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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

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人类通史

作者： (英)克里斯·斯特林格(Chris stringer)，(英)彼得·安德鲁(Peter Andrews)

来源：南通市图书馆图书评论

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儿科肝移植术前的血管影像学检查

世界核心医学期刊文摘（儿科学分册） 2006年第2期2卷 32-33页

作者： Ravindra K.V. Guthrie J.A. Woodley H. M.D. stringer 贺莉 Children' s Liver and GI Unit St. James' s University Hospital Beckett St Leeds LS9 7TF United Kingdom

Background/Purpose: There is a considerable variation in the use of vascular imaging techniques in the preoperative assessment of children scheduled for liver transplantation. Duplex Doppler ultrasound scan (US), magnetic resonance angiography (MRA), and conventional angiography are used to varying extents. The authors compared the results of preoperative vascular imaging studies with operative findings to determine their accuracy and usefulness. Methods: Results of preoperative vascular imaging in 37 consecutive children undergoing cadaveric liver transplantation were compared with operative findings. Those undergoing relatively elective transplantations were investigated by US and MRA (group 1), whereas those requiring urgent transplants were assessed only by US (group 2). Results: The median age of the cohort (15 boys; 22 girls) was 4 years (19 days to 16 years) and the median weight was 17 kg (2.9 to 82 kg). In group 1 (n = 26), 20 children had a normalcaliber, patent portal vein at transplant and 6 had a narrow but patent portal vein requiring venous reconstruction in 4. The sensitivity and specificity of MRA in the detection of an abnormally narrow portal vein were 100% (6/6) and 95% (19/20), respectively. If reversed or absent flow in the portal vein on US was taken as an indication of a potentially abnormal vein, the sensitivity and specificity of Doppler US were 83% (5/6) and 95% (19/20), respectively. Magnetic resonance angiography revealed arterial anomalies in 4 children but failed to detect small accessory hepatic arteries in 5. The single patient with an aberrant vena cava was identified by MRA. In group 2 (n = 11), venous findings at operation and on US were concordant in 10 (91% ) cases; one infant with reversed flow in the portal vein on US had a thrombosed vein at surgery. Magnetic resonance angiography was useful in 2 patient groups: those with reversed flow on Doppler US or suspected portal vein thrombosis in whom an abnormal portal vein was pres

关键词：肝移植术影像学检查血管影像学术前磁共振血管造影术 MRA检查 US检查二维多普勒门静脉异常儿科

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工商银行新任行长杨凯生答记者问

中国金融家 2005年第11期 54-59页

作者：龚暄杨凯生工商银行

10月28日，中国工商银行股份有限公司宣告成立。在随后的记者招待会上，中国工商银行新任行长杨凯生就大家共同关心的问题，与境内外各新闻媒体进行了面对面的交流。

关键词：中国工商银行答记者问杨凯行长股份有限公司记者招待会新闻媒体面对面境内

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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

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