活血化瘀中药临床试验注册现状分析

目的:基于中国临床试验注册中心和美国临床试验注册中心数据库,分析活血化瘀中药临床试验的注册现状。方法:检索中国临床试验注册中心和美国临床试验注册中心从建库至2022年12月31日注册的活血化瘀中药相关的临床试验,进行总结分析。结果:最终纳入752项活血化瘀中药临床试验,包括662项干预性研究、82项观察性研究。地域覆盖中国、新加坡和巴基斯坦3个国家,中药类型包括自拟方/经验方、中成药和中药注射液等。研究设计多为随机平行对照研究(587项,占78.06%)。结论:当前活血化瘀中药临床试验注册存在地域分布不均衡、研究设计欠规范、注册信息填写不完整和不规范的问题,研究者应规范临床试验设计,加强临床试验注册理念,提高临床研究质量。     

中国肝硬化临床试验注册现状分析

目的:基于中国临床试验注册中心相关资料，分析中国肝硬化临床研究的现状。方法:输入中国临床注册中心网址(www.chictr.org.cn),在数据库中搜集截至2021年8月15日所有关于肝硬化的临床试验，从试验的注册数量、注册时间、研究类型、干预措施、疾病类型等方面进行分析。结果:共检索到233项研究，纳入230项研究。近3年来该领域研究增长明显，占比67%,注册地区主要分布于北京、上海、广东等经济发达地区，南北差异明显。研究类型主要以干预性研究与观察性研究为主，各占比50.4%和33.5%。其中116项干预措施以西药占比最大，达39.7%。主要结局指标以肝硬化相关实验室检验为主，其次为预后与生存、再出血、食管胃底静脉曲张情况等；疾病类型以门静脉系统研究为首，后依次是单纯肝硬化相关、乙型肝炎相关肝硬化、肝硬化腹水等。结论:近年来中国肝硬化相关研究呈明显增加趋势，但存在明显的地区分布差异。研究类型以干预性研究为主，干预重点由乙型肝炎相关肝硬化逐步转变为以食管胃底静脉曲张破裂出血、门静脉血栓为代表的门静脉系统、肠道菌群、肝硬化营养及代谢相关疾病，从一定程度上反映了中国肝硬化临床研究的新趋势...     

关于临床试验进行注册的通知

2004年10月全球卫生研究高层会议确定，由世界卫生组织（WO）领导建立全球临床试验注册平台（WHOICTRP），按统一标准注册并公布临床试验信息。中国临床试验注册中心（ChiCTR）成为第4个WHOICTRP一级注册机构；任何人都可以通过国际互联网了解感兴趣的任何一个将要实施和在研临床试验的设计信息。     

关于临床试验进行注册的通知

2004年10月全球卫生研究高层会议确定，由世界卫生组织（WHO）领导建立全球临床试验注册平台（WHO ICTRP），按统一标准注册并公布临床试验信息。中国临床试验注册中心（ChiCTR）成为第4个WHOICTRP一级注册机构；任何人都可以通过国际互联网了解感兴趣的任何一个将要实施和在研临床试验的设计信息。     

关于临床试验进行注册的通知

2004年10月全球卫生研究高层会议确定，由世界卫生组织（WHO）领导建立全球临床试验注册平台（wH0ICTRP），按统一标准注册并公布临床试验信息。中国临床试验注册中心（ChiCTR）成为第4个WHOICTRP一级注册机构；任何人都可以通过国际互联网了解感兴趣的任何一个将要实施和在研临床试验的设计信息。     

关于临床试验进行注册的通知

2004年10月全球卫生研究高层会议确定，由世界卫生组织（WHO）领导建立全球临床试验注册平台（WH0ICTRP），按统一标准注册并公布临床试验信息。中国临床试验注册中心（ChiCTR）成为第4个WHOICTRP一级注册机构；任何人都可以通过国际互联网了解感兴趣的任何一个将要实施和在研临床试验的设计信息。     

关于临床试验进行注册的通知

2004年10月全球卫生研究高层会议确定，由世界卫生组织（WHO）领导建立全球临床试验注册平台（wHOICTRP），按统一标准注册并公布临床试验信息。中国临床试验注册中心（ChiCTR）成为第4个WHO ICTRP一级注册机构；任何人都可以通过国际互联网了解感兴趣的任何一个将要实施和在研临床试验的设计信息。     

关于临床试验进行注册的通知

2004年10月全球卫生研究高层会议确定，由世界卫生组织（WHO）领导建立全球临床试验注册平台（WHOICTRP），按统一标准注册并公布临床试验信息。中国临床试验注册中心（ChiCTR）成为第4个WHO ICTRP一级注册机构；任何人都可以通过国际互联网了解感兴趣的任何一个将要实施和在研临床试验的设计信息。     

关于临床试验进行注册的通知

2004年10月全球卫生研究高层会议确定，由世界卫生组织（WHO）领导建立全球临床试验注册平台（WHO ICTRP），按统一标准注册并公布临床试验信息。中国临床试验注册中心（ChiCTR）成为第4个WHO ICTRP一级注册机构；任何人都可以通过国际互联网了解感兴趣的任何一个将要实施和在研临床试验的设计信息。     

中医药治疗糖尿病足临床研究注册方案分析

目的 分析在中国临床试验注册中心及美国临床试验注册中心中注册的中医药治疗糖尿病足相关临床试验的研究方案,探讨相关研究现状,以期为之后的研究方案优化提供参考,从而减少研究浪费的情况。方法 分别在中国临床试验注册中心网站和美国临床试验注册中心网站检索所有中医药治疗糖尿病足临床研究试验,检索时间从建库到2021年3月1日,分别对试验的一般特征、研究类型、干预措施、结局指标等方面进行分析。结果 共纳入19个相关研究,自2006年开始有研究方案注册,在2020年注册研究数量最多,达到6个研究。其中18个研究为随机平行对照设计的干预性研究,1项为单臂设计的观察性研究。共有13项（68.42%）研究通过了医学伦理审查,18项（94.74%）研究体现了知情同意内容。从注册研究要素上看,样本量均较小（73.7%的少于100例）,多中心研究较少（26.3%）,受试者的纳入条件使用的标准不一,干预措施上兼具有中医内服和中医外用的方法,从注册方案来看,大多方案具有明显的针对性,局限于某一疾病阶段。评价指标方面以临床表现及实验室指标为主,且不同研究间结局指标选择存在不统一、不规范、不适用、不全面、定义不清、测量...     

Comparison of registered and published primary outcomes in randomized controlled trials of gastroenterology and hepatology

Abstract

Objectives. The need for trial registration as well as the benefits it has brought for the transparency of medical research has been recognized for years. Trial registration has turned from an exception to a mandatory guideline in recent years. The present study aimed to examine the characteristics of registered randomized controlled trials (RCTs) in a sample of recently published gastroenterology RCTs, and to assess the consistency of registered and published primary outcome (PO) in RCTs. Methods. Articles published in the top five “general and internal journals” and top five “gastroenterology and hepatology journals” categories between 2009 and 2012 were searched in PubMed. Basic characteristics and the registration information were identified and extracted from the included RCTs. PO consistency analysis was conducted to compare between the registered and published format. Results. A total of 305 RCTs were included; among them 252 could be identified with a registration number. Nearly half of these RCTs were funded solely by industry (141/305, 46.3%). ClinicalTrials.gov was the most popular registry for these RCTs (214/252, 84.9%). A total of 155 RCTs were included in the PO consistency analysis. Among them, 22 (14.2%) RCTs had discrepancies between POs registered in the trial registry compared to the published article. Conclusions. Based on the results of the present study, selective outcome reporting of gastroenterology RCTs published in leading medical journals has been much improved over the past years. However, there might be a sampling bias to say that consistency of registered and published POs of gastroenterology RCTs has been better than before.     

湖南省2003-2011年活动性肺结核患者登记的空间分析

目的 分析湖南省活动性肺结核患者登记的空间分布规律，找出聚集区域，为进一步研究结核病危险因素及其防控策略提供理论依据。 方法 2003-2011年湖南省共登记报告活动性肺结核患者475 125例，各市州年平均登记率为80.1/10万（61.3/10万～122.8/10万）。收集整理2003-2011年登记活动性肺结核患者数和各市州年平均人口数；应用SPSS 13.0统计软件包系统聚类分析法（hierarchical cluster）进行市州年平均登记水平空间分布分析；采用SaTScan(version 9.1.1)空间统计分析软件Possion分布概率模型对湖南省2003-2011年各市州活动性肺结核患者登记进行空间、时间和时空聚集性分析；应用MAPGIS 67软件绘制地图。结果 2003-2011年湖南省活动性肺结核患者登记空间分布规律呈由西北向东南递降的趋势。空间聚集性分析共扫描出4个聚集区域，一级聚集区域为湘西州、张家界市和怀化市，实际登记患者85 065例，预计登记患者62 095例，RR=1.45（P<0.001）；二级聚集区域为娄底市，实际登记患者31 381例，预计登记患者27 043例，RR=1.17（P<0.001）；三级聚集区域为常德市，实际登记患者47 831例，预计登记患者43 366例，RR=1.11（P<0.001）；四级聚集区域为永州市，实际登记患者41 837例，预计登记患者37 656例，RR=1.12（P<0.001）。时间聚集性分析发现，2004-2006年存在活动性肺结核患者登记的聚集现象，实际登记患者162 067例，预计登记患者151 859例，RR=1.10（P=0.001）。时空聚集性分析共扫描出4个聚集区域，一级聚集区域为湘西州、张家界市和怀化市，实际登记患者41 695例，预计登记患者25 306例，RR=1.71（P<0.001）；二级聚集区域为永州市，实际登记患者9518例，预计登记患者6334例，RR=1.51（P<0.001）；三级聚集区域为娄底市，实际登记患者7223例，预计登记患者4589例，RR=1.58（P<0.001）；四级聚集区域为常德市，实际登记患者23 058例，预计登记患者19 149例，RR=1.21（P<0.001）。结论 2003-2011年湖南省活动性肺结核患者登记呈由西北向东南递降的趋势，在时间、空间和时空上均不是随机分布的，存在聚集性，最可能存在聚集的区域是湘西州、张家界市和怀化市，聚集时间为2004-2006年。     

Debate forum: carnitine supplements have not been demonstrated as effective in patients on long-term dialysis therapy

The database for carnitine supplements in dialysis includes no large-scale randomized trials and no registered trials. Medical practitioners prefer to make treatment decisions based on the outcome of randomized clinical trials, with appropriate controls. Furthermore, registered trials provide a further level of integrity, since trial registration avoids publication bias by ensuring that all outcomes are reported, including trials that are not completed. Positive effects reported from carnitine administration in dialysis patients include decreased erythropoietin dose, increased hematocrit, less intradialytic hypotension, and less fatigue. The evidence for carnitine effectiveness is limited to trials that are mostly open-label and that include no more than a total of 1,000 patients. An analysis of recent carnitine administrations to patients in a large dialysis practice database indicates no overall change in hemoglobin or erythropoietin dose following 6 months of carnitine administration. As outcomes of controlled trials with appropriate power to examine for the benefits of carnitine are not yet available, the dialysis practitioner cannot justify the administration of carnitine.     

Alternative donor transplantation after reduced intensity conditioning: results of parallel phase 2 trials using partially HLA-mismatched related bone marrow or unrelated double umbilical cord blood grafts

The Blood and Marrow Transplant Clinical Trials Network conducted 2 parallel multicenter phase 2 trials for individuals with leukemia or lymphoma and no suitable related donor. Reduced intensity conditioning (RIC) was used with either unrelated double umbilical cord blood (dUCB) or HLA-haploidentical related donor bone marrow (Haplo-marrow) transplantation. For both trials, the transplantation conditioning regimen incorporated cyclophosphamide, fludarabine, and 200 cGy of total body irradiation. The 1-year probabilities of overall and progression-free survival were 54% and 46%, respectively, after dUCB transplantation (n = 50) and 62% and 48%, respectively, after Haplo-marrow transplantation (n = 50). The day +56 cumulative incidence of neutrophil recovery was 94% after dUCB and 96% after Haplo-marrow transplantation. The 100-day cumulative incidence of grade II-IV acute GVHD was 40% after dUCB and 32% after Haplo-marrow transplantation. The 1-year cumulative incidences of nonrelapse mortality and relapse after dUCB transplantation were 24% and 31%, respectively, with corresponding results of 7% and 45%, respectively, after Haplo-marrow transplantation. These multicenter studies confirm the utility of dUCB and Haplo-marrow as alternative donor sources and set the stage for a multicenter randomized clinical trial to assess the relative efficacy of these 2 strategies. The trials are registered at www.clinicaltrials.gov under NCT00864227 (BMT CTN 0604) and NCT00849147 (BMT CTN 0603).     

非双盲随机临床试验中降压药物疗效组别偏倚中国高血压临床研究荟萃分析

目的了解非双盲临床试验中同一降压药物作为试验药物和对照药物时,被观察的疗效结果是否存在差别.方法按照一定的标准,通过《中国医院知识仓库》收集降压药物的随机对照试验,寻找同一药物作为试验组的研究与作为对照组的研究进行配组,在配组的用药剂量、疗程和疗效标准相同的情况下,比较两组疗效的差别.结果寻找到11个配组,涉及18项试验药物研究和19项对照药物研究.①同一降压药物作为试验药物的各项研究与作为对照药物的各项研究的总有效率的差异具有统计学意义;②试验药物与对照药物的各配组的总有效率的差异具有统计学意义;③试验药物与对照药物的各药物的总有效率的差异没有统计学意义.试验药物与对照药物的加权平均总有效率分别为85.38%和77.17%,试验药物比对照药物高约10%.结论在非双盲随机对照试验中,试验组降压药物的疗效可能被夸大,对照组被贬低.应重视这种偏倚在新药临床试验和Meta分析中的影响.     

Effect of acupuncture treatment on cognitive impairment after traumatic brain injury in adults: A protocol for systematic review

Background:Acupuncture has been widely used to treat cognitive impairment after traumatic brain injury (TBI). But its efficiency has not been scientifically and methodically evaluated. The objective of this study is to evaluate the efficiency and safety of the acupuncture treatment for cognitive impairment after TBI in adults.Methods:This protocol of systematic review will be conducted in accordance with the Preferred Reporting Items for Systematic Review and Meta-analysis Protocols. We will conduct the literature searching in the following electronic databases: the Cochrane Library, MEDLINE, EMBASE, Web of Science, Springer, the Chinese Science Citation Database (CSCD), China National Knowledge Infrastructure (CNKI), the Chinese Biomedical Literature Database (CBM), Wanfang, and the Chinese Scientific Journal Database (VIP). The time limit for retrieving studies is from establishment to November 2021 for each database. All published randomized controlled trials related to this review will be included. Review Manager (V.5.3.5) will be implemented for the assessment of bias risk and data analyses. The selection of the studies, data abstraction, and validations will be performed independently by 2 researchers.Results:This review will assess the clinical efficacy and safety, as well as the acupoints characteristics of acupuncture on CI of TBI in adults.Conclusion:This review will summarize the current evidence of acupuncture on CI of TBI outcomes and provide guidance for clinicians and patients to select acupuncture for CI of TBI in adults.Trail registration number:This protocol of systematic review has been registered on INPLASY website (No. INPLASY2021110113).     

Data sharing: A new editorial initiative of the International Committee of Medical Journal Editors. Implications for the editors’ network

The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship -emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors’ Network of the European Society of Cardiology.     

Effects of acupuncture treatment on posttraumatic headache after traumatic brain injury in patients: A protocol for systematic review

Background:Posttraumatic headache (PTH) after traumatic brain injury (TBI) is a common clinical symptom, which refers to a headache that occurs after TBI. Acupuncture is often used for the treatment of such patients in China, and significant clinical effects have been achieved. However, to date, its efficacy has not been methodically evaluated. The purpose of this systematic review is to provide evidence to prove the effectiveness of acupuncture in the treatment of PTH in patients with TBI.Methods:This systematic review will be conducted in accordance with the preferred reporting items for systematic review and meta-analysis protocols. The following electronic databases will be searched from their inception to February 2022: PubMed, Web of Science, Embase, PsycINFO, the Cochrane Library, and Chinese databases such as Chinese Biomedical Literature (CBM), Chinese Medical Current Content (CMCC), Chinese Scientific Journal Database (VIP), WanFang Database, and China National Knowledge Infrastructure (CNKI). No language restrictions will be applied to the search strategy. Randomized controlled trials and cohort and case-control studies that met the inclusion and exclusion criteria will be included in this study. The meta-analysis will be performed using RevMan 5.3 software. Each session of this systematic review will be conducted independently by 2 members.Results:This review evaluates the efficacy of acupuncture in the treatment of PTH after TBI.Conclusion:This review provides substantial evidence for the clinical application of acupuncture in PTH treatment after TBI.Ethics and dissemination:Since the data in this study will be retrieved from published trials, therefore the Patient Consent Statement and Ethical Approval are not required. We will disseminate our results by publishing the research in a peer-reviewed journal.Trail registration number:The protocol was registered in INPLASY (INPLASY 202220073).     

2010—2019年青岛市学生肺结核流行病学特征分析

作者通过《中国疾病预防控制信息系统》的子系统《结核病信息管理系统》,收集2010—2019年青岛市登记职业为“学生”的患者资料、肺结核登记例数(不包括结核性胸膜炎),以及收集《青岛统计年鉴》学生人口数资料,分析学生肺结核登记情况及流行病学特征。结果显示,2019年学生肺结核登记发病率为11.91/10万(175/1468777),较2010年(16.53/10万,212/1282589)降低27.95%,呈下降趋势,差异有统计学意义(Z_趋势=-6.567,P<0.001);2010—2019年每年3、4月份为登记发病例数的高峰,在全年中占比为24.42%(443/1814);19~<22岁患者(大学阶段)在报告患者总例数中的占比最高(43.16%,783/1814);被动方式发现1650例,占90.96%(1650/1814);2010—2019年学生患者就诊延迟占比为62.24%(1129/1814)。研究认为,青岛市学生肺结核登记发病率整体处于较低水平,但仍需要继续重视学生肺结核的防控工作,并加强开展健康教育,提高学生的防病意识。     

Characteristics of the tuberculosis epidemic in schools in Qingdao in 2010—2019

作者通过《中国疾病预防控制信息系统》的子系统《结核病信息管理系统》,收集2010—2019年青岛市登记职业为“学生”的患者资料、肺结核登记例数(不包括结核性胸膜炎),以及收集《青岛统计年鉴》学生人口数资料,分析学生肺结核登记情况及流行病学特征。结果显示,2019年学生肺结核登记发病率为11.91/10万(175/1468777),较2010年(16.53/10万,212/1282589)降低27.95%,呈下降趋势,差异有统计学意义(Z_趋势=-6.567,P<0.001);2010—2019年每年3、4月份为登记发病例数的高峰,在全年中占比为24.42%(443/1814);19~<22岁患者(大学阶段)在报告患者总例数中的占比最高(43.16%,783/1814);被动方式发现1650例,占90.96%(1650/1814);2010—2019年学生患者就诊延迟占比为62.24%(1129/1814)。研究认为,青岛市学生肺结核登记发病率整体处于较低水平,但仍需要继续重视学生肺结核的防控工作,并加强开展健康教育,提高学生的防病意识。