共查询到20条相似文献,搜索用时 15 毫秒
1.
Li X Fan X Ren F Zhang Y Shen C Ren G Sun J Zhang N Wang W Ning G Yang J 《Diabetes research and clinical practice》2011,93(1):10-16
Objective
Fibroblast growth factor (FGF21) has beneficial effects on lipolysis. Highly sensitive C-reactive protein (hs-CRP) is a predictor of type 2 diabetes and nonalcoholic fatty liver disease (NAFLD). This study aimed to determine the levels of serum FGF21 and hs-CRP in newly diagnosed type 2 diabetes patients with and without NAFLD, and further explored the correlation between FGF21 with hs-CRP in newly diagnosed type 2 DM.Research design and methods
69 patients with newly diagnosed type 2 DM and 30 normal subjects were included in the study. FGF21 and hs-CRP were measured by ELISA kits. The severity of NAFLD was measured by ultrasound.Results
Serum FGF21 in newly diagnosed type 2 DM with NAFLD group were significantly increased (p < 0.01). There was no difference for the FGF21 level in normal control group and newly diagnosed type 2 DM without NFALD group. In type 2 DM group, the FGF21 level was positively correlated with hsCRP (r = 0.417, p < 0.001). In multiple stepwise regression models, only hsCRP was a significantly independent determinant for serum FGF21.Conclusions
Serum levels of FGF21 are closely related to liver steatosis in newly diagnosed type 2 DM patients. 相似文献2.
Aims
We aimed to assess changes in serum adiponectin and endothelial function after intensive insulin treatment in patients with newly diagnosed type 2 diabetes mellitus (T2DM).Methods
Patients with newly diagnosed T2DM were randomly assigned to Group A (intensive insulin treatment) or Group B (conventional insulin treatment). Before treatment and 2 weeks after plasma glucose concentrations had been maintained at the specified concentrations, blood samples were obtained to measure serum adiponectin and nitric oxide (NO) concentrations. A total of 21 patients were randomized to each Group.Results
Adiponectin, NO, endothelium-dependent vasodilation (EDD), and endothelium-independent vasodilation (EID) measures were significantly higher post-treatment than pre-treatment in Group A (all P < 0.05). Only EID was significantly higher in Group B (P < 0.05). Post-treatment adiponectin and NO concentrations, and EDD were significantly higher in Group A compared with Group B (all P < 0.05). Both treatment regimens were well tolerated (all patients completed the study). The most common adverse event was hypoglycemia. Thus, early intensive insulin therapy can increase serum adiponectin and NO concentrations and improve endothelial function in patients with newly diagnosed T2DM.Conclusions
These effects may underlie the reduced incidence of microvascular and macrovascular in patients who receive early intensive hypoglycemic therapy. 相似文献3.
Mercedes R. Carnethon Mary L. Biggs Joshua Barzilay Lewis H. Kuller Dariush Mozaffarian Kenneth Mukamal Nicholas L. Smith David Siscovick 《The American journal of medicine》2010,123(6):378
Background
Type 2 diabetes has been described as a coronary heart disease (CHD) “risk equivalent.” We tested whether cardiovascular and all-cause mortality rates were similar between participants with prevalent CHD vs diabetes in an older adult population in whom both glucose disorders and preexisting atherosclerosis are common.Methods
The Cardiovascular Health Study is a longitudinal study of men and women (n = 5784) aged ≥65 years at baseline who were followed from baseline (1989/1992-1993) through 2005 for mortality. Diabetes was defined by fasting plasma glucose ≥7.0 mmol/L or use of diabetes control medications. Prevalent CHD was determined by confirmed history of myocardial infarction, angina, or coronary revascularization.Results
Following multivariable adjustment for other cardiovascular disease risk factors and subclinical atherosclerosis, CHD mortality risk was similar between participants with CHD alone vs diabetes alone (hazard ratio [HR] 1.04, 95% confidence interval [CI], 0.83-1.30). The proportion of mortality attributable to prevalent diabetes (population-attributable risk percent = 8.4%) and prevalent CHD (6.7%) was similar in women, but the proportion of mortality attributable to CHD (16.5%) as compared with diabetes (6.4%) was markedly higher in men. Patterns were similar for cardiovascular disease mortality. By contrast, the adjusted relative hazard of total mortality was lower among participants with CHD alone (HR 0.85, 95% CI, 0.75-0.96) as compared with those who had diabetes alone.Conclusions
Among older adults, diabetes alone confers a risk for cardiovascular mortality similar to that from established clinical CHD. The public health burden of both diabetes and CHD is substantial, particularly among women. 相似文献4.
Franzese A Iafusco D Spadaro R Cavaliere O Prisco F Auricchio R Troncone R Valerio G;Study-Group on Diabetes of Italian Society of Pediatric Endocrinology Diabetology 《Diabetes research and clinical practice》2011,92(1):53-56
Aims
To describe the prevalence of potential celiac disease (pot-CD) in young patients with type 1 diabetes mellitus (T1DM) and characterize their clinical features.Methods
This cross-sectional multicenter study involved 8717 T1DM patients from 31 Italian centers. Information was collected on the total number of T1DM patients, CD patients and pot-CD patients. The following data were collected on pot-CD patients: gender, age at T1DM diagnosis, age at the first CD serological positivity, presence of CD-related symptoms, presence of other autoimmune disorders and treatment with gluten free diet (GFD). One thousand-three-hundred-sixty-one patients who were positive for CD serology were the control group.Results
CD serological positivity was found in 7.2% T1DM patients. Prevalence of pot-CD was 12.2% (n = 77) among CD positive patients: symptoms were present in 12/77; a third autoimmune disorder was found in 15 patients. Prevalence of pot-CD in the control population was 8.4% (n = 114; p = 0.005). No difference was found with regard to clinical features. Only few symptomatic patients were on GFD both in T1DM and control patients.Conclusions
A higher prevalence of pot-CD was found in T1DM patients, that may be ascribed to the routine screening, although the influence of genetic factors cannot be excluded. 相似文献5.
Ammash NM Phillips SD Hodge DO Connolly HM Grogan MA Friedman PA Warnes CA Asirvatham SJ 《International journal of cardiology》2012,154(3):270-274
Objectives
We sought to evaluate safety, efficacy, and outcome of direct current cardioversion (DCCV) for atrial arrhythmias in adults with congenital heart disease (CHD).Background
Atrial arrhythmias are increasingly noted in adults with CHD. The outcome of DCCV for atrial arrhythmias in this population is unknown.Methods
Our study was a retrospective review of patients 18 years or older with CHD who underwent DCCV between June 2000 and July 2003. This constituted the CHD group. Patient characteristics reviewed included the specific cardiac diagnosis and arrhythmia history. A subset of patients had transesophageal echocardiography (TEE) before DCCV; this subset was reviewed to evaluate spontaneous echocardiographic contrast. The outcome data evaluated included success of DCCV, complications, recurrence of arrhythmia, antiarrhythmic medication use, electrophysiology or pacemaker procedure in follow-up, and all-cause mortality. The recurrence rate of the arrhythmia was compared to a control group consisting of an age, gender, and rhythm matched group of patients who have no CHD and who underwent DCCV for atrial arrhythmias.Results
Sixty-three patients in the CHD group underwent 80 DCCVs, 59 of which were TEE-guided. Atrial flutter was more common in the CHD group (37 of 80 DCCV, 46%) than in the control group (13 of 56, 23%) (p < 0.001). DCCV was successful in 75 (94%). Mean follow-up was 387 days. No thromboembolic events were noted. All-cause mortality on follow-up was 11%. There was no death related to DCCV. Twenty-five patients in the CHD group (40%) remained in sinus rhythm throughout follow-up. This was similar to that observed in the control group (30/56, 54%, p = 0.13). Recurrent arrhythmia in the CHD group was predicted by the presence of atrial fibrillation (p = 0.009) and less so spontaneous echo contrast in the left atrium (p = 0.05).Conclusions
DCCV with appropriate anticoagulation is safe and effective for patients with CHD, even in the presence of an intracardiac shunt and spontaneous contrast on TEE. However, the recurrence rate is substantial. Spontaneous echo contrast in the left atrium along with atrial fibrillation predicts arrhythmia recurrence following DCCV in patients with CHD. 相似文献6.
Hara K Hirowatari Y Shimura Y Takahashi H 《Diabetes research and clinical practice》2011,94(2):167-171
Aims
Patients with diabetes mellitus (DM) are prone to atherosclerosis. Atherosclerosis activates platelets; activated platelets release serotonin, and therefore, evaluation of serotonin levels in blood could be a valuable biomarker for future risk of cardiovascular events.Methods
Plasma serotonin levels obtained from patients with DM complicated with chronic kidney disease were measured using HPLC and were compared to serotonin levels of healthy control subjects. Patients with DM were classified into 2 subgroups of mildly (group 1) and moderately/severely (group 2) impaired renal function.Results
Serotonin concentration in platelet-poor plasma for group 1 was significantly higher than that of healthy control subjects (p < 0.01), and was significantly higher than that of patients from group 2 (p < 0.05). The concentration of serotonin in whole blood for group 2 patients was significantly lower than that measured from healthy control subjects (p < 0.01). The ratio of the plasma to whole blood level was significantly elevated in both groups 1 and 2 compared with healthy controls (p < 0.01).Conclusions
Our results indicate that platelets are activated to release serotonin into plasma in diabetic patients with mildly impaired renal function. When renal damage is advanced, platelets are over-activated to release serotonin. 相似文献7.
R. Braham S. Hidar S. Trimeche B. Lakhal K. Ach H. Elghezal 《Annales d'endocrinologie》2010,71(4):286-290
Objectives
The aim of the present study was to characterize women with premature ovarian failure (POF) by their ovarian ultrasonographic appearances using transabdominal technique to establish the relationship to clinical, hormonal status, and genetic analysis.Patients and methods
We studied a cohort of 80 patients suffering from POF. The surface of the ovary was calculated and we identified the detection or not of follicles.Results
The detection of the two ovaries by ultrasound was positive in 33 patients; only one ovary was identified in seven patients; none was noted in 40 patients. The surface of the ovaries ranged between 0.74 et 5.92 cm2 (2.2 ± 1.13 cm2). Ultrasonography identified follicles in 23 patients (28.75%). The presence of follicles suggested at ultrasonography was detected in 14 cases (70%) in normal-sized ovaries (≥ 2 cm2) and in nine cases (45%) in small-sized ovaries (p = 0.1). No significative statistical difference was found between the ultrasonographic appearances and the type of amenorrhea, pubertal development, hormonal status (estradiol, testosterone and delta-4-androstendione) and the chromosomal analysis.Conclusion
The clinical and hormonal status and the genetic analysis can’t predict the presence or not of follicles in the ovaries of patients with POF. 相似文献8.
Yang Y Goh SY Tan SB Ho HJ Emmanuel S Wang P Ng HS 《European Journal of Internal Medicine》2012,23(1):e1-e4
Summary
Diabetes mellitus (DM) has been declared as a global public health threat to society. However, the burden of the disease in elderly Asian patients has not been described. The aim of the study is to assess the disease burden of DM and its associated adverse outcomes in elderly patients from an Asian hospital using the hospital inpatient database.Methods
Retrospective study of hospital discharge database from 2004 to 2008 to identify patients aged 65 years and above with DM and its associated ‘adverse outcomes’ using International Statistical Classification of Diseases and Related Health Problems, 9th Revision, Australian Modification (ICD-9-AM) codes.Results
Of 89,875 hospitalized patients aged 65 years and above over the 5 years, 31,124 (34.6%) patients had DM, and the percentage of DM cases increased steadily from 34.3% to 35.6%. Prevalence of DM-associated adverse outcomes was higher in DM patients than in non-DM patients (53.8% vs. 31.5%, p < 0.001). For trends over time, the adverse outcomes decreased in both DM patients (58.1% to 53.6%) and non-DM patients (34.3% to 31.4%, all p < 0.001). All disease-specific adverse outcomes except renal disease decreased over time both in DM and non-DM patients (all p < 0.05). There were increased trends over time for renal disease in both DM patients (16.1% to 23.2%, p < 0.001) and non-DM patients (6.7% to 10.4%, p < 0.001).Conclusion
The burden of DM in this group of elderly patients is high. Elderly patients with DM experienced much higher rates of the adverse outcomes. 相似文献9.
Forte L Cimmino G Loffredo F De Palma R Abbate G Calabrò P Ingrosso D Galletti P Carangio C Casillo B Calabrò R Golino P 《International journal of cardiology》2011,152(1):7-12
Background
C-reactive protein (CRP) plasma levels correlate with cardiovascular events. Although a direct role for CRP in atherothrombosis has been suggested, at the moment little is known about its involvement in the pathophysiology of acute coronary syndromes (ACS). Thus, the aim of this study was to determine whether CRP is produced in the culprit lesion and released within the coronary circulation of patients with ACS and whether it may affect coronary endothelial function.Methods
Blood samples were simultaneously obtained from the aorta (Ao) and the coronary sinus (CS) of patients with normal coronary artery (n = 16), stable angina (n = 30), and ACS (n = 29) for later measurement of plasma CRP levels. Endothelium-dependent and -independent coronary vasodilation were evaluated by means of a Doppler Flow Wire in response to the increasing intracoronary doses of acetylcholine and adenosine, respectively.Results
CRP plasma levels were significantly higher across the coronary circulation only in ACS patients with the culprit lesion located in the left coronary artery, while no differences between CS and Ao CRP plasma levels were observed in all other groups. Transcardiac CRP levels were correlated with impairment in coronary endothelium-dependent vasodilation. In six additional patients (SA = 3 and ACS = 3), subjected to coronary atherectomy, real-time quantitative PCR revealed presence of CRP mRNA only in unstable plaques.Conclusions
Thus, CRP is produced and released within the coronary circulation of patients with ACS; this is associated with impairment of endothelial function, suggesting a new pathophysiological link between CRP and ACS. 相似文献10.
Aim
Iron may contribute to the pathogenesis of Type 2 diabetes mellitus (DM). The aim of this study was to determine iron regulator hepcidin and iron metabolic parameters in Type 2 DM patients, the relationships among them were evaluated in this specific sub-groups.Materials and methods
The study included sixty-four people: 34 cases of diabetes and 30 age-matched controls. Serum hepcidin, IL-6, hsCRP, ferritin, sTfR, EPO as well as other clinical parameters were detected, and the associations between hepcidin levels and iron/inflammatory parameters were analyzed in diabetes and the controls.Results
Serum ferritin and hepcidin levels in diabetic patients were significant higher than the controls (p < 0.001 respectively). A positive correlation between hepcidin and ferritin, as well as between ferritin and IL-6 levels was existed in diabetes and the control groups (p < 0.001 respectively).Conclusion
All of these data demonstrated that the higher hepcidin levels in diabetic patients may be due to those higher ferritin and IL-6 levels, the elevated hepcidin might have adaptive value through down-regulated iron absorb and play an important role in pathogenesis of Type 2 DM. 相似文献11.
Yueh CY Chen JH Lee LW Lu CW Parekh B Chi CC 《Diabetes research and clinical practice》2011,94(1):64-70
Background
Abnormally elevated alanine aminotransferase (ALT) of nonspecific causes is a common outpatient problem. Without considering ethnicity, several studies had suggested that it was associated with insulin resistance (IR).Objective
To investigate whether nonspecific elevated ALT in Taiwanese population could reflect a likely underlying IR and was associated with impaired fasting glucose or type 2 diabetes mellitus (IFG/T2DM).Methods
The health examination profiles of 1313 Taiwanese were investigated cross-sectionally. The prevalence and odds ratios (ORs) for IFG/T2DM and metabolic abnormalities in relation to elevated ALT were analyzed.Results
Subjects with metabolic syndrome (MS) all had IFG/T2DM. The elevated ALT significantly correlated with MS and IFG/T2DM (i.e., 19.9-29.2% vs. 7.8% for MS, and 27.0-31.5% vs. 16.1% for IFG/T2DM). However, after excluding MS and adjustment for age and sex, the elevated ALT alone was not consistently associated with IFG/T2DM (36 < ALT ≤ 80 IU/L with OR 0.97, 95% CI 0.58-1.61; 80 < ALT ≤ 120 IU/L with OR 0.55, 95% CI 0.13-2.37; none with ALT > 120 had IFG).Conclusions
In a cross-sectional analysis of Taiwanese industrial employees, elevated ALT associated with MS, but in subjects who did not meet MS criteria, elevated ALT by itself did not associate with IFG/T2DM. 相似文献12.
Harold E. Bays Scott E. ConardLawrence A. Leiter Steven R. BirdRobert S. Lowe Andrew M. Tershakovec 《International journal of cardiology》2011,153(2):141-147
Background
Age, gender, and race are factors that influence atherosclerotic coronary heart disease (CHD) risk and may conceivably affect the efficacy of lipid-altering drugs.Methods
Post hoc analysis of two multicenter, 6-week, double-blind, randomized, parallel-group trials assessed age (< 65 and ≥ 65 years), gender, and race (white, black, and other) effects on atorvastatin plus ezetimibe versus up-titration of atorvastatin in hypercholesterolemic patients with CHD risk. High CHD risk subjects with low-density lipoprotein (LDL) cholesterol levels ≥ 70 mg/dL (~ 1.81 mmol/L) during stable atorvastatin 40 mg therapy were randomized to atorvastatin 40 mg plus ezetimibe 10 mg, or up-titrated to atorvastatin 80 mg. Moderately high CHD risk subjects with LDL cholesterol levels ≥ 100 mg/dL (~ 2.59 mmol/L) with atorvastatin 20 mg were randomized to atorvastatin 20 mg plus ezetimibe 10 mg, or atorvastatin 40 mg.Results
Although some variability existed, age, gender, and race subgroups did not substantially differ from the entire patient population with regard to lipid-altering findings. Ezetimibe plus atorvastatin produced greater percent reductions in LDL cholesterol, total cholesterol, triglycerides, non-high-density lipoprotein (HDL) cholesterol, and apolipoprotein B than up-titration of atorvastatin for all subgroups. HDL cholesterol and apolipoprotein AI changes were small and variable.Conclusion
Treatment efficacy in age, gender, and race subgroups did not substantially differ from the entire study population. Ezetimibe combined with atorvastatin generally produced greater incremental reductions in LDL cholesterol and several other key lipid parameters compared with doubling the atorvastatin dose in hypercholesterolemic patients with high or moderately high CHD risk. These results suggest that co-administration of ezetimibe with statins is a useful therapeutic option for treatment of dyslipidemia in differing patient populations. 相似文献13.
Background
Elevated plasma level of asymmetric dimethylarginine (ADMA) was reported to be associated with endothelial dysfunction and atherosclerotic risk factors. We assessed the prognostic value of plasma ADMA levels in 997 consecutive individuals referred for coronary angiography from July 2006 to June 2009.Methods
ADMA was measured by high performance liquid chromatography. All subjects were followed for a median period of 2.4 years for the occurrence of all-cause mortality, major adverse cardiovascular events (MACE, defined as cardiovascular death, non-fatal myocardial infarction and stroke), and MACE plus clinically-driven target vessel revascularization (TVR).Results
Plasma ADMA levels were significantly higher in patients with significant coronary artery disease (CAD) (≥ 50% stenosis, n = 655) than those with insignificant CAD (20-50% stenosis, n = 272) and normal coronary artery (< 20% stenosis, n = 70) (0.47 ± 0.10 μmol/l vs 0.44 ± 0.10 μmol/l vs 0.42 ± 0.08 μmol/l, p < 0.001). By multivariate analysis, plasma ADMA level was identified as a significant independent risk factor of significant CAD (OR: 1.29, 95% CI: 1.10−1.50; p = 0.002). Moreover, multivariate Cox regression analysis showed that, comparing with the ADMA tertile I, the highest ADMA tertile was a significant independent predictor for all adverse long-term clinical outcomes. Notably, plasma ADMA level remained associated with the long-term outcomes in non-diabetic individuals, but not in those with diabetes (interaction p = 0.04 for MACE plus TVR).Conclusions
Our findings suggest that elevated plasma ADMA level might be a risk factor of significant CAD, and might predict worse long-term clinical outcomes in subjects referred for cardiac catheterization, especially in non-diabetic individuals. 相似文献14.
15.
Aim
Diabetes is associated with abnormalities in lipid profile and increased oxidative stress. Statins are preferred agents in diabetic patients due to their antioxidant and LDL-C lowering effects. This study is designed to compare the effects of atorvastatin and rosuvastatin on low density lipoprotein cholesterol (LDL-C), lipid hydroperoxide (LOOH), total oxidant status (TOS) and total antioxidant capacity (TAC) in diabetic patients with hyperlipidemia.Materials and methods
Sixty two patients who have type 2 diabetes mellitus with serum LDL levels more than 100 mg/dL were randomly assigned to receive atorvastatin 20 mg (n = 31) or rosuvastatin 10 mg (n = 31). Blood tests were performed at the beginning of the study and after three months.Results
There were no statistically significant differences in the pre- and after treatment levels of the LDL-C between groups. TAC values were increased in both groups and statistically significant in the former group (p = 0.007). There was no diferrence between the change percentages ((after treatment TAC − pretreatment TAC) / pretreatment level) of TAC between two treatment groups. The effects of two drugs on the other oxidative parameters were not significantly different.Conclusion
Both atorvastatin and rosuvastatin may be helpful in reducing increased oxidative stress in diabetic patients with hyperlipidemia. 相似文献16.
Worthley MI Shrive FM Anderson TJ Traboulsi M 《The American journal of medicine》2007,120(7):643-643.e7
Purpose
The study assessed the relationship of admission blood glucose level to in-hospital mortality in patients presenting with an ST-segment elevation myocardial infarction and treated with primary angioplasty.Methods
A total of 980 patients presenting with an ST-segment elevation myocardial infarction and treated exclusively with primary angioplasty were evaluated. Patients were divided into quartiles based on their admission blood glucose level: group 1 (≤6.6 mmol/L [≤119 mg/dL]), group 2 (6.7-7.8 mmol/L [120-140 mg/dL]), group 3 (7.9-10.0 mmol/L [141-180 mg/dL], and group 4 (≥10.1 mmol/L [≥181 mg/dL]. The primary end point was in-hospital mortality.Results
The mean age of the patient cohort was 62 years, 260 (27%) of whom were female. The mean admission blood glucose level was 9.1 ± 4.4 mmol/L (164 ± 79 mg/dL). At admission, 16% of this group were known to have diabetes. The in-hospital mortality rate was 3.8% (n = 37), 5.2% in the diabetic group (n = 8) and 3.5% (n = 29) in the nondiabetic group. In-hospital mortality rates were significantly increased in patients with an elevated admission blood glucose level (P <.001). The in-hospital deaths in each admission blood glucose level quartile were 0.4% (n = 1) in group 1, 2% (n = 6) in group 2, 2% (n = 6) in group 3, and 10% (n = 24) in group 4.Conclusions
In this cohort of patients who were admitted with an ST-segment elevation myocardial infarction and treated exclusively with primary angioplasty, elevated admission blood glucose level is significantly associated with an increase in in-hospital mortality. 相似文献17.
Yan P Li L Yang M Liu D Liu H Boden G Yang G 《Diabetes research and clinical practice》2011,92(3):368-374
Objective
Omentin is a protein expressed and secreted from visceral but not subcutaneous adipose tissue, which increases insulin sensitivity in human adipocytes. However, its pathophysiologic role in humans remains largely unknown. The objective of this study is to assess plasma omentin-1 levels in patients with type 2 diabetes mellitus (T2DM) and matched control subjects and to investigate the effects of liraglutide on plasma omentin-1 levels in patients with T2DM.Patients and methods
Thirty T2DM patients with poor glycemic control after more than 3 months of treatment with one or two OHA(s) (T2DM), and 30 matched normal glycaemic controls (NGT) participated in the study. The T2DM group was given an injection of liraglutide once-daily for 16 weeks. Plasma omentin-1 levels were measured by enzyme-linked immunosorbent assay and the relationship between plasma omentin-1 levels and metabolic parameters was also analyzed.Results
Plasma omentin-1 levels were lower in T2DM than in the control (19.3 ± 4.0 μg/L vs. 26.4 ± 6.0 μg/L, P < 0.01). Plasma omentin-1 levels increased significantly in T2DM patients after treatment with liraglutide compared with pre-treatment (19.3 ± 4.0 μg/L vs. 21.2 ± 3.9 μg/L, P < 0.01). In all diabetic patients, multiple regression analysis showed that FINS and HOMA-IR were independently associated with plasma omentin-1 levels.Conclusions
In T2DM patients, plasma omentin-1 levels decreased, but significantly increased after the treatment with liraglutide and metformin. These data suggest that liraglutide may play a role in increasing omentin-1 levels in T2DM patients. 相似文献18.
19.
Greenberg JD Kishimoto M Strand V Cohen SB Olenginski TP Harrington T Kafka SP Reed G Kremer JM;Consortium of Rheumatology Researchers of North America Investigators 《The American journal of medicine》2008,121(6):532-538
Objective
The study objective was to investigate responsiveness according to whether patients satisfy eligibility criteria from randomized controlled trials of tumor necrosis factor (TNF) antagonists in a multicentered US cohort.Methods
Biologic-naïve patients with rheumatoid arthritis who were prescribed TNF antagonists (n = 465) in the Consortium of Rheumatology Researchers of North America registry were included. Patients were stratified by whether they met eligibility criteria from 3 major TNF antagonist trials. Two cohorts were examined: Cohort A (n = 336) included patients with complete American College of Rheumatology response criteria except acute phase reactants, and cohort B (n = 129) included patients with complete response criteria. Study outcomes included modified American College of Rheumatology 20% and 50% improvement responses (cohort A) and standard American College of Rheumatology improvement (cohort B).Results
A minority of patients (5.4%-19.4%) prescribed TNF antagonists met trial eligibility criteria and predominantly had high disease activity (78.5%-100%). For patients who met eligibility criteria in cohort A, rates of 20% improvement (52.3%-63.6%) and 50% improvement (30.8%-45.5%) were achieved. Among patients failing to meet eligibility criteria, rates of 20% improvement (16.2%-20.4%) and 50% improvement (8.9%-10.8%) were consistently inferior (P <.05 all comparisons). For cohort B, similar differences were observed.Conclusion
This multicentered US cohort study demonstrates that the majority of patients receiving TNF antagonists would not meet trial eligibility criteria and achieve lower clinical responses. These findings highlight the tradeoff between defining treatment responsive populations and achieving results that can be generalized for broader patient populations. 相似文献20.
Bengtsson I Karlson BW Herlitz J Evander MH Währborg P 《International journal of cardiology》2012,154(3):306-311