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1CONSORT 2010说明与详述:报告平行对照随机临床试验指南的更新显示文摘大量证据显示随机对照临床试验(randomised controlled trial,RCT)的报告质量不理想。报告不透明,则读者既不能评判试验结果是否真实可靠,也不能从中提取可用于系统综述的信息。最近的方法学分析表明,报告不充分和设计不合理与对治疗效果产生评价偏倚有关。这种系统误差对RCT损害严重,而RCT正是以其能减少或避免偏倚而被视为评价干预措施的金标准。为了提高RCT的报告质量,一个由专家和编辑组成的工作组制定了临床试验报告的统一标准(Consolidated Standards of Reporting Trials,CONSORT)声明。CONSORT声明于1996年首次发表,并于2001年更新。声明由对照检查清单和流程图组成,供作者在报告RCT时使用。许多核心医学期刊和主要国际性编辑组织都已认可CONSORT声明。该声明促进了对RCT的严格评价和解释。2001年,在对CONSORT进行修订时,人们就已经清楚地认识到,解释和说明制定CONSORT声明的原理,有助于研究人员等撰写或评价临床试验报告。一篇CONSORT说明与详述文章于2001年同2001版CONSORT声明一起发表。2007年1月的专家会议之后,对CONSORT声明作了进一步修订并已发表,即'CONSORT2010声明'。这次更新对原版对照检查清单作了文字上的修改,使其更为明晰,并收入了与一些新近才认识到的主题相关的建议,如选择性报告结局产生的偏倚。说明与详述文件旨在加强人们对CONSORT声明的理解、应用和传播,这次也作了大量修订,对每一项新增或更新的清单条目的含义和增改理由进行了解释,提供了优秀的报告实例,还尽可能地提供了相关的经验性研究的参考文献。文中收入了若干流程图实例。'CONSORT2010声明'、其说明与详述文件,以及相关网站(www.consort-statement.org),对于改进随机临床试验报告必将有所裨益。David Moher Sally Hopewell Kenneth F Schulz Victor Montori Peter C Gφtzsche P J Devereaux Diana Elbourne Matthias Egger Douglas G Altman 周庆辉 卞兆祥 刘建平 2010中西医结合学报2010,8,8:318
2Efficacy and safety of tenofovir in chronic hepatitis B: Australian real world experience显示文摘AIM To evaluate the long-term treatment outcomes of tenofovir therapy in patients in a real world Australian tertiary care setting.METHODS We performed a retrospective analysis of treatment outcomes among treatment-na?ve and treatment-experienced patients receiving a minimum 3 mo tenofovir therapy through St Vincent's Hospital Melbourne, Australia. We included patients receiving tenofovir [tenofovir disoproxil fumarate(TDF)] monotherapy, as well as patients treated with TDF in combination with a second antiviral agent. Patients were excluded if they demonstrated human immune-deficiency virus/hepatitis C virus/hepatitis delta virus coinfection or were less than 18 years of age. We considered virological and biochemicalresponse, as well as safety outcomes. Virological response was determined by measurement of hepatitis B virus(HBV) DNA using sensitive assays; biochemical response was determined via serum liver function tests; histological response was determined from liver biopsy and fibroscan; safety analysis focused on glomerular renal function and bone mineral density. The primary efficacy endpoint was complete virological suppression over time, defined by HBV DNA < 20 IU/m L. Secondary efficacy endpoints included rates of biochemical response, and HB e antigen(HBe Ag)/HB surface antigen loss and seroconversion over time.RESULTS Ninety-two patients were identified who fulfilled the enrolment criteria. Median follow-up was 26 mo(range 3-114). Mean age was 46(24-78) years, 64(70%) were male and 77(84%) were of Asian origin. 55(60%) patients were treatment-na?ve and 62 patients(67%) were HBe Ag-negative. Complete virological suppression was achieved by 45/65(71%) patients at 12 mo, 37/46(80%) at 24 mo and 25/28(89%) at 36 mo. Partial virological response(HBV DNA 20-2000 IU/m L) was achieved by 89/92(96.7%) of patients. Multivariate analysis showed a significant relationship between virological suppression at end of follow-up and baseline HBV DNA level(OR = 0.897, 95%CI: 0.833-0.967, P = 0.0046) and HBe Ag positive status(OR = 0.373, 95%CI: 0.183-0.762, P = 0.0069). There was no difference in response comparing treatment-na?ve and treatment-experienced patients. Three episodes of virological breakthrough occurred in the setting of noncompliance. Tenofovir therapy was well tolerated.CONCLUSION Tenofovir is an efficacious, safe and well-tolerated treatment in an Australian real-world tertiary care setting. Our data are similar to the reported experience from registration trials.Grace C Lovett Tin Nguyen David M Iser Jacinta A Holmes Robert Chen Barbara Demediuk Gideon Shaw Sally J Bell Paul V Desmond Alexander J Thompson 2017World Journal of Hepatology2017,9,1:7
3Evolving treatment landscape for early and advanced pancreatic cancer显示文摘Pancreatic ductal adenocarcinoma is an infrequent cancer with a high disease related mortality rate, even in the context of early stage disease. Until recently, the rate of death from pancreatic cancer has remained largely similar whereby gemcitabine monotherapy was the mainstay of systemic treatment for most stages of disease. With the discovery of active multiagent chemotherapy regimens, namely FOLFIRINOX and gemcitabine plus nab-paclitaxel, the treatment landscape of pancreatic cancer is slowly evolving. FOLFIRINOX and gemcitabine plus nab-paclitaxel are now considered standard first line treatment options in metastatic pancreatic cancer. Studies are ongoing to investigate the utility of these same regimens in the adjuvant setting. The potential of these treatments to downstage disease is also being actively examined in the locally advanced context since neoadjuvant approaches may improve resection rates and surgical outcomes. As more emerging data become available, the management of pancreatic cancer is anticipated to change significantly in the coming years.Sally C Lau Winson Y Cheung 2017World Journal of Gastrointestinal Oncology2017,9,7:3
4Polyp detection rates using magnification with narrow band imaging and white light显示文摘AIM: To compare the yield of adenomas between narrow band imaging and white light when using high definition/magnification. METHODS: This prospective, non-randomized comparative study was performed at the endoscopy unit of veteran affairs medical center in Phoenix, Arizona. Consecutive patients undergoing first average risk colorectal cancer screening colonoscopy were selected. Two experienced gastroenterologists performed all the procedures that were blinded to each other's findings. Demographic details were recorded. Data are presented as mean ± SEM. Proportional data were compared using the χ2 test and means were compared using the Student's t test. Tandem colonoscopy was performed in a sequential and segmental fashion using one of 3 strategies: white light followed by narrow band imaging [Group A: white light(WL) → narrow band imaging(NBI)]; narrow band imaging followed by white light(Group B: NBI → WL) and, white light followed by white light(Group C: WL → WL). Detection rate of missed polyps and adenomas were evaluated in all three groups. RESULTS: Three hundred patients were studied(100 in each Group). Although the total time for the colonoscopy was similar in the 3 groups(23.8 ± 0.7, 22.2 ± 0.5 and 24.1 ± 0.7 min for Groups A, B and C, respectively), it reached statistical significance between Groups B and C(P < 0.05). The cecal intubation time in Groups B and C was longer than for Group A(6.5 ± 0.4 min and 6.5 ± 0.4 min vs 4.9 ± 0.3 min; P < 0.05). The withdrawal time for Groups A and C was longer than Group B(18.9 ± 0.7 min and 17.6 ± 0.6min vs 15.7 ± 0.4 min; P < 0.05). Overall miss rate for polyps and adenomas detected in three groups during the second look was 18% and 17%, respectively(P = NS). Detection rate for polyps and adenomas after first look with white light was similar irrespective of the light used during the second look(WL → WL: 13.7% for polyps, 12.6% for adenomas; WL → NBI: 14.2% for polyps, 11.3% for adenomas). Miss rate of polyps and adenomas however was significantly higher when NBI was used first(29.3% and 30.3%, respectively; P < 0.05). Most missed adenomas were ≤ 5 mm in size. There was only one advanced neoplasia(defined by size only) missed during the first look. CONCLUSION: Our data suggest that the tandem nature of the procedure rather than the optical techniques was associated with the detection of additional polyps' and adenomas.Nooman Gilani Sally Stipho James D Panetta Sorin Petre Michele A Young Francisco C Ramirez 2015World Journal of Gastrointestinal Endoscopy2015,7,5:2
5Comparison of bacterial quantities in left and right colon biopsies and faeces显示文摘AIM:To compare quantities of predominant and pathogenic bacteria in mucosal and faecal samples.METHODS:Twenty patients undergoing diagnostic colonoscopy with endoscopically and histologically normal mucosa were recruited to the study,14 subjects of which also supplied faecal(F) samples between 15 d to 105 d post colonoscopy.Mucosal biopsies were taken from each subject from the midportion of the ascending colon(right side samples,RM) and the sigmoid(left side samples,LM).Predominant intestinal and mucosal bacteria including clostridial 16S rRNA gene clusters Ⅳ and ⅩⅣab,Bacteroidetes,Enterobacteriaceae,Bifidobacterium spp.,Akkermansia muciniphila(A.muciniphila),Veillonella spp.,Collinsella spp.,Faecalibacterium prausnitzii(F.prausnitzii) and putative pathogens such asEscherichia coli(E.coli),Clostridium difficile(C.difficile),Helicobacter pylori(H.pylori) and Staphylococcus aureus(S.aureus) were analysed by quantitative polymerase chain reaction(qPCR).Host DNA was quantified from the mucosal samples with human glyceraldehyde 3-phosphate dehydrogenase gene targeting qPCR.Paired t tests and the Pearson correlation were applied for statistical analysis.RESULTS:The most prominent bacterial groups were clostridial groups Ⅳ and ⅩⅣa+b andBacteroidetes and bacterial species F.prausnitzii in both sample types.H.pylori and S.aureus were not detected and C.difficile was detected in only one mucosal sample and three faecal samples.E.coli was detected in less than half of the mucosal samples at both sites,but was present in all faecal samples.All detected bacteria,except Enterobacteriaceae,were present at higher levels in the faeces than in the mucosa,but the different locations in the colon presented comparable quantities(RM,LM and F followed byP 1 for RMvs F,P 2 for LMvs F andP 3 for RM vs LM:4.17 ± 0.60 log 10 /g,4.16 ± 0.56 log 10 /g,5.88 ± 1.92 log 10 /g,P 1 = 0.011,P 2 = 0.0069,P 3 = 0.9778 forA.muciniphila;6.25 ± 1.3 log 10 /g,6.09 ± 0.81 log 10 /g,8.84 ± 1.38 log 10 /g,P 1 < 0.0001,P 2 = 0.0002,P 3 = 0.6893 forBacteroidetes;5.27 ± 1.68 log 10 /g,5.38 ± 2.06 log 10 /g,8.20 ± 1.14 log 10 /g,P 1 < 0.0001,P 2 ≤ 0.0001,P 3 = 0.7535 forBifidobacterium spp.;6.44 ± 1.15 log 10 /g,6.07 ±1.45 log 10 /g,9.74 ±1.13 log 10 /g,P 1 < 0.0001,P 2 ≤ 0.0001,P 3 = 0.637 forClostridium cluster Ⅳ;6.65 ± 1.23 log 10 /g,6.57 ± 1.52 log 10 /g,9.13 ± 0.96 log 10 /g,P 1 < 0.0001,P 2 ≤ 0.0001,P 3 = 0.9317 forClostridium cluster ⅩⅣa;4.57 ± 1.44 log10/g,4.63 ± 1.34 log10/g,7.05 ± 2.48 log 10 /g,P 1 = 0.012,P 2 = 0.0357,P 3 = 0.7973 for Collinsella spp.;7.66 ± 1.50 log 10 /g,7.60 ± 1.05 log 10 /g,10.02 ± 2.02 log 10 /g,P 1 ≤ 0.0001,P 2 = 0.0013,P 3 = 0.9919 forF.prausnitzsii;6.17 ± 1.3 log 10 /g,5.85 ± 0.93 log 10 /g,7.25 ± 1.01 log 10 /g,P 1 = 0.0243,P 2 = 0.0319,P 3 = 0.6982 for Veillonella spp.;4.68 ± 1.21 log 10 /g,4.71 ± 0.83 log 10 /g,5.70 ± 2.00 log 10 /g,P 1 = 0.1927,P 2 = 0.0605,P 3 = 0.6476 forEnterobacteriaceae).TheBifidobacterium spp.counts correlated significantly between mucosal sites and mucosal and faecal samples(Pearson correlation coefficients 0.62,P = 0.040 and 0.81,P = 0.005 between the right mucosal sample and faeces and the left mucosal sample and faeces,respectively).CONCLUSION:Non-invasive faecal samples do not reflect bacterial counts on the mucosa at the individual level,except for bifidobacteria often analysed in probiotic intervention studies.Anna Lyra Sofia Forssten Peter Rolny Yvonne Wettergren Sampo J Lahtinen Krista Salli Lennart Cedgrd Elisabeth Odin Bengt Gustavsson Arthur C Ouwehand 2012World Journal of Gastroenterology2012,18,32:2
6Further validation of the Chinese version of the level of expressed emotion scale for re search and clinical use显示文摘Wai - Tong Chiena Sally W Chan C 2010International Journal of Nursing Stud- ies2010,47,:1
7Prognostic signifi cance of visit-to-visit variability,maximum systolic blood pressure,and episodic hypertension显示文摘Peter M Rothwell Sally C Howard 2010The Lancet2010,375,9718:1
8Predictors of adoption and maintainance of vigorous physical activity in men and women 显示文摘Sallis J F Hovel M F Hofstetter C R 1992Preventive Medicine1992,21,:1
9Effects of beta blockers and calcium-channel blockers on within-individual variability in blood pressure and risk of stroke显示文摘Rothwell Peter M Howard Sally C Dolan Eamon 2010Lancet neurology2010,9,5:1
10Increase in primary liver cancer in the UK, 1979–94显示文摘Simon D Taylor-Robinson Graham R Foster Shona Arora Sally Hargreaves Howard C Thomas 1997The Lancet . 1997 (9085)1997,,9085:1
11Iron limits the cell division rate of Prochlorococcus in the eastern equatorial Pacific 显示文摘Elizabeth L M Sallie W C 2000Limnol Oceanogr2000,45,5:1
12An inter- laboratory study to test the ability of amendments to reduce the availability of Cd, Pb, and Zn in situ 显示文摘Sally B Barbara C Enzo L 2005Environmental Pollution2005,138,:1
13How to investigate and analyse clinical incidents: clinical risk unit and association of litigation and risk management protocol显示文摘Charles V Sally T A Jane E C et ol 2000BMJ2000,320,:1
14A Review of Correlates of Physical Activity of Children and Adoles- cents 显示文摘SALLIS J F PROCHASKA J J TAYLOR W C 2000Medicine and science in sports and exercise2000,32,5:1
15Effects of a mutual support group for families of Chinese people with schizophrenia:18-month follow-up显示文摘Wai-Tong Chien Sally W C Chan David R Thompson 2006The British journal of psychiatry:the journal of mental science2006,189,:1
16Hall Characterization of the class 3 integron and the site-specific recombination system it determines显示文摘Collis C M Kim Mi J Sally R 2002Bacteriol2002,184,11:1
17Evaluating the sustainability of SPARK physical education: A case study of translating research into practice显示文摘Dowda M C Sallis J F McKenzie T L 2005Research Quarterly for Exercise and Sport2005,76,:1
18Characteristics of Marketing Channels : A Theoretical Framework 显示文摘Nina Michaelidou David C Arnott Sally Dibb 2005The Marketing Review2005,5,:1
19Stages of Change,Self-efficacy,and the Adoption of Vigorous Exercise:A ProspectiveAnalysis显示文摘Armstrong C A Sallis J E Hovell M F 1993Journal of Sport and Exercise Psychology1993,15,:1
20Saccharopolyspora erythraea catalyzed bioconversion of 6-deoxyerythro-nolide B analogs for production of no- vel erythromycins显示文摘Christopher C Scott F Sally O 2002Journal of Biotechnology2002,92,3:1
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