Background Kidney biopsy provides important information for nephrologists, but the risk of complications has not been systematically described. Study Design Meta-analysis of randomized controlled ...trials and prospective or retrospective observational studies. Setting & Population Adults undergoing native kidney biopsy in an inpatient or outpatient setting. Selection Criteria for Studies MEDLINE indexed studies from January 1980 through June 2011; sample size of 50 or more. Intervention Native kidney biopsy with automated biopsy device and real-time ultrasonographic guidance. Outcomes Macroscopic hematuria and erythrocyte transfusion rates and factors associated with these outcomes. Results 34 studies of 9,474 biopsies met inclusion criteria. The rate of macroscopic hematuria was 3.5% (95% CI, 2.2%-5.1%), and erythrocyte transfusion was 0.9% (95% CI, 0.4%-1.5%). Significantly higher rates of transfusion were seen with the following: 14-gauge compared with smaller needles (2.1% vs 0.5%; P = 0.009), studies with mean serum creatinine level ≥2.0 mg/dL (2.1% vs 0.4%; P = 0.02), ≥50% women (1.9% vs 0.6%; P = 0.03), and ≥10% of biopsies for acute kidney injury (1.1% vs 0.04%; P < 0.001). Higher transfusion rates also were observed in studies with a mean age of 40 years or older (1.0% vs 0.2%; P = 0.2) and mean systolic blood pressure ≥130 mm Hg (1.4% vs 0.1%; P = 0.09). Similar relationships were noted for the macroscopic hematuria rate with the same predictors, but none was statistically significant. Limitations Publication bias, few randomized controlled trials, and missing data. Conclusions Native kidney biopsy using automated biopsy devices and real-time ultrasonography is associated with a relatively small risk of macroscopic hematuria and erythrocyte transfusion requirement. Using smaller gauge needles may lower complication rates. Patient selection may affect outcome because studies with higher serum creatinine levels, more women, and higher rates of acute kidney injury had higher complication rates. Future studies should further evaluate risk factors for complications.
KDIGO (Kidney Disease: Improving Global Outcomes) is an international initiative with a key mission of developing clinical practice guidelines in the area of chronic kidney disease (CKD). KDIGO ...recently published evidence-based clinical practice guidelines for the prevention, diagnosis, evaluation, and treatment of hepatitis C virus infection in individuals with CKD. The process of adaptation of international guidelines is an important task that, although guided by general principles, needs to be individualized for each region and country. Therefore, the National Kidney Foundation–Kidney Disease Outcomes Quality Initiative (KDOQI) convened a multidisciplinary group to comment on the application and implementation of the KDIGO guidelines for patients with CKD in the United States. This commentary summarizes the process undertaken by this group in considering the guidelines in the context of health care delivery in the United States. Guideline statements are presented, followed by a succinct discussion and annotation of the rationale for the statements. Research recommendations that are of particular interest to the United States are then summarized to highlight future areas of inquiry that would enable updating of the guidelines.
Background Hepatitis C virus (HCV) infection is prevalent in patients undergoing hemodialysis and is associated with greater mortality. We determined the efficacy and harms of interferon (IFN) and ...pegylated IFN (PEG-IFN) treatment of hemodialysis patients with chronic HCV infection and identified factors associated with these outcomes. Study Design Meta-analysis and meta-regression of randomized controlled trials, uncontrolled trials, and prospective observational studies. Setting & Population Hemodialysis patients with chronic HCV infection. Selection Criteria for Studies MEDLINE indexed studies since 1966, sample size greater than 10. Intervention IFN-based treatment, including PEG-IFN with and without ribavirin. Outcomes Sustained virological response (SVR) 6 months after treatment, rate of treatment discontinuation caused by adverse events, and factors associated with these outcomes. Results 20 studies of 459 IFN-treated patients, 3 studies of 38 PEG-IFN–treated patients, and 2 studies of 49 PEG-IFN and ribavirin-treated patients met inclusion criteria. The overall SVR rate was 41% (95% confidence interval CI, 33 to 49) for IFN and 37% (95% CI, 9 to 77) for PEG-IFN. Treatment discontinuation rates were 26% (95% CI, 20 to 34) for IFN and 28% (95% CI, 12 to 53) for PEG-IFN. SVR was higher with 3 million units (MU) or higher of IFN 3 times weekly, with lower mean HCV RNA, and with lower rates of cirrhosis, HCV genotype 1 or elevated transaminase, but these findings were not statistically significant. Treatment discontinuation rates were greater in studies using larger doses. Limitations Publication bias, few randomized controlled trials, and limitations in generalizability to all hemodialysis patients. Conclusion IFN treatment of hemodialysis patients results in an SVR rate of 41%. Higher dose, lower mean HCV RNA level, and lower rates of cirrhosis, transaminase level increase, and HCV genotype 1 may be associated with greater SVR rates, but additional studies using individual patient data are needed.
Background Apremilast works intracellularly to regulate inflammatory mediators. Objective ESTEEM 1 evaluated efficacy/safety of apremilast at 30 mg twice a day for moderate to severe plaque ...psoriasis. Methods This phase III, multicenter, double-blind, placebo-controlled study randomized adults (2:1) to apremilast or placebo. At week 16, the placebo group switched to apremilast through week 32, followed by a randomized treatment withdrawal phase to week 52. Binary end points were analyzed using χ2 test; continuous end points used analysis of covariance. Results In all, 844 patients were randomized (n = 282, placebo; n = 562, apremilast). At week 16, significantly more patients taking apremilast achieved 75% or greater reduction from baseline Psoriasis Area and Severity Index score (PASI-75) (33.1%) versus placebo (5.3%, P < .0001; primary end point). Most (61.0%) patients rerandomized to apremilast at week 32 achieved PASI-75 at week 52 versus 11.7% rerandomized to placebo. Of patients rerandomized to apremilast at week 32, mean percentage change from baseline PASI score was −88% to −81% (weeks 32-52). During the placebo-controlled period, 55.7% and 69.3% of patients randomized to placebo and apremilast, respectively, had 1 or more adverse events. Most adverse events were mild/moderate in severity. No new significant adverse events emerged with continued apremilast exposure versus the placebo-controlled period. Limitations Data were limited to 52 weeks and may not generalize to nonplaque psoriasis. Conclusions Apremilast was effective in moderate to severe plaque psoriasis.
Background Adalimumab is a fully human monoclonal antibody that binds tumor necrosis factor, a key proinflammatory cytokine involved in the pathogenesis of psoriasis. Objective We sought to evaluate ...clinical efficacy and safety of adalimumab for moderate to severe psoriasis and investigate continuous versus interrupted therapy. Methods We conducted a 52-week, multicenter study of 1212 patients randomized to receive adalimumab (40 mg) or placebo every other week for the first 15 weeks. At least 75% improvement in the Psoriasis Area and Severity Index (PASI) score was the criterion for advancement through this multiphase study. Results At week 16, 71% (578 of 814) of adalimumab- and 7% (26 of 398) of placebo-treated patients achieved greater than or equal to 75% improvement in the PASI score. During weeks 33 to 52, the percentage of patients rerandomized to placebo who lost adequate response (defined as <50% improvement in the PASI response relative to baseline and at least a 6-point increase in PASI score from week 33) was 28% compared with 5% of patients treated continuously with adalimumab. Limitations Lack of an active comparator and evaluation of maintenance of response beyond week 52 are limitations. Conclusion Adalimumab is efficacious and well-tolerated in the treatment of chronic plaque psoriasis. Trial Registration Clinical trials.gov. NCT00237887.
We have used the Very Large Array (VLA) FIRST survey and the Automated Plate Measuring Facility (APM) catalog of the Palomar Observatory Sky Survey I (POSS-I) plates as the basis for constructing a ...new radio-selected sample of optically bright quasars. This is the first radio-selected sample that is competitive in size with current optically selected quasar surveys. Using only two basic criteria, radio-optical positional coincidence and optical morphology, quasars and BL Lac objects can be identified with 60% selection efficiency; the efficiency increases to 70% for objects fainter than 17 mag. We show that a more sophisticated selection scheme can predict with better than 85% reliability which candidates will turn out to be quasars. This paper presents the second installment of the FIRST Bright Quasar Survey (FBQS), with a catalog of 636 quasars distributed over 2682 deg2. The quasar sample is characterized and all spectra are displayed. The FBQS detects both radio-loud and radio-quiet quasars out to redshift z>3. We find a large population of objects of intermediate radio loudness; there is no evidence in our sample for a bimodal distribution of radio characteristics. The sample includes {approx}29 broad absorption line quasars, both high and low ionization, and a number of new objects with remarkable optical spectra. (c) (c) 2000. The American Astronomical Society.
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