Clinical safety assessment of iotrolan 280 in European clinical studies

Iotrolan (280 mg iodine/ml) a new non ionic, isotonic dimeric, contrast agent, was evaluated in multicenter clinical stidues conducted in Europe between March 1987 and September 1992. The studies compared the efficacy and safety of the agent with the non-ionic monomeric contrast agents available at the time. Iotrolan was given intravenously to patients undergoing urography, head and body computed tomography phlebography and digital subtraction angiography. The agent was also studied after intra-arterial injections in cerebral, visceral and peripheral angiographic procedures as well as digital subtraction angiography. Data from 32 prospective double blind, randomized, controlled clinical studies, were evaluated. A total of 1203 patients received either iopromide, iohexol or iopamidol (all in concentration of 300 mg iodine/ml), and a further 1207 patients received iortrolan. As there were no sognificant differences (P = 0.0853) in adverse events between the comparative agents, their adverse event data were pooled for evaluation with data from patients receiving iotrolan. Adverse experiences were recorded in two categories — local tolerance (heat and pain) and general tolerance (generalized heat and adverse clinical events). After intra-arterial injection iotrolan had a significantly lower incidence of local heat sensation (P = 0.0001) and a significantly lower incidence of local pain (P = 0.0001) compared with comparator agents. Also, after intravenous injection iotrolan had a significantly lower incidence of local heat (P = 0.0038). In the overall evaluation of general tolerance for all indications, iotrolan was shown to produce significantly less generalized heat (P = 0.0012) and a lower incidence of adverse events (P = 0.061) compared with the reference agents.     

Pilot study of a visitor volunteer programme for community elderly people receiving home health care

There is a need to evaluate community support programmes for elderly people. In this randomized control trial (RCT), we determined the effectiveness of 'friendly visitors' in a volunteer programme of a visiting nurses organization in Southern Ontario, Canada. The Volunteer Friendly Visitor Programme was developed to support elderly people receiving homemaking and nursing care in the community. Volunteers are screened, trained, interviewed and matched to homebound elderly clients for general interest, visit expectations and personality. Volunteers spend three to four hours on average per week with clients socializing in mutually agreed-upon ways. The nursing staff identified clients who were lonely for this additional support. These newly-referred clients were randomly allocated to receive a friendly visitor or not for six weeks. Those receiving the volunteer visitor improved in life satisfaction and two social support measures: worth and social integration. Thus, the addition of volunteer visitors to planned homemaking and nursing care made a difference for elderly in the community.     

Kraepelin-oriented research-diagnosable schizophrenia,mania, and depression in schneider-negative schizophrenics

Summary The rigorous neo-Kraepelinean research criteria of the St. Louis/ Iowa and Taylor groups were applied to case record data of 116 first admissions of Schneider-negative schizophrenics—that is, those without first-rank symptoms (FRSs)—hospitalized in a strongly Schneider-oriented German University Psychiatric Clinic from 1962 to 1971. This sample had a total of 45.7% (53 cases) of psychiatric illness diagnosable by research methods. Indeed, only 31% (36 cases) of Schneider-negative schizophrenics turned out to have research-positive Kraepelin-oriented schizophrenia; and of these, 21 fulfilled both sets of research criteria for schizophrenia. It is important that 14.6% (17 cases) of Schneider-negative schizophrenia consisted of research-diagnosable affective disorder, with mania making up 5.2% and depression 9.4% of this figure. The findings suggest that a sample of Schneider-oriented schizophrenia without FRSs as routinely diagnosed in Germany does not seem to represent a clear-cut homogeneous and uncontaminated group of schizophrenics.     

The well-baby clinic

The termwell-baby clinic (literally, a clinic that concerns itself with healthy infants) is probably better known in the United States, where such clinics exist, than in central Europe, where, on the whole, they do not. For the convenience of readers accustomed to it a formal definition is proffered: A well-baby clinic is a service center, with emphasis on physical and mental hygiene and prophylaxis, where mothers are seen with their young, healthy infants and helped to understand and manage the infant's unfolding maturation [1: p. 5] and development [1: p. 5]. This may serve to differentiate well-baby clinics, on the one hand, from clinics for sick children and child guidance clinics (usually resorted to after disturbances have emerged) and, on the other hand, from maternity and child welfare clinics, whose primary object is to safeguard physical health. (Maternity and child welfare clinics are also known as family health clinics, child health clinics, and infant welfare clinics. The extent to which they can cater to the psychological needs of mother and infant depends on their staff's training.)This paper forms part of a research project entitled Childhood Pathology: Impact on Later Mental Health, which is being conducted at the Hampstead Child-Therapy Course and Clinic, London. The project is financed by National Institute of Mental Health Grant MH-05683-11. Appreciation is expressed to Anna Freud, Elizabeth Model, Professor A. J. Solnit, and Dr. Josefine Stross for their valuable suggestions. The authors acknowledge with gratitude the freedom to quote from the Well-Baby Clinic's annual reports, compiled by the clinic's pediatrician, Dr. Josefine Stross, with the active help of her past assistants, Annemarie Curson, Manna Friedmann, and Joyce Robertson, and her present assistants, Irene Freud and E. Model.This paper was originally published in German, in volume 2 of theJahrbuch der Psychohygiene, Ed. Gerd Biermann, Ernst Reinhardt Verlag, München/Basel, 1974.     

Cyclosporin A induced internalization of the bile salt export pump in isolated rat hepatocyte couplets.

Isolated rat hepatocyte couplets were used to perform the comparative study of two widely used immunosuppressors, cyclosporin A (CsA) and tacrolimus (FK506) on hepatocanalicular function. We assessed canalicular function by counting the percentage of couplets that were able to accumulate the fluorescent cholephile, cholyl-lysyl-fluorescein (CLF), into the canalicular vacuole between the two cells, i.e., canalicular vacuole accumulation (CVA) of CLF. Compared to controls (DMSO-treated cells), CsA, in the approximate range of concentrations used therapeutically, caused inhibition of CVA of CLF, disorganization of the bile salt export pump (Bsep) localization at canalicular level resulting in its relocation into the cell, and disruption of the pericanalicular F-actin cytoskeleton. In contrast, FK506, at both approximately therapeutic and supratherapeutic concentrations, had no deleterious effect upon CVA of CLF, upon the localization of the bile salt transporter at the canalicular membrane, or on the organization of the pericanalicular F-actin cytoskeleton. These results point to transporter and cytoskeletal disorganization as contributors or determinants of CsA-induced cholestasis at canalicular level, whereas FK506 does not appear to produce these cholestasis-determining responses even at supratherapeutic concentrations.     

Patterns and predictors of inpatient falls and fall-related injuries in a large academic hospital.

OBJECTIVES: Most research on hospital falls has focused on predictors of falling, whereas less is known about predictors of serious fall-related injury. Our objectives were to characterize inpatients who fall and to determine predictors of serious fall-related injury. METHODS: We performed a retrospective observational study of 1,082 patients who fell (1,235 falls) during January 2001 to June 2002 at an urban academic hospital. Multivariate analysis of potential risk factors for serious fall-related injury (vs no or minor injury) included in the hospital's adverse event reporting database was conducted with logistic regression to calculate adjusted odds ratios (aORs) with 95% confidence intervals (CI95) RESULTS: The median age of patients who fell was 62 years (interquartile range, 49-77 years), 50% were women, and 20% were confused. The hospital fall rate was 3.1 falls per 1,000 patient-days, which varied by service from 0.86 (women and infants) to 6.36 (oncology). Some (6.1%) of the falls resulted in serious injury, ranging by service from 3.1% (women and infants) to 10.9% (psychiatry). The most common serious fall-related injuries were bleeding or laceration (53.6%), fracture or dislocation (15.9%), and hematoma or contusion (13%). Patients 75 years or older (aOR, 3.2; CI95, 1.3-8.1) and those on the geriatric psychiatry floor (aOR, 2.8; CI95, 1.3-6.0) were more likely to sustain serious fall-related injuries. CONCLUSIONS: There is considerable variation in fall rates and fall-related injury percentages by service. More detailed studies should be conducted by floor or service to identify predictors of serious fall-related injury so that targeted interventions can be developed to reduce them.