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1.
EClinicalMedicine ; 68: 102429, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38371479

RESUMO

Background: Smoking cessation is challenging, despite making use of established smoking cessation therapies. Preclinical studies and one clinical pilot study suggest the antidiabetic drug glucagon-like peptide-1 (GLP-1) analogue to modulate addictive behaviours and nicotine craving. Previously, we reported the short-term results of a randomised, double-blind, placebo-controlled trial. Herein we report long-term abstinence rates and weight developments after 24 and 52 weeks. Methods: This single-centre, randomised, double-blind, placebo-controlled, parallel group trial was done at the University Hospital Basel in Switzerland. We randomly assigned (1:1) individuals with at least a moderate nicotine dependence willing to quit smoking to either a 12-week treatment with dulaglutide 1.5 mg or placebo subcutaneously once weekly in addition to standard of care smoking cessation therapy (varenicline 2 mg/day and behavioural counselling). After 12 weeks, dulaglutide or placebo injections were discontinued and the participants were followed up at week 24 and 52. The primary outcome of self-reported and biochemically confirmed point prevalence abstinence rate, and secondary outcome of secondary outcome of weight change were assessed at weeks 24 and 52. All participants who received one dose of the study drug were included in the intention to treat set and participants who received at least 10/12 doses of the study drug formed the per protocol set. The trial was registered at ClinicalTrials.gov, NCT03204396. Findings: Of the 255 participants who were randomly assigned between June 22, 2017 and December 3, 2020, 63% (80/127) (dulaglutide group) and 65% (83/128) (placebo group) were abstinent after 12 weeks. These abstinence rates declined to 43% (54/127) and 41% (52/128), respectively, after 24 weeks and to 32% (41/127) and 32% (41/128), respectively, after 52 weeks. Post-cessation weight gain was prevented in the dulaglutide group (-1.0 kg, standard deviation [SD] 2.7) as opposed to the placebo group (+1.9 kg, SD 2.4) after 12 weeks. However, at week 24, increases in weight from baseline were observed in both groups (median, interquartile range [IQR]: dulaglutide: +1.5 kg, [-0.4, 4.1], placebo: +3.0 kg, [0.6, 4.6], baseline-adjusted difference in weight change -1.0 kg (97.5% CI [-2.16, 0.16])), and at week 52 the groups showed similar weight gain (median, IQR: dulaglutide: +2.8 kg [-0.4, 4.7], placebo: +3.1 kg [-0.4, 6.0], baseline-adjusted difference in weight change: -0.35 kg (95% CI [-1.72, 1.01])). In the follow-up period (week 12 to week 52) 51 (51%) and 48 (48%) treatment-unrelated adverse events were recorded in the dulaglutide and the placebo group, respectively. No treatment-related serious adverse events or deaths occurred. Interpretation: Dulaglutide does not improve long-term smoking abstinence, but has potential to counteract weight gain after quitting. However, 3 months of treatment did not have a sustained beneficial effect on weight at 1 year. As post-cessation weight gain is highest in the first year after quitting smoking, future studies should consider a longer treatment duration with a GLP-1 analogue in abstinent individuals. Funding: Swiss National Science Foundation, the Gottfried and Julia Bangerter-Rhyner Foundation, the Goldschmidt-Jacobson Foundation, the Hemmi-Foundation, the University of Basel, the Swiss Academy of Medical Sciences.

3.
Front Med (Lausanne) ; 10: 1249618, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38020159

RESUMO

Objective: During the early stages of the COVID-19 pandemic, medical students were abruptly removed from clinical rotations and transitioned to virtual learning. This study investigates the impact of this shift on students' wellbeing and preparedness for advanced training. Methods: Through qualitative research methods, including semi-structured interviews, the experiences of medical students working on the COVID-19 frontline were explored. Results: The comprehensive findings of the study shed light on the profound emotional journey that medical students embarked upon during the relentless public health crisis. Within the chaos and overwhelming demands of the pandemic, medical students discovered a profound sense of purpose and fulfillment in their contributions to the welfare of the community. Despite the personal sacrifices they had to make, such as long hours, limited social interactions, and potentially risking their own health, students reported feelings of relief and gratitude. Conclusion: Tailored support systems for medical students' wellbeing are crucial for improving healthcare delivery during crises. Medical schools should adopt a holistic curriculum approach, integrating interdisciplinary learning and prioritizing student wellbeing. Recognizing the pandemic's impact on students and implementing targeted support measures ensures resilience and contributes to an improved healthcare system.

4.
JCI Insight ; 8(22)2023 Nov 22.
Artigo em Inglês | MEDLINE | ID: mdl-37991022

RESUMO

BACKGROUNDAlcohol use disorder has a detrimental impact on global health and new treatment targets are needed. Preclinical studies show attenuating effects of glucagon-like peptide-1 (GLP-1) agonists on addiction-related behaviors in rodents and nonhuman primates. Some trials have shown an effect of GLP-1 agonism on reward processes in humans; however, results from clinical studies remain inconclusive.METHODSThis is a predefined secondary analysis of a double-blind, randomized, placebo-controlled trial evaluating the GLP-1 agonist dulaglutide as a therapy for smoking cessation. The main objective was to assess differences in alcohol consumption after 12 weeks of treatment with dulaglutide compared to placebo. The effect of dulaglutide on alcohol consumption was analyzed using a multivariable generalized linear model.RESULTSIn the primary analysis, participants out of the cohort (n = 255) who reported drinking alcohol at baseline and who completed 12 weeks of treatment (n = 151; placebo n = 75, dulaglutide n = 76) were included. The median age was 42 (IQR 33-53) with 61% (n = 92) females. At week 12, participants receiving dulaglutide drank 29% less (relative effect = 0.71, 95% CI 0.52-0.97, P = 0.04) than participants receiving placebo. Changes in alcohol consumption were not correlated with smoking status at week 12.CONCLUSIONThese results provide evidence that dulaglutide reduces alcohol intake in humans and contribute to the growing body of literature promoting the use of GLP-1 agonists in treatment of substance use disorders.TRIAL REGISTRATIONClinicalTrials.gov NCT03204396.FUNDINGSwiss National Foundation, Gottfried Julia Bangerter-Rhyner Foundation, Goldschmidt-Jacobson Foundation, Hemmi Foundation, University of Basel, University Hospital Basel, Swiss Academy of Medical Science.


Assuntos
Diabetes Mellitus Tipo 2 , Abandono do Hábito de Fumar , Adulto , Feminino , Humanos , Consumo de Bebidas Alcoólicas/tratamento farmacológico , Diabetes Mellitus Tipo 2/complicações , Peptídeo 1 Semelhante ao Glucagon , Hipoglicemiantes , Método Duplo-Cego
5.
Diagnostics (Basel) ; 13(18)2023 Sep 07.
Artigo em Inglês | MEDLINE | ID: mdl-37761241

RESUMO

The influence of cuff inflations on night-time measurements during 24 h ambulatory blood pressure (BP) measurements is unknown. We investigated the potential effect of cuff inflations on sleep parameters using measurements taken simultaneously with a cuffless device using pulse-transit-time (PTT). On the first day of measurement, standard cuff-based 24 h BP and cuffless measurements were simultaneously performed on the right and left arms (CUFF/PTT-D). In this experiment, 1-2 days after the first measurement, the cuffless device was worn alone (PTT-D). Only data from the cuffless device were analyzed. The following mean sleep parameters were analyzed: mean systolic and diastolic BP, arousals, sleep efficiency, total arousals, arousal per hour, and desaturations. In total, 21 individuals were prospectively enrolled. The mean (SD) age was 47 (±15) years, and 57% were female. The mean systolic asleep BP during CUFF/PTT-D and during PTT-D were 131 (±21) and 131 (±26) mmHg, respectively. The mean diastolic asleep BP values during CUFF/PTT-D and during PTT-D were 80 (±14) and 84 (±14) mmHg, respectively (p = 0.860, p = 0.100, respectively). Systolic and diastolic asleep mean difference was 0.1 (±18.0) and -3.6 (±9.8) mmHg, respectively. There were significantly more total arousals during PTT-D (p = 0.042). There were no significant differences seen in sleep efficiency (p = 0.339) or desaturations (p = 0.896) between the two measurement periods. We could not show any significant impact from cuff inflations during sleep, as documented by PTT-D measurements.

6.
Trials ; 24(1): 284, 2023 Apr 20.
Artigo em Inglês | MEDLINE | ID: mdl-37081574

RESUMO

BACKGROUND: Cigarette smoking is the leading preventable cause of premature death. Despite dedicated programmes, quit rates remain low due to barriers such as nicotine withdrawal syndrome or post-cessation weight gain. Glucagon-like peptide-1 (GLP-1) analogues reduce energy intake and body weight and seem to modulate addictive behaviour. These GLP-1 properties are of major interest in the context of smoking cessation. The aim of this study is to evaluate the GLP-1 analogue dulaglutide as a new therapy for smoking cessation. METHODS: This is a placebo-controlled, double-blind, parallel group, superiority, single-centre randomized study including 255 patients. The intervention consists of a 12-week dulaglutide treatment phase with 1.5 mg once weekly or placebo subcutaneously, in addition to standard of care (behavioural counselling and pharmacotherapy with varenicline). A 40-week non-treatment phase follows. The primary outcome is the point prevalence abstinence rate at week 12. Smoking status is self-reported and biochemically confirmed by end-expiratory exhaled carbon monoxide measurement. Further endpoints include post-cessational weight gain, nicotine craving analysis, glucose homeostasis and long-term nicotine abstinence. Two separate substudies assess behavioural, functional and structural changes by functional magnetic resonance imaging and measures of energy metabolism (i.e. resting energy expenditure, body composition). DISCUSSION: Combining behavioural counselling and medical therapy, e.g. with varenicline, improves abstinence rates and is considered the standard of care. We expect a further increase in quit rates by adding a second component of medical therapy and assume a dual effect of dulaglutide treatment (blunting nicotine withdrawal symptoms and reducing post-cessational weight gain). This project is of high relevance as it explores novel treatment options aimed at preventing the disastrous consequences of nicotine consumption and obesity. TRIAL REGISTRATION: ClinicalTrials.gov NCT03204396 . Registered on June 26, 2017.


Assuntos
Abandono do Hábito de Fumar , Síndrome de Abstinência a Substâncias , Humanos , Vareniclina/uso terapêutico , Nicotina , Abandono do Hábito de Fumar/métodos , Peptídeo 1 Semelhante ao Glucagon , Síndrome de Abstinência a Substâncias/tratamento farmacológico , Método Duplo-Cego , Aumento de Peso , Ensaios Clínicos Controlados Aleatórios como Assunto
7.
EClinicalMedicine ; 57: 101865, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-36874396

RESUMO

Background: Quitting smoking is difficult due to barriers such as craving for cigarettes and post-cessation weight gain. Recent experimental data suggest a role of glucagon-like peptide-1 (GLP-1) in the pathophysiology of addiction in addition to appetite regulation and weight control. We hypothesized that a pharmacological intervention with the GLP-1 analogue dulaglutide during smoking cessation may improve abstinence rates and reduce post-cessation weight gain. Methods: This is a single-centre, randomized, double-blind, placebo-controlled, parallel group, superiority study conducted in the University Hospital Basel in Switzerland. We included adult smokers with at least moderate cigarette dependence who wanted to quit. Participants were randomly assigned to a 12-week treatment with dulaglutide 1.5 mg once weekly or placebo subcutaneously in addition to standard of care including behavioural counselling and oral varenicline pharmacotherapy of 2 mg/day. The primary outcome was self-reported and biochemically confirmed point prevalence abstinence rate at week 12. Secondary outcomes included post-cessation weight, glucose metabolism, and craving for smoking. All participants who received one dose of study drug were included in the primary and safety analyses. The trial was registered on ClinicalTrials.gov (NCT03204396). Findings: Between June 22, 2017, and December 3, 2020, 255 participants were enrolled and randomly assigned to each group (127 in the dulaglutide group and 128 in the placebo group). After 12 weeks, 63% (80/127) participants on dulaglutide and 65% (83/128) on placebo treatment were abstinent (difference in proportions -1.9% [95% Confidence interval (CI) -10.7, 14.4], p-value (p) = 0.859). Dulaglutide decreased post-cessation weight (-1 kg [standard deviation (SD) 2.7]), while weight increased on placebo (+1.9 kg [SD 2.4]). The baseline-adjusted difference in weight change between groups was -2.9 kg (95% CI -3.59, -2.3, p < 0.001). Haemoglobin A1c (HbA1c) level declined on dulaglutide treatment (baseline-adjusted median difference in HbA1c between groups -0.25% [interquartile range (IQR) -0.36, -0.14], p < 0.001). Craving for smoking declined during treatment without any difference between the groups. Treatment-emergent gastrointestinal symptoms were very common in both groups: 90% (114/127) of participants on dulaglutide and 81% (81/128) on placebo). Interpretation: Dulaglutide had no effect on abstinence rates but prevented post-cessation weight gain and decreased HbA1c levels. GLP-1 analogues may play a role in future cessation therapy targeting metabolic parameters such as weight and glucose metabolism. Funding: Swiss National Science Foundation, the Gottfried Julia Bangerter-Rhyner Foundation, the Goldschmidt-Jacobson Foundation, the Hemmi-Foundation, the University of Basel, the Swiss Academy of Medical Sciences.

8.
BMJ Nutr Prev Health ; 6(2): 301-309, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-38264360

RESUMO

Background: Women seem to have more difficulty quitting smoking than men. This is particularly concerning as smoking puts women at a higher risk of developing smoking-associated diseases. Greater concerns about postcessation weight gain in women have been postulated as a possible explanation. Methods: Predefined secondary analysis of a placebo-controlled, double-blind, parallel-group, superiority randomised trial including 255 adults who smoke daily (155 women, 100 men). Participants received weekly dulaglutide (1.5 mg) or placebo (0.9% sodium chloride) in addition to standardised smoking cessation care (varenicline 2 mg/day plus behavioural counselling) over 12 weeks. We aimed to investigate gender differences in weight change after dulaglutide-assisted smoking cessation. Weight change between baseline and week 12 was analysed as absolute and revative weight change and as substantial weight gain (defined as >6% increase). Results: No gender differences were observed in absolute or relative weight change neither on dulaglutide nor placebo treatment. However, substantial weight gain (defined as >6% increase) in the placebo group was almost five times more frequent in females than males (24% vs 5%). Female patients were less likely to have substantial weight gain on dulaglutide compared with placebo (1% (n=1/83) vs 24% (n=17/72); p<0.001), while this dulaglutide effect was less pronounced in males (0% (n=0/44) vs 5% (n=3/56); p=0.333). Conclusion: Dulaglutide reduced postcessation weight gain in both genders and was very effective in preventing substantial weight gain, which seems to be a specific observation in females. Trial registration number: NCT03204396.

9.
Praxis (Bern 1994) ; 111(9): 503-507, 2022 Jun.
Artigo em Alemão | MEDLINE | ID: mdl-35765793

RESUMO

Emergency Ultrasound Training for and with Medical Students Abstract. Practical basic skills in sonography are a mandatory part of Swiss medical schools since 2018. The universities of Basel and Bern teach students the content of the POCUS component "Basic Emergency Sonography" of the SGUM and have developed the e-learning tool "POCUS Emergency Sonography" for this purpose in cooperation. By using this innovative blend- ed learning concept, students acquire basic skills in sonography and can build upon this know-how in their further education.


Assuntos
Estudantes de Medicina , Currículo , Humanos , Aprendizagem , Faculdades de Medicina , Ultrassonografia
10.
Med Educ Online ; 27(1): 2082265, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-35638171

RESUMO

The COVID-19 pandemic caused complex and enduring challenges for healthcare providers and medical educators. The rapid changes to the medical education landscape forced universities across the world to pause traditional medical training. In Basel, Switzerland, however, medical students had the opportunity to work on the COVID-19 frontlines. Our purpose was to understand how they perceived both learning and professional identity development in this novel context. We conducted semi-structured interviews with 21 medical students who worked in a COVID-19 testing facility at the University Hospital of Basel. Using constructivist grounded theory methodology, we collected and analyzed data iteratively using the constant comparative approach to develop codes and theoretical themes. Most participants perceived working on the pandemic frontlines as a positive learning experience, that was useful for improving their technical and communication skills. Participants particularly valued the comradery amongst all team members, perceiving that the hierarchy between faculty and students was less evident in comparison to their usual learning environments. Since medical students reported that their work on the pandemic frontlines positively affected their learning, the need to create more hands-on learning opportunities for medical students challenges curriculum developers. Medical students wish to feel like full-fledged care team members rather than observing sideliners. Performing simple clinical tasks and collaborative moments in a supportive learning environment may promote learning and professional development and should be encouraged in the post-pandemic era.


Assuntos
COVID-19 , Estudantes de Medicina , COVID-19/epidemiologia , Teste para COVID-19 , Humanos , Aprendizagem , Pandemias
11.
Eur J Case Rep Intern Med ; 8(7): 002617, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34268264

RESUMO

OBJECTIVES: There is limited experience regarding the meaning of SARS-CoV-2 antibodies after vaccination in patients with naturally acquired immunity. METHODS: We describe the case of a patient who received the first dose of the mRNA-1273 SARS-CoV-2 vaccine 6 months after his recovery from moderately severe COVID-19. RESULTS: Our patient had a positive nucleocapsid SARS-CoV-2 IgG/IgM titre with 78.7 multiple of cut-off indicating persistent humoral immune response 6 months after infection. After vaccination, he developed prolonged systemic symptoms (fever, fatigue, nausea, diarrhoea and myalgia) for a duration of 6 days. CONCLUSION: SARS-CoV-2 nucleocapsid antibodies provide information about naturally acquired immunity. For the assessment of immune response to vaccination, measurement of the SARS-CoV-2 spike antibody titre before and after vaccination is essential. Patients with naturally acquired immunity might develop a prolonged systemic reaction to the first dose of the mRNA-1273 SARS-CoV-2 vaccine. LEARNING POINTS: Patients with naturally acquired immunity might develop a prolonged systemic reaction after receiving an mRNA SARS-CoV-2 vaccine.Depending on the clinical situation of SARS-CoV-2 infection and/or vaccination, different antibody titres should be determined.The SARS-CoV-2 nucleocapsid antibodies provide information on whether or not natural immunization has taken place. To quantify the immune response induced by vaccination, the SARS-CoV-2 spike antibody titre before and after vaccination has to be measured.

12.
Swiss Med Wkly ; 151: w20505, 2021 05 24.
Artigo em Inglês | MEDLINE | ID: mdl-34098583

RESUMO

AIM OF THE STUDY: Teaching is one of the three pillars of medical-academic activity, alongside patient care and research. The aim of our study was to assess current teaching practice in the medical departments of the University Hospital Basel, Switzerland, in order to organise a faculty development programme tailored to local needs. METHODS: We performed a cross-sectional online survey among the teaching faculty and the residents. For both groups, we assessed their estimation of the general importance and perceived frequency of various teaching formats in everyday practice. Additionally, we asked the senior physicians to evaluate their teaching competencies and the residents to state their opinion on factors promoting a positive learning experience. RESULTS: Twenty-eight of 34 senior physicians (82%) and 48 of 90 residents (53%) participated in the study. Both groups broadly agreed on the importance of various teaching formats for the professional development of physicians, placing particular importance on bedside teaching, providing feedback, teaching during case discussions, and observation and modeling. However, the residents perceived that they obtained less teaching, feedback and support than the senior physicians perceived they were giving. Overall, teaching during case discussions represented the format most often applied, and it was also the one in which the senior physicians felt most competent. Residents claimed “time” to be the most important factor promoting a positive learning experience, followed by a positive attitude und the personal characteristics of the supervisor. CONCLUSION: Our study shows that, despite being an integral part of everyday work at a university clinic, many aspects of current teaching practice allow discussion on possibilities of adaptations and improvement. Evaluation of current teaching practice provides the basis for designing a faculty development programme tailored to specific needs.


Assuntos
Internato e Residência , Médicos , Estudos Transversais , Hospitais Universitários , Humanos , Medicina Interna/educação , Pacientes Ambulatoriais , Suíça , Ensino
13.
PLoS One ; 16(3): e0248586, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33720945

RESUMO

BACKGROUND: Blood pressure measurement (BPM) is one of the most often performed procedures in clinical practice, but especially office BPM is prone to errors. Unattended automated office BPM (AOBPM) is somewhat standardised and observer-independent, but time and space consuming. We aimed to assess whether an AOBPM protocol can be abbreviated without losing accuracy. DESIGN: In our retrospective single centre study, we used all AOBPM (AOBPM protocol of the SPRINT study), collected over 14 months. Three sequential BPM (after 5 minutes of rest, spaced 2 minutes) were automatically recorded with the patient alone in a quiet room resulting in three systolic and diastolic values. We compared the mean of all three (RefProt) with the mean of the first two (ShortProtA) and the single first BPM (ShortProtB). RESULTS: We analysed 413 AOBPM sets from 210 patients. Mean age was 52±16 years. Mean values for RefProt were 128.3/81.3 mmHg, for ShortProtA 128.4/81.4 mmHg, for ShortProtB 128.8/81.4 mmHg. Mean difference and limits of agreement for RefProt vs. ShortProtA and ShortProtB were -0.1±4.2/-0.1±2.8 mmHg and -0.5±8.1/-0.1±5.3 mmHg, respectively. With ShortProtA, 83% of systolic and 92% of diastolic measurements were within 2 mmHg from RefProt (67/82% for ShortProtB). ShortProtA or ShortProtB led to no significant hypertensive reclassifications in comparison to RefProt (p-values 0.774/1.000/1.000/0.556). CONCLUSION: Based on our results differences between the RefProt and ShortProtA are minimal and within acceptable limits of agreement. Therefore, the automated procedure may be shorted from 3 to 2 measurements, but a single measurement is insufficient.


Assuntos
Determinação da Pressão Arterial/normas , Pressão Sanguínea , Hipertensão/fisiopatologia , Adulto , Idoso , Feminino , Humanos , Hipertensão/diagnóstico , Masculino , Pessoa de Meia-Idade , Padrões de Referência , Estudos Retrospectivos
15.
Sci Rep ; 11(1): 1143, 2021 01 13.
Artigo em Inglês | MEDLINE | ID: mdl-33441915

RESUMO

A cuffless blood pressure (BP) device (TestBP) using pulse transit time is in clinical use, but leads to higher BP values compared to a cuff-based 24 h-BP reference device (RefBP). We evaluated the impact of a recent software update on BP results and TestBP's ability to differentiate between normo- and hypertension. 71 individuals had TestBP (Somnotouch-NIBP) and RefBP measurements simultaneously performed on either arm. TestBP results with software version V1.5 were compared to V1.4 and RefBP. Mean 24 h (± SD) BP for the RefBP, TestBP-V1.4 and TestBP-V1.5 were systolic 134.0 (± 17.3), 140.8 (± 20) and 139.1 (± 20) mmHg, and diastolic 79.3 (± 11.7), 85.8 (± 14.1) and 83.5 (± 13.0) mmHg, respectively (p-values < 0.001). TestBP-V1.5 area under the curve (95% confidence interval) versus RefBP for hypertension detection was 0.92 (0.86; 0.99), 0.94 (0.88; 0.99) and 0.77 (0.66; 0.88) for systolic and 0.92 (0.86; 0.99), 0.92 (0.85; 0.99) and 0.84 (0.74; 0.94) for diastolic 24 h, awake and asleep BP respectively. TestBP-V1.5 detected elevated systolic/diastolic mean 24 h-BP with a 95%/90% sensitivity and 65%/70% specificity. Highest Youden's Index was systolic 133 (sensitivity 95%/specificity 80%) and diastolic 87 mmHg (sensitivity 81%/specificity 98%). The update improved the agreement to RefBP. TestBP was excellent for detecting 24 h and awake hypertensive BP values but not for asleep BP values.


Assuntos
Determinação da Pressão Arterial/instrumentação , Hipertensão/diagnóstico , Adulto , Idoso , Idoso de 80 Anos ou mais , Pressão Sanguínea , Determinação da Pressão Arterial/métodos , Feminino , Humanos , Hipertensão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Sensibilidade e Especificidade , Software
16.
J Allergy Clin Immunol Pract ; 9(6): 2406-2414.e2, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33486145

RESUMO

BACKGROUND: Hypersensitivity reactions (HSRs) to nondextran iron products (NDIPs) are rare, but can manifest with severe signs and symptoms. Predisposing risk factors are not well understood. OBJECTIVE: To characterize patients with HSRs to NDIPs, with a special focus on possible risk factors. METHODS: We analyzed clinical characteristics of patients with HSRs to NDIPs referred to our allergy division between 2007 and 2019 compared with tolerant controls, including the type of the eliciting NDIP, severity and characteristics of the HSR, atopy status, history of allergies and urticaria, laboratory and skin test results, and outcome of reexposure with NDIPs. RESULTS: We evaluated the data of 59 patients and 21 controls. Sixteen patients and 4 controls received the NDIP iron sucrose and 41 patients and 15 controls received ferric carboxymaltose. In 2 patients and in 2 controls, the culprit NDIP was not known. Twenty-seven patients (46%) experienced an anaphylactic reaction grade I, 15 (25%) a grade II reaction, and 17 (29%) a grade III reaction according to Ring and Messmer. On analyzing the history, we found that 22 patients (37%) and 3 controls (14%) reported previous HSRs to other medications. Interestingly, more than half the patients (n = 35 [59%]) compared with only 7 controls (33%) reported an episode of any type of urticaria in their previous history. Most patients (n = 15 [79%]) tolerated reexposure of an NDIP using a low-reactogenic administration protocol. CONCLUSIONS: A history of drug hypersensitivity and urticaria represent potential risk factors for HSRs to NDIPs. On the basis of our findings, we propose an algorithm for practical management of patients receiving NDIPs aiming to prevent HSRs.


Assuntos
Hipersensibilidade a Drogas , Hipersensibilidade Imediata , Hipersensibilidade a Drogas/diagnóstico , Hipersensibilidade a Drogas/epidemiologia , Humanos , Ferro , Fatores de Risco
17.
J Hypertens ; 39(6): 1246-1253, 2021 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-33323914

RESUMO

OBJECTIVE: Noninvasive thoracic bioimpedance by the HOTMAN System estimates hemodynamic modulators and expresses them as hemodynamic profiles. Aims of this analysis were to describe hemodynamic profiles among treatment-naive hypertensive patients compared with normotensive controls and to investigate whether a hemodynamic-guided choice of therapy improves blood pressure (BP) control within 4 weeks. METHOD: This exploratory post hoc analysis used data of a randomized parallel-group trial including 80 outpatients with newly diagnosed arterial hypertension (AHT), randomized to four antihypertensive first-line monotherapies, and 20 age-matched and sex-matched normotensive controls. Hemodynamic profiles were measured at baseline and after four weeks of treatment. On the basis of the hemodynamic profiles, the most appropriate pharmacological treatment was determined retrospectively and patients were categorised to have received concordant (ConTG) or discordant treatment (DisTG). RESULTS: In the hypertensive group, hypervolemia with vasoconstriction was the predominant hemodynamic profile in 48% of patients and hypervolemia without vasoconstriction in 45%, compared with 15 and 50%, respectively, in the control group. After 4 weeks of treatment, the mean (±SD) 24-h BP was 129.9 (±11.0)/81.5 (±8.0) mmHg in the DisTG vs. 133.9 (±12.3)/84.0 (±9.1) mmHg in the ConTG (P = 0.158/0.222). The mean 24-h BP reductions were -9.7 (±10.1)/-5.0 (±6.2) mmHg in the DisTG and -12.4 (±14.8)/-6.9(±6.9) mmHg in the ConTG (P = 0.353/0.223). After 4 weeks of treatment, the BP control rate was 53.7% (43/80) among all, 55.7% (29/52) in the DisTG and 48% (12/25) in the ConTG (P = 0.628). CONCLUSION: Our findings do not support the hypothesis that personalized treatment initiation based on hemodynamic profiles improves BP control in newly diagnosed hypertensive outpatients.


Assuntos
Anti-Hipertensivos , Hipertensão , Anti-Hipertensivos/farmacologia , Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea , Hemodinâmica , Humanos , Hipertensão/tratamento farmacológico , Estudos Retrospectivos
19.
J Clin Med ; 9(10)2020 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-33036445

RESUMO

This prospective observational study evaluated the safety and feasibility of a low threshold testing process in a Triage and Test Center (TTC) during the early course of the coronavirus disease 19 (COVID-19) pandemic. In addition, we aimed to identify clinical predictors for a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) swab result. Patients underwent informal triage, standardized history taking, and physician evaluation, only where indicated. Patients were observed for 30 days. Safety was the primary outcome and was defined as a COVID-19-related 30 day re-presentation rate <5% and mortality rate <1% in patients presenting to the TTC. Feasibility was defined as an overruling of informal triage <5%. Among 4815 presentations, 572 (11.9%) were tested positive for SARS-CoV-2, and 4774 were discharged. Mortality at 30-days was 0.04% (2 patients, one of which related to COVID-19). Fever (OR 2.03 [95% CI 1.70;2.42]), myalgia (OR 1.94 [1.63;2.31]), chills (OR 1.77 [1.44;2.16]), headache (OR 1.61 [1.34;1.94]), cough (OR 1.50 [1.24;1.83]), weakness (OR 1.46 [1.21;1.76]), and confusion (OR 1.39 [1.06;1.80]) were associated with test positivity. Re-presentation rate was 8% overall and 1.4% in COVID-19 related re-presentation (69 of 4774). The overruling rate of informal triage was 1.5%. According to our study, a low-threshold testing process in a TTC appeared to be safe (low re-presentation and low mortality) and is feasible (low overruling of informal triage). A COVID-19 diagnosis based on clinical parameters only does not appear possible.

20.
Diagnostics (Basel) ; 10(6)2020 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-32486521

RESUMO

: Background: The Somnotouch-Non-Invasive-Blood-Pressure (NIBP) device delivers raw data consisting of electrocardiography and photoplethysmography for estimating blood pressure (BP) over 24 hours using pulse-transit-time. The study's aim was to analyze the impact on 24-hour BP results when processing raw data by two different software solutions delivered with the device. METHODS: We used data from 234 participants. The Somnotouch-NIBP measurements were analyzed using the Domino-light and Schiller software and compared. BP values differing > 5 mmHg were regarded as relevant and explored for their impact on BP classification (normotension vs. hypertension). RESULTS: Mean (±standard deviation) absolute systolic/diastolic differences for 24-hour mean BP were 1.5 (±1.7)/1.1 (±1.3) mm Hg. Besides awake systolic BP (p = 0.022), there were no statistically significant differences in systolic/diastolic 24-hour mean, awake, and asleep BP. Twenty four-hour mean BP agreement (number (%)) between the software solutions within 5, 10, and 15 mmHg were 222 (94.8%), 231 (98.7%), 234 (100%) for systolic and 228 (97.4%), 232 (99.1%), 233 (99.5%) for diastolic measurements, respectively. A BP difference of >5 mmHg was present in 24 (10.3%) participants leading to discordant classification in 4-17%. CONCLUSION: By comparing the two software solutions, differences in BP are negligible at the population level. However, at the individual level there are, in a minority of cases, differences that lead to different BP classifications, which can influence the therapeutic decision.

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