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1.
Zhongguo Zhong Yao Za Zhi ; 45(17): 4277-4284, 2020 Sep.
Artigo em Chinês | MEDLINE | ID: mdl-33164415

RESUMO

To introduce current literature reporting situations of the off-label drug use(OLDU) by analyzing relevant literatures published in China, this study comprehensively focused on literatures about OLDU in China in seven Chinese and English databases, then extracted and analyzed the data by different literature types. A total of 667 papers were analyzed. The number of literatures about OLDU data analyzed in hospitals was 325, and the number of clinical studies relating to OLDU was 329, in which case series and case reports were the majority(69.91%). In addition, there were 13 expert consensuses of OLDU and another 56 studies about drug use based on the real-world data characteristics and influencing factors. The number of OLDU data studies has increased year by year. Based on the existing studies, there were more western medicine reports than traditional Chinese medicines, and OLDU types were mainly for over-dosage use. The literatures from OLDU data in hospital were mostly limited to one or several tertiary hospitals in a certain area, and the OLDU types were not uniform. Clinical studies were mainly clinical control trials and case series/reports, but with contradictory reporting results. There were fewer OLDU consensus, and the recommended classification was not uniform. The characteristics and analysis of influencing factors of drug using data in real-world focused on traditional Chinese medicine injections, and the results were not the same. In the future, we shall pay more attention to and strengthen reporting and analysis of OLDU, define study objectives, and unify the content and reporting standards, so as to promote the integrated utilization of OLDU data and reflect real situations in our country.


Assuntos
Rotulagem de Medicamentos , Uso Off-Label , China , Consenso , Medicina Tradicional Chinesa
2.
Medicine (Baltimore) ; 99(43): e22638, 2020 Oct 23.
Artigo em Inglês | MEDLINE | ID: mdl-33120753

RESUMO

RATIONALE: Extensive off-label use may affect the safety profile of tigecycline. Tigecycline-associated hypofibrinogenemia is potentially life threatening, although the frequency of life-threatening reactions is unknown and their incidence is easily overlooked. We report a case of 2 instances of treatment with high-dose tigecycline, each of which presented with hypofibrinogenemia. PATIENT CONCERNS: An 86-year-old male patient was treated twice with high-dose tigecycline and presented with hypofibrinogenemia both times. The decrease in fibrinogen occurred within 3 to 7 days of tigecycline treatment. Other coagulation parameters had slightly prolonged values. DIAGNOSES: Coagulopathy and hypofibrinogenemia. INTERVENTIONS: We discontinued the tigecycline. OUTCOMES: The fibrinogen level normalized within 5 days after the withdrawal of tigecycline. Following 80 days of hospitalization, the patient was transferred to the rehabilitation hospital for further treatment. LESSONS: We suggest routine strict monitoring of coagulation parameters, particularly fibrinogen. Attention should be paid to below-normal fibrinogen levels due to increased bleeding risk and severity of reaction at fibrinogen levels below 1 g/L.


Assuntos
Afibrinogenemia/induzido quimicamente , Antibacterianos/efeitos adversos , Tigeciclina/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/administração & dosagem , Antibacterianos/farmacologia , Feminino , Fibrinogênio/efeitos dos fármacos , Humanos , Masculino , Pessoa de Meia-Idade , Uso Off-Label , Tigeciclina/administração & dosagem , Tigeciclina/farmacologia
3.
J Transl Med ; 18(1): 405, 2020 10 21.
Artigo em Inglês | MEDLINE | ID: mdl-33087150

RESUMO

BACKGROUND: Tocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6), involved in pathogenesis of pneumonia the most frequent cause of death in COVID-19 patients. METHODS: A multicenter, single-arm, hypothesis-driven trial was planned, according to a phase 2 design, to study the effect of tocilizumab on lethality rates at 14 and 30 days (co-primary endpoints, a priori expected rates being 20 and 35%, respectively). A further prospective cohort of patients, consecutively enrolled after the first cohort was accomplished, was used as a secondary validation dataset. The two cohorts were evaluated jointly in an exploratory multivariable logistic regression model to assess prognostic variables on survival. RESULTS: In the primary intention-to-treat (ITT) phase 2 population, 180/301 (59.8%) subjects received tocilizumab, and 67 deaths were observed overall. Lethality rates were equal to 18.4% (97.5% CI: 13.6-24.0, P = 0.52) and 22.4% (97.5% CI: 17.2-28.3, P < 0.001) at 14 and 30 days, respectively. Lethality rates were lower in the validation dataset, that included 920 patients. No signal of specific drug toxicity was reported. In the exploratory multivariable logistic regression analysis, older age and lower PaO2/FiO2 ratio negatively affected survival, while the concurrent use of steroids was associated with greater survival. A statistically significant interaction was found between tocilizumab and respiratory support, suggesting that tocilizumab might be more effective in patients not requiring mechanical respiratory support at baseline. CONCLUSIONS: Tocilizumab reduced lethality rate at 30 days compared with null hypothesis, without significant toxicity. Possibly, this effect could be limited to patients not requiring mechanical respiratory support at baseline. Registration EudraCT (2020-001110-38); clinicaltrials.gov (NCT04317092).


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Betacoronavirus/efeitos dos fármacos , Infecções por Coronavirus/tratamento farmacológico , Pneumonia Viral/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Betacoronavirus/imunologia , Estudos de Coortes , Infecções por Coronavirus/epidemiologia , Feminino , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Mortalidade , Uso Off-Label , Pandemias , Pneumonia Viral/epidemiologia , Resultado do Tratamento , Estudos de Validação como Assunto
4.
Cien Saude Colet ; 25(9): 3413-3419, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32876249

RESUMO

When Covid-19 emerged in December last year, there was no vaccine nor was there specific effective treatment for this fast-spreading and life-threatening viral respiratory infection. Clinical trials were planned and are in progress to investigate whether drugs used for influenza, HIV and other viruses, and also anthelmintics (ivermectin, nitazoxanide, niclosamide), and antimalarials (chloroquine, hydroxychloroquine) showing antiviral activity in in vitro assays, are effective and safe for Covid-19. So far there is no convincing evidence that these antiviral and antiparasitic drugs are of any benefit for Covid-19. Notwithsanding the absence of evidence of clinical efficacy, these drugs are widely used outside of clinical trials (off label) for prophylaxis and treatment of this viral infection. The rationale behind the prescription of macrolide antibiotics (azithromycin) for Covid-19 is obscure as well. The widespread prescription and use of drugs of unproven efficacy and safety for Covid-19 is at odds with the rational use of medicines, a cornerstone principle of pharmacotherapy advanced by WHO in 1985. This irrational use of drugs is cause for concern because some of them are associated with serious heart disorders and deaths.


Assuntos
Infecções por Coronavirus/tratamento farmacológico , Uso Off-Label , Pneumonia Viral/tratamento farmacológico , Antivirais/administração & dosagem , Antivirais/efeitos adversos , Infecções por Coronavirus/virologia , Humanos , Prescrição Inadequada/estatística & dados numéricos , Pandemias , Pneumonia Viral/virologia , Padrões de Prática Médica/normas
6.
Lancet ; 396(10255): 909-917, 2020 09 26.
Artigo em Inglês | MEDLINE | ID: mdl-32979978

RESUMO

BACKGROUND: Chronic pelvic pain affects 2-24% of women worldwide and evidence for medical treatments is scarce. Gabapentin is effective in treating some chronic pain conditions. We aimed to measure the efficacy and safety of gabapentin in women with chronic pelvic pain and no obvious pelvic pathology. METHODS: We performed a multicentre, randomised, double-blind, placebo-controlled randomised trial in 39 UK hospital centres. Eligible participants were women with chronic pelvic pain (with or without dysmenorrhoea or dyspareunia) of at least 3 months duration. Inclusion criteria were 18-50 years of age, use or willingness to use contraception to avoid pregnancy, and no obvious pelvic pathology at laparoscopy, which must have taken place at least 2 weeks before consent but less than 36 months previously. Participants were randomly assigned in a 1:1 ratio to receive gabapentin (titrated to a maximum dose of 2700 mg daily) or matching placebo for 16 weeks. The online randomisation system minimised allocations by presence or absence of dysmenorrhoea, psychological distress, current use of hormonal contraceptives, and hospital centre. The appearance, route, and administration of the assigned intervention were identical in both groups. Patients, clinicians, and research staff were unaware of the trial group assignments throughout the trial. Participants were unmasked once they had provided all outcome data at week 16-17, or sooner if a serious adverse event requiring knowledge of the study drug occurred. The dual primary outcome measures were worst and average pain scores assessed separately on a numerical rating scale in weeks 13-16 after randomisation, in the intention-to-treat population. Self-reported adverse events were assessed according to intention-to-treat principles. This trial is registered with the ISRCTN registry, ISCRTN77451762. FINDINGS: Participants were screened between Nov 30, 2015, and March 6, 2019, and 306 were randomly assigned (153 to gabapentin and 153 to placebo). There were no significant between-group differences in both worst and average numerical rating scale (NRS) pain scores at 13-16 weeks after randomisation. The mean worst NRS pain score was 7·1 (standard deviation [SD] 2·6) in the gabapentin group and 7·4 (SD 2·2) in the placebo group. Mean change from baseline was -1·4 (SD 2·3) in the gabapentin group and -1·2 (SD 2·1) in the placebo group (adjusted mean difference -0·20 [97·5% CI -0·81 to 0·42]; p=0·47). The mean average NRS pain score was 4·3 (SD 2·3) in the gabapentin group and 4·5 (SD 2·2) in the placebo group. Mean change from baseline was -1·1 (SD 2·0) in the gabapentin group and -0·9 (SD 1·8) in the placebo group (adjusted mean difference -0·18 [97·5% CI -0·71 to 0·35]; p=0·45). More women had a serious adverse event in the gabapentin group than in the placebo group (10 [7%] of 153 in the gabapentin group compared with 3 [2%] of 153 in the placebo group; p=0·04). Dizziness, drowsiness, and visual disturbances were more common in the gabapentin group. INTERPRETATION: This study was adequately powered, but treatment with gabapentin did not result in significantly lower pain scores in women with chronic pelvic pain, and was associated with higher rates of side-effects than placebo. Given the increasing reports of abuse and evidence of potential harms associated with gabapentin use, it is important that clinicians consider alternative treatment options to off-label gabapentin for the management of chronic pelvic pain and no obvious pelvic pathology. FUNDING: National Institute for Health Research.


Assuntos
Analgésicos/efeitos adversos , Analgésicos/uso terapêutico , Dor Crônica/tratamento farmacológico , Gabapentina/efeitos adversos , Gabapentina/uso terapêutico , Dor Pélvica/tratamento farmacológico , Adolescente , Adulto , Método Duplo-Cego , Feminino , Humanos , Uso Off-Label , Resultado do Tratamento , Adulto Jovem
7.
BMC Med ; 18(1): 265, 2020 08 21.
Artigo em Inglês | MEDLINE | ID: mdl-32825816

RESUMO

BACKGROUND: New emerging infections have no known treatment. Assessing potential drugs for safety and efficacy enables clinicians to make evidence-based treatment decisions and contributes to overall outbreak control. However, it is difficult to launch clinical trials in the unpredictable environment of an outbreak. We conducted a bibliometric systematic review for the 2009 influenza pandemic to determine the speed and quality of evidence generation for treatments. This informs approaches to high-quality evidence generation in this and future pandemics. METHODS: We searched PubMed for all clinical data (including clinical trial, observational and case series) describing treatment for patients with influenza A(H1N1)pdm09 and ClinicalTrials.gov for research that aimed to enrol patients with the disease. RESULTS: Thirty-three thousand eight hundred sixty-nine treatment courses for patients hospitalised with A(H1N1)pdm09 were detailed in 160 publications. Most were retrospective observational studies or case series. Five hundred ninety-two patients received treatment (or placebo) as participants in a registered interventional clinical trial with results publicly available. None of these registered trial results was available during the timeframe of the pandemic, and the median date of publication was 213 days after the Public Health Emergency of International Concern ended. CONCLUSION: Patients were frequently treated for pandemic influenza with drugs not registered for this indication, but rarely under circumstances of high-quality data capture. The result was a reliance on use under compassionate circumstances, resulting in continued uncertainty regarding the potential benefits and harms of anti-viral treatment. Rapid scaling of clinical trials is critical for generating a quality evidence base during pandemics.


Assuntos
Antivirais/uso terapêutico , Ensaios de Uso Compassivo , Prescrição Inadequada/prevenção & controle , Vírus da Influenza A Subtipo H1N1 , Influenza Humana/tratamento farmacológico , Uso Off-Label , Betacoronavirus , Bibliometria , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/epidemiologia , Análise Custo-Benefício , Saúde Global , Humanos , Influenza Humana/epidemiologia , Pandemias , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/epidemiologia , Projetos de Pesquisa , Resultado do Tratamento
8.
Eur J Med Res ; 25(1): 37, 2020 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-32854774

RESUMO

BACKGROUND: COVID-19 is characterized by fast deterioration in the mechanism of cytokine storm. Therefore, treatment with immunomodulating agents should be initiated as soon as hyperinflammation is established. Evidence for the use of tocilizumab (TCZ) in COVID-19 is emerging, but the drug in this setting is used "off label" with limited data on both effectiveness and safety. Therefore, Hospital for Infectious Diseases in Warsaw established a Standard Operating Procedure (SOP) for the use of TCZ in severe COVID-19 cases. CASE PRESENTATION: Here, we present a case of 27-year-old, otherwise healthy man, who was successfully treated with chloroquine, azithromycin, tocilizumab and a standard of care. Initially the magnitude of lung devastation, clinical deterioration and the need for mechanical ventilation suggested unfavorable prognosis. However, we observed complete regression in radiological changes and rapid clinical improvement. Irrespective of this, patient's serum interleukin 6 and aminotransferases remained elevated even after a month from treatment. CONCLUSIONS: An overlapping effect of hyperinflammation, hypoxic organ injury and drug-related toxicity warrants a long-term follow-up for COVID-19 survivors. In addition, residual IL-6 receptors blockage may mask new infections. A standardized approach to follow-up for COVID-19 survivors is urgently needed. Current and future research should also investigate the impact of experimental therapies on lung tissue healing and regeneration, as well as long-term treatment toxicities.


Assuntos
Anticorpos Monoclonais Humanizados/administração & dosagem , Infecções por Coronavirus/tratamento farmacológico , Pneumonia Viral/tratamento farmacológico , Adulto , Azitromicina/administração & dosagem , Betacoronavirus , Cloroquina/administração & dosagem , Infecções por Coronavirus/diagnóstico por imagem , Citocinas/metabolismo , Humanos , Inflamação , Masculino , Uso Off-Label , Pandemias , Pneumonia Viral/diagnóstico por imagem , Polônia , Tomografia Computadorizada por Raios X
10.
Recenti Prog Med ; 111(7): 398-401, 2020.
Artigo em Italiano | MEDLINE | ID: mdl-32658877

RESUMO

The SARS-CoV-2 pandemic has lifted the veil about how medical knowledge is produced and disseminated. Action Bias, together with economic, academic and media-related interests, has concurred to generate and spread low-value and even unreliable information about some hypothetical therapeutic interventions for CoViD-19. Not only this "infodemic" has weakened people's ability to make informed health choices, but it also has influenced the process of new evidence generation through the violation of the equipoise principle. The CoViD-19 infodemic has further highlighted the need for reliable health information and for people to enter the process of understanding and promoting valuable research. Through a randomized controlled trial, the Informed Health Choices project has shown that it is not impossible neither quixotic to better orient people about health choices since primary school. Similar competencies should be disseminated to everyone through sources that are selected and validated for their capability of reporting evidence based health information about the effects of treatments.


Assuntos
Betacoronavirus , Disseminação de Informação , Pandemias , Antivirais/uso terapêutico , Betacoronavirus/imunologia , Comunicação , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/prevenção & controle , Tomada de Decisões , Reposicionamento de Medicamentos , Medicina Baseada em Evidências , Necessidades e Demandas de Serviços de Saúde , Humanos , Comportamento de Busca de Informação , Uso Off-Label , Pandemias/prevenção & controle , Educação de Pacientes como Assunto/métodos , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Equipolência Terapêutica , Vacinas Virais
11.
J Med Ethics ; 46(9): 574-578, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32647045

RESUMO

The controversy surrounding the use of hydroxychloroquine (HCQ), an antimalarial drug, for COVID-19 has raised numerous ethical and policy problems. Since the suggestion that HCQ has potential for COVID-19, there have been varying responses from clinicians and healthcare institutions, ranging from adoption of protocols using HCQ for routine care to the conduct of randomised controlled trials to an effective system-wide prohibition on its use for COVID-19. In this article, we argue that the concept of 'disease public profile' has become a prominent, if not the sole, determinant in decision-making across various healthcare responses to the pandemic. In the case of COVID-19, the disease's public profile is based on clinical and non-clinical factors that include contagiousness, clinical presentation and media coverage. In particular, we briefly examine the dangers of a heightened public profile in magnifying the inequality of diseases and undermining three key ethical concepts, namely (1) evidence-based practice, (2) sustainable allocation and (3) meaningful consent.


Assuntos
Tomada de Decisão Clínica/ética , Infecções por Coronavirus/tratamento farmacológico , Ética Médica , Hidroxicloroquina/uso terapêutico , Meios de Comunicação de Massa , Uso Off-Label , Pneumonia Viral/tratamento farmacológico , Políticas , Conscientização , Betacoronavirus , Medicina Baseada em Evidências , Alocação de Recursos para a Atenção à Saúde , Equidade em Saúde , Humanos , Consentimento Livre e Esclarecido , Pandemias , Medição de Risco
13.
Med Hypotheses ; 143: 110129, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32721814

RESUMO

In trying to understand the biochemical mechanism involved in the recent pandemic COVID-19, there is currently growing interest in angiotensin-converting enzyme II (ACE2). Nevertheless, the attempts to counteract COVID-19 interference with this enzymatic cascade are frustrating, and the results have thus far been inconclusive. Let's start again by considering the involved factors in an alternative way: we could postulate that COVID-19 could be more aggressive/fatal due to a high level of "basal" inflammation with low Nitric Oxide (NO) levels in hypertensive, diabetic and obese patients. Interestingly, the "protective" effects of several factors (such as estrogens) may play a role by increasing the formation of endogenous NO. From a therapeutic point of view, phosphodiesterase type 5 inhibitors such as oral Tadalafil, could be used in order to increase the basal NO levels. In this way, we don't fight the virus, but we may be able to mitigate its effects.


Assuntos
Betacoronavirus/fisiologia , Infecções por Coronavirus/tratamento farmacológico , Óxido Nítrico/metabolismo , Pandemias , Pneumonia Viral/tratamento farmacológico , Animais , Betacoronavirus/efeitos dos fármacos , Infecções por Coronavirus/complicações , Síndrome da Liberação de Citocina/etiologia , Síndrome da Liberação de Citocina/fisiopatologia , Estrogênios/fisiologia , Humanos , Hipertensão/complicações , Hipertensão/fisiopatologia , Inflamação , Interleucinas/fisiologia , Modelos Animais , Modelos Biológicos , Óxido Nítrico/uso terapêutico , Obesidade/complicações , Obesidade/fisiopatologia , Uso Off-Label , Peptidil Dipeptidase A/efeitos dos fármacos , Peptidil Dipeptidase A/fisiologia , Inibidores da Fosfodiesterase 5/farmacologia , Inibidores da Fosfodiesterase 5/uso terapêutico , Pneumonia Viral/complicações , Receptores Virais/efeitos dos fármacos , Receptores Virais/fisiologia , Citrato de Sildenafila/farmacologia , Citrato de Sildenafila/uso terapêutico , Tadalafila/farmacologia , Tadalafila/uso terapêutico
14.
Cell Mol Biol (Noisy-le-grand) ; 66(3): 221-229, 2020 Jun 05.
Artigo em Inglês | MEDLINE | ID: covidwho-603065

RESUMO

It can be misleading to think that the new severe acute respiratory syndrome coronavirus (SARS-CoV2) which has a very strong mutation and adaptation capabilities, uses only the angiotensin-converting enzyme II (ACE2) pathway to reach target cells. Despite all the precautions taken, the pandemic attack continues and the rapid increase in the number of deaths suggest that this virus has entered the cell through different pathways and caused damage through different mechanisms. The main reason why the ACE2 pathway comes to the fore in all scientific studies is that this receptor is located at the entry point of basic mechanisms that provide alveolo-capillary homeostasis. SARS-CoV-2 has to use nuclear factor-κB (NF-kB), caveloae, clathrin, lipoxin, serine protease and proteasome pathways in addition to ACE2 to enter the target cell and initiate damage. For this reason, while new drug development studies are continuing, in order to be beneficial to patients in their acute period, it is imperative that we are able to come up with drugs that activate or inhibit these pathways and are currently in clinical use. It is also critical that we adopt these new pathways to the treatment of pregnant women affected by SARS-CoV-2, based on the scientific data we use to treat the general population.


Assuntos
Betacoronavirus/metabolismo , Caveolina 1/metabolismo , Infecções por Coronavirus/metabolismo , Lipoxinas/metabolismo , NF-kappa B/metabolismo , Pneumonia Viral/metabolismo , Complicações Infecciosas na Gravidez/metabolismo , Complexo de Endopeptidases do Proteassoma/metabolismo , Bloqueadores do Receptor Tipo 1 de Angiotensina II/uso terapêutico , Anticolesterolemiantes/uso terapêutico , Sítios de Ligação , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/transmissão , Infecções por Coronavirus/virologia , Descoberta de Drogas/métodos , Reposicionamento de Medicamentos/métodos , Feminino , Humanos , Transmissão Vertical de Doença Infecciosa/prevenção & controle , NF-kappa B/antagonistas & inibidores , Uso Off-Label , Pandemias , Peptidil Dipeptidase A/metabolismo , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/transmissão , Pneumonia Viral/virologia , Gravidez , Complicações Infecciosas na Gravidez/virologia , Inibidores de Proteassoma/uso terapêutico , Serina Endopeptidases/metabolismo , Inibidores de Serino Proteinase/uso terapêutico , Internalização do Vírus
15.
A A Pract ; 14(7): e01243, 2020 May.
Artigo em Inglês | MEDLINE | ID: covidwho-600869

RESUMO

The coronavirus disease 2019 (COVID-19) pandemic created an unprecedented need for mechanical ventilation in critically ill patients. To meet this increased demand, some facilities were forced to use anesthesia gas machines (AGMs) as intensive care unit (ICU) ventilators. While an off-label use, AGM manufacturers, the Anesthesia Patient Safety Foundation, and the American Society of Anesthesiologists have guidelines for AGM use in the ICU, however, there is scant literature describing their use. This article describes our experiences at New York University Langone Medical Center using AGMs in the ICU for ventilating critically ill COVID-19 patients.


Assuntos
Anestesiologia/instrumentação , Infecções por Coronavirus/terapia , Pneumonia Viral/terapia , Respiração Artificial/instrumentação , Respiração Artificial/métodos , Ventiladores Mecânicos/provisão & distribução , Betacoronavirus , Infecções por Coronavirus/epidemiologia , Cuidados Críticos , Hospitais Universitários , Humanos , Unidades de Terapia Intensiva , Cidade de Nova Iorque/epidemiologia , Enfermeiras Anestesistas , Uso Off-Label , Pandemias , Pneumonia Viral/epidemiologia , Recursos Humanos
16.
A A Pract ; 14(7): e01243, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32539282

RESUMO

The coronavirus disease 2019 (COVID-19) pandemic created an unprecedented need for mechanical ventilation in critically ill patients. To meet this increased demand, some facilities were forced to use anesthesia gas machines (AGMs) as intensive care unit (ICU) ventilators. While an off-label use, AGM manufacturers, the Anesthesia Patient Safety Foundation, and the American Society of Anesthesiologists have guidelines for AGM use in the ICU, however, there is scant literature describing their use. This article describes our experiences at New York University Langone Medical Center using AGMs in the ICU for ventilating critically ill COVID-19 patients.


Assuntos
Anestesiologia/instrumentação , Infecções por Coronavirus/terapia , Pneumonia Viral/terapia , Respiração Artificial/instrumentação , Respiração Artificial/métodos , Ventiladores Mecânicos/provisão & distribução , Betacoronavirus , Infecções por Coronavirus/epidemiologia , Cuidados Críticos , Hospitais Universitários , Humanos , Unidades de Terapia Intensiva , Cidade de Nova Iorque/epidemiologia , Enfermeiras Anestesistas , Uso Off-Label , Pandemias , Pneumonia Viral/epidemiologia , Recursos Humanos
17.
Front Immunol ; 11: 1201, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32574268

RESUMO

The severe acute respiratory syndrome coronavirus 2 (SARS-COv-2) is the etiologic agent of the 2019 coronavirus disease (COVID19). The majority of infected people presents flu like symptoms and among them 15-20% develops a severe interstitial pneumonitis (IP) that may eventually evolve in acute respiratory distress syndrome (ARDS). IP is caused by the viral glycoprotein spike (S) binding to the angiotensin converting enzyme 2 (ACE2) expressed on the surface of alveolar pneumocytes. The virus is recognized by the "pattern recognition receptors" (PRR) of the immune cells that release cytokines activating more immune cells that produce a large number of pro-inflammatory cytokines, tissue factors and vasoactive peptides. Affected patients might develop the "cytokine storm syndrome," a fulminant and fatal hypercytokinaemia with multiorgan failure. In patients infected by SARS-COv-2 increase in T-helper 2 (TH2) cytokines (IL-4 and IL10) are reported in addition to the T-helper 1 (TH1) cytokines (IL1B, IFNγ, IP10, and MCP1) previously detected in other coronavirus infections. Cytokines and other molecules involved in immune response and inflammation are conceivable therapeutic targets for IP and ARDS, improving symptoms and decreasing intensive care unit admissions. To this aim off label drugs may be used taking into consideration the window timing for immunosuppressive drugs in virus infected patients. Some off label therapeutic options and preclinical evidence drugs are herein considered.


Assuntos
Antivirais/uso terapêutico , Betacoronavirus/imunologia , Infecções por Coronavirus/tratamento farmacológico , Uso Off-Label , Pneumonia Viral/tratamento farmacológico , Infecções por Coronavirus/imunologia , Estado Terminal , Citocinas/sangue , Humanos , Pandemias , Pneumonia Viral/imunologia
18.
Farm Hosp ; 44(7): 24-27, 2020 06 12.
Artigo em Inglês | MEDLINE | ID: mdl-32533665

RESUMO

Type 2 coronavirus pandemics that is plaguing almost all the world has caused  qualitative and quantitative strains in health systems that have had to be responded to. The lack of known vaccines and effective treatments has generated the need to  use drugs with very little evidence for their incorporation into pharmacotherapeutic  protocols agreed by the clinical team. The hospital pharmacist, within the  multidisciplinary team, has been responsible for critically evaluating the alternatives and positioning them in these protocols. Finally, some ethical and legal questions  that should be considered in this scenario are analyzed in this article.


Assuntos
Betacoronavirus , Infecções por Coronavirus , Medicina Baseada em Evidências , Pandemias , Farmacêuticos , Serviço de Farmácia Hospitalar/organização & administração , Comitê de Farmácia e Terapêutica/organização & administração , Pneumonia Viral , Protocolos Clínicos , Infecções por Coronavirus/tratamento farmacológico , Tratamento Farmacológico/normas , Humanos , Comunicação Interdisciplinar , Uso Off-Label/ética , Uso Off-Label/legislação & jurisprudência , Equipe de Assistência ao Paciente , Serviço de Farmácia Hospitalar/legislação & jurisprudência , Pneumonia Viral/tratamento farmacológico , Guias de Prática Clínica como Assunto , Propaganda , Papel (figurativo)
19.
Farm Hosp ; 44(7): 28-31, 2020 06 12.
Artigo em Inglês | MEDLINE | ID: mdl-32533666

RESUMO

During the pandemic caused by the SARS-CoV-2 virus, pharmacy services have  had to adapt their service portfolio, and yet ensure efficient, equitable and  quality pharmaceutical care. Given the limited scientific evidence available, most drugs have been used off-label or in the context of clinical trials, which should be the preferred option in order to create new evidence. Among kind different  situations we have faced are the increase in workload, the expansion of  coverage to new wards and ICUs and shortages, which have caused the use of  alternative drugs and even other routes of administration. Given that covid-19  affects elderly population with greater severity and many of them are  polymedicated, great effort have been focused on monitoring interactions, both  pharmacokinetic and pharmacodynamic (specially prolongation of the QT  interval), monitoring correct concentrations of electrolytes, nutritional support,  adaptation of chemotherapy treatment protocols and anticoagulant  management, among others. The use of personal protective equipment added  difficulty for nursing work and some measures had been taken to minimize the  number of entries into the rooms. Eventually, team's split to guarantee care, the challenge of teleworking, remote validation, telemedicine and telepharmacy for  communication between professionals and patients, as well as training in this pandemic situation have been a challenge for our profession. These  difficulties have risen up new learning opportunities we hope will be useful to us  in the event we have to face similar situations in the future.


Assuntos
Betacoronavirus , Infecções por Coronavirus/tratamento farmacológico , Pacientes Internados , Pandemias , Serviço de Farmácia Hospitalar/organização & administração , Pneumonia Viral/tratamento farmacológico , Assistência ao Convalescente , Comunicação , Comorbidade , Infecção Hospitalar/prevenção & controle , Vias de Administração de Medicamentos , Interações Medicamentosas , Monitoramento de Medicamentos , Previsões , Pessoal de Saúde/educação , Necessidades e Demandas de Serviços de Saúde , Humanos , Controle de Infecções/métodos , Controle de Infecções/organização & administração , Uso Off-Label , Educação de Pacientes como Assunto , Segurança do Paciente , Equipamento de Proteção Individual , Farmacovigilância , Relações Profissional-Paciente , Telemedicina
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