Improvement in the quality of life after i.v. PGE1 therapy for intermittent claudication.

BACKGROUND: Increasingly and justifiably, clinical studies are now being expected to investigate the influence of therapeutic measures also on the quality of life of the patient. PATIENTS AND METHODS: Since no data on the variability of changes in the quality of life of the patient following PGE1 treatment are so far available, the initial investigation was designed as an uncontrolled pilot study. 104 patients (median age 64.5 years) with a maximum of walking distance on the treadmill (3 km/12%) of 50-250 m were included and given a daily intravenous infusion of 60 micrograms PGE1 (Prostavasin) over a period of 4 weeks excluding weekends. This was followed by a treatment-free follow-up period of 3 months. Changes in the quality of life were recorded with both the newly developed disease-specific questionnaire PAVK-86, and the generic questionnaire SF 36; in addition, the pain-free and maximum walking distances on the treadmill were also established prior to and immediately following treatment, as also at the end of the follow-up period. RESULTS: The quality of life was significantly improved in all dimensions (functional status, complaints, pain, mood, anxiety, social life, treatment expectations) in addition to a marked increase in the median pain-free walking distance from 77 to 108 m (p < 0.001) and the maximum walking distance from 118 to 171 m (p < 0.001). At the end of the 3-month observation period, the improvement was essentially still demonstrable. CONCLUSION: The study has shown for the first time that treatment with intravenous PGE1 brings about not only the already known increase in the walking distance, but also a clinically relevant and significant improvement in the patient's quality of life.

[Problems of multiple tests and evaluations in drug research]. / Probleme des multiplen Testens und Schätzens in der Arzneimittelforschung.

The well known inferential statistical procedures only take into account the test of a single hypothesis or the estimation of a single parameter. In practical drug research the scientist in most cases is interested in multiple tests of several hypotheses or a simultaneous estimation of several parameters. After introducing the principal problems of simultaneous statistical inference several statistical methods are discussed. These methods can be applied to a variety of problems in drug research.

[Forecasting cohort fertility rates by using an exponential function]. / Projektion jahrgangsspezifischer Fruchtbarkeitsziffern mittels einer Exponentialfunktion

"Population forecasts based on cross sectional data do not allow for the variations in cohort fertility. In this paper methods are developed to fit cohort fertility rates by an exponential function. Out of a number of selected functions the Weibull-function shows the best fit. For predicting cohort fertility pattern the parameter values can be derived from the forecasts of a small number of demographic statistics." (summary in ENG)