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1.
Allergol. immunopatol ; 47(6): 535-543, nov.-dic. 2019. tab, graf, ilus
Artigo em Inglês | IBECS | ID: ibc-186545

RESUMO

Introduction: Food allergies are inflammatory conditions mediated by Th2 and probably STAT-6 dependent immune responses. Objective and design: Here we investigated the role of Signal Transducer and Activator of Transcription 6 (STAT-6) in development of inflammation in peanut allergy. Methods: To induce food allergy, wild-type (WT) and mice deficient for STAT-6 (Stat6-/-) were sensitized with peanut proteins and challenged with peanut seeds. Results: WT animals lost weight and refused the peanut diet, in contrast to Stat6-/- mice, which had a better maintenance of body weight and more regular seeds' consumption. The augmented peanut-specific IgG, IgG1 and IgE in the allergic WT was abolished in Stat6-/- animals that also presented increased IgG2a. There was an overall reduction in the gut mediators in the absence of STAT-6, including those related to inflammatory and Th2 responses, in contrast to a rising counter regulatory and Th1 reaction in Stat-6-/- mice. These animals had IFN-γ and IL-10 similar to WT after the four-week challenge. Most interestingly, Stat-6-/- mice had no intestinal damage, in contrast to WT animals, which had inflammatory infiltrate, tissue destruction, epithelial exulceration, edema, congestion and loss of villous architecture in the small gut segments. Conclusions: STAT-6 plays an important role in the establishment of the Th2 inflammatory responses and intestinal damage in peanut allergy


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Assuntos
Animais , Fator de Transcrição STAT6/uso terapêutico , Células Th2/imunologia , Hipersensibilidade a Amendoim/imunologia , Hipersensibilidade a Amendoim/veterinária , Hipersensibilidade Alimentar/imunologia , Hidróxido de Alumínio/uso terapêutico , Eutanásia , Ensaio de Imunoadsorção Enzimática
2.
Drug Dev Ind Pharm ; 45(3): 430-438, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30470147

RESUMO

OBJECTIVE: To investigate the intragastric acid neutralization activity of a combined alginate-antacid formulation. SIGNIFICANCE: Published studies have investigated the reflux-suppressing alginate component of Gaviscon Double Action (Gaviscon DA; RB, UK) but intragastric acid neutralization activity of the antacid component has not been evaluated in vivo. METHODS: Intragastric pH monitoring, using a custom-made 10-electrode catheter, was evaluated in a two-part exploratory study in healthy subjects; Part I (n = 6) tested suitability of the catheter using antacid tablets (Rennie; Bayer, Germany); Part II (n = 12) evaluated gastric acid neutralization activity of Gaviscon DA liquid (20 ml) versus placebo in fasted subjects using a randomized, open-label, crossover design. The primary endpoint was the percentage of time that intragastric pH ≥4 was measured during 30 min post-treatment. A confirmatory study of identical design was subsequently conducted (n = 20). RESULTS: Monitoring pH using the multielectrode catheter was a viable approach, directly detecting changes in intragastric pH following a single dose of antacid tablets. In the exploratory study, the percentage of time that pH ≥4 during 30 minutes post-treatment was 46.8% with Gaviscon DA liquid versus 4.7% with placebo (p = 0.0004). These findings were supported by the confirmatory study, where pH ≥4 was recorded 50.8% of the time with Gaviscon DA versus 3.5% with placebo (p = 0.0051). In this study, Gaviscon DA was safe and well tolerated. CONCLUSIONS: These studies demonstrate the effective acid neutralizing capacity of Gaviscon DA versus placebo in healthy, fasted subjects. This adds to the evidence base for the combination of alginates and antacids.


Assuntos
Alginatos/uso terapêutico , Hidróxido de Alumínio/uso terapêutico , Antiácidos/uso terapêutico , Antiulcerosos/uso terapêutico , Ácido Gástrico/metabolismo , Ácido Silícico/uso terapêutico , Bicarbonato de Sódio/uso terapêutico , Adulto , Carbonato de Cálcio/uso terapêutico , Química Farmacêutica/métodos , Estudos Cross-Over , Combinação de Medicamentos , Feminino , Refluxo Gastroesofágico/tratamento farmacológico , Voluntários Saudáveis , Humanos , Concentração de Íons de Hidrogênio , Magnésio/uso terapêutico , Masculino , Comprimidos/uso terapêutico , Adulto Jovem
3.
J. investig. allergol. clin. immunol ; 29(2): 103-111, 2019. ilus, tab
Artigo em Inglês | IBECS | ID: ibc-184052

RESUMO

Allergen-specific immunotherapy (AIT) is the only treatment that can affect the natural course of allergic diseases such as allergic asthma, allergic rhinitis, and IgE-mediated food allergy. Adjuvants are used to induce a quicker, more potent, and longer-lasting immune response. Only 4 compounds are used as adjuvants in currently marketed AIT products: aluminum hydroxide, calcium phosphate, microcrystalline tyrosine (MCT), and monophosphoryl lipid A (MPL). The first 3 adjuvants are delivery systems with a depot effect, although they may also have immunomodulatory properties. These first-generation adjuvants are still widely used, especially aluminum hydroxide. However, aluminum is subject to limitations. MCT is the depot formulation of L-tyrosine; it enhances IgG production without inducing a significant increase in IgE, is biodegradable, and has good local and systemic tolerability. In turn, MPL is an immunostimulatory agent that is the only second-generation adjuvant currently used for AIT. In addition, multiple adjuvants are currently being studied, including immunostimulatory sequences (ISSs), nanoparticles (liposomes, virus-like particles, and biodegradable polymers), and phosphatidylserine derivatives. In a murine model of allergic bronchial inflammation by sensitization to olive pollen, the specific IgE level was significantly higher in sensitized mice treated with olive pollen and aluminum hydroxide. However, specific IgE levels were significantly reduced and bronchial hyperreactivity significantly improved in sensitized mice treated with olive pollen and bacterial derivatives (MPL or ISSs)


La inmunoterapia específica con alérgenos (ITE) es el único tratamiento con potencial para modificar la evolución natural de enfermedades alérgicas como el asma alérgica, la rinitis alérgica y la alergia a alimentos mediada por IgE. Los adyuvantes se usan para provocar una respuesta inmune más rápida, más potente y de mayor duración. Hasta ahora, solo cuatro compuestos se usan como adyuvantes en los productos de ITE comercializados actualmente: hidróxido de aluminio, fosfato cálcico, tirosina microcristalina (MCT) y monofosforil lípido A (MPL). Los tres primeros son sistemas de liberación retardada (efecto depot), aunque también podrían tener propiedades inmunomoduladoras. Estos adyuvantes de primera generación todavía se usan ampliamente, sobre todo el hidróxido de aluminio. Sin embargo, el aluminio tiene algunas limitaciones. MCT es la formulación de liberación retardada de la L-tirosina; aumenta la producción de IgG sin provocar un incremento significativo de IgE, es biodegradable y tiene una buena tolerabilidad local y sistémica. A su vez, MPL es un inmunoestimulador y es el único adyuvante de segunda generación usado actualmente en ITE. Además, hay múltiples adyuvantes en investigación, como las secuencias inmunoestimuladoras (SIE), nanopartículas (liposomas, partículas similares a virus y polímeros biodegradables) y derivados de la fosfatidilserina.En un modelo múrido de inflamación bronquial alérgica por sensibilización al polen de olivo, el nivel de IgE específica fue significativamente mayor en los animales sensibilizados tratados con polen de olivo e hidróxido de aluminio. Sin embargo, en los animales sensibilizados tratados con polen de olivo y derivados bacterianos (MPL o SIE) se observó una disminución significativa del nivel de IgE específica y una mejoría significativa de la hiperreactividad bronquial


Assuntos
Humanos , Dessensibilização Imunológica/métodos , Hipersensibilidade/tratamento farmacológico , Adjuvantes Imunológicos/uso terapêutico , Fatores Imunológicos/uso terapêutico , Hidróxido de Alumínio/uso terapêutico , Fosfatos de Cálcio/uso terapêutico , Tirosina/uso terapêutico , Imunidade/efeitos dos fármacos , Imunoglobulina E/efeitos dos fármacos
4.
Immunotherapy ; 10(14): 1219-1228, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30244623

RESUMO

AIM: To compare the immunological and clinical changes induced by allergen-specific immunotherapy (AIT) using different adjuvants. MATERIALS & METHODS: Olea europaea pollen-sensitized mice were treated with olea plus aluminum hydroxide, calcium phosphate, monophosphoryl lipid A (MPL) or immunostimulatory sequences (ISS). RESULTS: Aluminum hydroxide seems to drive initially to a Th2-type response. Bacteria-derived adjuvants (MPL and ISS) skew the immune response toward Th1 and Treg pathways. Specific-IgE production was lower after AIT with MPL and ISS. Moreover, IgG2a production significantly increased in ISS-treated mice. Bacteria-derived adjuvants also improved the Th1 cytokine response due to IFN-γ higher secretion. In addition, they improved bronchial hyper-reactivity and lung inflammation. CONCLUSION: Bacteria-derived adjuvants may enhance the efficacy of AIT.


Assuntos
Adjuvantes Imunológicos/uso terapêutico , Alérgenos/uso terapêutico , Dessensibilização Imunológica/métodos , Hipersensibilidade/terapia , Extratos Vegetais/uso terapêutico , Alérgenos/imunologia , Hidróxido de Alumínio/uso terapêutico , Animais , Antígenos de Plantas/imunologia , Fosfatos de Cálcio/uso terapêutico , Modelos Animais de Doenças , Feminino , Humanos , Hipersensibilidade/imunologia , Lipídeo A/análogos & derivados , Lipídeo A/uso terapêutico , Camundongos , Camundongos Endogâmicos BALB C , Olea/imunologia , Extratos Vegetais/imunologia , Pólen/imunologia , Testes de Função Respiratória
5.
BMJ Open ; 8(3): e018430, 2018 03 27.
Artigo em Inglês | MEDLINE | ID: mdl-29593017

RESUMO

INTRODUCTION: This trial proposes to compare the effectiveness and cost-effectiveness of electroacupuncture (EA) plus on-demand gastrocaine with waiting list for EA plus on-demand gastrocaine in providing symptom relief and quality-of-life improvement among patients with functional dyspepsia (FD). METHODS AND ANALYSIS: This is a single-centre, pragmatic, randomised parallel-group, superiority trial comparing the outcomes of (1) EA plus on-demand gastrocaine group and (2) waiting list to EA plus on-demand gastrocaine group. 132 (66/arm) endoscopically confirmed, Helicobacter pylori-negative patients with FD will be recruited. Enrolled patients will respectively be receiving (1) 20 sessions of EA over 10 weeks plus on-demand gastrocaine; or (2) on-demand gastrocaine and being nominated on to a waiting list for EA, which entitles them 20 sessions of EA over 10 weeks after 12 weeks of waiting. The primary outcome will be the between-group difference in proportion of patients achieving adequate relief of symptoms over 12 weeks. The secondary outcomes will include patient-reported change in global symptoms and individual symptoms, Nepean Dyspepsia Index, Nutrient Drink Test, 9-item Patient Health Questionnaire (PHQ9), and 7-item Generalised Anxiety Disorder Scale (GAD7). Adverse events will be assessed formally. Results on direct medical costs and on the EuroQol (EQ-5D) questionnaire will also be used to assess cost-effectiveness. Analysis will follow the intention-to-treat principle using appropriate univariate and multivariate methods. A mixed model analysis taking into account missing data of these outcomes will be performed. Cost-effectiveness analysis will be performed using established approach. ETHICS AND DISSEMINATION: The study is supported by the Health and Medical Research Fund, Government of the Hong Kong Special Administrative Region of China. It has been approved by the Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee. Results will be published in peer-reviewed journals and be disseminated in international conference. TRIAL REGISTRATION NUMBER: ChiCTR-IPC-15007109; Pre-result.


Assuntos
Hidróxido de Alumínio/uso terapêutico , Aminobenzoatos/uso terapêutico , Atropina/uso terapêutico , Análise Custo-Benefício/economia , Dispepsia/terapia , Eletroacupuntura/métodos , Compostos de Magnésio/uso terapêutico , Projetos de Pesquisa , Padrão de Cuidado/economia , Adolescente , Adulto , Idoso , Hidróxido de Alumínio/economia , Aminobenzoatos/economia , Atropina/economia , Combinação de Medicamentos , Dispepsia/economia , Eletroacupuntura/economia , Feminino , Hong Kong , Humanos , Compostos de Magnésio/economia , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Qualidade de Vida , Inquéritos e Questionários , Resultado do Tratamento , Listas de Espera , Adulto Jovem
6.
Dis Esophagus ; 30(10): 1-7, 2017 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-28859383

RESUMO

Alginate-based formulations are frequently used as add-on proton pump inhibitor (PPI) therapy to help control of heartburn and regurgitation. There are limited data regarding the mechanisms and effects of alginate-based formulations. We aimed to evaluate the effects of the sodium alginate intake and its likely temporal relations on intraesophageal reflux events by MII-pH in patients with and without hiatal hernia (HH). Fifty GERD patients (18 with HH, 32 without HH) with heartburn or regurgitation once a week or more common were included. After combined multichannel intraluminal impedance and pH-metry (MII-pH) had been performed, all patients were asked to eat the same standard meal (double cheeseburger, 1 banana, 100 g regular yoghurt, and 200 mL water with total energy value of 744 kcal: 37.6% of carbohydrates, 21.2% of proteins, and 41.2% of lipids) during two consecutive days. On separate random two consecutive days, all patients took 10 mL of sodium alginate (GA; Gaviscon Advance; Reckitt Benckiser Healthcare, Hull, UK) or 10 mL of water, 30 minutes after the refluxogenic meal. After eating refluxogenic meal, patients were examined ½ hour for basal conditions, 1 hour in upright, and 1 hour in supine positions. Alginate significantly decreased acid reflux after intake at the first hour in comparison to water in patients with HH (6.1 vs. 13.7, P = 0.004) and without HH (3.5 vs. 5.5, P = 0.001). Weakly acid reflux were increased at the first hour in patients with HH (3.4 vs. 1.3, P = 0.019) and without HH (1.7 vs. 5, P = 0.02) compared to water. There was no distinctive effect of alginate on the height of proximal migration of reflux events in patients with HH and without HH. Alginate decreases acid reflux events within a limited time period, especially at the first hour both in patients with and without HH. Alginate has no effect on the height of reflux events along the esophagus both in patients with and without HH.


Assuntos
Alginatos/uso terapêutico , Hidróxido de Alumínio/uso terapêutico , Antiácidos/uso terapêutico , Refluxo Gastroesofágico/tratamento farmacológico , Hérnia Hiatal/complicações , Ácido Silícico/uso terapêutico , Bicarbonato de Sódio/uso terapêutico , Adulto , Idoso , Combinação de Medicamentos , Impedância Elétrica , Monitoramento do pH Esofágico , Feminino , Refluxo Gastroesofágico/complicações , Refluxo Gastroesofágico/fisiopatologia , Humanos , Masculino , Refeições , Pessoa de Meia-Idade , Período Pós-Prandial , Postura , Estudos Prospectivos , Fatores de Tempo
7.
Nefrología (Madr.) ; 37(3): 311-319, mayo-jun. 2017. graf, tab
Artigo em Espanhol | IBECS | ID: ibc-164645

RESUMO

Antecedentes y objetivos: Es difícil estimar clínicamente la eficacia de los captores de fósforo (CP). Este estudio analiza los cambios que se producen en la fosfatemia y excreción urinaria de fósforo tras la administración de CP a pacientes con enfermedad renal crónica, y la utilidad de la relación entre la excreción urinaria de fósforo y la tasa de catabolismo proteico (Po/TCP) en la estimación de la eficacia de estos fármacos. Métodos: Estudio retrospectivo de observación en una cohorte de pacientes adultos con enfermedad renal crónica en estadios 4-5. Se compararon parámetros bioquímicos basales y 45-60 días después de un tratamiento con dieta baja en fósforo más CP (subgrupo «captor»=260 pacientes) o solo con los consejos dietéticos (subgrupo «control»=79 pacientes). Resultados: La carga de fósforo (excreción urinaria total) por unidad de función renal (Po/GFR) fue el parámetro mejor relacionado con la fosfatemia (R2=0,61). La cifra media de Po/TCP fue de 8,2±2,3mg de fósforo por gramo de proteína. Tras la administración de CP, la fosfatemia descendió un 11%, la fosfaturia un 22%, la tasa de catabolismo proteico un 7% y la Po/TCP un 15%. En el subgrupo control la Po/TCP se incrementó un 20%. La excreción urinaria de fósforo y de nitrógeno ureico se correlacionaron fuertemente de forma lineal antes y después del tratamiento con CP o tras los consejos dietéticos en el subgrupo control. Conclusiones: La Po/TCP es un parámetro que podría reflejar la absorción intestinal de fósforo y, por tanto, sus variaciones tras la administración de CP podrían servir para estimar la eficacia de estos fármacos (AU)


Background and aims: The efficacy of phosphate binders is difficult to be estimated clinically. This study analyzes the changes in serum phosphate and urinary phosphate excretion after the prescription of phosphate binders (PB) in patients with chronic kidney disease stage 4-5 pre-dialysis, and the usefulness of the ratio between total urinary phosphate and protein catabolic rate (Pu/PCR) for estimating the efficacy of PB. Methods: This retrospective observational cohort study included adult chronic kidney disease patients. Biochemical parameters were determined baseline and after 45-60 days on a low phosphate diet plus PB (‘binder’ subgroup=260 patients) or only with dietary advice (‘control’ subgroup=79 patients). Results: Phosphate load (total urinary excretion) per unit of renal function (Pu/GFR) was the best parameter correlated with serum phosphate levels (R2=0.61). Mean±SD level of Pu/PCR was 8.2±2.3mg of urinary phosphate per each g of estimated protein intake. After treatment with PB, serum phosphate levels decreased by 11%, urinary phosphate 22%, protein catabolic rate 7%, and Pu/PCR 15%. In the control subgroup, Pu/PCR increased by 20%. Urinary phosphate and urea nitrogen excretion correlated strongly, both baseline and after PB or dietary advice. Conclusions: The proposed parameter Pu/PCR may reflect the rate of intestinal phosphate absorption, and therefore, its variations after PB prescription may be a useful tool for estimating the pharmacological efficacy of these drugs (AU)


Assuntos
Humanos , Adulto , Distúrbios do Metabolismo do Fósforo/tratamento farmacológico , Fósforo/urina , Insuficiência Renal Crônica/fisiopatologia , Fósforo/deficiência , Estudos Retrospectivos , Progressão da Doença , Hidróxido de Alumínio/uso terapêutico , Carbonato de Cálcio/uso terapêutico , Sevelamer/uso terapêutico
9.
Asian Pac J Cancer Prev ; 17(2): 631-8, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26925655

RESUMO

Radiation proctitis is a common complication after radiotherapy for pelvic malignant tumors. This study was conducted to assess the efficacy of novel almagate enemas in hemorrhagic chronic radiation proctitis (CRP) and evaluate risk factors related to rectal deep ulcer or fistula secondary to CRP. All patients underwent a colonoscopy to confirm the diagnosis of CRP and symptoms were graded. Typical endoscopic and pathological images, risk factors, and quality of life were also recorded. A total of 59 patients were enrolled. Gynecological cancers composed 93.1% of the primary malignancies. Complete or obvious reduction of bleeding was observed in 90% (53/59) patients after almagate enema. The mean score of bleeding improved from 2.17 to 0.83 (P<0.001) after the enemas. The mean response time was 12 days. No adverse effects were found. Moreover, long-term successful rate in controlling bleeding was 69% and the quality of life was dramatically improved (P=0.001). The efficacy was equivalent to rectal sucralfate, but the almagate with its antacid properties acted more rapidly than sucralfate. Furthermore, we firstly found that moderate to severe anemia was the risk factor of CRP patients who developed rectal deep ulcer or fistulas (P= 0.015). We also found abnormal hyaline-like thick wall vessels, which revealed endarteritis obliterans and the fibrosis underlying this disease. These findings indicate that almagate enema is a novel effective, rapid and well-tolerated method for hemorrhagic CRP. Moderate to severe anemia is a risk factor for deep ulceration or fistula.


Assuntos
Hidróxido de Alumínio/uso terapêutico , Carbonatos/uso terapêutico , Enema/métodos , Fístula/etiologia , Hemorragia Gastrointestinal/terapia , Hidróxido de Magnésio/uso terapêutico , Neoplasias/complicações , Proctite/terapia , Lesões por Radiação/terapia , Radioterapia/efeitos adversos , Adulto , Idoso , Antiácidos/uso terapêutico , Colonoscopia , Feminino , Fístula/diagnóstico , Seguimentos , Hemorragia Gastrointestinal/diagnóstico , Hemorragia Gastrointestinal/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neoplasias/patologia , Neoplasias/radioterapia , Proctite/diagnóstico , Proctite/etiologia , Prognóstico , Qualidade de Vida , Lesões por Radiação/diagnóstico , Lesões por Radiação/etiologia , Estudos Retrospectivos , Fatores de Risco
10.
Aliment Pharmacol Ther ; 43(8): 899-909, 2016 04.
Artigo em Inglês | MEDLINE | ID: mdl-26909885

RESUMO

BACKGROUND: Many reflux patients remain symptomatic on a standard dose of proton pump inhibitor (PPI). Alginates decrease the number of reflux events by forming a raft on top of the stomach content and thus offer a supplemental mechanism of action to acid suppression. AIM: To assess the efficacy of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. METHODS: This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using the Heartburn Reflux Dyspepsia Questionnaire (HRDQ). Based on symptom score during run-in, eligible patients were randomised to Gaviscon Advance 10 mL four times a day or placebo in addition to a once daily PPI. The primary endpoint was change in HRDQ score post-treatment compared to baseline. RESULTS: One hundred and thirty-six patients were randomised. Change in HRDQ reflux score was significantly greater for Gaviscon Advance (mean: -5.0, s.d.: 4.7) than for placebo (mean: -3.5, s.d.: 5.5) with an LS mean difference of 1.6 [95% CI -3.1 to -0.1], P = 0.03. A decrease in the mean (s.d.) number of nights with symptoms was observed from 3.6 (2.8) to 3.0 (3.0) in the placebo group and from 3.9 (2.8) to 2.2 (2.7) for the Gaviscon Advance group. This reduction was significantly greater in the Gaviscon Advance group than in the placebo group [LS mean difference = -0.9, 95% CI (-1.6 to -0.2), P < 0.01]. CONCLUSION: In patients with residual reflux symptoms despite PPI treatment, adding an alginate offers additional decrease in the burden of reflux symptoms (EudraCT/IND Number: 2011-005486-21).


Assuntos
Alginatos/uso terapêutico , Hidróxido de Alumínio/uso terapêutico , Refluxo Gastroesofágico/tratamento farmacológico , Azia/tratamento farmacológico , Ácido Silícico/uso terapêutico , Bicarbonato de Sódio/uso terapêutico , Adulto , Idoso , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Bomba de Prótons/uso terapêutico , Resultado do Tratamento
12.
Arch Oral Biol ; 61: 66-70, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26519789

RESUMO

OBJECTIVE: Mouthrinsing with antacids, following erosive episodes, have been suggested as a preventative strategy to minimize tooth surface loss due to their neutralizing effect. The purpose of this in situ study was to evaluate the effect of an antacid suspension containing sodium alginate, sodium bicarbonate and calcium carbonate in controlling simulated erosion of enamel of intrinsic origin. DESIGN: The experimental units were 48 slabs (3×3×2mm) of bovine enamel, randomly divided among 12 volunteers who wore palatal appliances with two enamel slabs. One of them was exposed extra-orally twice a day to 25mL of a hydrochloric acid (HCl) solution (0.01M, pH 2) for 2min. There were two independent phases, lasting 5 days each. In the first phase, according to a random scheme, half of the participants rinsed with 10mL of antacid suspension (Gaviscon(®), Reckitt Benckiser Healthcare Ltd.), while the remainder was rinsed with deionized water, for 1min. For the second phase, new slabs were inserted and participants switched to the treatment not received in the first stage. Therefore, the groups were as follows: (a) erosive challenge with HCl+antacid suspension; (b) erosive challenge with HCl+deionized water (DIW); (c) no erosive challenge+antacid suspension; (d) no erosive challenge+DIW. Specimens were assessed in terms of surface loss using optical profilometry and Knoop microhardness. The data were analyzed using repeated measures two-way analysis of variance and Tukey's tests. RESULTS: Compared to DIW rinses, surface loss of enamel was significantly lower when using an antacid rinse following erosive challenges (p=0.015). The Knoop microhardness of the enamel was significantly higher when the antacid rinse was used (p=0.026). CONCLUSIONS: The antacid suspension containing sodium alginate, sodium bicarbonate and calcium carbonate, rinsed after erosive challenges of intrinsic origin, reduced enamel surface loss.


Assuntos
Alginatos/uso terapêutico , Hidróxido de Alumínio/uso terapêutico , Antiácidos/uso terapêutico , Ácido Clorídrico/farmacologia , Antissépticos Bucais/uso terapêutico , Ácido Silícico/uso terapêutico , Bicarbonato de Sódio/uso terapêutico , Erosão Dentária/prevenção & controle , Adolescente , Adulto , Animais , Bovinos , Estudos Cross-Over , Combinação de Medicamentos , Feminino , Humanos , Masculino , Suspensões , Vômito/complicações
13.
Asia Pac J Clin Nutr ; 24(4): 753-5, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26693761

RESUMO

BACKGROUND: The possible pathophysiology of the relationship between gastro-esophageal reflux disease and apnea of prematurity has been widely investigated. Various physiological protective reflex responses provide a plausible biological link between gastro-esophageal reflux and apnea of prematurity. It is uncertain whether or not there is a causal relationship between the two diseases. PATIENT'S FINDINGS: Twins were admitted to the neonatal intensive care unit due to feeding problems. Physical examination was normal except for reticulated, blueviolet skin changes. Short apneic attacks occurred on the first day in twin 1 and on the second day in twin 2, and these were initially treated by stimulation and increased ambient O2 concentration. Then, we conducted methylxanthine and continuous positive airway pressure treatment. Laboratory and radiological analysis were normal. As gastro-esophageal reflux disease was thought to be the causes of the treatment-refractory apnea, therapy with gaviscon and domperidon was begun for both cases. Apneic attacks did not recur after gaviscon and domperidon therapy. CONCLUSION: Pharmacological therapy for gastro-esophageal reflux disease has not definitively been shown to be effective in improving symptoms and hence, should be reserved especially for infants with treatment refractory apnea episodes suspected as being gastro-esophageal reflux in premature infants.


Assuntos
Alginatos/uso terapêutico , Hidróxido de Alumínio/uso terapêutico , Apneia/terapia , Doenças em Gêmeos/tratamento farmacológico , Domperidona/uso terapêutico , Refluxo Gastroesofágico/complicações , Doenças do Prematuro/terapia , Ácido Silícico/uso terapêutico , Bicarbonato de Sódio/uso terapêutico , Antiácidos , Antieméticos , Combinação de Medicamentos , Refluxo Gastroesofágico/tratamento farmacológico , Idade Gestacional , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Doenças do Prematuro/etiologia , Gêmeos
14.
Cochrane Database Syst Rev ; (11): CD008327, 2015 Nov 12.
Artigo em Inglês | MEDLINE | ID: mdl-26561037

RESUMO

BACKGROUND: Bone disease is common in children with chronic kidney disease (CKD) and when untreated may result in bone deformities, bone pain, fractures and reduced growth rates. This is an update of a review first published in 2010. OBJECTIVES: This review aimed to examine the benefits (improved growth rates, reduced risk of bone fractures and deformities, reduction in PTH levels) and harms (hypercalcaemia, blood vessel calcification, deterioration in kidney function) of interventions (including vitamin D preparations and phosphate binders) for the prevention and treatment of metabolic bone disease in children with CKD. SEARCH METHODS: We searched the Cochrane Kidney and Transplant Specialised Register to 8 September 2015 through contact with the Trial's Search Co-ordinator using search terms relevant for this review. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing different interventions used to prevent or treat bone disease in children with CKD stages 2 to 5D. DATA COLLECTION AND ANALYSIS: Data were assessed for study eligibility, risk of bias and extracted independently by two authors. Results were reported as risk ratios (RR) or risk differences (RD) with 95% confidence intervals (CI) for dichotomous outcomes. For continuous outcomes the mean difference (MD) or standardised mean difference (SMD) with 95% confidence intervals (CI) was used. Statistical analyses were performed using the random-effects model. MAIN RESULTS: This review included 18 studies (576 children); three new studies were added for this update. Adequate sequence generation and allocation concealment were reported in 12 and 11 studies respectively. Only four studies reported blinding of children, investigators or outcome assessors. Nine studies were at low risk of attrition bias and 12 studies were at low risk of selective reporting bias.Eight different interventions were compared. Two studies compared intraperitoneal (IP) with oral calcitriol. PTH levels were significantly lower with IP compared with oral calcitriol (1 study: MD -501.00 pg/mL, 95% CI -721.54 to -280.46) but the number of children with abnormal bone histology did not differ between treatments. Three studies compared intermittent with daily oral calcitriol. The change in mean height SDS (1 study: MD 0.13, 95% CI -0.22 to 0.48) and the percentage fall in parathyroid hormone (PTH) levels at eight weeks (1 study: MD -5.50%, 95% CI -32.37 to 21.37) and 12 months (1 study: MD -6.00% 95% CI -25.27 to 13.27) did not differ between treatments.Four studies compared active vitamin D preparations (calcitriol, paricalcitol, 1α-hydroxyvitamin D) with placebo or no specific treatment. One study reported vitamin D preparations significantly reduced PTH levels (-55.00 pmol/L, 95% CI -83.03 to -26.97). There was no significant difference in hypercalcaemia risk with vitamin D preparations compared with placebo or no specific treatment (4 studies, 103 children: RD 0.08 mg/dL, 95% CI -0.08 to 0.24). However, there was heterogeneity (I(2) = 55%) with one study showing a significantly greater risk of hypercalcaemia with intravenous (IV) calcitriol administration. Two studies (97 children) compared calcitriol with other vitamin D preparations and both found no significant differences in growth between preparations.Two studies compared ergocalciferol in patients with CKD and vitamin D deficiency. Elevated PTH levels developed significantly later in ergocalciferol treated children (1 study: hazard ratio 0.30, 95% CI 0.09 to 0.93) though the number with elevated PTH levels did not differ between groups (1 study, 40 children: RR 0.33, 95% CI 0.11 to 1.05).Two studies compared calcium carbonate with aluminium hydroxide as phosphate binders. One study (17 children: MD -0.86 SDS, 95% CI -2.24 to 0.52) reported no significant difference in mean final height SDS between treatments. Three studies compared sevelamer with calcium-containing phosphate binders. There were no significant differences in the final calcium, phosphorus or PTH levels between binders. More episodes of hypercalcaemia occurred with calcium-containing binders. One study reported no significant differences between calcitriol and doxercalciferol in bone histology or biochemical parameters. AUTHORS' CONCLUSIONS: Bone disease, assessed by changes in PTH levels, is improved by all vitamin D preparations. However, no consistent differences between routes of administration, frequencies of dosing or vitamin D preparations were demonstrated. Although fewer episodes of high calcium levels occurred with the non-calcium-containing phosphate binder, sevelamer, compared with calcium-containing binders, there were no differences in serum phosphorus and calcium overall and phosphorus values were reduced to similar extents. All studies were small with few data available on patient-centred outcomes (growth, bone deformities) and limited data on biochemical parameters or bone histology resulting in considerable imprecision of results thus limiting the applicability to the care of children with CKD.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Doenças Ósseas Metabólicas/tratamento farmacológico , Nefropatias/complicações , Hidróxido de Alumínio/uso terapêutico , Doenças Ósseas Metabólicas/sangue , Doenças Ósseas Metabólicas/etiologia , Calcitriol/uso terapêutico , Cálcio/sangue , Carbonato de Cálcio/uso terapêutico , Criança , Doença Crônica , Ergocalciferóis/uso terapêutico , Humanos , Hormônio Paratireóideo/sangue , Fósforo/sangue , Poliaminas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Sevelamer/uso terapêutico , Vitamina D/uso terapêutico
15.
Cochrane Database Syst Rev ; (9): CD011379, 2015 Sep 19.
Artigo em Inglês | MEDLINE | ID: mdl-26384956

RESUMO

BACKGROUND: Heartburn is one of the most common gastrointestinal symptoms in pregnant women. It can occur in all trimesters of pregnancy. The symptoms of heartburn in pregnancy may be frequent, severe and distressing, but serious complications are rare. Many interventions have been used for the treatment of heartburn in pregnancy. These interventions include advice on diet, lifestyle modification and medications. However, there has been no evidence-based recommendation for the treatment of heartburn in pregnancy. OBJECTIVES: To assess the effects of interventions for relieving heartburn in pregnancy. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 June 2015), ClinicalTrials.gov (2 March 2015), Asian & Oceanic Congress of Obstetrics & Gynaecology (AOCOG) conference proceedings (20-23 October 2013, Centara Grand & Bangkok Convention Centre, Bangkok, Thailand), and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTS of interventions for heartburn in pregnancy compared with another intervention, or placebo, or no intervention. Cluster-RCTs would have been eligible for inclusion but none were identified. We excluded studies available as abstracts only and those using a cross-over design.Interventions could include advice on diet, lifestyle modification and medications (such as antacids, sucralfate, histamine 2-receptor antagonists, promotility drugs and proton pump inhibitors (PPIs)). DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. MAIN RESULTS: We included nine RCTs involving 725 women. However, five trials did not contribute data. Four trials involving 358 women contributed data. Trials were generally at mixed risk of bias.We only identified data for three comparisons: pharmaceutical treatment versus placebo or no treatment; acupuncture versus no treatment and pharmacological intervention versus advice on dietary and lifestyle changes. Pharmaceutical treatment compared with placebo or no treatmentTwo trials evaluated any pharmaceutical treatment compared with placebo or no treatment. One trial examined a treatment rarely used nowadays (intramuscular prostigmine 0.5 mg versus placebo). One trial evaluated the effect of magnesium and aluminium hydroxide plus simethicone liquid and tablet compared with placebo. For the primary outcome of this review (relief of heartburn), women who received pharmaceutical treatment reported complete heartburn relief more often than women receiving no treatment or placebo (risk ratio (RR) 1.85, 95% confidence interval (CI) 1.36 to 2.50 in two RCTs of 256 women, I(2) = 0%, moderate-quality evidence). Data on partial relief of heartburn were heterogenous and showed no clear difference (average RR 1.35, 95% CI 0.38 to 4.76 in two RCTs of 256 women, very low-quality evidence). In terms of secondary outcomes, there was no clear difference in the rate of side effects between the pharmaceutical treatment group and the placebo/no treatment group (RR 0.63, 95% CI 0.21 to 1.89 in two RCTs of 256 women, very low-quality evidence). Pharmacological intervention versus advice on dietary and lifestyle choicesOne study compared 1 g of sucralfate with advice on dietary and lifestyle choices in treating heartburn. More women in the sucralfate group experienced complete relief of heartburn compared to women who received advice on diet and lifestyle choices (RR 2.41, 95% CI 1.42 to 4.07; participants = 65; studies = one). The only secondary outcome of interest addressed by this trial was side effects. The evidence was not clear on intervention side effects rate between the two groups (RR 1.74, 95% CI 0.07 to 41.21; participants = 66; studies = one). There was only one instance of side effects in the pharmacological group. Acupuncture compared with no treatmentOne trial evaluated acupuncture compared with no treatment but did not report data relating to this review's primary outcome (relief of heartburn). In terms of secondary outcomes, there was no difference in the rate of side effects between women who had acupuncture and women who had no treatment (RR 2.43, 95% CI 0.11 to 55.89 in one RCT of 36 women). With regard to quality of life, women who had acupuncture reported improved ability to sleep (RR 2.80, 95% CI 1.14 to 6.86) and eat (RR 2.40, 95% CI 1.11 to 5.18 in one RCT of 36 women).The following secondary outcomes were not reported upon in any of the trials included in the review: miscarriage, preterm labour, maternal satisfaction, fetal anomalies, intrauterine growth restriction, low birthweight. AUTHORS' CONCLUSIONS: There are no large-scale RCTs to assess heartburn relief in pregnancy. This review of nine small studies (which involved data from only four small studies) indicates that there are limited data suggesting that heartburn in pregnancy could be completely relieved by pharmaceutical treatment. Three outcomes were assessed and assigned a quality rating using the GRADE methods. Evidence from two trials for the outcome of complete relief of heartburn was assessed as of moderate quality. Evidence for the outcomes of partial heartburn relief and side effects was graded to be of very low quality. Downgrading decisions were based in part on the small size of the trials and on heterogenous and imprecise results.There are insufficient data to assess acupuncture versus no treatment and no data to assess other comparisons (miscarriage, preterm labour, maternal satisfaction, fetal anomalies, intrauterine growth restriction, low birthweight).Further RCTs are needed to fully evaluate the effectiveness of interventions for heartburn in pregnancy. Future research should also address other medications such as histamine 2-receptor antagonists, promotility drugs, proton pump inhibitors, and a raft-forming alginate reflux suppressant in treatment of heartburn in pregnancy. More research is needed on acupuncture and other complimentary therapies as treatments for heartburn in pregnancy. Future research should also evaluate any adverse outcomes, maternal satisfaction with treatment and measure pregnant women's quality of life in relation to the intervention.


Assuntos
Terapia por Acupuntura , Antiácidos/uso terapêutico , Azia/terapia , Complicações na Gravidez/terapia , Adulto , Hidróxido de Alumínio/uso terapêutico , Feminino , Humanos , Hidróxido de Magnésio/uso terapêutico , Neostigmina/uso terapêutico , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Sucralfato/uso terapêutico
16.
Can Vet J ; 56(8): 867-71, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-26246635

RESUMO

A 13-year-old dog exhibited dramatic, radiographic osteopenia consistent with fibrous osteodystrophy secondary to primary hyperparathyroidism. Following parathyroidectomy, the dog developed severe, prolonged hypocalcemia, but was successfully treated and discharged 32 d after surgery. A variety of factors may have contributed to this dog's hypocalcemia including hypoparathyroidism and hungry bone syndrome.


Assuntos
Doenças Ósseas Metabólicas/veterinária , Doenças do Cão/patologia , Hiperparatireoidismo/veterinária , Hipocalcemia/veterinária , Paratireoidectomia/veterinária , Hidróxido de Alumínio/uso terapêutico , Animais , Doenças Ósseas Metabólicas/patologia , Calcitriol/uso terapêutico , Cálcio/metabolismo , Cálcio/uso terapêutico , Doenças do Cão/etiologia , Cães , Feminino , Hiperparatireoidismo/tratamento farmacológico , Hiperparatireoidismo/cirurgia , Hipocalcemia/etiologia , Paratireoidectomia/efeitos adversos
17.
Aliment Pharmacol Ther ; 42(7): 845-54, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26228097

RESUMO

BACKGROUND: There is a paucity of large-scale studies evaluating the clinical benefit of the Gaviscon Double Action (DA) alginate-antacid formulation for treating gastroesophageal reflux disease (GERD) symptoms. AIM: Randomised double-blind placebo-controlled parallel-group study to evaluate efficacy and safety of Gaviscon DA in reducing heartburn, regurgitation and dyspepsia symptoms in individuals with mild-to-moderate GERD in China. METHODS: Participants with symptomatic GERD (n = 1107) were randomised to receive Gaviscon DA or placebo (two tablets four times daily) for seven consecutive days. The primary endpoint compared the change in Reflux Disease Questionnaire (RDQ) score for the GERD (heartburn + regurgitation) dimension between Gaviscon DA and placebo. Secondary endpoints compared the change in RDQ scores for individual heartburn, regurgitation and dyspepsia dimensions, overall treatment evaluation (OTE) scores and incidence of adverse events (AEs). RESULTS: Mean RDQ GERD scores: 2.51 for Gaviscon DA and 2.50 for placebo at baseline; 1.25 for Gaviscon DA and 1.46 for placebo post treatment. Gaviscon DA was statistically superior to placebo in reducing GERD and dyspepsia RDQ scores [least-squares mean (LSM) difference: GERD -0.21, P < 0.0001; dyspepsia -0.18, P = 0.0004], despite a substantial placebo response. The Gaviscon DA group reported more favourable overall treatment responses than the placebo group across all OTE categories (P < 0.0001). Superior relief of GERD symptoms was observed both in those with non-erosive and those with erosive reflux disease (LSM difference -0.14 [P = 0.038] and -0.29 [P < 0.0001] respectively). Incidence of AEs was similar in both groups. CONCLUSION: Gaviscon DA tablets provide effective and safe reduction in acid reflux and dyspepsia symptoms in Chinese individuals with mild-to-moderate GERD. ClinicalTrials.gov: NCT01869491.


Assuntos
Alginatos/uso terapêutico , Hidróxido de Alumínio/uso terapêutico , Antiulcerosos/uso terapêutico , Dispepsia/tratamento farmacológico , Refluxo Gastroesofágico/tratamento farmacológico , Azia/tratamento farmacológico , Refluxo Laringofaríngeo/tratamento farmacológico , Ácido Silícico/uso terapêutico , Bicarbonato de Sódio/uso terapêutico , Trato Gastrointestinal Superior/efeitos dos fármacos , Adolescente , Adulto , Idoso , Alginatos/efeitos adversos , Hidróxido de Alumínio/efeitos adversos , Antiácidos/uso terapêutico , Antiulcerosos/efeitos adversos , China/epidemiologia , Método Duplo-Cego , Combinação de Medicamentos , Dispepsia/epidemiologia , Feminino , Refluxo Gastroesofágico/epidemiologia , Azia/epidemiologia , Humanos , Refluxo Laringofaríngeo/epidemiologia , Masculino , Pessoa de Meia-Idade , Placebos , Ácido Silícico/efeitos adversos , Bicarbonato de Sódio/efeitos adversos , Inquéritos e Questionários , Resultado do Tratamento , Trato Gastrointestinal Superior/patologia , Adulto Jovem
18.
Rev Esp Enferm Dig ; 106(7): 448-51, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25490163

RESUMO

BACKGROUND: Infection by Helicobacter pylori is common and affects both genders at any age. The 13C-urea breath test is a widely used test for the diagnosis of this infection. However, multiple drugs used for the treatment of Helicobacter pylori infection symptoms have interactions with this breath test that generate false negative results. This observational study was to assess the potential interaction between almagate and the breath test. METHODS: Thirty subjects on almagate therapy who underwent a breath test were included. If the result was negative, almagate was withdrawn for a month and the breath test was then repeated. RESULTS: In general, 51.9 % of assessed subjects had a negative result after the first test, and 100 % of these also had a negative result after the second test. CONCLUSIONS: It was concluded that the use of almagate does not interfere in breath test results. These results provide a drug therapy option for the treatment of symptoms associated with Helicobacter pylori infection during the diagnostic process.


Assuntos
Hidróxido de Alumínio/uso terapêutico , Antiácidos/uso terapêutico , Testes Respiratórios/métodos , Carbonatos/uso terapêutico , Infecções por Helicobacter/diagnóstico , Helicobacter pylori , Hidróxido de Magnésio/uso terapêutico , Adulto , Idoso , Hidróxido de Alumínio/análise , Antiácidos/análise , Carbonatos/análise , Reações Falso-Negativas , Feminino , Humanos , Hidróxido de Magnésio/análise , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes
19.
Rev. cuba. farm ; 48(4): 533-541, oct.-dic. 2014. ilus
Artigo em Espanhol | LILACS | ID: lil-748769

RESUMO

Introducción: el estudio de repetibilidad y reproducibilidad se basa en la cuantificación experimental de la contribución del sistema de medición a la variabilidad total observada, y determina si este es aceptable o no. Objetivo: evaluar el sistema de medición en la fabricación de gel de hidróxido de aluminio mediante el estudio de repetibilidad y reproducibilidad. Métodos: el estudio de repetibilidad y reproducibilidad se desarrolló a través de un experimento factorial balanceado de efecto aleatorio. Se tomaron 10 muestras (partes) del producto terminado, de un lote de producción, las que se midieron dos veces por tres operadores seleccionados aleatoriamente. Las mediciones se realizaron en el Laboratorio de Investigación de Medilip (nivel de confianza: α= 0,05; 95 por ciento). Se aplicó el método ANOVA cruzado. El procesamiento de los datos se realizó utilizando el paquete estadístico Minitab 16. Resultados: según los índices Cg y Cgk (estudio tipo I), se comprobó que el sistema de medición fue aceptable. Con el estudio de repetibilidad y reproducibilidad se determinó que el factor que contribuye en mayor cuantía resultó el denominado partes (96,85 por ciento) y que la contribución de la variabilidad del sistema de medición (3,15 por ciento) fue aceptable, así como el porcentaje de la varianza del estudio con respecto a la varianza total (17,75 por ciento). Conclusiones: el estudio de repetibilidad y reproducibilidad identifica al factor "parte" como el de mayor contribución a la variabilidad total y que el sistema de medición es adecuado, lo cual está avalado por los índices reconocidos internacionalmente, por lo que se recomenda tomar acciones para mejorar el desempeño(AU)


Introduction: the repeatability and reproducibility study is based on experimental quantitation of the measurement system contribution to the total observed variability, and is aimed at determining whether this system is acceptable. Objective: to evaluate the measurement system in aluminum hydroxide gel production process through the repeatability and reproducibility study. Methods: this study was carried out through a balanced factorial experiment of random effect. Ten finished product samples from a production batch were measured twice by three randomly selected operators. The measurements were made in the Medilip research laboratory (Cross ANOVA method. Confidence level α= 0.05; 95 percent). The statistical package Minitab 16 served to process relevant data. Results: according to Cg and Cgk (type I Study) indexes, the measurement system was acceptable. The repeatability and reproducibility study determined that the main contributing factor was parts (98.85 %) and that the measurement system variability (3.15) was also allowable as well as the percentage of the study variance with regard to the total variance (17.75 percent). Conclusions: the repeatability and reproducibility study identifies the factor called parts as the one largely contributing to the total variability and determines that the measurement system is adequate, which is endorsed by international set standards, so it is recommended to take actions to improve its performance(AU)


Assuntos
Humanos , Masculino , Feminino , Hidróxido de Alumínio/uso terapêutico , Análise de Variância , Estatísticas não Paramétricas
20.
Cochrane Database Syst Rev ; (11): CD006640, 2014 Nov 21.
Artigo em Inglês | MEDLINE | ID: mdl-25414987

RESUMO

Background Tranexamic acid reduces haemorrhage through its antifibrinolytic effects. In a previous version of the present review, we found that tranexamic acid may reduce mortality. This review includes updated searches and new trials.Objectives To assess the effects of tranexamic acid versus no intervention, placebo or other antiulcer drugs for upper gastrointestinal bleeding.Search methods We updated the review by performing electronic database searches (Cochrane Central Register of Controlled Trials (CENTRAL),MEDLINE, EMBASE, Science Citation Index) and manual searches in July 2014.Selection criteriaRandomised controlled trials, irrespective of language or publication status.Data collection and analysis We used the standard methodological procedures of the The Cochrane Collaboration. All-cause mortality, bleeding and adverse events were the primary outcome measures. We performed fixed-effect and random-effects model meta-analyses and presented results as risk ratios (RRs) with 95% confidence intervals (CIs) and used I² as a measure of between-trial heterogeneity. We analysed tranexamic acid versus placebo or no intervention and tranexamic acid versus antiulcer drugs separately. To analyse sources of heterogeneity and robustness of the overall results, we performed subgroup, sensitivity and sequential analyses.Main results We included eight randomised controlled trials on tranexamic acid for upper gastrointestinal bleeding. Additionally, we identified one large ongoing pragmatic randomised controlled trial from which data are not yet available. Control groups were randomly assigned to placebo (seven trials) or no intervention (one trial). Two trials also included a control group randomly assigned to antiulcer drugs(lansoprazole or cimetidine). The included studies were published from 1973 to 2011. The number of participants randomly assigned ranged from 47 to 216 (median 204). All trials reported mortality. In total, 42 of 851 participants randomly assigned to tranexamic acid and 71 of 850 in the control group died (RR 0.60, 95% CI 0.42 to 0.87; P value 0.007; I² = 0%). The analysis was not confirmed when all participants in the intervention group with missing outcome data were included as treatment failures, or when the analysis was limited to trials with low risk of attrition bias. Rebleeding was diagnosed for 117 of 826 participants in the tranexamic acid group and for 146 of 825 participants in the control group (RR 0.80, 95% CI 0.64 to 1.00; P value 0.07; I² = 49%).We were able to evaluate the risk of serious adverse events on the basis of only four trials. Our analyses showed 'no evidence of a difference between tranexamic acid and control interventions regarding the risk of thromboembolic events.' Tranexamic acid appeared to reduce the risk of surgery ina fixed-effect meta-analysis (RR 0.73, 95% CI 0.56 to 0.95), but this result was no longer statistically significant in a random-effects meta-analysis (RR 0.61, 95% CI 0.35 to 1.04; P value 0.07). No difference was apparent between tranexamic acid and placebo in the assessment of transfusion (RR 1.02, 95% CI 0.94 to 1.11; I² = 0%), and meta-analyses that compared tranexamic acid versus antiulcer drugs did not identify beneficial or detrimental effects of tranexamic acid for any of the outcomes assessed.Authors' conclusions This review found that tranexamic acid appears to have a beneficial effect on mortality, but a high dropout rate in some trials means that we cannot be sure of this until the findings of additional research are published. At the time of this update in 2014, one large study(8000 participants) is in progress, so this review will be much more informative in a few years. Further examination of tranexamic acid would require inclusion of high-quality randomised controlled trials. Timing of randomisation is essential to avoid attrition bias and to limit the number of withdrawals. Future trials may use a pragmatic design and should include all participants with suspected bleeding or with endoscopically verified bleeding, as well as a tranexamic placebo arm and co-administration of pump inhibitors and endoscopic therapy. Assessment of outcome measures in such studies should be clearly defined. Endoscopic examination with appropriate control of severe bleeding should be performed, as should endoscopic verification of clinically significant rebleeding. In addition, clinical measures of rebleeding should be included. Other important outcome measures include mortality (30-day or in-hospital), need for emergency surgery or blood transfusion and adverse events (major or minor).


Assuntos
Antifibrinolíticos/uso terapêutico , Hemorragia Gastrointestinal/tratamento farmacológico , Ácido Tranexâmico/uso terapêutico , Administração Oral , Hidróxido de Alumínio/uso terapêutico , Antiulcerosos/uso terapêutico , Antifibrinolíticos/efeitos adversos , Cimetidina/uso terapêutico , Combinação de Medicamentos , Endoscopia Gastrointestinal , Hemorragia Gastrointestinal/mortalidade , Humanos , Injeções Intravenosas , Lansoprazol/uso terapêutico , Magnésio/uso terapêutico , Hidróxido de Magnésio/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Ácido Tranexâmico/efeitos adversos
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