Mibefradil is a novel calcium antagonist belonging to a new chemical class of benzimidazolyl-substituted tetraline derivatives. The safety of mibefradil in patients with mild-to-moderate chronic congestive heart failure (CHF) due to coronary heart disease was assessed in a randomized, double-masked, placebo-controlled, multiple-ascending-dose trial in 45 patients. Patients were assigned to receive one of five dose levels (6.25, 12.5, 25, 50, or 100 mg/d) of mibefradil or placebo according to a randomization list. If safety variables remained stable, the subsequent group of patients was randomized to the next higher dose. The safety variables assessed included New York Heart Association class, vital signs, and ejection fraction. Patients were evaluated at baseline and day 8 of the dosing period. Mibefradil did not worsen clinical or cardiac variables. Approximately 23.3% (7 of 30) of the mibefradil-treated patients reported one or more adverse events compared with 13.3% (2 of 15) of the placebo group. The incidence of adverse events was not dose dependent. In summary, short-term oral dosing of mibefradil did not worsen measures of cardiac function in 30 patients with mild-to-moderate CHF.

Administration, Oral↗

PubMedDate not supplied

[Efficiency of a postoperative treatment after rotator cuff repair with a continuous passive motion device (CPM)].

AIM: The main objective of this study was to prove that a postoperative combined continuous passive motion (CPM) and physiotherapy treatment protocol (CPM group) can achieve 90 degrees active abduction in the shoulder joint earlier than physiotherapy alone (PT group). The indication was a complete tear of the rotator cuff. METHOD: The study was conducted under in-patient and out-patient conditions. 55 patients were included in this study. The prospective, randomized multicenter study design complies with DIN EN 540. The primary endpoint was the time span until 90 degrees active abduction was achieved by the patients. RESULTS: Patients in the CPM group reached the primary endpoint on average 12 days earlier than the control group. This difference was statistically significant (p = 0.0292). Analyzing the secondary endpoints, e. g., pain and disablement, the results in the CPM group showed again advantages of the combined treatment protocol (CPM + physiotherapy). CONCLUSION: The postoperative treatment of a total tear of the rotator cuff with a combined continuous passive motion and physiotherapy protocol provided a significantly earlier range of motion in the shoulder joint than physiotherapy alone. There was no report of CPM-related adverse effects.

Double-Blind Method↗

PubMedDate not supplied

Functional assessment and care of children with neurodevelopmental disabilities.

OBJECTIVES: To determine the relationship between pediatric assessment scores and ratings by parents and teachers regarding the amount of assistance required to complete basic activities of daily living; and to examine the relationship among scores for three commonly used pediatric assessments. DESIGN: Prospective correlational study. 205 children with developmental disabilities. The children ranged in age from 11 to 87 mo and included 72 females and 133 males of diverse socioeconomic and ethnic backgrounds. The children were evaluated by using the Battelle Developmental Inventory Screening Test, Vineland Adaptive Behavior Scales, Functional Independence Measure for Children (WeeFIM instrument), and the Amount of Assistance Questionnaire. RESULTS: The test-retest reliability coefficients for items on the Amount of Assistance Questionnaire were found to range from 0.82 to 0.97. Correlations among subscale scores and amount of assistance ratings were highest for the WeeFIM instrument and Battelle Developmental Inventory Screening Test. The highest correlation was between WeeFIM total rating and total amount of assistance rating (r = 0.91). CONCLUSION: Total WeeFIM instrument ratings and severity of disability were the best predictors of amount of assistance ratings provided by parents and teachers.

Activities of Daily Living↗

PubMedDate not supplied

Complications of burn care in patients with neurologic disorders.

Patients with neurologic disorders are frequently burned in mishaps related directly to their diseases. Once burned, these patients face a mortality rate significantly greater than that of the burn population as a whole. To assess the impact of neurologic disease on burn care, we reviewed the records of 37 patients admitted to our burn center with burns and neurologic illness. Thirty-three patients (89%) sustained injuries directly related to their neurologic problems, the most frequent being bathtub scalds (29.8%) and scald/spills (24.3%). We compared 31 of these patients having nonextensive burn injuries (less than or equal to 25% total body surface area) to a control population with similar-sized burns from our burn unit during the study period. This comparison revealed significantly longer length of stay for the neurologically impaired sample. We presume that costs of care are also increased for this sample. The high frequency of burn injury among neurologically impaired persons, coupled with the greater difficulty in caring for them, suggests that this group should receive intensive burn prevention educational efforts.

Accidents, Home↗

PubMedDate not supplied

A randomized controlled evaluation of a psychosocial intervention in adults with chronic lung disease.

The effect of a stress management program on morbidity and psychosocial and physical function in patients with chronic lung disease was assessed. Adults attending either a VA pulmonary clinic or university hospital pulmonary rehabilitation clinic who met criteria for obstructive or restrictive pulmonary disease were randomly assigned to receive the intervention or to a control group. The intervention was provided by a nurse and included one to three teaching sessions, reading material, audiotapes, and telephone follow-up. The program focused on stress management techniques such as cognitive restructuring, progressive relaxation, breathing exercises, and visual imagery. The 45 experimental subjects were similar to the 49 controls with respect to baseline characteristics. Experimental and control subjects had similar rates of mortality, hospital days, bed-disability days, restricted-activity days, and physician visits during the 12-month follow-up. There were no differences between the two groups in physical or psychosocial function at six months or in levels of stressful life changes, social supports, and self-esteem at six and 12 months. Intervention recipients had better function at 12 months, suggesting a possible benefit of the intervention.

Chronic Disease↗

PubMedDate not supplied

Characterization of tyrosine protein kinase associated with subcellular components of human colonic epithelium.

Tyrosine protein kinase (TPK) co-isolated with subcellular components derived from human colonic epithelium. The highest TPK activity, measured in the Triton X-100-insoluble cytoskeletal pellet, was directly related to the degree of malignancy of colonic tissue. TPK activity was assayed by measuring the incorporation of [gamma-32P] from [gamma-32]ATP into the synthetic polymer [Glu80Tyr20]n substrate. Lineweaver-Burk plots yielded an apparent Km of 167 micrograms/ml for [Glu80Tyr20]n and of 19 microM for ATP: Vmax for the phosphate donor was 0.9 nmol/min/mg protein. TPK activity was markedly stimulated by the metal ions Mg2+ and Mn2+ and significantly suppressed by tyrphostins, potent specific TPK inhibitors, shown to interfere with TPK-dependent growth processes. This is first report to present evidence for TPK activity associated with cytoskeleton-enriched subcellular preparations harvested from human colonic epithelium.

Benzylidene Compounds↗

PubMedDate not supplied

[Prevalence of enteropathogenic agents in the acute diarrheal syndrome in hospitalized and outpatient children].

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Acute Disease↗