Background:This study was to explore the clinical efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection(recombinant human erythropoietin injection,rHuEPO)for the treatment of anemia associ...Background:This study was to explore the clinical efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection(recombinant human erythropoietin injection,rHuEPO)for the treatment of anemia associated with chronic kidney failure in Chinese patients undergoing hemodialysis.Method:This study was a multicenter,randomized,open-label,intergroup parallel control phase III noninferiority trial from April 19,2013 to September 9,2014 at 25 sites.In this study,the members of the darbepoetin alfa group underwent intravenous administration once per week or once every two weeks.The members of the control drug epoetin alfa group underwent intravenous administration two or three times per week.All subjects underwent epoetin alfa administration during the 8-week baseline period.After that,subjects were randomly assigned to the darbepoetin alfa group or epoetin alfa group.The noninferiority in the changes of the average Hb concentrations from the baseline to the end of the evaluation period(noninferiority threshold:-1.0 g/dl)was tested between the two treatments.The time-dependent hemoglobin(Hb)concentration and the maintenance rate of the target Hb concentration(the proportion of subjects with Hb concentrations between 10.0 and 12.0 g/dl)were also evaluated.Iron metabolism,including changes in the serum iron,total iron-binding capacity,ferritin,transferrin saturation,and comparisons of the dose adjustments between the two groups during the treatment period were analyzed further.Adverse events(AEs)were also observed and compared,and the safety was analyzed between the two treatment groups.The conversion rate switching from epoetin alfa to darbepoetin alfa was also discussed.SAS?software version 9.2 was used to perform all statistical analyses.Descriptive statistics were used for all efficacy,safety,and demographic variable analyses,including for the primary efficacy indicators.Results:Four hundred and sixty-six patients were enrolled in this study,and ultimately 384 cases were analyzed for safety,including 26展开更多
Background:Erythropoietin is a glycoprotein that mainly regulates erythropoiesis.In patients with chronic renal failure with anemia,darbepoetin alfa can stimulate erythropoiesis,correct anemia,and maintain hemoglobin ...Background:Erythropoietin is a glycoprotein that mainly regulates erythropoiesis.In patients with chronic renal failure with anemia,darbepoetin alfa can stimulate erythropoiesis,correct anemia,and maintain hemoglobin levels.This study was designed to demonstrate the efficacy and safety of darbepoetin alfa injections as being not inferior to epoetin alfa injections(Recombinant Human Erythropoietin injection,rHuEPO)when maintaining hemoglobin(Hb)levels within the target range(10.0-12.0 g/dL)for the treatment of renal anemia.Methods:Ninety-five patients were enrolled in this study from April 15,2013 to April 10,2014 at 25 sites.In this study,patients(n=95)aged 18-70 years were randomized into a once per week intravenous darbepoetin alfa group(n=56)and a twice or three times per week intravenous epoetin alfa group(n=39)for 28 weeks,who had anemia with hemoglobin levels between 6 g/dL and 10 g/dL due to chronic kidney disease(CKD)and were undergoing hemodialysis or hemofiltration with ESA-naive(erythropoiesis stimulating agent-naive).The primary efficacy profile was the mean Hb level(the non-inferiority margin was-1.0 g/dL,week 21-28);the secondary efficacy profiles were the Hb increase rate(week 0-4),the target Hb achievement cumulative rate and time,the change trends of the Hb levels,and the target Hb maintenance ratio.Adverse events(AEs)were observed and compared,and the efficacy and safety were analyzed between the two treatment groups.Additionally,the frequencies of dose adjustments between the darbepoetin alfa and epoetin alfa groups were compared during the treatment period.SAS?software version 9.2 was used to perform all statistical analyses.Descriptive statistics were used for all efficacy,safety,and demographic variable analyses,including for the primary efficacy indicators.Results:The mean Hb level was 11.3 g/dL in the darbepoetin alfa group and 10.7 g/dL in the epoetin alfa group,respectively;the difference of the lower limits of the 95%confidence intervals(CI)between the two groups was 0.1 g/dL(>-1.0 g/dL展开更多
AIM: To assess systematically the spectrum and extent of depressive symptoms comparing patient groups receiving peginterferon or conventional interferon.METHODS: Ninety-eight patients with chronic hepatitis C and inte...AIM: To assess systematically the spectrum and extent of depressive symptoms comparing patient groups receiving peginterferon or conventional interferon.METHODS: Ninety-eight patients with chronic hepatitis C and interferon-based therapy (+ribavirin) were consecutively enrolled in a longitudinal study. Patients were treated with conventional interferon alfa-2b (48/98patients; 5 MIU interferon alfa-2b thrice weekly) or peginterferon alfa-2b (50/98 patients; 80-150 μgpeginterferon alfa-2b) in combination with weight-adapted ribavirin (800-1 200 mg/d). Repeated psychometric testing was performed before, three times during and once after antiviral therapy: Depression was evaluated by the Hospital Anxiety and Depression Scale (HADS), anger/hostility by the Symptom Checklist-90 Items Revised (SCL-90-R).RESULTS: Therapy with pegylated interferon alfa-2bproduces comparable scores for depression (ANOVA:P = 0.875) as compared to conventional interferon.Maximums of depression scores were even higher and cases of clinically relevant depression were frequent during therapy with peginterferon. Scores for anger/hostility were comparable for both therapy subgroups.CONCLUSION: Our findings suggest that the extent and frequency of depressive symptoms in total are not reduced by peginterferon. Monitoring and management of neuropsychiatric toxicity especially depression have to be considered as much as in antiviral therapy with unmodified interferon.展开更多
<strong>Aims: </strong>To evaluate the association of Nuclear factor kappa B1(NFkB1) gene polymorphism with inflammatory markers Urinary Monocyte Chemoattractant Protein 1 (UMCP1) and Tumor Necrosis Factor...<strong>Aims: </strong>To evaluate the association of Nuclear factor kappa B1(NFkB1) gene polymorphism with inflammatory markers Urinary Monocyte Chemoattractant Protein 1 (UMCP1) and Tumor Necrosis Factor alfa (TNF alfa) in Patients of diabetes mellitus with or without renal involvement in Eastern India. <strong>Material and Methods: </strong>Consecutive Patients of Type 2 Diabetes Mellitus (DM) with or without microalbuminuria attending SCB MEDICAL COLLEGE and HOSPITAL Medical OPDs in between September 2018 to September 2019 were recruited in this study. Patients were subjected to blood and urine investigations. DNA extraction and Restriction fragment Length Polymorphism (RFLP) was done in Department of Biochemistry. Controls were unrelated healthy attendants with no history of Diabetes Mellitus, HTN, Chronic Kidney Disease (CKD). <strong>Results:</strong> Mean Systolic BP, Fasting Blood Glucose, Post Prandial Blood Glucose, HBA1c, Total Cholesterol were significantly higher in diabetes mellitus and diabetic nephropathy groups than control group. Estimated Glomerular Filtration Rate was significantly lower in diabetic nephropathy (p value < 0.001). UMCP1, Urinary Albumin Creatinine Ratio, TNF alfa were higher in diabetes mellitus and nephropathy with p value (<0.001, 0.006 < 0.001) respectively. In between DM and Diabetic Nephropathy groups nfkb1 gene expression, umcp1 and tnf alfa levels were significantly increased in Diabetic nephropathy with p value 0.019, <0.01, 0.001 respectively. Insertion/insertion NFkB1 gene polymorphisms were more in diabetic nephropathy group and were positively correlated with inflammatory markers UMCP1 (r = 0.517, p < 0.01) and TNF alfa (r = 0.172, p = 0.19). <strong>Conclusion:</strong> insertion/insertion NFkB1 gene polymorphism increases the risk of nephropathy by 2.52 times (OR = 2.52, 95% CI: 0.04 - 0.63, p value = 0.019) in diabetes patients in eastern India.展开更多
Background: New erythropoiesis-stimulating agents (ESAs) with a longer half-life have been developed for the treatment of anemia as a complication of patients with end-stage renal disease. Objectives: The objective of...Background: New erythropoiesis-stimulating agents (ESAs) with a longer half-life have been developed for the treatment of anemia as a complication of patients with end-stage renal disease. Objectives: The objective of the present study was to assess the hemoglobin (Hb) stability of a Japanese cohort of hemodialysis (HD) patients who were simultaneously switched from darbepoetin alfa (DA) to epoetin beta pegol (CERA). Methods: This was an observational, prospective study of HD patients 20 years of age or more who were switched from intravenous (IV) DA to IV CERA and continued on HD for at least 3 months. The dose was adjusted to maintain the Hb level to within 1.0 g/dl of the baseline value. Results: A total of 68 HD patients (75.0% male, median age 63.0 years) were enrolled. The patients’ mean Hb levels were 10.8 ± (0.6) g/dl at Month 0, 10.9 ± 0.7 at Month 1, 10.8 ± 0.7 at Month 2, and 10.9 ± 0.8 at Month 3, and the differences from the level at Month 0 were not significant. After the switch, the ESA dose decreased significantly (P P < 0.0001). Conclusion: Switching from DA to CERA was associated with approximate 89% reduction of the required dose in Japanese HD patients being treated with an ESA and showed a favorable impact on the treatment of renal anemia, including the need for less frequent injections and a reduction of the ESA dose.展开更多
AIM:To study current treatment options for pediatric hepatitis C infection and their associated success rates.METHODS:We retrospectively reviewed charts of thirty children who had been treated with combination therapy...AIM:To study current treatment options for pediatric hepatitis C infection and their associated success rates.METHODS:We retrospectively reviewed charts of thirty children who had been treated with combination therapy of pegylated interferon alfa plus ribavirin for chronic hepatitis C infection.Patients had been treated with ribavirin(15 mg/kg per day) and either pegylated interferon alfa 2a(180 mg/m 2 once weekly) or pegylated interferon alfa 2b(1.5 mg/kg once weekly).Patients' follow-up included subjective assessment of complaints,physical examination including weight and height,as well as laboratory evaluations for viral load [before treatment,at 12 wk,and 6 mo following treatment completion,as determined by sustained viral response(SVR)],complete blood count,liver enzymes,alkaline phosphatase,bilirubin,renal function tests,and thyroid function tests.For patients not achieving a two log decrease in viral load at treatment week 12,treatment was discontinued and the patient was considered a treatment non-responder.RESULTS:Thirty children aged 3-18 years were included in the study.Twenty patients(11 males,9 females) received pegylated interferon alfa 2b and ten patients(6 males,4 females) received pegylated interferon alfa 2a.Twenty-three patients were infected with genotype 1,six patients were infected with genotype 3,and one patient was infected with genotype 2.Twenty patients(67%) achieved SVR.Treatment success rates were 90% with pegylated interferon alfa 2a vs 55% with pegylated interferon alfa 2b.Although a trend was noted for improved outcomes in the group receiving pegylated interferon alfa 2a,there were no statistically significant outcome differences between the two treatment groups(P = 0.1).Treatment success was 56.5% for patients infected with genotype 1 virus,compared to 100% for patients infected with other genotypes(P = 0.064).There was no difference in treatment response between males and females.A cut-off age of twelve years was used to dichotomize younger vs older participants;however,no differe展开更多
Natural fibers are nowadays increasingly employed for making nonwoven, replacing the synthetic materials due to economic and environmental considerations. In this setting, we examine the use of Alfa fibers in nonwoven...Natural fibers are nowadays increasingly employed for making nonwoven, replacing the synthetic materials due to economic and environmental considerations. In this setting, we examine the use of Alfa fibers in nonwoven. Extracted Alfa fibers present satisfying mechanical properties that allow them to be used to produce nonwoven textiles materials. Therefore, Alfa fibers are, mainly, blended with cotton, polyester, Tencel and wool. Webs are prepared using cotton or wool cards in regular width. The nonwoven consolidation is made by needle-punching method. The weight, thickness, air permeability, adiathermic capacity and tensile properties are investigated. The results exhibit that the air permeability increases with the increase of Alfa fibers ratio for the nonwoven Alfa blended with short fibers. It decreases in case of Alfa/Wool blend. We can conclude also that the nonwoven Alfa blended with wool fibers have the highest properties values for all the Alfa fibers blends. Data also revealed that the tensile properties are reduced with the increment of Alfa fibers ratio.展开更多
文摘Background:This study was to explore the clinical efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection(recombinant human erythropoietin injection,rHuEPO)for the treatment of anemia associated with chronic kidney failure in Chinese patients undergoing hemodialysis.Method:This study was a multicenter,randomized,open-label,intergroup parallel control phase III noninferiority trial from April 19,2013 to September 9,2014 at 25 sites.In this study,the members of the darbepoetin alfa group underwent intravenous administration once per week or once every two weeks.The members of the control drug epoetin alfa group underwent intravenous administration two or three times per week.All subjects underwent epoetin alfa administration during the 8-week baseline period.After that,subjects were randomly assigned to the darbepoetin alfa group or epoetin alfa group.The noninferiority in the changes of the average Hb concentrations from the baseline to the end of the evaluation period(noninferiority threshold:-1.0 g/dl)was tested between the two treatments.The time-dependent hemoglobin(Hb)concentration and the maintenance rate of the target Hb concentration(the proportion of subjects with Hb concentrations between 10.0 and 12.0 g/dl)were also evaluated.Iron metabolism,including changes in the serum iron,total iron-binding capacity,ferritin,transferrin saturation,and comparisons of the dose adjustments between the two groups during the treatment period were analyzed further.Adverse events(AEs)were also observed and compared,and the safety was analyzed between the two treatment groups.The conversion rate switching from epoetin alfa to darbepoetin alfa was also discussed.SAS?software version 9.2 was used to perform all statistical analyses.Descriptive statistics were used for all efficacy,safety,and demographic variable analyses,including for the primary efficacy indicators.Results:Four hundred and sixty-six patients were enrolled in this study,and ultimately 384 cases were analyzed for safety,including 26
文摘Background:Erythropoietin is a glycoprotein that mainly regulates erythropoiesis.In patients with chronic renal failure with anemia,darbepoetin alfa can stimulate erythropoiesis,correct anemia,and maintain hemoglobin levels.This study was designed to demonstrate the efficacy and safety of darbepoetin alfa injections as being not inferior to epoetin alfa injections(Recombinant Human Erythropoietin injection,rHuEPO)when maintaining hemoglobin(Hb)levels within the target range(10.0-12.0 g/dL)for the treatment of renal anemia.Methods:Ninety-five patients were enrolled in this study from April 15,2013 to April 10,2014 at 25 sites.In this study,patients(n=95)aged 18-70 years were randomized into a once per week intravenous darbepoetin alfa group(n=56)and a twice or three times per week intravenous epoetin alfa group(n=39)for 28 weeks,who had anemia with hemoglobin levels between 6 g/dL and 10 g/dL due to chronic kidney disease(CKD)and were undergoing hemodialysis or hemofiltration with ESA-naive(erythropoiesis stimulating agent-naive).The primary efficacy profile was the mean Hb level(the non-inferiority margin was-1.0 g/dL,week 21-28);the secondary efficacy profiles were the Hb increase rate(week 0-4),the target Hb achievement cumulative rate and time,the change trends of the Hb levels,and the target Hb maintenance ratio.Adverse events(AEs)were observed and compared,and the efficacy and safety were analyzed between the two treatment groups.Additionally,the frequencies of dose adjustments between the darbepoetin alfa and epoetin alfa groups were compared during the treatment period.SAS?software version 9.2 was used to perform all statistical analyses.Descriptive statistics were used for all efficacy,safety,and demographic variable analyses,including for the primary efficacy indicators.Results:The mean Hb level was 11.3 g/dL in the darbepoetin alfa group and 10.7 g/dL in the epoetin alfa group,respectively;the difference of the lower limits of the 95%confidence intervals(CI)between the two groups was 0.1 g/dL(>-1.0 g/dL
基金Supported by an Unrestricted Grant From Essex Pharma (Munich, Germany), a subsidiary of Schering-Plough (Kenilworth NJ, USA)
文摘AIM: To assess systematically the spectrum and extent of depressive symptoms comparing patient groups receiving peginterferon or conventional interferon.METHODS: Ninety-eight patients with chronic hepatitis C and interferon-based therapy (+ribavirin) were consecutively enrolled in a longitudinal study. Patients were treated with conventional interferon alfa-2b (48/98patients; 5 MIU interferon alfa-2b thrice weekly) or peginterferon alfa-2b (50/98 patients; 80-150 μgpeginterferon alfa-2b) in combination with weight-adapted ribavirin (800-1 200 mg/d). Repeated psychometric testing was performed before, three times during and once after antiviral therapy: Depression was evaluated by the Hospital Anxiety and Depression Scale (HADS), anger/hostility by the Symptom Checklist-90 Items Revised (SCL-90-R).RESULTS: Therapy with pegylated interferon alfa-2bproduces comparable scores for depression (ANOVA:P = 0.875) as compared to conventional interferon.Maximums of depression scores were even higher and cases of clinically relevant depression were frequent during therapy with peginterferon. Scores for anger/hostility were comparable for both therapy subgroups.CONCLUSION: Our findings suggest that the extent and frequency of depressive symptoms in total are not reduced by peginterferon. Monitoring and management of neuropsychiatric toxicity especially depression have to be considered as much as in antiviral therapy with unmodified interferon.
文摘<strong>Aims: </strong>To evaluate the association of Nuclear factor kappa B1(NFkB1) gene polymorphism with inflammatory markers Urinary Monocyte Chemoattractant Protein 1 (UMCP1) and Tumor Necrosis Factor alfa (TNF alfa) in Patients of diabetes mellitus with or without renal involvement in Eastern India. <strong>Material and Methods: </strong>Consecutive Patients of Type 2 Diabetes Mellitus (DM) with or without microalbuminuria attending SCB MEDICAL COLLEGE and HOSPITAL Medical OPDs in between September 2018 to September 2019 were recruited in this study. Patients were subjected to blood and urine investigations. DNA extraction and Restriction fragment Length Polymorphism (RFLP) was done in Department of Biochemistry. Controls were unrelated healthy attendants with no history of Diabetes Mellitus, HTN, Chronic Kidney Disease (CKD). <strong>Results:</strong> Mean Systolic BP, Fasting Blood Glucose, Post Prandial Blood Glucose, HBA1c, Total Cholesterol were significantly higher in diabetes mellitus and diabetic nephropathy groups than control group. Estimated Glomerular Filtration Rate was significantly lower in diabetic nephropathy (p value < 0.001). UMCP1, Urinary Albumin Creatinine Ratio, TNF alfa were higher in diabetes mellitus and nephropathy with p value (<0.001, 0.006 < 0.001) respectively. In between DM and Diabetic Nephropathy groups nfkb1 gene expression, umcp1 and tnf alfa levels were significantly increased in Diabetic nephropathy with p value 0.019, <0.01, 0.001 respectively. Insertion/insertion NFkB1 gene polymorphisms were more in diabetic nephropathy group and were positively correlated with inflammatory markers UMCP1 (r = 0.517, p < 0.01) and TNF alfa (r = 0.172, p = 0.19). <strong>Conclusion:</strong> insertion/insertion NFkB1 gene polymorphism increases the risk of nephropathy by 2.52 times (OR = 2.52, 95% CI: 0.04 - 0.63, p value = 0.019) in diabetes patients in eastern India.
文摘Background: New erythropoiesis-stimulating agents (ESAs) with a longer half-life have been developed for the treatment of anemia as a complication of patients with end-stage renal disease. Objectives: The objective of the present study was to assess the hemoglobin (Hb) stability of a Japanese cohort of hemodialysis (HD) patients who were simultaneously switched from darbepoetin alfa (DA) to epoetin beta pegol (CERA). Methods: This was an observational, prospective study of HD patients 20 years of age or more who were switched from intravenous (IV) DA to IV CERA and continued on HD for at least 3 months. The dose was adjusted to maintain the Hb level to within 1.0 g/dl of the baseline value. Results: A total of 68 HD patients (75.0% male, median age 63.0 years) were enrolled. The patients’ mean Hb levels were 10.8 ± (0.6) g/dl at Month 0, 10.9 ± 0.7 at Month 1, 10.8 ± 0.7 at Month 2, and 10.9 ± 0.8 at Month 3, and the differences from the level at Month 0 were not significant. After the switch, the ESA dose decreased significantly (P P < 0.0001). Conclusion: Switching from DA to CERA was associated with approximate 89% reduction of the required dose in Japanese HD patients being treated with an ESA and showed a favorable impact on the treatment of renal anemia, including the need for less frequent injections and a reduction of the ESA dose.
文摘AIM:To study current treatment options for pediatric hepatitis C infection and their associated success rates.METHODS:We retrospectively reviewed charts of thirty children who had been treated with combination therapy of pegylated interferon alfa plus ribavirin for chronic hepatitis C infection.Patients had been treated with ribavirin(15 mg/kg per day) and either pegylated interferon alfa 2a(180 mg/m 2 once weekly) or pegylated interferon alfa 2b(1.5 mg/kg once weekly).Patients' follow-up included subjective assessment of complaints,physical examination including weight and height,as well as laboratory evaluations for viral load [before treatment,at 12 wk,and 6 mo following treatment completion,as determined by sustained viral response(SVR)],complete blood count,liver enzymes,alkaline phosphatase,bilirubin,renal function tests,and thyroid function tests.For patients not achieving a two log decrease in viral load at treatment week 12,treatment was discontinued and the patient was considered a treatment non-responder.RESULTS:Thirty children aged 3-18 years were included in the study.Twenty patients(11 males,9 females) received pegylated interferon alfa 2b and ten patients(6 males,4 females) received pegylated interferon alfa 2a.Twenty-three patients were infected with genotype 1,six patients were infected with genotype 3,and one patient was infected with genotype 2.Twenty patients(67%) achieved SVR.Treatment success rates were 90% with pegylated interferon alfa 2a vs 55% with pegylated interferon alfa 2b.Although a trend was noted for improved outcomes in the group receiving pegylated interferon alfa 2a,there were no statistically significant outcome differences between the two treatment groups(P = 0.1).Treatment success was 56.5% for patients infected with genotype 1 virus,compared to 100% for patients infected with other genotypes(P = 0.064).There was no difference in treatment response between males and females.A cut-off age of twelve years was used to dichotomize younger vs older participants;however,no differe
文摘Natural fibers are nowadays increasingly employed for making nonwoven, replacing the synthetic materials due to economic and environmental considerations. In this setting, we examine the use of Alfa fibers in nonwoven. Extracted Alfa fibers present satisfying mechanical properties that allow them to be used to produce nonwoven textiles materials. Therefore, Alfa fibers are, mainly, blended with cotton, polyester, Tencel and wool. Webs are prepared using cotton or wool cards in regular width. The nonwoven consolidation is made by needle-punching method. The weight, thickness, air permeability, adiathermic capacity and tensile properties are investigated. The results exhibit that the air permeability increases with the increase of Alfa fibers ratio for the nonwoven Alfa blended with short fibers. It decreases in case of Alfa/Wool blend. We can conclude also that the nonwoven Alfa blended with wool fibers have the highest properties values for all the Alfa fibers blends. Data also revealed that the tensile properties are reduced with the increment of Alfa fibers ratio.
