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Biomedical subjects

J Hecker

Publications and source records attributed to J Hecker.

At least 19 recordsLinked to original sources
PubMed2004

Economic evaluation of donepezil in moderate to severe Alzheimer disease.

OBJECTIVE: To investigate the costs to society of Alzheimer disease (AD) care in a multinational, randomized, placebo-controlled trial of donepezil in patients with moderate to severe AD. METHODS: A total of 290 patients with AD (screening standardized Mini-Mental State Examination score 5 to 17) were randomized to receive either donepezil (n = 144; 5 mg/day for 28 days, followed by 10 mg/day as per clinician's judgment) or placebo (n = 146) for 24 weeks. The authors collected data on patient and caregiver health resource utilization prospectively using the Canadian Utilization of Services Tracking questionnaire. Costs were calculated for patients and caregivers in each group based on resource utilization multiplied by the unit prices for each resource. A cost (the average Ontario minimum wage for 1998 [Can 6.85 dollars per hour]) was assigned to unpaid time that caregivers spent assisting the patient with activities of daily living (ADL). RESULTS: Patient and caregiver demographics at baseline were similar across the two groups. After adjusting for baseline total cost per patient, the mean total societal cost per patient for the 24-week period was donepezil, Can 9,904 dollars (US 6,686 dollars) and placebo, Can 10,236 dollars (US 6,910 dollars). This net cost saving of Can 332 dollars (US 224 dollars) included the average 24-week cost of donepezil treatment. Most of the cost-saving with donepezil treatment was due to less use of residential care by patients, and caregivers spending less time assisting patients with ADL. CONCLUSION: This cost-consequence analysis reveals economic benefits of treatment of moderate to severe AD with donepezil.

Activities of Daily Living↗
PubMed2002

First-trimester trisomy screening: nuchal translucency measurement training and quality assurance to correct and unify technique.

OBJECTIVE: To describe the process of training for measuring nuchal translucency at five clinical centers in North America and to evaluate methods of quality assurance and feedback. DESIGN: Throughout a period of 18 months, the performance of sonographers in measuring fetal nuchal translucency was monitored using qualitative and quantitative methods of review. After 12 months, different approaches (written and personal feedback) were used to inform sonographers of technical aspects that needed to or could be improved. RESULTS: On initial qualitative review, discrepancies in judgment from different reviewers coincided with suboptimal magnification, failure to visualize the amniotic membrane and/or use of cross-shaped calipers. At subsequent global review, 13 (29%) images of nuchal translucency measurements were considered unacceptable. Quantitative assessment revealed that, during the first part of the study, the means from four sonographers were significantly smaller and the mean from the fifth sonographer was significantly larger than expected on the basis of findings from The Fetal Medicine Foundation (P < 0.0001). Following feedback, sonographers who underestimated nuchal translucency and who received a written report only did not change measurements overall (P = 0.9759). In contrast, those who received additional intervention showed a marked difference (P < 0.0001). CONCLUSIONS: Global qualitative review of images from one sonographer may be preferable to assessment of individual aspects of images. Results from global qualitative review correspond well with findings from quantitative analysis, indicating that the latter can be applied for ongoing audit. Observation of divergent results should prompt extensive personal feedback, rather than a written report, to prevent sonographers from settling in their own, inappropriate technique.

Allied Health Personnel↗
PubMed2002

Functional, cognitive and behavioral effects of donepezil in patients with moderate Alzheimer's disease.

OBJECTIVE: To investigate the efficacy and safety of donepezil in a subgroup of patients with Alzheimer's disease (AD) of moderate severity from a previous trial. METHODS: Two hundred and seven patients with moderate AD (standardized Mini-Mental State Examination [sMMSE] score 10-17) were randomized to treatment in this 24-week, double-blind, placebo-controlled trial. Patents received either donepezil, 5 mg/day for the first 28 days and 10 mg/day thereafter according to the clinician's judgement (n = 102), or placebo (n = 105). The primary outcome measure was the Clinician's Interview-Based Impression of Change with caregiver input (CIBIC-plus) at week 24 using a last observation carried forward (LOCF) analysis. RESULTS: Baseline patient demographics were similar between treatment groups. Mean age was 74.3 years (range 48-92). Least-squares (LS) mean sMMSE scores at baseline were 13.6 +/- 0.3 for the donepezil group and 13.9 +/- 0.3 for the placebo group. LS mean CIBIC-plus scores for donepezil-treated patients were improved from, or close to, baseline severity at all visits, and were significantly different from placebo at weeks 8, 12, 18, and 24 (week 24 LOCF mean difference = 0.53, p = 0.0003). LS mean change from baseline scores on the sMMSE and Severe Impairment Battery (SIB) for the donepezil group improved throughout the study, and were significantly different from placebo at each visit for the sMMSE (week 24 LOCF mean difference = 2.06, p = 0.0002) and from week 8 for the SIB (week 24 LOCF mean difference = -4.44, p = 0.0026). LS mean change scores on the Disability Assessment for Dementia remained at or above baseline levels throughout the study for the donepezil group, while the placebo group showed a steady decline; treatment differences were significant at each visit (week 24 LOCF mean difference = -9.25, p < 0.0001). LS mean change scores on the Neuropsychiatric Inventory 12-item total improved throughout the study for the donepezil group and were significantly different from placebo at weeks 4 and 24 (week 24 LOCF mean difference = 5.92, p = 0.0022). Eighty-one per cent of donepezil-treated and 89% of placebo-treated patients completed the trial, with 9% and 5%, respectively, discontinuing due to adverse events (AEs). Eighty-two per cent of donepezil-treated and 80% of placebo-treated patients experienced AEs, the majority of which were rated mild in severity and, in general, were similar between treatment groups. CONCLUSION: The significant treatment responses observed with donepezil in these patients reinforce the findings from earlier studies that show donepezil to have important benefits, compared wih placebo, across functional, cognitive, and behavioral symptoms, with good tolerability, in patients with AD of moderate severity.

Activities of Daily Living↗
PubMed2001

Cytomegalovirus early promoter induced expression of hCD59 in porcine organs provides protection against hyperacute rejection.

The critical shortage of human donor organs has generated growing interest for porcine to human xenotransplantation. The major immunological barrier to xenotransplantation is the hyperacute rejection (HAR) response that is mediated by preformed xenoreactive antibodies and complement. A promising strategy to control the complement activation, is the expression of human complement regulatory proteins in transgenic animals. We have used the human early cytomegalovirus (CMV) promoter to drive expression of the human complement regulatory protein CD59 (hCD59) in transgenic pigs. A total of eight live transgenic founder animals was born from which five transgenic lines could be established. mRNA analysis and Western blotting revealed high expression of hCD59 in heart, kidney, skeletal muscle, and skin in animals of lines 1 and 5, as well as in the pancreas of four lines. This pattern of expression was confirmed by immunhistological staining. A cell-specific expression in heart and kidney tissue of transgenic lines 1 and 5 was determined. Primary fibroblasts and endothelial cell cultures derived from the aorta of transgenic pigs showed a significantly diminished sensitivity against the challenge with xenoreactive human antibodies and complement whereas non-transgenic control cells were highly susceptible to complement mediated lysis. Ex vivo perfusion of kidneys with pooled human blood revealed a significant protective effect of hCD59 against HAR. The average survival of transgenic kidneys was significantly extended (P<0.05) over nontransgenic controls (207.5+/-54.6 vs. 57.5+/-64.5 min). These data support the concept that hCD59 protects nonprimate cells against human complement mediated lysis and suggest that donor pigs transgenic for hCD59 could play a crucial role in clinical xenotransplantation. Two of five hCD59 transgenic lines showed strong hCD59 expression in several organs relevant for xenotransplantation and a protective effect against HAR. This indicates that the use of the CMV-promoter can facilitate the selection process for optimized transgene expression.

3T3 Cells↗
PubMed2001

Pharmacological treatment of cognitive deficits in Alzheimer's disease.

Clinical trials and independent reviews support the use of cholinesterase inhibitors for treating the symptoms of patients with mild to moderate Alzheimer's disease (AD). Before initiating cholinesterase inhibitor therapy, patients should be thoroughly assessed, and the diagnosis confirmed, preferably by a specialist. Compliance with cholinesterase inhibitor therapy should be monitored and the response (in global, cognitive, functional and behavioural domains) reassessed after 2-3 months of treatment. Vitamin E may be protective against AD, and therapy with 1000 IU twice daily may be considered. There is insufficient evidence to support the use of other antioxidant agents, anti-inflammatory agents, monoamine oxidase B inhibitors, folate/homocysteine or antihypertensive drugs in patients with AD, or hormone replacement therapy in affected women.

Alzheimer Disease↗
PubMed2001

A 24-week, randomized, double-blind study of donepezil in moderate to severe Alzheimer's disease.

OBJECTIVE: To investigate the efficacy and safety of donepezil in patients with moderate to severe AD (standardized Mini-Mental State Examination [sMMSE] scores of 5 to 17; Functional Assessment Staging score < or =6 at baseline). METHODS: Two-hundred ninety patients were randomized to treatment in this 24-week, double-blind, placebo-controlled trial. Patients received either donepezil 5 mg/day for the first 28 days and 10 mg/day thereafter as per the clinician's judgment (n = 144) or placebo (n = 146). The primary outcome measure was the Clinician's Interview-Based Impression of Change with caregiver input (CIBIC+). RESULTS: Patients' mean age was 73.6 years (range 48 to 92 years). Baseline demographics were similar between the treatment groups. Least squares (LS) mean +/- SE sMMSE scores at baseline were 11.7 +/- 0.35 for the donepezil group and 12.0 +/- 0.34 for the placebo group. Patients receiving donepezil showed benefits on the CIBIC+, compared with placebo, at all visits up to week 24 (p < 0.001) and at week 24 last observation carried forward (LOCF) (p < 0.0001). All other secondary measures (including sMMSE, Severe Impairment Battery, Disability Assessment for Dementia, Functional Rating Scale, and Neuropsychiatric Inventory) showed significant differences between the groups in favor of donepezil at week 24 LOCF. Eighty-four percent of donepezil- and 86% of placebo-treated patients completed the trial. Adverse events (AE) were experienced by 83% of donepezil- and 80% of placebo-treated patients, the majority of which were rated mild in severity; 8% of donepezil- and 6% of placebo-treated patients discontinued because of AE. Laboratory and vital sign abnormalities were similar between the treatment groups. CONCLUSION: These data suggest that donepezil's benefits extend into more advanced stages of AD than those previously investigated, with very good tolerability.

Activities of Daily Living↗
PubMed2000

Pulmonary embolism complicated by patent foramen ovale and paradoxical embolization.

We present the case of a 74-year-old male with chest pain, dyspnea, and syncope secondary to an acute pulmonary embolism complicated by a patent foramen ovale with straddling thrombus and paradoxical embolization. We review the literature with specific focus on the pathogenesis and acute treatment of this life-threatening occurrence.

Aged↗
PubMed1994

Second-trimester echogenic small bowel: an increased risk for adverse perinatal outcome.

2267 singleton fetuses who had one ultrasound examination between 15 and 21 weeks' gestation were prospectively evaluated for echogenic small bowel. Thirty-two cases of echogenic small bowel were detected--a prevalence of 1.4 per cent. Echogenic fetal small bowel was divided into two grades: grade 1, where the small bowel was more echogenic than the liver; and grade 2, where the small bowel had the echogenicity of bone. In contrast to 19/23 fetuses with grade 1 small bowel echogenicity, only 2/9 fetuses with grade 2 echogenic bowel had a normal pregnancy outcome (Fisher's exact test; P < or = 0.01). Complications associated with second-trimester echogenic small bowel included in utero cytomegalovirus infection, second-trimester growth restriction, intrauterine fetal demise, and chromosomal abnormalities. Second-trimester fetal echogenic small bowel is associated with an increased risk of an adverse outcome. The prevalence of perinatal and neonatal complications is significantly greater when small bowel echogenicity approaches that of bone.

Adult↗
PubMed1992

[Cryosurgery of condylomata acuminata gigantea--a contribution to therapy].

Two cases of condylomata acuminata gigantea treated with cryosurgery are described. A clinical and histologic differentiation from Buschke-Loewenstein's tumours, sex-specific differences, possible malignant transformations and differential diagnostic diseases are described and references are made to confusions with condyloma-like, primary carcinomas. Compared to conservative surgical treatment of condylomata acuminata gigantea, cryosurgery offers the advantage of rapid necrosis of the condylomata which are repelled without any further surgical intervention and heal without scars. Therefore we consider cryosurgery a more refined technique in treatment of condylomata acuminata gigantea. In extensive involvement, however, cryosurgical measures must be repeated.

Adult↗
PubMed1991

China White epidemic: an eastern United States emergency department experience.

STUDY OBJECTIVE: The purpose of this study was to isolate significant clinical or demographic findings concerning overdose patients treated during a China White (3-methyl fentanyl) epidemic and compare them with data for all unintentional narcotic overdose patients during a 24-month period. DESIGN: We reviewed charts from 85,246 patient visits to our emergency department during the 24-month period of January 1987 through December 1988 to study this narcotic epidemic. Data from the Allegheny County Coroner's Office pertaining to unintentional drug overdose deaths that occurred during this same period also were reviewed. SETTING: The first outbreak of narcotic overdoses in the eastern United States involving China White occurred in Allegheny County, Pennsylvania, in 1988. TYPE OF PARTICIPANTS: Patients were included if they met the criteria of a suspected unintentional narcotic overdose, but excluded if they were not given naloxone. INTERVENTIONS: Emergency physicians became suspicious of China White use after an unusual increase in narcotic overdoses presenting to the ED coupled with "routine drug of abuse" screens negative for opiates despite dramatic patient responses to naloxone. In most of the cases in which specific testing was done, there were positive indicators of fentanyl derivatives. Investigations found China White present in street drugs and paraphernalia. MEASUREMENTS AND MAIN RESULTS: A cluster was defined as a time period with a statistically significant increase in overdoses over the expected number for an interval of equal length. Although there were no significant clinical differences in case presentation during the 24-month period, there was a statistically significant 13-fold increase in overdoses during the September through November 1988 cluster (mean, 13 vs 0.95 per month, P less than .001 by Wilcoxon rank-sum test). A dramatic increase in unintentional drug overdose deaths occurred in the county during this cluster. A total of 18 fentanyl-positive unintentional drug overdose deaths, predominantly male (89%) and black (56%), with an age range of 19 to 44 years (mean, 34.9 years), were reported by the county coroner (13 during the cluster). Narcotic overdoses and unintentional drug overdose deaths declined sharply with confiscation of a clandestine China White laboratory. CONCLUSIONS: China White was responsible for a dramatic rise in unintentional drug overdose deaths in Allegheny County in 1988. There were no significant clinical differences between China White overdose survivors and other unintentional narcotic overdose victims. Overdoses responsive to naloxone with inconsistent routine toxicologic screens may be due to a fentanyl analogue.

Adult↗
PubMed1991

PMMA microspheres for intradermal implantation: Part I. Animal research.

In search of a biocompatible implant for the correction of small deficiencies within the dermal corium as in wrinkles and acne scars, polymethylmethacrylate (PMMA) microspheres, 10 to 63 microns in diameter, were dispersed in Tween 80 medium and injected intradermally and subdermally into the abdominal skin of rats. Histological examination of specimens for up to 7 months revealed a modest tissue reaction, forming a delicate fibrous capsule around each individual microsphere within 4 months. Foreign body giant cells were seen rarely (in up to 1.5% of all cells). No break-down, corrosion, or phagocytosis of the spheres was observed at 7 months. The Tween 80 dispersion medium did not produce any histologically detectable reaction. Because PMMA products (Paladon, Palacos) have been used in medicine for almost 50 years without causing biological degradation or cancer, the material may be applied safely in the form of microspheres (Arteplast) in corium and subcutis of human patients with wrinkles or acne scars.

Animals↗
PubMed1990

Thermal effects of MR imaging: worst-case studies on sheep.

The objective of this study was to provide a worst-case estimate of thermal effects of MR imaging by subjecting anesthetized unshorn sheep to power deposition at specific absorption rates (SARs) well above approved standards for periods of time in excess of normal clinical imaging protocols. A control period with no RF power was followed by 20-105 min of RF power application. Afterward, there was a 20-min or longer recovery period with no RF power. Eight sheep were given whole-body RF exposure (1.5- to 4-W/kg SAR) while rectal and skin temperatures were monitored. Four sheep were subjected to 4-W/kg head scans for an average of 75 min while temperatures of the cornea, vitreous humor, head skin, jugular vein, and rectum were measured. In head scanning experiments, skin and eye temperatures increased about 1.5 degrees C. Jugular vein temperature rose a maximum of 0.4 degrees C after an average exposure of 75 min. In whole-body exposures, elevation of rectal temperature was correlated with energy input. Deep-body temperature rises in excess of 2.0 degrees C were attained for 4-W/kg whole-body exposure periods greater than 82 min. Animals exposed for 40 min to 4 W/kg in either body coil (three sheep) or head coil (two sheep) were recovered and observed to be in good health for 10 weeks; no cataracts were found. MR power deposition at SAR levels well above typical clinical imaging protocols caused body temperature to increase. For exposure periods in excess of standard clinical imaging protocols the temperature increase was insufficient to cause adverse thermal effects. Studies in healthy humans are needed to determine whether enhanced heat-loss effector mechanisms are likely to cause deep-body temperatures to plateau at an acceptable level, and to elucidate mechanisms that determine subcutaneous temperature.

Animals↗
PubMed1987

Heart transplantation candidates: psychological evaluation.

Most medical centers that perform heart transplantation have established medical review boards that consider medical, psychosocial, and financial factors in choosing appropriate candidates. The psychological evaluation described here can furnish clinically useful baseline data regarding the patient's emotional and cognitive functioning, and identify other individual and family variables that may affect patient compliance and the outcome of transplantation.

Attitude to Health↗
PubMed1986

[Potentialities and limits of cryosurgery of vulvar cancer--12 years' results of therapy].

From 1971 to 1982 146 patients suffering from vulvar carcinoma have been cryosurgically treated at the Department of Gynecology and Obstetrics of the Medical Academy of Erfurt. There were primary inoperable, progressive, metastatic or recurrent cases after preliminary operative or radiation therapy. The 5-years surviving rate by cryotherapy, rarely combined with other methods of therapy (cytostatic therapy with Bleomycin, x-radiation, operative lymphonodectomy) was 38.5%. Our results show that cryosurgery extends the possibilities of conventional treatment of vulvar carcinoma both in palliative therapy of progressive cancer and in primary treatment, especially in patients, who cannot be charged by other complicated operations. According to every other cancer-therapy cryosurgery should be performed only in a gynaecological centre for cancer treatment.

Adult↗
PubMed1985

[Cryotherapy of giant condylomata acuminata--a contribution to therapy (photographic report)].

Three cases of condylomata acuminata gigantea were treated with cryosurgery. Compared to conservative surgical treatment of condylomata acuminata gigantea, cryosurgery offers the advantage of rapid necrosis of the condylomata which are repelled without any further surgical intervention and heal without scars. Therefore we consider cryosurgery the more refined technique in treatment of condylomata acuminata gigantea. In extensive involvement, however, cryosurgical measures must be repeated.

Adolescent↗