Fumaderm® in daily practice for psoriasis: dosing, efficacy and quality of life.

BACKGROUND: Patients with psoriasis suffer from chronic skin disease and impaired quality of life. With a prevalence of 1-3% of the population, psoriasis is one of the most common chronic inflammatory autoimmune diseases. Fumaric acid esters (Fumaderm(®)) are approved for the treatment of psoriasis in Germany, but regular Fumaderm therapy with six tablets per day is often limited due to adverse events. OBJECTIVES: This observational study recorded data on quality of life, treatment efficacy and drug dosing in patients suffering from psoriasis treated with Fumaderm under conditions of daily practice in 78 dermatological centres. PATIENTS AND METHODS: In this prospective, multicentre, noninterventional trial we included adult patients with severe plaque psoriasis under outpatient conditions receiving Fumaderm according to the current summary of product characteristics for systemic treatment of psoriasis. At baseline and after 3, 6 and 12 months the dosing regimen under daily conditions, Dermatology Life Quality Index (DLQI) and clinical efficacy with the Psoriasis Area and Severity Index (PASI) were documented. RESULTS: A total of 249 patients were included. The mean DLQI score at study entry was 9·95; the mean PASI was 16·8. The average treatment dose of Fumaderm was 2·8 tablets daily. More than 70% of patients were treated with one to three tablets daily and < 30% were treated with a dose ranging from four to six tablets daily. DLQI and PASI improved in the entire study population by 67·2% and 66·6%, respectively. Specifically, when analysing patients who started Fumaderm within 4 weeks before baseline the mean DLQI score decreased from 11·8 to 2·9 (75% reduction) and the mean PASI score from 19·84 to 7·35 after 12 months (63% improvement). CONCLUSIONS: This is the first field study analysing the use of Fumaderm and the improvement of quality of life in patients with psoriasis under daily outpatient conditions. The improvement of DLQI obtained with Fumaderm was comparable with the improvement observed in patients with psoriasis treated with modern biologics. Importantly, in most patients with good clinical response, the treatment dose was one to three tablets daily.

[Medial end clavicle fractures: alternative osteosynthesis and brief review of the literature]. / Mediale Klavikulafraktur: alternative Osteosynthese und kurze Literaturübersicht.

Medial end clavicle fractures are rare injuries and typically treated conservatively. In contrast, displaced fractures have a higher incidence of delayed healing or non-union and might benefit from operative treatment. Thus, assessments of the stability and fracture morphology are essential for selection of the optimal treatment procedure. This article describes the diagnostics and surgical treatment of a displaced extra-articular fracture of the clavicle with a small medial fragment using an anatomically preformed radius plate.

Significance of myeloperoxidase plasma levels as a predictor for cardiac resynchronization therapy response.

OBJECTIVES: This study aimed to determine if changes in myeloperoxidase (MPO) levels correlate with response to cardiac resynchronization therapy (CRT) and the potential role of MPO as a predictor of response to CRT. BACKGROUND: CRT is a well-established treatment option in chronic heart failure (CHF) with 50-80% of patients benefiting. Inflammation and oxidative stress play a key role in CHF pathophysiology. Previous studies have demonstrated increased levels of MPO in CHF patients, but the correlation with CRT response remains incompletely understood. METHODS: Fifty-three patients underwent CRT implantation. During follow-up, patients were divided into two groups, responders and non-responders to CRT, based on improved physical capacity and NYHA classification. Levels of MPO and NT-pro-brain-natriuretic-peptide (NT-proBNP) were determined prior to implantation, 30 and 90 days after. Physical capacity, including a 6-min walking-test, NYHA class, and LVEF were evaluated at baseline and during follow-up. RESULTS: Thirty-four patients (64%) responded to CRT, showing improved physical capacity and LVEF. All responders revealed a significant decrease of MPO levels (503.8 ng/ml vs. 188.4 ng/ml; p < 0.001). Non-responding patients did not show any significant changes in clinical parameters or MPO levels (119.6 ng/ml vs. 134.3 ng/ml; p = 0.672) during follow-up. At baseline, physical capacity and NYHA class, as well as MPO levels differed significantly between both groups (p < 0.001). A ROC analysis identified an MPO cut-off value for response to CRT of 242 ng/ml with a sensitivity of 93.5% and specificity of 71.4%. There was a strong correlation between MPO and improvement of LVEF (Spearman's rho: - 0.453; p = 0.005) and physical capacity (Spearman's rho: - 0.335; p = 0.042). CONCLUSIONS: Response to CRT and course of MPO levels correlate significantly. MPO levels differ between responders and non-responders prior to CRT, which may indicate an additional value of MPO as a predictor for CRT response. Further randomized studies are required to confirm our data in larger patient cohorts.

Electrical cardioversion of patients with implanted pacemaker or cardioverter-defibrillator: results of a survey of german centers and systematic review of the literature.

AIMS: A relevant number of patients presenting for electrical cardioversion carry a pacemaker (PM) or ICD. Case reports suggest a potential hazard of external cardioversion/defibrillation. The incidence of shock related device complications is unknown. No guidelines or recommendations by international medical societies for a cardioversion protocol of cardiovascular implantable electronic device (CIED) patients exist. We conducted a nationwide survey to gather real-world clinical data on the current clinical approach towards these patients during electrical cardioversion and to estimate the incidence of shock-related complications. METHODS AND RESULTS: Ninety hospitals with > 380 ECV in 2014 were identified from mandatory hospital quality reports and 60 were randomly selected. All centers were provided with a standardized questionnaire on the general proceedings and complications during electrical cardioversion of pacemaker, ICD and CRT patients (CIED patients). Thirty-two centers (53%) participated in the survey. In total, 16,554 ECV were reported (534 ± 314 per center). Biphasic cardioversion with a first shock energy of ≥ 150 J via adhesive patches in antero-posterior orientation was preferred by most centers (78%). Eleven percent (n = 1809) of pts were reported to carry a PM/ICD. The ECV protocol was heterogeneous among centers. Complications associated with electrical cardioversion were reported in 11/1809 patients (0.6%), all were transitory elevations of pacing thresholds. CONCLUSIONS: In this nationwide snapshot survey of cardioversion procedures in Germany, approximately 11% of patients presenting for elective electrical cardioversion were pacemaker or ICD carriers. Cardioversion protocols in these patients are heterogeneous throughout centers and mostly not in accordance with recommendation of the German Cardiac Society. Complications associated with external electrical cardioversion are rare. Controlled trials and large registries are necessary to provide evidence for future recommendations.

Feasibility and clinical applicability of polihexanide for treatment of second-degree burn wounds.

OBJECTIVES: Due to a partial rejection of mesh split-thickness skin grafts (mesh grafts) after application of povidone-iodine and silver nitrate and due to its better in vitro tolerance, polihexanide was investigated as an alternative and its applicability in the treatment of second-degree burn wounds. METHODS: In 4 patients with poorly healing decubitus ulcers the mesh grafts were each divided into three areas which were pre-treated with either undiluted povidone-iodine solution, 1% silver nitrate solution or 0.04% polihexanide solution. After 7 days of application the wound areas were compared clinically and histologically. Thereafter 14 patients (average extent of burns 28% TBSA) were treated in the same way. RESULTS: Clinically and histologically the mesh grafts treated with polihexanide showed by far the best re-epithelialization compared with the deep tissue necrosis and marked fibrin discharge observed for application of povidone-iodine and silver nitrate. The second-degree burn wounds treated with polihexanide epithelialized without any further débridement after an average of 10 days with remarkable freedom from pain. Compared with silver nitrate treatment, no fibrin film was observed on the wound. CONCLUSION: Polihexanide proved clinically and histologically superior to povidone-iodine and silver nitrate. For the treatment of second-degree burns, which cannot primarily be covered by plastic surgery, polihexanide is suitable because in addition to its antiseptic efficacy it does not inhibit the re-epithelialization process.

[Endoscopic brow lift with resorbable anchors]. / Die endoskopische Brauenanhebung mit resorbierbaren Hautankern.

The fixation of the galea to the skull presents one of the main impairments of endoscopic forehead lifts, which are still to be improved. A precise positioning, variation of force vectors and the ability to correct asymmetries are among the demands on this aesthetic procedure. Since the introduction of resorbable skin anchors, we have used them pairwise in 27 consecutive cases of endoscopic forehead lifts. In a retrospective study we found that the advantage of this system is primarily found in a reduction of operating time, ease and reliability of use and the possibility to individually adjust the direction and strength of tension after inserting the anchors into the skull. The disadvantage - apart from the high cost of the device - lies in the unreliable resorption time which, in all cases controlled, exceeded the 8-month period, proclaimed by the manufacturer. This made it necessary to surgically remove the anchors in 7 out of 27 patients. Consequently every patient is now informed about the possibility of a second intervention as early as 4 to 6 weeks postoperatively to remove the device.

Depletion of CD25(+) CD4(+) T cells and treatment with tyrosinase-related protein 2-transduced dendritic cells enhance the interferon alpha-induced, CD8(+) T-cell-dependent immune defense of B16 melanoma.

Transduction of B16 melanoma cells with IFN alpha (B16-IFN alpha) enhances CD8(+) T-cell-dependent tumor immunity in mice, resulting in delayed outgrowth in vivo. Here we provide evidence that CD4(+) T cells down-regulate the IFN alpha-induced tumor immune defense. Importantly, depletion of regulatory CD25(+) CD4(+) T cells prevented growth of B16-IFN alpha in most mice and promoted long-lasting protective tumor immunity. Rejection of B16-IFN alpha could also be achieved with therapeutic injections of dendritic cells genetically engineered to express the melanoma antigen tyrosinase-related protein 2. These results support the development of novel strategies for the immunotherapy of melanoma using IFN alpha in combination with elimination of regulatory T cells or antigen-specific immunization.

[Assessment of REC (Reduction in Earning Capacity) after Thermal Trauma as Part of the Appraisal Process for Statutory Accident Insurance in Germany (Part 2): The New REC Form Developed by Ottomann and Hartmann in 2010]. / Die Einstufung der MdE nach thermischem Trauma im Rahmen der Begutachtung der gesetzlichen Unfallversicherung (Teil II): Der neue MdE Bogen nach Ottomann und Hartmann 2010.

The calculation of REC forms the basis of expert opinions for the purposes of making accident insurance assessments after an occupational accident or an accident suffered en route while travelling to or from the workplace. The estimation of REC is based on a procedure quoted in the 1995 "Jahrbuch der Versicherungsmedizin" (Yearbook of Insurance Medicine) using a form developed by Henkel von Donnersmarck and Hoerbrand. The overall estimation of damages resulting from the accident comprises 3 main components, namely the functional impairment, the assessment of local findings and the resulting somatic and vegetative complaints. The criteria for all 3 components are nevertheless imprecise and open to a great deal of interpretation on the part of the evaluator, leading to a highly variable and subjective overall assessment of REC. The new REC form includes a modified factor-based categorisation of the scar quality and the localisation, so that assessment can now be carried out in a differentiated manner. Visible, stigmatising areas such as the neck are provided with their own Q values. The pigmental and textural alterations describing the scar quality are now more precisely defined. Considering the complexity of the somatic and vegetative alterations, more precise (objective) assessments can now be derived. The new REC form increases the validity and transparency of post-thermal trauma REC assessments for the purposes of making statutory accident insurance assessments.

[The Assessment of REC after Thermal Trauma as Part of the Appraisal Process for Statutory Accident Insurance in Germany (Part 1): Low Validity of the REC Form Developed by Donnersmarck and Hörbrand]. / Die Einstufung der MdE nach thermischen Trauma im Rahmen der Begutachtung der gesetzlichen Unfallversicherung (Teil I): Geringe Validität des MdE Bogens nach Donnersmarck und Hörbrand.

The total REC (reduction in earning capacity) after a thermal trauma is usually assessed using an appraisal form for burns victims, initially developed by Hoerbrandt and von Donnersmarck (1995). The criteria for functional impairment, local findings and vegetative-somatic complaints are somewhat imprecise given the broad scope of interpretation which the evaluator can employ in making an appraisal. This means that the overall appraisal of REC is subjective on the part of the evaluator. In addition, one can only calculate an overall REC of at most 40% from local findings and vegetative-somatic symptoms, even in patients with extensive large area burns. Considering these points we investigated the dependency of the results on the evaluator as well as the limited validity of the appraisal form originally developed by Hörbrand and Donnersmark.

[Catheter ablation and the complications]. / Katheterablation und die Komplikationen.

Catheter ablation of atrial fibrillation has developed into a standard therapy and even in some cases as a first line therapy. This has resulted in a clear increase in the number of procedures in recent years. The published data from experienced centers indicate that the number of complications decreases with increasing experience; however, due to the parallel increase in the number of inexperienced centers, the average complication rate shows a tendency to increase. In the long term this necessitates a reliable quality assurance in order not to leave the choice of the "safe centers" up to the patient. Vascular complications are the most common, which in most cases have an uneventful course and do not necessitate further interventions. Particularly the incidence of ischemic stroke can be well-countered by strict control of periprocedural anticoagulation. The frequency of occurrence of phrenic nerve lesions, which are more common when selecting cryoenergy, can be reduced by stimulation of the phrenic nerve during ablation of the right pulmonary vein. The most feared complication of an atrioesophageal fistula is rare. No data for an effective avoidance of complications are available. A postprocedural therapy with proton pump inhibitors for 4-6 weeks, the intraprocedural measurement of esophageal temperature and reduction of the ablation energy on the posterior wall of the left atrium can possible help to reduce the frequency of complications.

Long-term prognosis in stroke related to cerebral blood flow.

In 180 patients, cerebral blood flow was measured between one and six weeks after acute cerebrovascular ischemia. Patients were grouped according to their clinical deficits at the time of blood flow study. Statistical analysis revealed highly significant differences among the flow values of the groups. The patients were followed up for a period of up to 6 years (mean, 34 months) after the attack, and then regrouped. In these groups, the statistical significances of differences among the flow values was even higher. Patients also were grouped according to changes in neurologic status, and again the flow values differed significantly among the groups. The results show significant relationships among flow values after cerebrovascular ischemia and neurologic deficits, change in status, and the final functional state. Cerebral blood flow measurement together with other clinical signs permits an estimation of a patient's chance for functional recovery after a stroke.

Treatment of partial thickness burns of the hand with the preshaped, semipermeable Procel Burn Cover: results of a multicentre study in the burn centres of Berlin, Duisburg and Munich.

The results of a prospective clinical study conducted in three German burn centres are reported. The subject of the evaluation was to show the effectiveness of a new, preshaped, semipermeable burn dressing that is resistant to fluids and bacteria but highly permeable to vapour. The dressing was used in conjunction with 1 per cent silver sulphadiazine cream in treating partial thickness burns of the hand. In 49 patients, 72 partial thickness burned hands were treated. The application proved to be very easy. The time for a dressing change was short (5-10 min). The duration of treatment was 13 days on average. Complications due to infections did not occur. Because of the semipermeable properties of the dressing material, skin macerations occurred in only a few instances (13 per cent) as a result of inappropriate cream application or extremely high exudation rates, and these did not adversely affect the healing process. Patients achieved the ability to perform activities of daily living early with positive results for the patients, the physician and the nursing team.

[Lactacidosis of the cerebrospinal fluid in apoplexy as indicator of prognosis (author's transl)]. / Die Laktazidose des Liquor cerebrospinalis (LCS) als Prognoseindikator beim enzephalomalazischen Insult.

Blood and CSF gases, as well as the level of lactate and pyruvate in blood and CSF were determined in 43 cases. of severe stroke with softening of the brain. It transpired that the CSF lactate level is the best prognostic indicator of survival. CSF values above 2,5 mMol/1 in apoplexy imply a very unfavourable prognosis. The CSF lactate level is also a very useful prognostic indicator in patients suffering from diabetes and/or uraemic metabolic disorders. As the determination of CSF lactate presents no tecnical difficulties and furnishes valuable prognostic information it would merit inclusion as a routine procedure in relevant cases.

[Changes in serum lipoproteins in cerebrovascular disease (author's transl)]. / Uber Veränderungen der Serumlipoprotein bei zerebrovaskuären Erkrankungen.

The determination of serum cholesterol, triglycerides and lipoprotein cholesterol (VLDL, LDL and HDL) in 96 patients suffering from cerebral vascular disease showed that some parameters were significantly different from those recorded in a control population of corresponding age HDL values below 40 mg/dl were found in 50% of cases. Pathological LDH/HDL and VLDL/HDL ratios were found in 30.9% and 37.7%, respectively, of patients with cerebrovascular disease, whose serum cholesterol level was below 250 mg/dl and triglyceride level was 175 mg/dl. Only 56% of all patients had elevated serum cholesterol and/triglyceride and triglyceride alone does not detect the risk. The difference in the VLDL/HDL ratio in patients with cerebrovascular disease and that of the control population is highly significant. The HDL values and the VLDL/HDL ratio differ significantly, also. On average, the HDL levels in women are higher than those in men, but the decrease faster with increasing age. In both sexes a decrease in HDL level occurs between the age of 40 and 80. Low HDL levels and unfavourable LDL/HDL and VLDL/HDL quotients are important risk indicators for cerebrovascular disease.

[Clinical course and CSF lactate in encephalomalacia (author's transl)]. / Uber die Korrelation von klinishcem Verlauf und Liquorlaktatspiegel bei enzephalomalazischen Insulten.

LCS level of lactate and clinical status correlate well during the initial stage of encephalomalacia (2nd-4th day) and during a period of 12 to 14 days after infarction LCS level of lactate may, therefore, be regarded as important parameter for short-term prognosis of encephalomalcia. The use of a semiquantitative clinical score also permits predictions as to the extent of remission to be expected. The reliability of this model of prognosis is limited by the comparatively small number of patients so far examined, the assumption of a linear relation between clinical alterations and changes in LCS lactate, as well as by the difficulty of determining LCS lactate in most severe cases at the specific time requested by the examination programme.

[Metabolic changes in ischemic brain infarct]. / Metabolische Veränderungen bei ischämischem Hirninfarkt.

Serum and cerebrospinal fluid (CSF) from 17 patients less than 3 days after brain infarction (measurement 1) and during recovery 7 +/- 2 days after infarction (measurement 2) were analysed for organic acids (energy metabolites, keto acids and amino acids). Clinical parameters improved by 32% over the period of assessment. Only serum pyruvate levels were elevated at both measurement times. Acute infarction was characterized by significant correspondence of serum and CSF concentrations for pyruvate and alpha-oxo-beta-methyl valeric acid which was lost during the recovery period. Amino acids of the L-system were roughly doubled (phenylalanine 7-fold in the CSF); increased concentrations were recorded for amino acids of the basic transport system, while amino acids of the A-system stayed unchanged (with the exception of alpha-amino butyric acid--20-fold in CSF). Except in the case of taurine, serum and CSF amino acid concentrations remained unchanged between the two measurement times. Mutual dependence of CSF and serum amino acid concentrations, existing initially for glycine, valine, leucine, tyrosine, as well as ornithine, lysine and histidine was lost in the recovery phase. This is interpreted as indication of a normalization of the blood-brain barrier.

[Experiences with a resorbable suture (PDS) in tendon sutures]. / Erfahrungen mit resorbierbarem Nahtmaterial (PDS) bei Sehnennähten.

67 tendon sutures were performed on 29 patients using polydioxanon (PDS), a synthetic absorbable suture material. The results after a mean survey period of twelve months are documented; there were no ruptures and fistula, only two infections and in four cases the need for tenolysis. In the reconstruction of isolated flexor tendon injuries 89% excellent results were found. The satisfactory and bad results in reconstructing flexor and extensor tendon injuries accompanied by complex hand injuries are analyzed and discussed.

[Early pressure on the gluteus maximus rotation flap in sacral decubitus ulcer]. / Die Frühbelastung des Glutaeus maximus-Verschiebelappens beim sakralen Dekubitus.

The myocutaneous gluteus maximus flap in V-Y technique has become the workhorse for covering extensive sacral pressure sores. clinical experience indicates that this flap can sustain pressure prior to the usual three week period. Transcutaneous pO2 measurements permitted us to follow the flaps perfusion and to develop a new mobilization regimen. Patients can lie in the supine position for 30 minutes immediately after surgery for two hourly intervals. Three days postoperatively the usual two-hour repositioning can be resumed. This regimen represents a considerable improvement for paraplegics and has shown a comparable complication rate in 18 cases.

[Psychosocial follow-up of burn patients]. / Psychosoziale Nachuntersuchung bei Brandverletzten.

A questionnaire was developed to gain information on the medical, social and psychological rehabilitation of 62 burn patients. The questionnaire was answered by each patient and a close relative of their choice. The patients selected were those with burns involving hands and face, or with burns exceeding 30% of the body surface area. The returned questionnaires were analysed with respect to posttraumatic care, the extent of physical reconstruction, changes in personality and social behaviour, occupation, workman's compensation and cause of accident.

[Morel-Fatio temporary management of the paretic eyelid]. / Zur temporären Versorgung des paretischen Oberlides nach Morel-Fatio.

Various alloplastic materials have been used to reestablish proper function of paretic upper eyelids. Modifying Morel-Fatio's method, the spring had been bent in a W-fashion and located in such a position that three dimensional movement of the lower branch was possible. Complications of the original method like swelling and perforation could be explained by occasional allergies against chromium and nickel. Therefore we used a new titan-molybdaen alloy, which has a slightly higher elasticity modul than the chrom-nickel alloy. The new material's characteristics correlate well with our own in vivo measurements of the strength of the levator palpebrae superioris muscle. Clinical observations during the last 3.5 years show an improvement by the use of the titan-molybdaen alloy for the durability of elasticity as well as for tissue compatibility.