将比较效益研究理念引入中医临床评价研究

比较效益研究（comparative effectiveness research,CER）的兴起在西方发达国家的医疗卫生改革浪潮中引起了巨大反响。CER也被称作为＂以病人为中心的结局研究＂。CER关心的核心问题是有效性、安全性和成本。CER不是一种具体的方法,也不是一个具体的学科,而是目前世界医学研究领域里的一种新理念。本文通过介绍CER兴起的背景、特点、具体内容,并通过对相关资料的总结,归纳出中医临床评价研究领域将来如何开展CER,旨在为今后的中医临床评价研究提供一些新的思路。     

美国CER和GWTG研究择撷与教益

深化医疗卫生体制改革和有效提升卫生保健服务效率是全球性难题,美国基于企望阻遏医疗卫生费用膨胀,提高卫生保健服务效益比的“疗效比较研究（CER）”,在全球经济危机背景下出笼。始于2000年针对冠心病、心力衰竭和脑卒中的“遵循指南”（GWTG）研究方兴未艾,入选患者已达100万人,在循证指南指导下,规范医疗行为,提高诊疗质量和改善患者预后的效益已经显现。笔者对CER和GWTG的研究背景与内涵作了介绍,并对CER和GWTG研究的教益,结合我国医疗卫生体制改革有关问题进行了探讨。     

比较效果研究常用方法之一:实用型随机对照试验设计

比较效果研究(comparative effectiveness research,CER)是在注重不同干预措施临床效果间比较的基础上,得出相对的临床效果,为指导临床决策提供依据。因此"效果"是此类研究评价和关注的焦点,与传统的解释性随机对照试验(randomized controlled trial,RCT)所评价的"效力"不同[1]。"效果"(effectiveness)是指一种特定的医疗干预措施在现实环境中针对某一特定人群的实际效果或作用程     

实效研究在中医传统疗法研究中的运用

实效研究(CER)以患者为中心,强调在真实医疗环境中评价综合疗效,对综合评价中医传统疗法具有实际应用价值,通过超大样本数据有效克服了因样本含量不足造成的抽样误差,体现了中医以病人为本,注重综合干预和个体化辨证论治等特点,对建立中医传统疗法循证医学证据体系具有重要意义.     

医疗大数据研究现状及其临床应用

介绍医疗大数据的内涵及其对医学研究的影响，指出医疗领域大数据研究的必要性，总结现阶段医疗大数据的研究现状，提出医疗大数据研究中的若干问题。分析医疗大数据如何应用于临床医学，包括临床诊断和临床药效分析等方面。     

临床医疗与研究复合型高级人才培养的探索与实践

介绍了首都医科大学在临床医疗与研究复合型高级人才培养中的探索与实践过程,提出了培养临床医疗与研究复合型高级人才的途径和方法。     

国外医疗风险管理措施和成效及对我国的启示

本文分别介绍了美国、英国采取的医疗风险管理措施和取得的成效,并提出了我国医疗风险管理应从中借鉴的经验,以期逐步完善我国医疗风险事前预防和事后处理措施,从而减少医疗差错等不安全事件发生,缓和医患矛盾。     

无汞体温计的应用与研究进展

本研究介绍无汞体温计的测温原理、测量部位及方法 ,综述了无汞体温计测量体温的研究现状,展望了无汞体温计的应用前景,提出医疗机构应积极响应"无汞医疗"行动,规范无汞体温计的管理措施和医务人员测温行为,真正实现无汞体温计测温快速、测温准确、测温安全、使用简便的目标,节省临床护理时间及减少汞对环境污染的危险,为临床患者的诊治提供可靠依据。     

免疫透射比浊法测定血清铜蓝蛋白

血清铜蓝蛋白(CER)属于一种时相反应蛋白,它是一种含铜的a2糖蛋白,分子量约12～16万,其具有氧化酶的活性,对多酚及多胺类底物有催化其氧化的能力.近年来的研究结果认为,CER起着抗氧化物和自由基的生成,在炎症进程度中具有重要意义,在感染、创伤和肿瘤等疾病时,血清CER可明显增加,其特殊作用于患者血清中CER含量明显下降时可协助Wilson病的诊断.     

队列研究的设计、实施及方法学问题

队列研究在循证医学的证据等级中为Ⅱ级证据。仅次于随机对照试验,是临床医疗防治措施评价的重要证据来源之一。近年来开始在传统医学疗法评价中得到应用。本文较为系统地介绍了队列研究的基本概念、原理、设计类型、实施步骤以及在中医药领域运用的关键方法学问题．旨在为中医药的临床研究拓宽思路，为新方法的引用提供借鉴。     

Brief communication: pSCANNER: patient-centered Scalable National Network for Effectiveness Research

This article describes the patient-centered Scalable National Network for Effectiveness Research (pSCANNER), which is part of the recently formed PCORnet, a national network composed of learning healthcare systems and patient-powered research networks funded by the Patient Centered Outcomes Research Institute (PCORI). It is designed to be a stakeholder-governed federated network that uses a distributed architecture to integrate data from three existing networks covering over 21 million patients in all 50 states: (1) VA Informatics and Computing Infrastructure (VINCI), with data from Veteran Health Administration''s 151 inpatient and 909 ambulatory care and community-based outpatient clinics; (2) the University of California Research exchange (UC-ReX) network, with data from UC Davis, Irvine, Los Angeles, San Francisco, and San Diego; and (3) SCANNER, a consortium of UCSD, Tennessee VA, and three federally qualified health systems in the Los Angeles area supplemented with claims and health information exchange data, led by the University of Southern California. Initial use cases will focus on three conditions: (1) congestive heart failure; (2) Kawasaki disease; (3) obesity. Stakeholders, such as patients, clinicians, and health service researchers, will be engaged to prioritize research questions to be answered through the network. We will use a privacy-preserving distributed computation model with synchronous and asynchronous modes. The distributed system will be based on a common data model that allows the construction and evaluation of distributed multivariate models for a variety of statistical analyses.     

腹腔镜胃癌 D2根治术的安全性、肿瘤根治性以及术后早期疗效

目的：观察腹腔镜下胃癌D2根治术的安全性、肿瘤根治性以及术后早期疗效。方法将72例胃癌患者按照入院先后顺序随机分为2组各36例。其中对照组采取传统开腹胃癌切除术,观察组实施腹腔镜胃癌 D2根治术,比较2组早期疗效、肿瘤根治性及手术安全性。结果观察组手术时间显著长于对照组,切口长度、术中出血量、胃肠功能恢复时间、下床活动时间及平均住院时间均显著短于或少于对照组（P ＜0．05或＜0．01）;2组淋巴结清扫数目、肿瘤近切缘长度和远切缘长度差异均无统计学意义（P ＞0．05）;观察组术后并发症发生率为11．11％（4／36）,显著低于对照组的27．78％（10／36）（P ＜0．05）。结论腹腔镜下胃癌 D2根治术近期疗效好,安全性高,且手术创伤小,有利于患者的术后恢复,具有较好的临床应用价值。     

改良经剑突下及肋弓下切口术式与传统经胸壁切口术式切除胸腺肿瘤的临床疗效对比研究

目的　比较改良经剑突下及肋弓下切口术式与传统经胸壁切口术式切除胸腺肿瘤的临床疗效。方法　选取2013年1月—2017年12月于沧州市中心医院胸外科行胸腺肿瘤切除术的患者175例,根据切口入路不同分为剑突下切口组（95例）与胸壁切口组（80例）。剑突下切口组应用改良经剑突下及肋弓下切口术式,胸壁切口组应用传统经胸壁切口术式。比较两组患者手术时间、术中出血量、术后带管时间、住院时间及术后第1、3天视觉模拟评分法（VAS）评分、术后并发症情况。结果　剑突下切口组手术时间、术后带管时间、住院时间短于胸壁切口组,术中出血量少于胸壁切口组,术后第1、3天VAS评分及并发症发生率低于胸壁切口组（P<0.05）。结论　改良经剑突下及肋弓下切口术式切较传统经胸壁切口术式切除胸腺肿瘤的手术时间短,操作更简单,患者创伤更小,术后疼痛更轻,恢复快,住院时间短,且并发症少。     

高职高专医学院校学生学习效果调查

目的分析影响高职高专医学院校学生学习效果的因素,探索提高医学高等职业教育教学效果的途径。方法采用自行设计问卷对639名学生进行基本情况、学习现状、教学满意度、影响学习成绩的原因等项目的调查。教学效果评价以专业基础课成绩均分（满分100）为准（≥85分为甲等、≤70分为丙等、其余为乙等）。采用SPSS14．0对数据进行统计处理,不同专业组学生学习效果等级比较采用秩和检验,以影响学生学习效果的因素为自变量,学习效果的等级为因变量,进行有序回归多因素分析。结果护理专业学生与临床医学专业学生的学习效果差异有统计学意义（Z=-4．817,P=O．000）;专业兴趣、家庭教育方式、中学教育方式、是否课前预习和对学风的满意度是影响学生学习效果的因素。结论加强专业思想教育和学风建设,激励并指导学生采取适宜的学习方法,可帮助其提高学习效果。     

Brief communication: Launching PCORnet,a national patient-centered clinical research network

The Patient-Centered Outcomes Research Institute (PCORI) has launched PCORnet, a major initiative to support an effective, sustainable national research infrastructure that will advance the use of electronic health data in comparative effectiveness research (CER) and other types of research. In December 2013, PCORI''s board of governors funded 11 clinical data research networks (CDRNs) and 18 patient-powered research networks (PPRNs) for a period of 18 months. CDRNs are based on the electronic health records and other electronic sources of very large populations receiving healthcare within integrated or networked delivery systems. PPRNs are built primarily by communities of motivated patients, forming partnerships with researchers. These patients intend to participate in clinical research, by generating questions, sharing data, volunteering for interventional trials, and interpreting and disseminating results. Rapidly building a new national resource to facilitate a large-scale, patient-centered CER is associated with a number of technical, regulatory, and organizational challenges, which are described here.     

A system to build distributed multivariate models and manage disparate data sharing policies: implementation in the scalable national network for effectiveness research

Background Centralized and federated models for sharing data in research networks currently exist. To build multivariate data analysis for centralized networks, transfer of patient-level data to a central computation resource is necessary. The authors implemented distributed multivariate models for federated networks in which patient-level data is kept at each site and data exchange policies are managed in a study-centric manner.Objective The objective was to implement infrastructure that supports the functionality of some existing research networks (e.g., cohort discovery, workflow management, and estimation of multivariate analytic models on centralized data) while adding additional important new features, such as algorithms for distributed iterative multivariate models, a graphical interface for multivariate model specification, synchronous and asynchronous response to network queries, investigator-initiated studies, and study-based control of staff, protocols, and data sharing policies.Materials and Methods Based on the requirements gathered from statisticians, administrators, and investigators from multiple institutions, the authors developed infrastructure and tools to support multisite comparative effectiveness studies using web services for multivariate statistical estimation in the SCANNER federated network.Results The authors implemented massively parallel (map-reduce) computation methods and a new policy management system to enable each study initiated by network participants to define the ways in which data may be processed, managed, queried, and shared. The authors illustrated the use of these systems among institutions with highly different policies and operating under different state laws.Discussion and Conclusion Federated research networks need not limit distributed query functionality to count queries, cohort discovery, or independently estimated analytic models. Multivariate analyses can be efficiently and securely conducted without patient-level data transport, allowing institutions with strict local data storage requirements to participate in sophisticated analyses based on federated research networks.     

超声引导下新型水灌肠仪器灌肠与传统空气灌肠治疗小儿肠套叠的有效性及安全性研究

背景　传统的X线引导下的空气灌肠治疗肠套叠存在较大的辐射,且有较大穿孔风险。目的　探讨超声引导下新型水灌肠仪器灌肠与传统空气灌肠在小儿肠套叠治疗中的有效性及安全性。方法　选取2016-05-10至2016-08-02于重庆医科大学附属儿童医院就诊,且符合纳入标准的原发性肠套叠患儿60例。使用电脑产生的随机数将其分为水灌肠组及空气灌肠组,各30例。水灌肠组使用超声引导下水灌肠仪器灌肠,空气灌肠组使用传统空气灌肠。观察记录两组患儿的复位成功率、复发率、复位时间及灌肠压力。结果　两组复位成功率、复发率比较,差异无统计学意义（P>0.05）。水灌肠组复位时间长于空气灌肠组,灌肠压力高于空气灌肠组（P<0.001）。两组均没有肠穿孔及迟发型肠坏死发生。结论　超声引导下新型水灌肠仪器灌肠治疗小儿肠套叠的复位成功率及复发率与传统空气灌肠无统计学差异,其复位时间较空气灌肠长,压力也更大,但是由于其压力可控等优点,仍值得推广使用。     

Clinical curative effect of electric acupuncture on acute cerebral infarction: a randomized controlled multicenter trial

ObjectiveTo examine whether electric acupuncture can improve the daily life of patients with ischemic cerebral apoplexy at acute stage.MethodsA stratified-block randomized controlled multicenter trial was designed for this study. Totally 340 patients with acute ischemic cerebral apoplexy were randomly divided into an electric acupuncture group and a control group. In the electric acupuncture group, 170 patients were treated with electric acupuncture and routine therapy, and 170 patients in the control group with routine therapy alone. Major indexes for judging curative effect were Barthel index at 3- and 6-months follow-up visits and number of re-hospitalized patients. Minor indexes for judging curative effect were change in the score for nervous dysfunction at 4 and 12 weeks follow-up visits and number of patients persisting in rehabilitation treatment with acupuncture during follow-up visit.ResultsBaseline data at the time of case selection between the two groups were similar. The odds ratio (OR) was 0.92, and the 95% confidence interval (CI) was 0.49–1.73 in disabled rate and 0.73 and 0.51–1.05 in the number of re-hospitalized patients in the electric acupuncture group at 6-month follow up visit compared with the control group. There was no difference in the score for nervous dysfunction at the end of 12-week follow-up visit between the two groups. The score for nervous dysfunction at the end of 4-week treatment in the electric acupuncture group was significantly higher than that in the control group (P<0.05). The number of patients discharged from hospital who persisted in rehabilitation treatment with acupuncture in the acupuncture group was significantly higher than that in the control group.ConclusionUsing electric acupuncture to treat patients with acute ischemic cerebral apoplexy can effectively improve the nervous dysfunction scores after 4-week treatment and their ability to deal with daily life after 6-month follow-up visit. Systematic treatment with acupuncture may also reduce the number of patients with secondary apoplexy.     

奥利司他胶囊联合胰岛素强化治疗初诊肥胖2型糖尿病患者的疗效分析

目的观察奥利司他胶囊联合胰岛素强化治疗初诊肥胖2型糖尿病(T2DM)的治疗效果。方法选取2019年2月至2020年2月新乡市中心医院收治的86例初诊肥胖T2DM患者,采用随机数字表法分为联合组与对照组,每组43例。对照组予以胰岛素强化治疗,联合组在对照组基础上予以奥利司他联合治疗。比较两组患者治疗前与治疗3个月后一般体格检查[体重、体重指数(BMI)、体脂量(PBF)]、糖代谢指标[糖化血红蛋白(HbAlc)、空腹血糖(FPG)、餐后2 h血糖(2 hPG)]及脂代谢指标[血清甘油三酯(TG)、总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)]水平变化情况,记录并及时处理两组患者治疗过程中药物不良反应的发生情况。结果两组治疗3个月后体重、BMI、PBF、HbAlc、FPG、2 hPG、TC、TG、LDL-C水平较治疗前降低,且联合组低于同一时间对照组(P<0.05);而两组治疗3个月后HDL-C水平较治疗前升高,且联合组高于同一时间对照组(P<0.05)。两组患者治疗过程中药物不良反应发生率比较,差异无统计学意义(P>0.05)。结论奥利司他胶囊联合胰岛素强化治疗初诊肥胖T2DM患者效果更佳,安全性良好,有较高的临床推广应用价值。     

火针五脏俞加膈俞配合毫针治疗慢性失眠症临床疗效观察

背景　慢性失眠症影响人们的工作和生活,增加罹患疾病的风险,降低患者工作效率以及引发意外事故造成巨大损失。目前对于慢性失眠症治疗仍以苯二氮卓类药物为主,长期大剂量使用会出现对此类药物反应性下降。五脏藏神,人的精神情志与五脏密切相关,五脏失调可以导致失眠,通过针刺五脏俞可以调和阴阳、调整脏腑功能。目的　探讨火针五脏俞加膈俞配合毫针治疗慢性失眠症的临床疗效。方法　选取2016年11月-2017年10月北京中医医院顺义医院针灸科收治的60例慢性失眠症患者为研究对象,采用随机数字表法分为火针组和毫针组,各30例。毫针组给予毫针针刺百会、四神聪、神门、三阴交等穴,1次/d,5次/周;火针组在毫针组基础上选取双侧五脏俞加膈俞,予贺氏火针点刺,隔日治疗1次,3次/周;两组均连续治疗4周。评定两组临床疗效,分别于治疗前、治疗4周时及治疗结束后1个月进行匹兹堡睡眠质量指数（PSQI）评分、焦虑自评量表（SAS）评分和抑郁自评量表（SDS）评分。结果　治疗后,火针组临床痊愈7例、显效12例、有效9例、无效2例;毫针组临床痊愈3例、显效9例、有效11例、无效7例;火针组临床疗效优于毫针组（Z=-2.152,P=0.031）。治疗方法与时间在PSQI评分、SAS评分、SDS评分上存在交互作用（P<0.05）,治疗方法在PSQI评分、SAS评分、SDS评分上主效应显著（P<0.05）,时间在PSQI评分、SAS评分、SDS评分上主效应显著（P<0.05）。其中治疗前两组患者PSQI评分、SAS评分、SDS评分比较,差异无统计学意义（P>0.05）;治疗4周及治疗结束后1个月火针组PSQI评分、SAS评分、SDS评分较毫针组降低（P<0.05）。火针组和毫针组治疗4周及治疗结束后1个月PSQI评分、SAS评分、SDS评分较治疗前降低（P<0.05）。结论　火针五脏俞加膈俞配合毫针针刺治疗能更有效地改善慢性失眠症患者的睡眠质量,临床疗效优于单纯毫针治疗。