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A long-standing challenge is how to formulate proteins and vaccines to retain function during storage and transport and to remove the burdens of cold-chain management. Any solution must be practical to use, with the protein being released or applied using clinically relevant triggers. Advanced biologic therapies are distributed cold, using substantial energy, limiting equitable distribution in low-resource countries and placing responsibility on the user for correct storage and handling. Cold-chain management is the best solution at present for protein transport but requires substantial infrastructure and energy. For example, in research laboratories, a single freezer at -80 °C consumes as much energy per day as a small household1. Of biological (protein or cell) therapies and all vaccines, 75% require cold-chain management; the cost of cold-chain management in clinical trials has increased by about 20% since 2015, reflecting this complexity. Bespoke formulations and excipients are now required, with trehalose2, sucrose or polymers3 widely used, which stabilize proteins by replacing surface water molecules and thereby make denaturation thermodynamically less likely; this has enabled both freeze-dried proteins and frozen proteins. For example, the human papilloma virus vaccine requires aluminium salt adjuvants to function, but these render it unstable against freeze-thaw4, leading to a very complex and expensive supply chain. Other ideas involve ensilication5 and chemical modification of proteins6. In short, protein stabilization is a challenge with no universal solution7,8. Here we designed a stiff hydrogel that stabilizes proteins against thermal denaturation even at 50 °C, and that can, unlike present technologies, deliver pure, excipient-free protein by mechanically releasing it from a syringe. Macromolecules can be loaded at up to 10 wt% without affecting the mechanism of release. This unique stabilization and excipient-free release synergy offers a practical, scalable and versatile solution to enable the low-cost, cold-chain-free and equitable delivery of therapies worldwide.
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Almacenaje de Medicamentos , Hidrogeles , Desnaturalización Proteica , Estabilidad Proteica , Proteínas , Jeringas , Humanos , Excipientes , Liofilización , Hidrogeles/química , Proteínas/administración & dosificación , Proteínas/química , Proteínas/economía , Trehalosa , Congelación , Refrigeración , Vacunas contra Papillomavirus/química , Almacenaje de Medicamentos/economía , Almacenaje de Medicamentos/métodosRESUMEN
Recent guidance from the World Health Organization strongly recommended hepatitis C virus (HCV) self-testing. We implemented the Vend-C pilot study to explore the effectiveness and feasibility of distributing rapid HCV antibody self-test kits to people who inject drugs via needle/syringe dispensing machines (SDMs). Over a 51-day study period between August and September 2022, we distributed HCV antibody self-test kits via two SDMs. During the study period, 63 self-test kits were dispensed, averaging 1.2 self-test kits per day. Our access methods for evaluation questionnaires failed to attract participants (n = 4). We implemented the Vend-C pilot study in direct response to recent WHO recommendations. While self-test kits were effectively distributed from the two SDMs, our evaluation methodology failed. Consequently, we cannot determine the success of linkage to care. Even so, with HCV treatment numbers dropping in Australia, innovative engagement solutions are needed, and considering the number of self-test kits provided in our pilot, the model could have an important future place in HCV elimination efforts.
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Hepatitis C , Abuso de Sustancias por Vía Intravenosa , Humanos , Programas de Intercambio de Agujas/métodos , Proyectos Piloto , Jeringas , Autoevaluación , Australia , Hepatitis C/diagnóstico , Hepacivirus , AntiviralesRESUMEN
INTRODUCTION: Medical syringes are widely used in hospitals to store and administer drugs, and the contact time between the drugs and these syringes can vary from a few minutes to several weeks like for pharmaceutical preparations. The aim of this comparative study was to evaluate the potential sorption phenomena occurring between three drugs (paracetamol, diazepam and insulin aspart) and polypropylene syringes (PP) or syringes made of Cyclic Olefin Copolymer (COC). MATERIALS AND METHODS: 50 mL 3-part syringes made of either COC with crosslinked silicone on the barrel inner surface (COC-CLS) and a bromobutyl plunger seal, or PP lubricated with silicone oil (PP-SOL) with a polyisoprene plunger seal were used. RESULTS: COC-CLS syringes induced less sorption of diazepam and insulin than PP-SOL syringes and the plunger seal material seemed to be the main cause of these interactions. An alkalinization of the medications in contact with the PP-SOL syringes was observed. It could be caused by leachable compounds and should be investigated further. CONCLUSION: This work shows once again that it is essential to consider content-container interactions to help improve the safe use of parenteral drugs.
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Cicloparafinas , Polipropilenos , Jeringas , Polímeros , Aceites de Silicona , Preparaciones Farmacéuticas , DiazepamRESUMEN
BACKGROUND: Anaesthetic drug administration is complex, and typical clinical environments can entail significant cognitive load. Colour-coded anaesthetic drug trays have shown promising results for error identification and reducing cognitive load. METHODS: We used experimental psychology methods to test the potential benefits of colour-coded compartmentalised trays compared with conventional trays in a simulated visual search task. Effects of cognitive load were also explored through an accompanying working memory-based task. We hypothesised that colour-coded compartmentalised trays would improve drug-detection error, reduce search time, and reduce cognitive load. This comprised a cognitive load memory task presented alongside a visual search task to detect drug errors. RESULTS: All 53 participants completed 36 trials, which were counterbalanced across the two tray types and 18 different vignettes. There were 16 error-present and 20 error-absent trials, with 18 trials presented for each preloaded tray type. Syringe errors were detected more often in the colour-coded trays than in the conventional trays (91% vs 83%, respectively; P=0.006). In signal detection analysis, colour-coded trays resulted in more sensitivity to the error signal (2.28 vs 1.50, respectively; P<0.001). Confidence in response accuracy correlated more strongly with task performance for the colour-coded tray condition, indicating improved metacognitive sensitivity to task performance (r=0.696 vs r=0.447). CONCLUSIONS: Colour coding and compartmentalisation enhanced visual search efficacy of drug trays. This is further evidence that introducing standardised colour-coded trays into operating theatres and procedural suites would add an additional layer of safety for anaesthetic procedures.
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Anestésicos , Jeringas , Humanos , Color , Anestésicos/farmacología , Errores de Medicación/prevención & control , CogniciónRESUMEN
BACKGROUND AND AIMS: Limited evidence exist regarding the association between ongericimab, a novel recombinant humanized anti-PCSK9 monoclonal antibody, and primary hypercholesterolemia and mixed dyslipidemia. This study aimed to evaluate the efficacy and safety of ongericimab administered by prefilled syringe (PFS) or autoinjector (AI) in Chinese patients with primary hypercholesterolemia and mixed dyslipidemia on stable optimized lipid-lowering therapy. METHODS AND RESULTS: A total of 255 patients on stable optimized lipid-lowering therapy were randomized in a 2:1:2:1 ratio to receive PFS for the subcutaneous injection of ongericimab 150 mg every 2 weeks (Q2W) or a matching placebo, or AI for the subcutaneous injection of ongericimab 150 mg Q2W or a matching placebo. The primary efficacy endpoint was the percent change in low-density lipoprotein cholesterol (LDL-C) levels from baseline to week 12. Safety was also evaluated. At week 12, the least squares mean percent changes were -72.7% (3.9%) for PFS and -71.1% (3.8%) for AI (all P < 0.001) compared to respective matching placebo groups. Beneficial effects were also seen for all secondary lipid parameters, notably with robust reduction in Lp (a). Treatment-emergent adverse events (TEAEs) and serious AEs with ongericimab were reported in 46.2% and 2.4% of patients, compared to 44.2% and 3.5% with placebo. CONCLUSION: In Chinese patients with primary hypercholesterolemia and mixed dyslipidemia, a 12-week treatment regimen with ongericimab administered by PFS or AI significantly reduced LDL-C and other lipid parameters, proving to be safe and well tolerated. Patients experienced consistent effects from PFS or AI devices. CLINICAL TRIAL REGISTRATION: CTR20220027; January 11, 2022; http://www.chinadrugtrials.org.cn/index.html.
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Anticuerpos Monoclonales Humanizados , Biomarcadores , LDL-Colesterol , Hipercolesterolemia , Inhibidores de PCSK9 , Jeringas , Humanos , Masculino , Femenino , Persona de Mediana Edad , Hipercolesterolemia/tratamiento farmacológico , Hipercolesterolemia/sangre , Hipercolesterolemia/diagnóstico , Resultado del Tratamiento , China , LDL-Colesterol/sangre , Inyecciones Subcutáneas , Anciano , Factores de Tiempo , Biomarcadores/sangre , Anticuerpos Monoclonales Humanizados/efectos adversos , Anticuerpos Monoclonales Humanizados/administración & dosificación , Método Doble Ciego , Anticolesterolemiantes/efectos adversos , Anticolesterolemiantes/administración & dosificación , Adulto , Hiperlipidemias/tratamiento farmacológico , Hiperlipidemias/diagnóstico , Hiperlipidemias/sangre , Proproteína Convertasa 9RESUMEN
PURPOSE: PRESTO 3 evaluated nurses' preference for the Somatuline® Autogel® syringe versus the Lanreotide Pharmathen syringe after injection-pad testing. METHODS: This international simulated-use study included oncology/endocrinology nurses with ≥ 1 years' experience in managing neuroendocrine tumours (NETs) and/or acromegaly. Each nurse tested both syringes twice in a randomised order before completing an electronic survey. The primary objective was to assess overall preference (%, 95% confidence interval [CI]) for the Somatuline Autogel syringe versus the Lanreotide Pharmathen syringe. Secondary objectives included rating syringe performance and ranking the importance of syringe attributes. RESULTS: Ninety-four nurses were enrolled: mean age, 41.0 (SD, 11.5) years. The percentage of nurses stating a preference ("strong" or "slight") for the Somatuline Autogel syringe (86.2% [95% CI 77.5-92.4%]) was significantly higher than 50% (p < 0.0001). Performance rating was significantly higher for the Somatuline Autogel syringe versus Lanreotide Pharmathen syringe for 10 of the 11 attributes tested (p < 0.05). The syringe attributes considered most important when injecting patients in routine clinical practice were "easy to use from preparation to injection" (30.9%) and "comfortable to handle during use from preparation to injection" (16.0%). The attribute most commonly rated as least important was "fast administration from preparation to injection" (26.6%). CONCLUSION: Nurses strongly preferred the user experience of the Somatuline Autogel syringe over the Lanreotide Pharmathen syringe. "Ease of use" and "comfortable to handle" were the most important syringe attributes, and performance rating was significantly higher with Somatuline Autogel versus Lanreotide Pharmathen syringe for all but one attribute.
Drugs called somatostatin analogues (SSAs) can be used to treat patients with neuroendocrine tumours or acromegaly over a prolonged period of time. SSAs are given as injections and act by slowing the production of hormones by the body and in some cases reducing the growth of the tumour. To help to provide the best care possible, it is important that the syringe used for the injection is easy to use and delivers the SSA effectively. Somatuline Autogel is a syringe that can be used to inject an SSA called lanreotide. Previous studies showed that patients and nurses preferred the injection experience when using the Somatuline Autogel syringe compared with a syringe used to inject another SSA called octreotide long-acting release. A new syringe used for lanreotide injections has been developed recently by a company called Pharmathen. In the PRESTO 3 study, we compared the user experience of the Somatuline Autogel syringe and the Lanreotide Pharmathen syringe. We asked 94 nurses from Europe and the US to test both syringes, in a randomised order, using injection pads, and then to answer questions about their overall preference between the two syringes and how well the syringe performed for a set of syringe features. Overall, 86% of nurses preferred the Somatuline Autogel syringe over the Lanreotide Pharmathen syringe. Of the 11 features of the syringe that we assessed, 10 were rated higher for the Somatuline Autogel syringe than the Lanreotide Pharmathen syringe. The syringe features "ease of use" and "comfortable to handle" were considered the most important. The results of the PRESTO 3 study indicated that there is a difference in the user experience between the syringes, particularly for confidence and ease of use, and that it is important to offer syringe choices to nurses who are using SSA injections to treat patients.
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Acromegalia , Tumores Neuroendocrinos , Enfermeras y Enfermeros , Somatostatina/análogos & derivados , Humanos , Adulto , Acromegalia/tratamiento farmacológico , Jeringas , Péptidos CíclicosRESUMEN
BACKGROUND: The Tessari method is commonly used in sclerotherapy for producing foam, involving 2 syringes pushed back and forth 20 times with the use of a 3-way connector. Many factors affect the foam stability which is crucial for clinical efficacy. OBJECTIVE: This study aimed to identify the optimal pushing rate which may impact the foam stability. MATERIALS AND METHODS: Polidocanol (POL) solution (1% and 3%) was used to make sclerosant foam via the Tessari method, with a total of 20 pushes performed at different time durations: 10, 15, 20, 25, 30, 35, and 40 seconds. The foam stability was recorded using foam half-life time (FHT), and the pushing pressure to the syringe was recorded using a self-made electric device. Both FHT and the pressure among different groups were compared respectively. RESULTS: The FHT was decreased as pushing duration exceeding 20 seconds in POL 1% and 15 seconds in POL 3%. Both the highest FHT and pressure point were located in the 10-second group. CONCLUSION: It is recommended to complete 20 back-and-forth passages within 10 seconds to create stable foam.
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Polidocanol , Soluciones Esclerosantes , Escleroterapia , Jeringas , Soluciones Esclerosantes/química , Soluciones Esclerosantes/administración & dosificación , Polidocanol/química , Polidocanol/administración & dosificación , Escleroterapia/métodos , Polietilenglicoles/química , Presión , Estabilidad de Medicamentos , Humanos , Factores de Tiempo , SemividaRESUMEN
Critical drug studies explore the discursive and material dimensions of sexualised drug use to overcome individualised and often pathologising notions such as risk, safety, responsibility and pleasure. This article uses an object-oriented approach-following the use and flow of social apps, syringes and antiretroviral therapy (ART)-to analyse gay and bisexual Taiwanese men's drug practices. Interview data from fourteen men are used to articulate how objects were brought into gay and bisexual men's chemsex repertoire in ways that shaped individuals' safe-sex communication, intimacy maintenance and stigma negotiation. An object-oriented approach scrutinises risk, pleasure and identities in assemblages of the human and nonhuman, and can help identify new opportunities for implementing health promotion interventions and policies.
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Homosexualidad Masculina , Minorías Sexuales y de Género , Masculino , Humanos , Jeringas , Conducta Sexual , Parejas SexualesRESUMEN
Between 2017 and 2021, the Brazilian Unified Health System (BUHS) administered a total of 527,903,302 doses of immunizations. Each immunization results in the presence of a residual volume (RV) due to syringe dead space (DS). The International Organization for Standardization 7886-1 allows a DS of up to 0.07mL in sterile single-use hypodermic syringes with volumes less than 5mL. This study aims to quantify the DS of immunization devices used in Brazil, study the best combinations of needles and syringes to minimize RV, estimate the number of wasted doses from 2017 to 2021, and evaluate the impact on the BUHS. Pneumococcal 10 vaccine with a 25x6mm needle and a regular 1mL syringe exhibited a significantly higher average RV (0.0826mL) and waste rate (14.42%). It was observed that for some intramuscular vaccines, there is less waste when using a 20x5.5mm needle compared to a 25x6mm needle. The use of syringes with plunger stoppers that penetrate the syringe barrel, denoted as low dead space syringes, results in less RV and an estimated difference in the waste rate of approximately 10% compared to the regular syringe. The estimated number of wasted doses from 2017 to 2021 by BUHS is approximately 32 million doses.
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Vacunas , Brasil , Humanos , Jeringas , Agujas , Programas Nacionales de SaludRESUMEN
BACKGROUND: Pharmacies are critical healthcare partners in community efforts to eliminate bloodborne illnesses. Pharmacy sale of sterile syringes is central to this effort. METHODS: A mixed methods "secret shopper" syringe purchase study was conducted in the fall of 2022 with 38 community pharmacies in Maricopa and Pima Counties, Arizona. Pharmacies were geomapped to within 2 miles of areas identified as having a potentially high volume of illicit drug commerce. Daytime venue sampling was used whereby separate investigators with lived/living drug use experience attempted to purchase syringes without a prescription. Investigator response when prompted for purchase rationale was "to protect myself from HIV and hepatitis C." A 24-item instrument measured sales outcome, pharmacy staff interaction (hostile/neutral/friendly), and the buyer's subjective experience. RESULTS: Only 24.6% (n = 28) of 114 purchase attempts across the 38 pharmacies resulted in syringe sale. Less than one quarter (21.1%) of pharmacies always sold, while 44.7% never sold. Independent and food store pharmacies tended not to sell syringes. There emerged distinct pharmacy staff interactions characterized by body language, customer query, normalization or othering response, response to purchase request and closure. Pharmacy discretion and pharmacy policy not to sell syringes without a prescription limited sterile syringe access. Investigators reported frequent and adverse emotional impact due to pharmacy staff negative and stigmatizing interactions. CONCLUSIONS: Pharmacies miss opportunities to advance efforts to eliminate bloodborne infections by stringent no-sale policy and discretion about syringe sale. State regulatory policy facilitating pharmacy syringe sales, limiting pharmacist discretion for syringe sales, and targeting pharmacy-staff level education may help advance the achievement of public health goals to eliminate bloodborne infections in Arizona.
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Infecciones por VIH , Farmacias , Farmacia , Abuso de Sustancias por Vía Intravenosa , Humanos , Infecciones por VIH/prevención & control , Jeringas , ArizonaRESUMEN
BACKGROUND: Community concerns surrounding syringe waste are a common barrier to syringe services program (SSP) implementation. In Kanawha County, West Virginia, community opposition to SSPs resulted in the closure of needs-based SSPs prior to and during an HIV outbreak among persons who inject drugs (PWID). This qualitative analysis examines views of PWID and community partners on syringe waste and disposal associated with needs-based SSPs. METHODS: Qualitative interviews with 26 PWID and 45 community partners (medical and social service providers, law enforcement personnel, policymakers, and religious leaders) were conducted. Interviews were recorded, transcribed, and coded. Code summaries described participants' views on syringe waste and disposal and needs-based SSPs. RESULTS: Community partners and PWID who favored needs-based SSPs reported that needs-based SSPs had not affected or reduced syringe waste. Conversely, community partners who favored one-to-one exchange models and/or barcoded syringes described needs-based SSPs increasing syringe waste. Community partners often cited pervasive community beliefs that SSPs increased syringe waste, risk of needlesticks, drug use, and crime. Community partners were unsure how to address syringe waste concerns and emphasized that contradictory views on syringe waste posed barriers to discussing and implementing SSPs. CONCLUSIONS: Participants' views on whether syringe waste was associated with needs-based SSPs often aligned with their support or opposition for needs-based SSPs. These differing views resulted in challenges finding common ground to discuss SSP operations amid an HIV outbreak among PWID. SSPs might consider addressing syringe waste concerns by expanding syringe disposal efforts and implementing community engagement and stigma reduction activities.
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Programas de Intercambio de Agujas , Abuso de Sustancias por Vía Intravenosa , Humanos , Abuso de Sustancias por Vía Intravenosa/psicología , Abuso de Sustancias por Vía Intravenosa/epidemiología , Femenino , Masculino , Adulto , Jeringas , Infecciones por VIH/prevención & control , West Virginia/epidemiología , Persona de Mediana Edad , Investigación CualitativaRESUMEN
PURPOSE: To assess the push out bond strength (POBS) of a syringe-mixed resin sealer and a premixed bioceramic sealer to root dentin exposed to different gutta-percha (GP) solvents and to determine the mode of failure. METHODS: A total of 200 horizontal root slices (1 mm thickness) were prepared up to size 40, 0.04 taper and randomly divided into four main groups based on solvent (Endosolv, orange oil, chloroform) and control (saline), then subdivided into two subgroups based on sealer type (AH Plus Jet and iRoot SP). Samples were exposed to respective solvents for 5 minutes and after the final rinsing, canal spaces were filled with either AH Plus Jet or iRoot SP. POBS test was performed 2 weeks after incubation and mode of failure following POBS test was evaluated. Data were analyzed using two-way ANOVA and Dunnett post hoc analysis (P< 0.05). Failure mode patterns were categorized as adhesive, cohesive and mixed failures. RESULTS: There was no significant difference (P> 0.05) in POBS between all solvent groups against the control in both AH Plus Jet and iRoot SP groups. Regardless of the use of solvents, AH Plus Jet group had significantly higher bond strength (P< 0.001) compared to iRoot SP group. The predominant mode of failure was mixed failure in all groups irrespective of type of sealer and exposure to solvents. CLINICAL SIGNIFICANCE: This study showed that exposure to gutta-percha solvents (chloroform, orange oil and Endosolv) for 5 minutes did not affect the bond strengths of both iRoot SP (bioceramic sealer) and AH Plus (resin sealer) to root dentin.
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Recubrimiento Dental Adhesivo , Materiales de Obturación del Conducto Radicular , Silicatos , Gutapercha/química , Resinas Epoxi/química , Solventes , Cloroformo , Jeringas , Materiales de Obturación del Conducto Radicular/química , Dentina , Ensayo de MaterialesRESUMEN
For liquid drug products, e.g., solutions or suspensions for oral or parenteral dosing, stability needs to be demonstrated in primary packaging during storage and in dosing devices during in-use periods per quality guidelines from the International Conference on Harmonisation (ICH) and the European Agency for the Evaluation of Medicinal Products (EMEA). One aspect of stability testing for liquid drug products is in-use stability, which typically includes transferring the liquid samples into another container for further sample preparation with extraction diluent and necessary agitation. Samples are then analyzed with traditional chromatography methods, which are laborious, prone to human errors, and time-consuming, especially when this process needs to be repeated multiple times during storage and in-use periods. Being able to analyze the liquid samples non-destructively would significantly improve testing efficiency. We investigated different Raman techniques, including transmission Raman (TRS) and back scatter Raman with a non-contact optic (NCO) probe, as alternative non-destructive tools to the UHPLC method for API quantitation in in-use liquid samples pulled into plastic dosing syringes. The linearity of the chemometric methods for these two techniques was demonstrated by cross-validation sample sets at three levels over an API concentration range of 60 to 80 mg/mL. The accuracy of the chemometric models was demonstrated by the accurate prediction of the API concentrations in independent samples from four different pilot plant batches manufactured at different sites. Both techniques were successful in measuring a signal through a plastic oral dosing syringe, and predicting the suspension API concentration to within 4% of the UHPLC-measured value. For future work, there are opportunities to improve the methodology by exploring additional probes or to expand the range of applications by using different sample presentations (such as prefilled syringes) or formulation matrices for solutions and suspensions.
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Medicamentos a Granel , Jeringas , Humanos , Embalaje de Medicamentos , Suspensiones , ExcipientesRESUMEN
Nuclear medicine (NM) professionals are potentially exposed to high doses of ionising radiation, particularly in the skin of the hands. Ring dosimeters are used by the workers to ensure extremity doses are kept below the legal limits. However, ring dosimeters are often susceptible to large uncertainties, so it is difficult to ensure a correct measurement using the traditional occupational monitoring methods. An alternative solution is to calculate the absorbed dose by using Monte Carlo simulations. This method could reduce the uncertainty in dose calculation if the exact positions of the worker and the radiation source are represented in these simulations. In this study we present a set of computer vision and artificial intelligence algorithms that allow us to track the exact position of unshielded syringes and the hands of NM workers. We showcase a possible hardware configuration to acquire the necessary input data for the algorithms. And finally, we assess the tracking confidence of our software. The tracking accuracy achieved for the syringe detection was 57% and for the hand detection 98%.
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Algoritmos , Medicina Nuclear , Exposición Profesional , Humanos , Exposición Profesional/análisis , Mano/efectos de la radiación , Método de Montecarlo , Inteligencia Artificial , Radiometría/métodos , JeringasRESUMEN
The purpose of this technique is to offer patients wishing a labial restoration without morphological changes a simple, fast, discreet, comfortable, adaptable and reversible method by combining the two compounds most used in aesthetic medicine, botulinum toxin and hyaluronic acid. The originality of this combination is based on their mixing in the same syringe and their injection with cannula through a paracommissural approach which makes it possible to treat the entire upper lip in a very homogeneous manner. Botulinum toxin diffuses directly into the underlying muscle layer; hyaluronic acid allows to unfold the damaged cutaneous fan. The useful reciprocal dose of the two products remains intuitive; for starting barcodes the dose of botulinum toxin will be 8-10 Speywood units (4 Allergan units), for those already marked at rest 10-20 Speywood units (4-8 Allergan units); the hyaluronic acid will be chosen according to the depth of the wrinkles. We present a series of 63 patients with an average age of 67 years with a result deemed positive in 79% of cases. The incidents reported are generally due to excessive doses of botulinum toxin which can lead to the classic incidents of fluid leaks in this location (6%). The expected efficacy of the treatment depends on that of the components used (four to six months) but prolonged results have been regularly observed (up to 18 months). All complementary resurfacing treatments have been discarded here since the aim pursued is that of a natural labial restoration allowing an immediate return to socio-professional activities.
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Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Humanos , Anciano , Ácido Hialurónico , Jeringas , Inyecciones , LabioRESUMEN
In 2016, the World Health Organization (WHO) released the Global Health Sector Strategy (GHSS) setting goals for global hepatitis elimination. To inform new or revised viral hepatitis national strategic action plans (NSAPs) for 2022-2030, NSAPs developed during 2016-2021 were assessed for alignment with the WHO GHSS. Country NSAPs were assessed to determine if they included components in the 2016 GHSS. Of 55 country NSAPs, 19 (35%) did not include hepatitis B and C virus elimination goals, only 18 (33%) included targets for needles and syringes for persons who inject drugs, and 21 (38%) had a national budget or financing plan for hepatitis activities. Gaps identified indicate need for technical support in NSAP development.
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Consumidores de Drogas , Hepatitis A , Hepatitis B , Abuso de Sustancias por Vía Intravenosa , Humanos , JeringasRESUMEN
Anakinra is a recombinant human interleukin-1 receptor antagonist approved for the treatment of inflammatory diseases. Kineret is available as a solution prepared in a borosilicate glass syringe. For implementing a placebo-controlled double-blind randomized clinical trial, anakinra is commonly transferred into plastic syringes. However, there is limited data on anakinra's stability in polycarbonate syringes. We described the results of our previous studies on the use of anakinra in glass (VCUART3) versus plastic syringes (VCUART2) compared with placebo. These studies were conducted in patients with ST-segment elevation myocardial infarction (STEMI), and we assessed the anti-inflammatory effects of anakinra versus placebo by comparing the area under the curve for high-sensitivity cardiac reactive protein (AUC-CRP) levels during the first 14 days of STEMI, its clinical effects on heart failure (HF) hospitalization, cardiovascular death, or new diagnosis of HF as well as adverse events profile between groups. The levels of AUC-CRP were 75 (50-255 mg·day/l) for anakinra in plastic syringes versus 255 (116-592 mg·day/l) in placebo and 60 (24-139 mg·day/l) and 86 (43-123 mg·day/l) for anakinra once and twice daily in glass syringes, respectively, compared with placebo 214 (131-394 mg·day/l). The rate of adverse events was also comparable between groups. There were no differences in the rate of HF hospitalization or cardiovascular death in patients who received anakinra in plastic or glass syringes. Fewer cases of new-onset heart failure occurred in patients receiving anakinra in plastic or glass syringes compared with placebo. Anakinra stored in plastic (polycarbonate) syringes provides comparable biologic and clinical effect to glass (borosilicate) syringes. SIGNIFICANCE STATEMENT: Anakinra (Kineret) 100 mg administered subcutaneously in patients with ST-segment elevation myocardial infarction (STEMI) for a duration of up to 14 days appears to have comparable safety and biological efficacy signals when delivered in prefilled glass or transferred into plastic polycarbonate syringes. This may have important implications for the feasibility of designing clinical trials in STEMI and other clinical conditions.
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Insuficiencia Cardíaca , Infarto del Miocardio con Elevación del ST , Humanos , Proteína Antagonista del Receptor de Interleucina 1/efectos adversos , Jeringas , Infarto del Miocardio con Elevación del ST/inducido químicamente , Infarto del Miocardio con Elevación del ST/tratamiento farmacológico , Resultado del Tratamiento , Proteínas Recombinantes/uso terapéutico , Insuficiencia Cardíaca/tratamiento farmacológico , PlásticosRESUMEN
PURPOSE: To utilize an in vitro microvascular hepatic tumor model to compare the deposition characteristics of glass yttrium-90 microspheres using the dual-syringe (DS) and traditional bolus administration methods. MATERIALS AND METHODS: The microvascular tumor model represented a 3.5-cm tumor in a 1,400-cm3 liver with a total hepatic flow of 160 mL/min and was dynamically perfused. A microcatheter was placed in a 2-mm artery feeding the tumor model and 2 additional nontarget arteries. Glass microspheres with a diameter of 20-30 µm were administered using 2 methods: (a) DS delivery at a concentration of 50 mg/mL in either a single, continuous 2-mL infusion or two 1-mL infusions and (b) bolus delivery (BD) of 100 mg of microspheres in a single 3-mL infusion. RESULTS: Overall, the degree of on-target deposition of the microspheres was 85% ± 11%, with no significant differences between the administration methods. Although the distal penetration into the tumor arterioles was approximately 15 mm (from the second microvascular bifurcation of the tumor model) for all the cases, the distal peak particle counts were significantly higher for the DS delivery case (approximately 5 × 105 microspheres achieving distal deposition vs 2 × 105 for the BD case). This resulted in significantly higher deposition uniformity within the tumor model (90% for the DS delivery case vs 80% for the BD case, α = 0.05). CONCLUSIONS: The use of this new in vitro microvascular hepatic tumor model demonstrated that the administration method can affect the deposition of yttrium-90 microspheres within a tumor, with greater distal deposition and more uniform tumor coverage when the microspheres are delivered at consistent concentrations using a DS delivery device. The BD administration method was associated with less favorable deposition characteristics of the microspheres.
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Arteria Hepática , Neoplasias Hepáticas , Humanos , Arteria Hepática/patología , Microesferas , Jeringas , Neoplasias Hepáticas/diagnóstico por imagen , Neoplasias Hepáticas/radioterapia , Neoplasias Hepáticas/irrigación sanguínea , Radioisótopos de Itrio , VidrioRESUMEN
BACKGROUND: Residual activity in dispensing syringes is a problem that has been sporadically reported with various radiopharmaceuticals. Studies with [99mTc]Tc-tetrofosmin are non-consistent so far. The aim was to quantify the residual activity of [99mTc]Tc-tetrofosmin in different syringes in a clinical setting and to assess its impact on the clinical imaging procedure. METHODS: The residual activity of [99mTc]Tc-tetrofosmin was measured in 3 types of syringes: 3-part lubricated and non-lubricated syringes and 2-part syringe (n ≥ 30 for each syringe). The residual activity was located and quantified using a CzT SPECT camera and radio-counting then was correlated with different clinical parameters and processed by multiple linear regression analysis. RESULTS: Residual activity was different in all syringe types but lubricated syringes showed significantly higher levels with a mean ± SD of 26.12 ± 10.21% (P < .001). For these syringes, the residual activity was mainly located on the lubricated body. They also have a positive and significant impact on the standardized counting duration of patients' acquisitions. CONCLUSION: Lubricated syringes with high residual activity should be avoided as they increase the risk of prolonging patient acquisition time and potentially increasing the risk of poor image quality.
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Imagen de Perfusión Miocárdica , Jeringas , Humanos , Radiofármacos , Tomografía Computarizada de Emisión de Fotón Único , Compuestos Organofosforados , Compuestos de OrganotecnecioRESUMEN
Kentucky is one of ten states that require syringe services program (SSP) approval from local officials to operate legally. Public health leaders and local officials participated in semi-structured interviews in 2016 about the barriers and facilitators of SSP adoption and implementation (N = 22). Interviews were transcribed verbatim, and a thematic content analysis was conducted using Nvivo software. Political support, program champions who led education efforts, and access to resources and training facilitated SSP adoption. The most frequently reported barriers to adoption were often rooted in stigma and included the lack of political will to approve SSPs or lack of recognition of the need for a SSP. Requiring approval from local governing authorities could impose significant implementation delays, limits to the range of harm reduction services provided, and threaten harm reduction program sustainability. Removing barriers to the adoption and implementation of harm reduction programs is critical in order to effectively scale up harm reduction services to reduce the risks of infection and fatal overdose.