摘要：Objective: The objective of the study was to determine whether the Toyota production system process improves Papanicolaou test quality and patient safety. Study design: An 8-month nonconcurrent cohort study that included 464 case and 639 control women who had a Papanicolaou test was performed. Of fice workflow was redesigned using Toyota production system methods by introducing a 1-by-1 continuous flow process. We measured the frequency of Papanicolaou tests without a transformation zone component, follow-up and Bethesda System diagnostic frequency of atypical squamous cells of undetermined significance, and diagnostic error frequency. Results: After the intervention, the percentage of Papanicolaou tests lacking a transformation zone component decreased from 9.9%to 4.7%(P = .001). The percentage of Papanicolaou tests with a diagnosis of atypical squamous cells of undetermined significance decreased from 7.8%to 3.9%(P = .007). The frequency of error per correlating cytologic-histologic specimen pair decreased from 9.52%to 7.84%. Conclusions: The introduction of the Toyota production system process resulted in improved Papanicolaou test quality.

摘要：The purpose of this study was to test whether modafinil is effective in alleviating the symptoms of fatigue in postpolio patients, because it has been helpful for such symptoms in other neurologic disorders. Using a double-blind, randomized, placebo-controlled cross-over design, 14 postpolio patients with moderate to severe fatigue were assigned to receive modafinil or placebo first. Piper Fatigue Scale, Epworth Sleepiness Scale, digit span, and reaction time tests were done at baseline and then at weekly intervals. The Piper Fatigue Scale scores im proved by 27 ±40%(mean ±SD) following modafinil and by 43 ±36%following pla cebo. Scores for most of the other tests did not change during the study. Therefore, we conclude that modafinil was not effective in alleviating the symptoms of fatigue in postpolio patients.

摘要：Objective: This study was undertaken to evaluate the performance of a 1- stop clinic for first- trimester assessment of risk (OSCAR)for trisomy 21 by a combination of maternal age, fetal nuchal translucency (NT) thickness, and maternal serum- free β - human chorionic gonadotrophin (hCG) and pregnancy- associated plasma protein- A (PAPP- A). Study design: OSCAR was carried out in 30,564 pregnancies at 11 to 13+ 6 weeks. Patient- specific risks for trisomy 21 and detection and falsepositive rates were calculated. Results: The median maternal age was 34 (range 15- 49) years. Chromosomal abnormalities were identified in 330 pregnancies, including 196 cases of trisomy 21. The estimated risk for trisomy 21 was 1 in 300 or greater in 7.5% of the normal pregnancies, in 93.4% of those with trisomy 21 and in 88.8% of those with other chromosomal defects. Conclusion: The most effective method of screening for chromosomal defects is by first- trimester fetal NT and maternal serum biochemistry.

摘要：目的对需要抗心绞痛治疗并且左心室功能代偿症状稳定的心绞痛患者建立预测全因死亡、心肌梗死和导致致残性卒中的复合危险评分。设计大型多中心临床试验数据的多变量Cox回归分析。背景西欧、以色列、加拿大、澳大利亚和新西兰的心脏专科门诊患者。入选者7311例具有全部需要资料的患者被入选。主要结局的测量指标平均随访4.9年时间内所有原因的死亡、心肌梗死或者致残性卒中。结果1063例患者发生任何原因死亡或者持久性心肌梗死或者致残性卒中。这些复合终点的5年危险性在危险性最低的十分位患者为4%,而在危险性最高的十分位患者为35%。危险评分结合16项临床常规变量的降序排序是:年龄、左心室射血分数、吸烟、白细胞计数、糖尿病、随机血糖浓度、肌酐浓度、既往卒中病史、1周至少1次心绞痛发作、冠状动脉造影发现(如果能够获得)、降脂治疗、QT间期、收缩期血压≥150mmHg、抗心绞痛药物数量、陈旧性心肌梗死以及性别。把这个模型分别应用于任何原因所致的死亡、心肌梗死和卒中进行预测评估,所得的结果相似。危险评分似乎不能预测事件性质(39%的死亡、46%心肌梗死以及15%致残性卒中)或者冠状动脉造影或血管重建率(占29%的患者)。结论该危险评分对客观地决定稳定性心绞痛患者进一步治疗措施以减少重要预后事件发生是有帮助的。该危险评分同样可以用于将来的计划性试验。

摘要：系统评价/Meta分析是循证医学重要的研究方法和最佳证据的重要来源之一,是当前临床医学各专业使用最频繁的工具之一。掌握系统评价方法还有助于提高临床研究设计的质量及发表高水平学术论文的能力。

摘要：背景：目前，有关社区中动脉粥样硬化血栓形成稳定患者心血管（cardiovascular，CV）事件发生率的资料比较少，既往也无国际性队列研究对冠状动脉病（coronary artery disease，CAD）、脑血管病（cerebrovascular disease，CVD）、外周动脉病（peripheral arterial disease，PAD）确诊患者以及此类疾病高危患者不同事件的发生率进行评估。目的：在患有动脉疾病的门诊患者或存在多个动脉粥样硬化血栓形成危险因素的门诊患者中确定当今世界1年内CV事件的发生率。设计、地点及参试者：“减少动脉粥样硬化血栓形成维系健康（Reduction of Artherotllrombosis for Continued Health，REACH）”注册研究是一项国际前瞻性队列研究。研究人员于2003—2004年从44个国家、5587名医生入选68236例已确诊的动脉粥样硬化性血管病患者（CAD、PAD、CVD；n=55814）以及至少存在3个动脉粥样硬化血栓形成危险因素的患者（n=12422）。主要观测指标：CV死亡、心肌梗死（myocardial infarction，MI）及卒中的发生率。结果：截至2006年7月，共有95．22％的患者（n=64977）提供了1年内的结局。心血管死亡、MI及卒中的总体发生率为4．24％；动脉粥样硬化性血管病患者为4．69％，仅存在多个危险因素的患者为2．15％。CAD、CVD及PAD患者CV死亡、MI及卒中的总体发生率分别为4．52％、6．47％和5．35％。CAD、CVD及PAD患者发生终点事件（即CV死亡、MI、卒中）以及因动脉粥样硬化血栓形成事件入院的几率分别为15．20％、14．53％和21．14％。上述事件发生率随症状性动脉疾病病变部位数量的增加而增加，仅存在危险因素的患者为5．31％，有1处症状性动脉疾病的患者为12．58％，有2处症状性动脉疾病的患者为21．14％，有3处症状性动脉疾病的患者为26．27％（趋势P〈0．001）。结论：在这项当代大型国际研究中，患有动脉粥样硬化性血管病的门诊患者以及有动脉粥样硬化血栓形成危险的门诊患者CV事件的年发生率相对较高。存在多部位病变者CV事件的1年发生率升高。

摘要：为了提高系统综述和荟萃分析文章报告的质量,2009年由国际著名专家组成的系统综述和荟萃分析优先报告的条目(Preferred Reporting Items for Systematic Reviews and Meta-Analyses,PRISMA)小组在国际重要医学期刊包括《英国医学杂志》、《临床流行病学杂志》、《内科学年鉴》和美国《公共科学图书馆医学杂志》等同步发表了《系统综述与荟萃分析优先报告条目:PRISMA声明》。该标准的制定对于改进和提高系统综述和荟萃分析的报告质量将起到重要作用。该声明较以往制定的《随机对照试验荟萃分析报告质量》(Quality of Reporting of Meta-Analyses),即《QUOROM声明》更加全面、完善。由于近年采国内外对系统综述的高度重视,发表的文章数量也越来越多,因此,有必要规范报告的标准,提高报告的质量。这份声明对系统综述和荟萃分析类文章报告的27个条目及流程图进行了定义和介绍,对相关条目进行了详细的解释和说明。及时向国内读者和临床试验研究人员介绍该声明具有重要的现实意义和学术价值。北京中医药大学循证医学中心刘建平等在第一时间内翻译了该声明,本刊希望通过介绍中文版《系统综述与荟萃分析优先报告的条目:PRISMA声明》,以进一步提高国内系统综述文章撰写和报告的质量,同时也有助于改进研究设计的方法学质量。本文的英文原文"Preferred reporring items for systematic reviews and meta-analyses:the PRISMAstatement"发表于PLoS Med.2009;6(7):***:10.1371/***.1000097。该文中文版本由北京中医药大学循证医学中心李迅、曹卉娟翻译,刘建平审校(Tel:010-64286760;E-mail:jianping_l@***)。中文译文的翻译出版由国家重点基础研究发展计划(973计划)项目资助(No.200608504602)。

摘要：Objective: The purpose of this study was to examine the sonographic features of trisomy 13 at 11 to 13+ 6 weeks of gestation. Study design: This was a retrospective study that examined the features of trisomy 13 at the ultrasound scan at 11 to 13+ 6 weeks of gestation, which in our center is performed for the measurement of crown-rump length, nuchal translucency thickness, and fetal heart rate and the examination for major defects. Results: In the 181 fetuses with trisomy 13, there were holoprosencephaly, exomphalos, and/or megacystis in 92 fetuses (50.2% ), fetal heart rate above the 95th percentile in 129 fetuses (71.3% )- , and nuchal translucency above the 95th percentile in 141 fetuses (77.9% ). There was no significant association between nuchal translucency and fetal heart rate, and it was estimated that inclusion of fetal heart rate in nuchal translucency screening can improve the detection rate of trisomy 13 by approximately 5% . Conclusion: At the 11 to 13+ 6- week scan, the measurement of fetal nuchal translucency and fetal heart rate and fetal examination for holoprosencephaly, exomphalos, and megacystis can identify >90% of fetuses with trisomy 13.

摘要：目的:观察 Fondaparinux 对具有中高度静脉血栓发生危险的老年急性内科住院患者的抗凝效果与安全性。设计:双盲随机安慰剂对照研究。背景:8个国家的35个中心。参与者:849例≥60岁内科患者,住院原因分别为充血性心力衰竭、慢性肺病合并急性呼吸系统疾患、急性炎症性或感染性疾病,预期至少住院4天以上。干预:2.5 mg Fondaparinux 或安慰剂,每天1次皮下注射,持续6～14天。观察指标:主要指标为静脉血栓形成(治疗后15天内采用双侧静脉造影检查)及有症状的静脉血栓;次要指标为死亡与出血。患者随访时间为1个月。结果:Fondaparinux 治疗组425例患者和安慰剂组414例患者接受了安全性分析(10例未治疗)。644例患者(75.9%)可接受主要指标分析。静脉血栓检出率在 Fondaparinux 治疗组为5.6%(18/321),安慰剂组为10.5%(34/323),相对危险减少46.7%(95% CI 7.7%～69.3%)。安慰剂组5例患者发生有症状的静脉血栓,Fondaparinux治疗组无患者发生有症状的静脉血栓(P=0.029)。两组均有1例(0.2%)患者发生严重出血。随访结束时,安慰剂组、Fondaparinux 治疗组分别死亡25(6.0%)、14(3.3%)例患者。结论:Fondaparinux 可有效预防急性内科老年患者无症状性及有症状的静脉血栓。严重出血几率两组相似。

摘要：背景：人们对基因与环境在原发性帕金森病（Parkinson disease,PD)中的相对作用，一直存在争论。虽然基因研究已识别出2个基因，它们的突变可引起罕见的单基因PD变异型，观察研究也提示有遗传成分，但是孪生子研究却表明遗传在PD常见型中几乎不起作用。目的：确定原发性PD的遗传性危险因素。设计、地点和参加者：于1995－2000年进行的基因连锁研究。该研究在美国大陆和澳大利亚的13个临床人群，通过先证者找出174个有多人被诊断患原发性PD的家系，进行了全基因组搜索（n=344标记物）。共检查870名家庭成员：378人诊断患PD，379人无PD，113人未定。主要观察指标：从参数和非参数遗传连锁分析得出优势对数（logarithm of odds,lod)得分。结果：用两点参数的最大参数Lod得分（MLOD）和多点非参数lod得分（LOD）的连锁分析检查5个不同的染色体区连锁的重要证据：在至少有1人于40岁前发生PD的家系中，是6号染色体上的parkin基因（MLOD＝5．07；LOD＝5．47），在全部家系及晚发PD的家系中，是染色体17q(MLOD=2.28;LOD=2.62),8p(MLOD=2.01;LOD=2.22)和5q(MLOD=2.39;LOD=1.50)，在含左旋多巴有效和无效的两种患者的家系中，是染色体9q(MLOD=1.52;LOD=2.59).结论：我们的数据表明，在早发PD中parkin基因是重要的，在原发性晚发PD的发生中则可能有多个遗传因素具有重要作用。