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| 1 | 帕博利珠单抗单用或与放疗联用治疗转移性非小细胞肺癌:两个随机试验的汇总分析显示文摘背景放疗可以提高整个机体对免疫治疗的应答。在Ⅱ期PEMBRO-RT研究和Ⅰ/Ⅱ期MDACC研究中,患有转移性非小细胞肺癌(NSCLC)的患者被随机分配入组,接受免疫治疗(帕博利珠单抗)+放疗联合疗法,或免疫治疗单一疗法。当上述2个研究单独分析时,联合疗法组显示出潜在获益。由于每个研究的样本量较小,缓解率和结局并未显示出统计学意义,然而却有显著的临床获益。因此,本研究进行汇总分析,来判断放疗是否会改善转移性NSCLC患者的免疫治疗应答。方法PEMBRO-RT和MDACC研究纳入标准:患者年龄≥18岁,患有转移性NSCLC,且有≥1处未经放疗照射的病灶,以便进行射野外应答监测。PEMBRO-RT研究纳入曾接受过化疗患者,MDACC研究纳入曾接受过治疗或新诊断患者。2个研究中的患者均未接受过免疫治疗。在PEMBRO-RT研究中患者被等比例随机分配入组,并根据吸烟状态进行分层(分为<10年组和≥10年组)。MDACC研究的患者根据放疗计划可行性被等比例随机分配入2个受试组。由于联合治疗组的干预本质,每个研究中的放疗均不适用盲法。在2个研究中,不论是否进行放疗,均静脉滴入帕博利珠单抗(每3周200 mg)。在PEMBRO-RT研究中,在放疗(24 Gy 3次分割照射)结束后1周给予第1剂帕博利珠单抗。在MDACC研究中,在第1次放疗(50 Gy 4次分割照射或45 Gy 15次分割照射)同时给予帕博利珠单抗。仅检测未经照射病灶的应答。本研究的终点为最佳射野外(远隔)应答率(ARR)、最佳射野外疾病控制率(ACR)、12周时ARR、12周时ACR、无进展生存期(PFS)和总生存期(OS)。2个研究的意向治疗(ITT)人群均纳入分析。PEMBRO-RT研究(NCT02492568)和MDACC研究(NCT02444741)均在ClinicalTrials.gov上注册。发现纳入148例患者,76例接受帕博利珠单抗治疗,72例接受帕博利珠单抗+放疗治疗。所有患者随访时间中位数为33个月[四分位距(IQR):32.4~33.6]。148例患者中124例(84%)组织学特征为非鳞癌,111例(75%)患者曾经接受过化疗。组间没有基线特征差异,包括PD-L1表达状态和转移灶体积。最常见的照射部位为肺转移灶(39%,28/72)、胸腔内淋巴结(21%,15/72)和非原发灶(17%,12/72)。帕博利珠单抗组和联合治疗组的最佳ARR分别为19.7%(15/76)和41.7%(30/72),OR=2.96,95%CI:1.42~6.20,P=0.0039;最佳ACR分别为43.4%(33/76)和65.3%(47/72),OR=2.51,95%CI:1.28~4.91,P=0.0071;PFS中位数分别为4.4(IQR:2.9~5.9)和9.0个月(IQR:6.8~11.2),HR=0.67,95%CI:0.45~0.99,P=0.045;OS中位数分别为8.7(IQR:6.4~11.0)和19.2个月(IQR:14.6~23.8),OR=0.67,95%CI:0.54~0.84,P=0.0004。在汇总分析中没有发现新的安全问题。解读帕博利珠单抗免疫疗法+放疗显著提高转移性NSCLC患者的应答和改善治疗结局。这些结果需要在三期临床试验中进行验证。 | 陈大卫(翻译) 于金明(校对) Willemijn S M E Theelen Vivek Verma Brian P Hobbs Heike M U Peulen Joachim G J V Aerts Idris Bahce Anna Larissa N Niemeijer Joe Y Chang Patricia M de Groot Quynh-Nhu Nguyen Nathan I Comeaux George R Simon Ferdinandos Skoulidis Steven H Lin Kewen He Roshal Patel John Heymach Paul Baas James W Welsh | 2021 | 中华肿瘤防治杂志2021，28，24： | 49 |
| 2 | Sharing Clinical Trial Data: A Proposal from the International Committee of Medical Journal Editors显示文摘The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk.In a growing consensus,many funders around the world-foundations,government agencies,and industry-now mandate data sharing.Here,we outline ICMJE's proposed requirements to help meet this obligation.We encourage feedback on the proposed requirements.Anyone can provide feedback at www.icmje.org by April 18,2016. | Darren B Taichman Joyce Backus Christopher Baethge Howard Bauchner Peter W de Leeuw Jeffrey M Drazen John Fletcher Frank Frizelle Irish Groves Abraham Haileamlak Astrid James Christine Laine Larry Peiperl Anja Pinborg Peush Sahni Si-Nan Wu | 2016 | Chinese Medical Journal2016，，2： | 20 |
| 3 | 血压变异性预测自发性脑出血患者的院内不良预后显示文摘越来越多的证据表明,较高的收缩压变异性(systolicblood pressure variability ,SBPV)可能与脑出血患者的不良预后相关。该研究探讨了 SB PV 与院内脑出血预后之间的关系。研究者在2个医疗系统中收集了10年的自发性脑出血患者的连续数据。记录人口统计学、病史、实验室测试、计算机断层扫描数据、院内治疗情况以及神经和功能评估。在入院后24h内获取血压记录。 | 刘青 叶鹏 Divani AA Liu X Di Napoli M Lattanzi S Ziai W James ML Jafarli A Jafari M Saver JL Hemphill JC Vespa PM Mayer SA Petersen A | 2019 | 中华高血压杂志2019，27，8： | 6 |
| 4 | 子痫前期:病理生理学和临床意义显示文摘子痫前期是一种常见疾病,尤其影响首次妊娠。其临床表现多样,但通常表现为高血压和蛋白尿。这些全身症状是由于在合体滋养细胞的压力作用下,胎盘释放了可溶性因子。子痫前期主要有早发型和迟发型2种亚型,其他几种亚型目前尚未确定。早发型子痫前期是由于胎盘缺陷而出现,而迟发型子痫前期可能是由于胎盘的正常衰老,以及母体对心血管和代谢疾病的遗传易感性交互产生。子痫前期因胎盘和母体因素产生的原因因人而异。最近的研究主要集中在早孕期的胎盘-子宫相互作用。本文旨在对关于子痫前期的预测、预防和治疗方法的最新文献进行归纳综述。 | Graham J Burton Christopher W Redman James M Roberts Ashley Moffett 秦萌(译) 金滢 潘凌亚(校 | 2019 | 英国医学杂志中文版2019，22，11： | 6 |
| 5 | Quality in the technical performance of colonoscopy and the continuous quality improvement process for colonoscopy: recommendations of the U.S. Multi-Society Task Force on Colorectal Cancer显示文摘 | Douglas K Rex John H Bond Sidney Winawer Theodore R Levin Randall W Burt David A Johnson Lynne M Kirk Scott Litlin David A Lieberman Jerome D Waye James Church John B Marshall Robert H Riddell | 2002 | The American Journal of Gastroenterology2002，，6： | 3 |
| 6 | Gastric intestinal metaplasia is associated with gastric dysplasia but is inversely correlated with esophageal dysplasia显示文摘AIM To determine which clinical factors might be associated with gastric intestinal metaplasia(IM) in a North American population.METHODS Pathology and endoscopy databases at an academicmedical center were reviewed to identify patients with and without gastric IM on biopsies for a retrospective cohort study. Patient demographics, insurance status, and other clinical factors were reviewed.RESULTS Four hundred and sixty-eight patients with gastric IM(mean age: 61.0 years ± 14.4 years, 55.5% female) and 171 without gastric IM(mean age: 48.8 years ± 20.8 years, 55.0% female) were compared. The endoscopic appearance of atrophic gastritis correlated with finding gastric IM on histopathology(OR = 2.05, P = 0.051). Gastric IM was associated with histologic findings of chronic gastritis(OR = 2.56, P < 0.001), gastric ulcer(OR = 6.97, P = 0.015), gastric dysplasia(OR = 6.11, P = 0.038), and gastric cancer(OR = 6.53, P = 0.027). Histologic findings of Barrett's esophagus(OR = 0.28, P = 0.003) and esophageal dysplasia(OR = 0.11, P = 0.014) were inversely associated with gastric IM. Tobacco use(OR = 1.73, P = 0.005) was associated with gastric IM.CONCLUSION Patients who smoke or have the endoscopic finding of atrophic gastritis are more likely to have gastric IM and should have screening gastric biopsies during esophagogastroduodenoscopy(EGD). Patients with gastric IM are at increased risk for having gastric dysplasia and cancer, and surveillance EGD with gastric biopsies in these patients might be reasonable. | Justin M Gomez James T Patrie Wissam Bleibel Jeanetta W Frye Bryan G Sauer Vanessa M Shami Edward B Stelow Christopher A Moskaluk Andrew Y Wang | 2017 | World Journal of Gastrointestinal Endoscopy2017，9，2： | 3 |
| 7 | Machine learning models compared to existing criteria for noninvasive prediction of endoscopic retrograde cholangiopancreatography-confirmed choledocholithiasis显示文摘Background and aims:Noninvasive predictors of choledocholithiasis have generally exhibited marginal performance characteristics.We aimed to identify noninvasive independent predictors of endoscopic retrograde cholangiopancreatography(ERCP)-confirmed choledocholithiasis and accordingly developed predictive machine learning models(MLMs).Methods:Clinical data of consecutive patients undergoing first-ever ERCP for suspected chol-edocholithiasis from 2015 to 2019 were abstracted from a prospectively-maintained database.Multiple logistic regression was used to identify predictors of ERCP-confirmed choledocholithiasis.MLMs were then trained to predict ERCP-confirmed choledocholithiasis using pre-ERCP ultrasound(US)imaging only as well as using all available noninvasive imaging(US,computed tomography,and/or magnetic reso-nance cholangiopancreatography).The diagnostic performance of American Society for Gastrointestinal Endoscopy(ASGE)“high-likelihood”criteria was compared to MLMs.Results:We identified 270 patients(mean age 46 years,62.2%female,73.7%Hispanic/Latino,59%with noninvasive imaging positive for choledocholithiasis)with native papilla who underwent ERCP for suspected choledocholithiasis,of whom 230(85.2%)were found to have ERCP-confirmed chol-edocholithiasis.Logistic regression identified choledocholithiasis on noninvasive imaging(odds ratio(OR)¼3.045,P¼0.004)and common bile duct(CBD)diameter on noninvasive imaging(OR¼1.157,P¼0.011)as predictors of ERCP-confirmed choledocholithiasis.Among the various MLMs trained,the random forest-based MLM performed best;sensitivity was 61.4%and 77.3%and specificity was 100%and 75.0%,using US-only and using all available imaging,respectively.ASGE high-likelihood criteria demonstrated sensitivity of 90.9%and specificity of 25.0%;using cut-points achieving this specificity,MLMs achieved sensitivity up to 97.7%.Conclusions:MLMs using age,sex,race/ethnicity,presence of diabetes,fever,body mass index(BMI),total bilirubin,maximum CBD diameter,and choledocholithiasis on pre-ERCP noninvasive imaging predict ERCP-confirmed choledocholithiasis with good sensitivity and specificity and outperform the ASGE criteria for patients with suspected choledocholithiasis. | Camellia Dalai John M Azizian Harry Trieu Anand Rajan Formosa C Chen Tien Dong Simon W Beaven James H.Tabibian | 2021 | Liver Research2021，5，4： | 3 |
| 8 | Drugs Associated with Hepatotoxicity and their Reporting Frequency of Liver Adverse Events in VigiBase(TM)显示文摘 | Suzuki Ayako Andrade Raul J Bjornsson Einar Lucena M Isabel Lee William M Yuen Nancy A Hunt Christine M Freston James W | 2010 | Drug Safety2010，，6： | 2 |
| 9 | Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials显示文摘 | Naveed Sattar David Preiss Heather M Murray Paul Welsh Brendan M Buckley Anton JM de Craen Sreenivasa Rao Kondapally Seshasai John J McMurray Dilys J Freeman J Wouter Jukema Peter W Macfarlane Chris J Packard David J Stott Rudi G Westendorp James Shepherd | 2010 | The Lancet2010，，9716： | 2 |
| 10 | Insulin resistance is associated with chronic hepatitis C and virus infection fibrosis progression显示文摘 | Jason M Hui Archana Sud Geoffrey C Farrell Priyanka Bandara Karen Byth James G Kench Geoffrey W McCaughan Jacob George | 2003 | Gastroenterology2003，，6： | 2 |
| 11 | Comparison of the efficacy and safety of rosuvastatin versus atorvastatin , simvastatin , and pravastatin across doses (STELLAR * * STELLAR = Statin Therapies for Elevated Lipid Levels compared Across doses to Rosuvastatin. Trial)显示文摘 | Peter H Jones Michael H Davidson Evan A Stein Harold E Bays James M McKenney Elinor Miller Valerie A Cain James W Blasetto | 2003 | The American Journal of Cardiology2003，，2： | 2 |
| 12 | Portal hypertension in polycystic liver disease patients does not affect wait-list or immediate post-liver transplantation outcomes显示文摘AIM To establish the impact of portal hypertension(PH) on wait-list/post-transplant outcomes in patients with polycystic liver disease(PCLD) listed for liver transplantation. METHODS A retrospective single-centre case controlled study of consecutive patients listed for liver transplantation over 12 years was performed from our centre. PH in the PCLD cohort was defined by the one or more of following parameters:(1) presence of radiological or endoscopic documented varices from our own centre or the referral centre;(2) splenomegaly(> 11 cm) on radiology inabsence of splenic cysts accounting for increased imaging size;(3) thrombocytopenia(platelets < 150 × 109/L); or(4) ascites without radiological evidence of hepatic venous outflow obstruction from a single cyst. RESULTS Forty-seven PCLD patients(F: M = 42: 5) were listed for liver transplantation(LT)(single organ, n = 35; combined liver-kidney transplantation, n = 12) with 19 patients(40.4%) having PH. When comparing the PH group with non-PH group, the mean listing age(PH group, 50.6(6.4); non-PH group, 47.1(7.4) years; P = 0.101), median listing MELD(PH group, 12; non-PH group, 11; P = 0.422) median listing UKELD score(PH group, 48; non-PH group, 46; P = 0.344) and need for renal replacement therapy(P = 0.317) were similar. In the patients who underwent LT alone, there was no difference in the duration of ICU stay(PH, 3 d; non-PH, 2 d; P = 0.188), hospital stay length(PH, 9 d; non-PH, 10 d; P = 0.973), or frequency of renal replacement therapy(PH, 2/8; non-PH, 1/14; P = 0.121) in the immediate post-transplantation period. CONCLUSION Clinically apparent portal hypertension in patients with PCLD listed for liver transplantation does not appear to have a major impact on wait-list or peri-transplant morbidity. | Neil Rajoriya Dhiraj Tripathi Joanna A Leithead Bridget K Gunson Sophie Lord James W Ferguson Gideon M Hirschfield | 2016 | World Journal of Gastroenterology2016，22，45： | 2 |
| 13 | Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials显示文摘 | Naveed Sattar David Preiss Heather M Murray Paul Welsh Brendan M Buckley Anton JM de Craen Sreenivasa Rao Kondapally Seshasai John J McMurray Dilys J Freeman J Wouter Jukema Peter W Macfarlane Chris J Packard David J Stott Rudi G Westendorp James Shepherd | 2010 | The Lancet2010，，9716： | 2 |
| 14 | β-Rhizobia from Mimosa pigra, a newly discovered invasive plant in Taiwan 显示文摘 | CHEN W M JAMES E K CHOU J H | 2005 | New Phytologist2005，168，3： | 1 |
| 15 | Quantitation of asbestos in synthetic mixtures using instrumental neutron activation analysis 显示文摘 | Pravin P P Richard J J James S W Thomas M S | 1992 | Analytical Chemistry1992，64，3： | 1 |
| 16 | Comprehensive, quantitative, congener-specific analysis of eight aroclors and complete PCB congener assignments 显示文摘 | George M F Robert E W James C C | 1996 | Chernosphere1996，33，： | 1 |
| 17 | Assessment and learning: Differ- enees and relationships between ormative and summa- rive assessment显示文摘 | Harlen W James M | 1997 | Assessment in Education: Princi- ples Policy and Practice1997，4，3： | 1 |
| 18 | Dy-namic loads on transmission line structures due to gal-loping conductors 显示文摘 | Baenziger M A James W D Wouters B | 1994 | IEEE Transactions on PowerDelivery1994，9，1： | 1 |
| 19 | Transitional care after the intensive care unit:Current trends and future directions显示文摘 | Chaboyer W James H Kendall M | 2005 | Crit Care Nurse2005，25，3： | 1 |
| 20 | Photorefractive volume holographic demodulation of in-fiber Bragg grating sensors 显示文摘 | S W James M L Dockney R P Tatam | 1996 | IEEE Photon Technol Lett1996，8，5： | 1 |
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