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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 | AGNP精神科治疗药物监测共识指南:2011显示文摘治疗药物监测(Therapeutic drug monitoring,TDM),如通过定量测定血清或血浆药物浓度指导用药剂量优化,已经成为对患者进行精神药物治疗的很有价值的工具。在患者用药依从性难以判断、药物耐受性不佳、治疗剂量下无效以及可能存在药代动力学药物-药物相互作用等情况下,测定药物浓度是很有用的。在精神科,有可能明显获益于TDM的主要患者群体包括儿童、孕妇、老年患者、智力障碍患者、涉及司法的患者、已知或怀疑携带药代动力学相关基因变异的患者,以及合并躯体疾病影响药代动力学的患者。然而,只有将TDM充分整合到临床治疗过程中去,才能发挥其优化药物治疗的潜在优势。为了促进TDM的合理应用,神经精神药理学与药物精神病学协会(Arbeitsgemeinschaft für Neuropsychopharmakologie und Pharmakopsychiatrie,AGNP)的TDM专家组在2004年发表了精神药物治疗药物监测指南。之后,随着知识不断更新,又有许多可能需要进行TDM的新药上市。因此,本次更新将神经精神药物的种类扩展到了128种,并将其TDM必要性划分为从'强烈推荐'到'可能有用'的四个等级。经过大量细致且全面的文献检索与分门别类的汇总整理,将基于循证医学理念的'治疗参考浓度范围'和'剂量相关参考浓度范围'呈现给大家。本共识指南引入了'实验室警戒浓度'的新概念,即实验室需要马上告知治疗医生的药物浓度上限。本共识指南还给出了诸如药物作为细胞色素P450酶的底物和抑制剂的性质,代谢物与母药浓度比值的常见范围,以及与结果解释相关的内容,还提供了何时将TDM与遗传药理学检测相结合的建议。遵循本指南,有助于改善许多患者精神药物治疗的效果,特别是那些存在药代动力学异常的患者。TDM是一门交叉学科,有时针对看起来不一致的数据,需要多学科坦诚地讨论,只有这样,患者才能从这种合作中获益。 | Hiemke C Baumann P Bergemann N Conca A Dietmaier O Egberts K Fric M Gerlach M Greiner C Gründer G Haen E Havemann-Reinecke U Jaquenoud Sirot E Kirchherr H Laux G Lutz UC Messer T Müller MJ Pfuhlmann B Rambeck B Riederer P Schoppek B Stingl J Uhr M Ulrich S Waschgler R Zernig G 李文标(译) 果伟(译) 阮灿军(译) 贺静(译) 汤宜朗(审校) 王传跃(审校) | 2016 | 实用药物与临床2016，19，10： | 37 |
| 3 | 利妥昔单抗治疗重度ANCA相关性血管炎与常规免疫抑制剂疗效相同显示文摘新英格兰医学杂志2013年8月发表了美国学者的研究结果,18个月的单疗程利妥昔单抗治疗重度抗中性粒细胞胞浆抗体(antineutrophilcytoplasmicantibody,ANCA)相关性血管炎,与常规免疫抑制剂环磷酰胺联合硫唑嘌呤的疗效相同。 | Specks U Merkel PA Seo P 王建中 | 2013 | 中华肾病研究电子杂志2013，2，5： | 33 |
| 4 | 腹股沟疝复发的时间分析显示文摘目的假设不同术式疝修补术术后复发的发病过程是不同的,那么疝复发的时间也是不同的。该研究的目的是分析影响初次手术到复发后再次手术时间间隔的危险因素。方法研究数据来自瑞典疝登记注册系统。将5年随访期间的每一年的资料作为亚组分列,后合为大组。对于每个危险因素以再次手术为研究终点,运用Cox回归分析复发时间与危险因素之间的关系。结果共分析了142578例,其中7.7%是女性,年龄平均59岁。5年总体复发率为4.3%。多因素分析显示复发疝修补后再次复发的时间较早(P<0.05);第一次手术后如果发生并发症,则发生复发也较早(P<0.05);缝合修补或腹腔镜修补后的复发要早于开放式补片修补者(P<0.05)。通过单因素分析提示,所有缝合修补的早期复发的危险要高于所有补片修补早期复发的危险(P<0.05)。结论不同术式疝修补术后复发的发病过程是不同的。腹腔镜修补、传统疝修补术(不应用补片)和复发疝修补术后早期复发率高可能是由于手术技术失误率较高。 | Magnusson N Nordin P Hedberg M Gunnarsson U Sandblom G | 2011 | 中国实用外科杂志2011，31，4： | 20 |
| 5 | Meta分析方法系统性分析腹腔镜疝修补术的选择——TEP与TAPP显示文摘腹股沟疝修补术是最常见的手术之一。一个好的疝修补术应该是操作简单、手术时间短、安全。手术结果必须是创伤小、疼痛轻以及复发率低口j。腹腔镜疝修补术和传统的开放式疝修补术(openherniarepair,OHR)相比,术后疼痛轻、对患者限制少。目前,在临床上使用最多的腹腔镜疝修补术方法分别是:经腹腔腹膜前疝修补(transabdominalpreperitoneal,TAPP)和完全腹膜外疝修补(totallyextraperitonealherniarepair,TEP)。本文运用随机对照法研究资料,分析TEP与TAPP孰优孰劣。 | Bracale U Melillo P Pignata G Di Salvo E Rovani M Merola G Pecchia L Surg Endosc 陈大伟 | 2013 | 中华疝和腹壁外科杂志(电子版)2013，7，4： | 15 |
| 6 | Chronic constipation in hemiplegic patients显示文摘AIM: To assess the prevalence of bowel dysfunction in hemiplegic patients, and its relationship with the site of neurological lesion, physical immobilization and pharmacotherapy. METHODS: Ninety consecutive hemiplegic patients and 81 consecutive orthopedic patients were investigated during physical motor rehabilitation in the same period, in the same center and on the same diet. All subjects were interviewed ≥ 3 mo after injury using a questionnaire inquiring about bowel habits before injury and at the time of the interview. Patients’ mobility was evaluated by the Adapted Patient Evaluation Conference System. Drugs considered for the analysis were nitrates, angiogenic converting enzyme (ACE) inhibitors, calcium antagonists, anticoagulants, antithrombotics, antidepressants, anti-epileptics. RESULTS: Mobility scores were similar in the two groups. De novo constipation (OR = 5.36) was a frequent outcome of the neurological accident. Hemiplegics showed an increased risk of straining at stool (OR: 4.33), reduced call to evacuate (OR: 4.13), sensation of incomplete evacuation (OR: 3.69), use of laxatives (OR: 3.75). Logistic regression model showed that constipation was significantly and independently associated with hemiplegia. A positive association was found between constipation and use of nitrates and antithrombotics in both groups. Constipation was not related to the site of brain injury. CONCLUSION: Chronic constipation is a possible outcome of cerebrovascular accidents occurring in 30% of neurologically stabilized hemiplegic patients. Its onset after a cerebrovascular accident appears to be independent from the injured brain hemisphere, and unrelated to physical inactivity. Pharmacological treatment with nitrates and antithrombotics may represent an independent risk factor for developing chronic constipation. | F Bracci D Badiali P Pezzotti G Scivoletto U Fuoco L Di Lucente A Petrelli E Corazziari | 2007 | World Journal of Gastroenterology2007，13，29： | 15 |
| 7 | 轻质材料气门的研究显示文摘多年来,减轻发动机运动件的质量是发动机制造业中的一项重点研究课题。过去是通过设计措施来减轻气门传动机构的运动质量。在进一步挖掘传统气门传动机构材料和结构轻型化的潜力情况下,一些替代材料,诸如陶瓷、钛-铝(Ti-Al)引起了人们重视。因而,BMW公司就这类气门对整个发动机的主要性能产生的影响进行了研究。 | Hoyer U Rahnavardi P 盛汉荣 | 2000 | 国外内燃机2000，，2： | 14 |
| 8 | 氧化铝对铁矿石烧结质量和生产率的影响(英文)显示文摘烧结矿是现代高炉生产的主要含铁原料。合理控制入炉烧结矿的理化性能与冶金性能对高炉生产和稳定操作是很必要的。铁矿粉是烧结矿的主要原料,其化学成分和烧结料层内的热量条件在烧结过程中起着重要的作用。化学成分等参数也决定着烧结矿矿相结构和质量。由于含氧化铝原料的低反应性及其液相的高粘性,因此在人们的预料中高铝矿石对烧结矿结构组成的影响并不好。烧结混合料中的氧化铝在同化过程中需要消耗大量热量,延迟烧结过程。在确保高炉渣的流动性方面,氧化铝也需要消耗较大热量。不论是烧结还是高炉的生产实绩均表明,氧化铝是有害的。一般而言,高含铁量与低脉石的印度矿与其他矿石的不同特点就是氧化铝含量高。由于高品味铁矿石的消耗殆尽,使用可利用的烧结原料成为生产必需。因此,必须要掌握氧化铝的作用及其对烧结矿质量和生产过程的影响。实验室完成了不同氧化铝含量水平(2.00%~5.46%)的实验,可从中了解氧化铝在烧结矿矿物学、生产率、物理性能和冶金性能方面的影响。随着烧结矿中氧化铝含量的增加,残存赤铁矿、复合铁酸钙(SFCA)和孔隙率增加,而磁铁矿和硅酸盐比例下降。烧结生产率和烧结矿转鼓强度(TI)随着氧化铝含量上升而下降,反映烧结矿冶金性能的诸如低温还原粉化率(RDI)和还原率(RI)提高。 | T Umadevi S Prakash U K Bandopadhyay P C Mahapatra M Prabhu Madhu Ranjan | 2010 | 世界钢铁2010，，1： | 4 |
| 9 | 在有症状的患者中,与传统危险因素相比,冠状动脉钙化积分能更准确地预测显著的冠状动脉狭窄:欧洲钙化性冠状动脉疾病研究显示文摘在这项回顾性研究中,研究人员评估了冠状动脉钙化积分相对于传统危险因素对显著狭窄(冠状动脉狭窄〉50%)的预测价值。方法与结果:纳入来自丹麦、法国、德国、意大利、西班牙和美国有症状的患者5515例,所有研究对象均进行危险因素评估、计算机断层冠状动脉造影(computed tomographic coronary angiogram,CTCA)或常规血管造影。 | 刘莉 叶鹏 Nicoll R Wiklund U Zhao Y Diederichsen A Mickley H Ovrehus K Zamorano P Gueret P Schmermund A Maffei E Cademartiri F Budoff M Henein M | 2016 | 中华高血压杂志2016，24，3： | 4 |
| 10 | Role of interleukin-1 and its antagonism of hepatic stellate cell proliferation and liver fibrosis in the Abcb4^(-/-) mouse model显示文摘AIM: To study the interleukin-1(IL-1) pathway as a therapeutic target for liver fibrosis in vitro and in vivo using the ATP-binding cassette transporter b4^(-/-)(Abcb4^(-/-)) mouse model.METHODS: Female and male Abcb4^(-/-) mice from 6 to 13 mo of age were analysed for the degree of cholestasis(liver serum tests), extent of liver fibrosis(hydroxyproline content and Sirius red staining) and tissue-specific activation of signalling pathways such as the IL-1 pathway [quantitative polymerase chain reaction(q PCR)]. For in vivo experiments, murine hepatic stellate cells(HSCs) were isolated via pronasecollagenase perfusion followed by density gradient centrifugation using female mice. Murine HSCs were stimulated with up to 1 ng/m L IL-1β with or without 2.5 μg/m L Anakinra, an IL-1 receptor antagonist, respectively. The proliferation of murine HSCs was assessed via the Brd U assay. The toxicity of Anakinra was evaluated via the fluorescein diacetate hydrolysis(FDH) assay. In vivo 8-wk-old Abcb4^(-/-) mice with an already fully established hepatic phenotype were treated with Anakinra(1 mg/kg body-weight daily intraperitoneally) or vehicle and liver injury and liver fibrosis were evaluated via serum tests, q PCR, hydroxyproline content and Sirius red staining. RESULTS: Liver fibrosis was less pronounced in males than in female Abcb4^(-/-) animals as defined by a lower hydroxyproline content(274 ± 64 μg/g vs 436 ± 80 μg/g liver, respectively; n = 13-15; P < 0.001; MannWhitney U-test) and lower m RNA expression of the profibrogenic tissue inhibitor of metalloproteinase-1(TIMP)(1 ± 0.41 vs 0.66 ± 0.33 fold, respectively; n = 13-15; P < 0.05; Mann-Whitney U-test). Reduced liver fibrosis was associated with significantly lower levels of F4/80 m RNA expression(1 ± 0.28 vs 0.71 ± 0.41 fold, respectively; n = 12-15; P < 0.05; Mann-Whitney U-test) and significantly lower IL-1β m RNA expression levels(1 ± 0.38 vs 0.44 ± 0.26 fold, respectively; n = 13-15; P < 0.001; Mann-Whitney U-test). No gender differences in the serum liver parameters [bilirubin; alanine aminotransferase(ALT); aspartate aminotransferase and alkaline phosphatase(AP)] were found. In vitro, the administration of IL-1β resulted in a significant increase in HSC proliferation [0.94 ± 0.72 arbitrary units(A.U.) in untreated controls, 1.12 ± 0.80 A.U. at an IL-1β concentration of 0.1 ng/m L and 1.18 ± 0.73 A.U. at an IL-1β concentration of 1 ng/m L in samples from n = 6 donor animals; P < 0.001; analyses of variance(ANOVA)]. Proliferation was reduced significantly by the addition of 2.5 μg/m L Anakinra(0.81 ± 0.60 A.U. in untreated controls, 0.92 ± 0.68 A.U. at an IL-1β concentration of 0.1 ng/m L, and 0.91 ± 0.69 A.U. at an IL-1β concentration of 1 ng/m L; in samples from n = 6 donor animals; P < 0.001; ANOVA) suggesting an anti-proliferative effect of this clinically approved IL-1 receptor antagonist. The FDH assay showed this dose to be non-toxic in HSCs. In vivo, Anakinra had no effect on the hepatic hydroxyprolinecontent, liver serum tests(ALT and AP) and profibrotic(collagen 1α1, collagen 1α2, transforming growth factor-β, and TIMP-1) and anti-fibrotic [matrix metalloproteinase 2(MMP2), MMP9 and MMP13 ] gene expression after 4 wk of treatment. Furthermore, the hepatic IL-1β and F4/80 m RNA expression levels were unaffected by Anakinra treatment.CONCLUSION: IL-1β expression is associated with the degree of liver fibrosis in Abcb4^(-/-) mice and promotes HSC proliferation. IL-1 antagonism shows antifibrotic effects in vitro but not in Abcb4^(-/-) mice. | Florian P Reiter Ralf Wimmer Lena Wottke Renate Artmann Jutta M Nagel Manuel O Carranza Doris Mayr Christian Rust Peter Fickert Michael Trauner Alexander L Gerbes Simon Hohenester Gerald U Denk | 2016 | World Journal of Hepatology2016，8，8： | 3 |
| 11 | 欧洲和中国的心脏与肾脏远程缺血预适应研究:一项随机对照试验显示文摘远程缺血预适应(remote ischemic preconditioning,RIPC)对经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)术后造影剂肾病(contrast-induced nephropathy,CIN)的潜在保护作用尚待确定。该研究为双盲、随机、安慰剂对照的多中心研究,纳入年龄〈85岁,肾清除率为30~60mL/(min·1.73m^2)的有临床适应证的患者,除了直接PCI外均按1∶1给予RIPC或标准治疗。主要终点是CIN的发生率。次要终点是围手术期心肌梗死(peri-procedural myocardial infarction,PMI)的发生率。 | 刘青 叶鹏 Moretti C Cerrato E Cavallero E Lin S Rossi ML Picchi A Sanguineti F Ugo F Palazzuoli A Bertaina M Presbitero P Shao-Liang C Pozzi R Giammaria M Limbruno U Lefèvre T Gasparetto V Garbo R OmedèP Sheiban I Escaned J Biondi-Zoccai G Gaita F Perl L D'Ascenzo F | 2018 | 中华高血压杂志2018，26，4： | 3 |
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