Cabergoline compared to levodopa in the treatment of patients with severe restless legs syndrome: results from a multi-center, randomized, active controlled trial.

We report the first large-scale double-blind, randomly assigned study to compare two active dopaminergic therapies for Restless Legs Syndrome (RLS), the dopamine agonist cabergoline (CAB) and levodopa/benserazide (levodopa). Patients with idiopathic RLS were treated with fixed daily doses of 2 or 3 mg CAB or 200 or 300 mg levodopa for 30 weeks. Efficacy was assessed by changes in the IRLS (International RLS Severity Scale) and by time to discontinuation of treatment due to loss of efficacy or augmentation. 361 of 418 screened patients (age 58 +/- 12 years, 71% females) were randomly assigned and treated (CAB: n = 178; levodopa: n = 183) in 51 centers of four European countries. Baseline IRLS total score was 25.7 +/- 6.8. The baseline-adjusted mean change from baseline to week 6 in IRLS sum score was d = -16.1 in the CAB group and d = -9.5 in the levodopa group (d = -6.6, P < 0.0001). More patients in the levodopa group (24.0%) than in the CAB group (11.9%, P = 0.0029, log-rank test) discontinued because of loss of efficacy (14.2% vs. 7.9%, P = 0.0290) or augmentation (9.8% vs. 4.0%, P = 0.0412). Adverse events (AEs) occurred in 83.1% of the CAB group and in 77.6% of the levodopa group. In both groups, most frequent AEs were gastrointestinal symptoms (CAB: 55.6%, levodopa: 30.6%, P < 0.0001). This first large-scale active controlled study in RLS showed superior efficacy of cabergoline versus levodopa after a 30-week long-term therapy. Tolerability was found more favorable with levodopa than with cabergoline.     

Tissue engineering of bone for mandibular augmentation in immunocompetent minipigs: preliminary study.

Large mandibular defects caused by trauma, infection or resection of a tumour are still a major problem for plastic and maxillofacial surgeons. The modern concept of tissue engineering combines the osteoinductive effects of osteogenic cells with a suitable scaffold structure to promote differentiation of osteoblasts and optimal matrix production. Critical size mandibular bone defects were therefore made to investigate the osteogenic potential of periosteal cells and a bioabsorbable polymer fleece (Ethisorb 510) in minipigs. Periosteal cells were isolated from four minipigs, expanded in vitro and seeded with fibrin glue into Ethisorb 510 fleeces. Tissue constructs were used to repair critical size mandibular defects and compared with two minipigs with untreated bone defects. Bone healing was evaluated after 90 and 180 days by radiographs and a histological scoring system. The radiographs showed increased radiodensity of defects filled with the cell-fibrin-fleece-constructs compared with the untreated control group after 90 and 180 days in vivo. The defects repaired by the cell-fibrin-scaffolds (180 days in vivo) obtained the highest histological mean score 2.9 (range 2-3), while defects filled by cell-fibrin-scaffolds (90 days in vivo) achieved a mean score of 2.1 (range 2-3). In contrast, the control group (n = 2) scored 1 and 2. The results show that a combination of periosteal cells and polymer fleeces may be a promising approach for clinical mandibular augmentation.     

Komplikationen nach arthroskopischer Rotatorenmanschettennaht

Rotator cuff tears are increasingly treated arthroscopically, preferentially with suture anchors since a stable anchorage in bone is possible, simple and rapid. However, the restricted view, especially with longer operating times, conceals a danger of misplacement. Such risks can be determined rapidly with experience and should be corrected as soon as possible, e.g. through a change to open procedures. In our case report, the migration of a metal anchor could be corrected in a later operation and a revision of the re-rupture was then carried out using mini-open technique.     

Rechtsprechung aktuell

Ohne Zusammenfassung     

Chirurgie der differenzierten Schilddrüsenkarzinome

Die 5-Jahres-überlebensrate von differenzierten Schilddrüsenkarzinomen ist generell sehr gut und betr?gt 80 – 95%. Hierbei bestehen Abh?ngigkeiten zum Alter des Patienten [15], zum prim?ren Tumorstadium, zur histologischen Differenzierung und zum Ausma? der region?ren und Fernmetastasierung [6]. Patienten mit Tumorfreiheit haben ebenfalls eine bessere Prognose gegenüber denen mit einem Resttumor. Dies spricht für ein konsequentes Vorgehen beim Prim?reingriff mit Thyreoidektomie und Entfernung der Lymphknoten des zentralen Kompartments. Stadienadaptiert schlie?t sich eine Radiojodtherapie oder die Kombination mit einer externen Radiatio an. Bei der Reoperation differenzierter Schilddrüsenkarzinome mu? zwischen der individuellen Prognose des Patienten, dem Ziel der Operation und der postoperativen Morbidit?t/Mortalit?t entschieden werden. Aufgrund des hohen Risikos sollten diese Operationen in Zentren durchgeführt werden, so da? postoperative Komplikationen (permanente Recurrensparese/Hypoparathyreoidismus) vertretbar gering gehalten werden k?nnen (Tabelle 11). Dennoch sollte nicht au?er Acht gelassen werden, da? individuell bei differenzierten Schilddrüsenkarzinomen im Stadium pT1 auch ein eingeschr?nkt radikales Vorgehen (Hemithyreoidektomie) ohne Verschlechterung der Prognose m?glich scheint. Strenge Nachuntersuchungsergebnisse und Ergebnisse weiterer klinischer Studien müssen hierzu abgewartet werden.     

Correction of camptodactyly with an external fixator

Camptodactyly is a flexion deformity of the proximal interphalangeal joint. Because of unsatisfactory results, treatment is not recommended for mild deformities, and in severe deformities surgery has been disappointing. A specially designed external fixator providing gradual distraction was used in a severe case. With this mildly aggressive method, an acceptable result was obtained. Received: 5 June 1997/Accepted: 2 February 1998     

Morphological study of neocortical areas in Rett syndrome

Various neocortical areas from four females aged 16–24 years with Rett syndrome (RS) were investigated and compared with brains of therapy-resistant partial epilepsy (TRPE) patients (18–25 years), infantile autism (IA), and control brains (24 and 58 years). The cytoarchitecture of area 10 (frontal), area 21 (temporal), area 4 (primary motor cortex), and area 17 (primary visual cortex) was studied by the combined Klüver-Barrera (luxol fast blue and cresyl violet) standard procedure. Autofluorescence of lipofuscin, immunofluorescence of synaptic vesicle proteins [synaptophysin (p38)] and lectin-stained (Wisteria floribunda agglutinin) perineuronal nets (PNs) were studied in the cortices using dual-channel confocal laser scanning microscopy. The brains of RS females show various types of morphological/cytoarchitectonical abnormalities of single pyramidal neurons in layers II–III, and V–VII of different cortical areas. The abnormalities include mild losses of pyramidal neurons, more pronounced in layers II and III than in layers V and VII, and more evident in frontal and temporal areas than in the visual cortex. Microdysgenesis, including abnormalities due to neuronal migration disorders, was not found in RS, in contrast to the observations in TRPE patients, strongly indicating that RS is not a neuronal migration disorder. Lipofuscin distribution was normal but amounts were lower in RS cases than in control and TRPE brains. PNs were less expressed in cortices of the IA case, but were clearly overexpressed in the motor cortex of RS. Quantitative analysis of p38 showed a decrease in the area occupied by p38 immunoreactivity by 20–40% in RS compared with controls. It is concluded that RS could best be explained by a postnatal synaptogenic developmental deficiency; the basic defect, however, is still completely unknown. Received: 26 February 1996 / Revised, accepted: 11 July 1996