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Schaefer M.,Psychotherapy and Addiction Medicine | Sarkar R.,Asklepios Westklinikum Hamburg | Knop V.,Goethe University Frankfurt | Effenberger S.,Charite - Medical University of Berlin | And 18 more authors.
Annals of Internal Medicine | Year: 2012

Background: Depression is a major complication during treatment of chronic hepatitis C virus (HCV) infection with interferon-α (IFN-α). It is unclear whether antidepressants can prevent IFN-induced depression in patients without psychiatric risk factors. Objective: To examine whether preemptive antidepressant treatment with escitalopram can decrease the incidence or severity of depression associated with pegylated IFN-α in HCV-infected patients without a history of psychiatric disorders. Design: Randomized, multicenter, double-blind, prospective, placebo-controlled, parallel-group trial. (ClinicalTrials.gov registration number: NCT00136318) Setting: 10 university and 11 academic hospitals in Germany. Patients: 181 HCV-infected patients with no history of psychiatric disorders enrolled between August 2004 and December 2008. Intervention: Escitalopram, 10 mg/d (n = 90), or placebo (n = 91) administered 2 weeks before and for 24 to 48 weeks during antiviral therapy. Measurements: The primary end point was the incidence of depression, defined as a Montgomery-Asberg Depression Rating Scale (MADRS) score of 13 or higher. Secondary end points were time to depression, incidence of major depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, quality of life, sustained virologic response, tolerability, and safety. Results: 32% (95% CI, 21% to 43%) of the patients in the escitalopram group developed a MADRS score of 13 or higher compared with 59% (CI, 48% to 69%) in the placebo group (absolute difference, 27 percentage points [CI, 12 to 42 percentage points]; P < 0.001). Major depression was diagnosed in 8% of the patients in the escitalopram group and 19% in the placebo group (absolute risk difference, 11 percentage points [CI, 5 to 15 percentage points]; P = 0.031). Tolerability and safety parameters did not differ between the groups. In the escitalopram group, 56% (CI, 46% to 66%) of patients achieved a sustained virologic response compared with 46% (CI, 37% to 57%) in the placebo group (P = 0.21). Limitations: Results might not be generalizable to patients with previous psychiatric disease. Some patients withdrew or developed temporary elevated MADRS scores after randomization but before the study medication was started. Conclusion: Prophylactic antidepressant treatment with escitalopram was effective in reducing the incidence and severity of IFN-associated depression in HCV-infected patients without previous psychiatric disease. Primary Funding Source: Roche Pharma and Lundbeck. © 2012 American College of Physicians.

Jochberger S.,Klinikum Rechts der Isar | Dunser M.W.,Paracelsus Medical University
Wiener Klinische Wochenschrift | Year: 2011

Concomitant hydrocortisone and arginine vasopressin therapy increases arginine vasopressin plasma levels and may improve survival in septic shock. The objective of this post hoc analysis of a prospective study was to determine whether hydrocortisone therapy increases arginine vasopressin plasma levels in patients with septic shock. Forty-five patients were included into the study, of whom 23 (51.1%) received a hydrocortisone infusion because of escalating vasopressor dosages. Median arginine vasopressin plasma levels did not differ between patients treated with and without hydrocortisone therapy [4.2 (2.2-6.2) vs. 4.3 (2.7-6.1) pmol/L] both in a bivariate (p = 0.43, Mann-Whitney U-test) and a logistic regression model adjusted for differences in disease severity (p = 0.38). No association was further detected between hydrocortisone therapy and arginine vasopressin plasma levels in an adjusted linear regression model [β-coefficient, -0.57 (-1.86-0.73), p = 0.39]. We conclude that increased arginine vasopressin plasma levels during concomitant arginine vasopressin and hydrocortisone therapy in septic shock result from reduced arginine vasopressin clearance and not increased arginine vasopressin secretion or interaction of hydrocortisone with the arginine vasopressin assay. © 2011 Springer-Verlag.

Morath S.,Praxisklinik fur Plastische und Asthetische Chirurgie | Papadopulos N.,Klinikum Rechts der Isar | Schaff J.,Praxisklinik fur Plastische und Asthetische Chirurgie
Handchirurgie Mikrochirurgie Plastische Chirurgie | Year: 2011

Background: Subcutaneous mastectomy in female to male transsexuals is one first important step in gender adjustment. Beside proper surgical technique, operative management of mastectomy procedures is important to allow for an optimised process of gender transformation including all necessary individual operations. Methods: 126 female-to-male transsexuals were prospectively included in the observation period, all undergoing a step 1 operation of gender adjustment. The mastectomy procedure is conventionally embedded in an overall approach for gender transformation and was regularly combined with procedures like colpectomy, extension of the urethra as well as hysterectomy and ovariectomy. 4 different methods for mastectomy were introduced at our institution, depending on and adjusted to the breast volume, grade of breast ptosis, the breast size and envelope and skin elasticity. For patient evaluation a standardised survey was conducted using a semiquantitative score (14) for grading aesthetic results and nipple sensibility. Results: Between 2006 and 2009 a total of 126 patients underwent a step 1 procedure of gender adjustment, 63 had mastectomy and 29 a revision procedure after external prior mastectomy. In 64/126 (50.8%) mastectomy was performed using a one-third edge cut, 30/126 (23.8%) were operated by a submammarian approach and pedicled nipples technique, in another 22/126 cases (17.5%) mastectomy was performed using circular tightening and 10/126 (7.9%) received freely transplanted nipples. For improving the aesthetic results, additional procedures were performed on 29 patients (46%). The patient survey revealed a high level of satisfaction with the aesthetic result, 42/50 (84%) of the patients rated results as good or very good. Conclusions: We newly introduced an operative concept of mastectomy being embedded and adjusted in an overall approach for gender adjustment (Munich Modular Operative Kit; MMOK). Using the presented individualised surgical techniques of mastectomy, all procedures were conducted in a very scar-saving manner, however, a higher rate of correction procedures was necessary to individually adjust skin shrinking and thereby optimising the prior aesthetic results. The new Munich Modular Operative Kit allows for gender reassignment including breast corrections usually using 4 operative steps. © Georg Thieme Verlag KG Stuttgart · New York.

Gastroesophageal cancer is the second leading cancer cause of death globally. Despite having improved treatment modalities over the last decade, for most patient's only modest improvements have been seen in overall survival with a median survival below one year. Therefore, in the era of intense translational research and personalized therapy, the identification of novel predictive and diagnostic targets is urgently needed. Patients with Her-2 overexpression or amplification have experienced significant gains in overall survival with the treatment of Trastuzumab in addition to chemotherapy. However, apart from the successful targeting of Her-2 overexpression in gastroesophageal cancer with Trastuzumab, other targeted therapies have fallen short. The molecular targets currently being evaluated in various phase II and III clinical trials include the epidermal derived growth factor receptor (EGFR) with subtypes ERBB-1, ERBB-2 (Her-2/neu), ERBB-3 and ERBB-4, vascular endothelial derived growth factor (VEGF) and its receptor (VEGFR), mammalian target of Rapamycin (mTOR) and antibodies against the tyrosinkinase receptor c-Met.

Glanzmann M.C.,Orthopadie Obere Extremitaten | Buchmann S.,Orthopadie Obere Extremitaten | Audige L.,Klinikum Rechts der Isar | Kolling C.,Orthopadie Obere Extremitaten | Flury M.,Orthopadie Obere Extremitaten
Archives of Orthopaedic and Trauma Surgery | Year: 2013

Introduction: Persistent horizontal instability after acute acromioclavicular (AC) joint separation may provoke unsatisfactory results of conservative treatment. Hypothesis: the arthroscopically assisted double flip button stabilization of acute horizontally unstable grade III and IV AC joint disruptions results in full functional restoration and stable radiological reposition. Materials: 21 patients treated for an acute grade III or IV AC joint separation were enrolled. Clinical assessment at least 2-year postoperative included the constant score (CS) and the simple shoulder test. A panorama stress view, bilateral axial view and an AC view were obtained for radiographic evaluation. Results: 19 individuals (mean 37 years; 17 men) with 16 Rockwood type III and 3 type IV injuries were available for examination 24-51 months postoperatively. The mean CS was 90.2 points (SD 6.5) with no statistically significant difference between CS and age-adjusted normative values. The mean Simple Shoulder Test scored 11.5 points (range 8-12). Loss of reduction of more than 2 mm in the coronal plane stress views was present in 6 patients (32 %) with no associated loss of functional outcome. Two of four reported complications in four patients were treated surgically (one open revision with graft augmentation for coracoid implant break out, one arthroscopic capsular release for persistent glenohumeral stiffness). Conclusion: Arthroscopically assisted double flip button stabilization for acute grade III and IV AC joint separation restores fully horizontal stability and age-expected shoulder function, resulting in high patient satisfaction, despite a loss of reduction observed radiographically in approximately one-third of patients. Level of evidence: IV. © 2013 Springer-Verlag Berlin Heidelberg.

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