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[PMID]:28453754
[Au] Autor:Turner D; Yerushalmi B; Kori M; Broide E; Mozer-Glassberg Y; Shaoul R; Kolho KL; Shteyer E; Shamaly H; Ledder O; Cohen S; Peleg S; On A; Levine A
[Ad] Endereço:Institute of Paediatric Gastroenterology, Hebrew University of Jerusalem, Jerusalem, Israel.
[Ti] Título:Once- Versus Twice-daily Mesalazine to Induce Remission in Paediatric Ulcerative Colitis: A Randomised Controlled Trial.
[So] Source:J Crohns Colitis;11(5):527-533, 2017 May 01.
[Is] ISSN:1876-4479
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Background: Trials in adults suggested that, in ulcerative colitis [UC], once-daily [OD] dosing of 5-ASA [5-amino salicylic acid] may be as or more effective than twice-daily [BD] dosing. In this induction of remission, investigator-blinded, randomised controlled-trial, we aimed to compare effectiveness and safety of once- versus twice-daily mesalazine in paediatric UC. Methods: Children, aged 4-18 years with a PUCAI [Paediatric Ulcerative Colitis Activity Index] of 10-55 points at inclusion, were randomised in blocks of six with blinded allocation to OD or BD mesalazine, using a weight-based dosing table. The primary outcome was mean PUCAI score at Week 6. Results: A total of 83/86 randomised children were eligible and analysed: 43 in the OD group and 40 in the BD group (mean age 14 ± 2.7 years, 43 [52%] males, 51 [62%] extensive colitis). The groups did not differ with regard to disease activity or any other parameter at baseline. There was no difference in median PUCAI score between the OD group and BD group at Week 6: 15 ( interquartile range [IQR] 5-40) versus 10 [0-40]; p = 0.48]. Response was seen in 25 [60%] OD versus 25 [63%] BD dosing [p = 0.78]. Proportion of children in remission [PUCAI < 10] at Week 6 was 13 [30%] OD versus 16 [40%] BD; p = 0.35]. Most adverse events were related to disease aggravation; the rates of serious adverse events were similar [p > 0.2]. Conclusions: In this first randomised controlled trial in children, no differences were found between OD and BD dosing for any clinical outcome. Remission was achieved in 35% of children treated with mesalazine for active UC.
[Mh] Termos MeSH primário: Anti-Inflamatórios não Esteroides/uso terapêutico
Colite Ulcerativa/tratamento farmacológico
Mesalamina/uso terapêutico
[Mh] Termos MeSH secundário: Adolescente
Anti-Inflamatórios não Esteroides/administração & dosagem
Criança
Pré-Escolar
Esquema de Medicação
Feminino
Seres Humanos
Masculino
Mesalamina/administração & dosagem
Indução de Remissão/métodos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Anti-Inflammatory Agents, Non-Steroidal); 4Q81I59GXC (Mesalamine)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170429
[St] Status:MEDLINE
[do] DOI:10.1093/ecco-jcc/jjw180


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[PMID]:29390381
[Au] Autor:Ek S; Rosenborg S
[Ad] Endereço:Department of Obstetrics and Gynecology, Center of Fetal Medicine, Karolinska University Hospital.
[Ti] Título:Mesalazine as a cause of fetal anemia and hydrops fetalis: A case report.
[So] Source:Medicine (Baltimore);96(50):e9277, 2017 Dec.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:RATIONALE: Mesalazine and its prodrug sulfasalazine are both used for inflammatory bowel disease. Sulfasalazine has been associated with hematological side-effects such as aplastic and hemolytic anemia in patients, but also in fetuses after intrauterine exposure. To our knowledge, we describe the first case of a fetus with severe anemia, and subsequent hydrops, where this drug was found at concentrations in the fetus corresponding to those in the mother and most likely responsible for the fetal condition. PATIENT CONCERNS: A uniparous woman was referred at 31 weeks of gestation due to a hydropic fetus with massive ascites and cardiomegaly. DIAGNOSES: The patient had Crohn's disease and was thus treated with 4 g mesalazine daily. The fetus had severe anemia with an initial hemoglobin level of 51 g/L. INTERVENTIONS: The maternal medication was discontinued and four intrauterine erythrocyte transfusions were given during three weeks. Plasma samples were drawn from mother and fetus during cordocentesis for later analysis of mesalazine. OUTCOMES: A healthy baby was born after 37 full weeks of gestation. Plasma levels of mesalazine were non-conspicuous in neither mother nor fetus. The mesalazine half-life in the fetus (37 h) was half that of the mother (80 h), both considerably longer than previously reported (about 19 h). LESSONS: A causal relationship must be suspected between the fetal anemia and the maternal use of mesalazine. This fetal side-effect should be considered in pregnant women on mesalazine (and its prodrug sulfasalazine).
[Mh] Termos MeSH primário: Anemia/induzido quimicamente
Anti-Inflamatórios não Esteroides/efeitos adversos
Doenças Fetais/induzido quimicamente
Hidropisia Fetal/induzido quimicamente
Mesalamina/efeitos adversos
[Mh] Termos MeSH secundário: Anemia/terapia
Transfusão de Eritrócitos
Feminino
Doenças Fetais/terapia
Seres Humanos
Hidropisia Fetal/terapia
Gravidez
Resultado da Gravidez
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Inflammatory Agents, Non-Steroidal); 4Q81I59GXC (Mesalamine)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180301
[Lr] Data última revisão:
180301
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180203
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000009277


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[PMID]:29352300
[Au] Autor:Wang Z; Koonen D; Hofker M; Bao Z
[Ad] Endereço:Department of Geriatrics and Gastroenterology, Huadong Hospital, Shanghai Medical College, Fudan University, Shanghai Key Laboratory of Clinical Geriatric Medicine, Shanghai, P.R. China.
[Ti] Título:5-aminosalicylic acid improves lipid profile in mice fed a high-fat cholesterol diet through its dual effects on intestinal PPARγ and PPARα.
[So] Source:PLoS One;13(1):e0191485, 2018.
[Is] ISSN:1932-6203
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Obesity is associated with a series of metabolic complications, including dyslipidemia and insulin resistance (IR) that lack effective therapies. In recent years, intestinal inflammation has been suggested to contribute to obesity related metabolic syndrome and targeting gut inflammation with 5-ASA improves diet induced IR, however, its role in dyslipidemia is unknown and has never been explored. In the present study, we reported for the first time that administration of 5-ASA for 12 weeks significantly improved lipid profile by repressing plasma triglycerides and free cholesterol levels in mice fed high-fat cholesterol diet (HFC). In addition, liver lipids were significantly reduced by 5-ASA treatment in HFC-fed mice. Mechanistically, anti-inflammatory genes peroxisome proliferator-activated receptor-γ (Pparγ) and M2 marker, such as Mrc1 and Ym1, were remarkably upregulated, while pro-inflammation gene monocyte chemoattractant protein-1 (Mcp-1) were downregulated in small intestine of mice treated by 5-ASA. Further, 5-ASA improved gastrointestinal barrier by increasing the expression of the tight junction marker ZO-1. 5-ASA also enhanced cholesterol translocation by elevating genes expression of Npc1l1 and Abcg5/8. Moreover, mice fed HFC 5-ASA expressed increased Pparα in small intestinal and its target genes function in lipid oxidation and hydrolysis were remarkable elevated. Taken together, we reported a novel role of 5-ASA which may serve as a therapy target intestinal inflammation induced dyslipidemia.
[Mh] Termos MeSH primário: Colesterol na Dieta/administração & dosagem
Dieta Hiperlipídica/efeitos adversos
Intestinos/efeitos dos fármacos
Intestinos/metabolismo
Metabolismo dos Lipídeos/efeitos dos fármacos
Mesalamina/farmacologia
PPAR alfa/metabolismo
PPAR gama/metabolismo
[Mh] Termos MeSH secundário: Animais
Anti-Inflamatórios não Esteroides/farmacologia
Dislipidemias/tratamento farmacológico
Dislipidemias/genética
Dislipidemias/metabolismo
Ácidos Graxos/metabolismo
Hipolipemiantes/farmacologia
Inflamação/tratamento farmacológico
Inflamação/genética
Inflamação/metabolismo
Metabolismo dos Lipídeos/genética
Lipídeos/sangue
Fígado/efeitos dos fármacos
Fígado/metabolismo
Masculino
Camundongos
Camundongos Endogâmicos C57BL
PPAR gama/genética
RNA Mensageiro/genética
RNA Mensageiro/metabolismo
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Anti-Inflammatory Agents, Non-Steroidal); 0 (Cholesterol, Dietary); 0 (Fatty Acids); 0 (Hypolipidemic Agents); 0 (Lipids); 0 (PPAR alpha); 0 (PPAR gamma); 0 (RNA, Messenger); 4Q81I59GXC (Mesalamine)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180226
[Lr] Data última revisão:
180226
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180121
[St] Status:MEDLINE
[do] DOI:10.1371/journal.pone.0191485


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[PMID]:29443756
[Au] Autor:Zhu Z; Shu X; Long S; Jiang X; Lu N; Zhu X; Liao W
[Ad] Endereço:Department of Gastroenterology, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, China.
[Ti] Título:Ulcerative colitis followed by the development of typical intestinal Behçet disease: A case report.
[So] Source:Medicine (Baltimore);97(7):e9882, 2018 Feb.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:RATIONALE: Intestinal Behçet disease (intestinal BD) and inflammatory bowel disease (IBD) share a lot of characteristics, including genetic background, clinical manifestations, and therapeutic strategies, especially the extraintestinal manifestations, such as oral ulcers, arthralgia, eye lesions, skin lesions, etc, but the coexistence of these 2 diseases are uncommon. Behçet disease with gastrointestinal involvement in ulcerative colitis (UC) patient has been reported in just 1 previous case report, but, which can not be diagnosed as definite intestinal BD based on Korean novel diagnositic criteria due to lacking the typical ileocecal ulcer. PATIENT CONCERNS: We present a 23-year-old woman with ulcerative disease who developed typical intestinal BD, which is the first case report of patient with coexisting UC and typical intestinal BD. DIAGNOSES: This patient was diagnosed as coexistence of intestinal BD and UC base on the clinical manifestations, extra intestinal manifestations and typical colonoscopic findings. INTERVENTIONS: Steroid and methotrexate were administered. OUTCOMES: This patient achieved clinical remission and mucosal healing. LESSONS: Coexistence of intestinal BD and UC is uncommon, and the combination with steroid, methotrexate, and 5-aminosalicylic acids is an effective therapy.
[Mh] Termos MeSH primário: Síndrome de Behçet
Colite Ulcerativa
Colonoscopia/métodos
Trato Gastrointestinal
Glucocorticoides/administração & dosagem
Mesalamina/administração & dosagem
Metotrexato/administração & dosagem
[Mh] Termos MeSH secundário: Adulto
Anti-Inflamatórios não Esteroides/administração & dosagem
Antirreumáticos/administração & dosagem
Síndrome de Behçet/complicações
Síndrome de Behçet/diagnóstico
Síndrome de Behçet/fisiopatologia
Colite Ulcerativa/complicações
Colite Ulcerativa/diagnóstico
Colite Ulcerativa/fisiopatologia
Trato Gastrointestinal/diagnóstico por imagem
Trato Gastrointestinal/patologia
Seres Humanos
Masculino
Indução de Remissão
Resultado do Tratamento
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Inflammatory Agents, Non-Steroidal); 0 (Antirheumatic Agents); 0 (Glucocorticoids); 4Q81I59GXC (Mesalamine); YL5FZ2Y5U1 (Methotrexate)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180222
[Lr] Data última revisão:
180222
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180215
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000009882


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[PMID]:29309107
[Au] Autor:Tarabar D; Kandolf-Sekulovic L; Tatomirovic Z; Mijuskovic Z; Milenkovic Z; Tarabar O; Pecelj-Brocic T
[Ti] Título:Cutaneous side effects caused by treatment for inflammatory bowel disease.
[So] Source:Vojnosanit Pregl;73(4):382-9, 2016 Apr.
[Is] ISSN:0042-8450
[Cp] País de publicação:Serbia
[La] Idioma:eng
[Mh] Termos MeSH primário: Erupção por Droga/etiologia
Doenças Inflamatórias Intestinais/tratamento farmacológico
[Mh] Termos MeSH secundário: Corticosteroides/efeitos adversos
Anti-Inflamatórios não Esteroides/efeitos adversos
Azatioprina/efeitos adversos
Ciclosporina/efeitos adversos
Erupção por Droga/terapia
Seres Humanos
Imunossupressores/efeitos adversos
Mercaptopurina/efeitos adversos
Mesalamina/efeitos adversos
Metotrexato/efeitos adversos
Fator de Necrose Tumoral alfa/antagonistas & inibidores
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Adrenal Cortex Hormones); 0 (Anti-Inflammatory Agents, Non-Steroidal); 0 (Immunosuppressive Agents); 0 (Tumor Necrosis Factor-alpha); 4Q81I59GXC (Mesalamine); 83HN0GTJ6D (Cyclosporine); E7WED276I5 (Mercaptopurine); MRK240IY2L (Azathioprine); YL5FZ2Y5U1 (Methotrexate)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180213
[Lr] Data última revisão:
180213
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180109
[St] Status:MEDLINE
[do] DOI:10.2298/VSP151123023D


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[PMID]:29369189
[Au] Autor:Bartal C; Sagy I; Barski L
[Ti] Título:Drug-induced eosinophilic pneumonia: A review of 196 case reports.
[So] Source:Medicine (Baltimore);97(4):e9688, 2018 Jan.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND AND OBJECTIVE: Eosinophilic pneumonia (EP) is an important subset of patients who present with pulmonary infiltrates and eosinophilia (PIE). EP is classified by chronicity and etiology and drug-induced EP is the main cause of secondary EP. The primary goal of this review was to examine all the case reports published since the syndrome was defined in 1990. It remains unclear whether acute or chronic EP (AEP or CEP) represent different diseases, and the secondary goal of this review is to determine if there are factors that may help distinguish these 2 entities. METHODS: PubMed (MEDLINE and Medical Subject Headings) was searched for case reports of drug-induced EP or PIE syndrome published between 1990 and 2017. Case reports were only included if the diagnostic criteria for AEP or CEP were fulfilled. For each case, data were extracted pertaining to age, sex, type of medication associated with the disease, time from the onset of symptoms to diagnosis, eosinophil counts in the blood, eosinophil fractions in bronchoalveolar lavage (BAL) fluid, initial chest radiograph and computed tomography results, use of mechanical ventilation, and use of steroid treatment and recurrence. RESULTS: We found 196 case reports describing drug-induced EP. The leading cause was daptomycin. From our review, we found that AEP is more common in younger patients with no gender preference. Eosinophilia in the blood at the time of diagnosis characterized only the CEP patients (80% in CEP vs. 20% in AEP). Abnormal findings on radiographic imagine was similar in both syndromes. A significant portion of AEP patients (20%) presented with acute respiratory failure requiring mechanical ventilation. Most patients with EP were treated with steroids with a higher rate of relapse observed in patients with CEP. CONCLUSION: AEP is a much more fulminant and severe disease than the gradual onset and slowly progressive nature of CEP. The pathogenesis of AEP and CEP remains unclear. However, there is significant clinical overlap among AEP and CEP that are associated with drug toxicity, suggesting the possibility that AEP and CEP are distinct clinical presentations that share a common pathogenic pathway.
[Mh] Termos MeSH primário: Antibacterianos/efeitos adversos
Anti-Inflamatórios não Esteroides/efeitos adversos
Eosinofilia Pulmonar/induzido quimicamente
[Mh] Termos MeSH secundário: Doença Aguda
Adulto
Doença Crônica
Daptomicina/efeitos adversos
Eosinófilos
Feminino
Seres Humanos
Masculino
Mesalamina/efeitos adversos
Meia-Idade
Minociclina/efeitos adversos
Eosinofilia Pulmonar/sangue
Sulfassalazina/efeitos adversos
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Anti-Bacterial Agents); 0 (Anti-Inflammatory Agents, Non-Steroidal); 3XC8GUZ6CB (Sulfasalazine); 4Q81I59GXC (Mesalamine); FYY3R43WGO (Minocycline); NWQ5N31VKK (Daptomycin)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180208
[Lr] Data última revisão:
180208
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180126
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000009688


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[PMID]:27778204
[Au] Autor:Fortinsky KJ; Kevans D; Qiang J; Xu W; Bellolio F; Steinhart H; Milgrom R; Greenberg G; Cohen Z; Macrae H; Stempak J; McLeod R; Silverberg MS
[Ad] Endereço:University of Toronto, Toronto, Canada. kyle.fortinsky@mail.utoronto.ca.
[Ti] Título:Rates and Predictors of Endoscopic and Clinical Recurrence After Primary Ileocolic Resection for Crohn's Disease.
[So] Source:Dig Dis Sci;62(1):188-196, 2017 01.
[Is] ISSN:1573-2568
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND AND AIMS: The utility of postoperative medical prophylaxis (POMP) and the treatment of mild endoscopic recurrence remain controversial. METHODS: This study is a retrospective review of patients undergoing a primary ileocolic resection for CD at a single academic center. Endoscopic recurrence (ER) was defined using the Rutgeerts score (RS), and clinical recurrence (CR) was defined as symptoms of CD with endoscopic or radiologic evidence of neo-terminal ileal disease. RESULTS: There were 171 patients who met inclusion criteria. The cumulative probability of ER (RS ≥ i-1) at 1, 2, and 5 years was 29, 51, and 77 %, respectively. The only independent predictors of ER were the absence of POMP (HR 1.50; P = 0.03) and penetrating disease behavior (HR 1.50; P = 0.05). The cumulative probability of CR at 1, 2, and 5 years was 8, 13, and 27 %, respectively. There was a higher rate of clinical recurrence in patients with RS-2 compared to RS-1 on the initial postoperative endoscopy (HR 2.50; P = 0.02). In 11 patients not exposed to POMP with i-1 on initial endoscopy, only 2 patients (18 %) progressed endoscopically during the study period while 5 patients (45 %) regressed to i-0 on subsequent endoscopy without treatment. CONCLUSIONS: Postoperative medical prophylaxis decreased the likelihood of ER while certain phenotypes of CD appear to increase the risk of developing ER and CR. There may be a role for watchful waiting in patients with mild endoscopic recurrence on the initial postoperative endoscopy.
[Mh] Termos MeSH primário: Corticosteroides/uso terapêutico
Anti-Inflamatórios não Esteroides/uso terapêutico
Colectomia
Doença de Crohn/cirurgia
Fatores Imunológicos/uso terapêutico
Cuidados Pós-Operatórios/métodos
Prevenção Secundária/métodos
[Mh] Termos MeSH secundário: Adulto
Fatores Etários
Idoso
Colo/cirurgia
Doença de Crohn/diagnóstico
Doença de Crohn/prevenção & controle
Endoscopia do Sistema Digestório
Feminino
Seguimentos
Seres Humanos
Íleo/cirurgia
Estimativa de Kaplan-Meier
Masculino
Mesalamina/uso terapêutico
Meia-Idade
Modelos de Riscos Proporcionais
Recidiva
Estudos Retrospectivos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Adrenal Cortex Hormones); 0 (Anti-Inflammatory Agents, Non-Steroidal); 0 (Immunologic Factors); 4Q81I59GXC (Mesalamine)
[Em] Mês de entrada:1707
[Cu] Atualização por classe:171212
[Lr] Data última revisão:
171212
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:161026
[St] Status:MEDLINE
[do] DOI:10.1007/s10620-016-4351-7


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[PMID]:28471622
[Au] Autor:Har-Noy O; Kim B; Haiat R; Engel T; Ungar B; Eliakim R; Ho Kim W; Hee Cheon J; Ben-Horin S
[Ad] Endereço:Department of Gastroenterology, Sheba Medical Center Tel Hashomer, Israel.
[Ti] Título:Combination of Corticosteroids with 5-Aminosalicylic Acids Compared to Corticosteroids Alone for Hospitalized Patients with Active Ulcerative Colitis.
[So] Source:Isr Med Assoc J;18(10):613-618, 2016 Oct.
[Is] ISSN:1565-1088
[Cp] País de publicação:Israel
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Although 5-amino-salycilic acids (5-ASA) are often used with corticosteroid treatment in moderate-to-severe ulcerative colitis, the value of continuing/initiating 5-ASA in this clinical setting has not been explored. OBJECTIVES: To investigate the impact of a combination 5-ASA+corticosteroid therapy on the outcome of hospitalized patients with acute moderate-severe ulcerative colitis. METHODS: We conducted a retrospective study of patients hospitalized with moderate-severe ulcerative colitis in two centers, Israel and South Korea. Patients were classified into those who received 5-ASA and corticosteroids and those who received corticosteroids alone. Analysis was performed for each hospitalization event. The primary outcome was the rate of treatment failure defined as the need for salvage therapy (cyclosporin-A/infliximab/colectomy). The secondary outcomes were 30 days re-admission rates, in-hospital mortality rates, time to improvement, and length of hospitalization. RESULTS: We analyzed 209 hospitalization events: 151 patients (72%) received 5-ASA+corticosteroids and 58 (28%) corticosteroids alone. On univariate analysis the combination therapy group had a lower risk for treatment failure (11% vs. 31%, odds ratio 0.28, 95% confidence interval 0.13-0.59, P = 0.001). However, this difference disappeared on multivariate analysis, which showed pre-admission oral corticosteroid treatment to be the most significant factor associated with the need for salvage therapy. CONCLUSIONS: A signal for possible benefit of a combination 5-ASA and corticosteroids therapy was found, but was confounded by the impact of pre-admission corticosteroid treatment.
[Mh] Termos MeSH primário: Corticosteroides/administração & dosagem
Anti-Inflamatórios não Esteroides/administração & dosagem
Colite Ulcerativa/tratamento farmacológico
Mesalamina/administração & dosagem
[Mh] Termos MeSH secundário: Administração Oral
Adulto
Colite Ulcerativa/fisiopatologia
Quimioterapia Combinada
Feminino
Mortalidade Hospitalar
Hospitalização
Seres Humanos
Israel
Tempo de Internação
Masculino
Meia-Idade
República da Coreia
Estudos Retrospectivos
Terapia de Salvação/métodos
Índice de Gravidade de Doença
Resultado do Tratamento
Adulto Jovem
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; MULTICENTER STUDY
[Nm] Nome de substância:
0 (Adrenal Cortex Hormones); 0 (Anti-Inflammatory Agents, Non-Steroidal); 4Q81I59GXC (Mesalamine)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171128
[Lr] Data última revisão:
171128
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170505
[St] Status:MEDLINE


  9 / 3117 MEDLINE  
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[PMID]:28656793
[Au] Autor:Sferrazza G; Siviero PD; Nicotera G; Turella P; Serafino A; Blandizzi C; Pierimarchi P
[Ad] Endereço:a Institute of Translational Pharmacology , National Research Council , Rome , Italy.
[Ti] Título:Regulatory framework on bioequivalence criteria for locally acting gastrointestinal drugs: the case for oral modified release mesalamine formulations.
[So] Source:Expert Rev Clin Pharmacol;10(9):1007-1019, 2017 Sep.
[Is] ISSN:1751-2441
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: Bioequivalence testing for locally acting gastrointestinal drugs is a challenging issue for both regulatory authorities and pharmaceutical industries. The international regulatory framework has been characterized by the lack of specific bioequivalence tests that has generated a negative impact on the market competition and drug use in clinical practice. Areas covered: This review article provides an overview of the European Union and United States regulatory frameworks on bioequivalence criteria for locally acting gastrointestinal drugs, also discussing the most prominent scientific issues and advances that has been made in this field. A focus on oral modified release mesalamine formulations will be also provided, with practical examples of the regulatory pathways followed by pharmaceutical companies to determine bioequivalence. Expert commentary: The development of a scientific rationale to demonstrate bioequivalence in this field has been complex and often associated with uncertainties related to scientific and regulatory aspects. Only in recent years, thanks to advanced knowledge in this field, the criteria for bioequivalence assessment are undergoing substantial changes. This new scenario will likely result in a significant impact on pharmaceutical companies, promoting more competition through a clearer regulatory approach, conceived for streamlining the demonstration of therapeutic equivalence for locally acting gastrointestinal drugs.
[Mh] Termos MeSH primário: Controle de Medicamentos e Entorpecentes
Fármacos Gastrointestinais/administração & dosagem
Mesalamina/administração & dosagem
[Mh] Termos MeSH secundário: Administração Oral
Preparações de Ação Retardada
Fármacos Gastrointestinais/farmacocinética
Seres Humanos
Mesalamina/farmacocinética
Equivalência Terapêutica
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Delayed-Action Preparations); 0 (Gastrointestinal Agents); 4Q81I59GXC (Mesalamine)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170904
[Lr] Data última revisão:
170904
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170629
[St] Status:MEDLINE
[do] DOI:10.1080/17512433.2017.1348227


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[PMID]:28422869
[Au] Autor:Dai YC; Zheng L; Zhang YL; Chen X; Chen DL; Tang ZP
[Ad] Endereço:Institute of Digestive Disease, China-Canada Center of Research for Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
[Ti] Título:Effects of Jianpi Qingchang decoction on the quality of life of patients with ulcerative colitis: A randomized controlled trial.
[So] Source:Medicine (Baltimore);96(16):e6651, 2017 Apr.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:This study aims to determine the effects of the Jianpi Qingchang decoction (JQD) on the quality of life (QOL) of patients with spleen deficiency and dampness-heat syndrome ulcerative colitis (UC).A total of 120 active UC patients with spleen deficiency and dampness-heat syndrome were enrolled into this study. These patients were randomly divided into 2 groups: test group and control group (n = 60, each group). Patients in the test group were treated with JQD, while patients in control group were treated with 5-amino salicylic acid. After treatment for 8 weeks, differences in inflammatory bowel disease questionnaire (IBDQ) scores, short form-36 health survey questionnaire (SF-36) scores, and Sutherland Disease Activity Index (DAI) values were compared between these 2 groups to assess the QOL of patients.Sutherland DAI scores decreased in both groups after the treatment, but the difference was not statistically significant (P < .05). However, the difference in bowel symptoms, systemic symptoms, total scores of the 4 IBDQ dimensions (physical function, bodily pain, vitality, and mental health), and total scores of the SF-36 questionnaires between these 2 groups were statistically significant (P < .05).JQD can be used as supplementary and alternative therapy to relieve clinical symptoms in patients with mild to moderate active UC, and consequently improve their QOL.
[Mh] Termos MeSH primário: Colite Ulcerativa/complicações
Colite Ulcerativa/tratamento farmacológico
Medicamentos de Ervas Chinesas/uso terapêutico
Fármacos Gastrointestinais/uso terapêutico
Qualidade de Vida
Esplenopatias/complicações
[Mh] Termos MeSH secundário: Adulto
Feminino
Nível de Saúde
Seres Humanos
Masculino
Saúde Mental
Mesalamina/uso terapêutico
Meia-Idade
Dor/tratamento farmacológico
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Drugs, Chinese Herbal); 0 (Gastrointestinal Agents); 0 (jianpi qingre huayu); 4Q81I59GXC (Mesalamine)
[Em] Mês de entrada:1705
[Cu] Atualização por classe:170509
[Lr] Data última revisão:
170509
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170420
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000006651



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