大样本多中心随机临床试验是药物再评价的最佳方法

由于新药上市前临床试验存在许多局限性,故上市后药品再评价非常重要。大样本多中心随机对照临床试验是药品上市后疗效再评价的最佳方法。大样本多中心随机对照临床试验可公正地评估药品的长期疗效和安全性,评估药物治疗对患者生存状况及并发症的影响,并可产生巨大的社会效益和经济效益。     

目视管理在静脉用药调配中心护理管理中的应用

[目的]探讨目视管理在静脉用药调配中心护理管理中的应用效果。[方法]比较目视管理前后静脉用药调配中心的质控记录,观察静脉用药调配中心实施目视管理的效果。[结果]实施目视管理前后剂量错误、相似药品调配错误、标签与药品不符、标签性质不符、病区不符、批次不符6项质量控制指标比较差异有统计学意义(P0.05)。[结论]实施目视管理后,静脉用药调配中心管理呈现高效化、简洁化、可视化,提高了护理工作质量。     

血液净化中心与门诊药房一体化管理在血透患者药品管理中的应用

目的 探讨血液净化中心与门诊药房一体化管理在血透患者药品管理中的应用效果.方法 收集我院2020年10月至2020年12月收治的220例、未经规范化管理的血液透析患者纳入对照组,2021年1月至2021年3月实施规范化管理措施的220例血液透析患者纳入实验组.分析比较两组血透患者药品规范管理前后的药品不良反应发生率、用药满意度及药品标准化管理规范率.结果 实验组用药不良反应发生率显著低于对照组(P＜0.05).实验组的用药满意度显著高于对照组(P＜0.05).实验组药品储存规范率、使用规范率均显著高于对照组(P＜0.05).结论 采用血液净化中心与门诊药房一体化管理的措施,能降低药品不良反应发生率,提高用药满意度及药品标准化管理规范率.     

基层医生基础与临床千题解

越来越多的证据表明用药不合理不仅不能治病 ,反而可以致病 ,并导致药物浪费、副作用发生和延误病情。因此 ,对消化系统的合理用药应引起高度重视。消化系统合理用药的原则是什么 ?1　掌握消化系疾病的发病机制和适应证 ,是合理用药之前提 ,依据疾病的病理生理机制选择用药 ,这符合传统医学的原则。2　追踪消化领域随机对照试验、Ｍｅｔａ 分析 (荟萃分析 )研究结果。 2 1世纪是循证医学的年代 ,临床医师应重视临床随机对照试验 ,特别是多中心大规模随机对照试验研究所获得的结果 ,并逐渐、自觉地将这些研究结果作为证据用于临床实践中 ,使…     

中心药站责任管理的体会

中心药站负责全院住院患者治疗用药的摆发，请领。微机与科室联网对临床用药实行宏现控制，统一管理．并设专人负责科室基数药品请领和口服用药的摆发．为了积极配合医院诊治，优质服务于临床。中心药站应有严格的工作制度与药品管理措施。1制度健全．管理到位我院是一所综合性治疗医院，根据病种不同由三个摆药台和发药台分管全院15个临床科室的各类治疗用药．同时做到三统一．三固定，三掌握，即科是用药统一存储，统一摆发，统一请领。药品的存储、摆发，请领固定专人，固定时间，固定基数种类。中心药站人员要：掌握药品的名称、片型、…     

研究护士对血液肿瘤临床试验药品的管理

从对血液肿瘤临床试验药品的接收、保存、领取、药物配制、给药流程、临床试验用药的盘点、回收等方面，总结药物临床试验中研究护士对血液肿瘤临床试验药品的管理。不难看出，对血液肿瘤临床试验药品规范的管理，是保障血液肿瘤药物临床试验顺利进行的关键。     

社区卫生服务中心药房管理

社区卫生服务中心药房药品管理是保证医院医疗质量、安全和经济效益的重要环节,本文从社区药房药品管理和对药房药剂人员的管理和培养两个方面讨论一些强化中心药房管理、提高经济效益的对策,社区卫生服务中心的药师应从简单的药学服务做起,不断充实和完善药学工作的内容及形式。通过为患者提供用药指导,能够真正达到合理用药的目的。     

中心手术室毒麻药品专职化管理与医疗安全

目的探讨中心手术室医院毒麻药品管理方法。方法对毒麻药品实行专人领取、专人发放、专柜保存、专册登记、专用处方与专人核对。结果毒麻药品能合理应用,防止毒麻药品使用混乱、过期及流入社会。结论加强手术室毒麻药品的专职化管理,可确保手术室的医疗用药安全。     

中心片摆的管理

中心药房是以最小单位的用药剂量提供给全院住院病人临床用药的科室。中心药房在全院的经济、药品的管理中起到很重要的作用。管理的好坏直接影响到临床住院病人用药的及时、安全。但现有的摆药环境、模式、人员结构、人员素质与现代化医院的要求有一定的差距。尤其是片摆，中心片摆是将拆封的裸药直接发给病人，所以在摆药的每个环节中要减少不必要的污染．防止药品的错发和漏发来确保用药的安全。笔者针对以上几点提出一些意见、建议。     

中心药房在优化试验用药品管理中的应用

重庆医科大学附属第一医院药物临床试验机构通过对试验用药品管理工作中的常见问题进行原因分析,制订改进策略,对中心药房成立前后的药物管理质量进行分析比较,探讨建立药物临床试验中心药房在优化试验用药品管理工作的应用,结果表明建立中心药房能有效提高试验用药品管理的规范性。     

Review article: Prophylactic metoclopramide for patients receiving intravenous morphine in the emergency setting: A systematic review and meta‐analysis of randomized controlled trials

The objective of the present study was to conduct a systematic review and meta‐analysis of randomized controlled trials, comparing metoclopramide with placebo, for preventing vomiting in patients who have received i.v. morphine for acute pain in the emergency setting, and to determine the level of evidence supporting the use of prophylactic metoclopramide in this population. Comprehensive systematic electronic searches were conducted of MEDLINE, EMBASE and the Cochrane Library for randomized controlled trials addressing the clinical question. Reference lists of identified articles were hand‐searched. Methodologically appropriate clinical trials identified in the search process were included in a meta‐analysis to provide a pooled estimate of effect. Three randomized controlled trials fulfilled the search criteria. All three studies were included in the final meta‐analysis that demonstrated an overall result of no difference between metoclopramide and placebo for the primary outcome of vomiting (odds ratios 0.72; 95% confidence intervals 0.11–4.58). There was little evidence that routine prophylactic administration of metoclopramide following the administration of i.v. morphine for acute pain management in the emergency setting is clinically beneficial. Routine metoclopramide administration might expose patients to a risk of harm, which is not justifiable given a lack of evidence of benefit.     

Beyond randomized, controlled trials

PURPOSE OF REVIEW: Most critical care physicians believe that randomized, controlled trials provide the best available evidence. This review contends that the importance of randomized, controlled trials was overemphasized and that they do not add more to knowledge and practice than physiologic and observational studies. In addition, protection of both patients and proxies may be less adequately ensured during randomized, controlled trials than during observational studies. RECENT FINDINGS: An analysis of the recent literature on critical care shows that conclusions from randomized, controlled trials are either disputable or do not affect existing practice. In addition, several papers reveal potential conflicts between randomized, controlled trials and ethical principles. SUMMARY: We may see in the future the twilight of randomized, controlled trials in critically ill patients because scientific, ethical, and sociologic substrata will be progressively lacking as will be funding.     

Ketamine as adjuvant to opioids for cancer pain. A qualitative systematic review

Ketamine is increasingly being used as an adjuvant to opioids in the treatment of refractory cancer pain. This systematic review examines the available evidence. Randomized, controlled trials, with or without crossover, were included. Studies were identified from MEDLINE, EMBASE, CANCERLIT, the Cochrane Library, handsearched reference lists from review articles and chapters from standard textbooks on pain and palliative care and reference lists from papers retrieved. Four randomized, controlled studies were identified. Two were excluded due to poor quality. Both included studies concluded that ketamine improves morphine treatment in cancer pain. Quantitative meta-analysis was not possible. The available evidence is not sufficient to conclude that ketamine improves the effectiveness of opioid treatment in cancer pain. High quality, randomized, controlled trials with larger numbers of patients and standardized, clinically relevant routes of administration of ketamine are needed.     

心血管病领域循证医学的发展

随机对照临床试验是循证医学发展的基础,心血管病内科领域是循证医学研究和实践的典范,一系列大规模随机对照临床试验为循证医学提供了证据,大大提高了心血管病临床治疗水平。进一步加强规范化管理,使我国大规模随机对照临床试验更健康地发展。     

The dangers of inferring treatment effects from observational data: a case study in HIV infection

Several recent articles have implicitly questioned the need for randomized controlled trials, based on a comparison of treatment effects from observational studies and related randomized controlled trials. We present here a counterexample of a comparison of two antiretroviral drugs used in the treatment of HIV infection, in which the observational analysis gave a potentially misleading result. Examples such as this emphasize the need to regard randomized controlled trials as the primary mechanism for assessing therapeutic efficacy.     

Mechanical thromboprophylaxis in critically ill patients: a systematic review and meta-analysis.

OBJECTIVE: To systematically review the randomized trials, observational studies, and survey evidence on compression and pneumatic devices for thromboprophylaxis in intensive care patients. METHODS: Published studies on the use of compression and pneumatic devices in intensive care patients were assessed. A meta-analysis was conducted by using the randomized controlled trials. RESULTS: A total of 21 relevant studies (5 randomized controlled trials, 13 observational studies, and 3 surveys) were found. A total of 811 patients were randomized in the 5 randomized controlled trials; 3421 patients participated in the observational studies. Trauma patients only were enrolled in 4 randomized controlled trials and 4 observational studies. Meta-analysis of 2 randomized controlled trials with similar populations and outcomes revealed that use of compression and pneumatic devices did not reduce the incidence of venous thromboembolism. The pooled risk ratio was 2.37, indicative of favoring the control over the intervention in reducing the deep venous thrombosis; however, the 95% CI of 0.57 to 9.90 indicated no significant differences between the intervention and the control. A range of methodological issues, including bias and confounding variables, make meaningful interpretation of the observational studies difficult. CONCLUSIONS: The limited evidence suggests that use of compressive and pneumatic devices yields results not significantly different from results obtained with no treatment or use of low-molecular-weight heparin. Until large randomized controlled trials are conducted, the role of mechanical approaches to thromboprophylaxis for intensive care patients remains uncertain.     

Intrathecal Drug Administration in Chronic Pain Syndromes

Chronic pain may recur after initial response to strong opioids in both patients with cancer and patients without cancer or therapy may be complicated by intolerable side effects. When minimally invasive interventional pain management techniques also fail to provide satisfactory pain relief, continuous intrathecal analgesic administration may be considered. Only 3 products have been officially approved for long‐term intrathecal administration: morphine, baclofen, and ziconotide. The efficacy of intrathecal ziconotide for the management of patients with severe chronic refractory noncancer pain was illustrated in 3 placebo‐controlled trials. A randomized study showed this treatment option to be effective over a short follow‐up period for patients with pain due to cancer or AIDS. The efficacy of intrathecal opioid administration for the management of chronic noncancer pain is mainly derived from prospective and retrospective noncontrolled trials. The effect of intrathecal morphine administration in patients with pain due to cancer was compared with oral or transdermal treatment in a randomized controlled trial, which found better pain control and fewer side effects with intrathecal opioids. Other evidence is derived from cohort studies. Side effects of chronic intrathecal therapy may either be technical (catheter or pump malfunction) or biological (infection). The most troublesome complication is, however, the possibility of granuloma formation at the catheter tip that may induce neurological damage. Given limited studies, the evidence for intrathecal drug administration in patients suffering from cancer‐related pain is more compelling than that of chronic noncancer pain.     

T HE D EVELOPMENT OF A R EGISTER OF R ANDOMIZED C ONTROLLED T RIALS IN P REHOSPITAL T RAUMA C ARE

Objectives. To establish a register of randomized controlled trials of interventions in the prehospital care of trauma patients. Methods. A systematic search was conducted for all randomized controlled trials of interventions in the prehospital care of trauma patients. The search included the Cochrane Controlled Trial Register, the Cochrane Injuries Group Specialised Register, Medline, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), Science Citation Index, National Research Register, Dissertation Abstracts, and PubMed for the time period 1966–2000. There were no language restrictions. In addition, full-text hand searching of a range of relevant journals was done, and the authors of included trials were contacted. Results. The combined search strategy identified 16,037 potentially eligible records, of which 28 were reports of randomized controlled trials evaluating prehospital trauma care interventions. After excluding duplicate reports, there were 24 separate randomized controlled trials including 6,806 patients. The largest and smallest trials involved 1,309 and 30 trauma patients, respectively. Conclusions. This register will facilitate the conduct of systematic reviews of the effectiveness of interventions in prehospital trauma care. However, despite the extensive searching, very few randomized trials in this area were found. In view of the absence of evidence for the effectiveness of many of the interventions that are used in the prehospital care of trauma patients, further randomized controlled trials are required.     

The development of a register of randomized controlled trials in prehospital trauma care

Objectives. To establish a register of randomized controlled trials of interventions in the prehospital care of trauma patients. Methods. A systematic search was conducted for all randomized controlled trials of interventions in the prehospital care of trauma patients. The search included the Cochrane Controlled Trial Register, the Cochrane Injuries Group Specialised Register, Medline, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), Science Citation Index, National Research Register, Dissertation Abstracts, and PubMed for the time period 1966-2000. There were no language restrictions. In addition, full-text hand searching of a range of relevant journals was done, and the authors of included trials were contacted. Results. The combined search strategy identified 16,037 potentially eligible records, of which 28 were reports of randomized controlled trials evaluating prehospital trauma care interventions. After excluding duplicate reports, there were 24 separate randomized controlled trials including 6,806 patients. The largest and smallest trials involved 1,309 and 30 trauma patients, respectively. Conclusions. This register will facilitate the conduct of systematic reviews of the effectiveness of interventions in prehospital trauma care. However, despite the extensive searching, very few randomized trials in this area were found. In view of the absence of evidence for the effectiveness of many of the interventions that are used in the prehospital care of trauma patients, further randomized controlled trials are required. PREHOSPITAL EMERGENCY CARE 2002;6:27-30     

Severity Grading of Childhood Poisoning: The Multicentre Study of Poisoning in Children (MSPC) Score

The evidence base of clinical toxicology suffers in comparison to other clinical disciplines. There is an excess of case reports and case series with little in the way of case control or cohort studies, and very few randomized controlled trials. While randomized controlled trials are rightly regarded as the gold standard for interventional studies, they have limitations that are particularly evident in the practice of clinical toxicology. Properly conducted observational studies using quantitative, epidemiological methods [nonrandomized trials, cohort studies (prospective and retrospective), case control methods] can provide answers that may be impossible to obtain from randomized controlled trials. Development of a strong evidence base is essential for progress in clinical toxicology. Whether that evidence base is derived from randomized controlled trials or observational studies, it is essential to collect data. Important observations can be made from basic clinical data and systematic collection of those data into some form of electronic database has significant advantages. A clinical database provides accurate information in the areas of clinical practice, quality assurance (audit), and research. In the area of research, an appropriately designed database can be both a source of hypotheses as well as a vehicle to test them. It can also serve as a repository of research data in subsequent randomized controlled trials.