Drug-resistant MS spasticity treatment with Sativex(®) add-on and driving ability.

OBJECTIVE: The aim of the present observational study was to determine the effects of a delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) oromucosal spray (Sativex(®) spray), brand name Sativex(®), indicated for drug-resistant MS spasticity, on the driving ability of treated MS patients. METHODS: The study was conducted over a period of 4-6 weeks. Thirty-three MS patients with moderate to severe treatment-resistant spasticity and planned to begin add-on treatment with Sativex(®) were enrolled at three specialized MS centres in Germany. A set of five driving test procedures from a validated computerized test battery was used to evaluate the driving ability of eligible patients. Tests were performed by patients at baseline and repeated after 4-6 weeks of treatment with Sativex(®) oromucosal spray. According to German normative data, the test thresholds achieved by the general population served as a reference to allow for a fitness/unfitness to drive classification. RESULTS: Patients showed comparable driving test results at baseline and at final visits. Only two patients changed classification shifting from 'unfit' to drive to 'fit' and vice versa. The mean severity of spasticity, as self-reported by the patients, improved with statistical significance. Sativex(®) was generally well tolerated. CONCLUSIONS: Treatment of MS patients with Sativex(®) does not negatively impact on driving ability and may improve moderate to severe treatment-resistant MS spasticity.

[Severe vascular complications of Le Fort I osteotomy]. / Complications vasculaires graves de l'ostéotomie de Le Fort I.

INTRODUCTION: Le Fort I osteotomy is a common orthognathic procedure. This surgery presents risk of severe vascular complications because of local anatomy. The aim of our study was to collect data on vascular complications of Le Fort I osteotomies performed in our department, describe the diagnostic and therapeutic aspects, and discuss prevention. PATIENTS AND METHODS: A retrospective analysis was made on the files of patient having undergone Le Fort 1 osteotomy, between 1998 and 2007. Severe vascular complications were recorded, defined as postoperative hemorrhagic or ischemic complications severe enough to require a specific procedure. RESULTS: Nine hundred and sixteen patient files were included (39% male and 61% female patients, mean-age: 24.42 years; range: 13 to 59 years). Five patients presented with severe hemorrhagic complication. There was no ischemic complication. Three hemorrhagic episodes occurred in the immediate postoperative phase. In two cases, delayed hemorrhagic complication occurred, diagnosed as a pseudo-aneurysm by angiography. These were treated by hyperselective embolization. DISCUSSION: Vascular complications of Le Fort I osteotomies are rare (0.55% in our series). They are most frequently hemorrhagic complications.

Outcome of orbital decompression for disfiguring proptosis in patients with Graves' orbitopathy using various surgical procedures.

AIM: To compare the outcome of various surgical approaches of orbital decompression in patients with Graves' orbitopathy (GO) receiving surgery for disfiguring proptosis. METHOD: Data forms and questionnaires from consecutive, euthyroid patients with inactive GO who had undergone orbital decompression for disfiguring proptosis in 11 European centres were analysed. RESULTS: Eighteen different (combinations of) approaches were used, the swinging eyelid approach being the most popular followed by the coronal and transconjunctival approaches. The average proptosis reduction for all decompressions was 5.0 (SD 2.1) mm. After three-wall decompression the proptosis reduction was significantly greater than after two-wall decompression. Additional fat removal resulted in greater proptosis reduction. Complications were rare, the most frequent being worsening of motility, occurring more frequently after coronal decompression. The average change in quality of life (QOL) in the appearance arm of the GO-QOL questionnaire was 20.5 (SD 24.8) points. CONCLUSIONS: In Europe, a wide range of surgical approaches is used to reduce disfiguring proptosis in patients with GO. The extent of proptosis reduction depends on the number of walls removed and whether or not fat is removed. Serious complications are infrequent. Worsening of ocular motility is still a major complication, but was rare in this series after the swinging eyelid approach.

[Hybrid osteosynthesis in orthognathic surgery: 28 cases of Le Fort I osteotomy]. / Ostéosynthèse hybride en chirurgie orthognathique: 28 cas d'ostéotomie de Le Fort I.

INTRODUCTION: The use of resorbable materials in orthognathic surgery is presently the object of numerous clinical and experimental studies. Their main drawbacks are their lack of rigidity and induced chronic inflammatory reactions. The purpose of this study was to propose and to test an original system of hybrid osteosynthesis associating a single titanium plate with three resorbable plates in Le Fort I osteotomies in the absence of maxillary expansion, or two titanium plates with two resorbable plates in case of maxillary expansion. METHODS: Our retrospective study concerned 28 patients operated between 2002 and 2005. A clinical follow-up of over one year detected the specific complications of the hybrid system and a cephalometric study analyzed the secondary relapse 5 months after surgery. These results were compared to the literature. RESULTS: One case of mobility and a case of instability of the jaw were observed, along with 5 cases of local chronic inflammatory reaction. The radiological results found a secondary sub-clinical relapse. The removal of the titanium material under local anesthesia was performed without difficulties in ambulatory care, which avoided a new hospitalization for the patient and a new general anesthesia. DISCUSSION: The hybrid system allowed obtaining a postoperative stability of the jaw comparable to that obtained by the exclusive use of titanium plates with an acceptable morbidity. This method of osteosynthesis combined the advantages of the resorbable material (removal of titanium plates under local anesthesia) and of titanium material (stability of the procedure). However this method requires a good experience of working with resorbable material, a good follow-up, and cooperative patients. These encouraging results urge us to extend the indications to mandibular sagittal osteotomy and to bi-maxillary osteotomies.

[Is condylar resorption a contra-indication for surgery?]. / La résorption condylienne contre-indique-t-elle la chirurgie orthognathique?

INTRODUCTION: Idiopathic condylar resorption, often fortuitously discovered when performing orthodontic-surgical assessment, is a clinical entity in itself. There is a significant risk of postoperative degenerating and worsening. Is this sufficient to contra-indicate orthognathic surgery? The authors suggest an answer after studying a series of patients. MATERIAL AND METHOD: A retrospective study of 10 consecutive patients was made from July 1999 to October 2004. The preoperative assessment was triple: clinical, radiological and photographic. At least 6 months of occlusal, radiological and morphological stability was observed before any therapy was initiated. A fixed orthodontic set-up was placed and patients were regularly followed by a speech therapist for parafunctions. Stability of the occlusal correction, acquisition of a more harmonious aesthetic profile, and resolution of joint symptomatology were used to define therapeutic success at one year. RESULTS: All patients were female. Resorption affected the mandibular side of the joint in all cases and the temporal side in 7 cases. Three types of osteotomies were performed: maxillary (N=1), mandibular (N=5), and bibasilar (N=4). Genioplasty was not systematic. Joint symptoms were resolved in all cases. Postoperative occlusion corresponded to the therapeutic project in 9 cases. All patients were aesthetically improved. DISCUSSION: Idiopathic condylar resorption is not a contra-indication for orthognathic surgery. However, this treatment requires meeting and respecting four principles: a minimal delay of 6 months of occlusal, radiological, and morphological stability, an adapted and meticulous surgical technique, early and prolonged parafunction therapy, and a close follow-up of the patients.

[Oxcarbazepine in the treatment of epilepsy]. / Oxcarbazepin in der Epilepsietherapie.

BACKGROUND: Oxcarbazepine (OXC; Timox) is a new antiepileptic drug (AED) chemically related to carbamazepine (CBZ), with comparable efficacy but superior safety according to controlled clinical trials. In a prospective, post-marketing surveillance (PMS) study the efficacy and tolerability of OXC were investigated under conditions of daily routine practice. METHODS: The treatment of 1385 male and female epilepsy patients aged between 1 month and 94 years, who were newly stabilized on OXC or changed over from another AED, was documented in 362 centers over a period of 8 weeks. Efficacy and tolerability were assessed by documenting the frequency of seizures and adverse drug reactions (ADRs) and by global efficacy and tolerability ratings obtained from the patients and investigators. RESULTS: Before the PMS study, 688/1335 patients (49.7 %) had received pre-treatment with CBZ, 342 (24.7 %) had received another AED and 335 (25.6 %) had had no AED pre-treatment (initial OXC monotherapy). In 161 patients pre-treated with CBZ (23,4 % of 688) an immediate (overnight) switch to OXC was performed while most others were switched during a titration phase. Of the patients with CBZ pre-treatment 21 % were switched to OXC at the recommended dose ratio of 1 : 1.4 - 1 : 1.6 (CBZ : OXC) while roughly 60 % were changed to OXC with a lower ratio. In the total sample the median OXC maintenance dose was 900 mg/day. During treatment with OXC the frequency of seizures per 4 weeks decreased by an average of 76 % in comparison to a retrospective pre-phase. 74 % of the patients showed an improved seizure situation, and 40.5 % became seizure-free under OXC (patients with initial monotherapy became seizure-free in 62 % of the cases). 71 % of the patients showed a reduction of their seizure frequency versus baseline by > or = 50 %. ADRs were reported in 10,8 % of the participants (incidence: 1 in 459 days of exposition to OXC; overnight switching from CBZ to OXC: 1 event in 1284 days). Only 2.5 % of the patients terminated OXC administration due to ADRs while 92 % continued treatment with OXC beyond the end of the study. CONCLUSIONS: The results underline the high antiepileptic efficacy and good tolerability of OXC previously demonstrated in controlled clinical trials. When changing from CBZ to OXC, immediate (overnight) switching showed particularly favorable results.

Costs and quality of life of multiple sclerosis in Germany.

This cost-of-illness analysis based on information from 2973 patients with multiple sclerosis (MS) in Germany is part of a Europe-wide study on the costs of MS. The objective was to analyze the costs and quality of life (QOL) related to the level of disease severity. Patients from six centres (office- and hospital-based physicians) and patients enrolled in a database were asked to participate in the survey; 38% answered a mail questionnaire. In addition to details on the disease (type of disease, relapses, level of functional disability), the questionnaire asked for information on all resource consumption, medical, non-medical, work absence, informal care, as well as QOL (measured as utility). The mean age of the cohort was 45 years, and 18% of patients were 65 years of age or older. Forty-seven percent of patients had mild disease (Expanded Disability Status Scale [EDSS] score 0-3), 36% had moderate disease (EDSS score 4-6.5) and 12% had severe disease (EDSS score > or =7). The mean EDSS score in the sample was 3.8 (median 4.0), with a mean utility of 0.62. Costs and utility are highly correlated with disease severity. Workforce participation decreases from 73% in very early disease to less than 10% in the very late stages, leading to a tenfold rise in productivity losses in the late stages of disease. Hospitalisation and ambulatory visits rise by a factor of 5-6 between early and late disease; investments and services increase from basically no cost to euro 2700; and informal care increases by a factor of 27 for patients with an EDSS score of 7 and by a factor of 50 for patients at the very severe end of the EDSS scale (8-9). Hence, total mean costs per patient are determined essentially by the distribution of the severity levels in the sample, increasing from approximately euro 18 500 at an EDSS score of 0-1 to euro 70 500 at an EDSS score of 8-9. The same is true for utility, which decreases from 0.86 to 0.10 as the disease becomes severe. However, the utility loss compared to the general population is high at all levels of the disease, leading to an estimated loss of 0.2 quality-adjusted life-years per patient. Relapses are associated with a cost of approximately euro 3 000 and a utility loss of 0.1 during the quarter in which they occur. Compared with a similar study performed in 1999, resource consumption, with the exception of drugs, is somewhat lower. This is most likely due to a difference in the severity distribution of the two samples and to changes in health-care consumption overall in the country, such as the introduction of diagnosis-related groups (DRGs, Fallpauschalen).

[Free fibular flaps in children: morbidity of the donor site and pitfalls to avoid]. / Lambeau libre de fibula chez l'enfant: morbidité du site donneur et piège à éviter.

INTRODUCTION: We report a case of donor site morbidity late after harvesting a free fibular flap for reconstruction of the mandibular symphsis. CASE REPORT: An 8-year-old boy presented a valgus deformity of the ankle 4 years harvesting of a vascularized fibular graft for mandibular reconstruction. The deformation was repaired with a tibial bone slit and pin fixation. The biomechanical result was very satisfactory, allowing normal gait. DISCUSSION: We recall the rules for fibular flap harvesting needed to prevent deformation of the donor site in children aged less than 9 years.

[Growth defects of fibular flaps in children]. / Troubles de croissance des lambeaux fibulaires prélevés chez l'enfant.

BACKGROUND: Mandibular reconstruction with fibula free flap is a challenge in pediatric patients because of the size of the bone and absence of growth without epiphyseal transplantation. CASE REPORT: We report 2 cases of free fibula flap in children for mandibular reconstruction. The 2 patients presented with growth insufficiency of the bone graft after few years of evolution. DISCUSSION: Growth insufficiency was treated with different surgical procedures which were discussed We review the consequences on growth after fibula free flap and the specific indications to achieve epiphyseal fibular growth in children.

[Grave's ophthalmopathy: therapeutic strategy. Review of 30 patients]. / Ophtalmopathie basedowienne: stratégie thérapeutique à partir de 30 cas.

BACKGROUND: Graves' ophthalmopathy is the primary etiology for exophthalmos in adults. It is a complex orbital disease whose pathophysiology remains controversial. Since its initial description more than 150 years ago, its heterogeneous clinical manifestations and poorly understood links with thyroid pathology remain unresolved issues. Disease activity is the main determinant for the management of Graves' ophthalmopathy, but treatments are often symptomatic, aiming at decreasing orbital inflammation. MATERIAL AND METHODS: We report a retrospective analysis of 30 patients diagnosed with Graves' ophthalmopathy followed in our department between 1991 and 2002. Following a phase of medical management of their disease, all patients underwent surgical orbital decompression. RESULTS: Medical and surgical care provided as well as results are presented with a mean follow-up of 23 months. DISCUSSION: Based on our clinical experience, new concepts in the field of Graves' ophthalmopathy are discussed. Disease activity, evaluated through various means, appears to be the primary guide for therapeutic management. Moreover, the importance of a multidisciplinary approach is highlighted, in order to improve the management of this difficult disorder.

[Orbital decompression for Graves' ophthalmopathy]. / Décompression orbitaire au cours des ophtalmopathies basedowiennes.

Graves' ophthalmopathy is a complex orbital condition with a controversial pathogenesis. It is the clinical expression of a discordance between the inextensible orbit and hypertrophic muscular and fatty elements within the orbit responding to immunological stimulation. The relationship between the orbital and its content can be improved by surgical expansion which increases the useful volume of the orbit. This procedure can be combined with lipectomy to decrease the volume of the orbital contents. We briefly recall the history of surgical decompression techniques and present our experience with Graves' ophthalmopathy patients.

[Vascularized osseous flaps for mandibular reconstruction after osteoradionecrosis]. / Reconstruction mandibulaire par lambeau osseux vascularisé après ostéoradionécrose.

INTRODUCTION: The reconstruction of mandibular continuity destroyed by osteoradionecrosis can be a difficult task. The aim of this study was to evaluate the reliability and contribution of vascular osseous flaps for mandibular reconstruction after osteoradionecrosis. MATERIAL AND METHOD: A retrospective study of patients undergoing mandibular reconstruction after osteoradionecrosis between 1989 and 2002 was performed. Twenty-five mandibular reconstructions were performed in 23 patients: 16 fibular free flaps, 5 osteomuscular serrato-costal free flaps, 1 osteocutaneous external brachial free flap, 1 medial femoral condylar free flap and 2 armed pectoralis major pediculed flaps. RESULTS: We observed two major complications (8%): loss of one fibular flap and one medial femoral condylar free flap. We observed 42% minor complications. Overall quality of life was constantly enhanced. DISCUSSION: Fibular flap is definitely a good method for immediate or secondary mandibular reconstruction. A serratocostal flap must be considered as an alternative flap when the fibular flap is unavailable.

[Focus on the effect of orthognathic surgery on condylar remodeling]. / Retentissement condylien de la chirurgie orthognathique.

Condylar remodeling is a physiologic process that aims to adapt the structure of the temporo-mandibular joint (TMJ) to meet the functional demands. It is based on an interaction between the mechanical forces sustained by the TMJ and the adaptative capacities of the condyle. Orthognathic surgery can sometimes be responsible for an excessive physical stress to the articular surfaces. In these cases, normal functional condylar remodelling shifts to the process of progressive condylar resorption. Effect of orthognathic surgery on condylar remodeling is a poorly understood and controversial issue. It is however considered as an etiology of postoperative skeletal relapse following orthognathic surgery. Based on two case reports, etiopathogenic hypotheses of this process are discussed as well as predisposing factors to condylar resorption following orthognathic surgery.

[Severe Class III malocclusion: long-term stability. Retrospective analysis of 12 cases]. / Classes III sévères: stabilité à long terme. Etude rétrospective: à propos de 12 cas.

PURPOSE: Long-term stability of severe class III is rarely evaluated in the literature. We present our findings with 12 patients who underwent surgery from June 1995 to December 1997 and analyze cephalometric superpositions. MATERIALS AND METHODS: Twelve operated patients were reviewed to analyze long-term results (follow-up 3 years 8 months). The sex ratio was well balanced. Mean age was 23 years. All patients were given pre- and postoperative orthodontic care and underwent bimaxillary surgery with Lefort 1 osteotomy and sagittal osteotomy of the rami. Delaire cephalometry on preoperative and early and late postoperative films was used to analyze outcome. Skeletal instability was defined as displacement greater than 4 mm. Recurrence was defined as secondary loss of the functional and esthetic result. RESULTS: Four patients (33%) developed skeletal instability. All patients achieved long-term stability. DISCUSSION: To detail the cause of skeletal instability, study of the principal factors of instability is presented together with a discussion of data in the literature.

[Brain abscess and diffuse cervico-facial cellulitis: complication after mandibular third molar extraction]. / Abcès intracérébral et cellulite cervico-faciale diffuse: complications d'une extraction de dent de sagesse: à propos d'un cas.

The authors report a case of cervico-facial cellulitis with brain abscess after mandibular third molar removal. This is the observation of a 26 years old boy surgically treated for a cervico-facial cellulitis ten days after a third molar's removal. He was given anti-inflammatory drugs after removal for analgesia. After a phase of clinical improving, the patient developed pulmonary and brain abscess with neurological signs. He needed neurosurgery in emergency. After eight weeks of antibiotic treatment, the patient was cured with aftereffects (jaw constriction and sensory disorders of the right thigh). Cerebro-meningeal complications of diffuse cervico-facial cellulitis are exceptional but are responsible for heavy aftereffects. This observation confirms that using anti-inflammatory drugs for analgesia is associated with a higher rate of complications after dental removal.

[Protocol for adapting treatment with vitamin K antagonists before dental extraction]. / Protocole d'adaptation des traitements aux anti-vitamines K avant extractions dentaires.

BACKGROUND: The purpose of this study was to validate a protocol for dental extraction in patients taking vitamin K antagonists without changing the treatment when the INR is lower than 2.8. MATERIAL AND METHODS: One hundred four extractions (96 patients) were performed during a 9 month period in patients taking vitamin K antagonists. Extraction was performed when the international normalized ratio (INR) was less than 2.8, otherwise, the treatment was modified until the desired INR was reached. Extractions were performed under para-apical and alveolar local anesthesia and sutured with hemostatic gauze. RESULTS: Three patients developed postoperative bleeding requiring alveolar revision with local application of tranexamic acid and in one case use of a biological glue. DISCUSSION: The following protocol can be proposed: ambulatory extraction under local anesthesia with an INR the day before extraction: the extraction is performed if the INR is<=2.8 using hemostatic gauze suture and tranexamic acid in case of persistent bleeding.

[Results of an evaluation of clinical practice in orthognathic surgery in France in 2002]. / Résultat d'une évaluation de pratique clinique en chirurgie orthognathique en France en 2002.

BACKGROUND: Over the years, orthognathic surgery has become a mainstay of maxillofacial surgery and is the object of many publications and oral communications. However, in spite of well-established methodology, disparities still exist in France basically concerning the way orthognathic surgery is performed. MATERIALS AND METHODS: In relation with the XXXIXth congress of Stomatology and Maxillofacial surgery, a questionnaire was mailed to 100 French maxillofacial surgeons. Questions dealing with some practical points of orthognathic surgery (condylar positioning, osteosynthesis technique, rate of condylar resorption.) were asked. RESULTS: Overall reply rate was 37%. Condylar positioning was performed empirically in 73% of the cases. Mandibular osteosynthesis was achieved by titanium miniplates alone in 70%. Post-operative condylar resorption rate was about 2%. This survey produced numerous astute comments. DISCUSSION: This survey highlighted the interest of maxillofacial surgeons for practical aspects of orthognathic surgery including the questions of condylar positioning or osteosynthesis technique. These points are instrumental in achieving high-quality surgical result.