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| 1 | 帕博利珠单抗治疗伴脑转移NSCLC患者的一项非随机、开放Ⅱ期试验的长期随访结果和生物标志物分析显示文摘背景与目的我们开展了一项帕博利珠单抗用于伴未治疗脑转移的非小细胞肺癌(non-small cell lung cancer,NSCLC)或黑色素瘤患者的疗效和安全性的II期试验,旨在评估程序性死亡受体1(programmed cell death 1,PD-1)抑制剂在中枢神经系统(central nervous system,CNS)中的疗效。中期结果已发表,现报道对NSCLC队列的更新分析结果。方法这是一项开放性、单中心、II期试验。纳入标准:年龄≥18岁,诊断为晚期NSCLC并伴有≥1个5 mm-20 mm脑转移病灶,既往从未治疗或之前放疗后进展,无神经系统症状,不需要激素治疗且美国东部肿瘤协作组(Eastern Cooperative Oncology Group,ECOG)<2分。患者每2周接受一次帕博利珠单抗(10 mg/kg)治疗。队列1为程序性死亡配体1(programmed cell death ligand 1,PD-L1)≥1%的患者,队列2为PD-L1<1%或未评估的患者。主要终点是脑转移患者缓解比例。所有经治患者均纳入疗效与安全性终点的分析。该研究已结束入组,并于Clinicaltrials.gov登记注册,注册号为NCT02085070。结果2014年3月31日-2018年5月21日,共42例患者接受治疗。中位随访时间为8.3个月(IQR:4.5个月-26.2个月)。队列1的37例患者中11例有脑转移缓解[29.7%(95%CI:15.9%-47.0%)]。队列2未观察到缓解。治疗相关的3级-4级不良事件(adverse events,AEs)包括2例肺炎、1例全身症状、1例结肠炎、1例肾上腺皮质功能不全、1例高血糖症和1例低钾血症。6例(14%)患者发生了治疗相关的严重不良事件,包括肺炎、急性肾损伤、低钾血症和肾上腺皮质功能不全。没有观察到治疗相关死亡病例。结论帕博利珠单抗治疗PD-L1≥1%的NSCLC伴脑转移患者有效,且对所有纳入的未经治疗的脑转移患者安全。需要进一步探索免疫治疗用于NSCLC合并CNS转移。 | Sarah B GOLDBERG Kurt A SCHALPER Scott N GETTINGER Amit MAHAJAN Roy S HERBST Anne C CHANG Rogerio LILENBAUM Frederick H WILSON Sacit Bulent OMAY James B YU Lucia JILAVEANU Thuy TRAN Kira PAVLIK Elin ROWEN Heather GERRSH Annette KOMLO Richa GUPTA Hailey WYATT Matthew RIBEIRO Yuval KLUGER Geyu ZHOU Wei WEI Veronica L CHANG Harriet M KLUGER 董晓荣(翻译/校对) | 2021 | 中国肺癌杂志2021，24，9： | 34 |
| 2 | 新生儿复苏培训降低新生儿死亡率的效能分析:文献综述,meta分析与Delphi法的应用显示文摘[背景]全球每年13600万新生儿中,约1000万需要外界的帮助才能建立自主呼吸,每年有约814000例新生儿死亡是由分娩相关足月儿死亡(以往定义为'出生窒息')所导致的。目前尚缺乏关于新生儿复苏培训降低新生儿死亡率效能的系统性评价。[目的]对在医院和社区层面开展的快速评估及初步刺激、基本的复苏措施这两种新生儿复苏培训干预方法在降低足月新生儿分娩相关死亡率('出生窒息')、早产相关并发症死亡率这两个生命指标方面的效能进行评价。[方法]采用系统综述的方法,检索并筛选符合标准的新生儿复苏培训研究文献。采用GRADE方法对文献的质量进行评价。对符合要求的文件进行Meta分析。对数据质量较低的文献采用专家咨询法估计效能大小。[结果]通过文献检索筛选了24篇新生儿复苏培训干预研究(20篇观察性研究,2篇半试验研究,2篇随机对照研究)。对其中3篇文献进行Meta分析结果显示,以医院为基础的新生儿复苏培训可使分娩相关足月儿死亡降低30%(RR=0.70,95%CI0.59~0.84);文献中涉及早产儿死亡率效能的数据质量不高,因此采用专家咨询法进行估计。以社区为基础的新生儿复苏培训干预研究具有较高的异质性,复苏培训通常是一系列培训包的一部分,且对早产儿和足月儿的定义标准不一致。专家咨询法估计结果显示,新生儿快速评估和初步刺激可使分娩相关新生儿死亡、早产儿死亡均降低10%;以医院为基础的培训可使早产儿死亡进一步降低10%,以社区为基础的培训可使分娩相关足月儿死亡率进一步降低20%,早产儿死亡率进一步降低5%。[结论]新生儿复苏培训在医院层面可以使足月新生儿分娩相关死亡率降低30%,然而中低收入水平的国家培训覆盖率仍较低。专家咨询法估计新生儿复苏培训在社区层面降低足月儿及早产儿死亡率的效能较小。需要对新生儿复苏培训的效果、成本、实施策略等进行更深入的研究与评价。 | Anne CC Lee Simon Cousens Stephen N Wall 徐韬 | 2012 | 中国妇幼卫生杂志2012，3，2： | 11 |
| 3 | Folic acid supplementation inhibits recurrence of colorectal adenomas:A randomized chemoprevention trial显示文摘AIM: To determine whether folic acid supplementation will reduce the recurrence of colorectal adenomas, the precursors of colorectal cancer, we performed a double-blind placebo-controlled trial in patients with adenomatous polyps. METHODS: In the current double-blind, placebo-controlled trial at this VA Medical Center, patients with colorectal adenomas were randomly assigned to receive either a daily 5 mg dose of folic acid or a matched identical placebo for 3 years. All polyps were removed at baseline colonoscopy and each patient had a follow up colonoscopy at 3 years. The primary endpoint was a reduction in the number of recurrent adenomas at 3 years. RESULTS: Of 137 subjects, who were eligible after confirmation of polyp histology and run-in period to conform compliance, 94 completed the study; 49 in folic acid group and 45 in placebo group. Recurrence of adenomas at 3-year was compared between the two groups. The mean number of recurrent polyps at 3-year was 0.36 (SD, 0.69) for folic acid treated patients compared to 0.82 (SD, 1.17) for placebo treated subjects, resulting in a 3-fold increase in polyp recurrence in the placebo group. Patients below 70 years of age and those with left-sided colonicadenomas or advanced adenomas responded better to folic acid supplementation. CONCLUSION: High dose folic acid supplementation is associated with a signif icant reduction in the recurrence of colonic adenomas suggesting that folic acid may be an effective chemopreventive agent for colorectal neoplasia. | Richard Jaszewski Sabeena Misra Martin Tobi Nadeem Ullah Jo Ann Naumoff Omer Kucuk Edi Levi Bradley N Axelrod Bhaumik B Patel Adhip PN Majumdar | 2008 | World Journal of Gastroenterology2008，14，28： | 10 |
| 4 | Retrograde-viewing device improves adenoma detection rate in colonoscopies for surveillance and diagnostic workup显示文摘AIM:To determine which patients might benefit most from retrograde viewing during colonoscopy through subset analysis of randomized,controlled trial data.METHODS:The Third Eye Retroscope Randomized Clinical Evaluation(TERRACE) was a randomized,controlled,multicenter trial designed to evaluate the efficacy of a retrograde-viewing auxiliary imaging device that is used during colonoscopy to provide a second video image which allows viewing of areas on the proximal aspect of haustral folds and flexures that are difficult to see with the colonoscope's forward view.We performed a post-hoc analysis of the TERRACE data to determine whether certain subsets of the patient population would gain more benefit than others from use of the device.Subjects were patients scheduled for colonoscopy for screening,surveillance or diagnostic workup,and each underwent same-day tandem examinations with standard colonoscopy(SC) and Third Eye colonoscopy(TEC),randomized to SC followed by TEC or vice versa.RESULTS:Indication for colonoscopy was screening in 176/345 subjects(51.0%),surveillance after previous polypectomy in 87(25.2%) and diagnostic workup in 82(23.8%).In 4 subjects no indication was specified.Previously reported overall results had shown a net additional adenoma detection rate(ADR) with TEC of 23.2% compared to SC.Relative risk(RR) of missing adenomas with SC vs TEC as the initial procedure was 1.92(P = 0.029).Post-hoc subset analysis shows additional ADRs for TEC compared to SC were 4.4% for screening,35.7% for surveillance,55.4% for diagnostic and 40.7% for surveillance and diagnostic combined.The RR of missing adenomas with SC vs TEC was 1.11(P = 0.815) for screening,3.15(P = 0.014) for surveillance,8.64(P = 0.039) for diagnostic and 3.34(P = 0.003) for surveillance and diagnostic combined.Although a multivariate Poisson regression suggested gender as a possibly significant factor,subset analysis showed that the difference between genders was not statistically significant.Age,bowel prep quality and withdrawal time did not significantly affect the RR of missing adenomas with SC vs TEC.Mean sizes of adenomas detected with TEC and SC were similar at 0.59 cm and 0.56 cm,respectively(P = NS).CONCLUSION:TEC allows detection of significantly more adenomas compared to SC in patients undergoing surveillance or diagnostic workup,but not in screening patients(ClinicalTrials.gov Identifier:NCT01044732). | Peter D Siersema Amit Rastogi Anke M Leufkens Paul A Akerman Kassem Azzouzi Richard I Rothstein Frank P Vleggaar Alessandro Repici Giacomo Rando Patrick I Okolo Olivier Dewit Ana Ignjatovic Elizabeth Odstrcil James East Pierre H Deprez Brian P Saunders Anthony N Kalloo Bradley Creel Vikas Singh Anne Marie Lennon Daniel C DeMarco | 2012 | World Journal of Gastroenterology2012，18，26： | 6 |
| 5 | Impact of chronic disease self-management programs on type 2 diabetes management in primary care显示文摘AIM: To assess the effectiveness of the Chronic Disease Self-Management Program(CDSMP) on glycated hemoglobin A1c(HbA1c) and selected self-reported measures.METHODS: We compared patients who received a diabetes self-care behavioral intervention, the CDSMP developed at the Stanford University, with controls whoreceived usual care on their HbA1c and selected self-reported measures, including diabetes self-care activities, health-related quality of life(HRQOL), pain and fatigue. The subjects were a subset of participants enrolled in a randomized controlled trial that took place at seven regional clinics of a university-affiliated integrated healthcare system of a multi-specialty group practice between January 2009 and June 2011. The primary outcome was change in HbA1c from randomization to 12 mo. Data were analyzed using multilevel statistical models and linear mixed models to provide unbiased estimates of intervention effects.RESULTS: Demographic and baseline clinical characteristics were generally comparable between the two groups. The average baseline HbA1c values in the CDSMP and control groups were 9.4% and 9.2%, respectively. Significant reductions in HbA1c were seen at 12 mo for the two groups, with adjusted changes around 0.6%(P < 0.0001), but the reductions did not differ significantly between the two groups(P = 0.885). Few significant differences were observed in participants' diabetes self-care activities. No significant differences were observed in the participants' HRQOL, pain, or fatigue measures.CONCLUSION: The CDSMP intervention may not lower HbA1c any better than good routine care in an integrated healthcare system. More research is needed to understand the benefits of self-management programs in primary care in different settings and populations. | Samuel N Forjuoh Marcia G Ory Luohua Jiang Ann M Vuong Jane N Bolin | 2014 | World Journal of Diabetes2014，5，3： | 6 |
| 6 | Update on Cardiovascular Implantable Electronic Device Infections and Their Management: A Scientific Statement From the American Heart Association显示文摘 | Larry M. Baddour Andrew E. Epstein Christopher C. Erickson Bradley P. Knight Matthew E. Levison Peter B. Lockhart Frederick A. Masoudi Eric J. Okum Walter R. Wilson Lee B. Beerman Ann F. Bolger N A. Mark Estes Michael Gewitz Jane W. Newburger Eleanor B. S | 2010 | Circulation2010，，3： | 4 |
| 7 | 运用ICF评定肌肉骨骼系统健康状况的影响显示文摘目的建议联合使用国际疾病分类(ICD)及国际功能、残疾和健康分类(ICF),并应用肌肉骨骼系统(MSK)状况的例子来说明运用方法。方法根据在ICD中MSK状况的分类和现有的ICF核心分类集(ICF Core Sets)MSK状况的类目作为备选类目来专门说明专项功能。另一方法是考虑来自在文献中出现的已经应用的测量方法或工具的类目。结果从6个MSK状况的核心分类集、两种特定的保健治疗环境、一种MSK临床研究环境和8篇工具相关的文献中抽取相关的ICF类目。结论 ICD-ICF联合使用通过考虑疾病和功能状况来强调健康状况的影响,从而促进临床保健治疗。因此,有证据显示,在ICD修订版背景下ICD和ICF之间有可操作性的联系和互补作用。 | Nenad Kostanjsek Reuben Escorpizo Annelies Boonen Nicolas E.Walsh Tefvik Bedirhan stün Gerold Stucki 李晶晶 祝捷 邹智 荀芳 邱卓英 | 2011 | 中国康复理论与实践2011，17，2： | 4 |
| 8 | Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial显示文摘 | David N Krag Stewart J Anderson Thomas B Julian Ann M Brown Seth P Harlow Joseph P Costantino Takamaru Ashikaga Donald L Weaver Eleftherios P Mamounas Lynne M Jalovec Thomas G Frazier R Dirk Noyes André Robidoux Hugh MC Scarth Norman Wolmark | 2010 | Lancet Oncology2010，，10： | 3 |
| 9 | Anti-porcine circovirus type 2(PCV2) antibody placental barrier leakage from sow to fetus: impact on the diagnosis of intra-uterine PCV2 infection显示文摘Dear Editor,Fetuses develop antibodies when they are infectedwith porcine circovirus type 2(PCV2).At abortion orbirth,both PCV2 and/or anti-PCV2 antibodies can thenbe detected.Finding anti-PCV2 antibodies in aborted fe-tuses or stillborn piglets is generally used as evidence ofan intra-uterine PCV2 infection.However,a recent anal-ysis of fetuses sent in for PCV2 diagnosis and caesare-an-derived,colostrum-deprived pigs revealed that | Dipongkor Saha Rubén Del Pozo Sacristán Nicolaas Van Renne Liping Huang Ruben Decaluwe Annelies Michiels Alfonso Lopez Rodriguez Maria José Rodrí-guez Margarita García Durán Ilse Declerk Dominiek Maes Hans J. Nauwynck | 2014 | Virologica Sinica2014，29，2： | 3 |
| 10 | Translational pain research: Evaluating analgesic effect in experimental visceral pain models显示文摘Deep visceral pain is frequent and presents major challenges in pain management, since its pathophysiology is still poorly understood. One way to optimize treatment of visceral pain is to improve knowledge of the mechanisms behind the pain and the mode of action of analgesic substances. This can be achieved through stand-ardized experimental human pain models. Experimental pain models in healthy volunteers are advantageous for evaluation of analgesic action, as this is often diff icult to assess in the clinic because of confounding factors such as sedation, nausea and general malaise. These pain models facilitate minimizing the gap between knowledge gained in animal and human clinical studies. Combining experimental pain studies and pharmacokinetic stud- ies can improve understanding of the pharmacokinetic-pharmacodynamic relationship of analgesics and, thus, provide valuable insight into optimal clinical treatment of visceral pain. To improve treatment of visceral pain, it is important to study the underlying mechanisms of pain and the action of analgesics used for its treatment. An experimental pain model activates different modalities and can be used to investigate the mechanism of action of different analgesics in detail. In combination with pharmacokinetic studies and objective assessment such as electroencephalography, new information re-garding a given drug substance and its effects can be obtained. Results from experimental human visceral pain research can bridge the gap in knowledge between animal studies and clinical condition in patients suffering from visceral pain, and thus constitute the missing link in translational pain research. | Anne Estrup Olesen Trine Andresen Lona Louring Christrup Richard N Upton | 2009 | World Journal of Gastroenterology2009，15，2： | 3 |
| 11 | Essential role of TRPC1 channels in cardiomyoblasts hypertrophy mediated by 5-HT 2A serotonin receptors显示文摘 | Cécile Vindis Romina D’Angelo Elodie Mucher Anne Nègre-Salvayre Angelo Parini Jeanne Mialet-Perez | 2009 | Biochemical and Biophysical Research Communications2009，，1： | 2 |
| 12 | Technical outcomes of sentinel-lymph-node resection and conventional axillary-lymph-node dissection in patients with clinically node-negative breast cancer: results from the NSABP B-32 randomised phase III trial显示文摘 | David N Krag Stewart J Anderson Thomas B Julian Ann M Brown Seth P Harlow Takamaru Ashikaga Donald L Weaver Barbara J Miller Lynne M Jalovec Thomas G Frazier R Dirk Noyes André Robidoux Hugh MC Scarth Denise M Mammolito David R McCready Eleftherios P Mamo | 2007 | Lancet Oncology2007，，10： | 2 |
| 13 | Insulin resistance and adiposity correlate with acute-phase reaction and soluble cell adhesion molecules in type 2 diabetes显示文摘 | Eeva Leinonen Eva Hurt-Camejo Olov Wiklund Lillemor Mattson Hultén Anne Hiukka Marja-Riitta Taskinen | 2002 | Atherosclerosis2002，，： | 2 |
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| 18 | Epitope mapping of cytochrome P4502D6 autoantigen in patients with chronic hepatitis C during α-interferon treatment显示文摘 | Georgios N Dalekos Heiner Wedemeyer Petra Obermayer-Straub Anne Kayser Ayse Barut Hannah Frank Michael P Manns | 1999 | Journal of Hepatology1999，，3： | 1 |
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