Objectives To establish whether transdermal continuous hormone replacement therapy (HRT) with estrogen/progestogen provides adequate long-term endometrial protection in postmenopausal women over a period of 96 weeks.Methods This multicenter, randomized, open-label, parallel-group study evaluated the endometrial effects and overall safety and tolerability of a transdermal matrix patch delivering estradiol (E2) 50 mu g/day and norethisterone acetate (NETA) 140 mu g/day (Estalis((R)); patches applied twice weekly without intermediate breaks) and a once-daily oral comparator (Kliogest((R)); one tablet containing E2 2mg/NETA 1mg) in postmenopausal women. A total of 406 women with an intact uterus, aged 44-69 years, were randomized in the 48-week core phase of the study, and 239 continued into the 48-week extension phase. Subjects were randomized in the ratio 3:1 to transdermal or oral E2/NETA treatment.Results No cases of endometrial hyperplasia or endometrial cancer were reported with either treatment during the core or extension phase. Both treatments were generally well tolerated, with most adverse events (> 90%) being mild to moderate, although minor differences in the tolerability profile were observed between treatments.Conclusions Continuous combined transdermal HRT with E2/NETA shows no evidence of an increased endometrial hyperplasia or endometrial cancer risk over a 96-week period.
Objectives To compare the incidence of increased breast density and tenderness in postmenopausal women associated with transdermal (Estalis/Combipatch®, Novartis, Basel, Switzerland) and oral (Kliogest®, Schering AG, Berlin, Germany) hormone replacement therapy (HRT).Methods A total of 202 postmenopausal women were randomized to transdermal or oral HRT. Mammograms obtained at study entry and after 1 year of treatment were assessed for percent breast density by means of the digital segmentation and thresholding technique. Breast tenderness was assessed at each study visit.Results The mean breast density by ANCOVA after adjusting for screening value at study end was significantly lower for women using Estalis® (38.4%, standard error 0.9%) compared with Kliogest® (46.9%, standard error 1.5%) (p < 0.0001). Significantly fewer women using transdermal HRT had an increase in mammographic breast density or breast tenderness compared to oral HRT. Of the women using transdermal HRT, 39.1% had no change in breast density compared to 15.7% for women using oral HRT. Only 4% of women using transdermal HRT had a marked increase in density ( > 25%) compared to 15.7% of women using oral HRT. Overall, 36.0% of patients in the transdermal group reported breast tenderness at some point during the 1-year study, compared with 57.6% in the oral HRT group (p = 0.0002).Conclusion Transdermal HRT use is associated with a significantly lower incidence of increased mammographic breast density and breast tenderness compared with oral HRT.
Im Rahmen eines EG-Projektes wurde die Patientenexposition bei pädiatrischen Röntgenuntersuchungen in 90 Kinderkliniken durch unmittelbare Dosismessung im Nutzstrahlenbündel ermittelt. Als Dosimeter dienten TLD-chips aus CaF2, die bei 70 kV zur Messung der Oberflächendosis in µGy kalibriert worden waren und mit der Post versandt wurden. Die Dosen pro Röntgenaufnahme liegen je nach Untersuchung zwischen dem unteren Bereich 26 - 80 µGy für Thorax ap bei Frühgeborenen und dem oberen Bereich 597 - 1686 µGy für Schädel ap/pa im Alter von 10 Monaten. Die (hier durch das 1. und 3. Quartil der bei einer bestimmten Untersuchung erhaltenen Dosiswerte dargestellte) Streubreite kann als Hinweis auf noch bestehende Optimierungsmöglichkeiten gewertet werden.
This Europe-wide dosimetry study, covering 89 departments in 11 EC countries, measured entrance surface dose (ESD) using TLDs, and surveyed X rav equipment and radiographic techniques used for frequent paediatric X ray examinations of the chest, abdomen, pelvis. skull and spine. The survey was limited to infants (10 months, 4 months and prematures of approximately 1 kg). Data analysis shows that radiographic techniques differed widely. This was one of the reasons for the large variations in ESD of an order of magnitude of 1:50. A substantial number of departments used either very old X ray generators and/or techniques which are poorly suited for paediatric radiology. A significant dose reduction was seen when recommended guidelines for good radiographic technique were followed. The results of this study emphasise the necessity for the adherence to easily followed guidelines for the improvement of training and equipment in paediatric radiology.
Zusammenfassung In einem Alderson-Rando-Rumpfphantom wurden bei einer Ganzkorpertomographie (125 kV, 2.2 mm Al + 0.4 mm Cu, 122 Schichten) und bei 60 Co-Ganzkorperbestrahlungen (ap und pa) Gewebedosismessungen mit TLD an 28 Targetpositionen ausgefuhrt. Aus den CT-Daten wurde auserdem ein dreidimensionales Voxel-Phantom konstruiert, das aus 8 verschiedenen Medien bestand und Monte-Carlo-Simulationen der gleichen Ganzkorpertomographie und Ganzkorperbestrahlungen erlaubte. Der resultierende Unterschied zwischen gemessenen und berechneten Gewebedosen an den einzelnen Targetpositionen variierte zwischen - 15 % und + 15 %; sein mittlerer Betrag war stets kleiner als 5 %. Diese Untersuchung erbringt somit eine direkte und detaillierte experimentelle Prufung und Bestatigung von Dosisberechnungen mithilfe dreidimensionaler Voxeiphantome.
122 CT scanners were studied in order to determine close values free in air on the axis of rotation during the most common types of examination. In addition, other exposure parameters were collected, which may be important in relation to dose to patients. The results showed a surprising variation in the dose values of CT examinations. It is concluded that it is not possible to estimate patient exposure reliably by using the information on exposure parameters supplied by the operator.
122 CT scanners were studied in order to determine close values free in air on the axis of rotation during the most common types of examination. In addition, other exposure parameters were collected, which may be important in relation to dose to patients. The results showed a surprising variation in the dose values of CT examinations. It is concluded that it is not possible to estimate patient exposure reliably by using the information on exposure parameters supplied by the operator.