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1.

Background

Biologics against tumor necrosis factor (anti-TNF) have dramatically changed the management of moderate-to-severe ulcerative colitis (UC). In pivotal clinical trials, golimumab showed efficacy as induction and maintenance therapy in anti-TNF naïve UC patients. However, confirmatory data on effectiveness in the real world setting are needed.

Aim

to summarize recent evidence on the effectiveness of golimumab in observational real-world studies.

Methods

A literature search was conducted using Medline, Embase, and congresses databases for English language articles or abstracts on the effectiveness of golimumab published between January 1, 2014 and May 15, 2018. Pooled short-term (6–14 weeks) and mid- and long-term (24–54 weeks) clinical response and remission rates were calculated.

Results

24 abstracts were included; of those 8 were published full-text articles and 16 were abstracts from medical conferences. Overall, pooled short-term clinical response and remission rates were 59.3% (range 35–85.5%; 13 studies; 1429 patients) and 35.9% (range 14–51.7%; 9 studies; 666 patients), respectively. Pooled mid- and long-term clinical response and remission rates were 60.3% (range 37.1–89.5%; 4 studies; 356 patients) and 39.2% (range 12–84%; 8 studies; 822 patients), respectively.

Conclusions

Results: of observational studies confirm that golimumab is an effective therapy for UC in clinical practice.  相似文献   

2.
3.

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 (p?<?0.001 and p?≤?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 (p?<?0.001) and EQ-5D (p?<?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.  相似文献   

4.

Background

The long-term management of perianal Crohn’s disease for patients on anti-TNF-α therapy remains challenging.

Aim

To evaluate the long-term course and complications of patients with perianal fistulas treated with anti-TNF-α based on their clinical remission and healing on MRI.

Methods

Patients were evaluated clinically and by MRI. Deep remission was defined as clinical remission associated with the absence of contrast enhancement and T2 hyperintensity on MRI. Flare-free survival, surgery and hospitalizations were compared based on the presence or not of deep remission.

Results

Forty-eight consecutive patients were included with a median follow-up of 62?months after anti-TNF-α first administration. Deep remission was observed in 16 patients (33.4%). For patients in deep remission, the median time to any perianal event was 116?months (95–130) versus 42?months (8–72) in patients with pathological MRI (p?<?0.001). Sixteen patients (50%) with pathological MRI had perianal surgery versus 2 (12.5%) in the deep remission group (p?<?0.05). The mean duration of cumulative hospital stays was 0.75?±?0.52?days in the deep remission group versus 19.7?±?7.4 in the pathological group (p?<?0.05).

Conclusions

Higher flare-free survival and lower rates of surgery and hospitalization were found in patients achieving deep remission.  相似文献   

5.

Backgound

A significant proportion of hepatitis B surface antigen (HBsAg) negative/anti-hepatitis B core antigen (anti-HBc) positive patients with non-Hodgkin lymphoma (NHL) undergoing rituximab-based chemotherapy (R-CT) may suffer hepatitis B virus (HBV) reactivation.

Aims

We wanted to assess efficacy and safety of lamivudine (LMV) prophylaxis to prevent this complication.

Methods

Eighty-five consecutive HBsAg negative/anti-HBc positive NHL patients (71 years, 100% serum HBV DNA undetectable, 74% anti-HBs positive) received LMV coadministered with R-CT and for 18 months after the end of R-CT. Serum ALT, HBsAg, anti-HBs and HBV DNA were assessed every 4 months during and after end of LMV.

Results

During 39 (2–108) months of study period, including 21 months of LMV and 27 additional months after LMV discontinuation, one patient (2%) had HBV reactivation, 31 months after stopping LMV and during administration of new immunosuppressive regimens, without LMV prophylaxis, owing to incomplete oncological response. A 50% decline of anti-HBs titers occurred in 22/63 (35%) patients, including 12 who became anti-HBs seronegative. Five (6%) patients had ALT increase during R-CT but none required R-CT discontinuation. Seventeen (20%) patients died, all for tumour progression.

Conclusion

LMV prophylaxis is safe and effective in preventing HBV reactivation in HBsAg negative/anti-HBc positive NHL patients receiving R-CT.  相似文献   

6.

Background

Cholangiocarcinoma (CCA) represents a devastating malignancy characterized by high mortality, and notoriously problematic to diagnose. Recently, microRNAs (miRs) have been intensively investigated due to their potential usefulness from a tumor treatment perspective.

Aims

The current study was aimed to investigate whether miR-494 influences epithelial-mesenchymal transition (EMT), tumor growth and metastasis of CCA.

Methods

The regulatory miRNAs of WDHD1 in CCA expression chip were predicted, followed by determination of the miR-494 and WDHD1 expression in normal cholangiocyte tissues and CCA tissues. The related protein levels were determined. CCA cell migration, invasion, viability, and cell cycle distribution and the dosage-dependent effect of miR-494 on CCA cell growth were subsequently detected. Finally, tumorigenicity and lymph node metastasis (LNM) were measured.

Results

Initially, miR-194 affected the CCA development via negatively regulating WDHD1 and miR-494 which were downregulated while WDHD1 was upregulated in CCA. In addition, miR-494 overexpression elevated E-cadherin expression while decreased expressions of WDHD1, N-cadherin, Vimentin, Snail, Twist and MMP-9. Finally, overexpressed miR-494 was observed to suppress EMT, cell viability, migration, invasion, arrest cell cycle progression, tumor formation, and LNM while accelerating cell apoptosis in vivo.

Conclusion

This study indicated that miR-494 overexpression suppresses EMT, tumor formation and LNM while promoting CCA cell apoptosis through inhibiting WDHD1 in CCA.  相似文献   

7.

Background

Sigmoid volvulus is a common cause of colonic obstruction in old and frail patients. Its standard management includes the endoscopic detorsion of the colonic loop, followed by an elective sigmoidectomy to prevent recurrence. However, these patients are often poor candidates for surgery.

Aim

The aim of this study was to compare death rate between elective sigmoidectomy and conservative management following endoscopic detorsion for sigmoid volvulus.

Methods

The medical records of 83 patients undergoing endoscopic detorsion of a sigmoid volvulus from 2008 to 2014 were retrospectively reviewed. Patients were divided into two groups: ‘elective surgery’ and ‘no surgery’.

Results

Patients in the ‘no surgery’ group (n?=?42) were older and had more loss of autonomy than in the ‘elective surgery’ group. Volvulus endoscopic detorsion was successful in 96% of patients with no complications. The median follow-up was 13 months (1 day-67 months). The death rate was 62% in the ‘no surgery’ group versus 32% in the ‘elective surgery’ group (p?=?0.02). In the ‘no surgery’ group, 23/42 of patients had volvulus recurrence. No recurrence occurred after surgery.

Conclusion

Elective surgery must be planned as soon as possible after the first episode of sigmoid volvulus. In frail patients, other options must be developed.  相似文献   

8.

Background

Few studies on the age of resolution of Food Protein Induced Enterocolitis Syndrome (FPIES) induced by solid foods are available. In particular, for FPIES induced by egg, the mean age of tolerance acquisition reported in the literature ranges from 42 to 63 months.

Objective

We have assessed whether the age of tolerance acquisition in acute egg FPIES varies depending on whether the egg is cooked or raw.

Methods

We conducted a retrospective and multicentric study of children with diagnosis of acute egg FPIES seen in 10 Italian allergy units between July 2003 and October 2017. The collected data regarded sex, presence of other allergic diseases, age of onset of symptoms, kind and severity of symptoms, cooking technique of the ingested egg, outcome of the allergy test, age of tolerance acquisition.

Results

Sixty-one children with acute egg FPIES were enrolled, 34 (56%) males and 27 (44%) females. Tolerance to cooked egg has been demonstrated by 47/61 (77%) children at a mean age of 30.2 months. For 32 of them, tolerance to raw egg has been demonstrated at a mean age of 43.9 months. No episodes of severe adverse reaction after baked egg ingestion have been recorded.

Conclusions

It is possible to perform an OFC with baked egg, to verify the possible acquisition of tolerance, at about 30 months of life in children with acute egg FPIES.  相似文献   

9.

Background

Chronic hepatitis B virus (HBV) infection remains a primary cause of morbidity and mortality worldwide.

Aim

The study is aimed at updating the clinical and epidemiological profile of chronic HBV infection in Italy.

Methods

A cross-sectional multicenter prospective study enrolled consecutive HBsAg positive patients seen in 73 Italian centers in the period 2012–2015. Individual patient data were collected using an electronic platform and analyzed using standard statistical methods.

Results

Among 2877 HBsAg positive individuals (median age 49.8?years, 68% males), 27% were non-Italian natives (NINs); 20% had chronic infection, 58.5% chronic hepatitis and 21.5% cirrhosis. Among NINs, age was younger, male gender was less prevalent and liver disease less advanced than in Italians (all p?<?0.0001). HBeAg positive cases were 23.6% among NINs vs 8.2% in Italians (p?<?0.0001); HDV coinfections 11.1% vs 7.3% (p?=?0.006) and HCV coinfections 2.3% vs 4.2% (p?=?0.017), respectively. Anti-HDV or anti-HCV antibodies were detected more frequently in patients with cirrhosis. Fifty percent of NINs with cirrhosis were aged below 45?years.

Conclusion

The study offers an insight into the evolving burden of chronic hepatitis B virus infection in the near future and highlights new territories for public health interventions.  相似文献   

10.

Aims

To study the association of EMR’s clinical reminder use on a comprehensive set of diabetes quality metrics in U.S. office-based physicians and within solo- versus multi-physician practices. We conducted a retrospective cohort study on visits made by adults with diabetes identified from the National Ambulatory Medical Care Survey (2012–2014).

Methods

Multiple logistic regression is used to test for associations between clinical reminder use and recommended services by the American Diabetes Association.

Results

Of 5508 visits, nationally representing 112,978,791 visits, 31% received HbA1c tests, 13% received urinalysis test, and <10% received retinal or foot exams. Main effects of practice size and clinical reminder use were found for HbA1c, urinalysis, and foot exams. We find no statistically significant relationship to suggest that clinical reminder use improve diabetes process guidelines for solo practices.

Conclusions

Resource efforts, beyond clinical reminders, are needed to reduce gaps in primary diabetes care between solo and non-solo practices.  相似文献   

11.

Background

Reflex testing of antibodies and viral load in the same sample for diagnosing hepatitis C virus infection speeds up access to treatment. However, how hepatitis C is diagnosed in Spanish hospitals is unknown.

Objective

To describe the available resources and procedures for the diagnosis of hepatitis C virus infection in Spain.

Methods

Survey sent to public and private Spanish hospitals with teaching accreditation with at least 200 beds.

Results

Of the 160 hospitals that met the inclusion criteria, 90 centres (response rate 56.3%) completed the survey. Two hospitals (2.2%) have no diagnostic resources, 15 (16.7%) can only test for anti-hepatitis C virus(Ab), 9 (10.0%) for Ab and viral load, 47 (52.2%) for Ab, viral load and genotype, 2 (2.2%) for Ab, viral load and core antigen, and 15 (16.7%) can perform Ab, core antigen, viral load and genotype tests. When an Ab test is positive, 28 (31.1%) hospitals perform reflex testing. When an active infection is diagnosed, some communication strategy is used in 62 (68.9%) hospitals. Approximately 44.2% of the respondents believe that all determinations needed to reach a definitive diagnosis should be done on a single blood sample.

Conclusion

Although 81% of Spanish hospitals have the resources to perform reflex hepatitis C virus infection testing, it is only done in 31%, and less than a half of respondents believe that the definitive diagnosis should be performed on a single sample.  相似文献   

12.
13.

Objective

Intra-articular corticosteroid injections (IACI) are a fundamental part in the treatment of juvenile idiopathic arthritis. The current situation of IACI is reviewed in a population of children.

Methods

We conducted a narrative review of the literature related to IACI in children, with respect to the injection technique, use of local and general anesthesia, ultrasound guidance of the procedure, indications, special joints and type of optimal corticosteroid.

Results

IACI are indicated in any subcategory of juvenile idiopathic arthritis, especially in oligoarticular juvenile idiopathic arthritis. The use of local anesthetic is highly recommended, and in patients younger than 6 years or requiring multiple joint injections, conscious sedation can also be an option. Ultrasound guidance of injections is recommended in expert hands, but not in a generalized way. Triamcinolone hexacetonide is the corticosteroid of choice in large joints, whereas a more soluble corticosteroid is a better alternative in small or superficial joints (betamethasone or methylprednisolone) to avoid subcutaneous atrophy or hypopigmentation, the most frequent adverse effect of IACI.

Conclusions

IACI are performed heterogeneously and scientific evidence is limited in many cases.  相似文献   

14.

Background

The growing number of gastric cancers together with improved survival resulted in an increasing population of survivors at risk of multiple primary cancers.

Aims

To estimate the 10-year risk and survival of third primary cancers (TPCs) among gastric first primary cancers (FPCs).

Methods

Gastric FPCs from the Portuguese North Region Cancer Registry, diagnosed in 2000-2006 (n?=?7409), were followed for a TPC (31/12/2012), and for all-cause death (31/12/2017). The cumulative incidence of TPCs was estimated. Patients with a TPC were matched (1:1, by sex, age group, years between FPC and second primary cancer [SPC] diagnosis, and SPC location) to FPC?+?SPC patients without a TPC.

Results

Overall, 25 (0.3% of FPCs and 6.8% of SPCs) TPCs were diagnosed. The most common sites were tobacco-related, mainly including digestive organs. Among all FPCs, 10-year cumulative incidence (95% confidence interval [CI]) of a TPC was 0.4% (0.2–0.5%) and among SPCs 7.6% (4.4–10.8%). For TPCs, compared to matched patients, age-adjusted hazard ratio (95%CI) for death was 1.68 (0.77–3.67). The 10-year cumulative mortality of TPCs and matched patients was 92.6% and 67.9%, respectively.

Conclusions

A clustering of tobacco-related cancers was observed in TPCs, with a 10-year cumulative incidence of 0.4% among FPCs. TPCs had worse survival than patients without a TPC.  相似文献   

15.
16.
17.

Background

The current definitions and etiologies of acute-on-chronic liver failure (ACLF) are clearly very different between East and West.

Aims

This study aimed to develop an effective prognostic nomogram for acute-on-chronic hepatitis B liver failure (ACHBLF) as defined by the Asia Pacific Association for the Study of the Liver (APASL).

Methods

The nomogram was based on a retrospective study of 573 patients with ACHBLF, defined according to the APASL, at the Beijing Ditan Hospital. The results were validated using a bootstrapped approach to correct for bias in two external cohorts, including an APASL ACHBLF cohort (10 hospitals, N?=?329) and an EASL-CLIF ACHBLF cohort (Renji Hospital, N?=?300).

Results

Multivariate analysis of the derivation cohort for survival analysis helped identify the independent factors as age, total bilirubin, albumin, international normalized ratio, and hepatic encephalopathy, which were included in the nomogram. The predictive value of nomogram was the strongest compared with CLIF-C ACLF, MELD and MELD-Na and similar to COSSH-ACLF in both the derivation and prospective validation cohorts with APASL ACHBLF, but the CLIF-C ACLF was better in the EASL-CLIF ACHBLF cohort.

Conclusions

The proposed nomogram could accurately estimate individualized risk for the short-term mortality of patients with ACHBLF as defined by APASL.  相似文献   

18.

Introduction

In iatrogenic or potentially reversible bradyarrhythmia, drug discontinuation or metabolic correction is recommended before permanent cardiac pacemaker (PM) implantation. These patients often have conduction system disease and there are few data on recurrence or the need for a permanent PM.

Objective

To analyze the need for PM implantation in patients with iatrogenic bradyarrhythmia or bradyarrhythmia associated with other potentially reversible causes.

Methods

We assessed consecutive symptomatic patients admitted to the emergency department with a primary diagnosis of bradyarrhythmia (atrioventricular [AV] node disease – complete or second‐degree AV block (AVB) [CAVB: 2nd‐degree AVB – 2:1], sinus bradycardia [SB] and atrial fibrillation [AF] with slow ventricular response [SVR]) in the context of iatrogenic causes or metabolic abnormalities. We determined the percentage of patients who required PM implantation.

Results

We studied 153 patients (47% male) admitted for iatrogenic or potentially reversible bradyarrhythmia. Diagnoses were SB 16%, CAVB 63%, second‐degree AVB 12%, and AF with SVR 10%. Eighty‐five percent of patients were under negative chronotropic therapy, 3% had hyperkalemia and 12% had a combined etiology. After correction of the cause, 55% of patients (n=84) needed a PM. In these patients the most common type of bradyarrhythmia was CAVB, in 77% (n=65) patients.

Conclusion

In a high percentage of patients with bradyarrhythmia associated with a potentially reversible cause, the arrhythmia recurs or does not resolve during follow‐up. Patients with AV node disease constitute a subgroup with a higher risk of recurrence who require greater vigilance during follow‐up and should be considered for PM implantation after the first episode.  相似文献   

19.

Introduction and objectives

To assess the cost-effectiveness of edoxaban vs acenocoumarol in the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF) in Spain.

Methods

Markov model, adapted to the Spanish setting from the perspective of the National Health System, stimulating the progression of a hypothetical cohort of patients with NVAF throughout their lifetime, with different health states: stroke, haemorrhage, and other cardiovascular complications. Efficacy and safety data were obtained from the available clinical evidence (mainly from the phase III ENGAGE AF-TIMI 48 study). The costs of managing NVAF and its complications were obtained from Spanish sources.

Results

Edoxaban use led to 0.34 additional quality-adjusted life years (QALY) compared with acenocoumarol. The incremental cost with edoxaban was 3916€, mainly because of higher pharmacological costs, which were partially offset by lower costs of treatment monitoring and managing NVAF events and complications. The cost per QALY was 11 518€, within the thresholds commonly considered cost-effective in Spain (25 000-30 000 €/QALY). The robustness of the results was confirmed by various sensitivity analyses.

Conclusions

Edoxaban is a cost-effective alternative to acenocoumarol in the prevention of stroke and systemic embolism in patients with NVAF in Spain.  相似文献   

20.

Background

Mother-to-child-transmission (MTCT) is the main route of HIV-1 infection in children. Genetic studies suggest HLA-B alleles play an important role on HIV-1 transmission, progression, and control of HIV-1 infection.

Objective

To evaluate which polymorphisms of HLA-B are involved in HIV-1 MTCT.

Methods

Two independent reviewers performed a systematic review on search engines PubMed, Europe PMC, Cochrane, Scientific Electronic Library Online (SciELO), and Literatura Latino-americana e do Caribe em Ciências da Saúde (Lilacs), using the following key terms: “HIV infection”, “HIV newborn”, “HLA polymorphisms”, “HLA-B”, and “Mother to child transmission”. All studies focusing on evaluation of HIV-1 MTCT, HIV infection evolution, and molecular analyses of HLA-B in children were selected.

Results

Nine studies fulfilled the inclusion criteria. Sixteen HLA-B alleles groups were associated with HIV-1 infection; seven of them (43.8%) were related to slow disease progression or reduced risk of MTCT, while six (37.5%) alleles groups were linked to a faster progression of HIV infection in children and to increased risk of MTCT. The available evidence suggest that HLA-B*57 group allele is associated with slow disease progression, while HLA-B*35 group allele is associated to increased risk of MTCT and rapid disease progression in infected children. The role of HLA-B*18, B*58 and B*44 are still controversial because they were associated to both, protection against MTCT, and to higher HIV replicative capacity, in different studies.

Conclusion

HLA-B*57 group allele can be protective against MTCT while HLA-B*35 groups alleles are consistently associated with HIV-1 MTCT.  相似文献   

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