Corneal birefringence changes after laser assisted in situ keratomileusis and their influence on retinal nerve fibre layer thickness measurement by means of scanning laser polarimetry

Aim: To evaluate changes in corneal polarisation properties and their influence on peripapillary retinal nerve fibre layer (RNFL) thickness measurements after laser assisted in situ keratomileusis (LASIK) by means of scanning laser polarimetry (SLP) with variable corneal polarisation compensator (VCC) in normal white subjects.     

The veterans' study to improve the control of hypertension (V-STITCH): design and methodology

BACKGROUND: Among the 60 million Americans with hypertension, only approximately 31% have their blood pressure (BP) under control (<140/90 mm Hg). Despite the damaging impact of hypertension and the availability of evidence-based target values for BP, interventions to improve BP control have had limited success. OBJECTIVES: A randomized controlled health services intervention trial with a split-plot design is being conducted to improve BP control. This 4-year trial evaluates both a patient and a provider intervention in a primary care setting among diagnosed hypertensive veterans. METHODS: In a cluster-randomization, 30 primary care providers in the Durham VAMC Primary Care Clinic were randomly assigned to receive the provider intervention or control. The provider intervention is a patient-specific electronically generated hypertension decision support system (DSS) delivering guideline-based recommendations to the provider at each patient's visit, designed to improve guideline-concordant therapy. For these providers, a sample of their hypertensive patients (n=588) was randomly assigned to receive a telephone-administered patient intervention or usual care. The patient intervention incorporates patients' need assessments and involves tailored behavioral and education modules to promote medication adherence and improve specific health behaviors. All modules are delivered over the telephone bi-monthly for 24 months. In this trial, the primary outcome is the proportion of patients who achieve a BP < or =140/90 mm Hg at each outpatient clinic visit over 24 months. CONCLUSION: Despite the known risk of poor BP control, a majority of adults still do not have their BP controlled. This study is an important step in testing the effectiveness of a patient and provider intervention to improve BP control among veterans in the primary care setting.     

Improving the quality of anticoagulation of patients with atrial fibrillation in managed care organizations: results of the managing anticoagulation services trial

Randomized trials have indicated that well-managed anticoagulation with warfarin could prevent more than half of the strokes related to atrial fibrillation. However, many patients with atrial fibrillation who are eligible for this therapy either do not receive it or are not maintained within an optimal prothrombin time-international normalized ratio (INR) range. We sought to determine whether an anticoagulation service within a managed care organization would be a feasible alternative for providing anticoagulation care.We performed a multi-site randomized trial in six large managed care organizations in the United States. Subjects were aged 65 years or older and had nonvalvular atrial fibrillation. At each site, physician practices were divided into two geographically defined practice clusters; each site was randomly assigned to have one intervention and one control cluster. The intervention cluster received an anticoagulation service that satisfied specifications for high-quality anticoagulation care and was coordinated through the managed care organization. Control clusters continued with their usual provider-based care. We measured the proportion of time that warfarin-treated patients in each of the clusters (intervention and control) were in the target range for the INR at baseline, and again during a follow-up period.Five of the six selected sites succeeded at developing an anticoagulation service. Patients in the intervention and control clusters had similar demographic characteristics, contraindications to warfarin, and risk factors for stroke. Among patients (n = 144 in the intervention clusters; n = 118 in the control clusters) for whom data were available during the baseline and follow-up periods, the changes in percentages of time in the target range were similar for those in the intervention clusters (baseline: 47.7%; follow-up: 55.6%) and in the control clusters (baseline: 49.1%; follow-up: 52.3%; intervention effect: 5%; 95% confidence interval: -5% to 14%; P = 0.32).Although it was feasible in a managed care organization to implement anticoagulation services that were tailored to local circumstances, provision of this service did not improve anticoagulation care compared with usual care. The effect of the anticoagulation service was limited by the utilization of the service, the degree to which the referring physician supports strict adherence to recommended target ranges for the INR, and the ability of the anticoagulation service to identify and to respond to out-of-range values promptly.     

Housewives with raw potato-induced bronchial asthma

Allergy to white potato has rarely been described. We report two cases of atopic patients, housewives, in whom peeling raw potatoes precipitated rhinoconjunctivitis and asthmatic attacks, and, in one of them, contact urticaria. Type I hypersensitivity to raw potato antigens was demonstrated by means of immediate skin test reactivity, specific IgE determination by RAST, basophil degranulation, histamine release test and an immediate bronchial provocation test response to raw potato extract. The controls did not react to any of these tests. Potato allergenic constituent is currently being investigated but, as far as we know, it is heat-labile and has an MW of more than 10 Kd.     

A clinical study assessing the pharmacokinetics,efficacy and safety of AlphaNine®, a high‐purity factor IX concentrate,in patients with severe haemophilia B

Summary. Effective treatment with factor IX (FIX) requires a thorough consideration of the properties of the concentrate to be used as replacement therapy, to date, the only available treatment for haemophilia B. The aim of the study was to determine the pharmacokinetics, clinical efficacy and safety in routine clinical use of AlphaNine^®, a high‐purity human FIX concentrate. This open, single‐arm, multicentre, non‐randomized trial included 25 subjects (age ≥ 12) with moderate/severe haemophilia B. Pharmacokinetics was assessed at baseline and after a 6‐month follow‐up. The degree of haemostasis control achieved was evaluated during a 12‐month follow‐up. Safety was evaluated in terms of tolerance, thrombogenicity, immunogenicity and viral safety. Mean recovery was 1.01 ± 0.19 IU dL^?1 per IU kg^?1 at baseline and 1.23 ± 0.34 IU dL^?1 per IU kg^?1 6 months later. Terminal half‐life was 34.5 ± 6.2 h and 33.7 ± 5.4 h, respectively. Ratios of each parameter between the two pharmacokinetic studies were all close to 1. A total of 1,576,890 IU AlphaNine^® were administered in 889 infusions (mean dose per infusion: 1774 IU; 3.2 infusions per month per patient). The main reasons for infusion were mild/moderate bleeding (62.3%) and prophylaxis (20.5% continuous, 15.6% intermittent). Overall, 93.0% of the efficacy assessments were rated as excellent/good and 88.8% of bleedings resolved after the first infusion. Twenty‐one adverse events were reported in eight patients, none of which was considered related to the study medication. AlphaNine^® showed a pharmacokinetic profile in agreement with that of other plasma‐derived FIX concentrates and provides safe and clinically effective substitution therapy for patients with haemophilia B.     

Calcium supplementation reduces the risk of pregnancy-induced hypertension in an Andes population

Summary. Previous studies have suggested that increased dietary calcium is associated with a decreased occurrence of pregnancy-induced hypertension. In this study 106 young healthy nulliparous women, residing in Quito, Ecuador, were enrolled in a double-blind, randomized, controlled clinical trial. From 24 weeks gestation until delivery they received either 2 g of elemental calcium per day or a placebo. Calcium supplementation was associated with a significantly decreased risk of pregnancy-induced hypertension, with 4.1% developing pregnancy-induced hypertension in the treatment group versus 27.9% in the placebo group. Treatment was associated with a decrease in both systolic and diastolic blood pressure over the course of pregnancy. In addition, there was a small but significant increase in serum ionized calcium levels in the calcium-supplemented group during the treatment period.     

Islet cell tumour with vacuolated lipid-rich cytoplasm: a new histological variant of islet cell tumour

Aims : A previously unreported clear cell variant of islet cell tumour of the pancreas is described. Methods and results : By light microscopy, the cytoplasm of the clear cells was finely reticulated and vacuolated. Immunohistochemical and electron microscopy studies confirmed the endocrine nature of the tumour. Conclusions : The clear cell morphology was due to the accumulation of lipid in the cytoplasm.