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1.
J Dermatolog Treat ; 32(1): 95-100, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31195857

RESUMO

Background: Multiple types of fillers have been developed for soft tissue augmentation.Objective: We investigated the efficacy and safety of the novel filler BM-PHA.Methods: In this multicenter, randomized, split-face study, 91 participants received injections of BM-PHA and Restylane Perlane (PER) into the nasolabial folds. Efficacy was determined by the improvements in the Wrinkle Severity Rating Score (WSRS) and Global Esthetic Improvement Scale (GAIS), and safety by adverse events, laboratory tests, and a check of vital signs.Results: WSRS scores assessed by independent evaluators at Week 24, the primary efficacy measure, showed no significant difference between the two treatments. The treatments also showed no significant differences in WSRS scores assessed by the evaluators at Week 8 and WSRS and GAIS scores assessed by the treating investigators and participants at Weeks 8 and 24. The proportion of nasolabial folds whose WSRS scores improved by at least one grade at Week 24 was similar between the treatments. Only minor local side effects were reported without sequelae.Conclusion: BM-PHA was not inferior to PER in the treatment of moderate to severe nasolabial folds and may be an appropriate alternative product for their improvement. Further studies are needed to confirm the long-term safety of BM-PHA.


Assuntos
Preenchedores Dérmicos/administração & dosagem , Sulco Nasogeniano/patologia , Adulto , Técnicas Cosméticas , Preenchedores Dérmicos/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Ácido Hialurônico/administração & dosagem , Ácido Hialurônico/efeitos adversos , Injeções Intradérmicas , Masculino , Pessoa de Meia-Idade , Dor/etiologia , Envelhecimento da Pele , Resultado do Tratamento
2.
Zhongguo Yi Liao Qi Xie Za Zhi ; 44(6): 549-552, 2020 Dec 08.
Artigo em Chinês | MEDLINE | ID: mdl-33314867

RESUMO

OBJECTIVE: An accuracy test method is proposed to reduce the amount of reagents used in the test and reduce the cost of spot checks and self-tests. METHODS: According to the requirements of dose accuracy test in standard atmospheric conditions in ISO 11608-1:2014, dose accuracy test is carried out for the same batch of reusable pen injector samples by using the test method proposed in this paper and the test method in relevant foreign research, and the data measured by the two methods are processed. RESULTS: After experimental testing and analysis, the data measured by the two methods did not exceed the dose accuracy limit specified in the ISO standard. There was no significant difference between the two methods when the dose of 60 U and 30 U were tested, but there was significant difference when the dose of 1 U was tested. CONCLUSIONS: Both methods can be used to evaluate dose accuracy, however, the method proposed in this paper can reduce the usage of drugs by 2/3, so it can reduce cost of supervised test.


Assuntos
Equipamentos Descartáveis/normas , Injeções Intradérmicas/instrumentação , Segurança de Equipamentos , Seringas
3.
Trials ; 21(1): 881, 2020 Oct 26.
Artigo em Inglês | MEDLINE | ID: mdl-33106170

RESUMO

OBJECTIVES: The BCG vaccine, widely used in Brazil in new-borns, induces adjuvant protection for several diseases, including childhood virus infections. BCG activates monocytes and innate memory NK cells which are crucial for the antiviral immune response. Therefore, strategies to prevent COVID-19 in health workers (HW) should be carried out to prevent them becoming unwell so that they can continue to work during the pandemic. The hypothesis is that BCG will improve the innate immune response and prevent symptomatic infection or COVID-19 severity. The primary objective is to verify the effectiveness and safety of the BCG vaccine to prevent or reduce incidence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection in the city of Goiânia (Brazil) among HW previously vaccinated with BCG and also its severity and mortality during the pandemic of the disease. Secondary objectives are to estimate the incidence of COVID-19 among these professionals and the innate immune response elicited to BCG. TRIAL DESIGN: This a phase II trial for repositioning BCG as a preventive strategy against COVID-19. The trial is an open-label, parallel-group randomised clinical trial, comparing HW vaccinated with BCG and HW not vaccinated. PARTICIPANTS: The trial will recruit 800 HW of Goiânia - Goiás, Brazil to reach a total of 400 HW included after comorbidities questioning and laboratorial evaluation. Eligibility criteria: Any HW presenting BCG vaccination scar with direct contact with suspected COVID-19 patients for at least 8 hours per week, whether in hospital beds, ICU, or in transportation or admission (nurses, doctors, physiotherapists, nutritionists, receptionists, etc.) who have negative IgM and IgG COVID-19 test. Participants with any of the following characteristics will be excluded: - Have had in the last fifteen days any signs or symptoms of virus infection, including COVID-19; - Have had fever in the last fifteen days; - Have been vaccinated fifteen days before the inclusion; - Have a history or confirmation of any immunosuppressive disease such as HIV, presented solid tumour in the last two years or autoimmune diseases; - Are under preventive medication with antibiotics, steroid anti-inflammatories, or chemotherapy; - Have less than 500 neutrophils per mL of blood; - Have previously been diagnosed with tuberculosis; - Are breastfeeding or pregnant; - Are younger than 18 years old; - Are participating as an investigator in this clinical trial. INTERVENTION AND COMPARATOR: HW will be randomized into the BCG vaccinated group or the BCG unvaccinated control group. The BCG vaccinated group will receive in the right arm, intradermally, a one off dose of 0.1 mL corresponding to approximately 2 x105 to 8 x105 CFU of live, freeze-dried, attenuated BCG Moscow 361-I, Bacillus Calmette Guerin vaccine (Serum Institute of India PVT. LTD.). The unvaccinated control group will not be vaccinated. The HW allocated in both groups will be followed up at specific times points until 180 days post inclusion. The vaccinated and control groups will be compared according to COVID-19 related outcomes. MAIN OUTCOMES: The primary outcomes are the incidence coefficient of infection by SARS-CoV-2 determined by RT-PCR of naso-oropharyngeal swab specimen or rapid lateral flow IgG and IgM test, and presence of general COVID-19 symptoms, disease severity and admission to hospital during the 180 days of follow up. The secondary outcome is the innate immune response elicited 15-20 days after vaccination. RANDOMISATION: The vaccine vial contains approximately 10 doses. In order to optimize the vaccine use, the randomisation was performed in blocks of 20 participants using the platform randomization.com [ http://www.jerrydallal.com/random/permute.htm ]. The randomization was prepared before any HW inclusion. The results were printed and inserted in sealed envelopes that were numbered with BCG-001 to BCG-400. The printed results as well the envelopes had the same numbers. At the time of the randomisation, each participant that meets the inclusion criteria will receive a consecutive participant number [BCG-001-BCG-400]. The sealed envelope with the assigned number, blinded to the researchers, will be opened in front of the participant and the arm allocation will be known. BLINDING (MASKING): There is no masking for the participants or for the healthcare providers. The study will be blinded to the laboratory researchers and to those who will be evaluating the outcomes and performing the statistical analyses. In this case, only the participant identification number will be available. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Four hundred heath workers will be randomised in two groups. Two hundred participants will be vaccinated, and 200 participants will not be vaccinated. TRIAL STATUS: The protocol approved by the Brazilian Ethical Committee is the seventh version, number CAAE: 31783720.0.0000.5078. The trial has been recruiting since September 20th, 2020. The clinical trial protocol was registered on August 5th, 2020. It is estimated that recruitment will finish by March 2021. TRIAL REGISTRATION: The protocol number was registered on August 5th, 2020 at REBEC (Registro Brasileiro de Ensaios Clínicos). Register number: RBR-4kjqtg and WHO trial registration number UTN: U1111-1256-3892. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Assuntos
Vacina BCG/administração & dosagem , Infecções por Coronavirus/prevenção & controle , Imunidade Inata/imunologia , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Betacoronavirus/imunologia , Brasil/epidemiologia , Estudos de Casos e Controles , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/virologia , Proteção Cruzada/imunologia , Seguimentos , Pessoal de Saúde/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Humanos , Imunização Secundária/métodos , Imunoglobulina G/sangue , Imunoglobulina M/sangue , Incidência , Injeções Intradérmicas , Células Matadoras Naturais/imunologia , Pneumonia Viral/epidemiologia , Pneumonia Viral/imunologia , Pneumonia Viral/virologia , Reação em Cadeia da Polimerase Via Transcriptase Reversa/métodos , Segurança , Resultado do Tratamento
4.
Vaccine ; 38(48): 7629-7637, 2020 11 10.
Artigo em Inglês | MEDLINE | ID: mdl-33071000

RESUMO

This work demonstrates the presence of immune regulatory cells in the cervical lymph nodes draining Bacillus Calmette-Guérin (BCG) vaccinated site on the dorsum of the ear in guinea pigs. It is shown that whole cervical lymph node cells did not proliferate in vitro in the presence of soluble mycobacterial antigens (PPD or leprosin) despite being responsive to whole mycobacteria. Besides, T cells from these lymph nodes separated as a non-adherent fraction on a nylon wool column, proliferated to PPD in the presence of autologous antigen presenting cells. Interestingly, addition of as low as 20% nylon wool adherent cells to these, sharply decreased the proliferation by 83%. Looking into what cells in the adherent fraction suppressed the proliferation, it was found that neither the T cell nor the macrophage enriched cell fractions of this population individually showed suppressive effect, indicating that their co-presence was necessary for the suppression. Since BCG induced granulomas resolve much faster than granulomas induced by other mycobacteria such as Mycobacterium leprae the present experimental findings add to the existing evidence that intradermal BCG vaccination influences subsequent immune responses in the host and may further stress upon its beneficial role seen in Covid-19 patients.


Assuntos
Antígenos de Bactérias/farmacologia , Vacina BCG/farmacologia , Granuloma/imunologia , Linfonodos/imunologia , Linfócitos T/imunologia , Tuberculina/farmacologia , Animais , Células Apresentadoras de Antígenos/efeitos dos fármacos , Células Apresentadoras de Antígenos/imunologia , Células Apresentadoras de Antígenos/microbiologia , Adesão Celular , Proliferação de Células , Infecções por Coronavirus/prevenção & controle , Orelha , Feminino , Granuloma/microbiologia , Cobaias , Humanos , Injeções Intradérmicas , Linfonodos/microbiologia , Macrófagos/efeitos dos fármacos , Macrófagos/imunologia , Macrófagos/microbiologia , Masculino , Mycobacterium bovis/imunologia , Mycobacterium leprae/imunologia , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Remissão Espontânea , Linfócitos T/classificação , Linfócitos T/efeitos dos fármacos , Linfócitos T/microbiologia
5.
Nat Commun ; 11(1): 5173, 2020 10 14.
Artigo em Inglês | MEDLINE | ID: mdl-33057068

RESUMO

In ovarian cancer (OC), IL-17-producing T cells (Th17s) predict improved survival, whereas regulatory T cells predict poorer survival. We previously developed a vaccine whereby patient-derived dendritic cells (DCs) are programmed to induce Th17 responses to the OC antigen folate receptor alpha (FRα). Here we report the results of a single-arm open-label phase I clinical trial designed to determine vaccine safety and tolerability (primary outcomes) and recurrence-free survival (secondary outcome). Immunogenicity is also evaluated. Recruitment is complete with a total of 19 Stage IIIC-IV OC patients in first remission after conventional therapy. DCs are generated using our Th17-inducing protocol and are pulsed with HLA class II epitopes from FRα. Mature antigen-loaded DCs are injected intradermally. All patients have completed study-related interventions. No grade 3 or higher adverse events are seen. Vaccination results in the development of Th1, Th17, and antibody responses to FRα in the majority of patients. Th1 and antibody responses are associated with prolonged recurrence-free survival. Antibody-dependent cell-mediated cytotoxic activity against FRα is also associated with prolonged RFS. Of 18 patients evaluable for efficacy, 39% (7/18) remain recurrence-free at the time of data censoring, with a median follow-up of 49.2 months. Thus, vaccination with Th17-inducing FRα-loaded DCs is safe, induces antigen-specific immunity, and is associated with prolonged remission.


Assuntos
Vacinas Anticâncer/administração & dosagem , Células Dendríticas/transplante , Recidiva Local de Neoplasia/epidemiologia , Neoplasias Ovarianas/terapia , Células Th17/imunologia , Idoso , Vacinas Anticâncer/efeitos adversos , Vacinas Anticâncer/imunologia , Intervalo Livre de Doença , Feminino , Receptor 1 de Folato/imunologia , Humanos , Imunidade Humoral , Injeções Intradérmicas , Interferon gama/metabolismo , Interleucina-17/metabolismo , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/imunologia , Recidiva Local de Neoplasia/prevenção & controle , Neoplasias Ovarianas/imunologia , Neoplasias Ovarianas/mortalidade , Células Th17/metabolismo , Transplante Autólogo/efeitos adversos , Transplante Autólogo/métodos
7.
Am J Trop Med Hyg ; 103(3): 970-975, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32602433

RESUMO

Nine criteria regarding the infectious agent, mode of transmission, portal of entry, route of spread, target organs, target cells, pathologic lesions, incubation period, and modifiable spectrum of disease and outcomes appropriate to the intended experimental purpose are described. To provide context for each criterion, mouse models of two vector-borne zoonotic infectious diseases, scrub typhus and dengue, are summarized. Application of the criteria indicates that intravenous inoculation of Orientia tsutsugamushi into inbred mice is the best current model for life-threatening scrub typhus, and intradermal inoculation accurately models sublethal human scrub typhus, whereas the immunocompromised mouse models of dengue provide disease outcomes most closely associated with human dengue. In addition to addressing basic questions of immune and pathogenic mechanisms, mouse models are useful for preclinical testing of experimental vaccines and therapeutics. The nine criteria serve as guidelines to evaluate and compare models of vector-borne infectious diseases.


Assuntos
Vírus da Dengue/imunologia , Dengue/imunologia , Modelos Animais de Doenças , Hospedeiro Imunocomprometido , Orientia tsutsugamushi/imunologia , Tifo por Ácaros/imunologia , Animais , Dengue/patologia , Dengue/virologia , Vírus da Dengue/patogenicidade , Humanos , Período de Incubação de Doenças Infecciosas , Injeções Intradérmicas , Injeções Intravenosas , Fígado/microbiologia , Fígado/virologia , Tecido Linfoide/microbiologia , Tecido Linfoide/virologia , Camundongos , Camundongos Knockout , Orientia tsutsugamushi/patogenicidade , Tifo por Ácaros/microbiologia , Tifo por Ácaros/patologia , Baço/microbiologia , Baço/virologia
8.
Am J Emerg Med ; 38(9): 1935-1937, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32245702

RESUMO

Hiccup is a condition caused by involuntary contraction of inspiratory muscles, especially the diaphragm. Although it is generally considered as a physiological. response, if hiccup persists for a long time, it can lead to many undesirable conditions such as depression, weight loss, insomnia, and fatigue. A 35-year-old male patient was admitted to our emergency department with hiccup lasting for 15 h. He had a history of several hiccup attacks. Classical non-pharmacological and pharmacological therapies were used to treat the condition without any response. As an alternative method, an intradermal injection was applied. A mixture of thiocolchicoside and lidocaine was administered intradermally to a depth of 1-3 mm at the epigastric region and adjacent to the sternocleidomastoid muscle. The patient's hiccup ended after the intradermal injection procedure. During 48 h of follow-up the hiccup attack did not develop again. No complications related to the process were detected. This is the first case in the literature demonstrating the use of intradermal injection to terminate hiccups. The intradermal injection approach can be administered in cases of hiccups that do not respond to medical treatment.


Assuntos
Anestésicos Locais/administração & dosagem , Colchicina/análogos & derivados , Serviço Hospitalar de Emergência , Soluço/tratamento farmacológico , Lidocaína/administração & dosagem , Adulto , Anestésicos Locais/uso terapêutico , Colchicina/administração & dosagem , Colchicina/uso terapêutico , Diafragma , Combinação de Medicamentos , Humanos , Injeções Intradérmicas , Lidocaína/uso terapêutico , Masculino , Resultado do Tratamento
9.
Virology ; 544: 55-63, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32174514

RESUMO

Historic observations suggest that survivors of smallpox maintained lifelong immunity and protection to subsequent infection compared to vaccinated individuals. Although protective immunity by vaccination using a related virus (vaccinia virus (VACV) strains) was the key for smallpox eradication, it does not uniformly provide long term, or lifelong protective immunity (Heiner et al., 1971). To determine differences in humoral immune responses, mice were inoculated with VACV either systemically, using intranasal inoculation (IN), or locally by an intradermal (ID) route. We hypothesized that sub-lethal IN infections may mimic systemic or naturally occurring infection and lead to an immunodominance reaction, in contrast to localized ID immunization. The results demonstrated systemic immunization through an IN route led to enhanced adaptive immunity to VACV-expressed protein targets both in magnitude and in diversity when compared to an ID route using a VACV protein microarray. In addition, cytokine responses, assessed using a Luminex® mouse cytokine multiplex kit, following IN infection was greater than that stemming from ID infection. Overall, the results suggest that the route of immunization (or infection) influences antibody responses. The greater magnitude and diversity of response in systemic infection provides indirect evidence for anecdotal observations made during the smallpox era that survivors maintain lifelong protection. These findings also suggest that systemic or disseminated host immune induction may result in a superior response, that may influence the magnitude of, as well as duration of protective responses.


Assuntos
Imunidade Humoral , Vírus Vaccinia/imunologia , Vaccinia/imunologia , Imunidade Adaptativa , Administração Intranasal , Animais , Anticorpos Neutralizantes , Anticorpos Antivirais , Injeções Intradérmicas , Camundongos , Camundongos Endogâmicos BALB C , Testes de Neutralização , Vaccinia/virologia
10.
Radiology ; 295(2): 458-466, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32208098

RESUMO

Background Abnormalities of the central lymphatic system (CLS) are increasingly treated by interventional radiology approaches. Planning of these procedures, however, is challenging because of the lack of clinical imaging tools. Purpose To evaluate the clinical usefulness of contrast agent-enhanced interstitial transpedal MR lymphangiography in the preinterventional workup of lymphatic interventions in patients with thoracic chylous effusions. Materials and Methods Patients with chylous effusions evaluated from January 2014 and December 2017 were included in this retrospective analysis of transpedal MR lymphangiography. Indications were chylothorax (n = 19; 76%), cervical lymphatic fistula (n = 2; 8%), and combined chylothorax and chylous ascites (n = 4; 16%). Patients underwent transpedal MR lymphangiography at 1.5 T with T1-weighted imaging after interstitial pedal of gadolinium-based contrast medium under local anesthesia. Contrast-enhanced MRI was evaluated for technical success, depiction of pathologic abnormalities of the CLS, and access site for lymphatic interventions (ie, clinically useful examination). Reader agreement for image quality and overall degree of visualization was assessed with weighted κ. Interrelations between overall image quality and degree of visualization of CLS structures were assessed by Spearman ρ. Efficacy of transpedal MR lymphangiography was calculated by using radiographic lymphangiography as the reference standard. Results Twenty-five patients (mean age, 54 years ± 18 [standard deviation]; 13 men) were evaluated. Eight percent (two of 25) of examinations failed (lymphoma in one patient and technical failure in one patient). Contrast agent injection was well tolerated without complications. Interrater agreement of image quality was excellent (κ = 0.96). The degree of CLS visualization correlated with overall image quality (ρ = 0.71; P < .001). Retroperitoneal lymphatics, cisterna chyli, and thoracic duct were viewed with an accuracy of 23 of 25 (92%), 24 of 25 (96%), and 23 of 25 (92%), respectively. Anatomic variations, a lymphatic pathologic abnormality, and interventional access routes were identified with an accuracy of 22 of 25 (88%), 23 of 25 (92%), and 24 of 25 (96%), respectively. Overall, 23 of 25 (92%) transpedal MR lymphangiograms provided clinically useful information. Conclusion Transpedal interstitial MR lymphangiography was well tolerated by the patient and identified specific pathologic abnormalities causing thoracic chylous leakages before lymphatic intervention. © RSNA, 2020 Online supplemental material is available for this article. See also the editorial by Maki and Itkin in this issue.


Assuntos
Quilotórax/diagnóstico por imagem , Meios de Contraste/administração & dosagem , Óleo Etiodado/administração & dosagem , Sistema Linfático/diagnóstico por imagem , Imagem por Ressonância Magnética/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Ascite Quilosa/diagnóstico por imagem , Feminino , , Humanos , Injeções Intradérmicas , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
11.
Prev Vet Med ; 176: 104932, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32088530

RESUMO

Mycobacterial diseases are important health issues in farmed deer. The single intradermal tuberculin test is the standard test for tuberculosis testing in deer. We studied two factors which might influence the response of deer to skin testing: the inoculation site and the injection device. Deer included in this study were 2.5 years old farmed red deer (Cervus elaphus) hinds (n = 80). Two areas of 3 cm × 3 cm were shaved at the left side of the neck. Site A (SA) was situated about 10 cm caudal to the head, while site B (SB) was 10 cm caudal to SA. All hinds received at the same time two 0.1 ml inoculations of Mycobacterium avium derived purified protein derivative (aPPD). One inoculation was made by syringe and the other one with the needle-free syringe Dermojet. To test the inoculation site effect, half of the animals were inoculated by Dermojet in SA and by syringe in SB to compare with the inoculation in SA by syringe and Dermojet in SB in the other half. No differences were recorded for the injection device nor for the inoculation site. Ten hinds had a skinfold increase larger than 30 tenths of mm by any injection device and inoculation site. Seven (9%) and 6 (8%) hinds were classified as positive by syringe and Dermojet, and at the anterior or posterior inoculation site, respectively. The distribution of skinfold thickness increases did not differ by injection device. Our findings support the needle-free Dermojet syringe as a suitable tool for skin-testing in red deer and suggest no relevant effect of the position of the inoculation site along the neck in red deer.


Assuntos
Cervos , Injeções Intradérmicas/métodos , Mycobacterium avium/fisiologia , Teste Tuberculínico/veterinária , Tuberculina/farmacologia , Tuberculose/veterinária , Animais , Feminino , Injeções Intradérmicas/instrumentação , Tuberculose/diagnóstico
12.
Sci Rep ; 10(1): 571, 2020 01 17.
Artigo em Inglês | MEDLINE | ID: mdl-31953428

RESUMO

Diphtheria is an infectious disease caused by Corynebacterium diphtheriae. The bacterium primarily infects the throat and upper airways and the produced diphtheria toxin (DT), which binds to the elongation factor 2 and blocks protein synthesis, can spread through the bloodstream and affect organs, such as the heart and kidneys. For more than 125 years, the therapy against diphtheria has been based on polyclonal horse sera directed against DT (diphtheria antitoxin; DAT). Animal sera have many disadvantages including serum sickness, batch-to-batch variation in quality and the use of animals for production. In this work, 400 human recombinant antibodies were generated against DT from two different phage display panning strategies using a human immune library. A panning in microtiter plates resulted in 22 unique in vitro neutralizing antibodies and a panning in solution combined with a functional neutralization screening resulted in 268 in vitro neutralizing antibodies. 61 unique antibodies were further characterized as scFv-Fc with 35 produced as fully human IgG1. The best in vitro neutralizing antibody showed an estimated relative potency of 454 IU/mg and minimal effective dose 50% (MED50%) of 3.0 pM at a constant amount of DT (4x minimal cytopathic dose) in the IgG format. The targeted domains of the 35 antibodies were analyzed by immunoblot and by epitope mapping using phage display. All three DT domains (enzymatic domain, translocation domain and receptor binding domain) are targets for neutralizing antibodies. When toxin neutralization assays were performed at higher toxin dose levels, the neutralizing capacity of individual antibodies was markedly reduced but this was largely compensated for by using two or more antibodies in combination, resulting in a potency of 79.4 IU/mg in the in vivo intradermal challenge assay. These recombinant antibody combinations are candidates for further clinical and regulatory development to replace equine DAT.


Assuntos
Anticorpos Neutralizantes/administração & dosagem , Corynebacterium diphtheriae/metabolismo , Toxina Diftérica/antagonistas & inibidores , Mapeamento de Epitopos/métodos , Animais , Anticorpos Neutralizantes/farmacologia , Corynebacterium diphtheriae/imunologia , Toxina Diftérica/química , Cobaias , Humanos , Imunoglobulina G/farmacologia , Injeções Intradérmicas , Modelos Moleculares , Fator 2 de Elongação de Peptídeos/metabolismo , Biblioteca de Peptídeos , Conformação Proteica , Anticorpos de Cadeia Única/farmacologia
13.
Lasers Med Sci ; 35(5): 1179-1184, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31939036

RESUMO

Microneedle radiofrequency (FMR) for the treatment of primary axillary hyperhidrosis radiofrequency (RF) technology is a new modality that applied deep heat energy directly affecting the epidermis and dermis. Limiting data about FMR for axillary hyperhidrosis is concerning. To compare clinical efficacy between fractional microneedle radiofrequency and intradermal botulinum toxin type A injection. This study was a randomized, intraindividual split-side comparative study. Twenty female subjects clinically diagnosed of primary axillary hyperhidrosis were enrolled. All subjects randomly assigned to receive either FMR device on one side of axilla or 50 units of intradermal botulinum toxin A on contralateral side of axilla. Treatment with FMR device was scheduled for 2 sessions for 4 weeks apart. After treatment, mean Hyperhidrosis Disease Severity Score (HDSS) of both groups revealed remarkably better reduction from the baseline (p < 000.1). By comparing between the two groups at the endpoint visit (12th week), the botulinum toxin A group had significantly better reduction of mean HDSS score than the microneedle RF group with 1.60 (0.59) versus 2.05 (0.68), respectively (p = 0.0332). At the week-12 visit, the botulinum toxin A group had significantly better participant's satisfaction score by quartile rating scale than the microneedle RF group (2.55 + 0.69 versus 1.70 + 1.03, respectively, p = 0.004). Therefore, the botulinum toxin A group also demonstrated with significantly better improvement for their quality of life by DLQI score at the 12th week than the microneedle RF group (p = 0.013). Intradermal botulinum toxin A had better efficacy than fractional microneedle radiofrequency for the treatment of primary axillary hyperhidrosis.


Assuntos
Axila/fisiologia , Toxinas Botulínicas Tipo A/administração & dosagem , Toxinas Botulínicas Tipo A/uso terapêutico , Hiperidrose/tratamento farmacológico , Agulhas , Ondas de Rádio , Adulto , Método Duplo-Cego , Feminino , Humanos , Injeções Intradérmicas , Pessoa de Meia-Idade , Satisfação do Paciente , Qualidade de Vida , Autorrelato , Resultado do Tratamento , Perda Insensível de Água , Adulto Jovem
14.
Int J Pharm ; 576: 119021, 2020 Feb 25.
Artigo em Inglês | MEDLINE | ID: mdl-31917298

RESUMO

The development of drug delivery vehicles to cancer and/or immune cells in lymph nodes is important for cancer diagnosis, therapy, and immunotherapy. We previously reported that anionic carboxyl-terminal dendrimers were accumulated in lymph nodes. In this study, three anionic dendrimers with carboxyl-, sulfonyl-, and phosphate-terminal groups were prepared to examine the lymph node targeting and the association with immune cells in the lymph nodes. These anionic dendrimers were accumulated in the lymph node by intradermal injection. Although the carboxyl- and sulfonyl-terminal dendrimers were diffused from the injection site, the phosphate-terminal dendrimers were mostly retained. The phosphate-terminal dendrimer was recognized by the macrophages, dendritic cells, and B cells in the lymph node, whereas the carboxyl- and sulfonyl-terminal dendrimers were not. Our results show that these anionic dendrimers were accumulated in the lymph node where the association with immune cells could be controlled by the terminal structure of the dendrimer. The phosphate-terminal dendrimer can be used as a nanoplatform for the delivery of some bioactive molecules to some immune cells, including B cells, in the lymph node.


Assuntos
Dendrímeros/farmacocinética , Portadores de Fármacos , Corantes Fluorescentes/farmacocinética , Linfonodos/metabolismo , Nanopartículas , Imagem Óptica , Animais , Dendrímeros/administração & dosagem , Dendrímeros/síntese química , Composição de Medicamentos , Feminino , Corantes Fluorescentes/administração & dosagem , Corantes Fluorescentes/química , Injeções Intradérmicas , Linfonodos/diagnóstico por imagem , Linfonodos/imunologia , Camundongos Endogâmicos BALB C , Fosforilação , Distribuição Tecidual
15.
Ir J Med Sci ; 189(3): 1023-1026, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31898163

RESUMO

BACKGROUND: Axillary hyperhidrosis is a common complaint affecting 5% of the general population. It can significantly impact quality of life (QOL) and may be extremely debilitating. Administration of intra-dermal botulinum toxin type-A (Botox) has been proven to be effective in managing axillary hyperhidrosis; however, to date, no long-term data has assessed its efficacy. AIM: We aim to assess long-term (> 5 years) QOL outcomes in this patient cohort. METHODS: In this single-centre series, all patients attending for axillary botox, with five or more years of follow-up, were prospectively included. QOL was assessed in all patients using the validated assessment tool, the modified Dermatology Life Quality Index (DLQI). Standard statistical methods were utilised with data reported as mean (± standard deviation). Subgroup analysis utilising previously published departmental data allowed for further assessment of change in QOL over time. RESULTS: A total of 75 patients (83% female) met the inclusion criteria with 67% completing the DLQI assessment. Follow-up ranged from 5 to 10 years with a mean age of 37.6 years (± 8.82). The mean number of treatments over the study period was 12 (± 3.1). Mean overall post-treatment DLQI score was 1.6 (± 2.01). This represented a significant improvement in patient QOL (p = < 0.0001) associated with long-term botox application. This statistical significance was identified consistently across all components of the DLQI tool. CONCLUSION: These data suggest that the established early QOL benefits associated with intra-dermal botox administration for AH are sustained in the long term. This benefit was seen across all subsets of the DLQI tool.


Assuntos
Axila/anormalidades , Toxinas Botulínicas Tipo A/uso terapêutico , Hiperidrose/tratamento farmacológico , Adulto , Feminino , Seguimentos , Humanos , Injeções Intradérmicas , Masculino , Fatores de Tempo , Resultado do Tratamento
16.
Transbound Emerg Dis ; 67(1): 234-249, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31483955

RESUMO

In this work, an experimental model for chronic besnoitiosis in bovine was developed and characterized. Using a previously established calf model, two new variables (parasite stage and inoculation route) were combined and used. Twelve Holstein Friesian 3-month-old male calves were randomly divided into four groups of three animals each. Bradyzoites were obtained from a chronically infected bull and used for inoculation via three different inoculation routes. Three groups were inoculated with 106 bradyzoites by intravenous (G1), subcutaneous (G2) and intradermal (G3) routes, and a non-infected control group (G4) was inoculated with PBS. The trial lasted for 90 days and included daily clinical monitoring as well as weekly skin biopsies and blood sampling. Sera were obtained to analyse both cellular and humoral responses. Once the calves were euthanized, tissues from the skin, eyes, respiratory and reproductive tracts, among others, were collected to study presence of the parasite. Clinically, the infection was classified as mild to moderate for the acute stage since all infected calves showed lymphadenopathy from four days post-infection (pi) and fever from one week pi until 24 days pi. However, the most relevant results were achieved during the chronic stage that was classified as moderate to severe. In fact, pathognomonic conjunctival cysts were observed in all infected calves from 40 days pi onwards and were more abundant in G3. Moreover, one calf from this group developed skin lesions (49 days pi). The microscopic tissue cysts and Besnoitia DNA were detected primarily in skin, reproductive tract and respiratory tissue samples, and parasite load was higher in G3. In conclusion, the parasite stage (bradyzoite) and the inoculation route are key factors that influence the outcome of an infection. In particular, the intradermal route led to more severe clinical signs of the chronic phase in the inoculated calves.


Assuntos
Doenças dos Bovinos/parasitologia , Coccidiose/veterinária , Sarcocystidae/crescimento & desenvolvimento , Animais , Bovinos , Doença Crônica , Coccidiose/parasitologia , Modelos Animais de Doenças , Injeções Intradérmicas , Estágios do Ciclo de Vida , Masculino , Parasitos , Sarcocystidae/genética
17.
Immunology ; 159(2): 133-141, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31593303

RESUMO

The majority of human vaccines are administered above the deltoid muscle of the arm, a site that is chronically sun-exposed in many people. It is known that exposure of the skin to the UV wavelengths in sunlight stimulates systemic immunosuppression, an outcome that is associated with reduced immunity to microbial infections in animal models. Here we consider whether immunization of humans through a UV-irradiated skin site will lead to a less effective immune response compared with immunization through an unexposed site. Studies showing that the efficacy of vaccination can be reduced when surrogates of increased levels of sun exposure, such as latitude of residence and season of the year, are considered. Results from a limited number of intervention experiments in humans demonstrate a similar pattern. To provide an explanation for these findings, changes in the number and functional potential of immune cells in chronically sun-exposed compared with unexposed skin are outlined. UV radiation-induced changes to skin cells are also relevant when considering skin sites for administration of immune-tolerizing peptides. The review provides the basis for further research into the effects of acute and chronic UV radiation exposure on skin cells in the context of vaccination.


Assuntos
Tolerância Imunológica/efeitos da radiação , Imunogenicidade da Vacina , Pele/efeitos da radiação , Luz Solar , Vacinação , Vacinas/administração & dosagem , Animais , Células Dendríticas/imunologia , Células Dendríticas/efeitos da radiação , Humanos , Memória Imunológica/efeitos da radiação , Injeções Intradérmicas , Mastócitos/imunologia , Mastócitos/efeitos da radiação , Estações do Ano , Pele/imunologia , Linfócitos T Reguladores/imunologia , Linfócitos T Reguladores/efeitos da radiação
18.
Dermatol Surg ; 46(1): 26-30, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-30829774

RESUMO

BACKGROUND: Recently, the safety of lidocaine plus epinephrine use in outpatient surgery has come under scrutiny despite its long history of use in outpatient dermatologic procedures and surgeries. OBJECTIVE: To assess the frequency of crash cart and other emergency interventions during Mohs micrographic surgery when lidocaine plus epinephrine is used as a local anesthetic and evaluate patient comorbidities associated with these events. MATERIALS AND METHODS: A retrospective chart review was conducted in an outpatient Mohs micrographic surgery clinic. RESULTS: One thousand one hundred twenty-seven Mohs cases were reviewed from the period of March 2015 to June 2016 with 864 meeting the inclusion criteria of patient weight, medical history, and amount of lidocaine administered recorded. No adverse events requiring emergency intervention with a crash cart or transfer to the emergency department occurred despite a patient population with advanced age and a wide range of comorbidities. CONCLUSION: No serious adverse events requiring emergency intervention were associated with lidocaine with epinephrine doses administered below the Food and Drug Administration recommended maximum. The authors did not find evidence from this study or after a literature search to support the requirement for a crash cart and other emergency equipment to be present during procedures.


Assuntos
Anestésicos Locais/efeitos adversos , Epinefrina/efeitos adversos , Lidocaína/efeitos adversos , Cirurgia de Mohs/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Simpatomiméticos/efeitos adversos , Idoso , Anestésicos Locais/administração & dosagem , Epinefrina/administração & dosagem , Feminino , Humanos , Injeções Intradérmicas , Injeções Subcutâneas , Lidocaína/administração & dosagem , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Simpatomiméticos/administração & dosagem
19.
J Cosmet Dermatol ; 19(2): 456-461, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31241854

RESUMO

BACKGROUND: Multiple therapeutic approaches are usually required when treating atrophic acne scars. Subcision was reported to be of value in improving rolling scars. Autologous platelet-rich plasma (PRP) has recently been proposed as an adjuvant treatment option for atrophic acne scars with few reports evaluating its efficacy. OBJECTIVE: Our objective was to compare the effect of intradermal injection of PRP vs combined PRP and subcision in the treatment of atrophic acne scars. METHODS: Thirty patients with bilateral atrophic acne scars were enrolled. Each patient received three monthly sessions. Each side of the face was randomly treated either with intradermal PRP alone or with combined treatment with subcision followed by PRP injection. Patients were assessed at 3 and 6 months following the last treatment session. Evaluation of serial photographs was performed by two blinded investigators. RESULTS: Platelet-rich plasma alone showed a better response, fewer side effects, and shorter downtime compared to combined subcision and PRP. CONCLUSION: Autologous PRP injection can be a therapeutic option in the treatment of atrophic acne scars, with fewer complications and better tolerability than combined subcision and autologous PRP.


Assuntos
Acne Vulgar/terapia , Transfusão de Sangue Autóloga/métodos , Cicatriz/terapia , Técnicas Cosméticas/instrumentação , Plasma Rico em Plaquetas , Acne Vulgar/complicações , Adolescente , Adulto , Atrofia/etiologia , Atrofia/terapia , Cicatriz/etiologia , Terapia Combinada/métodos , Feminino , Seguimentos , Humanos , Injeções Intradérmicas , Masculino , Agulhas , Satisfação do Paciente , Resultado do Tratamento , Adulto Jovem
20.
J Infect Dis ; 221(6): 895-901, 2020 03 02.
Artigo em Inglês | MEDLINE | ID: mdl-31242300

RESUMO

BACKGROUNDS: Intradermal (id) fractional inactivated poliovirus vaccine ([fIPV] one fifth of normal IPV dose) is safe and immunogenic; however, id administration is perceived as difficult. We compared fIPV immunogenicity administered id or intramuscularly (im). METHODS: This noninferiority trial was conducted among polio vaccine-naive Cuban infants who received 2 IPV doses at 4 and 8 months of age. Infants were randomized into 4 arms: (A) fIPV, 0.1 mL im; (B) fIPV, 0.2 mL im; (C) fIPV, 0.1mL id; and (D) IPV, 0.5 mL im. Blood collected before and after vaccinations was tested for poliovirus-neutralizing antibodies. RESULTS: A total of 196 of 214 (91.6%) enrolled children completed study. Seroconversion after 2 IPV doses in each arm were as follows: (A) 97.3% (90.6-99.7), 98.7% (92.7-99.9), and 90.5% (81.5-96.1) for serotypes 1, 2, and 3, respectively; (B) 97.2% (90.3-99.7), 100%, 95.8% (88.3-99.1) for serotypes 1, 2, and 3, respectively; (C) 89.3% (71.8-97.7), 92.9% (76.5-99.1), 82.1% (63.1-93.9) for serotypes 1, 2, and 3, respectively; and (D) 100%, 100%, 100% for serotypes 1, 2, and 3, respectively. Seroconversion with fIPV im was noninferior to fIPV id for all serotypes. CONCLUSIONS: We demonstrated noninferiority of fIPV im compared with id when administered at 4 and 8 months of age. Further investigations in an earlier infant schedule should be pursued to explore fIPV im as option for dose-sparing strategy in countries reluctant to use fIPV id due to programmatic difficulties of id administration.


Assuntos
Imunogenicidade da Vacina , Vacina Antipólio de Vírus Inativado/administração & dosagem , Vacina Antipólio de Vírus Inativado/imunologia , Relação Dose-Resposta Imunológica , Feminino , Humanos , Lactente , Injeções Intradérmicas , Injeções Intramusculares , Masculino
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