风险管理在病区高警讯药物管理中的应用

目的 探讨风险管理在病区高警讯药物管理中的效果.方法 对病区高警讯药物的风险进行识别和评价,确立病区高警讯药物的种类,制定相应的对策实施风险管理.实施16个月后评价效果.结果 与实施高警讯药物风险管理前同期比较,用药缺陷、药物护理缺陷显著降低,护士对高警讯药物知晓率显著提高(均P＜0.05).结论 对高警讯药物实施风险管理可提高护理人员对高警讯药物风险的认识,减少用药缺陷和纠纷,提高临床用药安全性.     

风险管理在病区高警讯药物管理中的应用

目的探讨风险管理在病区高警讯药物管理中的效果。方法对病区高警讯药物的风险进行识别和评价,确立病区高警讯药物的种类,制定相应的对策实施风险管理。实施16个月后评价效果。结果与实施高警讯药物风险管理前同期比较．用药缺陷、药物护理缺陷显著降低,护士对高警讯药物知晓率显著提高（均P〈0．05）。结论对高警讯药物实施风险管理可提高护理人员对高警讯药物风险的认识,减少用药缺陷和纠纷,提高临床用药安全性。     

对卫生部抗菌药物临床应用监测网病历用药合理性评价标准探讨

目的探讨卫生部抗菌药物临床应用监测网病历用药合理性评价意见(纸质)表的评价标准。方法依据《抗菌药物临床应用指导原则》和《卫生部办公厅关于抗菌药物临床应用管理有关问题的通知》(卫办医政发[2009]38号)的相关规定,结合抗菌药物在临床使用的实际情况,参考相关法规、文件、指南,对意见表中的评价项目进行解释。结果经过对评价标准相关问题的探讨,有助于卫生部抗菌药物临床应用监测网各成员单位对意见表评价标准的理解,使各单位评价结果更加趋于一致。结论探讨评价标准有助于降低评价结果偏差,使评价过程更加规范化和标准化。     

药物临床试验中受试者服药依从性的管理

药物临床试验是确定药物疗效和安全性的重要方法。药物临床试验是指在人体(患者或健康志愿者等受试者)中进行的关于新药效应的一系列临床实验性研究,以证实或揭示试验用药的疗效和不良反应。受试者依从性可定义为按照规定的药物剂量和疗程服用试验药物的程度。在药物临床实验中,受试者的依从性与试验结果的质量密切相关:受试者不依从或依从性差是导致影响实验结果,造成偏倚的关键因素。目前我国在新药临床实验中,影响依从性的因素普遍存在,也没有一种足够可靠、有效、敏感的测量依从性的金标准,并缺乏客观评价受试者依从性的有效工具。因此,药物临床试验受试者的依从性管理已成为当代医学界亟待解决的重要课题。本文就依从性的影响因素、依从性的评价方法、管理措施做出如下探讨。以期在药物临床试验中,为提高受试者依从性提供理论和实践依据。     

化疗及靶向药物治疗肉瘤样肾癌的Meta分析

目的 系统评价化疗及靶向药物治疗肉瘤样肾癌的有效性和安全性.方法 计算机检索PubMed、中国期刊全文数据库(CN KI)等,收集2000年1月～2013年12月国内外公开发表的有关化疗及靶向药物治疗肉瘤样肾癌的试验研究文献.根据Cochrane的质量评价标准评价,采用RevMan4.2软件进行统计学分析.结果 最终纳入5个文献,共128例患者.meta分析结果显示与化疗相比,靶向药物联合化疗不但显著提高了肉瘤样肾癌的疾病控制率(OR =2.11,95％ CI:1.30 ～2.61,P＜0.0001),还显著提高了有效率(OR =2.25,95％ CI:1.53 ～3.11,P＜0.0001).结论 与化疗相比,靶向药物联合化疗可进一步提高疗效,是肉瘤样肾癌较好的治疗方案.     

胃癌根治术后静脉化疗效果的系统评价

目的:评价胃癌根治术后接受不同药物、剂量(经静脉)化疗的疗效和安全性。方法:应用国际Cochrane协作网的系统评价方法,研究文献中关于胃癌根治术后接受不同药物、剂量(经静脉)化疗组与单纯根治手术组疗效比较的随机和半随机试验进行了系统评价。结果:17个试验包括2915例病人,经异质性检验,χ2=37.58,P=0.0017,17个试验存在异质性;采用随机效应模型(D鄄L)法进行meta分析,合并效应量OR=0.66,95%可信区间为0.51～0.85,经u检验,P=0.002,说明胃癌根治术后接受不同药物、剂量(经静脉)化疗组的疗效优于单纯根治手术组。17篇文章中有9篇对化疗药物的毒性反应按WHO分度标准进行描述,副作用主要有胃肠道症状、骨髓抑制、心脏毒性、血液毒性等,5例病人死于化疗相关毒性事件。结论:胃癌根治术后接受化疗可能有一定效果,毒性事件发生率较低;在接受根治性切除术后,全身静脉化疗对提高胃癌病人的5年生存率可能有一定的作用。     

尿路上皮癌膀胱药物灌注致重度膀胱功能损害的碱化利多卡因灌注治疗

目的:评价碱化利多卡因扩张性灌注治疗尿路上皮癌膀胱灌注后药物相关性重度膀胱损害的疗效与安全性。方法:对6例尿路上皮癌患者因行吡柔比星、丝裂霉素及BCG灌注引起的重度膀胱损害,其中3例为灌注BCG行三联抗结核药物等综合治疗无效而被迫放弃、中止治疗者,采用膀胱镜检后碱化利多卡因扩张性灌注方法进行治疗,并评估治疗前、后下尿路症状及其相关指标。结果:6例患者下尿路症状及评分、膀胱容量流率、膀胱敏感性明显改善,并完全恢复原来的化学药物灌注。平均随访10(3～16)个月,无膀胱损害症状复发,效果满意。结论:应用碱化利多卡因扩张性灌注治疗尿路上皮癌膀胱灌注后药物相关性重度膀胱损害,是有效和安全的,可恢复尿路上皮癌患者行膀胱灌注药物的耐受依从性。     

枸橼酸爱地那非治疗勃起功能障碍的安全性和有效性研究

目的:探索枸橼酸爱地那非治疗男性勃起功能障碍(ED)的临床有效剂量,并评价其安全性和有效性。方法:采用多中心、随机、双盲、安慰剂对照研究方法,在国内5家医院对口服枸橼酸爱地那非30mg、60mg和安慰剂的250例ED患者进行临床观察。结果:3个主要疗效指标的统计学分析显示,试验药物组疗效均优于安慰剂组,60mg组更为明显。次要疗效指标分析结果与主要疗效指标一致。与药物相关的主要不良事件有头晕、头痛、面部潮红和恶心,严重程度为轻至中度,呈一过性,无需处理。结论:口服枸橼酸爱地那非30mg和60mg治疗ED安全、有效,60mg为最佳剂量。     

瘘道切缝结扎术治疗肛瘘131例

目的:评价瘘道切缝结扎术治疗肛瘘的疗效和安全性。方法:患者分为治疗组和切除(挂线)法对照组。以愈合时间、治愈率等作为主要的观测指标,采用肛门直肠测压法进行安全性评价,并对两种手术方法的卫生经济学评价指导进行比较。结果:治疗组和对照组比较有统计学意义,治疗组住院总费用要低于对照组(P<0.01)。结论:瘘道切缝结扎术治疗肛瘘可以缩短病程、降低住院费用,并能保护肛管括约肌的功能。     

规范化操作培训在静脉药物配置中心的应用

目的探讨规范化操作程序应用于静脉药物配置中心,加快配药速度的方法。方法建立规范化操作程序,对配药人员进行严格培训,观察培训前后配完同等药液所需要的时间变化。结果培训后配药速度明显加快,差异有统计学意义,P<0.01。结论规范化操作培训在静脉药物配置中心有着非常的意义。     

A critical assessment of the quality of reporting of randomized, controlled trials in the urology literature

PURPOSE: Randomized, controlled trials are the gold standard for evidence based assessment of therapeutic interventions. In 1996 the Consolidated Standards of Reporting Trials statement was published in an effort to standardize the reporting of clinical trials. To our knowledge we report the first systematic assessment of randomized, controlled trial quality in the urology literature by Consolidated Standards of Reporting Trials standards. MATERIALS AND METHODS: All human subject randomized, controlled trials published in 4 leading urology journals in 1996 and 2004 were identified for formal review. A standardized evaluation form was developed based on the Consolidated Standards of Reporting Trials statement. Each article was evaluated by 2 independent reviewers and discrepancies were settled by consensus. A Consolidated Standards of Reporting Trials criteria summary score was calculated on a scale of 0 to 22. RESULTS: A total of 152 randomized, controlled trials met inclusion criteria. The mean+/-SEM Consolidated Standards of Reporting Trials summary score was 10.2+/-0.3 (median 10.3) and 12.0+/-0.3 (median 12.2) in 1996 and 2004, respectively, with a mean difference of 1.8 (95% CI 1.0, 2.6; p=0.001). Reporting of important methodological criteria, eg sample size justification and randomization implementation, improved from 1996 to 2004. Improvement notwithstanding, reporting of key methodological criteria remained consistently below 50% in 2004. CONCLUSIONS: This formal review suggests that randomized, controlled trial reporting in the urology literature has improved since the publication of the Consolidated Standards of Reporting Trials statement in 1996. Certain areas, such as reporting of trial methods, continue to meet Consolidated Standards of Reporting Trials criteria in fewer than half of publications. Ongoing graduate and postgraduate education in trial design and evidence based practice may result in further improvement in randomized, controlled trial reporting.     

体外循环和非体外循环冠状动脉旁路移植术后心肌梗死发生率的Meta分析

目的 使用Meta分析比较常规体外循环冠状动脉旁路移植术(CCABG)和非体外循环冠状动脉旁路移植术(OPCAB)术后心肌梗死发生率的差异.方法 在 Medline、SCI、Cochrane图书馆临床对照试验注册库(CENTRAL)和中国生物医学文献光盘数据库(CBMdisc)检索中文和英文的相天随机对照临床试验,并检索相关文献的参考文献,检索时间截止至2009年1月.根据严格的纳入和排除标准,两名评价员独立地筛选文献,并按照Cochrane系统评价员手册5.0.0版所建议的评价方法 对纳入临床试验进行质量评价,最后将提取的资料用RevMan 5软件进行数据处理和分析.结果 共纳入22个试验进行Meta分析,OPCAB组共纳入1494例病人,心肌梗死总发生率为2.81%;CCABG组共1512例,心肌梗死总发生率为3.57%.Meta分析结果 显示OPCAB和CCABG术后心肌梗死发生率的差异尤统计学意义(OR=0.80,95%CI=0.54～1.20,P=0.28).结论 依据现有的随机对照试验进行Meta分析结果 显示,OPCAB和CCABG术后心肌梗死发生率的差异无统计学意义.     

体外循环和非体外循环冠状动脉旁路移植术后心肌梗死发生率的Meta分析

目的 使用Meta分析比较常规体外循环冠状动脉旁路移植术(CCABG)和非体外循环冠状动脉旁路移植术(OPCAB)术后心肌梗死发生率的差异.方法 在 Medline、SCI、Cochrane图书馆临床对照试验注册库(CENTRAL)和中国生物医学文献光盘数据库(CBMdisc)检索中文和英文的相天随机对照临床试验,并检索相关文献的参考文献,检索时间截止至2009年1月.根据严格的纳入和排除标准,两名评价员独立地筛选文献,并按照Cochrane系统评价员手册5.0.0版所建议的评价方法 对纳入临床试验进行质量评价,最后将提取的资料用RevMan 5软件进行数据处理和分析.结果 共纳入22个试验进行Meta分析,OPCAB组共纳入1494例病人,心肌梗死总发生率为2.81%;CCABG组共1512例,心肌梗死总发生率为3.57%.Meta分析结果 显示OPCAB和CCABG术后心肌梗死发生率的差异尤统计学意义(OR=0.80,95%CI=0.54～1.20,P=0.28).结论 依据现有的随机对照试验进行Meta分析结果 显示,OPCAB和CCABG术后心肌梗死发生率的差异无统计学意义.     

Interventions for treating the radial tunnel syndrome: a systematic review of observational studies

PURPOSE: For some disorders, such as radial tunnel syndrome (RTS), no randomized controlled trials and controlled clinical trials are available. To gain insight into the effectiveness of conservative and surgical interventions for treating RTS, we systematically reviewed all available observational studies on treatment of RTS. Although the validity of case series is inferior to that of controlled trials, the case series might provide valuable data about the efficacy of treatment options. METHODS: A literature search and additional reference checking resulted in 21 eligible case series for this review. Based on previous checklists, we constructed a new quality assessment and rating system to analyze the included case series. The methodological quality was assessed, and data extraction was performed. Studies with less than 50% of the maximum points on the methodological quality assessment were considered inadequate and were excluded from the analysis. To summarize the results according to the rating system for the strength of the scientific evidence for these case series, we introduced 4 levels: (1) tendency, (2) slight tendency, (3) conflicting tendency, and (4) no tendency. RESULTS: After the methodological quality assessment, 6 articles were included in the final analysis. They all reported on surgical treatment. CONCLUSIONS: There is a tendency that surgical decompression of the radial tunnel might be effective in patients with RTS. The effectiveness of conservative treatments for RTS is unknown because, for most treatments, no studies were available. Additional high-quality controlled studies are needed to assess the level of conclusive evidence for surgical treatment and also to evaluate conservative treatments for RTS. For this, we recommend a multicenter, randomized clinical trial. Due to the lack of a clear protocol for diagnosing RTS, a reliable and valid diagnostic tool should be developed. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.     

Use of intravenous tranexamic acid in total knee arthroplasty: a meta-analysis of randomized controlled trials

Objective:The effect of tranexamic acid (TA) on patients receiving total knee arthroplasty (TKA) has been reported in many small clinical trials.But single trials are not sufficient enough to clarify t...     

体外循环和非体外循环冠状动脉旁路移植术后心肌梗死发生率的Meta分析

目的 使用Meta分析比较常规体外循环冠状动脉旁路移植术(CCABG)和非体外循环冠状动脉旁路移植术(OPCAB)术后心肌梗死发生率的差异.方法 在 Medline、SCI、Cochrane图书馆临床对照试验注册库(CENTRAL)和中国生物医学文献光盘数据库(CBMdisc)检索中文和英文的相天随机对照临床试验,并检索相关文献的参考文献,检索时间截止至2009年1月.根据严格的纳入和排除标准,两名评价员独立地筛选文献,并按照Cochrane系统评价员手册5.0.0版所建议的评价方法 对纳入临床试验进行质量评价,最后将提取的资料用RevMan 5软件进行数据处理和分析.结果 共纳入22个试验进行Meta分析,OPCAB组共纳入1494例病人,心肌梗死总发生率为2.81%;CCABG组共1512例,心肌梗死总发生率为3.57%.Meta分析结果 显示OPCAB和CCABG术后心肌梗死发生率的差异尤统计学意义(OR=0.80,95%CI=0.54～1.20,P=0.28).结论 依据现有的随机对照试验进行Meta分析结果 显示,OPCAB和CCABG术后心肌梗死发生率的差异无统计学意义.     

Systematic review of enhanced recovery programmes in colonic surgery

BACKGROUND: Fast track (FT) programmes optimize perioperative care in an attempt to accelerate recovery, reduce morbidity and shorten hospital stay. The aim of this review was to assess FT programmes for elective segmental colonic resections. METHODS: A systematic review was performed of all randomized controlled trials and controlled clinical trials on FT colonic surgery. The main endpoints were number of applied FT elements, hospital stay, readmission rate, morbidity and mortality. Quality assessment and data extraction were performed independently by three observers. RESULTS: Six papers were eligible for analysis (three randomized controlled and three controlled clinical trials), including 512 patients. FT programmes contained a mean of nine (range four to 12) of the 17 FT elements as defined in the literature. Primary hospital stay (weighted mean difference - 1.56 days, 95 per cent confidence interval (c.i.) - 2.61 to - 0.50 days) and morbidity (relative risk 0.54, 95 per cent c.i. 0.42 to 0.69) were significantly lower for FT programmes. Readmission rates were not significantly different (relative risk 1.17, 95 per cent c.i. 0.73 to 1.86). No increase in mortality was found. CONCLUSIONS: FT appears to be safe and shortens hospital stay after elective colorectal surgery. However, as the evidence is limited, a multicentre randomized trial seems justified.     

Multidisciplinary biopsychosocial rehabilitation for neck and shoulder pain among working age adults: a systematic review within the framework of the Cochrane Collaboration Back Review Group

STUDY DESIGN: A systematic review of randomized controlled trials. OBJECTIVES: To evaluate the effectiveness of multidisciplinary biopsychosocial rehabilitation for neck and shoulder pain among working age adults. SUMMARY OF BACKGROUND DATA: Multidisciplinary biopsychosocial rehabilitation programs for neck and shoulder pain require substantial staff and financial resources. They are widely used, despite questionable evidence of their effectiveness. METHODS: The reviewed randomized controlled and controlled trials appraising the effectiveness of biopsychosocial rehabilitation for working age patients with neck and shoulder pain were identified by searching electronic bibliographic databases, checking references, and consulting experts in the rehabilitation field. Four blinded reviewers selected the trials. Two specialists on rehabilitation evaluated the clinical relevance. Two other blinded reviewers extracted the data and assessed the main results and the methodologic quality of the studies. A qualitative analysis was performed to evaluate the level of scientific evidence. RESULTS: After 1808 abstracts and the references of 65 reviews were screened, only two relevant studies were found that satisfied the criteria. One of these was considered a methodologically low-quality randomized controlled trial, and the other was a methodologically low-quality controlled clinical trial. The clinical relevance of included studies was satisfactory. The level of scientific evidence for the effectiveness of multidisciplinary biopsychosocial rehabilitation for neck and shoulder pain was limited. CONCLUSIONS: There appears to be little scientific evidence for the effectiveness on neck and shoulder pain of multidisciplinary biopsychosocial rehabilitation compared with other rehabilitation methods. There is an urgent need for high-quality trials in this field.     

Randomized trials in orthopaedics: why, how, and when?

There is increasing recognition that major new medical therapies should be rigorously evaluated before they are put into general clinical use. Randomized controlled trials provide the most unbiased assessment of the risks and benefits of such therapies. In this article, the most important aspects of the design and execution of a randomized clinical trial in orthopaedics are discussed. These include the reasons for and mechanisms of randomization, appropriate selection of patients and therapy, reasons for the blinding of therapy, types of measures of outcome that can be used, aspects of sample-size calculation and analysis of data, and ethics of randomized controlled trials.     

Low-frequency ultrasound (20-40 kHz) as an adjunctive therapy for chronic wound healing: a systematic review of the literature and meta-analysis of eight randomized controlled trials

Ultrasound as a therapeutic agent in chronic wound healing has been studied extensively. This systematic review and meta-analysis specifically examines low-frequency (20-30 kHz) ultrasound delivered at either low or high intensity. The objective of this review was to determine whether low-frequency ultrasound used as an adjunctive therapy improves the outcomes of complete healing and reduction of size of chronic lower limb wounds. PubMed, Cochrane/CENTRAL, technical assessment, relevant wound-related journals, and clinical guidelines were searched along with contacting manufacturers and authors of relevant randomized controlled trials were completed. Searches focused on the use of low-frequency ultrasound in randomized controlled trials. Data were collected via a data collection form and was adjudicated independently via coauthors. Meta-analyses and heterogeneity checks were performed using Mantel-Haenszel and inverse variance (fixed and random effects) statistical methods on studies with similar outcomes (complete healing and percent wound area reduction) over similar time periods. Single study results were reported via the statistical methods used in the study. Eight randomized controlled trials were identified. Results demonstrated that early healing (at ≤5 months) in patients with venous stasis and diabetic foot ulcers was favorably influenced by both high- and low-intensity ultrasound delivered at a low frequency-either via contact or noncontact techniques. However, the quality of the data may be suspect, especially for low-frequency low-intensity noncontact ultrasound because of significant biases. In patients presenting with either venous stasis or diabetic foot ulcers (Wagner classification 1-3), early healing appears to be facilitated by either low-frequency low-intensity noncontact ultrasound or low-frequency high-intensity contact ultrasound.