Feasibility of the Epworth Sleepiness Scale in a sample of geriatric in-hospital patients.

Excessive daytime sleepiness (EDS) is a major health concern in geriatric patients. EDS affects quality of life, daytime function, and mortality. The Epworth Sleepiness Scale (ESS) is a standard tool for the assessment daytime sleepiness, but the feasibility of the ESS has never been investigated in elderly subjects. We applied the ESS to a random sample of geriatric in-hospital patients. The aim of the study was to reveal the frequency and the risk factors for processing failure of the ESS in geriatric patients. 458 patients with a mean age of 82+/-8 years were included. One hundred sixty six (36%) completed the ESS, 118 (28%) patients had omissions of items, and 174 (38%) patients were unable to respond to any item. Completion of the ESS correlated significantly with age, disability, dementia, impairment of vision, and hearing. Omitted items were related to mobility and activities outside the house. Logistic regression analysis with completed ESS as a dependent variable revealed that dementia, disability, heart failure, and COPD were independent and significant risk factors for processing failure. The majority of patients of a geriatric unit are unable to complete the ESS. Since EDS is a frequent finding with a negative impact on health, the development of a reliable and valid tool for the assessment of EDS in elderly subjects is needed.

Monoclonality in normal epithelium and in hyperplastic and neoplastic lesions of the breast.

The clonal nature of neoplastic lesions such as invasive breast cancer and ductal carcinoma in situ (DCIS) has been widely proven by several proliferative, genetic or other malignancy-associated markers. The aim of this study is to clarify whether benign hyperplastic lesions such as ductal hyperplasia of usual type (DH) and papilloma can be distinguished from neoplastic lesions such as DCIS by X-chromosome inactivation analysis. Clonal analysis was performed using a polymerase chain reaction-based assay for non-random X-chromosome inactivation of the human androgen receptor gene (HUMARA). Formalin-fixed and paraffin-embedded archival tissue of ten DCIS, sixteen DH, nine papillomas, and seven normal terminal ductal lobular units (TDLUs) was laser-microdissected to avoid contamination with surrounding tissue. All of the cases analysed revealed a monoclonal origin. Furthermore, in one of these cases, opposite X chromosomes were inactivated within the same breast. X-linked inactivation analysis clearly demonstrates that, at least in the breast, monoclonality is not restricted to neoplastic processes. The data support the hypothesis that the mammary gland is organized into distinct stem cell-derived monoclonal patches and that TDLUs are monoclonal in origin. Any proliferative lesion arising within such a pre-existing clonal patch should therefore be clonal, irrespective of whether it originates from one or more patch cells. Thus, X-chromosome inactivation analysis cannot be considered a valid method for distinguishing between neoplastic and hyperplastic breast lesions.

[Side effects and efficiency of 15 mg and 25 mg methotrexate per week in chronic polyarthritis]. / Nebenwirkungen und Wirksamkeit von 15 mg und 25 mg Methotrexat pro Woche bei der chronischen Polyarthritis.

To examine the rate of side effects and the dose dependence of side effects 185 consecutive patients with active rheumatoid arthritis were randomized to receive 15 mg (group A) or 25 mg (group B) methotrexate (MTX) per week and studied prospectively over 12 months. Dose adjustments were performed according to tolerability and efficacy. With 168 patients eligible for evaluation the rate of withdrawal for any reason was 26% in group A and 27% in B. Withdrawal due to side effects occurred in 16% versus 18%, dose reduction due to side effects in 10% versus 9%. The higher dose was associated with a significantly higher rate of gastrointestinal side effects (28% vs. 17%, p < 0.05) and a tendency for more frequent elevations of transaminases. Other side effects were not dose dependent. A significantly higher rate of dose reduction due to improvement (35% versus 10%, p < 0.001), a more rapid decline of morning stiffness, and a higher number of patients reporting marked improvement are evidence in favour of higher therapeutic efficacy of the higher dose. In conclusion, an initial dose of 25 mg MTX/week is not associated with a higher rate of limiting side effects as compared with 15 mg/week. The efficacy of doses up to 25 mg/week should be examined in more detail.

Tolerability of methotrexate starting with 15 or 25 mg/week for rheumatoid arthritis.

The objective of the present study was to assess the rate of side-effects and dose-limiting toxicity in patients with rheumatoid arthritis (RA) receiving methotrexate (MTX) at an initial dose of 15 or 25 mg/week. One hundred and eighty-five patients with active RA were enrolled into a prospective non-blind trial over 12 months and randomized to start at a dose of 15 mg/week with subsequent increases if necessary (group A) or 25 mg/week with subsequent dose reductions according to effect (group B). With 168 patients eligible for evaluation 74% of patient in group A and 73% of patients in group B were on MTX after 12 months. Withdrawal due to side-effects amounted to 16% of patients in group A and 18% in group B, and decreases in dose due to side-effects amounted to 10% in group A and 9% in group B. The higher dose of MTX elicited a significantly higher rate of gastrointestinal side-effects (28% versus 17%, P < 0.05) and a tendency towards a higher rate of liver enzyme elevations (47% versus 39%). The frequencies of other side-effects did not differ significantly between the groups. We concluded that starting MTX treatment at a dose of 25 mg/week was associated with a higher rate of minor but not major toxicity as compared with 15 mg/week. With this profile of tolerability it is possible to examine the therapeutic potential of MTX doses exceeding 15 mg/week.