临床实践指南与系统评价/Meta分析注册平台的比较与应用

当今医学研究透明化概念备受关注.通过研究注册,向社会公开研究方案的概况及具体信息,可提高研究质量和透明度.当前可进行指南注册的机构主要为国际实践指南注册与透明化平台(Practice Guideline REgistration for TransPAREncy,PREPARE);系统评价/Meta分析注册机构主要有C...     

系统评价与Meta分析的类型及制作步骤

系统评价与Meta分析有多种类型,各种类型的制作步骤是大体相同的。掌握好各个类型特点是选择最佳类型的前提。本文对Meta分析的方法学及系统评价与Meta分析的制作步骤进行了介绍,并介绍了不同的分型。同时介绍了间接比较Meta分析、网状Meta分析、序贯Meta分析、剂量-反应Meta分析、Meta整合、动物实验系统评价,以及Cochrane系统评价、JBI系统评价、Campbell系统评价和CEE系统评价。     

Review Manager(RevMan)——临床医生通向Meta分析的桥梁

循证医学的理念在不断地影响着不同专业的医学工作者,他们非常关心的一个问题是:什么叫Meta分析、如何进行?Review Manager(RevMan)是Cochrane协作网提供给评价者准备和维护更新Cochrane系统评价而设计的软件,是专门为临床医生度身订做的、用于完成Meta分析的软件,本文作者以“图文并茂”的形式向广大读者介绍Review Manager 4.2的具体操作过程,相信对初次从事系统评价的人员较好地应用Review Manager会有所帮助。 循证医学编辑部     

临床试验注册制度与循证医学

本文介绍了当前新药临床试验,院内制剂、上市后药物临床试验及其他类型临床试验的管理情况,世界卫生组织临床试验注册平台的结构和运作机制以及全球临床试验注册制度的建立概况,中国临床试验注册中心和中国临床试验注册与发表协作网及其运作机制;提出以循证医学基本思想作为临床试验研究者的思想和行为准则是临床试验真实性的内部保障系统。     

急性大出血患者输注血小板联合冷沉淀疗效的Meta分析

【摘要】 目的 系统评价急性大出血患者输注血小板联合冷沉淀的临床疗效。方法 通过万方医药期刊数据库（wanfang）、中国生物医学文献数据库（CBM）、维普中文科技期刊全文数据库（VIP）及中国期刊全文数据库（CNKI）检索2005~2016年公开发表的中文文献，同时辅以其他的检索，收集同期未发表的中文文献资料（包括会议论文、学术报告、毕业论文等）。按照严格的纳入/排除标准筛选符合标准的文献7篇，采用Cochrane协作网推荐的方法评价文献质量，并采用Cochrane协作网提供的RevMan5.3软件进行Meta分析。结果 根据Cochrane协作网推荐的评价方法，7篇文献评价均为B或C级，为低质量研究。Meta分析显示，在凝血酶时间（TT）、凝血酶原时间（PT）、活化部分凝血酶时间（APTT）和纤维蛋白原（Fbg）这4个指标体现的凝血功能方面，实验组都比对照组疗效更加明显，血小板（PLT）不明显。结论 与单独的血小板输注或者冷沉淀输注相比，血小板联合冷沉淀输注对于大出血患者的疗效更加明显。     

中医外治法治疗近视的系统评价再评价

目的 对中医外治法治疗近视的系统评价和Meta分析再评价,为中医临床治疗近视提供循证依据。方法 通过计算机检索PubMed、Embase、Web of Science、The Cochrane Library、中国知识基础设施工程、维普数据库、中国生物医学文献数据库和万方数据库自建库至2021年12月2日中医外治法治疗近视的系统评价和Meta分析,由2位研究人员按照纳入、排除标准背对背独立筛选文献,提取纳入文献相关信息资料,采用AMSTAR量表和PRISMA声明评价纳入文献方法学和报告质量,分析有效性和安全性指标变化情况。结果 共纳入14篇系统评价和Meta分析。（1） AMSTAR评价结果显示,前期设计方案和利益冲突声明的报告率仅为7%。（2） PRISMA评价结果显示,结构式摘要、研究方案注册和资金条目的完整报告度仅为7%。结论 中医外治总体疗效优于常规治疗,可提高患者的裸眼视力。中医外治法治疗近视的系统评价方法学和报告质量有待提升,尤其需重点关注利益冲突和研究方案注册等重点条目。     

中医药治疗癫痫的meta分析

目的 应用Meta-分析评价中医药治疗癫痫的整体疗效及同纯西药相比较. 方法 通过国内多数据库平台电子服务系统检索有关中医药治疗癫痫的随机对照试验(RCTs)文献,用Cochrane协作网专用软件RevMan4.2进行统计分析. 结果检索符合RCTs纳入标准的中医药治疗各型癫痫的随机对照试验论文13篇.其中有关儿童癫痫的论文6篇.Meta分析结果显示中药治疗癫痫可以提高癫痫的控制率及缓解率,降低复发率.结论 中药治疗癫痫不但可以稳定疗效,而且可以减少复发,中药治疗还能发挥减毒增效的作用.     

颈动脉粥样硬化斑块分布特点的Meta分析

目的 系统评价颈总动脉斑块分布特点对颈动脉粥样硬化的影响.方法 按Cochrane系统评价方法,计算机检索Cochrane图书馆、CENTRAL、MEDLINE、EMBASE、SCI、CBM、CNKI等数据库,并手工检索相关会议文献及已发表与未发表的资料.检索语言为中英文.按照纳入标准严格筛选文献,并进行文献方法学质量评价,对可以合并分析的数据采用Cochrane协作网提供的RevMan 5.1软件进行Meta分析.结果 经过全面检索及筛查后,共纳入5个随机对照研究.Meta分析结果显示:颈总动脉斑块左右侧分布率差异有统计学意义,左侧多于右侧,比值比0.72,95％可信区间0.67～0.78,P＜0.000 01.结论 颈总动脉斑块的形成表现为左侧多于右侧,并且左侧更能提示颈动脉粥样硬化的程度;因本系统评价仍有一些未纳入的评价指标,上述结论需更多设计严谨的随机对照试验加以验证.     

Campbell协作网:为公共卫生决策及教育提供最佳证据的国际协作组织

Campbell协作网是国际Cochrane协作网的姊妹网,旨在与世界上其他促进循证公共卫生决策的组织和机构密切合作,制作与公共卫生决策及教育相关的Campbell系统评价;帮助人们制定遵循科学证据的公共卫生和教育的循证决策,促进21世纪的公共卫生决策从经验决策走向循证决策的转变.本文就Campbell协作网的发生、发展及运作方式等进行简介.     

中国临床试验注册和发表机制及实施说明

2006年4月16-17日在成都召开第四届亚太地区循证医学研讨会期间，中国48家医（药）学期刊和中国临床试验注册中心（Chinese Clinical Trial Register。ChiCTR）、卫生部中国循证医学中心、循证医学教育部网上合作研究中心和Chinese Cochrane Centre的代表经过充分讨论达成共识，决定共同发起创建中国临床试验注册和发表机制，并成立“中国临床试验注册和发表协作网（Chinese Clinical Trial Registration and Publishin gCollaboration，ChiCTRPC）”。这种临床医学研究管理新模式的创建和应用，将对提高中国临床试验信息透明度和质量、提高医学研究公信度发挥极其重要的作用。本文介绍其结构特点和运作方式。     

Value of D-Dimers in patients with acute aortic dissection

Objective: To evaluatel the value of D-dimers in patients with acute aortic dissection (AAD). Methods: This study consisted of 16 patients with AAD and 27 non-AAD patients. Serum D-dimets were measured by Sta-Liatest D-DI immunoturbidimetric assay. Results: D-dimer level was higher (P ＜ 0.001) in patients with AAD(7.91 ± 5.52 μg/ml) than that in non- AAD group(1.57±1.24 μg/ml). D-dimer was positive (＞0.4 μg/ml) in all patients with AAD and in 10 control group patients (37%). Among patients with acute AAD, D-dimers tended to be higher in Stanford A than in Stanford B (8.67 ± 4.31 μg/ml vs. 3.24±1.27 μg/ml, P ＜0.01). D-dimer values tended to be higher in more extended disease(3.84 ± 1.65 μg/ml, 8.57 ± 3.58 μg/ml and 11.87 ± 5.69 μg/ml in thoracic aorta, thoracic and abdominal aorta, thoracic and abdominal aorta and iliacal arteries, respectively, P ＜ 0.05 for both 8.57 ± 3.58 and 11.87 ± 5.69 vs. 3.84 ± 1.65 ). Including the control group into the analysis, we found a sensitivity of 100%, a negative predictive value of 100%, and a specificity of 66% and a positive predictive value of 64% for D-dimer in diagnosis of AAD in our patients with suspected AAD. Conclusion: D-dimer was elevated in patients with AAD. A negative D-dimer test result could be useful in excluding AAD.     

Research of combined liver-kidney transplantation model in rats

Objective： To set up a simple and reliable rat model of combined liver-kidney transplantation. Methods： SD rats served as both donors and recipients. 4℃ sodium lactate Ringer＇s was infused from portal veins to donated livers,and from abdominal aorta to donated kidneys, respectively. Anastomosis of the portal vein and the inferior vena cava （IVC） inferior to the right kidney between the graft and the recipient was performed by a double cuff method, then the superior hepatic vena cava with suture. A patch of donated renal artery was anastomosed to the recipient abdominal aorta. The urethra and bile duct were reconstructed with a simple inside bracket. Results： Among 65 cases of combined liver-kidney transplantation, the success rate in the late 40 cases was 77.5%. The function of the grafted liver and kidney remained normal. Conclusion： This rat model of combined liver-kidney transplantation can be established in common laboratory conditions with high success rate and meet the needs of renal transplantation experiment.     

BLOOD PRESSURE CHANGE WITH AGE IN SALT-SENSITIVE TEENAGERS

Objective To observe blood pressure change with age in salt-sensitive teenagers whose salt sensitivity were determined by repeated testing.Methods Salt sensitivity was determined through intravenous infusion of normal saline combined with volume-depletion by oral diuretic furosemide in 55 teenagers. After five years, salt sensitivity was re-examined and subject blood pressure was followed up. Blood pressure changes in salt-sensitive teenagers were compared to that of non-salt sensitive teenagers over five years.Results After 5 years, the repetition rate of salt sensitivity determined by intravenous saline loading is 92.7%. In teenagers with salt sensitivity on the baseline, both the systolic blood pressure increments and increment rates were much higher than non-salt sensitive teenagers (12.7±12.1 mmHg vs. 2.8±5.2 mmHg, P＜ 0.01; 12.2%± 12.0% vs. 2.5% ±4.4%, P＜ 0.001,respectively). There was a similar trend for diastolic blood pressure (8.4 ± 6.4 mmHg vs. 3.7 ± 6.4 mmHg, P = 0.052; 13.2% ±10.6 % vs. 6.8%± 10.1%, P = 0.053, respectively).Conclusions Salt sensitivity determined by intravenous saline loading showed good reproducibility. Blood pressure increments with age were much higher in salt-sensitive teenagers than non-salt sensitive teenagers, especially in terms of systolic blood pressure.     

安心颗粒对急诊经皮冠状动脉介入术后生活质量影响的研究

目的：评价使用安心颗粒对急诊经皮冠状动脉介入术（PPCI）术后生活质量的影响.方法：将160例接受PPCI的急性ST段抬高型心肌梗死患者随机分为安心颗粒组（术前顿服安心颗粒8.8g,术后安心颗粒4.4 g/次,每日2次）和对照组（仅接受基础药物治疗）.所有患者均服用阿司匹林、氯吡格雷和阿托伐他汀.分别在入院时、出院前1d、出院后180 d时,应用心肌梗死多维度量表（MIDAS）、中文版SF-36评价量表对患者生活质量评分.并观察术后30 d以内的出血并发症、血小板减少症发生情况.结果：入院时和出院前1d,两组患者的心肌梗死MIDAS、SF-36量表评分比较无差异（P＞0.05）;出院后180 d时,与对照组比较,安心颗粒组MIDAS、SF-36评分明显减低（P＜0.05）;组内与入院时比较,两组出院前1d、出院后180 d时,MIDAS、SF-36评分均降低（P＜0.05）.两组患者在随访期间均无大量出血、少量出血、重度和极重度血小板减少症发生,安心颗粒组有4例、对照组有7例发生不明显出血（P＞0.05）.两组发生轻度血小板减少症的患者数比较无差异（P＞0.05）.结论：PPCI使用安心颗粒,能改善急性ST段抬高型心肌梗死患者的生活质量,且不增加出血风险.     

The comparative studies of the influences of Urapidil and Nicardipine on sino-atrial node function, atrio-ventricular node function and hemodynamics

Objective:To investigate the influences of urapidil and nicardipine on rabbit sinus function,atrio-ventricular node function and hemodynamics.Methods:Thirty-two Angora's rabbits were selected and randomly divided into four groups.U1 group:urapidil 0.25 mg/kg;U2 group:urapidil 0.5 mg/kg;N1 group:nicardipine 10 μg/kg;N2 group:nicardipine 20 μg/kg.All these medicine were administrated within 30 seconds.Measurements were taken before and after the administration of urapidil or nicardipine for the following data:mean blood pressure(MAP),heart rate(HR),sino-atrial conduction time(SACT),maximal sinoatrial recovery time(SNRTmax)corrected sinus node recovery time(CSNRT),index of sinus node recovery time(SNRTI),Wenckebach A-V conduction frequency (WB),and P-R interval.Results:Significant MAP and HR changes were identified in all of the four groups before and after administration of both urapidil and nicardipine.No significant changes could be found in the rest of the parameters.Intergroup analysis showed that SACT and CSNRT of N1 and N2 groups were shorter than those of the U2 group(P＜0.01);the MAP decreased(P＜0.01)and the HR increased drastically(P＜0.01).Conclusions:Neither urapidil(0.25 mg/kg,0.5 mg/kg)nor nicardipine(10μg/kg,20μg/kg)has any significant influence on rabbit sinus function or rabbit atrio-ventricular node function.Nicardipine could be a better choice than urapidil for parafunctional sinus node patients.     

Expression of OPGmRNA and ODFmRNA in the patients of hip fracture due to osteoporosis

Objective：To investigate the gene expression of osteoprotegerin（OPG） and osteoclast differentiation factor（ODF） in the bone tissue of patients with hip fracture due to osteoporosis. Methods：OPGmRNA and ODFmRNA in the bone tissue in 50 cases of osteoporosis sufferers（over 50 years old） with hip fracture（Observer Group） and 30 cases of hip facture sufferers with no osteoporosis（Control group） were analyzed with the Semi-Quantitative RT-PCR method. Results：The mRNA expressed of ODF, OPG were both high in the patients with hip fracture. In the control group, the expression of OPG mRNA was observed, while the expression of ODF mRNA was very slight. Conclusion：Aged patients contained all signals including OPG, ODF that are essential for inducing osteoclastogenesis and promoting bone resorption.     

The clinicopathological and immuohistochemical analysis of solid-pseudopapillary tumor of the pancreas： report of 9 cases

Objective：To investigate the clinical features, pathological characteristics and immunophenotype of solid-pseudopapillary tumor of the pancreas（SPTP）. Methods：Nine surgically treated cases of SPTP were retrospectively reviewed. Hematoxylin and Eosin（HE） staining and immunohistochemical staining were used to analyze all cases, and the general clinical data was collected. Results：Six patients were asymptomatic except for a palpable mass. Two patients complained of vague-epigastric pain. One patient appeared jaundice. The tumor was encapsulated and solid tissues alternately with cystic tissues. Histologically, the histological structure of solid portion was pseudopapillary with a fibrovascular core. Tumor cells were uniform and medium-sized which were arranged in sheets ets or nests or pseudopapillary patterns. Immunohistochemical studies demonstrated that SPTP proved positive in vimentin（9/9 cases）, AAT（9/9 cases）, NSE（9/9 cases）, ACT（7/9 cases）, CK20（2/9 cases）, CgA（1/9 cases）, S-100（3/gcases）, PR（4/gcases）, Syn（3/9 cases） and CD56（5/9cases）, negative in CEA and ER. Conclusion：SPTP is a tumor predominantly occurring in young women frequently without special symptoms. This tumor has various characteristical histological patterns with different immunophenotype.     

Dynamic Changes in Serum Estradiol and Progesterone levels in Patients of Premenstrual Syndrome with Adverse Flow of Liver-qi

Objective:To probe into the influence of changes of ovarian hormones on the pathogenesis of the specific sub-type premenstrual syndrome(PMS)and reveal partial microcosmic mechanisms of adverse flow of liver-qi.Methods:Estradiol(E2)and progesterone(P)levels in serum were determined at different phases of menstrual cycle by radioimmunoassay.Results:In the group of PMS with adverse flow of liver-qi.the secretive peak value Of E2 and P at the follicular phase significantly decreased,and the secretive peak value at the luteal phase did not come into being.Conclusions:Low E2 and P secretive peak at the follicular phase and absence of secretive peak at the luteal phase is one of the microcosmic mechanisms of PMS with adverse flow of liver-qi.One of the pathophysiologic mechanisms of specific sub-type PMS is probably the continuous low level of E2and P.     

Real-time Three-dimensional Echocardiography in Assessment of Left Ventricular and Right Ventricular Volumes

Real-time three-dimensional echocardiography (RT3DE)is a new ultrasound technique that enables dynamic threedimensional visualization and quantification of the heart in real time. Investigation of feasibility and methodology of RT3DE in determining left ventricular (LV) and right ventricular (RV) volumes, RT3DE was performed in 35 normal adults using Philips SONOS 7500 system with a 2-4 MHz matrix array transducer. The 60°×60° "pyramid" volume database was obtained and analyzed on a TomTec echo workstation. Both LV and RV volumes were calculated with four 3DE methods (i.e. apical 2, 4, 8, and 16-plane) through manually tracing ventricular endocardial borders in end diastole and end systole. Stroke volumes were then calculated. LV volume was also measured by 2DE Simpson's rule using GE VIVID 7 ultrasound machine.     

SCREENING FOR A 21-CHROMOSOME ABNORMALITY IN PREIMPLANTED EMBRYOS OF ELDERLY WOMEN

Increasing maternal age is the only etiological factor unequivocally linked to Down's syndrome in humans. The occurrence rate of newborns with Down's syndrome is about 1/220 in women over 35 years old. However, the occurrence rate in embryos fertilized in vitro, of the elder woman is unclear. Using FISH we screened the number of chromosome 21 in preimplanted embryos of 5 elderly women (average age, 38.4 years) to study the feasibility and necessity of screening trisomy 21 in embryos in patients over 35 years old at the in vitro fertilization (IVF) center.