Randomisierte, Placebo-kontrollierte klinische Phase III-Doppelblindstudie zur Wirksamkeit und Sicherheit von Hyaluronidase, Hylase® „Dessau“ 75 I.E. als Zusatz zu Lokalanästhetika bei der Kataraktoperation

Es wurde in einer 80 Patienten umfassenden Studie die Wirksamkeit und Sicherheit der Hyaluronidase als Zusatz zu Lokalanästhetika bei der Kataraktoperation untersucht. Die Studie war prospektiv angelegt. Die Zuteilung der Hyaluronidase bzw. des Placebos erfolgte randomisiert und doppel-blind. Beurteilungskriterien für die Wirksamkeit waren allgemeine und spezielle Parameter, die prä-, intra- und postoperativ bestimmt wurden. Allgemeine Parameter waren das Alter und das Geschlecht des Patienten, der systolische und der diastolische Blutdruck, sowie die Herzfrequenz. Spezielle Parameter waren die Bulbusmotilität bzw. die Akinesie der extraokulären Augenmuskeln, die Anzahl der Nachinjektionen, das potentielle Auftreten unerwünschter Ereignisse, die Ptosis der Lider, die objektive und die subjektive Schmerzempfindung des Patienten, sowie die Beurteilung der Wirksamkeit und der Verträglichkeit des Medikaments durch den Patienten und den Operateur. Zwischen der Gruppe mit Hyaluronidase bzw. ohne Hyaluronidase (Kontrollgruppe) gab es bezüglich des Geschlechts und des Alters der Patienten keine Unterschiede. Auch hinsichtlich der Kreislaufparameter gab es keine Unterschiede. Der systolische und der diastolische Blutdruck stieg in beiden Gruppen vor der retrobulbären Injektion und vor dem Beginn der Operation geringfügig an. In der Gruppe mit Hyaluronidase wurde eine vollständige Akinesie und eine komplette Ptosis der Lider früher als in der Kontrollgruppe erreicht. Zu jedem Messpunkt, also 5 Minuten nach der Injektion bis zum Ende der Operation, hatten mehr Patienten aus der Gruppe mit Hyaluronidase eine vollständige Akinesie und eine komplette Ptosis, als Patienten der Kontrollgruppe. Bei 5 Patienten aus der Kontrollgruppe und bei keinem Patienten aus der Gruppe mit Hyaluronidase war eine Nachinjektion erforderlich. Neben den motorischen Parametern wurde durch den Zusatz von Hyaluronidase auch die Dauer bis zum Erreichen einer vollständigen Anästhesie verkürzt. Direkt nach der Operation und drei Stunden danach waren mehr Patienten aus der Gruppe mit Hyaluronidase schmerzfrei. Die Retrobulbäranästhesie mit Hyaluronidase wurde daher sowohl von den Patienten als auch vom Operateur zu diesen beiden Zeitpunkten wirksamer eingeschätzt als die Retrobulbäranästhesie ohne Hyaluronidase. Während der gesamten Studie traten keine unerwünschten Ereignisse auf. Die Verträglichkeit der Anästhesie wurde vom Patienten und vom Operateur nach der Operation in beiden Gruppen überwiegend positiv bewertet. Zusammenfassend lässt sich feststellen, dass die Retrobulbäranästhesie bei der Kataraktoperation durch den Zusatz der Hyaluronidase wirksamer ist. Die Akinesie der extraokulären Augenmuskeln und die Ptosis des Oberlides wird schneller und weitaus häufiger vollständig erreicht. Das Medikament ist sicher und ohne Nebenwirkungen

The construction problem for Hodge numbers modulo an integer in positive characteristic

Let k be an algebraically closed field of positive characteristic. For any integer 5 ≥ 2, we show that the Hodge numbers of a smooth projective k-variety can take on any combination of values modulo m, subject only to Serre duality. In particular, there are no non-trivial polynomial relations between the Hodge numbers

Comparison of Intravitreal Bevacizumab Upload Followed by a Dexamethasone Implant versus Dexamethasone Implant Monotherapy for Retinal Vein Occlusion with Macular Edema

Purpose: To compare the efficacy and safety of three intravitreal bevacizumab upload injections followed by a dexamethasone implant versus dexamethasone implant monotherapy in eyes with macular edema due to retinal vein occlusion. Methods: Sixty-four eyes of 64 patients were included in this prospective, consecutive, nonrandomized case series: group 1 consisted of 38 patients (22 with central retinal vein occlusion, CRVO, 16 with branch retinal vein occlusion, BRVO) treated using a dexamethasone implant (Ozurdex) alone; group 2 consisted of 26 patients (14 CRVO, 12 BRVO) treated with three consecutive intravitreal bevacizumab injections at monthly intervals followed by a dexamethasone implant. In case of recurrence, both cohorts received further dexamethasone implants. Preoperatively and monthly best corrected visual acuity (BCVA, ETDRS), central retinal thickness (Spectralis-OCT), intraocular pressure, and wide-angle fundus photodocumentation (Optomap) were performed. The primary clinical endpoint was BCVA at 6 months after initiation of therapy. Secondary endpoints were central retinal thickness and safety of the therapy applied. Results: In group 1, an increase in BCVA of 2.5 (+/- 1.6) letters in the CRVO and of 13.0 (+/- 3.2) letters in BRVO patients was seen after 6 months, in group 2 of 5.9 (+/- 0.4) letters (CRVO) and 3.8 (+/- 2.4) letters (BRVO), which was not statistically significant. When comparing the two treatment groups with respect to the type of vein occlusion, there was a significant advantage for BRVO patients for the dexamethasone implant monotherapy (BRVO patients in group 1, p = 0.005). Central retinal thickness showed a significant reduction after 6 months only in patients of group 1, both for CRVO (p = 0.01) and BRVO (p = 0.003). First recurrence after the first dexamethasone implant injection occurred after 3.8 months (mean) in CRVO and 3.5 months in BRVO patients (group 1), versus 3.2 and 3.7 months, respectively, in group 2. In group 1, 63.6% with CRVO and 50% with BRVO showed an increased intraocular pressure after treatment; in group 2, 57.1% with CRVO and 50.0% with BRVO, respectively. Conclusion: In CRVO, there was no difference between the two treatment strategies investigated. However, in BRVO, dexamethasone implant monotherapy was associated with better functional outcome. Copyright (C) 2012 S. Karger AG, Base

Phosphorus recovery from municipal and fertilizer wastewater: China's potential and perspective

Phosphorus (P) is a limited resource, which can neither be synthesized nor substituted in its essential functions as nutrient. Currently explored and economically feasible global reserves may be depleted within generations. China is the largest phosphate fertilizer producing and consuming country in the world. China's municipal wastewater contains up to 293,163 Mg year of phosphorus, which equals approximately 5.5% of the chemical fertilizer phosphorus consumed in China. Phosphorus in wastewater can be seen not only as a source of pollution to be reduced, but also as a limited resource to be recovered. Based upon existing phosphorus-recovery technologies and the current wastewater infrastructure in China, three options for phosphorus recovery from sewage sludge, sludge ash and the fertilizer industry were analyzed according to the specific conditions in China

An amino acid transporter involved in gastric acid secretion

Gastric acid secretion is regulated by a variety of stimuli, in particular histamine and acetyl choline. In addition, dietary factors such as the acute intake of a protein-rich diet and the subsequent increase in serum amino acids can stimulate gastric acid secretion only through partially characterized pathways. Recently, we described in mouse stomach parietal cells the expression of the system L heteromeric amino acid transporter comprised of the LAT2-4F2hc dimer. Here we address the potential role of the system L amino acid transporter in gastric acid secretion by parietal cells in freshly isolated rat gastric glands. RT-PCR, western blotting and immunohistochemistry confirmed the expression of 4F2-LAT2 amino acid transporters in rat parietal cells. In addition, mRNA was detected for the B0AT1, ASCT2, and ATB(0+) amino acid transporters. Intracellular pH measurements in parietal cells showed histamine-induced and omeprazole-sensitive H+-extrusion which was enhanced by about 50% in the presence of glutamine or cysteine (1mM), two substrates of system L amino acid transporters. BCH, a non-metabolizable substrate and a competitive inhibitor of system L amino acid transport, abolished the stimulation of acid secretion by glutamine or cysteine suggesting that this stimulation required the uptake of amino acids by system L. In the absence of histamine glutamine also stimulated H+-extrusion, whereas glutamate did not. Also, phenylalanine was effective in stimulating H+/K+-ATPase activity. Glutamine did not increase intracellular Ca2+ levels indicating that it did not act via the recently described amino acid modulated Ca2+-sensing receptor. These data suggest a novel role for heterodimeric amino acid transporters and may elucidate a pathway by which protein-rich diets stimulate gastric acid secretio

Climate change and cropland management compromise soil integrity and multifunctionality

Soils provide essential ecosystem functions that are threatened by climate change and intensified land use. We explore how climate and land use impact multiple soil function simultaneously, employing two datasets: (1) observational – 456 samples from the European Land Use/Land Cover Area Frame Survey; and (2) experimental – 80 samples from Germany’s Global Change Experimental Facility. We aim to investigate whether manipulative field experiment results align with observable climate, land use, and soil multifunctionality trends across Europe, measuring seven ecosystem functions to calculate soil multifunctionality. The observational data showed Europe-wide declines in soil multifunctionality under rising temperatures and dry conditions, worsened by cropland management. Our experimental data confirmed these relationships, suggesting that changes in climate will reduce soil multifunctionality across croplands and grasslands. Land use changes from grasslands to croplands threaten the integrity of soil systems, and enhancing soil multifunctionality in arable systems is key to maintain multifunctionality in a changing climate

Intermetallic Fe6Ge5Fe_{6} Ge_{5} formation and decay of a core–shell structure during the oxygen evolution reaction

Herein, we report on intermetallic iron germanide ($Fe_{6} Ge_{5}$) as a novel oxygen evolution reaction (OER) precatalyst with a Tafel slope of 32 mV $dec^{−1}$ and an overpotential of 272 mV at 100 mA $cm^{−2}$ in alkaline media. Furthermore, we uncover the in situ formation of a core–shell like structure that slowly collapses under OER conditions

Competitiveness and the export performance of the euro area

Chapter 1 provides an overview and assessment of the price competitiveness and export performance of the euro area and the larger euro area countries, as well as an evaluation of how standard equations have been able to explain actual export developments. Chapter 2 carries out a constant market share analysis for the euro area and thereby sheds light on the reasons for movements in aggregate export market shares by looking at the sectoral and geographical composition of euro area exports. Chapter 3 looks at the evolution of the technological competitiveness of the euro area and major competitors – proxied by patenting activity and R&D expenditure – and analyses some structural indicators of competitiveness using survey data. Chapter 4 then looks at the impact of FDI on competitiveness and export performance. Finally, Chapter 5 summarises the main findings of the report, but also critically evaluates their importance and implications.

Pilot testing methodologies, models, scenarios and validation approach

This report describes the pilot tests that will be carried out within GARPUR. The pilot tests aim at assessing and validating, as closely as possible to real-life conditions, the new Reliability Management Approach and Criteria (RMACs) developed in work package 2 and the socio-economic impact assessment framework developed in work package 3, while considering the methodologies and approaches for practical implementation in work packages 4, 5 and 6. The proposed RMACs are compared against the current N-1 practices and approaches determined in work package 1. In addition, some pilot tests will make use of the GARPUR Quantification Platform (GQP) that has been developed by work package 7. A total of eight pilot tests are proposed by five different transmission system operators (TSOs) and given different priority levels for implementation. Three pilot tests make use of the GQP. The five other pilot tests will be implemented at TSOs’ premises in near real-life context. The pilot tests cover real-time operations, short-term operation planning and long-term system development. Different indicators are proposed to assess the proposed reliability management approach and criteria and compare them with current practices. The diversity of the pilot tests in terms of time horizons and the number of involved TSOs demonstrate the general nature of the reliability management approach and criteria proposed within GARPUR