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1.
Z Gastroenterol ; 58(1): 49-56, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31931540

RESUMO

BACKGROUND: Hepatic encephalopathy (HE) is a severe complication of liver cirrhosis with impairment of quality of life and prognosis. Management patterns among physicians have not been investigated yet. METHODS: A questionnaire containing 17 questions was sent out to 1468 gastroenterologists and 120 general practitioners (GPs). It included questions regarding diagnostic, therapeutic, and management strategies used in patients with overt HE (OHE) and covert HE (CHE). RESULTS: The response rate was 12 % (n = 172) for gastroenterologists and 45 % (n = 54) for GPs. Of gastroenterologists, 26.7 % examine patients with an initial diagnosis of liver cirrhosis regarding HE. Gastroenterologists favored a combination of different testing strategies (27.9 %) and clinical examination (23.0 %), while the biggest part of the GPs use clinical examination (55.3 %); 63.7 % of gastroenterologists and 28.3 % of GPs give correct nutritional advices to patients with HE. Treatment strategies for acute bouts of OHE and secondary prophylaxis varied widely in both groups. Preferred medication was lactulose followed by rifaximin or a combination therapy. More than half of the GPs (53.7 %) were not familiar with minimal HE (MHE). About one-third of both groups never tried to diagnose MHE. CONCLUSION: Our data strongly indicate that management of HE is very heterogeneous among gastroenterologists as well as selected GPs working in Germany and not driven by evidence-based international guidelines. Thus, the national guideline is more than welcome.


Assuntos
Gastroenterologistas , Fármacos Gastrointestinais/uso terapêutico , Clínicos Gerais , Encefalopatia Hepática/diagnóstico , Encefalopatia Hepática/terapia , Cirrose Hepática/complicações , Padrões de Prática Médica/estatística & dados numéricos , Gerenciamento Clínico , Alemanha , Encefalopatia Hepática/psicologia , Humanos , Lactulose/uso terapêutico , Cirrose Hepática/terapia , Qualidade de Vida , Rifaximina/uso terapêutico , Prevenção Secundária/métodos , Inquéritos e Questionários
2.
Medicine (Baltimore) ; 99(2): e18723, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31914087

RESUMO

Effectiveness, efficacy and safety of biosimilar infliximab (CT-P13) in inflammatory bowel disease (IBD) patients has been shown in previous studies. Limited data exist on health-related quality of life (HRQoL) of switching originator to biosimilar infliximab (IFX) in IBD patients. The objective of this study was to evaluate impact of switching originator to biosimilar IFX on HRQoL, disease activity, and health care costs in IBD maintenance treatment.In this single-center prospective observational study, all IBD patients receiving maintenance IFX therapy were switched to biosimilar IFX. HRQoL was measured using the generic 15D health-related quality of life instrument (15D) utility measurement and the disease-specific Inflammatory Bowel Disease Questionnaire (IBDQ). Crohn Disease Activity Index (CDAI) or Partial Mayo Score (pMayo), and fecal calprotectin (FC) served for evaluation of disease activity. Data were collected at time of switching and 3 and 12 months after switching. Patients' characteristics, clinical background information and costs were collected from patient records and the hospital's electronic database.Fifty-four patients were included in the analysis. No statistically significant changes were observed in 15D, CDAI, pMayo, and FC during 1-year follow-up. IBDQ scores were higher (P = .018) in Crohn disease 3 months after switching than at time of switching. Costs of biosimilar IFX were one-third of costs of originator one. Total costs related to secondary health care (excluding costs of IFX), were similar before and after the onset of biosimilar IFX.HRQoL and disease activity were after switching from originator to biosimilar IFX comparable, but the costs of biosimilar IFX were only one-third of those of the originator one.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Fármacos Gastrointestinais/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Infliximab/uso terapêutico , Qualidade de Vida , Adulto , Anticorpos Monoclonais/economia , Medicamentos Biossimilares/economia , Substituição de Medicamentos/economia , Feminino , Fármacos Gastrointestinais/economia , Recursos em Saúde/economia , Serviços de Saúde/economia , Serviços de Saúde/estatística & dados numéricos , Humanos , Infliximab/economia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Indução de Remissão
3.
Gut ; 69(2): 274-282, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31196874

RESUMO

OBJECTIVES: To better understand the real-world impact of biologic therapy in persons with Crohn's disease (CD) and ulcerative colitis (UC), we evaluated the effect of marketplace introduction of infliximab on the population rates of hospitalisations and surgeries and public payer drug costs. DESIGN: We used health administrative data to study adult persons with CD and UC living in Ontario, Canada between 1995 and 2012. We used an interrupted time series design with segmented regression analysis to evaluate the impact of infliximab introduction on the rates of IBD-related hospitalisations, intestinal resections and public payer drug costs over 10 years among patients with CD and 5 years among patients with UC, allowing for a 1-year transition. RESULTS: Relative to what would have been expected in the absence of infliximab, marketplace introduction of infliximab did not produce significant declines in the rates of CD-related hospitalisations (OR at the last observation quarter 1.06, 95% CI 0.811 to 1.39) or intestinal resections (OR 1.10, 95% CI 0.810 to 1.50), or in the rates of UC-related hospitalisations (OR 1.22, 95% CI 1.07 to 1.39) or colectomies (OR 0.933, 95% CI 0.54 to 1.61). The findings were similar among infliximab users, except that hospitalisation rates declined substantially among UC patients following marketplace introduction of infliximab (OR 0.515, 95% CI 0.342 to 0.777). There was a threefold rise over expected trends in public payer drug cost among patients with CD following infliximab introduction (OR 2.98,95% CI 2.29 to 3.86), suggesting robust market penetration in this group, but no significant change among patients with UC (OR 1.06, 95% CI 0.955 to 1.18). CONCLUSIONS: Marketplace introduction of infliximab has not yielded anticipated reductions in the population rates of IBD-related hospitalisations or intestinal resections, despite robust market penetration among patients with CD. Misguided use of infliximab in CD patients and underuse of infliximab in UC patients may largely explain our study findings.


Assuntos
Fármacos Gastrointestinais/uso terapêutico , Hospitalização/estatística & dados numéricos , Doenças Inflamatórias Intestinais/tratamento farmacológico , /uso terapêutico , Adulto , Colectomia/estatística & dados numéricos , Colectomia/tendências , Colite Ulcerativa/tratamento farmacológico , Colite Ulcerativa/epidemiologia , Colite Ulcerativa/cirurgia , Doença de Crohn/tratamento farmacológico , Doença de Crohn/epidemiologia , Doença de Crohn/cirurgia , Custos de Medicamentos/estatística & dados numéricos , Custos de Medicamentos/tendências , Feminino , Hospitalização/tendências , Humanos , Doenças Inflamatórias Intestinais/epidemiologia , Doenças Inflamatórias Intestinais/cirurgia , Análise de Séries Temporais Interrompida , Masculino , Pessoa de Meia-Idade , Ontário/epidemiologia , Fatores Socioeconômicos
6.
Gut ; 69(1): 32-41, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-30979718

RESUMO

INTRODUCTION: The optimal trial design for assessing novel therapies in paediatric IBD (PIBD) is a subject of intense ongoing global discussions and debate among the different stakeholders. However, there is a consensus that the current situation in which most medications used in children with IBD are prescribed as off-label without sufficient paediatric data is unacceptable. Shortening the time lag between adult and paediatric approval of drugs is of the upmost importance. In this position paper we aimed to provide guidance from the global clinical research network (Pediatric Inflammatory Bowel Disease Network, PIBDnet) for designing clinical trials in PIBD in order to facilitate drug approval for children. METHODS: A writing group has been established by PIBDnet and topics were assigned to different members. After an iterative process of revisions among the writing group and one face-to-face meeting, all statements have reached consensus of >80% as defined a priori. Next, all core members of PIBDnet voted on the statements, reaching consensus of >80% on all statements. Comments from the members were incorporated in the text. RESULTS: The commentary includes 18 statements for guiding data extrapolation from adults, eligibility criteria to PIBD trials, use of placebo, dosing, endpoints and recommendations for feasible trials. Controversial issues have been highlighted in the text. CONCLUSION: The viewpoints expressed in this paper could assist planning clinical trials in PIBD which are both of high quality and ethical, while remaining pragmatic.


Assuntos
Ensaios Clínicos como Assunto/métodos , Fármacos Gastrointestinais/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Fatores Etários , Produtos Biológicos/administração & dosagem , Produtos Biológicos/uso terapêutico , Criança , Ensaios Clínicos como Assunto/normas , Relação Dose-Resposta a Droga , Aprovação de Drogas/métodos , Fármacos Gastrointestinais/administração & dosagem , Humanos , Seleção de Pacientes , Projetos de Pesquisa , Índice de Gravidade de Doença , Resultado do Tratamento
7.
Gut ; 69(1): 74-82, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-30996042

RESUMO

OBJECTIVE: Over half of patients with IBS have either diarrhoea (IBS-D) or a mixed stool pattern (IBS-M). The relative efficacy of licenced pharmacological therapies is unclear in the absence of head-to-head trials. We conducted a network meta-analysis to resolve this uncertainty. DESIGN: We searched MEDLINE, Embase, Embase Classic, the Cochrane central register of controlled trials, and Clinicaltrials.gov through January 2019 to identify randomised controlled trials (RCTs) assessing the efficacy of licenced pharmacological therapies (alosetron, eluxadoline, ramosetron and rifaximin) in adults with IBS-D or IBS-M. Trials included in the analysis reported a dichotomous assessment of overall response to therapy, and data were pooled using a random effects model. Efficacy and safety of all pharmacological therapies were reported as a pooled relative risk with 95% CIs to summarise the effect of each comparison tested. Treatments were ranked according to their p score. RESULTS: We identified 18 eligible RCTs (seven alosetron, five ramosetron, two rifaximin and four eluxadoline), containing 9844 patients. All were superior to placebo for the treatment of IBS-D or IBS-M at 12 weeks, according to the Food and Drug Administration (FDA)-recommended endpoint for trials in IBS. Alosetron 1 mg twice daily was ranked first for efficacy, based on the FDA-recommended composite endpoint of improvement in both abdominal pain and stool consistency, effect on global symptoms of IBS and effect on stool consistency. Ramosetron 2.5µg once daily was ranked first for effect on abdominal pain. Total numbers of adverse events were significantly greater with alosetron 1 mg twice daily and ramosetron 2.5µg once daily, compared with placebo. Rifaximin 550 mg three times daily ranked first for safety. Constipation was significantly more common with all drugs, except rifaximin 550 mg three times daily. CONCLUSION: In a network meta-analysis of RCTs of pharmacological therapies for IBS-D and IBS-M, we found all drugs to be superior to placebo, but alosetron and ramosetron appeared to be the most effective.


Assuntos
Diarreia/tratamento farmacológico , Fármacos Gastrointestinais/uso terapêutico , Síndrome do Intestino Irritável/tratamento farmacológico , Dor Abdominal/tratamento farmacológico , Dor Abdominal/etiologia , Diarreia/etiologia , Determinação de Ponto Final/normas , Fármacos Gastrointestinais/efeitos adversos , Humanos , Síndrome do Intestino Irritável/complicações , Manejo da Dor/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Falha de Tratamento , Resultado do Tratamento
8.
BMJ ; 367: l6483, 2019 Dec 11.
Artigo em Inglês | MEDLINE | ID: mdl-31826881

RESUMO

OBJECTIVE: To determine the effectiveness of management strategies for uninvestigated dyspepsia. DESIGN: Systematic review and network meta-analysis. DATA SOURCES: Medline, Embase, Embase Classic, the Cochrane Central Register of Controlled Trials, and clinicaltrials.gov from inception to September 2019, with no language restrictions. Conference proceedings between 2001 and 2019. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials that assessed the effectiveness of management strategies for uninvestigated dyspepsia in adult participants (age ≥18 years). Strategies of interest were prompt endoscopy; test for Helicobacter pylori and perform endoscopy in participants who test positive; test for H pylori and eradication treatment in those who test positive ("test and treat"); empirical acid suppression; or symptom based management. Trials reported dichotomous assessment of symptom status at final follow-up (≥12 months). RESULTS: The review identified 15 eligible randomised controlled trials that comprised 6162 adult participants. Data were pooled using a random effects model. Strategies were ranked according to P score, which is the mean extent of certainty that one management strategy is better than another, averaged over all competing strategies. "Test and treat" ranked first (relative risk of remaining symptomatic 0.89, 95% confidence interval 0.78 to 1.02, P score 0.79) and prompt endoscopy ranked second, but performed similarly (0.90, 0.80 to 1.02, P score 0.71). However, no strategy was significantly less effective than "test and treat." Participants assigned to "test and treat" were significantly less likely to receive endoscopy (relative risk v prompt endoscopy 0.23, 95% confidence interval 0.17 to 0.31, P score 0.98) than all other strategies, except symptom based management (relative risk v symptom based management 0.60, 0.30 to 1.18). Dissatisfaction with management was significantly lower with prompt endoscopy (P score 0.95) than with "test and treat" (relative risk v "test and treat" 0.67, 0.46 to 0.98), and empirical acid suppression (relative risk v empirical acid suppression 0.58, 0.37 to 0.91). Upper gastrointestinal cancer rates were low in all trials. Results remained stable in sensitivity analyses, with minimal inconsistencies between direct and indirect results. Risk of bias of individual trials was high; blinding was not possible because of the pragmatic trial design. CONCLUSIONS: "Test and treat" was ranked first, although it performed similarly to prompt endoscopy and was not superior to any of the other strategies. "Test and treat" led to fewer endoscopies than all other approaches, except symptom based management. However, participants showed a preference for prompt endoscopy as a management strategy for their symptoms. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number CRD42019132528.


Assuntos
Antibacterianos/uso terapêutico , Dispepsia/tratamento farmacológico , Fármacos Gastrointestinais/uso terapêutico , Infecções por Helicobacter/complicações , Helicobacter pylori/isolamento & purificação , Meta-Análise em Rede , Dispepsia/diagnóstico , Gastroscopia , Infecções por Helicobacter/tratamento farmacológico , Infecções por Helicobacter/microbiologia , Humanos
9.
Clin Biochem ; 74: 73-75, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31669514

RESUMO

BACKGROUND: Infliximab (IFX) is a monoclonal antibody used to treat patients with inflammatory bowel disease (IBD). For IFX therapeutic drug monitoring (TDM), the most commonly used analysis is enzyme-linked immunosorbent assays (ELISA) which do not allow results to be provided in real-time. The aim of this study was to compare the in-house ELISA (Promonitor IFX) with the much faster assay Quantum Blue® IFX (QB) for quantification of serum IFX concentration among IBD patients in maintenance IFX therapy. METHODS: We studied 30 serum samples from outpatients in IFX maintenance therapy at Copenhagen University Hospital Hvidovre, Denmark. Samples were used to compare IFX measurements from Promonitor IFX with QB. Therapeutic intervals of <3 µg/mL, 3-7 µg/mL and >7 µg/mL were equally covered. Differences were evaluated using Bland-Altman plots and Student t-test. Correlation was evaluated using x,y-plot and Pearson's correlation coefficient. The intermediate imprecision (CV%) of QB was measured at two levels (3 µg/mL and 7 µg/mL). For qualitative comparison, weighted kappa statistics (κ) were determined after stratification of results by therapeutic interval. RESULTS: Promonitor IFX and QB were strongly correlated (r = 0.92, p < 0.001). The mean difference between Promonitor IFX and QB was -0.57 µg/mL (p = 0.2). The CV% of QB was 16.3% at 3 µg/mL and 16.7% at 7 µg/mL. Classification of results according to therapeutic interval showed almost perfect agreement (κ = 0.81). CONCLUSIONS: QB is a suitable alternative to Promonitor IFX for TDM in patients treated with IFX for IBD. The results revealed a strong correlation between methods, in particular at lower IFX concentrations, representing the most interesting clinical range. When the samples were stratified according to the therapeutic interval, an almost perfect agreement between the methods was observed.


Assuntos
Monitoramento de Medicamentos/métodos , Ensaio de Imunoadsorção Enzimática/métodos , Fármacos Gastrointestinais/sangue , Doenças Inflamatórias Intestinais/sangue , Infliximab/sangue , Sistemas Automatizados de Assistência Junto ao Leito , Dinamarca , Fármacos Gastrointestinais/uso terapêutico , Hospitais Universitários , Humanos , Doenças Inflamatórias Intestinais/tratamento farmacológico , Infliximab/uso terapêutico , Pesquisa Qualitativa
10.
Arq Gastroenterol ; 56(3): 312-317, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31633731

RESUMO

BACKGROUND: There is scarce data regarding efficacy and safety of vedolizumab in inflammatory bowel diseases in Latin America. OBJECTIVE: To describe the first observational real-world experience with vedolizumab in Latin American inflammatory bowel diseases patients. METHODS: Retrospective observational multicentric study of patients with Crohn's disease (CD) and ulcerative colitis (UC) who used vedolizumab at any phase of their treatment. Clinical remission and response (according to Harvey-Bradshaw index for CD and Mayo score for UC), mucosal healing, need for surgery and adverse events were evaluated. RESULTS: A total of 90 patients were included (52 with CD and 38 with UC), the majority with previous exposure to anti-TNF agents (88.46% in CD and 76.31% in UC). In CD (as observed analysis) remission rates at weeks 12, 26 and 52 were 42.89% (21/49), 61.9% (26/42) and 46.15% (12/26), respectively. In UC, remission rates at weeks 12, 26 and 52 were 28.94% (11/38), 36.66% (11/30) and 41.17% (7/17). Mucosal healing rates were 36.11% in CD and 43.4% in UC. During the study period, 7/52 CD patients underwent major abdominal surgery and 4/38 UC patients needed colectomy. CONCLUSION: Vedolizumab was effective in induction and maintenance of clinical response and remission in CD and UC, with no new safety signs.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Colite Ulcerativa/tratamento farmacológico , Doença de Crohn/tratamento farmacológico , Fármacos Gastrointestinais/uso terapêutico , Adulto , Brasil , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Indução de Remissão , Estudos Retrospectivos , Resultado do Tratamento
12.
Medicine (Baltimore) ; 98(39): e17295, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31574851

RESUMO

BACKGROUND: In this study, investigators will evaluate the efficacy and safety of lactulose for the treatment of irritable bowel syndrome (IBS). METHODS: Literature search for relevant studies up to present will be conducted in MEDICINE, EMBASE, Google Scholar, Web of Science, Cochrane Library, Wangfang, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure. The included studies are randomized controlled trials of lactulose in patients with IBS. We will use RevMan 5.3 software using statistical analysis. RESULTS: This study will provide a high-quality integration of current evidence of lactulose for treating IBS on several aspects including global IBS symptoms, abdominal pain, defecation urgency, stool frequency, stool consistency, quality of life, and adverse events. CONCLUSIONS: This study will provide the evidence for the clinical efficacy and safety of lactulose for the treatment of IBS. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42019140639.


Assuntos
Fármacos Gastrointestinais/uso terapêutico , Síndrome do Intestino Irritável/tratamento farmacológico , Lactulose/uso terapêutico , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Revisão Sistemática como Assunto , Resultado do Tratamento
13.
Expert Rev Clin Pharmacol ; 12(11): 1019-1026, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31575291

RESUMO

Introduction. Chronic idiopathic constipation (CIC) is a functional gastrointestinal disorder that is associated with an increased healthcare cost and an abnormally poor quality of life. Plecanatide is a natural analog to the peptide agonist of the guanylate cyclase-C (GC-C) receptor, uroguanylin. The conversion of guanosine 5-triphosphate to cyclic guanosine monophosphate results in an increased bowel fluid secretion. Plecanatide is a promising new agent for CIC unresponsive to current therapeutic regimes.Areas covered. A comprehensive online search of Medline and the Science Citation Index was made using the keywords 'plecanatide', 'guanylate cyclase-C agonists', and 'constipation', in various combinations. We reviewed the pharmacodynamics, pharmacokinetics, and metabolism of this agent, and the most significant studies regarding the clinical efficacy and safety of plecanatide in CIC therapy.Expert opinion. Experimental studies showed that plecanatide was significantly better than placebo in reducing CIC severity, straining, stool consistency, bowel movements and quality of life. Apart from limited cases of diarrhea, no serious adverse events were reported. However, few data are available on its long-term safety. Furthermore, patients' affordability of plecanatide can be limited by its costs. Finally, this new agent with a different way of action can be proposed in patients refractory to common therapy.


Assuntos
Constipação Intestinal/tratamento farmacológico , Agonistas da Guanilil Ciclase C/uso terapêutico , Peptídeos Natriuréticos/uso terapêutico , Adulto , Animais , Doença Crônica , Fármacos Gastrointestinais/efeitos adversos , Fármacos Gastrointestinais/farmacologia , Fármacos Gastrointestinais/uso terapêutico , Agonistas da Guanilil Ciclase C/efeitos adversos , Agonistas da Guanilil Ciclase C/farmacologia , Humanos , Peptídeos Natriuréticos/efeitos adversos , Peptídeos Natriuréticos/farmacologia , Qualidade de Vida
14.
Acta Gastroenterol Belg ; 82(3): 429-432, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31566332

RESUMO

The authors describe a 31 years old male, admitted for hematemesis, epigastric pain and lower limb edema. Laboratorial data showed haemoglobin 18.4g/dl, total proteins 2.8g/dl, albumin 1.6g/dl and hipogammaglobulinaemia. 24h urinary proteins were normal. HIV and CMV serology were negative. Upper GI endoscopy revealed markedly enlarged gastric folds covered by abundant exudative fluid. Endoscopic ultrasound showed ascites, pleural effusion and gastric wall thickening with mucosa expansion and intact submucosa. In gastric biopsies foveolar hyperplastic and regenerative mucosa were observed being suggestive of Ménétrier´s disease. Helicobacter pylori was not detected. Albumin replacement and diuretics corrected anasarca and long-acting octreotide was instituted. Nine months later, the patient was asymptomatic, serum proteins were normal (albumin 4.6g/dl and total proteins 6.5g/dl), signs of endoscopic improvement were observed with marked reduction in gastric folds and mucosal inflammation and no ultrastructural changes were detected in gastric specimens sent for electron microscopy. Ménétrier´s Disease (MD) is a rare form of hypertrophic gastropathy characterized by massive enlargement of gastric folds causing marked protein exudation. The increase in tight junction diameter is the most consistent ultraestrutural change. Octreotide is a somatostatin analogue that acts by modulating TGFαEGFR pathway, which has been associated with the pathogenic mechanisms. As well as other cases reported in literature, this case report highlights the potential of long-acting octreotide for MD treatment avoiding more expensive therapies like cetuximab and gastrectomy.


Assuntos
Gastrite Hipertrófica/tratamento farmacológico , Fármacos Gastrointestinais/uso terapêutico , Octreotida/uso terapêutico , Adulto , Mucosa Gástrica , Gastrite Hipertrófica/diagnóstico , Gastroscopia , Humanos , Masculino , Resultado do Tratamento
15.
Medicine (Baltimore) ; 98(38): e17196, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31567967

RESUMO

BACKGROUND: The use of octreotide prophylaxis following pancreatic surgery is controversial. We aimed to evaluate the effectiveness of octreotide for the prevention of postoperative complications after pancreatic surgery through this systematic review and meta-analysis. METHODS: Literature databases (including the MEDLINE, EMBASE, and Cochrane databases) were searched systematically for relevant articles. Only randomized controlled trials (RCTs) were eligible for inclusion in our research. We extracted the basic information regarding the patients, intervention procedures, and all complications after pancreatic surgery and then performed the meta-analysis. RESULTS: Thirteen RCTs involving 2006 patients were identified. There were no differences between the octreotide group and the placebo group with regard to pancreatic fistulas (PFs) (relative risk [RR] = 0.79, 95% confidence interval [CI] = 0.62-0.99, P = .05), clinically significant PFs (RR = 1.01, 95% CI = 0.68-1.50, P = .95), mortality (RR = 1.21, 95% CI = 0.78-1.88, P = .40), biliary leakage (RR 0.84, 95% CI = 0.39-1.82, P = .66), delayed gastric emptying (RR = 0.83, 95% CI = 0.54-1.27, P = .39), abdominal infection (RR = 1.00, 95% CI = 0.66-1.52, P = 1.00), bleeding (RR = 1.16, 95% CI = 0.78-1.72, P = .46), pulmonary complications (RR = 0.73, 95% CI = 0.45-1.18, P = .20), overall complications (RR = 0.80, 95% CI = 0.64-1.01, P = .06), and reoperation rates (RR = 1.18, 95% CI = 0.77-1.81, P = .45). In the high-risk group, octreotide was no more effective at reducing PF formation than placebo (RR = 0.81, 95% CI = 0.67-1.00, P = .05). In addition, octreotide had no influence on the incidence of PF (RR = 0.38, 95% CI = 0.14-1.05, P = .06) after distal pancreatic resection and local pancreatic resection. CONCLUSION: The present best evidence suggests that prophylactic use of octreotide has no effect on reducing complications after pancreatic resection.


Assuntos
Fármacos Gastrointestinais/uso terapêutico , Octreotida/uso terapêutico , Pancreatectomia/efeitos adversos , Complicações Pós-Operatórias/prevenção & controle , Humanos , Pâncreas/cirurgia
16.
Gut ; 68(12): 2238-2250, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31563877

RESUMO

Gastroparesis is defined by delayed gastric emptying (GE) and symptoms of nausea, vomiting, bloating, postprandial fullness, early satiety and abdominal pain. Most common aetiologies include diabetes, postsurgical and postinfectious, but in many cases it is idiopathic. Clinical presentation and natural history vary by the aetiology. There is significant morbidity and healthcare utilisation associated with gastroparesis. Mechanistic studies from diabetic animal models of delayed GE as well as human full-thickness biopsies have significantly advanced our understanding of this disorder. An innate immune dysregulation and injury to the interstitial cells of Cajal and other components of the enteric nervous system through paracrine and oxidative stress mediators is likely central to the pathogenesis of gastroparesis. Scintigraphy and 13C breath testing provide the most validated assessment of GE. The stagnant gastroparesis therapeutic landscape is likely to soon see significant changes. Relatively newer treatment strategies include antiemetics (aprepitant), prokinetics (prucalopride, relamorelin) and fundic relaxants (acotiamide, buspirone). Endoscopic pyloromyotomy appears promising over the short term, especially for symptoms of nausea and vomiting. Further controlled trials and identification of the appropriate subgroup with pyloric dysfunction and assessment of long-term outcomes are essential. This review highlights the clinical presentation, diagnosis, mechanisms and treatment advancements for gastroparesis.


Assuntos
Endoscopia Gastrointestinal/métodos , Esvaziamento Gástrico/fisiologia , Fármacos Gastrointestinais/uso terapêutico , Gastroparesia , Gastroparesia/diagnóstico , Gastroparesia/fisiopatologia , Gastroparesia/terapia , Humanos
17.
Pharm Res ; 36(11): 155, 2019 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-31485804

RESUMO

PURPOSE: The purpose of this study was to determine the impact of food on gastric pH and the ability of over the counter betaine hydrochloride (BHCl) acid to reacidify gastric pH after food-induced elevations in gastric pH. METHODS: This open-label cross over clinical study (NCT02758015) included 9 subjects who were randomly assigned to one of 16 possible, 4-period cross-over sequences to determine the impact and relationship of food and gastric pH with acid supplementation. Subjects were administered various doses (1500 mg, 3000 mg and 4500 mg) of betaine hydrochloride (BHCl) to determine the ability of acid supplementation to reacidify gastric pH after the elevation of gastric pH caused by the ingestion of food. RESULTS: Following the administration of food and the resulting elevation in gastric pH, time to return to baseline gastric pH levels without acid supplementation was 49.7 ± 14.0 min. Administering 4500 mg of BHCl acid in capsules was able to reacidify gastric pH levels back to baseline following the administration of food in approximately 17.3 ± 5.9 min. AUCpH of each treatment were similar and not statistically different. Mean max pH following the administration of food was 3.20 ± 0.55. CONCLUSION: The ability of food to elevate and maintain gastric pH levels in the presence of acid supplementation was made evident throughout the study. A 4500 mg dose of BHCl was required to reacidify gastric pH after the administration of food. This study details the difficulty faced by clinicians in dosing a poorly soluble, weakly basic drug to patients receiving acid reducing agents where administration with food is recommended to avoid gastric side effects. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02758015.


Assuntos
Betaína/uso terapêutico , Alimentos , Absorção Gástrica , Ácido Gástrico/metabolismo , Fármacos Gastrointestinais/uso terapêutico , Preparações Farmacêuticas/metabolismo , Administração Oral , Adolescente , Adulto , Estudos Cross-Over , Feminino , Interações Alimento-Droga , Determinação da Acidez Gástrica , Humanos , Concentração de Íons de Hidrogênio , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
18.
Medicine (Baltimore) ; 98(33): e16607, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415353

RESUMO

BACKGROUND: We performed this meta-analysis to assess the efficacy and safety of Jianpi Liqi therapy (JLT), a traditional Chinese medicine therapy, in treating functional dyspepsia (FD). METHODS: We systematically searched 13 databases from their inception to 15th, May 2019. Eligible studies were randomized controlled trials (RCTs) that compared JLT medicine with conventional pharmacotherapy (CP) in treating patients with FD. Cochrane Collaboration tool, Review Manager 5.3 and STATA 11.0, GRADE profiler 3.6 were used for evaluating risk of bias, analyzing, and assessing quality of evidence respectively. RESULTS: After exclusions, 15 RCTs including a total of 1451 participants were included for analysis. We found evidence that JLT had better efficacy than CP (domperidone, omeprazole, esomeprazole, mosapride, lansoprazole, compound digestive enzymes, lactasin tablets) for FD (OR 0.34; 95% CI 0.26, 0.45; P < .00001). Moreover, JLT had more improvement on symptoms including abdominal pain, abdominal distention, early satiety, belching, poor appetite, and fatigue compared with CP. In addition, serious adverse events were not observed in treatment courses. CONCLUSION: This meta-analysis suggested that JLT appears to have better efficacy in treating FD compared with CP. It may be an effective and safe therapy option for patients with FD. Though, more large-sample and strictly designed RCTs are needed to confirm our findings.PROSPERO registration number: CRD42019133241.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Dispepsia/tratamento farmacológico , Fármacos Gastrointestinais/uso terapêutico , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
19.
Medicine (Baltimore) ; 98(33): e16622, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415355

RESUMO

OBJECTIVE: This study aimed to investigate the correlation of serum Jun-amino-terminal kinase (JNK) pathway-associated phosphatase (JKAP) level with disease risk, severity, inflammation, and treatment response to tumor necrosis factor (TNF)-α inhibitor in Crohn disease (CD) patients. METHOD: Ninety-six active CD patients and 90 healthy controls (HCs) were consecutively enrolled. Serum JKAP level of participants was determined via enzyme-linked immunosorbent assay (ELISA). In CD patients, C-reactive protein (CRP), erythrocyte sedimentation rate, Crohn disease activity index (CDAI), and inflammatory cytokine levels (determined by ELISA) were recorded. All CD patients underwent infliximab (IFX) treatment for 12 weeks, then treatment response (defined as decrement of CDAI ≥70) was assessed at week 12 (W12). RESULTS: Serum JKAP level in CD patients was lower compared to HCs, and it disclosed a good predictive value for decreased CD risk; meanwhile, it was negatively correlated with CRP level, CDAI score, TNF-α, interleukin (IL)-6, and IL-17 levels in CD patients. Sixty-eight (70.8%) patients achieved treatment response to IFX at W12, and JKAP level was increased at W12 compared to baseline. Interestingly, baseline JKAP level in response patients was decreased compared to nonresponse patients, and it exhibited a good predictive value for decreased treatment response to IFX, multivariate logistic regression revealed that JKAP was an independent factor for predicting reduced IFX response. CONCLUSION: Circulating JKAP expression correlates with decreased disease risk, activity, and inflammation level, and it could be served as a novel biomarker for predicting reduced clinical response to TNF-α inhibitor in CD patients.


Assuntos
Doença de Crohn/tratamento farmacológico , Fármacos Gastrointestinais/uso terapêutico , Sistema de Sinalização das MAP Quinases/fisiologia , Monoéster Fosfórico Hidrolases/sangue , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adulto , Biomarcadores/sangue , Sedimentação Sanguínea , Proteína C-Reativa/metabolismo , Doença de Crohn/sangue , Citocinas/sangue , Ensaio de Imunoadsorção Enzimática , Feminino , Humanos , Inflamação , Infliximab/uso terapêutico , Masculino , Fatores de Risco , Resultado do Tratamento
20.
Khirurgiia (Mosk) ; (8): 91-94, 2019.
Artigo em Russo | MEDLINE | ID: mdl-31464282

RESUMO

A successful administration of NPWT-therapy combined with Reamberin infusion for gastroenterostomy failure after stomach resection is reported in the article. It was noted that antioxidant/antihypoxic drug Reamberin combined with NPWT-therapy has a positive metabolic effect and results more active and rapid healing of the wounds. The absence of adverse effects of the drug allows us to recommend its inclusion into complex treatment of patients with this pathology.


Assuntos
Antioxidantes/uso terapêutico , Gastrectomia/métodos , Gastroenterostomia/efeitos adversos , Fármacos Gastrointestinais/uso terapêutico , Meglumina/análogos & derivados , Tratamento de Ferimentos com Pressão Negativa , Estômago/cirurgia , Succinatos/uso terapêutico , Gastrectomia/efeitos adversos , Humanos , Meglumina/uso terapêutico , Cicatrização/efeitos dos fármacos
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