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Patient Characteristics, Safety, and Tolerability With Telaprevir Treatment for HCV in the Clinic:a Retrospective, Multicenter Study

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journal of Clinical and Translational Hepatology 2014年第2期2卷 65-73页

作者： Steven L. Flamm paul.j. pockros Leif Bengtsson Mark Friedman Northwestern University Feinberg School of Medicine Chicago Illinois USA Scripps Clinic and Scripps Translational Science Institute La Jolla California USA Vertex Pharmaceuticals Incorporated Boston Massachusetts USA

Background and Aims: There is a paucity of information regarding similarities and differences between patients from the phase 3 studies of telaprevir and those receiving telaprevir in clinical practice. Methods: This retrospective chart review evaluated baseline characteristics and follow-up safety and tolerability data for patients with hepatitis C virus (HCV) infection treated with telaprevir and peginterferon alfa and ribavirin (PR) in clinical practice. Results: In total, 338 charts from patients at four academic and three community US treatment centers who received telaprevir and PR and had at least 12 weeks of follow-up data were included;62%were from academic centers and 38% were from community centers. Of the 338 patients, 269 completed 12 weeks of telaprevir and PR;32 discontinued due to adverse events. Mean age was 55 years;patients were predominantly white (79.3%) males (58.9%) with genotype 1a HCV infection (61.8%);35.5%were reported to have cirrhosis at baseline;and 55.3%previously received PR. Hypertension and depres-sion were the most common comorbidities. Patient charac-teristics outside the per-protocol minimum criteria used in the phase 3 studies of telaprevir were, e.g., hemoglobin, 9.2%;albumin, 5.3%;platelets, 11.5%;and neutrophil count, 5.6%. Adverse events occurred in 329/338 (97.3%) patients, with anemia, fatigue, nausea, and rash being the most common. Of 38 hospitalizations, 26 were deemed related to telaprevir and PR. Three patients died due to pneumonia, septic shock, and hepatorenal syndrome (n=1 each). Conclusions: These findings complement those reported from rigorous, randomized controlled studies with telaprevir-based treatment and provide a general assess-ment of similarities and/or differences between patients from the phase 3 studies of telaprevir and those treated with telaprevir in clinical practice.

关键词： Hepatitis C virus Combination drug therapy Protease inhibitors Liver diseases

Comparison of esophageal capsule endoscopy and esophagogastroduodenoscopy for diagnosis of esophageal varices

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World journal of Gastroenterology 2008年第28期14卷 4480-4485页

作者： Catherine T Frenette john G Kuldau Donald j Hillebrand jill Lane paul.j.pockros Division of Gastroenterology and Hepatology Scripps ClinicLa JollaCaliforniaSan Francisco 94115United States

AIM： To investigate the utility of esophageal capsule endoscopy in the diagnosis and grading of esophageal varices. METHODS： Cirrhotic patients who were undergoing esophagogastroduodenoscopy （EGD） for variceal screening or surveillance underwent capsule endoscopy. Two separate blinded investigators read each capsule endoscopy for the following results： variceal grade, need for treatment with variceal banding or prophylaxis with beta-blocker therapy, degree of portal hypertensive gastropathy, and gastric varices. RESULTS： Fifty patients underwent both capsule and EGD. Forty-eight patients had both procedures on the same day, and 2 patients had capsule endoscopy within 72 h of EGD. The accuracy of capsule endoscopy to decide on the need for prophylaxis was 74%, with sensitivity of 63% and specificity of 82%. Interrater agreement was moderate （kappa = 0.56）. Agreement between EGD and capsule endoscopy on grade of varices was 0.53 （moderate）. Inter-rater reliability was good （kappa = 0.77）. In diagnosis of portal hypertensive gastropathy, accuracy was 57%, with sensitivity of 96% and specificity of 17%. Two patients had gastric varices seen on EGD, one of which was seen on capsule endoscopy. There were no complications from capsule endoscopy.CONCLUSION： We conclude that capsule endoscopy has a limited role in deciding which patients would benefit from EGD with banding or beta-blocker therapy. More data is needed to assess accuracy for staging esophageal varices, PHG, and the detection of gastric varices.

关键词： Esophageal varices Capsule endoscopy Portal hypertension

Pulmonary complications of transcatheter arterial chemoembolization for hepatocellular carcinoma

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World journal of Respirology 2016年第3期6卷 69-75页

作者： Quan M Nhu Harry Knowles paul.j.pockros Catherine T Frenette Department of Medicine Scripps Clinic-Scripps Green Hospital Scripps Translational Science Institute Division of Interventional Radiology Scripps Clinic-Scripps Green Hospital Division of Gastroenterology/Hepatology Scripps Clinic-Scripps Green Hospital Scripps Center for Organ Transplantation Scripps Clinic-Scripps Green Hospital

Transcatheter arterial chemoembolization(TACE) is an effective palliative intervention that is widely accepted for the management of hepatocellular carcinoma(HCC). Post-TACE pulmonary complications resulting in acute lung injury(ALI) or acute respiratory distress syndrome(ARDS) are rare events. Pulmonary complications after TACE are thought to be related to chemical injury subsequent to the migration of the infused ethiodized oil or chemotherapeutic agent to the lung vasculature, facilitated by arteriovenous(AV) shunts within the hyper-vascular HCC. We review herein the literature on pulmonary complications related to TACE for HCC. Post-TACE pulmonary complications have included pulmonary oil embolism, interstitial pneumonitis, chemical pneumonitis, ALI, ARDS, lipoid pneumonia, acute eosinophilic and neutrophilic pneumonia, bilious pleuritis, pulmonary abscess, pulmonary tumor embolism, and possibly pulmonary metastasis with HCC. The risk factors associated with post-TACE pulmonary complications identified in the literature include large hyper-vascular HCC with AV shunts, large-volume Lipiodol infusion, and embolization via the right inferior phrenic artery. However, the absence of known risk factors is not a guarantee against serious complications. An astute awareness of the potential post-TACE pulmonary complications should expedite appropriate therapeutic interventions and increase potential for early recovery.

关键词： Transcatheter arterial chemoembolization Liver cirrhosis Pulmonary complications Hepatocellular carcinoma Acute lung injury Acute respiratory distress syndrome Pneumonitis Pulmonary oil embolism

A functional tacrolimus-releasing nerve wrap for enhancing nerve regeneration following surgical nerve repair

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Neural Regeneration Research 2025年第1期20卷 291-304页

作者： Simeon C.Daeschler Katelyn j.W.So Konstantin Feinberg Marina Manoraj jenny Cheung jennifer Zhang Kaveh Mirmoeini jpaul Santerre Tessa Gordon Gregory HBorschel SickKids Research Institute Neuroscience and Mental Health ProgramTorontoONCanada Institute of Biomaterials and Biomedical Engineering University of TorontoTorontoONCanada Indiana University School of Medicine IndianapolisINUSA Division of Plastic and Reconstructive Surgery the Hospital for Sick ChildrenTorontoONCanada Translational Biology and Engineering Program Ted Rogers Centre for Heart ResearchInstitute of Biomedical EngineeringFaculty of DentistryUniversity of TorontoTorontoONCanada

Axonal regeneration following surgical nerve repair is slow and often incomplete,resulting in poor functional recovery which sometimes contributes to lifelong ***,there are no FDA-approved therapies available to promote nerve *** accelerates axonal regeneration,but systemic side effects presently outweigh its potential benefits for peripheral nerve *** authors describe herein a biodegradable polyurethane-based drug delivery system for the sustained local release of tacrolimus at the nerve repair site,with suitable properties for scalable production and clinical application,aiming to promote nerve regeneration and functional recovery with minimal systemic drug *** is encapsulated into co-axially electrospun polycarbonate-urethane nanofibers to generate an implantable nerve wrap that releases therapeutic doses of bioactive tacrolimus over 31 *** and drug loading are adjustable for applications in small and large caliber nerves,and the wrap degrades within 120 days into biocompatible *** released from the nerve wrap promotes axon elongation in vitro and accelerates nerve regeneration and functional recovery in preclinical nerve repair models while off-target systemic drug exposure is reduced by 80%compared with systemic *** its surgical suitability and preclinical efficacy and safety,this system may provide a readily translatable approach to support axonal regeneration and recovery in patients undergoing nerve surgery.

关键词： biodegradable local drug delivery nerve injury nerve regeneration nerve wrap tacrolimus

The Bemisia tabaci Species Complex:Questions to Guide Future Research

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journal of Integrative Agriculture 2012年第2期11卷 187-196页

作者： paul.j.De Barro CSIRO Ecosystem Sciences Brisbane QLD 4001Australia

Since 2007 we have began to consider the relationships between the different members of the Bemisia tabaci species complex in a more structured and systematic *** of these relationships has been infered from considerations of a portion of the mitochondrial cytochrome oxidase one（mtCOI）*** this is a quite limited approach which would benefit from the consideration of a much greater diversity of genetic material,it is the only publically available data that spans the diversity of the species *** the limitations,the phylogenetic reconstruction that can be derived from this data is useful and can be used as a basis to frame questions and construct testable hypotheses that will form the basis for future *** study uses the largest available mtCOI dataset,consisting of 383 unique mtCOI haplotypes that spans the full diversity of the *** species complex as we currently know it,to make a range of observations which are then used to develop questions as guide for future research.

关键词： mitochondrial cytochrome oxidase one phylogenetic analysis

The rise of 3D cellular spheroids: efficient culture via upward growth from a superamphiphobic surface

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National Science Review 2019年第6期6卷 1068-1069页

作者： paul.j.Dyson Institut des Sciences et Ingénierie Chimiques Ecole Polytechnique Fédérale de Lausanne

Cell culture assays are extensively used in drug discovery and development programs, biomedical research, and in many others areas of science. Currently,2D monolayer cellular assays serve as the gold standard. However, while they provide seemingly indispensable information on drug activity, it is estimated that of the putative drug candidates selected

关键词： The rise of 3D cellular spheroids efficient culture via upward growth from a superamphiphobic surface

Reconstituting mammalian spermatogenesis using stem ：ells

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Asian journal of Andrology 2011年第6期13卷 795-796页

作者： paul.j.Turek The Turek Clinic San Francisco CA 94133 USA

While stock markets and economies are smoldering all over the world, stem cell science is on fire. The promise of curing many untreatable forms of human male infertility is now one small step closer based on a recent paper in Cell. In this work, scientists from Kyoto University in japan created mature, fertile sperm from embryonic and induced pluripotent stem cells by grabbing the primitive germ cells called primordial germ cells just as they were being made from their pluripotent precursors in vitro and transplanting them back into genetically sterile mice.

关键词： Biological sciences Cell biology Microbiology

Hyperbolic Divergence Cleaning in Lattice Boltzmann Magnetohydrodynamics

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Communications in Computational Physics 2023年第1期33卷 245-272页

作者： paul.j.Dellar OCIAM Mathematical InstituteUniversity of OxfordRadcliffe Observatory QuarterOxford OX26GGUK

Magnetohydrodynamics couples the Navier-Stokes and Maxwell’s equations to describe the flow of electrically conducting fluids in magnetic ***’s equations require the divergence of the magnetic field to vanish,but this condition is typically not preserved exactly by numerical *** can develop artifacts because structural properties of the magnetohydrodynamic equations then fail to *** with hyperbolic divergence cleaning permits a nonzero divergence that evolves under a telegraph equation,designed to both damp the divergence,and propagate it away from any sources,such as poorly resolved regions with large spatial gradients,without significantly increasing the computational *** show that existing lattice Boltzmann algorithms for magnetohydrodynamics already incorporate hyperbolic divergence cleaning,though they typically use parameter values for which it reduces to parabolic divergence cleaning under a slowly-varying *** recover hyperbolic divergence cleaning by adjusting the relaxation rate for the trace of the tensor that represents the electric field,and absorb the contribution from the symmetric-traceless part of this tensor using a change of *** experiments confirm that the qualitative behaviour changes from parabolic to hyperbolic when the relaxation time for the trace of the electric field tensor is increased.

关键词： Magnetohydrodynamics divergence cleaning telegraph equations matrix collision operators linear viscoelasticity

Evolving landscape and novel treatments in, metastatic castrate-resistant prostate cancer

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Asian journal of Andrology 2013年第3期15卷 342-349页

作者： paul.j.Toren Martin E Gleave Department of Urologic Sciences Faculty of Medicine University of British Columbia Vancouver BC V5Z 1M9 Canada

Treatment options for castrate-resistant prostate cancer （CRPC） have advanced in recent years and significantly improved the Outlook for patients with this aggressive and lethal disease. Further understanding of the biology＇of CRPC has led to several new targeted therapies and continues to emphasize the importance of androgen receptor （AR） directed therapy. The treatment landscape is rapidly changing and further biologically rationale, biomarker-based ongoing clinical trials are needed. We review the recent results of major clinical trials in CRPC. New and investigational agents now in clinical evaluation are reviewed including inhibitors of angiogenesis, microtubules, chaperones, AR and intracellular kinases, as well as immunotherapy, radiopharmaceuticals and bone-targeted agents. The recent improvement in prognosis for CRPC brings continued optimism for further improvements. Thoughtful planning of clinical trials and further understanding of the mechanisms of resistance to therapies will allow for continued progress in patient care.

关键词： prostate cancer treatment resistance androgen receptor antagonists molecular targets