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2.
Medicine (Baltimore) ; 99(40): e22536, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019461

RESUMO

RATIONALE: Paroxysmal autonomic instability with dystonia (PAID) is an underdiagnosed syndrome that describes a collection of symptoms following diverse cerebral insults, such as traumatic brain injury, hydrocephalus, hemorrhagic stroke, or brain anoxia. It is manifested by systemic high blood pressure, hyperthermia, tachycardia, tachypnea, diaphoresis, intermittent agitation, and certain forms of dystonia. PATIENT CONCERNS: A semi-comatose 46-year-old man was transferred from the regional rehabilitation hospital with various complaints involving fluctuating vital signs, including uncontrolled hyperthermia, hypertension, tachycardia, and tachypnea, and dystonia in all extremities. The patient underwent brain surgery for astrocytoma in 1996. The patient also had a history of first ischemic stroke on the basal ganglia in 2008 and a second one in the same area in 2017. DIAGNOSIS: The laboratory, electrocardiography, and radiologic findings were normal. Brain imaging indicated an old infarction on the basal ganglia with hydrocephalus. Tractography using diffusion tensor imaging showed discontinuity of multiple tracts, and electrophysiologic tests, such as evoked potentials, displayed an absent response. Based on the dysautonomic symptoms and brain evaluations, the physiatrist diagnosed the patient with PAID. INTERVENTIONS: Bromocriptine, propranolol, and clonazepam were administered sequentially, but autonomic instability persisted. Then, intravenous opioid was administered, and fluctuations in body temperature, heart rate, and respiratory rate, as well as decerebrate-type dystonia were improved. However, simultaneously, drug-induced severe hypotension developed (systolic blood pressure, 57 mm Hg). Subsequently, a transdermal opioid (fentanyl) patch for PAID was applied once every 3 days. OUTCOMES: Ultimately, all vital signs and dystonia were managed without further complications, and the patient was discharged. LESSONS: A patient diagnosed with PAID following multiple cerebral insults was observed, whose condition was controlled by application of opioid patch rather than by intravenous or oral routes. A transdermal opioid patch, such as fentanyl patch, can thus be effective in the treatment of patients with PAID following multiple cerebral insults.


Assuntos
Analgésicos Opioides/uso terapêutico , Doenças do Sistema Nervoso Autônomo/tratamento farmacológico , Distonia/diagnóstico , Fentanila/uso terapêutico , Doenças do Sistema Nervoso Autônomo/diagnóstico , Doenças do Sistema Nervoso Autônomo/fisiopatologia , Gânglios da Base/patologia , Isquemia Encefálica/diagnóstico por imagem , Imagem de Tensor de Difusão/métodos , Distonia/etiologia , Febre/diagnóstico , Febre/etiologia , Humanos , Hidrocefalia/etiologia , Hipertensão/diagnóstico , Hipertensão/etiologia , Hipotensão/induzido quimicamente , Masculino , Pessoa de Meia-Idade , Síndrome , Taquicardia/diagnóstico , Taquicardia/etiologia , Taquipneia/diagnóstico , Taquipneia/etiologia , Adesivo Transdérmico/efeitos adversos , Resultado do Tratamento
3.
J Opioid Manag ; 16(4): 237-238, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32886349

RESUMO

The COVID-19 ARDS appears to have worse outcomes than ARDS from other causes. It is a predictable serious complication and the key strategy is to maintain oxygenation. Adopting the prone position for conscious COVID-19 patients requiring basic respiratory support, is shown to benefit patients in terms of improving oxygenation, reducing the need for invasive ventilation and potentially even reducing mortality. Cough and myalgia are the common and most distressing symptoms seen in conscious COVID-19 patients which can impair tolerance to awake proning. Modified awake proning with application of transdermal fentanyl patch (TFP) can improve the compliance to conscious proning in COVID-19 patients.


Assuntos
Analgésicos Opioides/administração & dosagem , Estado de Consciência , Infecções por Coronavirus/terapia , Fentanila/administração & dosagem , Pneumonia Viral/terapia , Decúbito Ventral , Betacoronavirus , Humanos , Pandemias , Síndrome do Desconforto Respiratório do Adulto/terapia , Síndrome do Desconforto Respiratório do Adulto/virologia , Adesivo Transdérmico
4.
Yakugaku Zasshi ; 140(9): 1175-1183, 2020.
Artigo em Japonês | MEDLINE | ID: mdl-32879249

RESUMO

The mock patches were prepared with novel acrylic polymers as adhesive layer where biphenyl-4-ylacetic acid (BAA) or 2-(2-fluorobiphenyl-4-yl) propanoic acid (FPA) was used as model active pharmaceutical ingredients (APIs). In addition, the mock patches were formulated with typical ester ingredients for transdermal dosage forms. The molecular state of the model APIs in the adhesive layer was observed by polarized microscope and microscopic Raman spectroscopy, which contains both conventional and low frequency (LF) region. Crystallization behavior would be depended on the interaction between API and polymers in the adhesive layer. In particular, LF Raman measurement was useful to discriminate API polymorphs. The pharmaceutical properties including dissolution and skin permeation of APIs were also evaluated for mock patches. The drug release and transdermal permeation were enhanced with the ester ingredients such as isopropyl myristate and diethyl sebacate due to their diffusion to the test solution or the skin stratum corneum as well as reducing the interaction between API and polymers. Further, the tack strength was not changed, but the peel strength was weakened by the additives. Thus, the adhesive properties were controllable by formulation with the additives. These findings could enable to evaluate the interaction between API and the polymers for adhesive layer and select the appropriate polymer and additives for used APIs when designing the drug products.


Assuntos
Anti-Inflamatórios não Esteroides/administração & dosagem , Polímeros , Adesivo Transdérmico , Adesividade , Administração Cutânea , Ácidos Decanoicos , Liberação Controlada de Fármacos , Miristatos , Fenilacetatos/administração & dosagem , Fenilacetatos/metabolismo , Propionatos/administração & dosagem , Propionatos/metabolismo , Absorção Cutânea , Solubilidade , Análise Espectral Raman
5.
An Acad Bras Cienc ; 92(2): e20191073, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32696844

RESUMO

The objectives of this study are to prepare a 5 wt% lidocaine/aspirin ionic liquid drug-loaded gelatin/polyvinyl alcohol composite film using a freeze-thaw procedure and to evaluate their physicochemical characteristics, in vitro drug release, and stability. Lidocaine/aspirin ionic liquid drugs can be prepared by an ion-pair reaction between the hydrochloride salts of lidocaine and the sodium salts of aspirin, which showed a significant change in their thermal properties when compared to those pure drugs. The results showed that a transdermal patch could feasibly be used in pharmaceutical transdermal patches with good physicochemical properties. A chemical interaction between the drug and polymer base was not found. Decomposition of the lidocaine/aspirin ionic liquid drug was found in the patch; however, the properties of the patch were not changed after drug loading. The patch controlled the drug release and showed good stability during the studied period of three months when kept at 4°C more than at ambient temperature and 45°C.


Assuntos
Líquidos Iônicos , Adesivo Transdérmico , Administração Cutânea , Aspirina , Gelatina , Lidocaína , Álcool de Polivinil
6.
AAPS PharmSciTech ; 21(5): 180, 2020 Jun 29.
Artigo em Inglês | MEDLINE | ID: mdl-32601758

RESUMO

Rheumatoid arthritis, a chronic disorder, limits the use of chemical penetration enhancers for a prolonged period of time. Moreover, systemic routes of administration of the first-line drug, methotrexate, have shown undesirable systemic as well as local side effects. The objective of this research was to overcome the limitations associated with treatment of rheumatoid arthritis by utilizing three physical transdermal penetration enhancement techniques namely cold-laser, electroporation, and sonophoresis to deliver methotrexate. Methotrexate patch was prepared using solvent casting method and the ex-vivo release of methotrexate in combination with three physical penetration enhancers (sonophoresis, electroporation, and cold laser) were studied. The best technique was employed in pre-clinical testing in arthritic and control groups of male Wistar rats excluding remaining two techniques. The comparative ex-vivo studies showed that the penetration enhancement of methotrexate is maximum by sonophoresis followed by electroporation and cold laser (sonophoresis > electroporation > cold laser). In pharmacodynamic studies, the reduction in diameter of injected and non-injected paw on day 5 and day 21 for group 4 (ultrasound pre-treated group) was higher as compared to group 3 (group receiving only methotrexate patch). The motility score and the reduction in pain were significantly improved for group 4 than group 3 on both day 5 and day 21 (P Ë‚ 0.05) which confirmed the faster recovery of animals of group 4 due to penetration enhancement of methotrexate patch by ultrasound treatment. From the results, it can be concluded that sonophoresis along with methotrexate patch has shown a significant effect in the treatment of rheumatoid arthritis.


Assuntos
Antirreumáticos/administração & dosagem , Artrite Reumatoide/tratamento farmacológico , Metotrexato/administração & dosagem , Adesivo Transdérmico , Terapia por Ultrassom , Administração Cutânea , Animais , Masculino , Ratos , Ratos Wistar , Pele/metabolismo , Absorção Cutânea
7.
C R Biol ; 343(1): 33-39, 2020 Jun 05.
Artigo em Inglês | MEDLINE | ID: mdl-32720486

RESUMO

SARS-CoV-2 epidemics raises a considerable issue of public health at the planetary scale. There is a pressing urgency to find treatments based upon currently available scientific knowledge. Therefore, we tentatively propose a hypothesis which hopefully might ultimately help save lives. Based on the current scientific literature and on new epidemiological data which reveal that current smoking status appears to be a protective factor against the infection by SARS-CoV-2 [1], we hypothesize that the nicotinic acetylcholine receptor (nAChR) plays a key role in the pathophysiology of Covid-19 infection and might represent a target for the prevention and control of Covid-19 infection.


Assuntos
Infecções por Coronavirus/fisiopatologia , Infecções por Coronavirus/terapia , Nicotina/uso terapêutico , Agonistas Nicotínicos/uso terapêutico , Pneumonia Viral/fisiopatologia , Pneumonia Viral/terapia , Receptores Nicotínicos , Infecções por Coronavirus/prevenção & controle , Humanos , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Fumar , Adesivo Transdérmico
8.
Medicine (Baltimore) ; 99(24): e20405, 2020 Jun 12.
Artigo em Inglês | MEDLINE | ID: mdl-32541462

RESUMO

BACKGROUND: The efficacy and safety of buprenorphine transdermal patch (BTP) has been well established in chronic pain, but data regarding acute postoperative pain relief is still very limited. Therefore, we design a prospective, randomized, controlled study to evaluate the effectiveness and safety of the BTP for postoperative analgesia in total hip arthroplasty. METHODS: This study is designed as a single-center, prospective, double-blind, randomized controlled trial. Group A receives a 10 mg patch of buprenorphine at the conclusion of surgery which is continued for 14 days. Group B receives a conventional analgesic regimen, that is, IV paracetamol 1 mg every 8 hours alternating with parenteral tramadol 50 mg every 8 hours for the first 2 postoperative days followed by oral administration of the same drug still the end of 2 weeks. A total of 160 patients are needed with an allowance for 10% drop-out. The primary outcome of this noninferiority study is opioid consumption within the first 24 hours following surgery. The secondary outcomes included numerical rating scale scores at rest, postoperative complications, length of hospital stay, and patient satisfaction. RESULTS: This trial is expected to be the largest randomized trial assessing the efficacy of BTP after primary total hip arthroplasty and powered to detect a potential difference in the primary outcome. TRIAL REGISTRATION NUMBER: This study protocol was registered in Research Registry (researchregistry5524).


Assuntos
Analgésicos Opioides/uso terapêutico , Artroplastia de Quadril/efeitos adversos , Buprenorfina/uso terapêutico , Dor Pós-Operatória/tratamento farmacológico , Adesivo Transdérmico/efeitos adversos , Acetaminofen/administração & dosagem , Acetaminofen/uso terapêutico , Administração Intravenosa , Administração Oral , Analgésicos não Entorpecentes/administração & dosagem , Analgésicos não Entorpecentes/uso terapêutico , Analgésicos Opioides/administração & dosagem , Buprenorfina/administração & dosagem , Estudos de Casos e Controles , Método Duplo-Cego , Feminino , Humanos , Tempo de Internação/estatística & dados numéricos , Masculino , Medição da Dor/estatística & dados numéricos , Medição da Dor/tendências , Satisfação do Paciente/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Tramadol/administração & dosagem , Tramadol/uso terapêutico
9.
Expert Opin Pharmacother ; 21(11): 1377-1387, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32511032

RESUMO

INTRODUCTION: Neuropathic pain (NP) is caused by a lesion or disease of the somatosensory system, which can severely impact patients' quality of life. The current-approved treatments for NP comprise of both centrally acting agents and topical drugs, including capsaicin 8% dermal patches, which is approved for the treatment of peripheral NP. AREAS COVERED: The authors summarize literature data regarding capsaicin use in patients who suffer from NP and discuss the clinical applications of this topical approach. EXPERT OPINION: Overall, the capsaicin 8% dermal patch is as effective in reducing pain intensity as other centrally active agents (i.e. pregabalin). Some studies have also reported fewer systemic side effects, a faster onset of action and superior treatment satisfaction compared with systemic agents. In our opinion, capsaicin 8% dermal patches also present additional advantages, such as a good systemic tolerability, the scarcity of adverse events, the possibility to combine it with other agents, and a good cost-effective profile. It is important to note that, as the mechanism of action of capsaicin 8% is the 'defunctionalization' of small afferent fibers through interaction with TRPV1 receptors, the peripheral expression of this receptor on nociceptor fibers, is crucial to predict patient's response to treatment.


Assuntos
Analgésicos/administração & dosagem , Analgésicos/uso terapêutico , Capsaicina/administração & dosagem , Capsaicina/uso terapêutico , Neuralgia/tratamento farmacológico , Administração Tópica , Analgésicos/efeitos adversos , Capsaicina/efeitos adversos , Análise Custo-Benefício , Prova Pericial , Humanos , Neuralgia/metabolismo , Pregabalina/administração & dosagem , Pregabalina/efeitos adversos , Pregabalina/uso terapêutico , Qualidade de Vida , Canais de Cátion TRPV/metabolismo , Adesivo Transdérmico
10.
AAPS PharmSciTech ; 21(5): 165, 2020 Jun 04.
Artigo em Inglês | MEDLINE | ID: mdl-32500420

RESUMO

A transdermal drug delivery system (TDDS) is generally designed to deliver an active pharmaceutical ingredient (API) through the skin for systemic action. Permeation of an API through the skin is controlled by adjusting drug concentration, formulation composition, and patch design. A bilayer, drug-in-adhesive TDDS design may allow improved modulation of the drug release profile by facilitating varying layer thicknesses and drug spatial distribution across each layer. We hypothesized that the co-release of two fixed-dose APIs from a bilayer TDDS could be controlled by modifying spatial distribution and layer thickness while maintaining the same overall formulation composition. Franz cell diffusion studies demonstrated that three different bilayer patch designs, with different spatial distribution of drug and layer thicknesses, could modulate drug permeation and be compared with a reference single-layer monolith patch design. Compared with the monolith, decreased opioid antagonist permeation while maintaining fentanyl permeation could be achieved using a bilayer design. In addition, modulation of the drug spatial distribution and individual layer thicknesses, control of each drug's permeation could be independently achieved. Bilayer patch performance did not change over an 8-week period in accelerated stability storage conditions. In conclusion, modifying the patch design of a bilayer TDDS achieves an individualized permeation of each API while maintaining constant patch composition.


Assuntos
Sistemas de Liberação de Medicamentos , Adesivo Transdérmico , Idoso , Animais , Composição de Medicamentos , Humanos , Masculino , Pele/metabolismo
11.
BMJ Support Palliat Care ; 10(3): 343-349, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32546559

RESUMO

BACKGROUND: Anticipatory prescribing (AP) of injectable medications in advance of clinical need is established practice in community end-of-life care. Changes to prescribing guidelines and practice have been reported during the COVID-19 pandemic. AIMS AND OBJECTIVES: To investigate UK and Ireland clinicians' experiences concerning changes in AP during the COVID-19 pandemic and their recommendations for change. METHODS: Online survey of participants at previous AP national workshops, members of the Association for Palliative Medicine of Great Britain and Ireland and other professional organisations, with snowball sampling. RESULTS: Two hundred and sixty-one replies were received between 9 and 19 April 2020 from clinicians in community, hospice and hospital settings across all areas of the UK and Ireland. Changes to AP local guidance and practice were reported: route of administration (47%), drugs prescribed (38%), total quantities prescribed (35%), doses and ranges (29%). Concerns over shortages of nurses and doctors to administer subcutaneous injections led 37% to consider drug administration by family or social caregivers, often by buccal, sublingual and transdermal routes. Clinical contact and patient assessment were more often remote via telephone or video (63%). Recommendations for regulatory changes to permit drug repurposing and easier community access were made. CONCLUSIONS: The challenges of the COVID-19 pandemic for UK community palliative care has stimulated rapid innovation in AP. The extent to which these are implemented and their clinical efficacy need further examination.


Assuntos
Cuidadores , Vias de Administração de Medicamentos , Cuidados Paliativos/métodos , Padrões de Prática Médica/estatística & dados numéricos , Assistência Terminal/métodos , Administração Bucal , Administração Sublingual , Analgésicos não Entorpecentes/administração & dosagem , Analgésicos Opioides/administração & dosagem , Betacoronavirus , Infecções por Coronavirus/epidemiologia , Fentanila/administração & dosagem , Clínicos Gerais , Cuidados Paliativos na Terminalidade da Vida/métodos , Hospitais para Doentes Terminais , Humanos , Hipnóticos e Sedativos/administração & dosagem , Irlanda/epidemiologia , Lorazepam/administração & dosagem , Metotrimeprazina/administração & dosagem , Antagonistas Muscarínicos/administração & dosagem , Enfermeiras Especialistas , Medicina Paliativa , Pandemias , Médicos , Pneumonia Viral/epidemiologia , Guias de Prática Clínica como Assunto , Inquéritos e Questionários , Telemedicina/métodos , Adesivo Transdérmico , Reino Unido/epidemiologia
12.
Pan Afr Med J ; 35(Suppl 1): 3, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32373254

RESUMO

The African Region is committed to measles elimination by 2020 but coverage with the first dose of measles-containing vaccine was only 70% in 2017. Several obstacles to achieving high coverage with measles and rubella vaccines exist, some of which could be overcome with new vaccine delivery technologies. Microarray array patches (MAPs) are single-dose devices used for transcutaneous administration of molecules, including inactivated or attenuated vaccines, that penetrate the outer stratum corneum of the skin, delivering antigens to the epidermis or dermis. MAPs to deliver measles and rubella vaccines have the potential to be a transformative technology to achieve elimination goals in the African Region. MAPs for measles and rubella vaccination have been shown to be safe, immunogenic and thermostable in preclinical studies but results of clinical studies in humans have not yet been published. This review summarizes the current state of knowledge of measles and rubella MAPs, their potential advantages for immunization programs in the African Region, and some of the challenges that must be overcome before measles and rubella MAPs are available for widespread use.


Assuntos
Vacina contra Sarampo/administração & dosagem , Sarampo/prevenção & controle , Vacina contra Rubéola/administração & dosagem , Rubéola (Sarampo Alemão)/prevenção & controle , Adesivo Transdérmico , Cobertura Vacinal/métodos , Administração Cutânea , África/epidemiologia , Humanos , Programas de Imunização/métodos , Microtecnologia/instrumentação , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Cobertura Vacinal/estatística & dados numéricos
13.
J Pharmacol Sci ; 143(3): 182-187, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32386904

RESUMO

Memory CD8+ cytotoxic T-lymphocytes (CTLs) play a key role in protective immunity against infection and cancer. However, the induction of memory CTLs with currently available vaccines remains difficult. The chemokine receptor XCR1 is predominantly expressed on CD103+ cross-presenting dendritic cells (DCs). Recently, we have demonstrated that a high activity form of murine lymphotactin/XCL1 (mXCL1-V21C/A59C), a ligand of XCR1, can induce antigen-specific memory CTLs by increasing the accumulation of CD103+ DCs in the vaccination site and the regional lymph nodes. Here, we combined a hydrophilic gel patch as a transcutaneous delivery device and mXCL1-V21C/A59C as an adjuvant to further enhance memory CTL responses. The transcutaneous delivery of ovalbumin (OVA) and mXCL1-V21C/A59C by the hydrophilic gel patch increased CD103+ DCs in the vaccination site and the regional lymph nodes for a prolonged period of time compared with the intradermal injection of OVA and mXCL1-V21C/A59C. Furthermore, the hydrophilic gel patch containing OVA and mXCL1-V21C/A59C strongly induced OVA-specific memory CTLs and efficiently inhibited the growth of OVA-expressing tumors more than the intradermal injection of OVA and mXCL1-V21C/A59C. Collectively, this type of hydrophilic gel patch and a high activity form of XCL1 may provide a useful tool for the induction of memory CTL responses.


Assuntos
Adjuvantes Imunológicos/administração & dosagem , Linfócitos T CD8-Positivos/imunologia , Vacinas Anticâncer/administração & dosagem , Quimiocinas C/administração & dosagem , Quimiocinas C/imunologia , Imunização/métodos , Adesivo Transdérmico , Animais , Antígenos CD , Linhagem Celular , Células Dendríticas/imunologia , Géis , Interações Hidrofóbicas e Hidrofílicas , Cadeias alfa de Integrinas , Camundongos Endogâmicos C57BL , Ovalbumina/administração & dosagem , Ovalbumina/imunologia , Fatores de Tempo
14.
Zhongguo Zhong Yao Za Zhi ; 45(4): 854-860, 2020 Feb.
Artigo em Chinês | MEDLINE | ID: mdl-32237486

RESUMO

L_9(3~4) orthogonal experiment design was used to optimize the preparation of the patches,and investigate its affecting factors and skin irritation. Eugenol was taken as the index component to study the release behavior in vitro and percutaneous penetration of Cangai oil transfersomes patches by HPLC.The results showed that the optimal prescription for preparing Cangai oil transfersomes patches were Eudragit E100 0.6 g, succinic acid 0.08 g,triethyl citrate 0.25 g,glycerol 0.2 g.Patches prepared by the preferred preparation had a flat appearance without obvious bubbles.The initial adhesion was 18.33±2.52, the stickiness was(30.01±2.45) min,and the peel strength was(5.62±0.95) kN·m~(-1).The results of affecting factors experiment showed the order of factors affecting its adhesion was humidity>temperature>lighting,and the skin irritation test results showed no significant skin irritation after 24 h of single administration. The results of drug release behavior in vitro showed that the release and the percutaneous penetration of both Cangai oil patches and Cangai oil transfersomes patches conformed to the Higuchi equation.The release amount of eugenol were 80.66% and 82.25% at 72 h, with no significant difference. The cumulative permeation area of eugenol per unit area reached(0.195 6±0.065 9),(0.131 0±0.045 5) mg·cm~(-2) at 72 h, with significant differences(P<0.05).The experiment results proved that the preparation process of Cangai oil transfersomes patches was stable,and the prepared patches had a good adhesion. At the same time,the preparation of transfersomes patches could alleviate and control the release of the drug to a certain extent, and provide a certain experimental basis for clinical pediatric drug safety.


Assuntos
Óleos Vegetais/farmacologia , Absorção Cutânea , Pele/efeitos dos fármacos , Adesivo Transdérmico , Administração Cutânea , Portadores de Fármacos , Liberação Controlada de Fármacos , Humanos , Ácidos Polimetacrílicos
15.
Med. infant ; 27(1): 25-28, Marzo de 2020. tab, ilus
Artigo em Espanhol | LILACS, BINACIS, UNISALUD | ID: biblio-1118643

RESUMO

Los parches de EMLA son frecuentemente utilizados como anestésicos locales durante la realización en procedimientos invasivos. Con el fin de valorar su eficacia y compararla con la de otros analgésicos y anestésicos disponibles, se realizó una revisión sistemática de todos los estudios realizados que cumplieran criterios de inclusión entre los años 1990 y 2019. Población y métodos: la búsqueda bibliográfica de la evidencia disponible fue realizada en las bases de datos de Cochrane Medline y Lilacs. Se incluyeron todos los ECA y revisiones sistemáticas en pacientes menores de 16 años entre los años 1990 y 2019. Resultados: Fueron hallados 31 artículos de los cuales 21 cumplían con los criterios de inclusión. De dichos 21, solamente 8 estudios resultaron de muy buena y excelente calidad metodológica (JADAD). Conclusiones: El EMLA demostró mayor eficacia como analgésico en el 100% de los estudios donde se comparaba respecto del placebo. Sin embargo, no se encontraron diferencias significativas respecto de otros analgésicos farmacológicos y no farmacológicos.(AU)


EMLA patches are commonly used as local anesthetics in minor invasive procedures. To assess efficacy and compare the patches with other available analgesics and anesthetics, a systematic review was conducted evaluated all studies that met the inclusion criteria published between 1990 and 2019. Population and methods: A literature search of the available evidence was conducted in the Cochrane, Medline, and Lilacs databases. All RCTs and systematic reviews in patients younger than 16 years published between 1990 and 2019 were included. Results: 31 articles were identified of which 21 met the inclusion criteria. Of these 21, of only 8 studies the methodology was of very good and excellent quality (JADAD). Conclusions: EMLA better efficacy as an analgesic in 100% of the studies comparing EMLA patches with placebo. However, no significant differences were found when comparing the patches with other pharmacological and non-pharmacological analgesics.(AU)


Assuntos
Humanos , Recém-Nascido , Lactente , Pré-Escolar , Criança , Adolescente , Dor/prevenção & controle , Adesivo Transdérmico , Manejo da Dor/métodos , Combinação Lidocaína e Prilocaína/uso terapêutico , Anestésicos Locais/uso terapêutico , Resultado do Tratamento , Pesquisa Comparativa da Efetividade
17.
PLoS Med ; 17(3): e1003024, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32181756

RESUMO

BACKGROUND: The Vaxxas high-density microarray patch (HD-MAP) consists of a high density of microprojections coated with vaccine for delivery into the skin. Microarray patches (MAPs) offer the possibility of improved vaccine thermostability as well as the potential to be safer, more acceptable, easier to use, and more cost-effective for the administration of vaccines than injection by needle and syringe (N&S). Here, we report a phase I trial using the Vaxxas HD-MAP to deliver a monovalent influenza vaccine that was to the best of our knowledge the first clinical trial to evaluate the safety, tolerability, and immunogenicity of lower doses of influenza vaccine delivered by MAPs. METHODS AND FINDINGS: HD-MAPs were coated with a monovalent, split inactivated influenza virus vaccine containing A/Singapore/GP1908/2015 H1N1 haemagglutinin (HA). Between February 2018 and March 2018, 60 healthy adults (age 18-35 years) in Melbourne, Australia were enrolled into part A of the study and vaccinated with either: HD-MAPs delivering 15 µg of A/Singapore/GP1908/2015 H1N1 HA antigen (A-Sing) to the volar forearm (FA); uncoated HD-MAPs; intramuscular (IM) injection of commercially available quadrivalent influenza vaccine (QIV) containing A/Singapore/GP1908/2015 H1N1 HA (15 µg/dose); or IM injection of H1N1 HA antigen (15 µg/dose). After 22 days' follow-up and assessment of the safety data, a further 150 healthy adults were enrolled and randomly assigned to 1 of 9 treatment groups. Participants (20 per group) were vaccinated with HD-MAPs delivering doses of 15, 10, 5, 2.5, or 0 µg of HA to the FA or 15 µg HA to the upper arm (UA), or IM injection of QIV. The primary objectives of the study were safety and tolerability. Secondary objectives were to assess the immunogenicity of the influenza vaccine delivered by HD-MAP. Primary and secondary objectives were assessed for up to 60 days post-vaccination. Clinical staff and participants were blind as to which HD-MAP treatment was administered and to administration of IM-QIV-15 or IM-A/Sing-15. All laboratory investigators were blind to treatment and participant allocation. Two further groups in part B (5 participants per group), not included in the main safety and immunological analysis, received HD-MAPs delivering 15 µg HA or uncoated HD-MAPs applied to the forearm. Biopsies were taken on days 1 and 4 for analysis of the cellular composition from the HD-MAP application sites. The vaccine coated onto HD-MAPs was antigenically stable when stored at 40°C for at least 12 months. HD-MAP vaccination was safe and well tolerated; any systemic or local adverse events (AEs) were mild or moderate. Observed systemic AEs were mostly headache or myalgia, and local AEs were application-site reactions, usually erythema. HD-MAP administration of 2.5 µg HA induced haemagglutination inhibition (HAI) and microneutralisation (MN) titres that were not significantly different to those induced by 15 µg HA injected IM (IM-QIV-15). HD-MAP delivery resulted in enhanced humoral responses compared with IM injection with higher HAI geometric mean titres (GMTs) at day 8 in the MAP-UA-15 (GMT 242.5, 95% CI 133.2-441.5), MAP-FA-15 (GMT 218.6, 95% CI 111.9-427.0), and MAP-FA-10 (GMT 437.1, 95% CI 254.3-751.3) groups compared with IM-QIV-15 (GMT 82.8, 95% CI 42.4-161.8), p = 0.02, p = 0.04, p < 0.001 for MAP-UA-15, MAP-FA-15, and MAP-FA-10, respectively. Higher titres were also observed at day 22 in the MAP-FA-10 (GMT 485.0, 95% CI 301.5-780.2, p = 0.001) and MAP-UA-15 (367.6, 95% CI 197.9-682.7, p = 0.02) groups compared with the IM-QIV-15 group (GMT 139.3, 95% CI 79.3-244.5). Results from a panel of exploratory immunoassays (antibody-dependent cellular cytotoxicity, CD4+ T-cell cytokine production, memory B cell (MBC) activation, and recognition of non-vaccine strains) indicated that, overall, Vaxxas HD-MAP delivery induced immune responses that were similar to, or higher than, those induced by IM injection of QIV. The small group sizes and use of a monovalent influenza vaccine were limitations of the study. CONCLUSIONS: Influenza vaccine coated onto the HD-MAP was stable stored at temperatures up to 40°C. Vaccination using the HD-MAP was safe and well tolerated and resulted in immune responses that were similar to or significantly enhanced compared with IM injection. Using the HD-MAP, a 2.5 µg dose (1/6 of the standard dose) induced HAI and MN titres similar to those induced by 15 µg HA injected IM. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR.org.au), trial ID 108 ACTRN12618000112268/U1111-1207-3550.


Assuntos
Imunogenicidade da Vacina , Vírus da Influenza A Subtipo H1N1/imunologia , Vacinas contra Influenza/administração & dosagem , Influenza Humana/prevenção & controle , Vacinação , Administração Cutânea , Adolescente , Adulto , Anticorpos Antivirais/sangue , Austrália , Células Cultivadas , Estabilidade de Medicamentos , Feminino , Humanos , Imunoglobulina A/metabolismo , Vacinas contra Influenza/efeitos adversos , Influenza Humana/imunologia , Influenza Humana/virologia , Injeções Intramusculares , Masculino , Saliva/imunologia , Saliva/virologia , Linfócitos T/imunologia , Linfócitos T/virologia , Fatores de Tempo , Adesivo Transdérmico , Resultado do Tratamento , Vacinação/efeitos adversos , Adulto Jovem
18.
PLoS One ; 15(2): e0228908, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32107483

RESUMO

The aim of the current study was to develop membrane-based transdermal patches of lornoxicam gel using oleic acid (OA)and propylene glycol (PG) as penetration enhancers to improve drug delivery across the skin and to evaluate in vivo analgesic and anti-inflammatory activity. For this purpose, nine formulations were developed in accordance with 32 factorial design using Design Expert® 11. The concentration of propylene glycol (X1) and oleic acid (X2) were selected as independent variable whereas Q10 (Y1), flux (Y2) and lag time (Y3) were considered as the response variables. The impact of drug loading, surface area, gel concentration, membrane variation and agitation speed on drug release and permeation was also studied. The skin sensitivity reaction, analgesic activity and anti-inflammatory action of the optimized patch were also determined in Albino Wistar rats. Stability studies were performed for three months at three different temperature conditions. The result suggests that a membrane-based system with controlled zero-order drug release of 95.8 ± 1.121% for 10 h exhibiting flux of 126.51±1.19 µg/cm2/h and lag time of 0.908 ±0.57h was optimized with the desired analgesic and anti-inflammatory effect can be obtained by using propylene glycol and oleic acid co-solvents as a penetration enhancer. The patch was also found stable at 4˚C for a period of 6.44 months. Formulation F9 comprising of 10% PG and 3% OA was selected as an optimized formulation. The study demonstrates that the fabricated transdermal system of lornoxicam can deliver the drug through the skin in a controlled manner with desired analgesic and anti-inflammatory activity and can be considered as a suitable alternative of the oral route.


Assuntos
Sistemas de Liberação de Medicamentos/métodos , Piroxicam/análogos & derivados , Administração Cutânea , Analgésicos/farmacologia , Animais , Anti-Inflamatórios não Esteroides/farmacologia , Química Farmacêutica , Preparações de Ação Retardada/farmacologia , Géis/metabolismo , Masculino , Ácido Oleico/farmacologia , Piroxicam/farmacologia , Propilenoglicol/farmacologia , Ratos , Ratos Wistar , Pele/metabolismo , Absorção Cutânea/fisiologia , Solventes/farmacologia , Adesivo Transdérmico
19.
Clin Exp Hypertens ; 42(6): 539-544, 2020 Aug 17.
Artigo em Inglês | MEDLINE | ID: mdl-32009474

RESUMO

ß blockers (BBs) play an important role in heart failure (HF) treatment. However, orthostatic hypotension (OH) is sometimes caused by BBs. The bisoprolol transdermal patch works more slowly and is long acting compared with the bisoprolol fumarate tablet. The risk of OH may be reduced by using the bisoprolol transdermal patch. We evaluated 57 consecutive patients who were taking the bisoprolol fumarate tablet for chronic HF with hypertension from November 2016 to September 2017. We switched the patients to the bisoprolol transdermal patch. Because 12 of 57 subjects could not continue using the bisoprolol transdermal patch, we analyzed the remaining 45 patients. We investigated BP, blood tests, and changes in BP from supine to standing positions before and after 6 months of switching from tablet to patch. OH was diagnosed by observing a systolic/diastolic BP drop of at least 20/10 mmHg or an absolute systolic BP (sBP) of <90 mmHg from the standing position. No significant changes were observed in the BP and BPs from supine to standing positions, whereas log brain natriuretic peptide was significantly reduced after switching from patch to tablet (2.102 to 2.070pg/dl, P = .039). OH, which occurred in originally 17 patients, showed improvement and eventually appeared in 4 patients. In these patients, changes in BP from supine to standing positions were also significantly improved (changes in sBP, -11 to -6mmHg, P = .016). This study demonstrated that switching from the bisoprolol fumarate tablet to transdermal patch reduced the morbidity of OH in HF patients.


Assuntos
Bisoprolol/administração & dosagem , Insuficiência Cardíaca/complicações , Hipertensão/complicações , Hipotensão Ortostática , Antagonistas Adrenérgicos beta/administração & dosagem , Idoso , Pressão Sanguínea/efeitos dos fármacos , Pressão Sanguínea/fisiologia , Feminino , Insuficiência Cardíaca/fisiopatologia , Humanos , Hipertensão/fisiopatologia , Hipotensão Ortostática/tratamento farmacológico , Hipotensão Ortostática/etiologia , Hipotensão Ortostática/fisiopatologia , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Adesivo Transdérmico
20.
Sci Rep ; 10(1): 2027, 2020 02 06.
Artigo em Inglês | MEDLINE | ID: mdl-32029808

RESUMO

A multifunctional system comprised of hyaluronic acid microneedles was developed as an effective transdermal delivery platform for rapid local delivery. The microneedles can regulate the filling amount on the tip, by controlling the concentration of hyaluronic acid solution. Ultrasonication induces dissolution of the HA microneedles via vibration of acoustic pressure, and AC iontophoresis improves the electrostatic force-driven diffusion of HA ions and rhodamine B. The effect of ultrasound on rhodamine release was analyzed in vitro using a gelatin hydrogel. The frequency and voltage dependence of the AC on the ion induction transfer was also evaluated experimentally. The results showed that the permeability of the material acts as a key material property. The delivery system based on ultrasonication and iontophoresis in microneedles increases permeation, thus resulting in shorter initial delivery time than that required by delivery systems based on passive or ultrasonication alone. This study highlights the significance of the combination between ultrasonic waves and iontophoresis for improving the efficiency of the microneedles, by shortening the reaction duration. We anticipate that this system can be extended to macromolecular and dependence delivery, based on drug response time.


Assuntos
Sistemas de Liberação de Medicamentos/métodos , Ácido Hialurônico/farmacologia , Iontoforese/métodos , Adesivo Transdérmico , Administração Cutânea , Animais , Sistemas de Liberação de Medicamentos/instrumentação , Liberação Controlada de Fármacos/efeitos dos fármacos , Liberação Controlada de Fármacos/efeitos da radiação , Iontoforese/instrumentação , Agulhas , Permeabilidade/efeitos dos fármacos , Permeabilidade/efeitos da radiação , Rodaminas/administração & dosagem , Rodaminas/farmacocinética , Pele/metabolismo , Pele/efeitos da radiação , Absorção Cutânea/efeitos da radiação , Suínos , Ondas Ultrassônicas
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