BackgroundIron deficiency anaemia is common in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) and is often treated with oral or intravenous (IV) iron therapy. This trial compared the efficacy and safety of IV iron isomaltoside 1000 (Monofer®) and oral iron in NDD-CKD patients with renal-related anaemia.MethodsThe trial was a Phase III open-label, comparative, multicentre, non-inferiority trial conducted in 351 iron-deficient NDD-CKD patients, randomized 2:1 to either iron isomaltoside 1000 (Group A) or iron sulphate administered as 100 mg elemental oral iron twice daily (200 mg daily) for 8 weeks (Group B). The patients in Group A were randomized into A1 (infusion of max. 1000 mg single doses over 15 min) and A2 (bolus injections of 500 mg over 2 min). A modified Ganzoni formula was used to calculate IV iron need. The primary end point was change in haemoglobin concentrations from baseline to Week 4.ResultsIron isomaltoside 1000 was both non-inferior to oral iron at Week 4 (P < 0.001) and sustained a superior increase in haemoglobin from Week 3 until the end of the study at Week 8 (P = 0.009 at Week 3). The haemoglobin response was more pronounced with iron isomaltoside 1000 doses ≥1000 mg (P < 0.05). Serum-ferritin and transferrin saturation concentrations were also significantly increased with IV iron. Adverse drug reactions were observed in 10.5% in the iron isomaltoside 1000 group and 10.3% in the oral iron group. More patients treated with oral iron sulphate withdrew from the study due to adverse events (4.3 versus 0.9%, P = 0.2).ConclusionsIron isomaltoside 1000 was more efficacious than oral iron for increase in haemoglobin and proved to be well tolerated at the tested dose levels in NDD-CKD patients.
The study was undertaken to evaluate physical, psychological and functional aspects in quality of life (QoL) assessment prospectively in biopsy-proven head and neck cancer patients receiving radical radiotherapy. Fifty male patients were assessed using Karnofsky's Performance Status (KPS), Beck's Depression Inventory (BDI) and the Functional Living Index-Cancer (FLIC). Patient questionnaires were completed before radiotherapy, during 3-4 weeks of radiotherapy and 3 months after radiotherapy. Before the start of radiotherapy, KPS was 91 +/- 10.26, FLIC was 129.98 +/- 33.41 and BDI was 7.10 +/- 4.57. This indicated good performance and functional status with lower depression. In weeks 3-4 of radiotherapy, KPS (71.00 +/- 20.12) and FLIC (81.34 +/- 45.23) decreased, while BDI (16.56 +/- 9.01) increased, indicating impairment in QoL. Three months after radiotherapy, KPS (78.37 +/- 23.0), FLIC (119.51 +/- 43.62) and BDI (9.02 +/- 7.81) improved but were not restored to pre-treatment levels. When patients were scheduled for radical radiotherapy, maximum deterioration in QoL was seen in weeks 3-4. This is the time when maximum supportive care and psychologic counselling is required.
Renal tubular acidosis (RTA) is essentially characterized by normal anion gap and hyperchloremic metabolic acidosis. It is important to understand that despite knowing the disease for 60-70 years, complexities in the laboratory tests and their interpretation still make clinicians cautious to diagnose and label types of tubular disorder. Hence, we are writing this mini-review to emphasize on the step wise approach to RTA with some understanding on its basic etiopathogenesis. This will definitely help to have an accurate interpretation of urine and blood reports in correlation with the clinical condition. RTA can be a primary or secondary defect and results either due to abnormality in bicarbonate ion absorption or hydrogen ion secretion. Primary defects are common in children due to gene mutation or idiopathic nature while secondary forms are more common in adults. We are focusing and explaining here in this review all the clinical and laboratory parameters which are essential for making the diagnosis of RTA and excluding the extrarenal causes of hyperchloremic, normal anion gap metabolic acidosis.
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