | DOI:10.1007/s00432-023-04630-4

J Korean Med Sci. 2023 Feb 27;38(8):e56. doi: 10.3346/jkms.2023.38.e56.

ABSTRACT

BACKGROUND: Adverse drug reactions (ADRs) are escalating, and their socioeconomic burden is increasing. However, large-scale prospective studies investigating ADRs during hospitalization are rare in Korea. We prospectively investigated the incidence, characteristics, and economic burden of ADRs in hospitalized patients based on electronic medical records (EMRs).

METHODS: Among patients admitted to three hospitals from October 2016 to October 2017, 5,000 patients were randomly selected and prospectively observed during hospitalization. Research nurses monitored and detected patients who had symptoms, signs, or laboratory findings suspicious for ADRs using an EMR-based detection protocol. Next, allergy and ADR specialists reviewed the medical records to determine the relationship between adverse reactions and drugs. Cases in which a causal relationship was certain, probable/likely, or possible were included in the ADR cases. Clinically meaningful ADR cases or those leading to prolonged hospitalization were defined as significant ADRs.

RESULTS: ADRs occurred in 510 (10.2%) patients. The mean length of hospital stay was approximately 5 days longer in patients with ADRs. Opioids accounted for the highest percentage of total ADRs. Significant ADRs were observed in 148 (3.0%) patients. Antibiotics accounted for the highest percentage of significant ADRs. Drug hypersensitivity reactions (DHRs) occurred in 88 (1.8%) patients. Antibiotics accounted for the highest percentage of DHRs. The average medical expenses for one day of hospitalization per patient were highest in significant ADRs, followed by non-significant ADRs, and non-ADRs.

CONCLUSION: ADRs in hospitalized patients are an important clinical issue, resulting in a substantial socioeconomic burden. EMR-based strategy could be a useful tool for ADR monitoring and early detection.

PMID:36852852 | DOI:10.3346/jkms.2023.38.e56

Drug Dev Ind Pharm. 2023 Feb 28:1-12. doi: 10.1080/03639045.2023.2183724. Online ahead of print.

ABSTRACT

OBJECTIVE: The present work provides characterization of rheological properties of a new bentonite-based thixotropic gel emulsion nasal spray (AM-301), its nasal residence time, distribution, safety and tolerability.

SIGNIFICANCE: The nasal epithelium is a portal of entry for allergens and primary infection by airborne pathogens. Non-pharmacological interventions, which enhance physical and biological barriers, protect against allergens and pathogens without drug-related side effects. AM-301 has shown promising efficacy and safety in the nasal epithelium against viruses (in vitro) and pollen (clinical).

METHODS: Technical part (i) spray characterization was performed with a validated droplet size distribution method; evaluation of the rheological properties of the formulation was performed by a validated amplitude sweep method and a validated oscillation, rotation, oscillation; Clinical part (ii) nasal and oropharyngeal endoscopy were used to provide a semi-quantitative evaluation of distribution and residence time of fluorescein-labelled AM-301 in the nose and oropharynx of healthy volunteers; (iii) tolerability and safety.

RESULTS: (i) The non-Newtonian rheological properties of the formulation allow AM-301 to be sprayed and then to revert to a gel to prevent run-off from the nasal cavity; (ii) the formulation remains on the inferior turbinate, septum and oropharynx of volunteers for up to 210 min and on the middle turbinate for up to 60 min; two nasal sprays provide no substantial benefit over a single application with regards to coverage or retention; (iii) the spray is well tolerated.

CONCLUSIONS: Single dose spray delivery of AM-301 provides extended coverage of the nasal mucosa up to the inferior turbinates.

PMID:36852769 | DOI:10.1080/03639045.2023.2183724

Hepatol Res. 2023 Feb 28. doi: 10.1111/hepr.13895. Online ahead of print.

ABSTRACT

AIM: To compare patient characteristics and outcomes between the overall and Japanese populations of GLIMMER.

METHODS: GLIMMER was a multicenter, double-blind, randomized, placebo-controlled, Phase 2b study evaluating linerixibat for the treatment of pruritus in patients with primary biliary cholangitis (PBC).

RESULTS: A total of 147 patients were randomized in the GLIMMER overall population with 38 patients comprising the Japanese population. Demographics and baseline clinical characteristics were similar across treatment groups and between both populations. A reduction in mean worst daily itch score from baseline to Week 16 (primary endpoint) was seen in all groups, with the largest reduction observed with linerixibat 40 mg twice daily (BID; -2.92 [95% CI: -5.07, -0.76] and -2.86 [95% CI: -3.76, -1.95] for Japanese and overall populations, respectively). The highest proportion of responders was generally in the 40 mg BID group in both populations regardless of the responder definition applied. Improvements in health-related quality of life were generally consistent in both populations. In the Japanese and overall populations, on-treatment drug-related adverse events were reported in 25% and 19% of patients in the placebo group and 0-86% and 31-78% of patients in the linerixibat groups, respectively. Consistent with the mechanism of action, the most common events were gastrointestinal in nature. Effects of linerixibat on pharmacodynamic biomarkers favored BID dosing.

CONCLUSIONS: Therapeutic responses and safety of linerixibat were consistent between the Japanese and overall populations of GLIMMER. Linerixibat may provide an effective treatment option for cholestatic pruritus in patients with PBC. This article is protected by copyright. All rights reserved.

PMID:36852705 | DOI:10.1111/hepr.13895

Drug Deliv. 2023 Dec;30(1):2184307. doi: 10.1080/10717544.2023.2184307.

ABSTRACT

Rheumatoid arthritis (RA), a systemic autoimmune disease that dramatically affects patients' quality of life. Given the intricacy of RA's pathophysiology, no single treatment can completely halt the disease progression. Here, we attempted to treat RA holistically and synergistically by co-delivering methotrexate (MTX), a standard slow-acting anti-rheumatic drug, and phenethyl isothiocyanate (PEITC), a bioactive phytochemical, using a sodium alginate (SA)-pluronic F127 (PF-127) in situ hydrogel formulation. Therefore, in the current study, the co-delivery of MTX and PEITC in the nanoparticulate form could help enhance stability and solubility and facilitate greater penetration in the target arthritic tissues. The fabricated MTX NP and PEITC NE were found to have a minimum particle size, PDI, and good zeta potential. Results from in vitro release studies showed that MTX and PEITC were simultaneously released from the DD NP HG matrix over 6-7 days through diffusion and erosion mechanisms. An intra-articular (IA) injection of DD NP HG dramatically reduced chronic inflammation in adjuvant-induced arthritis (AIA) rats, delayed the onset of bone erosion, significantly reduced synovitis, and down-regulated the inflammatory cytokine expression. Most notably, the co-delivery strategy almost entirely restored the morphological features of the ankle joints of RA rats. The hepatic and renal function tests indicated good biological safety for DD NP HG in RA conditions. Taken together, these findings indicated that DD NP HG could achieve good anti-inflammatory activity and reverse cartilage disruption through a synergistic effect between two nanoparticulate forms of MTX and PEITC, which can effectively improve the drawbacks of their free forms.

PMID:36852696 | DOI:10.1080/10717544.2023.2184307

JAMA Netw Open. 2023 Feb 1;6(2):e230803. doi: 10.1001/jamanetworkopen.2023.0803.

ABSTRACT

IMPORTANCE: The US leads the world in the raw number of incarcerated persons as well as the rate of incarceration, with detrimental effects on individual-, family-, community-, and population-level health; as such, federal research has a critical role in documenting and addressing the health-related impacts of the US criminal legal system. How often incarceration-related research is funded at the National Institutes of Health (NIH), National Science Foundation (NSF), and US Department of Justice (DOJ) levels has a direct association with the public attention given to mass incarceration as well as the efficacy of strategies to mitigate negative effects and poor health related to incarceration.

OBJECTIVE: To understand how many incarceration-related projects have been funded at the NIH, NSF, and DOJ.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used public historical project archives to search for relevant incarceration-related keywords (eg, incarceration, prison, parole) since January 1, 1985 (NIH and NSF), and since January 1, 2008 (DOJ). Quotations and Boolean operator logic were used. All searches and counts were conducted and double verified by 2 coauthors between December 12 and 17, 2022.

MAIN OUTCOMES AND MEASURES: Number and prevalence of funded projects related to incarceration and prison keywords.

RESULTS: The term incarceration resulted in 3540 of 3 234 159 total project awards (0.11%) and prisoner-related terms resulted in 11 455 total project awards (0.35%) across the 3 federal agencies since 1985. Nearly a tenth of all projects funded at NIH since 1985 related to education (256 584 [9.62%]) compared with only 3373 projects (0.13%) that related to criminal legal or criminal justice or correctional system and 18 projects (0.0007%) that related to incarcerated parents. Only 1857 (0.07%) of all NIH-funded projects have been funded related to racism since 1985.

CONCLUSIONS AND RELEVANCE: This cross-sectional study found that a very low number of projects about incarceration have historically been funded at the NIH, DOJ, and NSF. These findings reflect a dearth of federally funded studies investigating the effects of mass incarceration or intervention strategies to mitigate adverse effects. Given the consequences of the criminal legal system, it is undoubtedly time for researchers, and our nation, to invest more resources into studying whether this system should be maintained, the intergenerational effects of mass incarceration, and strategies to best mitigate its impact on public health.

PMID:36848087 | PMC:PMC9972190 | DOI:10.1001/jamanetworkopen.2023.0803

Pharmacol Res Perspect. 2023 Apr;11(2):e01067. doi: 10.1002/prp2.1067.

ABSTRACT

Protein kinase inhibitors (PKIs) used in oncology can induce severe and even fatal hepatotoxicity. Several PKIs are registered within a certain class to target a specific kinase. No systematic comparison of the reported hepatotoxicity and clinical guidance for monitoring and management of hepatotoxic events between the various PKI summaries of product characteristics (SmPC) is yet available. A systematic analysis of data on 21 hepatotoxicity parameters obtained from the SmPCs and European public assessment reports (EPARs) of European Medicines Agency-approved antineoplastic PKIs (n = 55) has been conducted. The median reported incidence (range) of all grades of aspartate aminotransferase (AST) elevations was 16.9% (2.0%-86.4%) for PKI monotherapy, with 2.1% (0.0%-10.3%) being grade 3/4 and for all grades alanine aminotransferase (ALT) elevations 17.6% (2.0%-85.5%), with 3.0% (0.0%-25.0%) being grade 3/4. Fatalities due to hepatotoxicity were reported for 22 out of 47 PKIs (monotherapy) and for 5 out of 8 PKIs (combination therapy). A maximum grade of grade 4 and grade 3 hepatotoxicity was reported for 45% (n = 25) and 6% (n = 3), respectively. Liver parameter monitoring recommendations were present in 47 of the 55 SmPCs. Dose reductions were recommended for 18 PKIs. Discontinuation was recommended for patients meeting Hy's law criteria (16 out of 55 SmPCs). Severe hepatotoxic events are reported in approximately 50% of the analyzed SmPCs and EPARs. Differences in the degree of hepatotoxicity are apparent. Although liver parameter monitoring recommendations are present in the vast majority of the analyzed PKI SmPCs, the clinical guidance for hepatotoxicity was not standardized.

PMID:36846954 | DOI:10.1002/prp2.1067

Pan Afr Med J. 2022 Jul 20;42:218. doi: 10.11604/pamj.2022.42.218.32239. eCollection 2022.

ABSTRACT

INTRODUCTION: even though Highly Active Antiretroviral Therapy (HAART) is effective in managing Human Immuno-deficiency Virus (HIV) infection, it is not without its adverse drug effects (ADE) and or adverse drug reactions (ADRs). The study of ADRs associated with HAART in hospitals and clinics is crucial in gauging the burden of the severity of morbidity and mortality in such facilities, hence the reporting of such ADRs is important.

METHODS: the study was divided into 2 phases: the 1st phase entailed collecting data from HIV infected patients using a questionnaire on ADR experienced, whilst the 2nd phase was a retrospective analysis of respective patients´ medical files to record if an ADR was experienced. Three antiretroviral clinics linked to public sector facilities in EThekwini Metro, Kwa-Zulu Natal were the study sites.

RESULTS: seventy-two percent of patients reported at least one ADR after HAART initiation. Skin rash (11%) was the most commonly stated ADR by patients, whilst anemia (29%) and cardiovascular disease (23%) were the most commonly recorded ADRs on the patients´ medical files. Of those patients who reported ADRs, 57% were on the first line regimen consisting of Tenofovir, Emtricitabine and Efavirenz. Thirty-six patients reported that they were admitted to hospitals due to ADRs, however none resulted in death. These ADRs were experienced by patients on different regimens, with 10 admissions from the same regimen.

CONCLUSION: adverse drug reactions were experienced by South African patients, however the reporting of ADRs by patients were inconsistent with what was recorded on their medical files.

PMID:36845236 | PMC:PMC9949296 | DOI:10.11604/pamj.2022.42.218.32239

Front Immunol. 2023 Feb 9;14:1030810. doi: 10.3389/fimmu.2023.1030810. eCollection 2023.

ABSTRACT

OBJECTIVE: This study aimed to investigate the Coronavirus disease 2019 (COVID-19) vaccination rate, reasons for vaccine hesitancy and clinical effects on patients with Takayasu's arteritis (TAK).

METHODS: A web-based survey was administered to a TAK cohort established by the Department of Rheumatology, Zhongshan Hospital through WeChat in April, 2022. Responses from a total of 302 patients were received. The Sinovac or Sinopharm inactivated vaccination rate, side effects, and vaccine hesitancy reasons were analyzed. In addition, disease flare, new disease onset, and changes of immune-related parameters after vaccination were analyzed in vaccinated patients.

RESULTS: Among 302 patients, 93 (30.79%) received the inactivated COVID-19 vaccination. Among the 209 unvaccinated patients, the most common reason for hesitancy were concern about side effects (136, 65.07%). Vaccinated patients had a longer disease duration (p = 0.08) and lower use of biologic agents (p < 0.001); 16 (17.20%) of the 93 vaccinated patients developed side effects, and most of them were mild; 8 (8.60%) developed disease flares or new-onset disease 12-128 days post-vaccination and 2 (2.15%) developed serious adverse effects (vision defect and cranial infarction). Immune-related parameters of 17 patients indicated decreases in IgA and IgM after vaccination (p < 0.05). Eighteen (19.35%) of the 93 vaccinated patients were diagnosed post-vaccination.These patients had a significantly higher percentage of CD19+ B cells at disease onset (p < 0.05) than the unvaccinated patients diagnosed at the same time.

CONCLUSION: The vaccination rate was low in TAK, which was mainly caused by concerns about negative effects of vaccination on their disease. An acceptable safety profile was observed in vaccinated patients. The risk of disease flare associated with COVID-19 vaccination warrants further investigation.

PMID:36845121 | PMC:PMC9946967 | DOI:10.3389/fimmu.2023.1030810

Drug Ther Bull. 2023 Feb 27:dtb-2023-000011. doi: 10.1136/dtb.2023.000011. Online ahead of print.

ABSTRACT

Overview of: Pham C, Le K, Draves M, et al Assessment of FDA-approved drugs not recommended for use or reimbursement in other countries, 2017-2020. JAMA Intern Med 2023. doi:10.1001/jamainternmed.2022.6787. [Epub ahead of print 13 Feb 2023].

PMID:36849223 | DOI:10.1136/dtb.2023.000011