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Hormônio do Crescimento Humano , Prolactina , Somatostatina , Somatostatina/análogos & derivados , Somatostatina/uso terapêutico , Humanos , Prolactina/metabolismo , Prolactina/sangue , Hormônio do Crescimento Humano/análogos & derivados , Tumores Neuroendócrinos/tratamento farmacológico , Tumores Neuroendócrinos/metabolismo , Neoplasias Hipofisárias/tratamento farmacológico , Neoplasias Hipofisárias/metabolismoRESUMO
AIM: To investigate the impact of pituitary surgery on glucose metabolism and to identify predictors of remission of diabetes after pituitary surgery in patients with acromegaly. METHODS: A national multicenter retrospective study of patients with acromegaly undergoing transsphenoidal surgery for the first time at 33 tertiary Spanish hospitals (ACRO-SPAIN study) was performed. Surgical remission of acromegaly was evaluated according to the 2000 and 2010 criteria. RESULTS: A total of 604 acromegaly patients were included in the study with a total median follow up of 91 months (interquartile range [IQR] 45-163). At the acromegaly diagnosis, 23.8% of the patients had diabetes mellitus (DM) with a median glycated hemoglobin (HbA1c) of 6.9% (IQR 6.4-7.9) [51.9 mmol/mol (IQR 46.4-62.8)]. In the multivariate analysis, older age (odds ratio [OR] 1.02, 95% CI 1.00-1.05), dyslipidemia (OR 5.25, 95% CI 2.81 to 9.79), arthropathy (OR 1.39, 95% CI 2.82 to 9.79), and higher IGF-I levels (OR 1.30, 95% CI 1.05 to 1.60) were associated with a greater prevalence of DM. At the last follow-up visit after surgery, 21.1% of the DM patients (56.7% of them with surgical remission of acromegaly) experienced diabetes remission. The cure rate of DM was more common in older patients (hazard ratio [HR] 1.77, 95% CI 1.31 to 2.43), when surgical cure was achieved (HR 2.10, 95% CI 1.01 to 4.37) and when anterior pituitary function was not affected after surgery (HR 3.38, 95% CI 1.17 to 9.75). CONCLUSION: Glucose metabolism improved in patients with acromegaly after surgery and 21% of the diabetic patients experienced diabetes remission; being more frequent in patients of older age, and those who experienced surgical cure and those with preserved anterior pituitary function after surgery.
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OBJECTIVE: The aim of this study is to compare the response to first-line medical treatment in treatment-naive acromegaly patients with pure growth hormone (GH)-secreting pituitary adenoma (GH-PA) and those with GH and prolactin cosecreting PA (GH&PRL-PA). DESIGN: This is a retrospective multicentric study of acromegaly patients followed from 2003 to 2023 in 33 tertiary Spanish hospitals with at least 6 months of first-line medical treatment. METHODS: Baseline characteristics, first-line medical treatment strategies, and outcomes were analyzed. We employed a multiple logistic regression full model to estimate the impact of some baseline characteristics on disease control after each treatment modality. RESULTS: Of the 144 patients included, 72.9% had a GH-PA, and 27.1% had a GH&PRL-PA. Patients with GH&PRL-PA were younger (43.9 ± 15.0 vs 51.9 ± 12.7 years, P < .01) and harboring more frequently macroadenomas (89.7% vs 72.1%, P = .03). First-generation somatostatin receptor ligand (fgSRL) as monotherapy was given to 106 (73.6%) and a combination treatment with fgSRL and cabergoline in the remaining 38 (26.4%). Patients with GH&PRL-PA received more frequently a combination therapy (56.4% vs 15.2%, P < .01). After 6 months of treatment, in the group of patients under fgSRL as monotherapy, those patients with GH&PRL-PA had worse control compared to GH-PAs (29.4% vs 55.1%, P = .04). However, these differences in the rate of disease control between both groups disappeared when both received combination treatment with fgSRL and cabergoline. CONCLUSION: In GH&PRL-PA, the biochemical control achieved with fgSRL as monotherapy is substantially worse than in patients harboring GH-PA, supporting the inclusion of cabergoline as first-line medical treatment in combination with fgSRLs in these subgroups of patients.
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Acromegalia , Cabergolina , Prolactina , Humanos , Acromegalia/tratamento farmacológico , Acromegalia/sangue , Feminino , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Adulto , Cabergolina/uso terapêutico , Resultado do Tratamento , Prolactina/sangue , Adenoma Hipofisário Secretor de Hormônio do Crescimento/tratamento farmacológico , Adenoma Hipofisário Secretor de Hormônio do Crescimento/sangue , Adenoma Hipofisário Secretor de Hormônio do Crescimento/metabolismo , Hormônio do Crescimento Humano , Adenoma/tratamento farmacológico , Adenoma/sangue , Adenoma/metabolismo , Adenoma/complicações , Idoso , Quimioterapia Combinada , Somatostatina/análogos & derivados , Somatostatina/uso terapêutico , Neoplasias Hipofisárias/tratamento farmacológico , Neoplasias Hipofisárias/sangue , Neoplasias Hipofisárias/metabolismo , Neoplasias Hipofisárias/complicações , Espanha/epidemiologiaRESUMO
The objective of the study was to evaluate the efficacy of second-line therapies in patients with acromegaly caused by a growth hormone (GH) and prolactin (PRL) co-secreting pituitary neuroendocrine tumor (GH&PRL-Pit-NET) compared to their efficacy in patients with acromegaly caused by a GH-secreting pituitary neuroendocrine tumor (GH-Pit-NET). This is a multicenter retrospective study of patients with acromegaly on treatment with pasireotide and/or pegvisomant. Patients were classified in two groups: GH&PRL-Pit-NETs when evidence of hyperprolactinemia and immunohistochemistry (IHC) for GH and PRL was positive or if PRL were >200 ng/dL regardless of the PRL-IHC and GH-Pit-NETs when the previously mentioned criteria were not met. A total of 28 cases with GH&PRL-Pit-NETs and 122 with GH-Pit-NETs met the inclusion criteria. GH&PRL-Pit-NETs presented at a younger age, caused hypopituitarism, and were invasive more frequently than GH-Pit-NETs. There were 124 patients treated with pegvisomant and 49 with pasireotide at any time. The efficacy of pegvisomant for IGF-1 normalization was of 81.5% and of pasireotide of 71.4%. No differences in IGF-1 control with pasireotide and with pegvisomant were observed between GH&PRL-Pit-NETs and GH-Pit-NETs. All GH&PRL-Pit-NET cases treated with pasireotide (n = 6) and 82.6% (n = 19/23) of the cases treated with pegvisomant normalized PRL levels. No differences in the rate of IGF-1 control between pegvisomant and pasireotide were detected in patients with GH&PRL-Pit-NETs (84.9% vs 66.7%, P = 0.178). We conclude that despite the more aggressive behavior of GH&PRL-Pit-NETs than GH-Pit-NETs, no differences in the rate of IGF-1 control with pegvisomant and pasireotide were observed between both groups, and both drugs have shown to be effective treatments to control IGF-1 and PRL hypersecretion in these tumors.
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Acromegalia , Hormônio do Crescimento Humano , Tumores Neuroendócrinos , Prolactina , Somatostatina , Humanos , Somatostatina/análogos & derivados , Somatostatina/uso terapêutico , Masculino , Feminino , Hormônio do Crescimento Humano/análogos & derivados , Hormônio do Crescimento Humano/uso terapêutico , Pessoa de Meia-Idade , Adulto , Prolactina/sangue , Prolactina/metabolismo , Estudos Retrospectivos , Tumores Neuroendócrinos/tratamento farmacológico , Tumores Neuroendócrinos/metabolismo , Acromegalia/tratamento farmacológico , Acromegalia/metabolismo , Neoplasias Hipofisárias/tratamento farmacológico , Neoplasias Hipofisárias/metabolismo , Idoso , Adulto JovemRESUMO
Introduction: Skin lesions are a common extraintestinal manifestation associated with inflammatory bowel disease (IBD), although they may also appear as a complication of IBD treatment. Prompt referral to the dermatologist can be very helpful in practice. Teledermatology complements the traditional in-person health care modality, improving access to dermatological care. Objective: To evaluate the impact of a store-and-forward teledermatology electronic consultation (e-consult) program on the care of IBD patients. Methods: A retrospective study assessing the outcomes of our teledermatology program over its first 2 years of implementation. Results: A total of 39 consultations involving 33 patients (69.2% women, mean age 39.6 years [12-63]) were conducted. The mean number of teleconsultations was 2.8 per month in the initial implementation stage: 33 consultations were carried out in patients with Crohn's disease and 6 in ulcerative colitis. Only 18% of the patients had an active flare-up. The most frequent reason for the e-consult was paradoxical psoriasiform lesions (n = 13, 33.3%), commonly related with anti-tumor necrosis factor agents (70% of the patients) and hidradenitis suppurativa (n = 4, 10.3%). Resolution was achieved in 87% of patients, with a mean waiting time of 4.7 days (0-14). Almost all patients (97%) were satisfied with our program, and considered the referral through the program to be appropriate (92%). Best valued features were the reduced waiting time and the coordinated approach between the two departments involved. Conclusions: Dermatology e-consult is an efficient and useful means of optimizing IBD patient care.
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PURPOSE: To evaluate differences in clinical presentation and in surgical outcomes between growth hormone-secreting pituitary adenomas (GH-PAs) and GH and prolactin co-secreting pituitary adenomas (GH&PRL-PAs). METHODS: Multicenter retrospective study of 604 patients with acromegaly submitted to pituitary surgery. Patients were classified into two groups according to serum PRL levels at diagnosis and immunohistochemistry (IHC) for PRL: a) GH&PRL-PAs when PRL levels were above the upper limit of normal and IHC for GH and PRL was positive or PRL levels were >100ng/and PRL IHC was not available (n=130) and b) GH-PAs who did not meet the previously mentioned criteria (n=474). RESULTS: GH&PRL-PAs represented 21.5% (n=130) of patients with acromegaly. The mean age at diagnosis was lower in GH&PRL-PAs than in GH-PAs (P<0.001). GH&PRL-PAs were more frequently macroadenomas (90.6% vs. 77.4%, P=0.001) and tended to be more invasive (33.6% vs. 24.7%, P=0.057) than GH-PAs. Furthermore, they had presurgical hypopituitarism more frequently (OR 2.8, 95% CI 1.83-4.38). IGF-1 upper limit of normality (ULN) levels at diagnosis were lower in patients with GH&PRL-PAs (median 2.4 [IQR 1.73-3.29] vs. 2.7 [IQR 1.91-3.67], P=0.023). There were no differences in the immediate (41.1% vs 43.3%, P=0.659) or long-term post-surgical acromegaly biochemical cure rate (53.5% vs. 53.1%, P=0.936) between groups. However, there was a higher incidence of permanent arginine-vasopressin deficiency (AVP-D) (7.3% vs. 2.4%, P=0.011) in GH&PRL-PAs patients. CONCLUSIONS: GH&PRL-PAs are responsible for 20% of acromegaly cases. These tumors are more invasive, larger and cause hypopituitarism more frequently than GH-PAs and are diagnosed at an earlier age. The biochemical cure rate is similar between both groups, but patients with GH&PRL-PAs tend to develop permanent postsurgical AVP-D more frequently.
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INTRODUCTION: Immune-mediated inflammatory diseases (IMID) are a group of disorders characterized by chronic inflammation caused by an altered immune regulation in targeted organs or systems. IMID itself could have an implied increased risk of venous thromboembolism (VTE) and this risk varies throughout the course of the disease as well as with some contraceptive methods and treatments. The aim of this study was to present some key considerations in relation to contraception in women with IMID. METHODS: This was an exploratory study conducted in Spain following the online modified Delphi methodology with two rounds of participation. Four questionnaires were designed for each medical specialty: gastroenterology, rheumatology, dermatology, and gynecology. Each questionnaire was divided in three domains: general recommendations about IMID, specific recommendations, and contraceptive methods for patients with IMID. A 5-point Likert scale measured agreement with each statement, with an 80% agreement threshold. Following the first round, the percentage of each response was calculated for every item. Subsequently, a second round was conducted to reach a consensus on the items for which discrepancies were observed. RESULTS: A total of 52 and 50 experts participated in the first and second round, respectively. Participants agreed on the existence of a higher risk of VTE in inflammatory bowel diseases, psoriasis, and rheumatoid arthritis diseases. Regarding recommendations for contraceptive methods in patients with IMID, experts considered the hormonal intrauterine device (IUD) as a first-line contraceptive (80.0%) and low doses of progesterone-only pills if the latter is not recommended (88.0%). Most of the interviewees concurred on the importance of the patients' contraceptive needs during the disease course (98.1%). CONCLUSION: Raising awareness and promoting a multidisciplinary relationship among the physicians involved in the therapeutic decisions by considering all the risk factors when prescribing a contraceptive method is important to prevent VTE in women with IMID.
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Anticoncepcionais , Tromboembolia Venosa , Humanos , Feminino , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controle , Consenso , Técnica Delphi , Anticoncepção/métodosRESUMO
Introduction: The internet is emerging as a source of information for patients with inflammatory bowel disease (IBD). However, it is not always reliable and may cause anxiety. We aim to assess patients' information habits and patients' and professionals' perceptions of a national website integrated as an educational resource for the IBD unit. Methods: Patients aged 18-65 years, comfortable with the internet, and attending follow-ups at participating IBD units (March-June 2019) and their professionals were invited to evaluate a recommended website through an online survey. Results: Three hundred eighty-nine patients and 95 professionals completed the survey. The internet (n = 109; 27.4%) was the second preferred source of information after the health care team (n = 229; 57.5%). Eighty percent of patients searched the internet for information on their disease and 28.6% did so at least once a week (n = 114), especially newly diagnosed ones (<2 years). Patients valued a website recommended by their professional (n = 379; 95.2%) and endorsed by the National Working Group (n = 377; 94.7%). They would attend online educational initiatives on the website (n = 279; 70.1%) and complete periodical surveys to improve its usefulness (n = 338; 84.9%). According to IBD professionals, this type of website is the best patient source of supplementary information (n = 76; 80%) and they "prescribe" it to most patients (67.0 ± 25.2%), especially the newly diagnosed patients (52.7 ± 26.5%). It effectively integrates routine face-to-face education (n = 95; 100%). Conclusions: Patients of IBD units, especially newly diagnosed ones, appreciate a trusted e-Health resource to back up professional information. The favorable opinion of patients and professionals will allow its use in training interventions.
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Educação a Distância , Doenças Inflamatórias Intestinais , Humanos , Inquéritos e Questionários , Doenças Inflamatórias Intestinais/terapia , InternetRESUMO
The authors wish to make the following corrections to this paper [...].
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INTRODUCTION: Serum cortisol levels within the first days after pituitary surgery have been shown to be a predictor of post-surgical adrenal insufficiency. However, the indication of empirical glucocorticoids to avoid this complication remains controversial. The objective is to assess the role of cortisol in the early postoperative period as a predictor of long-term corticotropic function according to the pituitary perisurgical protocol with corticosteroid replacement followed in our center. METHODS: One hundred eighteen patients who underwent surgery in a single center between December 2012 and January 2020 for a pituitary adenoma were included. Of these, 54 patients with previous adrenal insufficiency (AI), Cushing's disease, or tumors that required treatment with high-dose glucocorticoids (GC) were excluded. A treatment protocol with glucocorticoids was established, consisting of its empirical administration at rapidly decreasing doses, and serum cortisol was determined on the third day after surgery. Subsequent adrenal status was assessed through follow-up biochemical and clinical evaluations. RESULTS: Out of the 64 patients treated, there were 56 macroadenomas and 8 microadenomas. The incidence of adrenal insufficiency after pituitary surgery was 4.7%. The optimal cut-off value that predicted an adequate corticotropic reserve, taking into account the best relationship of specificity and sensitivity, was ≥4.1 µg/dl for serum cortisol on the third day (sensitivity 95.1%, specificity 100%). CONCLUSION: Serum cortisol on the third day predicts the development of adrenal insufficiency. We suggest a cortisol cut-off point of ≥4.1 µg/dl on postoperative on the third day after surgery as a predictor of the adrenal reserve in the long-term.
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Adenoma , Insuficiência Adrenal , Neoplasias Hipofisárias , Adenoma/cirurgia , Insuficiência Adrenal/tratamento farmacológico , Insuficiência Adrenal/etiologia , Glucocorticoides/uso terapêutico , Humanos , Hidrocortisona , Neoplasias Hipofisárias/cirurgiaRESUMO
INTRODUCTION: Familial non-medullary thyroid carcinoma (FNMTC) is defined by the presence of 2 or more first-degree family members with differentiated thyroid carcinoma (DTC). The aim of this study is to compare clinicopathological features and prognosis of FNMTC and sporadic carcinoma (SC). MATERIALS AND METHODS: Retrospective study of DTC included in the hospital database during the period 1990-2018. RESULTS: A total of 927 patients were analyzed, 61 of them were FNMTC, with a mean follow-up of 9.7⯱â¯6.5 years. The prevalence of FNMTC was 6.6%, with a lower TNM staging presentation (Pâ¯=â¯0.003) consequence of a higher proportion of tumors smaller than 2â¯cm (Pâ¯=â¯0.003), combined with a greater multifocality (Pâ¯=â¯0.034) and papillary histologic subtype (Pâ¯=â¯0.022) compared to SC. No significant differences in age at diagnosis (Pâ¯=â¯0.347), gender (Pâ¯=â¯0.406), neither in other aggressiveness markers (bilaterality, extrathyroidal extension, lymph node involvement and metástasis) were detected. Rate of persistence/recurrence (Pâ¯=â¯0.656), disease-free survival (Pâ¯=â¯0.929) and mortality caused by the tumor itself (Pâ¯=â¯0.666) were comparable. Families with ≥3 affected relatives, had smaller tumors (Pâ¯=â¯0.005), more multifocality (Pâ¯=â¯0.040) and bilaterality (Pâ¯=â¯0.002), as well as a higher proportion of males (Pâ¯=â¯0.020). Second generation patients present earlier FNMTC compared to those of the first generation (Pâ¯=â¯0.001). CONCLUSION: In our study FNMTC presents a lower TNM staging, higher multifocality and papillary variant, with similar aggressiveness and prognosis compared to SC.
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Carcinoma Papilar , Carcinoma , Neoplasias da Glândula Tireoide , Carcinoma/diagnóstico , Carcinoma/epidemiologia , Carcinoma/genética , Carcinoma Papilar/patologia , Humanos , Masculino , Prognóstico , Estudos Retrospectivos , Câncer Papilífero da Tireoide/epidemiologia , Neoplasias da Glândula Tireoide/diagnóstico , Neoplasias da Glândula Tireoide/epidemiologia , Neoplasias da Glândula Tireoide/genéticaRESUMO
OBJECTIVE: No studies evaluating the rapidity of response to biological therapies are available for Crohn's disease (CD). The aim of this study was to evaluate rapidity of onset of clinical response and impact on quality of life (QoL) of adalimumab therapy in adult anti-TNF-naïve patients with moderately-to-severely active CD. PATIENTS AND METHODS: RAPIDA was an open-label, single-arm, prospective, multicenter clinical trial. Adult patients with moderately-to-severely active luminal CD, anti-TNF-naïve, and unresponsive to conventional therapy were treated with adalimumab. Clinical disease activity, QoL and inflammatory biomarkers were measured at day 4, and weeks 1, 2, 4, and 12 after treatment initiation. RESULTS: Eighty-six patients were included in the intention-to-treat (ITT) analyses. Clinical disease activity was reduced from a median of 9.0 points to 6.0 points at day 4. Clinical response (≥ 3-point reduction in the Harvey-Bradshaw Index, HBI) was achieved by 61.6% (d4) and 75.6% (w1) of patients in the ITT population (median 2.5 days) and with non-responder imputation (NRI), by 55.8% and 53.4%, respectively. The proportion of patients in clinical remission (HBI<5) at weeks 2 and 4 in the ITT population was 54.7% and 62.8%, respectively (median 7.0 days), and 38.4% and 45.3% in the NRI population. All QoL scores significantly improved and inflammatory biomarkers significantly decreased from day 4 onwards (p<0.0001). CONCLUSION: Rapid clinical response and remission, improvement in QoL and fatigue, and a reduction of inflammatory biomarkers were achieved with adalimumab as early as day 4 in adult anti-TNF-naïve patients with moderately-to-severely active CD.
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Adalimumab/uso terapêutico , Doença de Crohn/tratamento farmacológico , Qualidade de Vida , Inibidores do Fator de Necrose Tumoral/uso terapêutico , Adulto , Idoso , Biomarcadores/sangue , Doença de Crohn/sangue , Fadiga/tratamento farmacológico , Feminino , Humanos , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Indução de Remissão , Índice de Gravidade de Doença , Espanha , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
INTRODUCTION: Familial non-medullary thyroid carcinoma (FNMTC) is defined by the presence of 2or more first-degree family members with differentiated thyroid carcinoma (DTC). The aim of this study is to compare clinicopathological features and prognosis of FNMTC and sporadic carcinoma (SC). MATERIALS AND METHODS: Retrospective study of DTC included in the hospital database during the period 1990-2018. RESULTS: A total of 927 patients were analyzed, 61 of them were FNMTC, with a mean follow-up of 9.7±6.5 years. The prevalence of FNMTC was 6.6%, with a lower TNM staging presentation (P=.003) consequence of a higher proportion of tumors smaller than 2 centimeters (P=.003), combined with a greater multifocality (P=.034) and papillary histologic subtype (P=.022) compared to SC. No significant differences in age at diagnosis (P=.347), gender (P=.406), neither in other aggressiveness markers (bilaterality, extrathyroidal extension, lymph node involvement and metástasis) were detected. Rate of persistence/recurrence (P=.656), disease-free survival (P=.929) and mortality caused by the tumor itself (P=.666) were comparable. Families with ≥3 affected relatives, had smaller tumors (P=.005), more multifocality (P=.040) and bilaterality (P=.002), as well as a higher proportion of males (P=.020). Second generation patients present earlier FNMTC compared to those of the first generation (P=.001). CONCLUSION: In our study FNMTC presents a lower TNM staging, higher multifocality and papillary variant, with similar aggressiveness and prognosis compared to SC.
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(1) Aims: To assess the incidence of inflammatory bowel disease (IBD) in Spain, to describe the main epidemiological and clinical characteristics at diagnosis and the evolution of the disease, and to explore the use of drug treatments. (2) Methods: Prospective, population-based nationwide registry. Adult patients diagnosed with IBD-Crohn's disease (CD), ulcerative colitis (UC) or IBD unclassified (IBD-U)-during 2017 in Spain were included and were followed-up for 1 year. (3) Results: We identified 3611 incident cases of IBD diagnosed during 2017 in 108 hospitals covering over 22 million inhabitants. The overall incidence (cases/100,000 person-years) was 16 for IBD, 7.5 for CD, 8 for UC, and 0.5 for IBD-U; 53% of patients were male and median age was 43 years (interquartile range = 31-56 years). During a median 12-month follow-up, 34% of patients were treated with systemic steroids, 25% with immunomodulators, 15% with biologics and 5.6% underwent surgery. The percentage of patients under these treatments was significantly higher in CD than UC and IBD-U. Use of systemic steroids and biologics was significantly higher in hospitals with high resources. In total, 28% of patients were hospitalized (35% CD and 22% UC patients, p < 0.01). (4) Conclusion: The incidence of IBD in Spain is rather high and similar to that reported in Northern Europe. IBD patients require substantial therapeutic resources, which are greater in CD and in hospitals with high resources, and much higher than previously reported. One third of patients are hospitalized in the first year after diagnosis and a relevant proportion undergo surgery.
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Colonic inflammatory bowel diseases have a higher risk of developing colorectal cancer compared to the general population, which is why they require endoscopic screening techniques with specific follow-up intervals based on the different risk factors described on the literature. This position paper analyzes the current scientific evidence for the different endoscopic techniques available today, how their implementation should be carried out in endoscopic units and describes in detail how their implementation should be carried out, in which patients and with what interval, and finally, what should be the response to finding dysplasia, proposing a specific follow-up algorithm.
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Carcinoma in Situ/diagnóstico por imagem , Neoplasias Colorretais/diagnóstico por imagem , Corantes , Consenso , Doença de Crohn , Endoscopia Gastrointestinal/métodos , Doenças Inflamatórias Intestinais/complicações , Colite Ulcerativa/complicações , Neoplasias Colorretais/etiologia , Doença de Crohn/complicações , Detecção Precoce de Câncer , Endoscopia Gastrointestinal/normas , Humanos , EspanhaRESUMO
Objectives: Mobile apps are useful tools in e-health and self-management strategies in disease monitoring. We evaluated the Harvey-Bradshaw index (HBI) mobile app self-administered by the patient to see if its results agreed with HBI in-clinic assessed by a physician. Methods: Patients were enrolled in a 4-month prospective study with clinical assessments at months 1 and 4. Patients completed mobile app HBI and within 48 h, HBI was performed by a physician (gold standard). HBI scores characterized Crohn's disease (CD) as remission <5 or active ≥5. We determined agreement per item and total HBI score and intraclass correlation coefficients (ICCs). Bland-Altman plot was performed. HBI changes in disease activity from month 1 to month 4 were determined. Results: A total of 219 patients were enrolled. All scheduled assessments (385 pairs of the HBI questionnaire) showed a high percentage of agreement for remission/activity (92.4%, κ = 0.796), positive predictive value (PPV) for remission of 98.2%, and negative predictive value of 76.7%. High agreement was also found at month 1 (93.15%, κ = 0.82) and month 4 (91.5%, κ = 0.75). Bland-Altman plot was more uniform when the HBI mean values were <5 (remission). ICC values were 0.82, 0.897, and 0.879 in all scheduled assessments, 1 and 4 months, respectively. Conclusions: We found a high percentage of agreement between patients' self-administered mobile app HBI and in-clinic physician assessment to detect CD activity with a remarkably high PPV for remission. The mobile app HBI might allow a strict control of inflammation by remote monitoring and flexible follow-up of CD patients. Reduction of sanitary costs could be possible.
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Doença de Crohn/diagnóstico , Doença de Crohn/terapia , Aplicativos Móveis , Autogestão , Adulto , Idoso , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Índice de Gravidade de Doença , Inquéritos e Questionários , TelemedicinaRESUMO
OBJECTIVE. The purpose of this article is to assess the ability of MR enterography (MRE) to predict the evolution of Crohn disease (CD) under anti-tumor necrosis factor-α (anti-TNF) therapy. In particular, we analyzed the effect of achieving a radiologic response (RR) on long-term patient outcomes. MATERIALS AND METHODS. We included patients with small-bowel CD who successfully started receiving anti-TNF (infliximab or adalimumab) therapy and achieved clinical remission between 2008 and 2015. MRE was performed at baseline and close to 1 year after treatment initiation. The degree of CD activity was evaluated on the basis of a per-patient MRE score used at our hospital. Individual scores were calculated and recorded on the day of analysis. The median duration of follow-up after induction therapy was 5 years (interquartile range, 2.5-9.0 years). Cumulative probabilities of not having a loss of response (LOR) were assessed using the Kaplan-Meier method and compared using the log-rank test. RESULTS. Thirty-four patients fulfilled the prerequisites for inclusion in the study. Complete RR was achieved in nine patients (26.5%), partial RR in 13 (38.2%), and either no RR or worsening in 12 (35.3%). For the three aforementioned response groups, the estimated probability of absence of LOR at 5 years was 0.88, 0.69, and 0.25, respectively, and the log-rank test suggested that the risk rates for LOR were different (p = 0.023). Based on Cox regression, an MRE score reduction of less than 50% at close to 1 year after treatment initiation was an independent risk factor for LOR (hazard ratio, 0.257; 95% CI, 0.070-0.953; p = 0.027). CONCLUSION. The MRE response after 1 year is a predictor of the efficacy of anti-TNF treatment.
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Adalimumab/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Doença de Crohn/diagnóstico por imagem , Doença de Crohn/tratamento farmacológico , Infliximab/uso terapêutico , Intestino Delgado , Imageamento por Ressonância Magnética/métodos , Adolescente , Adulto , Idoso , Meios de Contraste , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Indução de Remissão , Estudos RetrospectivosAssuntos
Formação de Anticorpos , Fatores Imunológicos , Adalimumab , Humanos , Infliximab , PacientesRESUMO
BACKGROUND: In APPRECIA trial, Crohn's disease (CD) patients undergoing intestinal resection were randomized to postoperative adalimumab (ADA) or azathioprine (AZA). AIMS: To evaluate health-related quality of life (HRQoL) in APPRECIA trial. METHODS: HRQoL was evaluated using disease-specific shortened Spanish version of the IBDQ (SIBDQ-9) and generic European Quality of Life-5 Dimensions (EQ-5D) questionnaires, completed at baseline and at weeks 24 and 52. RESULTS: Sixty-one patients (37 ADA and 24 AZA) had evaluable data for HRQoL. Patients treated with ADA or AZA had significant improvement from baseline to weeks 24 and 52 in SIBDQ-9 and EQ-5D (pâ¯<â¯0.001 and pâ¯≤â¯0.006 for all comparisons, respectively). There were no differences between treatment arms in mean change in SIBDQ-9 and EQ-5D at weeks 24 and 52 vs baseline. Only patients without endoscopic recurrence had significant improvement in SIBDQ-9 (pâ¯<â¯0.001) and EQ-5D (pâ¯<â¯0.001) at week 52. At week 52, there was a high to moderate negative correlation between CDAI score with SIBDQ-9 score (Pearson's r: -0.768) and with EQ-5D index (r: -0.644). CONCLUSION: HRQoL improved after intestinal resection in CD, irrespective of the postoperative therapy used (ADA or AZA). Outcomes in HRQoL were associated with prevention of endoscopic recurrence, since improvements in HRQoL were only significant in patients with endoscopic remission at 1 year.
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Adalimumab/uso terapêutico , Azatioprina/uso terapêutico , Doença de Crohn/tratamento farmacológico , Imunossupressores/uso terapêutico , Qualidade de Vida , Adulto , Doença de Crohn/cirurgia , Endoscópios Gastrointestinais , Feminino , Humanos , Masculino , Período Pós-Operatório , Recidiva , Indução de Remissão , Espanha , Inquéritos e QuestionáriosRESUMO
OBJECTIVES: (a) To evaluate the diagnostic accuracy of anti-TNF trough levels to predict mucosal healing in inflammatory bowel disease (IBD); (b) to determine the best cut-off point to predict mucosal healing in IBD patients treated with anti-TNF. METHODS: This is a multicenter, prospective study. IBD patients under anti-TNF treatment for at least 6 months that had to undergo an endoscopy were included. Mucosal healing was defined as: Simple endoscopic score for Crohn's Disease < 3 for Crohn's disease (CD), Rutgeerts score < i2 for CD in postoperative setting, or Mayo endoscopic score ≤ 1 for ulcerative colitis (UC). Anti-TNF concentrations were measured using SMART ELISAs at trough. RESULTS: A total of 182 patients were included. Anti-TNF trough levels were significantly higher among patients that had mucosal healing than among those who did not. The area under the curve of infliximab for mucosal healing was 0.63 (best cutoff value 3.4 µg/mL), and for adalimumab 0.60 (best cutoff value 7.2 µg/mL). In the multivariate analysis, having anti-TNF drug levels above the cutoff values [odds ratio (OR) 3.1]) and having UC instead of CD (OR 4) were associated with a higher probability of having mucosal healing. Additionally, the need for an escalated dosage (OR 0.2) and current smoking habit (OR 0.2) were also associated with a lower probability of mucosal healing. CONCLUSIONS: There was an association between anti-TNF trough levels and mucosal healing in IBD patients; however, the accuracy of the determination of infliximab and adalimumab concentrations able to predict mucosal healing was suboptimal.