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  • 文章类型: Systematic Review
    背景:经皮乙醇注射(PEI)已被证明是甲状腺结节病理和转移性宫颈腺病的有价值的治疗方法。
    目的:为了评估有效性,安全,PEI在甲状腺结节病理和转移性宫颈腺病中的成本效益。
    方法:使用荟萃分析对PEI的有效性和安全性进行了系统评价(SR)。还进行了关于成本效益的SR。SRs是根据CochraneCollaboration制定的方法进行的,并根据PRISMA声明进行报告。使用决策树模型进行了成本最小化分析。假设两种微创技术(PEI和射频消融(RFA))的有效性相同,该模型从西班牙国家卫生系统的角度比较了六个月替代方案的成本。
    结果:搜索确定了三个RCT(n=157),用于评估诊断为良性甲状腺结节的患者的PEI和RFA:96例主要为囊性结节的患者和61例实性结节的患者。没有发现其他技术或甲状腺结节病理学的证据。PEI和RFA在体积减少(%)方面没有观察到统计学上的显著差异,症状评分,化妆品评分,治疗成功和主要并发症。没有确定经济评估。成本最小化分析估计PEI手术每位患者的成本为326欧元,而RFA为4781欧元。这意味着-4455欧元的增量差额。
    结论:PEI和RFA在安全性和有效性方面没有差异,但是经济评估确定前一种选择更便宜。
    BACKGROUND: Percutaneous ethanol injection (PEI) has been shown to be a valuable treatment for thyroid nodular pathology and metastatic cervical adenopathies.
    OBJECTIVE: To evaluate the effectiveness, safety, and cost-effectiveness of PEI in thyroid nodular pathology and metastatic cervical adenopathies.
    METHODS: A systematic review (SR) using meta-analysis was conducted on the effectiveness and safety of PEI. A SR on cost-effectiveness was also performed. The SRs were conducted according to the methodology developed by the Cochrane Collaboration with reporting in accordance with the PRISMA statement. A cost-minimization analysis was carried out using a decision tree model. Assuming equal effectiveness between two minimally invasive techniques (PEI and radiofrequency ablation (RFA)), the model compared the costs of the alternatives with a horizon of six months and from the perspective of the Spanish National Health System.
    RESULTS: The search identified three RCTs (n=157) that evaluated PEI versus RFA in patients diagnosed with benign thyroid nodules: ninety-six patients with predominantly cystic nodules and sixty-one patients with solid nodules. No evidence was found on other techniques or thyroid nodular pathology. No statistically significant differences were observed between PEI and RFA in volume reduction (%), symptom score, cosmetic score, therapeutic success and major complications. No economic evaluations were identified. The cost-minimization analysis estimated the cost per patient of the PEI procedure at €326 compared to €4781 for RFA, which means an incremental difference of -€4455.
    CONCLUSIONS: There are no differences between PEI and RFA regarding their safety and effectiveness, but the economic evaluation determined that the former option is cheaper.
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  • 文章类型: Systematic Review
    炎症性肠病包括两种慢性炎症性疾病,溃疡性结肠炎和克罗恩病。全世界的疾病负担正在增加。已经发表了一些评估儿科使用肿瘤坏死因子(TNF)拮抗剂的评论,尽管这些主要包括观察性研究,不考虑经济评估。本系统综述评估了有关疗效的现有证据,安全,和TNF拮抗剂治疗小儿炎症性肠病的成本效益。我们搜索了PubMed/MEDLINE,Embase,和CochraneCentral(截至2022年5月)。9项随机临床试验和4项经济评估检查了任何抗TNF药物(例如,英夫利昔单抗,阿达木单抗,戈利木单抗,包括针对不同替代品的certolizumab)。在评估抗TNF药物对克罗恩病的疗效的研究中,大多数人评估了先前对诱导有反应的患者的维持方案的疗效(反应=28%-63%,临床缓解=17%-83%,取决于剂量,药物,和后续行动)。在溃疡性结肠炎中,抗TNF药物维持治疗的临床缓解率在17%至44%之间.9项研究报告了有关不良事件的信息。没有发现比较不同抗TNF药物的临床试验。这篇综述的结果表明,用抗TNF药物(如英夫利昔单抗和阿达木单抗)维持治疗小儿炎症性肠病可能是有效和安全的。然而,经济评估报告的成本效益比结果相互矛盾。协议注册:开放科学框架:https://osf.io/wjmvf。
    Inflammatory bowel disease includes two chronic inflammatory diseases, ulcerative colitis and Crohn\'s disease. The burden of disease is increasing worldwide. A few reviews evaluating the paediatric use of tumour necrosis factor (TNF) antagonists have been published, although these mostly include observational studies and do not consider economic evaluations. This systematic review evaluated the available evidence regarding the efficacy, safety, and cost-effectiveness of TNF antagonist therapy for paediatric inflammatory bowel disease. We searched PubMed/MEDLINE, Embase, and Cochrane Central (up to May 2022). Nine randomized clinical trials and four economic evaluations that examined any anti-TNF drugs (e.g., infliximab, adalimumab, golimumab, and certolizumab) against different alternatives were included. In studies evaluating the efficacy of anti-TNF drugs in Crohn\'s disease, most assessed the efficacy of maintenance regimen in patients who had previously responded to induction (response=28%-63%, and clinical remission=17%-83% depending on dose, drug, and follow-up). In ulcerative colitis, maintenance treatment with anti-TNF drugs reported clinical remission rates between 17% and 44%. Nine studies reported information on adverse events. No clinical trials comparing different anti-TNF drugs were found. The findings from this review suggest that maintenance treatment with anti-TNF drugs (such as infliximab and adalimumab) in paediatric inflammatory bowel disease is probably effective and safe. However, the economic evaluations reported contradictory results of the cost-effectiveness ratios. Protocol registry: Open Science Framework: https://osf.io/wjmvf.
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  • 文章类型: Journal Article
    背景:必须结束由大流行引起的西班牙外科护理中断。从这项活动中恢复必须选择性地进行,并与可能的COVID-19病例结合进行。本综述的目的是将与COVID-19相关的良好实践标准纳入安全手术的背景中,这将有可能制定适合该疾病患者的拟议手术安全检查表。
    方法:叙事文献综述,遵循PRISMA协议,在Medline和Cochrane目录中,使用MeSH术语(冠状病毒,感染,安全,外科手术,Operative,清单)和布尔运算符AND。此外,审查了来自科学机构和社会的建议(灰色文献)。
    结果:33项最终研究包括安全手术建议和适用于COVID-19的手术安全检查表,最常见的是与治疗相关的方面(41.3%)和预防和控制措施(27.6%)。
    结论:对COVID手术患者推荐的良好做法存在广泛共识,因此有可能向这些患者提出手术安全清单的建议。
    BACKGROUND: The interruption of surgical care in Spain caused by the pandemic must end. Recovery from this activity must be carried out on an elective basis and in conjunction with possible cases of COVID-19. The objective of this review was to incorporate good practice criteria related to COVID-19 into the context of safe surgery, which would make it possible to develop a proposed surgical safety checklist adapted to patients with this disease.
    METHODS: Narrative literature review, following the PRISMA protocol, in the Medline and Cochrane directories, using the MeSH terms (coronavirus, infections, safety, surgical procedures, operative, checklist) and the Boolean operator AND. In addition, recommendations from scientific bodies and societies were reviewed (grey literature).
    RESULTS: Thirty-three final studies were included with recommendations for safe surgery and surgical safety checklist adapted for COVID-19, the most frequent being aspects related to treatment (41.3%) and prevention and control measures (27.6%).
    CONCLUSIONS: The existence of a broad consensus on good practices recommended for COVID surgical patients makes it possible to make a proposal for surgical safety checklist to these patients.
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  • 文章类型: Journal Article
    At present, there is no aetiological treatment available for irritable bowel syndrome, and dietary modifications, particularly the low-FODMAP (monosaccharide, disaccharide, oligosaccharides and fermentable polyols) diet is increasingly used to control the symptoms of irritable bowel syndrome, although its actual efficacy and safety are unknown. The objective of this overview is to determine whether the low FODMAP diet is really effective and safe in the long term in the dietary management of irritable bowel syndrome. The review, following an appropriate methodology, was carried out with 25 studies, which were retrieved full text. Of these, 3 were meta-analyses, 2 were systematic reviews, and 3 were both types of studies. The rest of the studies were, in general, of low methodological quality and very heterogeneous, with a low level of evidence and low degree of recommendation. It can be concluded that, in the short term, the low-FODMAP diet is effective in most patients with irritable bowel syndrome, so its use as first-line therapy could be supported. However, of all the studies, only one was prospective for long-term follow-up, between 6 and 18 months, with good results. More follow-up studies, designed for this purpose, are needed to investigate long-term effects. Furthermore, if this type of diet is advised, it should be led by specialised dietitians.
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  • 文章类型: Journal Article
    To gather all published information about the stability of drugs commonly used in Intensive Care Units (ICU); evaluate the methodology of published data; and generate a compatibility table.
    i) A systematic review was conducted searching the following databases: Medline, Stabilis, Handbook of Injectable Drugs and Micromedex. Articles published from 1990 to 2017 in English, Spanish and French were included. ii) Article quality was analyzed according to the stability studies practice guidelines. iii) A compatibility table was produced with data for 44 binary combinations of drugs frequently used in the ICU.
    Spanish and international hospital ICU.
    The systematic review included 29 studies (27 originals, 2 reviews). None of the included studies followed all the methodological requirements. However, 93% guaranteed correct reproducibility. Accordingly, drug stability knowledge was available for 50.3% of the studied admixtures, in which 77.1% of the binary combinations proved compatible and 16.8% proved incompatible.
    This review provides new reliable evidence about the physicochemical stability of drugs commonly used in the critical care setting. The study contributes to the safe administration of intravenous drugs in critical patients with a view to avoiding adverse events in this frail population.
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  • 文章类型: Journal Article
    BACKGROUND: The intravesical administration of hazardous drug products is a standard practice in the urology setting, which potentially exposing medical personnel to these drug products. It was deemed necessary to have a consensus document among the scientific societies involved (the Spanish Urological Association and the Spanish Society of Hospital Pharmacy) that collects the best available evidence on the safest handling possible of dangerous drug products in the setting of urology departments.
    METHODS: We reviewed the legislation and recommendations on the handling of dangerous drug products, both at the national and international level.
    RESULTS: There is national legislation and regulations for protecting workers who handle dangerous drugs and products, as well as recommendations for handling to protect both the product and workers.
    CONCLUSIONS: Following the strategic lines of the European Parliament for 2014-2020 in the chapter on occupational safety and health, the Spanish Urological Association and the Spanish Society of Hospital Pharmacy proposed a series of actions that decrease the risks of exposure for practitioners and caregivers involved in the handling of these products.
    CONCLUSIONS: After this review, 19 recommendations were established for handling dangerous drug products, which can be summarised as the need to train all individuals involved (from management teams to patients and caregivers), adopt systems that prevent contaminating leaks, implement exposure surveillance programmes and optimise available resources.
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  • 文章类型: Comparative Study
    BACKGROUND: In mild gallstone pancreatitis, cholecystectomy decreases the risk of recurrence. This should be performed during the initial hospitalization, but even when this is performed, the hospital stay can be prolonged, with an increase in costs and morbidity. The aim of this study is to compare the complication rate between patients who underwent an early cholecystectomy (<48 hours) vs. a late one (>48 hours).
    METHODS: A systematic search was performed in the following data bases: PubMed, EMBASE, LILACS and Scielo. Articles on patients with acute, mild gallstone pancreatitis who required a cholecystectomy during their initial hospitalization were included and compared with those undergoing a late cholecystectomy, in order to evaluate the complications, number of days of hospitalization and need for readmission. The quality of the studies and the risks of bias were evaluated.
    RESULTS: A total of 580 articles and summaries were identified which included 3 observational studies and a randomized clinical trial. A total of 636 patients who underwent a cholecystectomy during the initial hospitalization were included,. Ten of 207 (4.83%) in the early cholecystectomy group showed some type of complication, and 19 of 429 (4.42%) in the late cholecystectomy group, with a risk difference of -0.0016 IC 95% ([-0.04]-0.04). Three of the included studies should be considered of low quality and one of high quality. No publication bias was evidenced.
    CONCLUSIONS: No differences in complication rate were found between patients who underwent an early cholecystectomy versus a late cholecystectomy; nevertheless, further studies should be carried out in order to confirm these findings.
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  • 文章类型: Journal Article
    目的:评估MF59佐剂化大流行性流感A/H1N1疫苗在儿童中的有效性和安全性。
    方法:在搜索MedLine和Embase电子数据库后,对文献进行了系统回顾,在专业期刊上手动搜索,具有MeSH条款和免费条款。纳入标准是儿童接种MF59佐剂流感A/H1N1疫苗的临床试验,与含或不含MF59佐剂的其他疫苗剂量相比。记录疫苗的免疫原性和安全性。纳入研究的质量通过CASPe核对表进行评估。
    结果:选择了四个中等质量的临床试验。局部和全身不良反应罕见且轻微,组间没有差异。MF59佐剂化疫苗的血清转化和血清保护水平较高。佐剂疫苗的抗体滴度也较高。
    结论:佐剂疫苗具有良好的疗效和安全性。可能发生的不良反应是常见的,并且在两个疫苗接种组中相似。
    OBJECTIVE: To assess the efficacy and safety of MF59-adjuvanted pandemic influenza A/H1N1 vaccine in children.
    METHODS: A systematic review of the literature was performed after searching the MedLine and Embase electronic databases, and manual search in specialties journals, with MeSH terms and and free terms. Inclusion criteria were clinical trials with children vaccinated with MF59-adjuvanted influenza A/H1N1 vaccine, compared with other vaccines doses with/without MF59-adjuvanted. The immunogenicity and safety of the vaccine was recorded. The quality of the studies included was assessed by CASPe checklist.
    RESULTS: Four clinical trials with moderate quality were selected. The local and systemic adverse effects were rare and mild, with no differences between groups. Seroconversion and seroprotection levels were higher with MF59-adjuvanted vaccines. Antibody titres were also higher with the adjuvant vaccines.
    CONCLUSIONS: The adjuvant vaccine has a good efficacy and safety profile. The adverse effects that may occur are common and appear similarly in both vaccination groups.
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