Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials

Background

The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was ≥90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies.

Single fiber electromyography of extraocular muscles: A sensitive method for the diagnosis of ocular myasthenia gravis

We performed single fiber electromyography (SFEMG) in the superior rectus and levator palpebralis (SR-LP) muscles of 17 patients with pure ocular myasthenia gravis (MG) and 9 controls. Thirteen patients were also assessed with SFEMG in the orbicularis oculi (OO) muscle. All the MG patients but none of the control subjects showed abnormal SFEMG jitter in the SR-LP muscles. On the other hand, only 62% of the MG patients had abnormal SFEMG jitter in the OO muscle. The procedure was well tolerated by the patients, and complications were minor. We conclude that SFEMG of the SR–LP muscles is a safe and highly sensitive technique for the diagnosis of ocular MG. © 1995 John Wiley & Sons, Inc.     

CD4+ lymphocyte subsets in the cerebrospinal fluid of multiple sclerosis and non-inflammatory neurological diseases

Summary We studied paired cerebrospinal fluid (CSF) and peripheral blood (PB) samples from 18 inactive multiple sclerosis (MS) patients and 10 with non-inflammatory neurological diseases. By means of a dual-colour cytofluorimetric micromethod we were able to count 1500 cells on average in each CSF sample. We found a significant reduction of CD45RA+ and CD4+CD45RA+ cells in the CSF of MS patients. Similarly, CD45RA+ and CD4+CD45RA+ CSF/PB ratios were lower compared with controls. The reduction of suppressor-inducer T-cells did not correlate with CD8+ cell levels in the CSF. The CD4+ subset ratio (CD4+CD45RA–/CD4+CD45RA+) was significantly increased in the CSF of MS patients. Our data suggest that the reduction of CD4+CD45RA+ cells in the PB is not due to a segregation of such cells in the CSF. Conversely, CSF changes reflect changes in the PB similar to these found for other T-cell subsets.     

Tension-free vaginal tape for the treatment of urodynamic stress incontinence with intrinsic sphincteric deficiency

The purpose of this study was to evaluate the outcome of tension-free vaginal tape (TVT) procedure in women with urodynamic stress incontinence diagnosed as having intrinsic sphincteric deficiency (ISD). The combination of a maximal urethral closure pressure <20 cm H₂O and a Valsalva leak point pressure <60 cm H₂O was considered as diagnostic of ISD. Subjects with detrusor overactivity on preoperative urodynamics were excluded. A total of 35 patients with both low closure pressure and leak point pressure were enrolled. Bladder perforation occurred in three (8.6%) cases. Postoperative urinary voiding difficulties occurred in nine (25.7%) women. Two patients underwent surgical detension of the tape, with complete resolution of urinary retention and no relapse of incontinence. Women with postoperative voiding dysfunction had a significantly lower detrusorial pressure at the peak flow on preoperative urodynamics compared to those who voided efficiently after TVT. The mean (range) follow-up time was 12.5 months (3–36). The objective cure rate for stress incontinence was 91.4%. Two of the three (66%) patients in whom the TVT procedure failed had a fixed urethra. De novo urge incontinence was found in five (14.3%) patients.     

Prevalence of HCV antibodies in a uraemic population undergoing maintenance dialysis therapy and in the staff members of the dialysis unit.

We studied, by both 1st and 2nd generation assay, the prevalence rate of HCVAb in a population of 141 dialysis patients, 37 transplanted patients and 55 staff members. From this study emerges a higher sensitivity of the 2nd generation HCVAb test (15.38 versus 36.79% of positive responses, respectively), and a significant positive correlation between lengths of dialysis period. We have not found a significant difference between HCVAb-positive and -negative patients in relation to the blood transfusions. None of the 21 CAPD patients (home dialysis) resulted positive, even if transfused. Two nurses were positive. In our experience, the environmental factor seems more important. Since the isolation of the positive patients is an effective but not feasible measure, it is necessary to improve the operating management of the hemodialysis sessions, avoiding any contact between patients via material (instrumentation, monitors) and teaching the staff members to use severe preventive standards with all hemodialysis patients.     

Preclinical hypogonadism in genetic hemochromatosis in the early stage of the disease: evidence of hypothalamic dysfunction.

We studied endocrine functions at baseline and after TRH and LHRH stimulation in a group of 7 young male patients with genetic hemochromatosis (HE) without liver damage (i.e. fibrosis and cirrhosis). In five patients endocrine re-evaluations after complete iron depletion was also performed. Mean basal testosterone (T), FSH, LH and PRL were significantly lower than in controls. Serum T increased normally after HCG stimulation. The normal or high increments of LH after LHRH stimulation suggest that secretion capacity of LH was intact and that hypothalamic dysfunction could be responsible for the preclinical gonadal deficiency found in our patients. The response of PRL to TRH indicates that secretion capacity of lactotrophs although present, was decreased and did not improve after phlebotomy therapy. After iron depletion the two patients with the lowest basal T levels showed the highest increments indicating that in the early stages of hypothalamic-pituitary damage gonadal dysfunction is still reversible in HE patients.     

Metabolic and hormonal blood flow modeling in patients with coronary heart disease: In vitro and clinical study

The blood flow pattern investigations are of great importance in coronary blood flow destabilization pathogenesis understanding, and consequently in acute coronary event (ACE) risk stratification in patients with coronary heart disease. The aim of the study was to research the principal hormonal and metabolic blood flow regulative aspects and its structure in patients with ischemic heart disease and the contribution to cumulative ACE risk.A total of 182 patients with stable angina pectoris were included in the prospective study (2000–2006). Complex clinical examination, biochemical tests and blood tests were performed. Whole-blood (WB) viscosity, erythrocyte aggregation and deformation ability, WB suspension stability, and initial erythrocytes disaggregation parameter were studied. Dynamic characteristics of blood flow were obtained in the experiment.Received results allow marking the principle components of blood flow pattern with proven high prognostic value of ACE in patients with ischemic heart disease. ACE risk stratification program was developed.