RESUMO
AIM: To compare the cardiovascular (CV) safety of linagliptin with glimepiride in older and younger participants in the CAROLINA trial in both prespecified and post hoc analyses. MATERIALS AND METHODS: People aged 40 to 85 years with relatively early type 2 diabetes, inadequate glycaemic control and elevated CV risk were randomly assigned to linagliptin 5 mg or glimepiride 1 to 4 mg. The primary endpoint was time to first occurrence of three-point major adverse CV events (MACE: CV death, non-fatal myocardial infarction, or non-fatal stroke). We evaluated clinical and safety outcomes across age groups. RESULTS: Of 6033 participants, 50.7% were aged <65 years, 35.3% were aged 65 to 74 years, and 14.0% were aged ≥75 years. During the 6.3-year median follow-up, CV/mortality outcomes did not differ between linagliptin and glimepiride overall (hazard ratio [HR] for three-point MACE 0.98, 95.47% confidence interval [CI] 0.84, 1.14) or across age groups (interaction P >0.05). Between treatment groups, reductions in glycated haemoglobin were comparable across age groups but moderate-to-severe hypoglycaemia was markedly reduced with linagliptin (HR 0.18, 95% CI 0.15, 0.21) with no differences among age groups (P = 0.23). Mean weight was -1.54 kg (95% CI -1.80, -1.28) lower for linagliptin versus glimepiride. Adverse events increased with age, but were generally balanced between treatment groups. Significantly fewer falls or fractures occurred with linagliptin. CONCLUSIONS: Linagliptin and glimepiride were comparable for CV/mortality outcomes across age groups. Linagliptin had significantly lower risk of hypoglycaemia and falls or fractures than glimepiride, including in "older-old" individuals for whom these are particularly important treatment considerations.
Assuntos
Diabetes Mellitus Tipo 2 , Inibidores da Dipeptidil Peptidase IV , Adulto , Idoso , Idoso de 80 Anos ou mais , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Inibidores da Dipeptidil Peptidase IV/efeitos adversos , Dipeptidil Peptidases e Tripeptidil Peptidases , Método Duplo-Cego , Hemoglobinas Glicadas , Humanos , Hipoglicemiantes/efeitos adversos , Linagliptina/efeitos adversos , Pessoa de Meia-Idade , Compostos de Sulfonilureia , Resultado do TratamentoRESUMO
BACKGROUND: Patients with atrial fibrillation and atrial flutter scheduled to undergo open heart surgery can receive ablation treatment of arrhythmogenic foci during the same intervention. Sinus rhythm is restored in the majority in the short term, but the long-term results are more uncertain. This study, which is part of the international CURE-AF trial, evaluates results after Cox-Maze IV surgery for atrial fibrillation in Norway at six-year follow-up. MATERIAL AND METHOD: Nineteen patients were included in this prospective cohort study. Atrial fibrillation had persisted for 40 months in the group with long-standing persistent atrial fibrillation (n = 12) and 6 months in the group with persistent atrial fibrillation (n = 7). Surgery for atrial fibrillation was performed according to the Cox-Maze IV procedure in the CURE-AF protocol. Follow-up in the first 12 months was strictly according to the CURE-AF protocol, thereafter conducted by the primary health service. RESULTS: Sinus rhythm was restored in 11 patients at the time of discharge and in 14 patients six months postoperatively. After 5-6 years of follow-up, all patients with long-standing persistent atrial fibrillation had experienced recurrence. Two achieved sinus rhythm after electroconversion. Six of the seven in the group with persistent atrial fibrillation had sinus rhythm after 5-6 years. INTERPRETATION: The results were good initially, with restoration of sinus rhythm in more than two thirds of the patients after 6-9 months. Five years later, a high recurrence rate was found in patients with long-standing persistent atrial fibrillation. Several recurrences had not been detected by the public health service or treatment had not been attempted.
Assuntos
Fibrilação Atrial , Procedimentos Cirúrgicos Cardíacos , Ablação por Cateter , Fibrilação Atrial/cirurgia , Seguimentos , Humanos , Noruega/epidemiologia , Estudos Prospectivos , Resultado do TratamentoRESUMO
PURPOSE: The purpose of this study was to investigate the subjective recovery from pregnancy-related pelvic girdle pain (PGP) during the first 6 weeks after delivery and to detect possible risk factors for a poor recovery. METHODS: The participants were included in this study at the routine ultrasound examination at 18 weeks of pregnancy. The women received a weekly SMS with the question "How many days during the last week has your PGP been bothersome?" The SMS-track from the final 10 weeks of pregnancy and first 6 weeks after delivery were assessed and sorted, based on individual graphs. A total of 130 women who reported PGP during pregnancy and met for clinical examination 6 weeks after delivery were included in the study. RESULTS: In all, 83% of the women experienced substantial recovery from severe or moderate PGP within 6 weeks after delivery. Of these, 44% reported a substantial recovery already within 2 weeks after delivery. More multiparous women, women reporting PGP the year before pregnancy, and women with high pain intensity during pregnancy had a poor recovery. CONCLUSIONS: The prognosis following PGP in pregnancy is good and the majority of women recovered substantially from severe and moderate pregnancy-related PGP within 6 weeks after delivery. For many women, a subjective substantial recovery occurred within 2 weeks after delivery. Predictors for a poor recovery were multiparity, PGP the year before pregnancy and a high pain intensity during pregnancy. These slides can be retrieved under Electronic Supplementary Material.
Assuntos
Dor da Cintura Pélvica , Complicações na Gravidez , Estudos de Coortes , Feminino , Humanos , Estudos Longitudinais , Medição da Dor , Dor da Cintura Pélvica/epidemiologia , Gravidez , Complicações na Gravidez/epidemiologia , Estudos ProspectivosRESUMO
OBJECTIVE: The purpose of this study was to investigate the feasibility of conducting a study examining the influence of individualized rehabilitation and chiropractic treatment, compared with individualized rehabilitation alone, in women with persistent dominating 1-sided pelvic girdle pain (PGP) 3 to 6 months after delivery. METHODS: Women were recruited from an outpatient clinic at Stavanger University Hospital, Norway and in a private chiropractic clinic in Stavanger. Those with persistent, dominating 1-sided PGP were included in this pilot study. Those who met inclusion criteria were randomized into 2 groups, one group received individualized rehabilitation and chiropractic treatment and the other group women received individualized rehabilitation alone. Treatment was measured for 20 weeks. RESULTS: Of 330 consenting women who were recruited who reported pelvic pain during pregnancy, 68 reported PGP or low back pain, and 63 consented to fill in a questionnaire. Forty-seven women underwent a clinical examination 3 to 6 months after delivery. During the examination, the women were diagnosed into subgroups for PGP. After exclusion of the women with low back pain only, a total of 13 women were diagnosed with dominating 1-sided PGP and thus included in this study. Six were randomized to the individualized rehabilitation and chiropractic treatment group and 5 to the individualized rehabilitation alone group. After 20 weeks of intervention, both groups reported improvement in disability and pain, but not in general health status. No serious or long-lasting adverse events were registered after treatment or training. CONCLUSION: We found that a study of this nature is feasible. However, the conditions of patient recruitment need to be considered carefully. We learned that a trial to investigate the effect of chiropractic treatment for PGP pain should include all subgroups of PGP to reach an acceptable sample size.
Assuntos
Dor Crônica/terapia , Terapia por Exercício , Manipulação Quiroprática , Dor da Cintura Pélvica/terapia , Adulto , Terapia Combinada , Avaliação da Deficiência , Feminino , Humanos , Medição da Dor , Projetos Piloto , Gravidez , Complicações na Gravidez , Transtornos Puerperais/terapiaRESUMO
AIM: To report results at week 208, including a 104-week masked extension, of the EMPA-REG H2H-SU trial in patients with type 2 diabetes with inadequate glycaemic control on metformin, in which empagliflozin 25 mg given for 104 weeks provided a sustained reduction in glycated haemoglobin (HbA1c) with a small but statistically significant benefit vs glimepiride, sustained reductions in weight and blood pressure, and low risk of hypoglycaemia. RESEARCH DESIGN AND METHODS: Patients with type 2 diabetes and HbA1c 53-86 mmol/mol (7% to 10%) were randomized to empagliflozin 25 mg or glimepiride 1 to 4 mg for 104 weeks as add-on to metformin. Patients who completed the randomized treatment period could participate in a 104-week extension in which they continued the double-blind treatment allocated at randomization. RESULTS: Of 765 and 780 patients treated with empagliflozin and glimepiride, 576 and 549 patients, respectively, entered the extension period of the study. At week 208, the adjusted mean difference in change from baseline in HbA1c with empagliflozin vs glimepiride was -1.96 mmol/mol, 95% CI -3.57, -0.35 (-0.18%, 95% CI -0.33, -0.03); P = 0.0172. Rescue therapy was given to 23% of patients on empagliflozin and 34% on glimepiride (odds ratio 0.56 [95% CI 0.45, 0.71]; P < 0.0001). Confirmed hypoglycaemic adverse events (plasma glucose ≤3.9 mmol/L and/or requiring assistance) occurred in 3% of patients on empagliflozin and 28% on glimepiride (odds ratio 0.08 [95% CI 0.05, 0.13]; P < 0.0001). CONCLUSIONS: In patients with type 2 diabetes, empagliflozin 25 mg as add-on to metformin for 208 weeks reduced HbA1c with a significantly lower risk of hypoglycaemia and a significantly smaller proportion of patients receiving rescue therapy compared with glimepiride.
Assuntos
Compostos Benzidrílicos/administração & dosagem , Diabetes Mellitus Tipo 2/tratamento farmacológico , Glucosídeos/administração & dosagem , Hipoglicemiantes/administração & dosagem , Metformina/administração & dosagem , Compostos de Sulfonilureia/administração & dosagem , Adulto , Glicemia/efeitos dos fármacos , Diabetes Mellitus Tipo 2/sangue , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Hemoglobinas Glicadas/efeitos dos fármacos , Humanos , Hipoglicemia/induzido quimicamente , Masculino , Pessoa de Meia-Idade , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: The aim of this study was to investigate the outcome of chiropractic management for a subgroup of pregnant women with dominating one-sided pelvic girdle pain (PGP). METHODS: The study population was recruited from a prospective longitudinal cohort study of pregnant women. Women reporting pelvic pain (PP), and who were diagnosed with dominating one-sided PGP after a clinical examination, were invited to participate in the intervention study. Recruitment took place either at 18 weeks, or after an SMS-tracking up to week 29. The women were randomized into a treatment group or a control group. The treatment group received chiropractic treatment individualized to each woman with regards to treatment modality and number of treatments. The control group was asked to return to conventional primary health care. The primary outcome measure was new occurrence of full time and/or graded sick leave due to PP and/or low back pain. Secondary outcome measures were self-reported PP, physical disability and general health status. Proportion of women reporting new occurrence of sick leave were compared using Chi squared tests. Differences in secondary outcome measures were estimated using linear regression analyses. RESULTS: Fifty-Six women were recruited, and 28 of them were randomized into the treatment group, and 28 into the control group. There was no statistically significant difference in sick leave, PP, disability or general health status between the two groups during pregnancy or after delivery. CONCLUSION: The study did not demonstrate superiority of chiropractic management over conventional care for dominating one-sided PGP during pregnancy. However, the analyses revealed wide confidence intervals containing both positive and negative clinically relevant effects. TRIAL REGISTRATION: The study was registered in ClinicalTrials.gov ( NCT01098136 ; 22/03/2010).
Assuntos
Manipulação Quiroprática/métodos , Dor da Cintura Pélvica/terapia , Complicações na Gravidez/terapia , Adulto , Distribuição de Qui-Quadrado , Feminino , Nível de Saúde , Humanos , Incidência , Dor Lombar/epidemiologia , Dor da Cintura Pélvica/patologia , Pelve/patologia , Gravidez , Complicações na Gravidez/patologia , Estudos Prospectivos , Licença Médica/estatística & dados numéricos , Resultado do TratamentoRESUMO
BACKGROUND: Flight related low back pain (LBP) among helicopter pilots is frequent and may influence flight performance. Prolonged confined sitting during flights seems to weaken lumbar trunk (LT) muscles with associated secondary transient pain. Aim of the study was to investigate if structured training could improve muscular function and thus improve LBP related to flying. METHODS: 39 helicopter pilots (35 men and 4 women), who reported flying related LBP on at least 1 of 3 missions last month, were allocated to two training programs over a 3-month period. Program A consisted of 10 exercises recommended for general LBP. Program B consisted of 4 exercises designed specifically to improve LT muscular endurance. The pilots were examined before and after the training using questionnaires for pain, function, quality of health and tests of LT muscular endurance as well as ultrasound measurements of the contractility of the lumbar multifidus muscle (LMM). RESULTS: Approximately half of the participants performed the training per-protocol. Participants in this subset group had comparable baseline characteristics as the total study sample. Pre and post analysis of all pilots included, showed participants had marked improvement in endurance and contractility of the LMM following training. Similarly, participants had improvement in function and quality of health. Participants in program B had significant improvement in pain, function and quality of health. CONCLUSIONS: This study indicates that participants who performed a three months exercise program had improved muscle endurance at the end of the program. The helicopter pilots also experienced improved function and quality of health. TRIAL REGISTRATION: Identifier: NCT01788111 Registration date; February 5th, 2013, verified April 2016.
Assuntos
Aeronaves , Terapia por Exercício/métodos , Exercício Físico/fisiologia , Dor Lombar/terapia , Resistência Física/fisiologia , Pilotos , Adulto , Feminino , Seguimentos , Humanos , Dor Lombar/diagnóstico , Dor Lombar/fisiopatologia , Masculino , Estudos ProspectivosRESUMO
BACKGROUND: The incidence of pelvic girdle pain (PGP) in pregnancy is wide ranged depending on definition, the utilised diagnostic means, and the design of the studies. PGP during pregnancy has negative effects on activities of daily living and causes long sick leave, which makes it a major public health issue. Our objectives were to explore the frequency of sick leave in pregnancy due to PGP, assess the relationship between different types of pain-related activities of daily living, examine physical workload, type of work in relation to sick leave, and to explore factors that make women less likely to take sick leave for PGP. METHODS: All women giving birth at the maternity ward of Stavanger University Hospital, Norway, were asked to participate and complete a questionnaire on demographic features, PGP, pain-related activities of daily living, sick leave in general and for PGP, frequency of exercising before and during pregnancy. Drawings of pelvic girdle and low back area were used for the localization of pain. PGP intensity was then rated retrospectively on a numerical rating scale. Non-parametric tests, multinomial logistic regression and sequential linear regression analysis were used in the statistical analysis. RESULTS: PGP is a frequent and major cause of sick leave during pregnancy among Norwegian women, which is also reflected in activities of daily living as measured with scores on all Oswestry disability index items. In the multivariate analysis of factors related to sick leave and PGP we found that work satisfaction, problems with lifting and sleeping, and pain intensity were risk factors for sick leave. In addition, women with longer education, higher work satisfaction and fewer problems with sitting, walking and standing, were less likely to take sick leave in pregnancy, despite the same pain intensity as women being on sick leave. CONCLUSIONS: A coping factor in pregnant women with PGP was discovered, most likely dependant on education, associated with work situation and/or work posture, which decreases sick leave. We recommend these issues to be further examined in a prospective longitudinal study since it may have important implications for sick leave frequency during pregnancy.
Assuntos
Dor da Cintura Pélvica/epidemiologia , Complicações na Gravidez/epidemiologia , Licença Médica/estatística & dados numéricos , Atividades Cotidianas , Adulto , Avaliação da Deficiência , Escolaridade , Feminino , Humanos , Satisfação no Emprego , Remoção , Noruega/epidemiologia , Medição da Dor , Esforço Físico , Postura , Gravidez , Estudos Retrospectivos , Transtornos do Sono-Vigília/epidemiologia , Inquéritos e Questionários , Carga de Trabalho/estatística & dados numéricos , Adulto JovemRESUMO
AIMS: Empagliflozin has been shown to reduce the risk of adverse cardiovascular outcomes in patients with type 2 diabetes and in those with heart failure. The impact of empagliflozin in post-acute myocardial infarction (AMI) patients is unknown. METHODS AND RESULTS: The Study to Test the Effect of Empagliflozin on Hospitalization for Heart Failure and Mortality in Patients with Acute Myocardial Infarction (EMPACT-MI) trial screened 6610 participants with AMI and randomized 6522 to empagliflozin or placebo in addition to standard of care. The median (interquartile) age was 64 (56-71) years and 75.1% of patients were male. Major comorbidities included hypertension (69.1%), type 2 diabetes (31.7%), prior myocardial infarction (13.0%), and atrial fibrillation (10.9%). The majority (74.3%) of patients presented with an ST-elevation myocardial infarction. Overall, 56.9% of patients had acute signs or symptoms of congestion requiring treatment and 78.3% had left ventricular systolic dysfunction with ejection fraction <45%. Clinical characteristics, including baseline demographics, rates of revascularization, and cardiovascular medications at discharge were largely comparable to recent trials of the post-AMI population. CONCLUSION: The EMPACT-MI trial will establish the benefit and risks of empagliflozin treatment in patients with AMI.
Assuntos
Diabetes Mellitus Tipo 2 , Insuficiência Cardíaca , Infarto do Miocárdio , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Compostos Benzidrílicos/uso terapêutico , Volume SistólicoRESUMO
OBJECTIVE: The purpose of this study was to investigate the cumulative prevalence of low back pain (LBP), pelvic pain (PP), and lumbopelvic pain during pregnancy, including features possibly associated with development of pregnancy-related PP, in an unselected population of women. METHODS: A retrospective cohort study was conducted in which all women giving birth at Stavanger University hospital in a 4-month period were asked to participate and to fill in a questionnaire on demographic features, pain, disability, and Oswestry Disability Index. Inclusion criteria were singleton pregnancy of at least 36 weeks and competence in the Norwegian language. RESULTS: Nearly 50% of the women experienced moderate and severe PP during pregnancy. Approximately 50% of them had PP syndrome, whereas the other half experienced lumbopelvic pain. Ten percent of the women experienced moderate and severe LBP alone. These pain syndromes increased sick leave and impaired general level of function during pregnancy. Approximately 50% of women with PP had pain in the area of the symphysis. The analysis of risk factors did not present a unidirectional and clear picture. CONCLUSIONS: Pelvic pain in pregnant women is a health care challenge in which moderate and severe pain develops rather early and has important implications for society. The observed associations between possible causative factors and moderate and severe LBP and PP in this study may, together with results from other studies, bring some valuable insights into their multifactorial influences and provide background information for future studies.
Assuntos
Dor Lombar/epidemiologia , Dor Pélvica/epidemiologia , Complicações na Gravidez/epidemiologia , Adulto , Estudos de Coortes , Feminino , Humanos , Noruega/epidemiologia , Gravidez , Prevalência , Estudos Retrospectivos , Índice de Gravidade de DoençaRESUMO
OBJECTIVES: The long-term prognostic value (>5 years) of elevated cardiac biomarkers after elective cardiac surgery is not clear. Most previous studies have included high-risk, unstable patients. The aim of this study was to determine the prognostic value of creatine kinase-myocardial band (CK-MB) mass after elective cardiac surgery in low-risk patients with stable angina. METHODS: A total of 230 consecutive patients undergoing cardiac surgery were included in the final analysis. Blood samples were drawn just before and 1-3 and 4-8 h after the procedure, and every morning thereafter for 3 days. Using a cutoff value of 5 times the reference, 100 patients (43.6%) had peak CK-MB mass values > or =25 microg/l, and 130 patients had values <25 microg/l (defined as controls). No patient developed new Q waves on ECG. The median follow-up time was 95 months. RESULTS: All-cause mortality and readmission for acute coronary syndromes were more frequent in the high-CK-MB group (30.0 vs. 17.9%, p = 0.022), as was target vessel revascularization (20.6 vs. 5.4%). Comparing the quartiles of peak CK-MB values in a Kaplan-Meier survival plot, event-free survival for the upper quartile (n = 60) was 68.3%, and for the lower quartile (n = 55), it was 83.6% (p = 0.046). In a multivariate logistic regression analysis, high CK-MB and ejection fraction were the only variables independently related to reduced event-free survival. CONCLUSIONS: CK-MB values > or =5 times the reference after elective cardiac surgery are associated with reduced long-term event-free survival.
Assuntos
Angina Pectoris/sangue , Angina Pectoris/epidemiologia , Ponte de Artéria Coronária/estatística & dados numéricos , Creatina Quinase Forma MB/sangue , Complicações Pós-Operatórias/sangue , Complicações Pós-Operatórias/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Intervalo Livre de Doença , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Prognóstico , Fatores de RiscoRESUMO
BACKGROUND: Flying related transient Low Back Pain (LBP) among helicopter pilots is considered an occupational distress. OBJECTIVE: To examine if exercise programs can alleviate transient LBP. METHODS: Sixty-five helicopter pilots (92% males), all reporting flying related LBP, responded to an epidemiological survey and a long-term follow-up, 44.8 months later, comprising questions regarding transient LBP and number of sick leaves. Data from 37 pilots participating in two exercise programs, A; general for LBP, B; focused for lumbar trunk (LT), included information from clinical examinations and muscular endurance tests of the LT before and after intervention. Twenty-eight pilots did not participate in any intervention. RESULTS: At long-term follow-up 42% of the pilots still reported flying related transient LBP. Among participants in program B 26% had persistent pain, 70% in program A and 46% among pilots without intervention. Sick-leave reduction was only observed among participants in program B (30% to 4%). Upon re-occurrence of LBP symptoms, half of the pilots in program B again performed exercises to improve their pain. CONCLUSION: This study indicates that exercise programs focused towards lumbar trunk muscular endurance reduces flying related transient LBP and sick-leave among helicopter pilots. These findings may have implications for the pilots' working conditions.
Assuntos
Aeronaves , Terapia por Exercício/métodos , Exercício Físico/fisiologia , Dor Lombar/reabilitação , Pilotos , Adulto , Feminino , Humanos , Dor Lombar/fisiopatologia , Masculino , Inquéritos e QuestionáriosRESUMO
OBJECTIVE: To explore if pregnant women with pelvic girdle pain (PGP), subgrouped following the results from two clinical tests with high validity and reliability, differ in demographic characteristics and weekly amount of days with bothersome symptoms through the second half of pregnancy. DESIGN: A prospective longitudinal cohort study. PARTICIPANTS: Pregnant women with pelvic and lumbopelvic pain due for their second-trimester routine ultrasound examination. SETTING: Obstetric outpatient clinic at Stavanger University Hospital, Norway. METHODS: Women reporting pelvic and lumbopelvic pain completed a questionnaire on demographic and clinical features. They were clinically examined following a test procedure recommended in the European guidelines for the diagnosis and treatment of PGP. Women without pain symptoms completed a questionnaire on demographic data. All women were followed weekly through an SMS-Track survey until delivery. PRIMARY AND SECONDARY OUTCOME MEASURES: The outcome measures were the results from clinical diagnostic tests for PGP and the number of days per week with bothersome pelvic pain. RESULTS: 503 women participated. 42% (212/503) reported pain in the lumbopelvic region and 39% (196/503) fulfilled the criteria for a probable PGP diagnosis. 27% (137/503) reported both the posterior pelvic pain provocation (P4) and the active straight leg raise (ASLR) tests positive at baseline in week 18, revealing 7.55 (95% CI 5.54 to 10.29) times higher mean number of days with bothersome pelvic pain compared with women with both tests negative. They presented the highest scores for workload, depressed mood, pain level, body mass index, Oswestry Disability Index and the number of previous pregnancies. Exercising regularly before and during pregnancy was more common in women with negative tests. CONCLUSION: If both P4 and ASLR tests were positive mid-pregnancy, a persistent bothersome pelvic pain of more than 5 days per week throughout the remainder of pregnancy could be predicted. Increased individual control over work situation and an active lifestyle, including regular exercise before and during pregnancy, may serve as a PGP prophylactic.
Assuntos
Dor da Cintura Pélvica/diagnóstico , Complicações na Gravidez/diagnóstico , Adulto , Feminino , Humanos , Estudos Longitudinais , Noruega/epidemiologia , Medição da Dor , Dor da Cintura Pélvica/epidemiologia , Dor da Cintura Pélvica/fisiopatologia , Dor da Cintura Pélvica/psicologia , Valor Preditivo dos Testes , Gravidez , Complicações na Gravidez/epidemiologia , Complicações na Gravidez/fisiopatologia , Complicações na Gravidez/psicologia , Segundo Trimestre da Gravidez , Estudos Prospectivos , Reprodutibilidade dos Testes , Ultrassonografia Pré-NatalRESUMO
Narthecium ossifragum, a perennial herb of the lily family, causes toxic renal tubular necrosis in several ruminant species. 3-Methoxy-2(5H)-furanone (3M2F) has been identified as a nephrotoxin present in N. ossifragum extracts. We studied effects of three different 3M2F-containing fractions isolated from N. ossifragum and synthetic 3M2F on the porcine kidney cell line LLC-PK1. In some of the experiments, we included the glioma cell lines U251 and BT4Cn to compare the effects of the toxin on LLC-PK1 cells to the effect on these cell lines. The synthetic 3M2F was shown to be only mildly toxic, and the most purified fraction from N. ossifragum showed the highest degree of toxicity in our studies. When monolayer cultures were exposed to increasing amounts of 3M2F-containing extract, a dose-dependent increase in cell death was observed. Similarly, reduced neutral red uptake and 3H-thymidine uptake (DNA synthesis) was observed. There was increased apoptotic activity in the LLC-PK1 cells with increasing concentration of 3M2F-containing extract. Multicellular three-dimensional spheroids from LLC-PK1 cells stopped fluid transport, showed degenerative changes and collapsed totally 6 h after extract exposure. Our findings indicate junctional damage, reduced cellular endocytosis and DNA-synthesis as well as induction of apoptosis as possible mechanisms for the acute tubular necrosis observed in ruminant species.
Assuntos
Furanos/toxicidade , Túbulos Renais Proximais/efeitos dos fármacos , Plantas Tóxicas/química , Animais , Apoptose/efeitos dos fármacos , Linhagem Celular Tumoral , Sobrevivência Celular/efeitos dos fármacos , DNA/biossíntese , Relação Dose-Resposta a Droga , Furanos/síntese química , Glioma/tratamento farmacológico , Glioma/metabolismo , Glioma/patologia , Túbulos Renais Proximais/metabolismo , Túbulos Renais Proximais/patologia , Células LLC-PK1 , Vermelho Neutro/metabolismo , Extratos Vegetais/toxicidade , Esferoides Celulares/efeitos dos fármacos , Esferoides Celulares/metabolismo , Esferoides Celulares/patologia , SuínosRESUMO
BACKGROUND: Accidental hypothermia with arrested circulation remains a condition associated with high mortality. In our institution, extracorporeal circulation (ECC) rewarming has been the cornerstone in treating such patients since 1987. We here explore characteristics and outcomes of this treatment, to identify significant merits and challenges from 3 decades of experience in ECC rewarming. METHODS: Sixty-nine patients rewarmed by ECC during the period from December 1987 to December 2015 were analyzed. One patient was excluded from the analyses because of combined traumatic cerebral injury. The analysis was focused on patient characteristics, treatment procedures, and outcomes were focused. Survivors were evaluated according to the cerebral performance categories scale. Simple statistics with nonparametric tests and χ2 tests were used. Median value and range are reported. RESULTS: Median age was 30 years (minimum 1.5, maximum 76), and the cause of accidental hypothermia was cold exposure (27.9%), avalanche (5.9%), and immersion/submersion accidents (66.2%). Eighteen patients survived (26.5%). The survival rate did not improve during the years. Survivors had lower serum potassium (p = 0.002), higher pH (p = 0.03), lower core temperature (p = 0.02), and shorter cardiopulmonary resuscitation time (p = 0.001), but ranges were wide. Although suspected primary hypoxia and hypothermia were associated with lower survival, we observed a 10.5% survival of these victims. Sixteen survivors had good outcome (cerebral performance category 1 or 2), whereas 2 patients with suspected primary hypoxia survived with severe cerebral disability (cerebral performance category 3). CONCLUSIONS: Despite extended experience with ECC rewarming, improved handling strategies, and intensive care, no overall improvement in survival was observed. Good outcome was observed even among patients with a dismal prognosis.
Assuntos
Circulação Extracorpórea , Hipotermia/mortalidade , Hipotermia/terapia , Reaquecimento , Acidentes , Adolescente , Adulto , Idoso , Criança , Pré-Escolar , Feminino , Humanos , Hipotermia/etiologia , Lactente , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Taxa de Sobrevida , Resultado do Tratamento , Adulto JovemRESUMO
OBJECTIVE: The aim of this study was to provide information on the occurrence of spinal pain, i.e., low back and neck pain, among commercial helicopter pilots, along with possible associations between pain and anthropometric and demographic factors and flying exposure. METHODS: Data were collected through a subjective and retrospective survey among all the 313 (294 men, 19 women) full-time pilots employed by two helicopter companies. A questionnaire was used to assess the extent of spinal complaints in a transient and recurrent pain pattern along with information on physical activities, occupational flying experience, and airframes. RESULTS: The survey had 207 responders (194 men, 13 women). The pilots had extensive flying experience. Spinal pain was reported by 67%. Flying-related transient pain was reported among 50%, whereas recurrent spinal pain, not necessarily associated with flying, was reported by 52%. Women experienced more pain, but sample size prevented further conclusions. Male pilots reporting any spinal pain flew significantly more hours last year (median 500 h, IQR 400-650) versus men with no pain (median 445 h, IQR 300-550). Male pilots with transient or recurrent spinal pain did not differ from nonaffected male colleagues in the measured parameters. CONCLUSION: Spinal pain is a frequent problem among male and female commercial helicopter pilots. For men, no significant associations were revealed for transient or recurrent spinal pain with age, flying experience in years, total hours, annual flying time, type of aircraft, or anthropometric factors except for any spinal pain related to hours flown in the last year.
Assuntos
Aeronaves , Dor Lombar/epidemiologia , Cervicalgia/epidemiologia , Doenças Profissionais/epidemiologia , Adulto , Medicina Aeroespacial , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Noruega/epidemiologia , Estudos RetrospectivosRESUMO
BACKGROUND: Recent studies have focused on the use of fixed-rate intraaortic balloon pumping (IABP) during cardiopulmonary bypass (CPB) to achieve pulsatile flow. Because application of an IABP catheter may represent a functional obstruction within the descending aorta, we explored the effect of IABP-pulsed CPB-perfusion with special attention to perfusion above and below the IABP balloon. METHODS: Sixteen animals received an IABP catheter that remained turned off position (NP group, n = 8) or was switched to an automatic mode of 80 beats/min during CPB (PP group, n = 8). Flow-data and pressure-data were obtained above and below the IABP balloon. Tissue perfusion was evaluated by microspheres. RESULTS: IABP-pulsed CPB-perfusion, as assessed at 30 minutes on CPB, increased proximal mean aortic pressure (p < 0.05) and carotid artery blood flow (p < 0.001), but decreased distal mean aortic pressure (p < 0.001). The decrease of distal mean aortic pressure in the PP group was associated with a 75 % decrease (p < 0.001) of renal tissue perfusion. During nonpulsed perfusion the respective variables remained essentially unchanged compared with pre-CPB levels. CONCLUSIONS: Using IABP as a surrogate to achieve pulsatile perfusion during CPB contributes significantly to lowered aortic pressure in the distal portion of aorta and impaired tissue perfusion of the kidneys. The results are focusing on effects that may contribute to organ dysfunction and acute kidney injury. Consequently, assessment of perfusion pressure distal to the balloon should be addressed whenever IABP is used during CPB.
Assuntos
Ponte Cardiopulmonar , Balão Intra-Aórtico/efeitos adversos , Fluxo Sanguíneo Regional , Animais , Pressão Arterial , Contrapulsação , Feminino , Período Intraoperatório , Masculino , Fluxo Pulsátil , SuínosRESUMO
BACKGROUND: Several studies have shown that patients with perioperative myocardial infarction (MI) are at higher risk for subsequent cardiac events and the identification of these patients is important. However, the diagnosis of perioperative MI can be difficult in many cases. The cardiac troponins are biomarkers with high cardiospecificity, and the aim of this study was to assess cTnI and cTnT among other cardiac biomarkers after thoracotomy and lung surgery. METHODS: 24 consecutive patients were included in the final analysis. Venous blood samples were drawn prior to the procedure, 1-3, 4-6, 16-18 and 30-32 h after surgery. Thoracotomy was performed as a standard posterolateral incision on the left or right side under general anesthesia. RESULTS: Both cTnI and cTnT were completely unaffected by the thoracotomy and the lung surgery. Furthermore, no single value of the troponins was above the 99th percentile at any time. In contrast, CK-MB was elevated in nearly half the patients, although the mean values complied well with the reference limit. CK and myoglobin were both considerably elevated and did not discriminate between acute myocardial infarction and release of the markers due to extracardiac injury. CONCLUSIONS: Only the troponins were unaffected by extracardiac surgery and were, thus, reliable markers of myocardial injury in patients who underwent thoracotomy and lung surgery. If the troponins are unavailable, CK-MB mass combined with the CK-MB/CK percentage should be preferred.
Assuntos
Pulmão/cirurgia , Miocárdio/enzimologia , Mioglobina/sangue , Toracotomia , Troponina I/sangue , Troponina T/sangue , Adulto , Idoso , Idoso de 80 Anos ou mais , Aspartato Aminotransferases/metabolismo , Biomarcadores/sangue , Creatina Quinase/metabolismo , Creatina Quinase Forma MB , Feminino , Humanos , Isoenzimas/metabolismo , L-Lactato Desidrogenase/metabolismo , Masculino , Pessoa de Meia-Idade , Período Pós-Operatório , Fatores de TempoRESUMO
BACKGROUND: Metformin is the recommended first-line pharmacotherapy for patients with type 2 diabetes. There is no consensus on the optimum second-line pharmacotherapy. We compared the efficacy and safety of the sodium glucose cotransporter 2 inhibitor empagliflozin and the sulfonylurea glimepiride as add-on to metformin in patients with type 2 diabetes. METHODS: In this double-blind phase 3 trial, patients (aged ≥18 years) with type 2 diabetes and HbA1c concentrations of 7-10%, despite metformin treatment and diet and exercise counselling, were randomly assigned in a 1:1 ratio with a computer-generated random sequence, stratified by HbA1c, estimated glomerular filtration rate (eGFR), and region, to empagliflozin (25 mg once daily, orally) or glimepiride (1-4 mg once daily, orally) as add-on to metformin for 104 weeks. Patients and investigators were masked to treatment assignment. The primary endpoint was change from baseline in HbA1c levels at weeks 52 and 104. Differences in the primary endpoint were first tested for non-inferiority (based on a margin of 0·3%). If non-inferiority was shown, differences in the primary endpoint at week 104 were then tested for superiority. Analysis was done on the full-analysis set-ie, patients who were treated with at least one dose of study drug and had a baseline HbA1c value. This study is registered with ClinicalTrials.gov, number NCT01167881. A 104-week extension is ongoing. FINDINGS: Between August, 2010, and June, 2011, 1549 patients were randomly assigned to receive empagliflozin (n=769) or glimepiride (n=780); four patients in the empagliflozin group did not receive the assigned treatment. Empagliflozin was non-inferior to glimepiride at both timepoints. At week 104, adjusted mean difference in change from baseline in HbA1c with empagliflozin versus glimepiride was -0·11% (95% CI -0·19 to -0·02; p=0·0153 for superiority). Adverse events were reported in 661 (86%) patients treated with empagliflozin and 673 (86%) patients treated with glimepiride. Severe adverse events were reported in 72 (9%) patients in the empagliflozin group and 68 (9%) in the glimepiride group. Serious adverse events were reported in 119 (16%) patients in the empagliflozin group and 89 (11%) in the glimepiride group. Confirmed hypoglycaemic adverse events (plasma glucose ≤3·9 mmol/L or requiring assistance) at week 104 were reported in 19 (2%) patients treated with empagliflozin and 189 (24%) patients treated with glimepiride. INTERPRETATION: Empagliflozin might be an effective and a well tolerated second-line treatment option for patients with type 2 diabetes who have not achieved good glycaemic control on metformin. FUNDING: Boehringer Ingelheim and Eli Lilly.