Background Anaemia in chronic kidney disease (CKD) remains one of the predictable and modifiable non-traditional cardiovascular risk factors. Epoetin zeta, which is a biosimilar product, is used in the treatment of anaemia associated with chronic kidney disease. Purpose This study was performed to evaluate the efficacy and safety of the biosimilar product epoetin zeta to maintain stable haemoglobin levels in dialysis patients. Materials and MethodsThis study was conducted in 2 dialysis centres with 33 patients. Before the study 30 of the 33 patients were on various erythropoiesis-stimulating agents (ESA). After a run-in period of 2 months, all patients were switched to epoetin zeta and were followed for 6 months. The initial weekly doses as well as the frequency of use per week were kept constant (1–3 times/week). During the follow-up, haemoglobin levels, iron status, dialysis efficiency, body weight and adverse events were monitored at least once a month. Results 33 patients were treated with biosimilar Epoetin zeta (27 men and 6 women); average age 59.1 (28–76) years; the frequency of used was 1–3 doses/week subcutaneously, over a period of 6 months. Dosing was to be adjusted to keep the Hb levels within 10.5–12 g/dl. Anaemia management and iron supplementation were at the discretion of the investigator and was to be in compliance with the current label. Throughout this study epoetin zeta was within the target range for Hb levels (10.5–11.5 g/dl ± 0.5 g/dl). The main AEs (adverse events) were in 1 patient hypotension (3%), in 1 patient in-dialyzer clotting (3%) and SAE (serious adverse event) was in 1 patient thrombosis of arteriovenous fistula (AVF) (3%). No anti-epoetin antibodies and no clinical signs of pure red cell aplasia (PRCA) were observed in any patients on the study. Conclusions Treatment of anaemia with Epoetin zeta was shown to be effective and safe. The mean Epoetin zeta doses remained stable in patients switched from all pre-study ESAs. The observed adverse events profile was in line with expectations for the study population. No conflict of interest.
Background Urinary tract infections (UTIs) are one of the most common bacterial infections during pregnancy. UTIs are serious complications associated with risk to both the fetus and mother, including pyelonephritis, preterm birth and low birth weight. Purpose To identify and treat pregnant women with asymptomatic and symptomatic bacteriuria. Materials and methods 67 pregnant women at 12 – 16 weeks gestation were included. 24 of them were diagnosed with asymptomatic bacteriuria incidentally on routine urine analysis and 8 with symptomatic cystitis. The diagnosis of UTIs was based on the culture of a urine specimen collected in a manner that minimises contamination. Urine culture showed the presence of Escherichia coli in 24 women and Proteus in 8 women. The treatment was by administration of appropriate oral or parenteral antibiotics. Results Antibiotic treatment for UTIs was initiated after all necessary cultures were obtained. 24 ambulatory women were treated with cefpodoxime 100 mg orally every 12 h for seven days. 8 pregnant women were admitted to hospital because of complications (nausea and pain) and were treated with ceftriaxone 2 g intravenous in 5% dextrose every 24 h for 5 days. Regarding cure rates and recurrent infections, the results in the ambulatory group were better than in the hospitalised group (23/5). Gestational age at birth was greater in women from the ambulatory group (21 vs 4). Conclusion Treatment of UTIs is important. Although the study had a very small sample size The authors recommended cephalosporins for the treatment of UTIs. The administration schedule of these antibiotics is unobtrusive for the patients and complications are very rare, so they are promising antibiotics for maternal and neonatal outcomes.
Background Hepatitis C (HCV) virus infection is the most common cause of liver disease in patients on haemodialysis (HD). It's a very serious and difficult health problem in these patients because of increased mortality. It reduces the chance of a kidney transplant and reduces the quality of life. The Hepatitis C virus is a RNK virus from the Flaviviridae family. For the treatment of Hepatitis C PEGASYS, peginterferon alfa-2a is recommended, which is a covalent conjugate of recombinant alfa-2a interferon. Purpose To evaluate the efficacy and safety of using peginterferon alfa-2a (Pegasys) in our hospital. Materials and methods A retrospective descriptive study of patients treated with peginterferon alfa-2a for periods of 6 years (2005-2011). The information was obtained from medical records. The following data were recorded: age, sex, diagnosis, treatment, dose, laboratory test (alanine aminotransferase-ALT), AST, anti-HCV with micro Elisa and HCV-RNK with the PCR. The safety profile was evaluated by type of side effect. Results 32 patients were treated with Pegasys (29 men and 3 women); average age of 49.91 (32-70) years; the dose administered was 135 mcg/week SC (subcutaneous) over a period of 48 weeks. After the treatment, 30 patients had undetectable HCV-RNK, however 2 of them became again HCV-RNK positive, 6 months after the treatment. In these patients treatment with peginterferon alfa-2a was repeated successfully. In 2 patients the treatment was discontinued after 12 weeks due to absence of early virological response. The main side effects were muscle pains, fatigue, fever and anaemia (anaemia in our patients was corrected with erythropoietin). Conclusions The treatments were effective and safe for our patients. Pegasys showed efficacy in 30 out of 32 patients. The side effects did not stop treatment; it was well accepted by our patients. Pegasys remains the drug of choice in treating patients with hepatitis C, for effectiveness and safety.
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