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Safety of a 13-Valent Pneumococcal Conjugate Vaccine in Elderly Adults Previously Immunized with a 23-Valent Pneumococcal Polysaccharide Vaccine: An Open-Label Trial

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World Journal of Vaccines 2013年第4期3卷 123-129页

作者： Tino F. Schwarz Karlis Pauksens Christine Juergens Deepthi Jayawardene Daniel A. Scott William C. Gruber Beate Schmoele-Thoma Central Laboratory and Vaccination Centre Stiftung Juliusspital Würzburg Germany Department of Medical Sciences Section of Infectious Diseases Uppsala University Akademiska Sjukhuset Uppsala Sweden pfizer Inc. Collegeville USA pfizer pharma gmbh Berlin Germany pfizer Vaccine Research Pfizer Pearl River USA

An open-label, multicenter study was conducted to describe the safety of the 13-valent pneumococcal conjugate vaccine (PCV13) in 1049 individuals aged ≥68 years, who had previously been immunized with the unconjugated 23-valent pneumococcal polysaccharide vaccine (PPSV23). In addition, the safety profile of PCV13 in this study was compared, in a post-hoc descriptive analysis, to that observed in other elderly populations, who had received PCV13 or PPSV23 as part of other completed studies. Local (56.6%) and systemic reactions (58.4%) were very common, but were mainly mild, and of short duration (mean: 1.3 - 4.6 days). There were no related serious adverse events (AEs) within 1 month after PCV13. 123 days after PCV13 and 94 days after a nonstudy influenza vaccine, a case of transient Guillain-Barré syndrome occurred, which the investigator assessed as possibly related to the vaccination. Reactogenicity observed in this study population was generally similar to that of other elderly study populations with PPSV23-preimmunized adults, and with PPSV23-naive adults. Reactogenicity was less common in this study than that observed in PPSV23-preimmunized adults who were revaccinated with PPSV23 rather than a subsequent dose of PCV13. There were no related serious AEs reported after PCV13 and PPSV23 in these comparator studies. Conclusion: PCV13 may be administered safely to older adults previously immunized with PPSV23. (ClinicalTrials. gov Identifier: NCT00500266)

关键词： 13-Valent Pneumococcal Conjugate Vaccine 23-Valent Pneumococcal Polysaccharide Vaccine Streptococcus pneumoniae Reactogenicity Safety

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Bcl-x_L and Myeloid cell leukaemia-1 contribute to apoptosis resistance of colorectal cancer cells

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World Journal of Gastroenterology 2008年第24期14卷 3829-3840页

作者： Henning Schulze-Bergkamen Roland Ehrenberg Lothar Hickmann Binje Vick Toni Urbanik Christoph C Schimanski Martin R Berger Arno Schad Achim Weber Steffen Heeger Peter R Galle Markus Moehler First Department of Medicine Johannes-Gutenberg-University Mainz German Cancer Research Center Institute of Pathology University of Mainz Department of Pathology Institute of Surgical PathologyUniversity Hospital Merck pharma gmbh

AIM： TO explore the role of Bcl-XL and Myeloid cell leukaemia （Mcl）-I for the apoptosis resistance of colorectal carcinoma （CRC） cells towards current treatment modalities. METHODS： Bcl-XL and Mcl-1 mRNA and protein expression were analyzed in CRC cell lines as well as human CRC tissue by Western blot, quantitative PCRand immunohistochemistry. Bcl-XL and Mcl-1 protein expression was knocked down or increased in CRC cell lines by applying specific siRNAs or expression plasmids, respectively. After modulation of protein expression, CRC cells were treated with chemotherapeutic agents, an antagonistic epidermal growth factor receptor （EGFR1） antibody, an EGFR1 tyrosine kinase inhibitor, or with the death receptor ligand TRAIL. Apoptosis induction and cell viability were analyzed. RESULTS： Here we show that in human CRC tissue and various CRC cell lines both Bcl-xL and Mcl-1 are expressed. Bcl-xL expression was higher in CRC tissue than in surrounding non-malignant tissue, both on protein and mRNA level. Mcl-1 mRNA expression was significantly lower in malignant tissues. However, protein expression was slightly higher. Viability rates of CRC cells were significantly decreased after knock down of Bcl-xL expression, and, to a lower extent, after knock down of Mcl-1 expression. Furthermore, cells with reduced Bcl-xL or Mcl-1 expression was more sensitive towards oxaliplatinand irinotecan-induced apoptosis, and in the case of Bcl-xL also towards 5-FU-induced apoptosis. On the other hand, upregulation of Bcl-xL by transfection of an expression plasmid decreased chemotherapeutic drug-induced apoptosis. EGF treatment clearly induced Bcl-xL and Mcl-1 expression in CRC cells. Apoptosis induction upon EGFR1 blockage by cetuximab or PD168393 was increased by inhibiting Mcl-1 and Bcl-xL expression. More strikingly, CD95- and TRAIL-induced apoptosis was increased by Bcl-xL knock down. CONCLUSION： Our data suggest that Bcl-xL and, to a lower extent, Mcl-1, are important anti-apoptotic

关键词： Colorectal carcinoma Bcl-XL Myeloid cellleukaemia-1 Epidermal growth factor receptor 1 Apoptosis 5-fluorouracil Irinotecan Oxaliplatin

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Polyphenol-Rich Olive Mill Wastewater Extract and Its Potential Use in Hair Care Products

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Journal of Cosmetics, Dermatological Sciences and Applications 2021年第4期11卷 356-370页

作者： Lisa-Marie Sittek Thomas M. Schmidts Peggy Schlupp RSC pharma gmbh & Co. KG Giessen Germany

In this work, the influence of phenol-enriched olive mill wastewater (OMWW) extract on hair growth was investigated in vitro on human follicle dermal papilla cells. OMWW has already shown great potential for use in skincare products, and its high polyphenol content is predestined to have a positive effect on hair growth. The studies included caffeine, a positive modulator of hair growth, and dihydrotestosterone, which causes hair loss in vivo, as controls. The impact of the investigated compounds on hair growth was evaluated by studies on cell viability and proliferation, the release of growth factors (insulin-like growth factor-1 and vascular endothelial growth factor), and the reduction of reactive oxygen species formation. OMWW showed a positive influence on the proliferation of the human follicle dermal papilla cells. Moreover, the extract leads to a significantly increased secretion of insulin-like growth factor-1, and a considerable reduction in reactive oxygen species formation was observed. Overall, our results show that the investigated phenol-enriched OMWW extract is a promising ingredient for hair care to improve hair growth, prevent hair loss due to oxidative stress and maintain a healthy scalp.

关键词： Hair Growth Hair Loss Human Follicle Dermal Papilla Cells Caffeine Dihydrotestosterone IGF-1 VEGF Reactive Oxygen Species

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Impact of human sequences in variable domains of therapeutic antibodies on the location of CD4 T-cell epitopes

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Cellular & Molecular Immunology 2020年第6期17卷 656-658页

作者： Sylvain Meunier Moustafa Hamze Anette Karle Marie de Bourayne Abdelaziz Gdoura Sebastian Spindeldreher Bernard Maillère CEA-Saclay Institut Frederic JoliotSIMOPROUniversitéParis-Saclay91191 Gif sur YvetteFrance Novartis pharma AG BaselSwitzerland Present address:Integrated Biologix gmbh BaselSwitzerland

The clinical efficacy of therapeutic antibodies is recognized in many indications,explaining their rapid rise in the worldwide drug ***,therapeutic antibodies can be immunogenic by inducing a specific immune response characterized by the production of anti-drug antibodies(ADAs).ADAs can potentially increase the clearance of therapeutic antibodies,decrease their therapeutic effects1 and induce hypersensitivity *** humans are thought to be tolerant to their own proteins,sequences of the therapeutic antibodies have been humanized or human antibodies have been directly generated by technologies using human ***,human(ized)antibodies exhibit highly variable levels of immunogenicity,1,2 illustrating the poor understanding of the role of sequence humanization in mitigating the immunogenicity of therapeutic *** lines of evidence highlight the role of CD4 T lymphocytes during the initiation of an ADA response,3 but few T-cell epitopes of marketed therapeutic antibodies have been described to date.

关键词： therapeutic antibodies clinical

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Adjuvant effects of different TLR agonists on the induction of allergen-specific Th2 responses

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Open Journal of Immunology 2012年第1期2卷 17-24页

作者： Matthias J. Duechs James E. Brunt Florian Gantner Klaus J. Erb Respiratory Diseases Research Boehringer Ingelheim Pharma GmbH & Co. KG Biberach an der Riss Germany

Currently different Toll-like receptor (TLR) agonists are tested in humans for their ability to enhance the efficacy of specific immunotherapy (SIT). Recent clinical data suggest that this may be achieved by increasing allergen-specific Th1 responses. However, it is not clear which TLR agonist is best suited to be used in combination with SIT. We tested the ability of five TLR agonists, LTA, poly(I:C), LPS, R848, and CpG-ODN, activating TLR2, 3, 4, 7, and 9, to induce allergen-specific Th1 and suppress allergen-specific Th2 responses in a preclinical setting. Mice were immunized by intraperitoneal injection of ovalbumin (OVA)/Al(OH)3 together with different doses (0.0025, 0.025, 0.25, and 2.5 mg/kg) of agonists followed by two OVA aerosol challenges. The results of these experiments showed, that the suppression of allergen-specific Th2 responses and the induction of Th1 responses dependedon the dose and the agonists used. All TLR agonists increased allergen-specific IgG2a, and with the exception of poly(I:C), reduced allergen-specific IgE levels in the serum. Allergic cutaneous anaphylaxis was also suppressed in mice when LPS or CpG was given together with OVA/alum. The strongest Th1 responses were induced by CpG and poly(I:C), characterized by the presence of IFN-g in the BAL and the highest OVA-specific IgG2a levels in the serum. This study suggests that the TLR9 agonist CpG-ODN and TLR4 agonist LPS have the strongest suppressive effects on the development of aller-gen-specific Th2 responses in mice and CpG-ODN induces the strongest allergen-specific Th1 responses. Therefore these two TLR agonists may be good candidates to combine with allergen in novel SIT formulations in humans.

关键词： Asthma TLR-Agonists Innate-Inflammation Inhibition

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The many faces of cGAS:how cGAS activation is controlled in the cytosol,the nucleus,and during mitosis

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Signal Transduction and Targeted Therapy 2021年第8期6卷 2261-2263页

作者： Anna-Maria Herzner Martin Schlee Eva Bartok Department of Cancer Immunology and Immune Modulation Boehringer Ingelheim Pharma GmbH&Co.KGBiberach an der RiBGermany lnstitute of Clinical Chemistry and Clinical pharmacology University HospitalUniversity of BonnBonnGermany Unit of Experimental Immunology Department of Biomedical SciencesInstitute of Tropical MedicineAntwerpBelgium

In their recently published study in Science,Li et al.1 unravel how hyperphosphorylation and chromatin-tethering of the double-stranded(dsDNA)sensor cGAMP synthase(cGAS)prevent self DNA recognition during mitosis(Fig.1);providing important insight into how this innate immune sensor balances its essential function for pathogen defense against potential autoinflammation.

关键词： activation sensor insight

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Predictors of premature delivery in patients with intrahepatic cholestasis of pregnancy

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World Journal of Gastroenterology 2007年第46期13卷 6226-6230页

作者： Jurate Kondrackiene Ulrich Beuers Rimantas Zalinkevicius Horst-Dietmar Tauschel Vladas Gintautas Limas Kupcinskas Department of Gastroenterology Kaunas University of MedicineKaunasLithuania Department of Gastroenterology and Hepatology Academic Medical CenterUniversity of AmsterdamAmsterdamThe Netherlands Institute of Endocrinology Kaunas University of MedicineKaunasLithuania Dr.Falk pharma gmbh FreiburgGermany Department of Obstetrics and Gynecology Kaunas University of MedicineKaunasLithuania

AIM： To evaluate the predictive value of clinical symptoms and biochemical parameters for prematurity in intrahepatic cholestasis of pregnancy （ICP）. METHODS： Sixty symptomatic patients with ICP were included in this retrospective analysis. Preterm delivery was defined as delivery before 37 wk gestation. Predictors of preterm delivery were disclosed by binary multivariate logistic regression analysis. RESULTS： Mean time of delivery was 38.1 ± 1.7 wk. No stillbirths occurred. Premature delivery was observed in eight （13.3%） patients. Total fasting serum bile acids were higher （47.8 ±15.2 vs 41.0 ± 10.0 μmol/L, P 〈 0.05）, and pruritus tended to start earlier （29.0 ± 3.9 vs 31.6 ± 3.3 wk, P = 0.057） in patients with premature delivery when compared to those with term delivery. Binary multivariate logistic regression analysis revealed that early onset of pruritus （OR 1.70, 95% CI 1.23-2.95, P = 0.038） and serum bile acid （OR 2.13, 95% CI 1.13-3.25, P = 0.013） were independent predictors of preterm delivery. CONCLUSION： Early onset of pruritus and high levels of serum bile acids predict preterm delivery in ICP, and define a subgroup of patients at risk for poor neonatal outcome.

关键词： Intrahepatic cholestasis Delivery Pregnancy

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pharmacokinetics of Micafungin in Adult Patients with Invasive Candidiasis and Candidemia

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Open Journal of Medical Microbiology 2012年第3期2卷 84-90页

作者： Nasrullah A. Undre Paul Stevenson Ernst-Rüdiger Kuse Ignace Demeyer Astellas pharma Europe Ltd. Staines-upon-Thames UK Formerly of Astellas pharma gmbh Munich Munich Germany Medizinische Hochschule Hannover Hannover Germany Onze Lieve Vrouw Ziekenhuis Aalst Belgium

Micafungin is an efficacious and well-tolerated echinocandin with in vitro and in vivo activity against a broad range of Candida species. The objective of this randomized, double-blind study was to examine the pharmacokinetic parameters of micafungin and its metabolites in a subset of adult patients with invasive candidiasis or candidemia. The study was conducted at 27 sites in four countries, including eight in Europe. Micafungin 100 mg/day or liposomal amphotericin B 3 mg/kg/day were administered once daily as a 1-hour infusion in a blinded manner. The minimum duration of therapy was 14 days. To define plasma analyte (micafungin and metabolites) concentration-time profiles, serial blood samples were collected after the first dose (Day 1), and at the end of therapy (EOT). For patients who received treatment for longer than 2 weeks, an additional profile was obtained during Week 2. To determine plasma trough analyte concentrations, blood samples were collected immediately prior to dosing on Day 2, Week 2, and EOT. In 20 evaluable, micafungin-treated patients, plasma micafungin concentrations peaked at completion of the 1-hour infusion and then declined biexponentially. Plasma concentrations of the micafungin metabolites (M-1, M-2, and M-5) remained low (pharmacokinetics in adult patients with invasive candidiasis and candidemia.

关键词： Micafungin pharmacokinetics Invasive Candidiasis Candidemia

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Uromedic^(■) Pumpkin Seed Derived Δ7-Sterols, Extract and Oil Inhibit 5α-Reductases and Bind to Androgen Receptor in Vitro

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pharmacology & pharmacy 2018年第6期9卷 193-207页

作者： Stefan Heim Stephanie Seibt Heike Stier Margret I More Omega pharma Manufacturing gmbh&Co.KG Benzstr.25HerrenbergGermany analyze & realize gmbh Department of Consulting and Strategic InnovationWaldseeweg 6BerlinGermany

Dihydrotestosterone (DHT) is implicated in the development of benign prostate hyperplasia (BPH). We investigated if Uromedic? pumpkin (variety of Cucurbita pepo L. convar. citrullinina GREB. var. styriaca GREB) seed soft extract (active ingredients of GRANUFINK? Prosta forte 500 mg), seed oil and isolated Δ7-sterols could inhibit the conversion of [1,2,6,7-3H(N)]-testosterone to DHT by 5α-reductases. Also, we tested competition with [3H]-DHT for binding to the androgen receptor (AR). Pumpkin seed oil and pumpkin seed soft extract were identified as moderately active inhibitors of 5α-R1 and 5α-R2, with almost similar inhibitory capacities (IC50 5 mg/ml for 5α-R1 and about IC50 = 6 mg/ml for 5α-R2). The isolated Δ7-sterols were more active inhibitors (IC50 = 0.3 mg/ml for 5α-R1, IC50 = 1.0 mg/ml for 5α-R2). All three test compounds bound to the AR dose-dependently, with strong binding by Δ7-sterols (IC50 = 0.2 mg/ml) and weaker binding by pumpkin seed oil (IC50 = 0.4 mg/ml) and pumpkin seed soft extract (IC50 = 1.1 mg/ml). We propose that inhibition of 5α-reductases and competitive binding to the AR are mechanisms of action, by which the Uromedic? pumpkin seed derived test compounds, most specifically Δ7-sterols, counteract DHT and thereby exert clinically positive effects on the prostate, as well as bladder-strengthening effects.

关键词： 5-Alpha-Reductases 5α-R1 and 5α-R2 Androgen Receptor Dihydrotestosterone Uromedic? Pumpkin Seed Oil and Soft Extract (Delta-7) Δ7-Sterols

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Prevalence of Wild-Type Butyrylcholinesterase Genotype in Patients with Alzheimer’s Dementia

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World Journal of Neuroscience 2015年第3期5卷 175-179页

作者： Beate Mueller Georg Adler Novartis pharma gmbh Nürnberg Germany Institut für Studien zur Psychischen Gesundheit Mannheim Germany

Approximately, two-thirds patients with Alzheimer’s disease (AD) are reported to have homozygous wild-type butyrylcholinesterase (BuChE) gene expression. It is associated with a higher rate of hydrolysis of acetylcholine, which ultimately leads to increase in the levels of BuChE in advanced stages of the disease. Rivastigmine, a dual inhibitor of acetylcholinesterase (AChE) and BuChE, might be of additional benefit in patients with AD with wild-type BuChE allele.

关键词： Butyrylcholinesterase Alzheimer’s Disease Genotype

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