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1.

Background

Drug de-escalation is considered in Crohn’s disease patients in sustained remission on optimized infliximab treatment.

Aim

We built a model to evaluate the magnitude of cost savings in patients’ disease course with or without drug de-escalation guided by infliximab trough levels.

Methods

We designed 4 virtual cohorts (P1–P4) of 10,000 patients in clinical remission on optimized infliximab treatment followed for 2?years. P1: no drug de-escalation — 10?mg/kg/8?weeks; P2: drug de-escalation from 10?mg/kg/8?weeks to 5?mg/kg/8?weeks according to trough levels; P3: no drug de-escalation — 10?mg/kg/6?weeks; and P4: drug de-escalation from 10?mg/kg/6?weeks to 10?mg/kg/8?weeks according to trough levels. For P2 and P4 cohorts, drug de-escalation was decided if trough levels were ≥7?μg/mL and no de-escalation if trough levels were <7?μg/mL. Only costs related to drug administration were considered.

Results

The cost differences when comparing P1 versus P2 and P3 versus P4 were 7.6% and 4.6%, respectively, corresponding to costs savings of €30.5 millions and €20.3 million for 10,000 patients.

Conclusion

Over a 2-year period, infliximab de-escalation according to trough levels led to cost saving of about 6%, corresponding to around €25.4 million.  相似文献   

2.

Background

Till now, pooled data about the safety and efficacy of different direct-acting antiviral (DAAs) regimens in different renal situations are still under evaluation.

Aim

To evaluate a real-life experience of the efficacy and safety of ombitasvir/paritaprevir/ritonavir plus ribavirin (OBV/PTV/r plus RIB) in patients with end-stage kidney disease (ESKD).

Patients and methods

Between January 2017 and January 2018, an open-label multicenter prospective study was designed to enroll all consecutive patients with proven CHC genotype 4 infections and concomitant ESKD based on estimated glomerular filtration rate (eGFR) with (HD group) or without hemodialysis (non-HD group). Patients were given a co-formula of OBV/PTV/r (25/150/100?mg) once-daily plus RIB was given for 12?weeks. Sustained virologic response (SVR 12) was the primary endpoint.

Results

A total of 110 patients were enrolled. An overall SVR 12 was reported in 104 (94.5%) patients, and treatment failure were reported in 6 patients [2 patients (1.8%) were relapsed, and 4 patients (3.6%) patients were non-responders]. SVR12 was 96% in HD and 91.4% in non-HD patients (P?=?0.286).There were no reported serious adverse events. Anemia was reported in 66.6% (n?=?50) in HD group and in 31.4% (n?=?11) in non-HD group.

Conclusion

Although it is still challenging, achievement of SVR12 in patients with chronic HCV and concomitant end-stage kidney disease in the era of DAAs became possible with a 12?weeks course of a co-formula of ombitasvir/paritaprevir /ritonavir plus ribavirin.

ClinicalTrials.gov ID

NCT03341988.  相似文献   

3.

Background

There is no single reliable marker of iron homeostasis in inflammatory bowel disease.

Aims

To determine diagnostic usefulness of soluble transferrin receptor and soluble transferrin receptor/log ferritin index in iron deficiency anemia in children with inflammatory bowel disease.

Methods

We assessed soluble transferrin receptor in serum and calculated soluble transferrin receptor/log ferritin index in 75 children with inflammatory bowel disease. Diagnostic ability to identify iron deficiency anemia was examined by receiver operating characteristic analysis.

Results

Study group comprised 27 cases of iron deficiency anemia, 6 anemia of chronic disease with iron deficiency, 5 anemia of chronic disease. Soluble transferrin receptor was significantly increased in children with iron deficiency anemia (median: 1.63?μg/ml) compared to non-anemic children (median: 1.02?μg/ml). Soluble transferrin receptor/log ferritin index was significantly higher in iron deficiency anemia (median: 1.76) than in anemia of chronic disease (median: 0.55), anemia of chronic disease with iron deficiency (median: 0.68) or patients without anemia (median: 0.72). Soluble transferrin receptor and its index were not correlated with disease activity or inflammatory markers. Diagnostic power for soluble transferrin receptor/log ferritin index (0.864) was superior to soluble transferrin receptor (0.768) in iron deficiency anemia recognition.

Conclusion

Soluble transferrin receptor/log ferritin index has better diagnostic utility than soluble transferrin receptor for iron deficiency anemia detection in pediatric inflammatory bowel disease.  相似文献   

4.

Background and aims

Lynch syndrome (LS) is associated with an increased risk of small bowel tumors but routine screening is not recommended in international guidelines. The aim of our study was to determinate the prevalence of duodenal tumors in a French cohort of LS patients.

Methods

Patients carrying a germline pathogenic variant in a MMR gene, supported by our local network, in which at least one upper endoscopy had been performed, were included. We registered the occurrence of duodenal lesions in those patients.

Results

154 LS patients were identified including respectively 85 MSH2 and 41 MLH1 mutated patients respectively. Seven out of 154 (4.5%) had at least one duodenal lesion. Median age at diagnosis was 58 years (range: 49–73). The twelve lesions locations were: descending duodenum (n?=?7), genu inferius (n?=?2), duodenal bulb (n?=?1), ampulla (n?=?1), fourth duodenum (n?=?1). Three lesions were invasive adenocarcinomas. The incidence rate of duodenal lesions in patients with MSH2 or MLH1 pathogenic variants was respectively 7.1% (6 out of 85) and 2.4% (1 out of 41) emphasizing a trend toward increased risk of developing duodenal lesion in MSH2 mutated patients: OR: 5.17, IC95% (0.8–60.07), p?=?0.1307.

Conclusion

Regarding this high prevalence rate, especially in MSH2 patients, regular duodenal screening during upper endoscopy should be considered in routine in LS patients.  相似文献   

5.

Background

Growing evidence suggests that colorectal cancer (CRC) screening based on the fecal immunochemical test (FIT) reduces CRC incidence and surgical resection rates.

Aims

To compare trends in surgery for proximal and distal CRC among Italian regions at different stages of screening implementation.

Methods

From the National Hospital Discharge Database we selected hospitalizations with CRC resection of residents aged 50–74 years during 2002–2014, and computed surgery rates for the 8 most populous Italian regions with/without a screening program.

Results

In regions with screening, implemented around 2006–2007, the annual percent change (APC) of distal CRC resection was +1.7 (95% confidence interval ?1.0, 4.4) during 2002–2007 and ?9.1 (?10.6, ?7.7) during 2007–2014. No significant change was observed in regions without screening. The APC for proximal colon resection in regions with screening was +5.8 (2.5, 9.0) during 2002–2007 and ?4.1 (?5.8, ?2.4) during 2007–2014, while in regions without screening surgical rates increased through the whole study period. Compared to 2002, in 2014 distal CRC resection rates were greatly reduced in regions with screening, reaching values similar to proximal CRC resection.

Conclusion

Following the implementation of screening programs surgery rates steeply decreased, confirming the deep impact of FIT-based screening on the burden of CRC.  相似文献   

6.

Background

Previous studies investigating the association between statin use and pancreatic cancer (PDAC) risk for a possible chemopreventive effect gathered heterogeneous results.

Aims

To conduct a systematic review and meta-analysis to clarify this association.

Methods

Comprehensive literature search of articles published up to February 2018, including case-control (CC),cohort studies (C), randomized controlled trials (RCTs) assessing association between statin use and PDAC risk. Studies had to report odds ratio (OR)/relative risk (RR), estimates with 95% confidence interval (CI), or provide data for their calculation. Pooled ORs with 95%CIs were calculated using random effects model, publication bias through Begg and Mazumdar test and heterogeneity by I2 value.

Results

27 studies(13 CC, 9C, 5 RCTs) for a total population of 11,975 PDAC/3,433,175 controls contributed to the analysis. The overall pooled result demonstrated a reduced PDAC risk among statin users (OR 0.70; 95% CI 0.60–0.82; p?<?0.0001), compared to non-users. Sensitivity analyses suggested the risk reduction to be more important in CC studies, studies conducted in Asia and Europe, in males and atorvastatin users. No publication bias found.

Conclusions

The present meta-analysis suggests that statin use is associated with an overall PDAC risk reduction of 30%. Further studies are needed to clarify the association.  相似文献   

7.

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   

8.

Background

Data on rescue treatment of autoimmune hepatitis in patients that fail standard treatment are sparse.

Aims

To report our long-term experience with mycophenolate mofetil.

Methods

Retrospective study in 22 patients with autoimmune hepatitis who failed azathioprine and prednisolone due to adverse events (n?=?14, 64%), lack of remission (n?=?5, 23%) or a combination (n?=?3, 13%).

Results

Mycophenolate mofetil was started at a dose of 20?mg/kg/day and increased to a maximum of 3?g/day. Follow-up was 0–6 months in 7 patients; more than 12 months in 15 (68%) and more than 24 months in 10. Normal aminotransferase levels were obtained (n?=?3) or maintained (n?=?7) in 10 patients (45%) after three to 30 weeks. 12 patients (55%) were withdrawn during the first 6 months, due to adverse events. Three patients were switched to cyclosporine and one underwent liver transplantation. Successful treatment with mycophenolate mofetil continued in 10 patients (45%) for a median of 71 months (range 20–124). Of these, one stopped prednisolone, five have a prednisolone dose <5?mg daily and four patients 5–10?mg.

Conclusion

Approximately one of two patients with autoimmune hepatitis that fail standard treatment benefit from long-term maintenance with mycophenolate mofetil, especially those with previous intolerance to thiopurines, where mycophenolate mofetil is effective in two thirds.  相似文献   

9.

Background

Symptomatic bradycardia has been reported in adults treated for chronic hepatitis C using sofosbuvir based regimens.

Aim

We studied the cardiac safety of sofosbuvir/ledipasvir in Egyptian children, treated for chronic hepatitis C.

Methods

The study included 40 hepatitis C virus infected children and adolescents 12–17 years old, using the combination of sofosbuvir (400?mg)/ledipasvir (90?mg) in a single oral tablet (Harvoni) taken daily for 12 weeks. All subjects underwent a baseline standard 12-lead surface Electrocardiography that was repeated at 4 and 12 weeks of therapy. Electrocardiography parameters (Heart Rate, RR interval, PR interval, QRS, QT interval, corrected QT interval, QT dispersion, JT interval, corrected JT interval, JT dispersion, Tpeak-Tend interval) were compared at the 3 different time points during antiviral therapy.

Results

No symptoms related to the cardiovascular system were reported during treatment. There were no cases of symptomatic bradycardia/syncope. Heart rate was noted to be significantly lower and RR and QT intervals were significantly longer in the baseline electrocardiography. Heart rate was significantly lower and RR interval was significantly longer in patients with higher viral load.

Conclusion

No adverse cardiovascular events were observed in this group of HCV infected children and adolescents treated with sofosbuvir/ledipasvir. None of the patients developed bradyarrhythmias during treatment.  相似文献   

10.

Background

Autoimmune liver disease (AILD) includes autoimmune hepatitis (AIH) and autoimmune sclerosing cholangitis (ASC). AILD is often associated with other extra-hepatic immune-mediated disorders (EDs), but there are few pediatric studies available to date. In this study we evaluated the association between AILD and EDs in our pediatric series.

Methods

In this single centre retrospective study 48 patients (39 AIH and 9 ASC children) were evaluated. Thirty-six children were primarily referred to our Centre for liver disease suspicion, while the remaining twelve had a previous diagnosis of EDs. All the patients were screened for various EDs at AILD diagnosis and yearly during the follow-up.

Results

Mean duration of follow-up was 9?years and 1 month. Twenty-two (46%) patients had a diagnosis of EDs. Ulcerative colitis (UC) was the most frequent EDs (9 patients), followed by autoimmune thyroid disease (5 patients) and celiac disease (5 patients). In 7 out of 9 UC patients, ASC was present.

Conclusions

Our study showed a high association (46%) between AILD and EDs. In particular, in 8 out of 9 ASC patients UC was diagnosed (p-value 0.007). It is important to look for EDs in AILD children and, conversely, AILD in EDs children with abnormal liver function tests.  相似文献   

11.

Background

There is increasing awareness of HBV reactivation in HCV-RNA-positive/HBV-coinfected patients with chronic liver disease (CLD) treated with oral direct-acting antivirals (DAAs).

Aim

To provide figures on the prevalence of HBV markers in HCV-RNA-positive subjects in Italy, where these findings are lacking.

Methods

All subjects aged ≥18?years with CLD consecutively referring to Italian liver units located throughout country were prospectively enrolled in two national surveys in 2001 and 2014.

Results

The total number of HCV-RNA-positive cases was 6984; 356 (5.1%) subjects vaccinated against HBV were excluded. A total of 6628 cases were evaluated. The prevalence rates of HBsAg, isolated anti-HBc and anti-HBc/anti-HBs-positivity were 2.9%, 8.1% and 14.7%, respectively. Among the estimated one million HCV-RNA-positive subjects in Italy, a substantial number of subjects are at risk of HBV reactivation due to DAA therapy. The prevalence of liver cirrhosis was higher than that of CLD in HBsAg-positive subjects (4.4% vs. 2.6%, p?<?0.01) but not in those positive for other HBV markers.

Conclusions

These findings outline the burden of HBV markers among HCV-RNA-positive subjects in Italy, where in 2017 reimbursement for DAA therapy by the National Health System became universal for all patients with chronic HCV infection. HBV vaccination coverage should be greatly extended, since nearly two thirds of subjects in this study resulted negative for any HBV marker.  相似文献   

12.

Background

Data about the outcomes after adalimumab dose de-escalation in inflammatory bowel disease (IBD) are scarce.

Objectives

To assess the outcomes after adalimumab dose de-escalation, and to identify potential factors associated with failure.

Methods

Retrospective, observational study including all IBD patients who had undergone adalimumab dose de-escalation to 40?mg every three weeks across seven GETAID centers, between June 2011 and September 2017. Failure of adalimumab dose de-escalation was defined as the need for treatment re-escalation, discontinuation of adalimumab, or clinical, biochemical and/or morphologic disease relapse.

Results

Fifty-six patients were identified (n?=?46 Crohn’s disease, n?=?10 ulcerative colitis). Median (IQR) duration of follow-up after adalimumab dose de-escalation was 15.9 (7.9–30.6) months. Adalimumab dose de-escalation was a failure in 21/56 (37.5%) patients and successful in 35/56 (62.5%) patients. Median (IQR) time until failure was 8.9 (4.6–15.6) months. At multivariate analysis, inactive disease at magnetic resonance imaging and/or endoscopy in the year before adalimumab dose de-escalation decreased the risk of failure with a factor five (P?=?0.02).

Conclusions

Adalimumab dose de-escalation to 40?mg every three weeks is possible in almost two thirds of IBD patients. Objective morphologic signs of active disease should be ruled out before considering a de-escalation strategy with adalimumab.  相似文献   

13.

Background

We evaluated the risk of advanced colorectal neoplasia (ACRN) and colorectal cancer (CRC) according to time to colonoscopy after positive fecal immunochemical test (FIT), fecal hemoglobin concentration, and combination of both.

Methods

We analyzed the records of 2362 patients aged ≥50?years who underwent colonoscopy because of a positive FIT result through the National Cancer Screening Program of Korea.

Results

ACRN risk increased with increasing time to colonoscopy after a positive FIT (17.2%, 18.6%, 19.1%, 21.4%, and 27.2% in <30, 30–59, 60–149, 150–179, and ≥180?days; P?=?0.034), and ACRN and CRC risk increased with increasing fecal hemoglobin concentration (ACRN, 13.2%, 16.9%, 18.5%, 23.2%, and 26.6%; CRC, 1.3%, 1.7%, 4.7%, 5.7%, and 12.8% with 100–200, 200–300, 300–500, 500–1000, and ≥1000?ng Hb/mL; both P?<?0.001). Even after adjusting for confounders, follow-up after 180?days tended to be associated with a higher ACRN risk (adjusted odds ratio, 1.73; 95% confidence interval [CI], 0.91-3.27), compared with follow-up colonoscopy at <30?days, and fecal hemoglobin 500–1000, and ≥1000?ng Hb/mL were associated with a significantly higher ACRN and CRC risk, compared with 100–200?ng Hb/mL. Moreover, the group with ≥180?days and ≥1000?ng Hb/mL had a much higher CRC risk compared with the group with <180?days and <1000?ng?Hb/mL (12.45-fold; 95% CI, 3.73–41.57).

Conclusions

Patients with positive FIT results, especially those with higher fecal hemoglobin levels, should undergo timely follow-up colonoscopy.  相似文献   

14.

Background

The pediatric obesity epidemic calls for the noninvasive detection of individuals at higher risk of complications.

Aims

To investigate the diagnostic role of combined salivary uric acid (UA), glucose and insulin levels to screen noninvasively for metabolic syndrome (MetS) and nonalcoholic fatty liver disease.

Methods

Medical history, clinical, anthropometric, and laboratory data including serum triglyceride, glucose, insulin, HOMA, HDL-cholesterol, and UA levels of 23 obese children (15 with [St+] and 8 without [St?] ultrasonographic hepatic steatosis) and 18 normal weight controls were considered.

Results

Serum and salivary UA (p?<?0.05; R2?=?0.51), insulin (p?<?0.0001; R2?=?0.79), and HOMA (p?<?0.0001; R2?=?0.79) levels were significantly correlated; however their values tended to be only slightly higher in the obese patients, predominately in [St+], than in the controls. Notably, UA and insulin levels in both fluids increased in parallel to the number of MetS components. After conversion of the z-logit function including salivary/anthropometric parameters in a stepwise logistic regression analysis, a factor of 0.5 allowed for predicting hepatic steatosis with high sensitivity, specificity, and total accuracy.

Conclusions

Salivary testing together with selected anthropometric parameters helps to identify noninvasively obese children with hepatic steatosis and/or having MetS components.  相似文献   

15.

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   

16.

Background

Despite the improvement of medical therapies, nearly half of patients with Crohn’s disease require surgery within 10?years after diagnosis. However, intestinal resection is not curative and recurrence may occur.

Aims

To evaluate post-surgical outcomes for patients with Crohn’s disease in a large monocentric cohort, and to identify variables associated with clinical and surgical relapse.

Methods

Patients with Crohn’s disease who had surgery for ileal and colonic Crohn’s disease between 2004 and 2016 and on at least one-year follow-up following surgery were included.

Results

One hundred ninety-three patients were included in the study. Crohn’s disease recurrence concerned 53% of patients after a median 56-month (6–158) follow-up and 29% of patients required a second surgical intervention. At logistic regression analysis, active smoking and young age at diagnosis were identified as independent risk factor for post-surgical relapse (p?=?0.01), while colonic or ileocolonic resection was recognized as a risk factor for surgical Crohn’s disease relapse (p?=?0.003).

Conclusions

Post-surgery recurrence is frequent for patients with Crohn’s disease. Active smoking and young age at diagnosis are risk factors for Crohn’s disease recurrence. As compared with patients undergoing small-bowel surgery, patients with colonic resection are proner to relapse requiring a second surgical intervention.  相似文献   

17.

Background

Clostridium difficile infection (CDI) is the most common nosocomial infection in the US and cirrhotic patients with CDI have increased risk for poor outcome.

Aim

The aim of this study is to evaluate the impact of CDI on short-term mortality in patients with cirrhosis and identify predictors of mortality in these patients.

Methods

We retrospectively identified patients at Montefiore Medical Center from 2010 to 2014 with cirrhosis, diarrhea and a C. difficile toxin assay. Demographics, co-morbidities, medications, laboratory data and outcomes were recorded.

Results

Of 701 patients with cirrhosis who had a CDI assay, 183 were CDI+ and 518 CDI?. Patients with CDI were older, had more frequent CKD on hemodialysis and heart failure, were less frequently on rifaximin and lactulose and had increased glucocorticoid exposure. 30-day mortality was higher in patients with CDI (23.0% vs 16.6%, p?<?0.05) compared to those without. Univariate predictors of 30-day mortality included WBC, corticosteroid use, AST, ALT, MELD, albumin, HBV and HCV infection; however, via multivariate analysis, only MELD (HR: 1.04?±?0.02, p?<?0.05) remained significant.

Conclusion

Patients with cirrhosis and CDI are at greater risk of 30-day mortality than those without CDI and the only multivariate predictor of mortality is MELD. These patients should have their disease severity triaged based upon MELD score.  相似文献   

18.

Background

Digestive diseases imply a substantial burden for health care systems. Effectiveness of specialized gastroenterology care has been demonstrated in a few real life surveys.

Aims

To perform an in-depth analysis of Hospital Discharge Records (HDRs) of patients admitted for digestive diseases (DDs) from all Italian regions over the years 2010–2014.

Methods

Data on National HDRs were provided by the Italian Health Ministry.

Results

During the years 2010–2014, a mean of 949,830 patients with DDs were admitted to hospital per year, representing 10.0% of all admissions in Italy. Only 7.4% of patients with DDs were admitted to Gastroenterology units due to the limited number of the specialty-focused beds (3.4/100,000 inhabitants). DDs urgent admissions in Gastroenterology units represented 33% of admissions. The mean length of stay was 8.1?days in Gastroenterology units, as opposed to 8.3 in other units. Mortality rate for DDs altogether, for urgent admissions, and for urgent admissions with bleeding were 2.2%, 1.7%, 2.2% in Gastroenterology units, and 3.1%, 3.9%, 3.5% in other units, respectively. DDs admissions were appropriate in 81.3% in Gastroenterology units as opposed to 66.6% in all other units.

Conclusions

Gastroenterology units offer a better specific care in terms of length of hospital stay and mortality even for patients admitted for emergent conditions.  相似文献   

19.

Aim

To evaluate the serum paraoxonase 1 activity and determine its association with duration in type 2 Diabetes mellitus patients.

Methods

A total of 80 cases from type 2 diabetes mellitus and healthy controls were enrolled in the present case control study. Human serum PON1 concentration was measured by ELISA and western blotting and it activity was determined spectrophotometrically using 4-nitrophenyle acetate. Diagnostic accuracy of serum PON1 to identify type 2 Diabetes mellitus was calculated with ROC analysis.

Result

Serum concentration of LDL, VLDL, TG, A1C, FBS and TC levels showed significantly higher levels in type 2 diabetes patients as compared to healthy controls, however there were no significant differences found in the level of HDL. Serum PON1 concentration and activity monitored in patients with >1?year diabetes showed higher level (75.1?±?6.8?ng/mL) as compared to patients with >3?years diabetes (65.24?±?1.6?ng/mL), its level was further decreased in patients with >5 (53.8?±?2.6?ng/mL) and >7?years (48.1?±?2.7?ng/mL) of diabetes. PON1 concentration decreased as the duration of diabetes increased. PON1 level was further decreased due to habits like smoking and alcohol consumption.

Conclusion

Serum PON1 levels decrease in states of high oxidative stress like metabolic syndrome, obesity, uncontrolled diabetes, and dyslipidemia. It can be used as diagnostic marker for diabetes mellitus along with increased TG, LDL, VLDL and FBG.  相似文献   

20.

Introduction

Combination of cisplatine and Gemcitabine (CisGem) is the reference 1st line Chemotherapy in patients with advanced biliary cancer. FOLFIRINOX demonstrated an overall survival superiority when compared to gemcitabine in 1st line for patients with metastatic pancreatic adenocarcinoma. Because of similarities between pancreatic and biliary cancers, we proposed a randomized trial comparing mFOLFIRINOX and CisGEm.

Aim

PRODIGE38-AMEBICA is a phase II/III trial evaluating efficacy of modifed FOLFIRINOX (D1 bolus removed) or CisGEm on patients with locally advanced non resectable or metastatic biliary tract cancer.

Patients and methods

Main inclusion criteria are histologically or cytologically proven biliary tract tumor (intra or extra hepatic or hilar or gallbladder carcinoma), measurable disease (metastases and/or primary tumor), Bilirubin <1,5?N and transaminases <5?N. The randomization (ratio 1:1) will be stratified on center, stage of the disease, tumor localization and previous adjuvant treatment. The Phase II trial has an objective of 73% patients alive and without progression at 6?months for Folfirinox (versus 59% for Gemcis). 128 additional patients should be added in the phase III trial with an objective of overall survival improvement of 4?months in favor of mFOLFIRINOX.

Conclusion

The study is opened in France (EudraCT no.: 2015-002282-35). All the patients (188) of the phase II part are currently randomized.  相似文献   

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