流行病学的文献评价.doc

the principle of simplified EIA of construction projects in the region. In terms of land, linked to the implementation of urban and rural construction land increase and decrease, replacement indicators for priority areas project. Charges, into the projects of water, electricity, administrative charges and preferential policies. In the area of taxation, and settled in areas of industry and its production company, within 5 years after the completion of fiscal incentives to enterprises. In terms of financing, integration of land, tax, financial and other resources, and construct Government credit + business credit credit system, establishment of marketization, commercialization and modernization of the investment and financing platform; effective Bank-enterprise docking, encourages private capital into the Park, to raise industry development fund. 5, optimize the environment and service industries. To create policy lowlands, Highlands, integrity of service land, development land as the goal, to optimize the area under development environment. All administrative law enforcement departments to appoint a full-time personnel stationed in areas dedicated to coordinating and solving problems associated with businesses in this sector. When there are substantial issues, sector leaders arranged to personally intervene, in-person, in-person push tangible area building a green light, easy line. To further reduce and standardize administrative examination and approval items, simplify examination and approval links, improve efficiency; according to the .Since the educational practice of the mass line of the party, himself seriously in the education, practical control central eight rules and opposing the four winds and practicing three Suns, and check the spirit of Jiao Yulu, ideology, solicit opinions based on outstanding problems checked swing, careful analysis and reflection. Will now check report is as follows: first, adherence to the partys political discipline, eight in the central provision, change the style of the basic situation of 1, in compliance with the partys political disciplines. Conscientiously abide by the partys political discipline, abide by the Constitution and the rules and regulations of the party, in the political, ideological and maintain highly consistent with the CPC Central Committee on the action, there is no violation of the partys political discipline problems. 2, in the implementation of the central authorities of the eight provisions. Improving research, improving research methods, but there are less grass-roots units, primary first-hand an inadequate grasp of the problem, which is to be strengthened in the future. Second, construction, strictly in accordance with the provisions to streamline and improve the quality of meetings of the Conference. Third, streamlining file briefs, culture involves all aspects of propaganda and ideology, sometimes due to the practical needs of invention notifications, this area needs further2012级临床流行病学治疗性研究文献评价姓名： 孙 博 学号： S12146 专业： 泌尿外 导师： 董 隽 一、 研究目的与选题1研究目的：该试验目的明确，探索盐酸坦索罗辛缓释胶囊联合非那雄胺治疗良性前列腺增生症的疗效。2文献依据：该试验选题依据有相关文献支持，包括：中国泌尿外科疾病诊断治疗指南、哈乐治疗103例良性前列腺增生的临床对照研究、长时间应用非那雄胺对老年大鼠前列腺组织的影响等。3创新性：该实验创新性欠佳，理由：盐酸坦索罗辛属于受体阻滞剂，非那雄胺属于5-还原酶抑制剂，这两类药物对良性前列腺增生症的治疗效果在单独应用及联合用药方面均在多年前已经获得中国泌尿外科疾病诊断治疗指南（2006年出版）的确认。4临床意义：该实验临床意义有限，理由：两种药物在临床已使用多年，盐酸坦索罗辛缓释胶囊（安斯泰来产约2000年在我国上市），非那雄胺（默沙东产约1994年在我国），作为两种治疗良性前列腺增生的常见药物，多年来国内外关于其临床疗效的相关文献发表很多，而该文献在2011年发表，故临床意义有限。二、 设计方案该试验属于治疗性研究，采用随机对照试验方案，但设计缺陷较多，具体如下：1随机化：该文仅提到“随机分为治疗组、对照组”但未提及具体随机化方法,这样难以判断其随机化分组是否正确、充分。2对照：该文设立了安慰剂对照组，含患者47例，实验组和对照组的病例均为该医院2007年4月一2009年3月的94例良性前列腺增生门诊患者。对照组有一定可比性，但文中仅提及“2组患者年龄、症状、最大尿流率、前列腺体积、残余尿量等无显著性(P005)，具有可比性”，未提及均衡性检验的具体方法及数据，组间差别不确定。3盲法：本研究未采用盲法，无法有效避免受试者或研究者的主观偏见和测量性偏倚。三、 研究对象1诊断标准：该文仅提及“所有病例诊断符合标准1”，未详细阐述诊断标准。经查阅文中参考文献1中国泌尿外科疾病诊断治疗指南，良性前列腺增生症的诊断标准为：以下尿路症状为主诉就诊的50岁以上男性患者，首先应该考虑BPH的可能,至少应行下列检查：病史及I-PSS、QOL评分 ；体格检查(直肠指诊)；尿常规；血清PSA；超声检查(包括残余尿量测定)；尿流率。2纳入标准：该文仅提及“所有病例入组前均查尿常规、血肝肾功能、血清前列腺特异性抗原(PSA)的测定和直肠指诊。”结合诊断标准，该文中患者入组前未提及病史、I-PSS评分、QOL评分、尿流率、超声检查，同时考虑到前列腺增生症是一种症状性疾病，诊断的主观性较大，该文的纳入标准不够明确。3排除标准：该文提及 “剔除标准：(1)伴有严重肝、肾功能不全者；(2)由感染、前列腺癌、尿道狭窄、膀胱低张力、神经源性紊乱等所致下尿路梗阻者；(3)治疗前2周内使用其他治疗前列腺增生药。” 并没有考虑到年龄因素、精神症状（主观精神因素对该病症状影响较大）、前列腺体积的影响而作出排除标准。4研究对象的代表性：良性前列腺增生症(BPH)是老年男性很常见的一种疾病，按照前列腺体积可以分为，按照IPSS评分可以分为轻度、中度、重度。该文中的入组对象均为该院门诊患者，未明确提及患者具体分型，对于评价两种药物的疗效有一定影响。四、 干预方案及实施1干预方案：1）文中仅提及“治疗组每日给予盐酸坦索罗辛缓释胶囊02 mg联合非那雄胺5 mg，连续服药”。2）文中未明确说明实用药物的厂家、剂型、规格，未提及服药时间（原则上非那雄胺应早上服用，坦索罗辛应睡前服用）。无明确统一化标准。2干预的依从性：该文中未提及患者依从性。3沾染与混杂：该文未提及沾染与混杂相关因素。五、 观察与测量1测量指标：文中选取的测量指标包括：前列腺体积、国际前列腺症状评分(IPSS)、最大尿流率Qmax、尿潴留和血尿的发生率、残余尿量。下面就测量指标的客观性、测量方法的真实性、可靠性进行阐述：1）前列腺体积、残余尿量的测量均采用国际通用的超声测量及通用公式，但是未考虑到超声检查的主观性，也未提及是否使用相同超声机器检查。2）国际前列腺症状评分(IPSS)主要考察的主观症状评分。3）最大尿流率Qmax的测定未提及使用的尿动力检查仪器的品牌，文中仅提及“要求患者饮水1 000 mL，待膀胱充盈，并有急迫尿意感时，嘱患者自然排尿”，这样并不能确定患者排尿时的膀胱容量，而排尿时的膀胱容量对“最大尿流率Qmax”的影响极大。 4）尿潴留和血尿的发生率，文中提及“对照组前列腺增生患者发生尿潴留3例，前列腺源性出血1例，观察12个月反复泌尿系感染8例”。并未对终点事件发生后的处理措施进行阐述。2盲法、失访：文中未提及盲法及失访，对终点事件的描述也不明确。3测量的质量控制：文中未提及相关质量控制措施。六、 数据分析与结果解释1统计学方法：该文献使用统计学SPSS软件，用2样本均数t检验比较前后各项观察指标的差异，P001为统计学显著性差异。但为提及SPSS软件的版本。2前列腺体积数据分析：该文数据显示：治疗组服药3个月后前列腺体积缩小105 (P001)，12个月观察前列腺体积缩小1505(P001)，具有显著性差异。说明治疗组应用盐酸坦索罗辛缓释胶囊联合非那雄胺治疗后前列腺体积明显缩小。3最大尿流率变化数据分析：该文数据显示：治疗组服药前3个月最大尿流率增加明显，12个月最大尿流率增加435 ml/s (P0O1)，具有显著性差异。说明治疗组应用盐酸坦索罗辛缓释胶囊联合非那雄胺治疗后最大尿流率明显增加。4国际前列腺症状评分变化数据分析：该文数据显示：治疗前2538 4-271，治疗12个月后1396 4-249，国际前列腺症状评分平均下降921分(P001)，具有统计学意义。说明治疗组应用盐酸坦索罗辛缓释胶囊联合非那雄胺治疗后国际前列腺症状评分明显下降。5残余尿量变化数据分析：该文数据显示：治疗前残余尿量3631 4-1869，治疗12个月后8991076，(P001)，残余尿量下降36 mL，具有统计学意义。说明治疗组应用盐酸坦索罗辛缓释胶囊联合非那雄胺治疗后残余尿量明显减少。6组间差异：该文仅阐述了治疗组应用盐酸坦索罗辛缓释胶囊联合非那雄胺治疗前后的数据对比。对照组的数据未进行统计学分析，治疗组与对照组之间的数据未做对比。7.终点事件及不良反应：该文仅提及治疗组未发生终点事件（尿潴留、血尿、前列腺增生引起的肾功能不全及反复的泌尿系统感染），对照组出现12例。文中对不良反应的描述模糊：“治疗组在用药34 d后1例出现头晕、乏力，1例出现胃肠道反应，可能与药物的不良反应有关，症状轻，一般23 d自行消失。对照组在用药24 d后2例出现胃肠道反应，一般12 d白行消失”，没有相应的处理措施。8.是否报告全部纳入病例：本研究94名患者按治疗方案接受治疗，随访12个月，文中并未提及失访情况。9.结论：应用盐酸坦索罗辛缓释胶囊联合非那雄胺治疗良性前列腺增生，迅速产生作用，显著缓解症状，防止或延缓前列腺增生的进展；联合用药，既可缩少前列腺体积，又能降低终点事件发生率，可以阻止良性前列腺增生的进展，显著地提高了患者的生活质量，患者的耐受性好，值得临床推广。七、 总结该研究试验目的明确，有相关文献支持，但是缺乏创新性，临床意义有限。在试验设计上，采用随机对照试验方案，但未提及具体随机方法；对照组有一定可比性，但未提及均衡性检验的具体方法及数据，组间差别不确定；未采用盲法。对良性前列腺增生症的诊断缺乏“金标准”或可量化的客观指标，纳入标准不够明确，排除标准考虑不全面。在干预方案的实施中，无统一化标准，未提及依从性、混杂、沾染等因素。数据测量方面，前列腺体积、残余尿量的测量未考虑到超声检查的主观性，也未提及是否使用相同超声机器检查；未考虑到IPSS评分的主观性；最大尿流率Qmax的测定中未考虑到排尿前的膀胱容量对结果的影响。未提及失访，对不良反应和终点事件的描述模糊。结果分析方面，仅对治疗组用药前后的数据进行了比较，对照组的数据未进行统计学分析，治疗组与对照组之间的数据未做对比。综上所述，该文献结论的推广还需要更大样本量、更多中心、更严格设计的RCT实验来进一步论证。发包人指定专人负责协调施工中的有关事宜，并监督施工进度、安全与文明施工。发包人对承包人施工中违规操作有权做好处理决定或经济处罚。streamlining. Four are standard visits, except as required to participate in training, no other activity. Five is to improve news reporting, for propaganda work strictly according to the regulations. Six is strictly your presentation published strictly according to the regulations. Seven is strictly thrift, required the use of vehicles and office space and corporate hospitality. 3, change the style. Propaganda and ideological work of the new situation and new requirements of the new tasks, had done a lot of fruitful work, has made many achievements, but further closer to the grass roots, close to reality, close to the masses and also inadequate innovation must continue to improve. Second, the four winds some outstanding issues 1, oppose formalism. One theory is that he didnt, with less close contact. Theoretical study of consciousness is not high enough, system performance is not strong enough; more passive learning, active learning few generalities and learn more, delving into less. Especially based on rational thinking on major issues, applying theory to guide the work done is not good enough, not really understand and grasp the spirit and essence of the scientific Outlook on development, did not truly achieve mastery, to apply, to a certain extent, affect the development and implementation of ideas and initiatives. Second, work arrangements, and less supervision. Propaganda and ideological work is the objective, which needs to keep the continuity efforts deployed, but stressed in the work time, less supervision. For example, color weekends in the summer theatrical activities, city square performances, urging townships, communities and rural areas shows the implementation is inadequate, insufficient cultural an educational role to play. Third base enough, master grass-less real. Propaganda and ideological work in the new situation of characteristics and regularity of enough, deep enough for grass-roots public opinion Dynamics survey, for grass-roots typically drive less. For example, rural culture team active, . Im not actively take the initiative to take up, the lack of spirit of daring to, resulting in some job had a lot of power, but