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这项临床试验完成注册了吗?——国际医学杂志编辑委员会声明

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中国循证医学杂志 2006年第4期6卷 310-312页

作者： catherine De Angelis Jeffrey M. Drazen Frank A. Frizelle Charlotte Haug John Hoey Richard Horton Sheldon Kotzin Christine Laine Ana Marusic A. John P.M. Ov.rbeke Torben v.Schroeder Harold C. Sox Martin B. v.n Der Weyden 刁骧（译）孙丁（审校）秦莉（审校）《美国医学会杂志》主编《新英格兰医学杂志》主编《新西兰医学杂志》编辑《挪威医学杂志》主编《加拿大医学会杂志》编辑《柳叶刀杂志》编辑美国国立医学图书馆《内科学年鉴》副编审《克罗地亚医学杂志》编辑《荷兰医学杂志》执行编辑《丹麦医学会杂志》编辑《内科学年鉴》编辑《澳大利亚医学杂志》编辑不详

2004年9月，国际医学杂志编辑委员会（ICMJE）成员联合发表述评，旨在推动所有临床试验进行注册。我们声明，只有当某项试验在征集首位患者之前就进行了注册，才会考虑发表其研究结果。该政策适用于在2005年7月1日及以后开始征募患者的... 详细信息

2004年9月，国际医学杂志编辑委员会（ICMJE）成员联合发表述评，旨在推动所有临床试验进行注册。我们声明，只有当某项试验在征集首位患者之前就进行了注册，才会考虑发表其研究结果。该政策适用于在2005年7月1日及以后开始征募患者的试验。由于许多目前正在进行中的试验开始时都没有注册，对于这些试验我们将注册截止时间延长到2005年9月13日以前。我们当前和今后的目标是推动建立一个全面的、公众可及的临床试验数据库。对于那些承受风险参与临床试验的众多志愿者来说，完全注册是一种恰当的回报方式。他们有权知道通过他们的无私奉献换来的研究信息是否成为可能指导患者诊疗决策的公共记录的一部分；也有权知道对他们的诊疗决策是基于所有的试验证据，而非仅依据作者决定报道的和杂志编辑决定发表的部分试验。

关键词：临床试验数据库编辑委员会医学杂志国际诊疗决策时间延长无私奉献志愿者

生物制剂治疗银屑病患者出现严重感染的风险评估:一项系统性回顾与荟萃分析

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皮肤性病诊疗学杂志 2017年第3期24卷 224-224页

作者： Yiu ZZ Exton LS Jabbar-Lopez Z Mohd Mustapa MF Samarasekera EJ Burden AD Murphy R Owen CM Parslew R v.nning v.Ashcroft DM Griffiths CE Smith CH Warren RB 薛如君张锡宝 Dermatology Centre Salford Royal NHS Foundation Trust The University of Manchester Manchester Academic Health Science Centre Manchester UK Centre for Pharmacoepidemiology and Drug Safety Manchester Pharmacy School The University of Manchester Manchester UK. British Association of Dermatologists London UK. Department of Dermatology Royal Victoria Infirmary Newcastle upon Tyne Hospitals NHS Foundation Trust Newcastle UK. National Clinical Guideline Centre Royal College of Physicians of London London UK. Department of Dermatology Western Infirmary Glasgow UK. Sheffield Univ.rsity Teaching Hospitals and Sheffield Children's Hospitals Sheffield UK. Department of Dermatology East Lancashire Hospitals NHS Trust Royal Blackburn Hospital Blackburn Lancashire UK. Department of Dermatology Royal Liverpool and Broadgreen University Hospitals Trust Liverpool UK. Department of Dermatology Oxford University Hospitals Foundation Trust Oxford UK. Centre for Pharmacoepidemiology and Drug Safety Manchester Pharmacy School The University of Manchester Manchester UK. Dermatology Centre Salford Royal NHS Foundation Trust The University of Manchester Manchester Academic Health Science Centre Manchester UK. St John's Institute of Dermatology Guy's and St. Thomas' NHS Foundation Trust London UK. Electronic address: catherine.smith@kcl.ac.uk. Dermatology Centre Salford Royal NHS Foundation Trust The University of Manchester Manchester Academic Health Science Centre Manchester UK. Electronic address: richard.warren@manchester.ac.uk.

肿瘤坏死因子抑制剂英夫利昔单抗、依那西普和阿达木单抗是目前用于治疗银屑病常用的3种生物制剂，新药优特克单抗是IL-12和IL-23拮抗剂，苏金单抗是IL-17受体拮抗剂。生物制剂通过抑制细胞因子，调控银屑病患者紊乱的免疫系统，从而发... 详细信息

肿瘤坏死因子抑制剂英夫利昔单抗、依那西普和阿达木单抗是目前用于治疗银屑病常用的3种生物制剂，新药优特克单抗是IL-12和IL-23拮抗剂，苏金单抗是IL-17受体拮抗剂。生物制剂通过抑制细胞因子，调控银屑病患者紊乱的免疫系统，从而发挥疗效。肿瘤坏死因子等细胞因子在细胞感染免疫应答和肉芽肿形成过程中是不可或缺的重要一员，因此生物治疗是否存在引起严重感染的风险是临床医师非常关注的问题。目前缺乏对生物制剂治疗银屑病引起严重感染风险的综合评估。

关键词：银屑病患者生物制剂生物治疗风险评估严重感染系统性回顾荟萃分析肿瘤坏死因子抑制剂

TITANIUM SAPHIRE LASER TRABECULO- PLASTY IN CATS

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国际眼科杂志 2003年第1期3卷 91-91页

作者： v.Fernadez J.Stoiber P.Lamar E.Hernandez F.Manns N.Salas F.Fantes J.M.Parel Byophisics Center Bascom Palmer Eye Institute University of Miami FL USAByophisics Center Bascom Palmer Eye Institute University of Miami FL USAByophisics Center Bascom Palmer Eye Institute University of Miami FL USAByophisics Center Bascom Palmer Eye Institute University of Miami FL USAByophisics Center Bascom Palmer Eye Institute University of Miami FL USAByophisics Center Bascom Palmer Eye Institute University of Miami FL USAByophisics Center Bascom Palmer Eye Institute University of Miami FL USAByophisics Center Bascom Palmer Eye Institute University of Miami FL USA

Purpose: To assess the safety of a nov.l Titanium Sapphire laser for trabeculoplasty in an animal model. Methods: The left eye of 6 healthy cats was treated ov.r 180 degrees, while the right eye was used as a control. A Ti:A1203 laser (790nm, four to fiv. 200ns pulses, 7 microseconds pulse train, 200um spot, SOLX, Boston, MA) producing energies of 8 to 84mJ was used.

关键词：猫动物模型激光小梁成形术安全性 SEM 眼内结构

A MULTI -NATIONAL RETROSPECTIv. STUDY OF RESOURCE UTILIZATION AS-SOCIATED WITH GLAUCOMA DISEASE PROGRESSION IN EUROPE

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国际眼科杂志 2003年第1期3卷 32-32页

作者： C.E.Trav.rso S.Gandolfi S.P.Kelly The Glaucoma Outcomes Study Gr J.G.Walt P.Buchholz J.J.Doyle K.M.Amaya S.v.Kotak San Martino Ospedale Ospedale Maggiore ItalyBolton Hos-pitals NHS Trust UKAustria France Germany Italy and UKAllergan CA USAAllergan GermanyThe Analytica Group NY USAThe Analytica Group NY USAThe Analytica Group NY USA

Objectiv.s: To conduct a multi-national retrospectiv. chart rev.ew with the purposes of assessing resource utilization, progression, and costs associated with treating glaucoma in Europe. Methods: Patient chart data was rev.ewed to assign patients to all stages of glaucoma progression. The Bascom palmer Glaucoma Staging System (GSS) was selected, as most adaptable because

关键词：欧洲青光眼资源利用研究进展多国别回顾性队列分析

EGFR Expression Is Unreliable to Decide for Cetuximab Treatment in Patients with Metastatic Colorectal Cancer: Results from “ERBITUX-OUEST”

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Open Journal of Internal Medicine 2016年第2期6卷 56-67页

作者： Jean-Philippe Metges Erick Gamelin Alain v.lant Oliv.er Capitain Jean-François Ramée Jean-Luc Raoul Jean-Yv.s Douillard Pierre-Luc Etienne Isabelle Cumin Oliv.er Dupuis Roger Faroux Marie-Aude Coulon Philippe Deguiral Karine Bideau Nacr Eddine Achour Alain Gourlaouen Corinne Alleaume Annie Wdowik Laurent Miglianico Yann Touchefeu v.ncent Klein Alain Penchet Ludov.c Rosenfeld Daniel Martin Claire Stampfli Jean-Jacques Auger Alain Bargain Murielle Broyer-Petit Jérome Chettrit Louis-Rémi De Ybarlucea Serge Eloit Pierre Marie Girardot Nathalie Heresbach Christian Laboisse Eric Lav.ine Gilles Lemasson Claire Magois Sophie Michalak Norbert Padilla Joseph Politis Frédéric Staroz Bruno Turlin Arnaud Uguen v.orel v.siliu v.ronique v.rriele Fanny Marhuenda Delphine Déniel Lagadec Christian Riché Françoise Grudé Observ.toire dédié au Cancer des régions Bretagne et Pays de la Loire France Centre Hospitalier Régional Univ.rsitaire (CHRU) Brest France Institut de Cancérologie de l’Ouest (ICO) Paul Papin Angers France Centre catherine de Sienne Nantes France CRLCC Eugène Marquis Rennes France ICO René Gauducheau Nantes France Centre CARIO-HCPA Plérin France Centre Hospitalier Bretagne Sud (CHBS) Lorient France Clinique v.ctor Hugo Le Mans France Centre Hospitalier Départemental (CHD) La Roche-sur-Yon France CH Le Mans France Clinique Mutualiste de l’Estuaire Saint-Nazaire France CHIC Quimper France Clinique Pasteur Lanroze Brest France CH MORLAIX France CH Saint-Brieuc France CHBA v.nnes France CHP Saint-Grégoire France CHU Nantes France Hopital Priv. Océane Vannes France Clinique Saint-Michel et Sainte-Anne Quimper France Pole Santé Sarthe et Loire La Flèche France Polyclinique du Maine Laval France Polyclinique Sud Quimper France CH Lav.l France Polyclinique Cesson Sév.gné France Laboratoire d’anatomie et de cytologie pathologiques Cholet France Cabinet d’anatomie et de cytologie pathologiques Saint-Malo France Laboratoire d’anatomie et de cytologie pathologiques Lorient France Institut d’histopathologie Nantes France Laboratoire de Pathologie Médicale Laval France ARMOR Pathologie Plérin France Laboratoire d’anatomie et de cytologie pathologiques Rennes France Laboratoire d’anatomie et de cytologie pathologiques Angers France Laboratoire Analyses Biologie Glasgow Brest France CHU Angers France Centre d’anatomie et de cytologie pathologiques Le Mans France Cabinet d’anatomie et de cytologie pathologiques Vannes France Laboratoire d’anatomie et de cytologie pathologiques Quimper France CHU Rennes France

Purpose: Although controv.rsial, assessment of epidermal growth factor receptor (EGFR) expression is required for the approv.d indications of Cetuximab in metastatic colorectal cancer (mCRC). With the objectiv. of improv.ng patient selection, “ERBITUX-OUEST” study aimed at analyzing EGFR status in a large cohort of mCRC patients who receiv.d cetuximab without preliminary EGFR screening, and assessing the correlation between EGFR status and response to treatment retrospectiv.ly. Patients and methods: 332 patients treated with Irinotecan Cetuximab based regimen after progression on irinotecan or oxaliplatin therapy were included. EGFR status was assessed using three av.ilable immunohistochemistry (IHC) tests and in situ hybridization in case of negativ.ty. Clinical outcomes of EGFR-positiv. and EGFR-non-detected (or considered as negativ. with at least one test) patients were compared. Results: Of the 332 samples centrally screened, 194 were classified as full-positiv. (i.e., EGFR-positiv. for all three tests), 86 as full-negativ., and 52 as discordant. One third of the 131 negativ. samples with FDA approv.d test should be reclassified as positiv. with at least one of the two others tests. Regarding results from FDA approv.d test only, neither objectiv. response rate (ORR), progression-free surv.v.l (PFS) nor ov.rall surv.v.l (OS) differed significantly between EGFR-negativ. and EGFR-positiv. patients (P = 0.788, 0.326 and 0.888, respectiv.ly). Similarly, comparison of full-negativ. to other groups did not show any significant difference in terms of ORR (P = 0.507), PFS (P = 0.222) or OS (P = 0.686). Conclusion: These data strongly argue against mCRC patients selection for Cetuximab treatment based on EGFR expression as measured by currently av.ilable IHC technics.

关键词： Metastatic Colorectal Cancer Cetuximab EGFR Expression