Background: To assess the long-term course of the feasibility and safety of orally administered heroin [diacetylmorphine (DAM)] tablets in substitution treatment of severely addicted opioid users. Design: Open-label, prospective cohort study with 2 non-randomly assigned treatment arms: DAM tablets only (n = 128) or DAM tablets combined with injected DAM and/or other opioids (n = 237). The average duration of the observation period was 62 months. Study endpoints were the time to discharge from treatment and the number of serious adverse events. Results: Both patient groups had a higher than 70% retention rate after the first 48 months of treatment, with similar long-term retention rates (after 8 years both groups had retention over 50%). The physician-verified rate of serious adverse events was 0.01 events per application year among the exclusively oral substitution group (intention-to-treat analysis) during the last year of observation, and 0.005 events per application year in the other group. Conclusions: Because of their feasibility and safety over years, DAM tablets may be a valuable long-term therapeutic alternative. / Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.

Untersuchungsziel: Untersucht wurden Auswirkungen einer ambulanten orthopädischen Rehabilitation nach der Implantation einer Hüft- bzw. Knieendoprothese auf die individuelle Lebensqualität. Um zu erkennen, ob Zusammenhänge von individuellen Parametern wie Geschlecht, Alter, Bildungsstand und dem Rehabilitationsverlauf bzw. –ergebnis bestehen, wurden medizinisch-funktionelle und psychosoziale Daten erhoben, sowie ergänzende Variablen durch Schichtenindices und mittels eines strukturierten Interviews erfasst. Methode: Systematische Datenerhebung von medizinisch funktionellen (Gelenkbeweglichkeit, Muskelkraft) und psychosozialen (Aktivitäten des täglichen Lebens) Daten von n=60 Pat. mit Knie-TEP und n=61 Pat. mit Hüft-TEP zu vier Messzeitpunkten (Anfang Reha=t0, Ende Reha=t1, 6 Monate nach Reha= t2 und 24 Monate nach Reha= t3) und strukturiertes Interview zur Erfassung von soziodemographischen Merkmalen, Motivation und Behandlungszuversicht. Analysemethoden: Signifikanzanalyse und Berechnung der Effektstärke (Cohens d) der Veränderungen zwischen t0 – t1 für abhängige Stichproben (getrennt nach Indikation), Längsschnittdarstellung der funktionellen und psychosozialen Parameter mit deskriptivstatistischen Analysen getrennt nach Indikation und Geschlecht. Ergebnisse: Für beide Indikationen ergaben sich hohe Effekte für Verbesserungen der funktionellen Parameter und mittlere (teilhabebezogen) bzw. hohe (aktivitätsbezogen) Effekte bei den psychosozialen Parametern am Ende der Rehabilitation. Die teilstandardisierten Rehabilitationsmaßnahmen wirken sich indikations- und geschlechtsbezogen unterschiedlich aus. Unter Beachtung der psychophysischen Leistungsvoraussetzungen und sozialen Rahmenbedingungen ist die ambulante Rehabilitation gut geeignet für Patienten im höheren Lebensalter. / Study objective: Effects of an outpatient orthopedic rehabilitation after the implantation of a hip or knee replacement on the individual quality of life were studied. In order to analyze the existence of significant relationships between individual parameters such as gender, age, education and the rehabilitation outcome medical-functional and psychosocial data were collected, and additional layers of indices and variables by using a structured interview were applied. Method: Systematic data collection from medical functional (joint mobility, muscle strength) and psychosocial (activities of daily living) data of n = 60 patient with total knee replacement and n = 61 patient with total hip replacement to four time points (beginning of rehabilitation = t0, end rehab = t1, t2 = 6 months after rehabilitation and 24 months after discharge = t3) and structured interview for socio-demographic characteristics, motivation and confidence in treatment Analysis: Significance analysis and calculation of effect size (Cohen''s d) of the changes between t0 and t1 for dependent samples (separated by indication), longitudinal section view of the functional and psychosocial parameters with descriptive-statistical analyses apart from indication and sex Results: For both indications high effects of improvement in functional parameters, mean effects (participatory based) and high (activity-related) effects on the psycho-social parameters at the end of rehabilitation could be identified. The semi-standardized rehabilitation measures had shown differences by indication just like gender. In accordance with the psychophysical performance conditions and social environment outpatient rehabilitation is well suited for patients in advanced age.

Background: To assess the long-term course of the feasibility and safety of orally administered heroin [diacetylmorphine (DAM)] tablets in substitution treatment of severely addicted opioid users. Design: Open-label, prospective cohort study with 2 non-randomly assigned treatment arms: DAM tablets only (n = 128) or DAM tablets combined with injected DAM and/or other opioids (n = 237). The average duration of the observation period was 62 months. Study endpoints were the time to discharge from treatment and the number of serious adverse events. Results: Both patient groups had a higher than 70% retention rate after the first 48 months of treatment, with similar long-term retention rates (after 8 years both groups had retention over 50%). The physician-verified rate of serious adverse events was 0.01 events per application year among the exclusively oral substitution group (intention-to-treat analysis) during the last year of observation, and 0.005 events per application year in the other group. Conclusions: Because of their feasibility and safety over years, DAM tablets may be a valuable long-term therapeutic alternative. / Dieser Beitrag ist mit Zustimmung des Rechteinhabers aufgrund einer (DFG-geförderten) Allianz- bzw. Nationallizenz frei zugänglich.