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2016年全球新药研发报告--第一部分:新药和生物制品(Ⅲ)

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药学进展 2017年第7期41卷 549-555页

作者： Graul A I Pina P Cruces E stringer m 科睿唯安

2016年全球首次批准或上市的新药和生物制品接近90种,其中包括重要的延伸性新药。与往年相比,这一数字相对较低。2016年全球首次上市的新药和新生物制品共44种,比前一年减少近10%。新上市药物中,7种药物为首创药物,即具有全新作用机制,... 详细信息

2016年全球首次批准或上市的新药和生物制品接近90种,其中包括重要的延伸性新药。与往年相比,这一数字相对较低。2016年全球首次上市的新药和新生物制品共44种,比前一年减少近10%。新上市药物中,7种药物为首创药物,即具有全新作用机制,并在全球首次通过批准并上市的新药。此外,2016年共批准了23种延伸性新药(即新配方、新联合用药和新适应证)。另有21种产品于2016年首次获批,但截至2016年12月15日尚未上市。在制药和生物技术领域年度报告的第一部分中,将深入报道这些新药的相关信息。

关键词：新上市药物新批准药物延伸性新药首创药物

2012年全球新药研发报告——第一部分:新药及生物制品(续)

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药学进展 2013年第10期37卷 534-541页

作者： Graul A I Lupone B Gruces E stringer m 史志祥张宇辉 Thomson Reuters 中国药科大学

该年度总结涉及37种最新上市的药物,包括2012年全球范围内首次上市的36种药物和生物制品以及在2011年12月底上市的1种药物;此外,还讨论了2012年首次推出的26种重要的延伸性新药(新适应证、新剂型以及现有药物的新复方),以及2012年1月至1... 详细信息

该年度总结涉及37种最新上市的药物,包括2012年全球范围内首次上市的36种药物和生物制品以及在2011年12月底上市的1种药物;此外,还讨论了2012年首次推出的26种重要的延伸性新药(新适应证、新剂型以及现有药物的新复方),以及2012年1月至12月通过审批但未在年内上市的新药、生物制品以及延伸性新药。

关键词：上市新药新生物制品获批新药延伸性新药

Kasai肝门肠吻合术:肝脏组织学上的新认识

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世界核心医学期刊文摘（儿科学分册） 2005年第7期1卷 37-38页

作者： Hussein A. Wyatt J. Guthrie A. stringer m.D. 宁亮 Department of Histopathology Children's Liver Unit St.James's University Hospital Leeds LS9 7TF United Kingdom

Background/Purpose: The aim of this paper was to investigate the mechanism of long-term biliary drainage after Kasai portoenterostomy by clinicopathologic study of hepatic morphology in explanted ***: Explanted livers from 13 consecutive children undergoing transplantation for biliary atresia were examined in detail using a standardized *** 1 (n = 6) had no Kasai procedure before transplantation at a median age of 8 *** 2 (n = 4) were transplanted at a median age of 10 m after a failed Kasai *** 3 (n = 3) had a successful Kasai but required transplantation for complications of chronic liver disease at 12-14 *** findings were correlated with hepatic morphology determined by pretransplant magnetic resonance ***: Large perihilar regenerative nodules (8-14 cm diameter) were observed in 2 patients after successful Kasai portoenterostomy, less well-de-fined perihilar nodules in group 2 patients, and no regenerative nodules in group ***, group 1 had diffuse biliary cirrhosis with evidence of progressive ductopenia during *** group 2, perihilar regenerative nodules showed variable portal fibrosis but no cirrhosis and bile ducts were present with 68%-100%of hepatic arteries; in peripheral cirrhotic areas, bile ducts were absent in patients older than 9 *** perihilar regenerative nodules in group 3 patients had a noncirrhotic architecture with preserved bile ducts, but the peripheral parenchyma was cirrhotic; one patient had diffuse macronodular *** morphologic findings correlated well with magnetic resonance images, highlighting the preservation of relatively normal perihilar liver architecture after successful Kasai ***: Unoperated biliary atresia is associated with progressive intrahepatic ductopenia leading to diffuse biliary *** portoenterostomy can result in the growth of large perihilar regenerative nodules, probably as a conseque

关键词：肝门肠吻合术 Kasai 肝脏组织学胆管闭锁肝门肠吻合手术再生结节大结节性肝硬化慢性肝脏疾病移植术胆汁性肝硬化

2012年全球新药研发报告——第一部分:新药及生物制品(续Ⅲ)

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药学进展 2013年第11期 591-599页

作者： Graul A I Lupone B Gruces E stringer m 史志祥张宇辉陈菁中国药科大学

关键词：上市新药新生物制品获批新药延伸性新药

局部氨基乙酰丙酸光动力疗法治疗寻常性痤疮:临床效果和作用机制研究

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世界核心医学期刊文摘（皮肤病学分册） 2005年第3期1卷 42-43页

作者： Pollock B. Turner D. stringer m.R. 牛新武 Department of Dermatol ogy Leeds General Infirmary Leeds LS1 3EX United Kingdom

BackgroundAcne affects 83- 95% of 16- year-oldsof both sexes, and many seek help from a clinician. Emerging problems with conventional acne treatments, specifically antibiotic resistance of Propionibacterium acnes and fears over th e safety and tolerance of oral isotretinoin, create a demand for novel treatment modalities in acne. Objectives To study the efficacy of aminolaevulinic acid- photodynamic therapy (ALA-PDT) in the treatment of acne and to identify the mode of acti on, looking specifically at the effects on surface numbers of P. acnes and on se bum excretion. methods Ten patients (nine men and one woman, age range 16- 40 y ears) with mild to moderate acne on their backswere recruited. Each patient’s backwasmarkedwith four 30- cm2 areas of equal acne severity. Each site was then randomly allocated to either ALA-PDT treatment, light alone, ALAalone or an u ntreated control site. At baseline, numbers of inflammatory and noninflammatory acne lesions were counted, sebum excretionmeasured by Sebutapes (CuDerm, Dallas, TX, U.S.A.) and surface P. acnes swabs performed. ALA cream (20% in Unguentum merck) was applied under occlusion to the ALA-PDT and ALA alone sites for 3 h . Red light from a diode laser was then delivered to the ALA-PDT and light alo ne sites (635 nm, 25 mW cm- 2, 15 J cm- 2). Each patient was treated weekly fo r 3 weeks. At each visit acne lesion counts were performed and 3 weeks following the last treatment sebum excretion rates and P. acnes swabs were repeated. Resu lts There was a statistically significant reduction in inflammatory acne lesion counts from baseline after the second treatment at the ALA-PDT site but not at any of the other sites. No statistically significant reduction in P. acnes numb ers or sebum excretion was demonstrated at any sites including the ALA-PDT sit e. Conclusions ALA-PDT is capable of clinically improving acne. An alternative mode of action for ALA-PDT other than direct damage to sebaceous glands or ph otodynamicki

关键词：寻常性痤疮光动力疗法氨基乙酰丙酸作用机制中度痤疮异维甲酸非炎性痤疮新型治疗方法临床改善封包

2017年全球新药研发报告——第一部分：新药和生物制剂（Ⅲ）

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药学进展 2018年第6期42卷 466-477页

作者： Granl A I Pina P Stnnger m 科睿唯安

2017年全球首次获批或上市的新药和生物制剂共113种，包括首次上市的52种新药和生物制剂，其中有7种为首创药物（first—inclass），即该药物具有全新作用机制并在全球首次获批并上市：36种产品线拓展产品（即新适应证、新联合用药和新... 详细信息

2017年全球首次获批或上市的新药和生物制剂共113种，包括首次上市的52种新药和生物制剂，其中有7种为首创药物（first—inclass），即该药物具有全新作用机制并在全球首次获批并上市：36种产品线拓展产品（即新适应证、新联合用药和新制剂等）;以及2017年首次获批,但2017年12月31日前尚未上市的25种产品。美国是全球新药研发最活跃的市场，肿瘤是最为活跃的治疗领域。在制药和生物技术领域年度报告的第一部分中，将深入报道这些新药和生物制剂的相关信思。

关键词：新上市药物新批准药物延伸性新药首创药物

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腹裂畸形胎儿选择性早产的随机对照试验研究

世界核心医学期刊文摘（儿科学分册） 2006年第4期2卷 44-45页

作者： Logghe H.L. mason G.C. Thornton J.G. stringer m.D. 刘凯 Department of Paediatric Surgery St. James's University Hospital LS9 7TF Leeds United Kingdom

Background: Elective preterm delivery of the fetus with gastroschisis may help to limit injury to the extruded fetal gut and thus promote faster recovery of neonatal gut function and earlier hospital discharge. This hypothesis has not previously been tested in a prospective randomized controlled trial. methods: Between may 1995 and September 1999, all women referred to a single tertiary center before 34 weeks’ gestation with a sonographically diagnosed fetal gastroschisis were invited to participate in a randomized controlled trial. Eligible patients were randomized to elective delivery at 36 weeks or to await the onset of spontaneous labor. The method of delivery was not prescribed by the trial. Primary outcome measures in the neonate were the time taken to tolerate full enteral feeding (150 mL/kg per day) and duration of hospital stay. Results: Of 44 eligible women, 42 were randomized, 21 to elective delivery and 21 to await spontaneous labor. There were 20 liveborn infants in each group. Four babies in the elective group and 4 in the spontaneous group delivered before 36 weeks’ gestation but were included in the analysis on an intention-to-treat basis. mean gestational age at delivery was 35.8 weeks in the elective group and 36.7 weeks in the spontaneous group. Primary closure of the gastroschisis was achieved in a similar proportion (80% - 85% ) of infants in both groups. Two babies in the elective group died from short gut complications. In the survivors, there was a trend in favor of a shorter median time to achieve full enteral feeding (30.5 vs 37.5 days) and a shorter median duration of hospital stay (47.5 vs 53 days) in the elective group, but this was not statistically significant. These findings remained unaltered when the data were reanalyzed after (a) excluding infants with intestinal atresia or (b) excluding infants born before 36 weeks’ gestation. Conclusions: Although limited by the small number of patients, this randomized controlled trial demonstra

关键词：腹裂畸形随机对照试验肠管挤压伤周前超声诊断三级医疗自然分娩肠闭锁分娩组短肠综合征

IGF1-PI3K-induced physiological cardiac hypertrophy:Implications for new heart failure therapies,biomarkers,and predicting cardiotoxicity

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Journal of Sport and Health Science 2021年第6期10卷 637-647,I0001页

作者： Sebastian Bass-stringer Celeste m.K.Tai Julie R.mcmullen Baker Heart and Diabetes Institute MelbourneVIC 3004Australia Department of Physiology Anatomy and MicrobiologyLa Trobe UniversityBundooraVIC 3086Australia Department of Diabetes Central Clinical SchoolMonash UniversityMelbourneVIC 3004Australia Department of Physiology and Department of medicine Alfred Hospital Monash UniversityMelbourneVIC 3004Australia

Heart failure represents the end point of a variety of cardiovascular *** is a growing health burden and a leading cause of death *** date,limited treatment options exist for the treatment of heart failure,but exercise has been well-established as one of the few safe and effective interventions,leading to improved outcomes in ***,a lack of patient adherence remains a significant barrier in the implementation of exercise-based therapy for the treatment of heart *** insulin-like growth factor 1(IGF1)phosphoinositide 3-kinase(PI3K)pathway has been recognized as perhaps the most critical pathway for mediating exercisedinduced heart growth and ***,we discuss how modulating activity of the IGF1PI3K pathway may be a valuable approach for the development of therapies that mimic the protective effects of exercise on the *** outline some of the promising approaches being investigated that utilize PI3K-based therapy for the treatment of heart *** discuss the implications for cardiac pathology and cardiotoxicity that arise in a setting of reduced PI3K ***,we discuss the use of animal models of cardiac health and disease,and genetic mice with increased or decreased cardiac PI3K activity for the discovery of novel drug targets and biomarkers of cardiovascular disease.

关键词： Cardiac protection Cardiotoxicity Exercise Heart failure IGF1 PI3K Therapies

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肝脏纤毛性前肠囊肿

世界核心医学期刊文摘（儿科学分册） 2006年第11期2卷 50-50页

作者： stringer m.D. Jones m.O. Woodley H. Wyatt J. 刘凯 Children's Liver Unit St. James's University Hospital LS9 7TF Leeds United Kingdom

A male infant was found to have a large congenital hepatic cyst,first noted in late gestation by prenatal ultrasound scan. The cyst communicated with the biliary tree and was eventually removed completely by an extended right hepatectomy. Histopathologic examination showed a thick-walled, unilocular cyst lined predominantly by ciliated, stratified squamous epithelium with an outer wall composed of smooth muscle cells and fibrous *** features are diagnostic of a ciliated hepatic foregut cyst,a rare congenital malformation with histologic similarities to bronchogenic cysts. The young age of our patient, prenatal detection, large size of the cyst, and a clear communication with the biliary tree have not been previously described with ciliated hepatic foregut cysts.

关键词：肠囊肿胆管系统肝右叶扩大切除术产前超声检查单房性支气管囊肿先天性畸形交通支复层扁平