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Analysis of the selection process for new drugs in a tertiary hospital 2004-2007 2004-2007年某三级医院新药选择过程分析
Pub Date : 2010-01-01 DOI: 10.1016/S2173-5085(10)70003-4
E.R. Alfaro-Lara , M. Galván-Banqueri , E. Prado-Mel , B. Santos-Ramos , J.M. Varela-Aguilar , J. Torelló-Iserte , M.M. Castellano Zurera , F.J. Bautista Paloma

Objective

The purpose of this study is to describe the structure of the CFyT, the Pharmacy and Therapeutics Committee, and a tertiary hospital's selection process for new drugs.

Material and methods

All annals of the PTC and the New Drug Incorporation Guides (GINF) to incorporate new drugs received at Hospital Virgen del Rocío between 2004 and 2007 were reviewed. We carried out a descriptive study which collected variables having to do with the drug (drug type, type of register, route of administration and legal category), the petitioner (responsible division, professional category and request type) and the result of the evaluation (final decision, elapsed time between the request and the decision).

Results

Of the 72 requested drugs, 45 (62.5%) were approved: six as equivalent treatments, 36 (80%) with specific recommendations, and three (4.2%) with no restrictions. Twelve drugs (81.1%) were not included due to insufficient evidence of their effectiveness compared with the current treatment. The most frequently-requested drug type was the antineoplastics, most commonly requested by Oncology and Haematology divisions. We highlight the fact that many of the petitioners included clinical trials (97.2%) and data referring to costs (84.7%).

Conclusions

There is a high level of compliance with the GINF guide in our centre, which guarantees that the P&TC's final decision is based on scientific evidence.

目的本研究的目的是描述CFyT、药学和治疗学委员会的结构,以及一家三级医院的新药选择过程。材料和方法回顾了2004年至2007年期间在维珍医院Rocío收到的所有PTC年报和新药纳入指南(GINF)。我们进行了一项描述性研究,收集了与药物(药物类型、注册类型、管理途径和法律类别)、申请人(负责部门、专业类别和请求类型)和评估结果(最终决定、请求和决定之间的经过时间)有关的变量。结果在申请的72种药物中,有45种(62.5%)获得批准:6种作为等效治疗,36种(80%)具有特定推荐,3种(4.2%)没有限制。12种药物(81.1%)由于与当前治疗相比有效性证据不足而未纳入。最常要求的药物类型是抗肿瘤药物,最常见于肿瘤科和血液科。我们强调的事实是,许多请愿书包括临床试验(97.2%)和涉及成本的数据(84.7%)。结论我们中心对GINF指南的遵守程度很高,这保证了P&TC的最终决定是基于科学证据的。
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引用次数: 2
Assessing lenalidomide for treating multiple myeloma, myelofibrosis and myelodysplastic syndrome 来那度胺治疗多发性骨髓瘤、骨髓纤维化和骨髓增生异常综合征的疗效评估
Pub Date : 2010-01-01 DOI: 10.1016/S2173-5085(10)70015-0
C. Hernández Prats , F. Romero Iborra , E. Arroyo Domingo , I. Castillo Valero , M. Real Panisello , M.I. Sánchez Casado

Objective

Lenalidomide (LDM) is an immunomodulatory and anti-angiogenic drug which has been shown to be effective in several haematological disorders (multiple myeloma [MM], myeloid metaplasia with myelofibrosis [MF] and myelodysplastic syndrome [MDS]). The objective of this study is to evaluate the effectiveness and tolerability of LDM in our patients.

Method

Retrospective observational study which included patients at our hospital who were monitored by the haematology unit, diagnosed with MM, MF and MDS and candidates for LDM treatment. Treatment effectiveness was assessed after approximately 4 cycles of treatment.

Results

Between February 2007 and March 2008, 16 patients were listed as candidates for receiving treatment with LDM (50% female/50% male, with a mean age of 69.6 years); of these candidates, 3 never initiated treatment. Five of the six patients with MM treated at our hospital obtained some sort of response (83.3%). Of the 4 patients with MF, 2 (66.6%) experienced some sort of response to treatment. Of the 6 patients diagnosed with MDS, treatment was initiated in 3, and it had to be suspended in 2 cases due to different reasons. Treatment only had to be suspended in two of the 13 patients who began it (15.4%) due to adverse effects (AE).

Conclusion

LDM is well-tolerated and produces sustained clinical benefits, especially in MM and MF. More studies are needed for in-depth examination of treatment duration, new indications and the use of treatments combined with other drugs.

来那度胺(LDM)是一种免疫调节和抗血管生成药物,已被证明对多种血液系统疾病(多发性骨髓瘤(MM)、骨髓化生伴骨髓纤维化(MF)和骨髓增生异常综合征(MDS))有效。本研究的目的是评估LDM患者的有效性和耐受性。方法回顾性观察性研究,纳入我院血液科监测的MM、MF、MDS患者和LDM治疗候选者。大约4个疗程后评估治疗效果。结果2007年2月至2008年3月,16例患者被列为LDM治疗候选者,其中女性占50%,男性占50%,平均年龄69.6岁;在这些候选人中,3人从未开始治疗。在我院治疗的6例MM患者中,有5例(83.3%)获得了某种程度的缓解。在4例MF患者中,2例(66.6%)对治疗有一定的反应。6例确诊为MDS的患者中,3例开始治疗,2例因不同原因不得不暂停治疗。由于不良反应(AE), 13例开始治疗的患者中只有2例(15.4%)不得不暂停治疗。结论ldm耐受性良好,具有持续的临床疗效,尤其是MM和MF患者。对于治疗时间、新的适应症以及与其他药物联合治疗的使用,需要进行更多的深入研究。
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引用次数: 0
Monitoring polymedicated elderly patients in a health care unit 在卫生保健单位监测使用多种药物的老年患者
Pub Date : 2010-01-01 DOI: 10.1016/S2173-5085(10)70019-8
C. Galán-Retamal, R. Garrido-Fernández, S. Fernández-Espínola, V. Padilla-Marín

Objective

To implement a coordinated strategy for the family care unit and the pharmacy division in order to enable revising treatment in polymedicated patients. To this end, we have developed a software tool permitting the patient's primary doctor to have a quick, summarised description of the patient's updated pharmacological treatments, and detect iatrogenic risks and/or dosage adjustments and pharmacotherapy advice.

Methods

In this study, polymedicated patients are defined as those taking 10 or more medications during at least one month.

Development phases:

Designing a guide form to assist the family doctor in reviewing treatments.

Developing a drug treatment report (DTR) as a complementary document to assist the doctor in reviewing treatments.

Introducing a coordinated communication system between the family doctor and the pharmacist.

Reviewing work instructions and distributing them to staff members involved.

Results

The target population of the study consists of 1897 polymedicated patients. We issued 1897 reports, containing the following: 8530 recommendations (10% alerts from regulatory authorities, 31% recommendations regarding high-risk drugs in elderly patients, 7% gave information about new treatments and 52% recommendations on proper drug use); 399 had high clinically relevant drug interactions; and 5036 dose adjustment recommendations. These pharmacotherapy reports allow treatment to be revised for nearly 100% of the selected population.

Conclusion

The development and implementation of software tools for monitoring polymedicated patients enables us to create DTRs that facilitate routine medical reviews of pharmacological treatment in a fairly wide range of patients.

目的实施家庭护理单位与药学部门的协调策略,使多药患者的治疗得以改进。为此,我们开发了一种软件工具,使患者的主治医生能够快速、概括地描述患者最新的药物治疗情况,并检测医源性风险和/或剂量调整和药物治疗建议。方法在本研究中,多重用药患者定义为在至少一个月内服用10种或10种以上药物的患者。开发阶段:设计指导表格,帮助家庭医生评估治疗方案。制定药物治疗报告(DTR)作为补充文件,以协助医生审查治疗。引入家庭医生与药剂师之间的协调沟通系统。审查工作指示并分发给相关员工。结果本研究的目标人群为1897例综合用药患者。我们发布了1897份报告,包含以下内容:8530条建议(10%来自监管部门的警告,31%关于老年患者高风险药物的建议,7%提供新治疗信息,52%关于正确用药的建议);399例临床相关药物相互作用高;5036个剂量调整建议。这些药物治疗报告允许对几乎100%的选定人群的治疗进行修订。结论开发和实施用于监测多种药物患者的软件工具使我们能够创建dtr,从而促进对相当大范围患者的药物治疗进行常规医学审查。
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引用次数: 1
Analysis of the budget impact for the Spanish National Health System of the fixed combination of amlodipine 5 or 10 mg and atorvastatin 10 mg 氨氯地平5或10mg与阿托伐他汀10mg固定组合对西班牙国家卫生系统的预算影响分析
Pub Date : 2010-01-01 DOI: 10.1016/S2173-5085(10)70010-1
M. De Salas , J. Fernández De Bobadilla , B. Ferro , J. Rejas

Objective

To carry out a Budget Impact Analysis (BIA) of the inclusion of the administration of the fixed combination (FC) of amlodipine 5 or 10 mg and atorvastatin 10 mg for approved indications in the Spanish National Health System (SNHS).

Material and methods

A BIA was carried out from the SNHS perspective for a 3-year period (2009–2011). A tree-type decision model was designed (patient tree), based on epidemiological data and scientific literature, in order to estimate the hypertensive population that could be treated with the FC. The total per annum BIA was calculated by attributing the retail price+VAT of the FC to the number of patients to be treated, and deducting the cost of the treatment for hypertension that was replaced and the updated average cost per patient of cardiovascular events (CVEs) prevented by the use of the FC by the SNHS during the period of study.

Results

The patient population likely to be treated with the FC was 51,104 patients (1st year), with a growth rate of 1%–2% over the following years, which means an annual cost (€) of 15.9 M (2009), 19.9 M (2010) and 24.1 M (2011), with a total of 60.0 M. The BIA was compensated showing negative impact values for the SNHS when the cost of replaced antihypertensive treatment and prevented CVEs was deducted, with savings of 69.9 M € over 3 years.

Conclusion

The BIA of a FC of atorvastatin and amlodipine shows that the use of this medication for approved indications could generate net savings for the SNHS of 9.9 M € for the period 2009–2011.

目的对西班牙国家卫生系统(SNHS)批准适应症纳入氨氯地平5或10mg与阿托伐他汀10mg固定联合用药(FC)进行预算影响分析(BIA)。材料与方法从SNHS角度进行了为期3年(2009-2011)的BIA。基于流行病学资料和科学文献,设计了树型决策模型(患者树),以估计可应用FC治疗的高血压人群。每年的总BIA是通过将FC的零售价格+增值税归因于治疗的患者数量,并减去研究期间SNHS使用FC预防的高血压治疗费用和更新的每位患者心血管事件(CVEs)的平均成本来计算的。ResultsThe与FC患者人群可能是治疗51104例(1年),1% - -2%的增长率在随后的几年里,这意味着每年成本(€)15.9(2009),19.9(2010)和19.9(2011),共有60.0 M . BIA补偿SNHS显示负面影响值时的成本取代抗高血压治疗和预防cf扣除,与储蓄69.9€3年。结论:对阿托伐他汀和氨氯地平的BIA分析表明,在2009-2011年期间,在批准的适应症中使用该药物可为SNHS节省990万欧元。
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引用次数: 1
New technologies applied to the medication-dispensing process, error analysis and contributing factors 配药过程中应用的新技术、误差分析及影响因素
Pub Date : 2010-01-01 DOI: 10.1016/S2173-5085(10)70001-0
A.M. Álvarez Díaz, E. Delgado Silveira, C. Pérez Menéndez-Conde, R. Pintor Recuenco, E. Gómez de Salazar López de Silanes, J. Serna Pérez, T. Mendoza Jiménez, T. Bermejo Vicedo

Objective

Calculate error prevalence occurred in different medication-dispensing systems, the stages of occurrence, and contributing factors.

Methodology

Prospective observational study. The staging of the dispensing process were reviewed in five dispensing systems: Stock, Unitary-Dose dispensing systems (UDDS) without Computerised Prescription Order Entry (CPOE), CPOE-UDDS, Automated Dispensing Systems (ADS) without CPOE and CPOE-ADS. Dispensing errors were identified, together with the stages of occurrence of such errors and their contributing factors.

Results

Two thousand one hundred eighty one errors were detected among 54,169 opportunities of error. Error-rate: Stock, 10.7%; no-CPOE-UDDS, 3.7%, CPOE-UDDS, 2.2%, no-CPOE-ADS, 20.7%; CPOE-ADS, 2.9%. Most frequent stage when error occurs: Stock, preparation of order; no-CPOEUDDS and CPOE-UDDS, filling of the unit dose cart; no-CPOE-ADS and CPOE-ADS, filling of the ADS. Most frequent error: Stock, no-CPOE-ADS and CPOE-ADS, omission; CPOE-UDDS, different amount of drug and no-CPOE-UDDS, extra medication. Contributing factor: Stock, CPOE-ADS and no-CPOE-ADS, stock out/supply problems; CPOE-UDDS, inexperienced personnel and deficient communication system between professionals; no-CPOE-UDDS, deficient communication system between professionals.

Conclusions

Applying new technologies to the dispensing process has increased its safety, particularly, implementation of CPOE has enabled to reduce dispensing errors.

目的了解不同药品调剂系统的差错发生率、发生阶段及影响因素。方法:前瞻性观察研究。在五种配药系统中回顾了配药过程的分期:库存、没有计算机化处方单输入(CPOE)的单一剂量配药系统(UDDS)、CPOE-UDDS、没有CPOE的自动配药系统(ADS)和CPOE-ADS。确定了配药错误,以及发生此类错误的阶段及其促成因素。结果在54,169个错误机会中,检出错误21,881个。错误率:股票,10.7%;无CPOE-UDDS, 3.7%,无CPOE-UDDS, 2.2%,无cpoe - ads, 20.7%;CPOE-ADS, 2.9%。出错最频繁的阶段:备货、准备订单;无cpoeudds和cpoeudds,填充单位剂量车;最常见的错误:Stock, no-CPOE-ADS和CPOE-ADS,遗漏;CPOE-UDDS,不同剂量的药物和没有CPOE-UDDS,额外的药物。促成因素:库存,CPOE-ADS和无CPOE-ADS,缺货/供应问题;CPOE-UDDS,人员经验不足,专业人员沟通系统不足;无cpoe - udds,专业人员之间缺乏沟通系统。结论在配药过程中应用新技术提高了配药的安全性,特别是CPOE的实施减少了配药错误。
{"title":"New technologies applied to the medication-dispensing process, error analysis and contributing factors","authors":"A.M. Álvarez Díaz,&nbsp;E. Delgado Silveira,&nbsp;C. Pérez Menéndez-Conde,&nbsp;R. Pintor Recuenco,&nbsp;E. Gómez de Salazar López de Silanes,&nbsp;J. Serna Pérez,&nbsp;T. Mendoza Jiménez,&nbsp;T. Bermejo Vicedo","doi":"10.1016/S2173-5085(10)70001-0","DOIUrl":"10.1016/S2173-5085(10)70001-0","url":null,"abstract":"<div><h3>Objective</h3><p>Calculate error prevalence occurred in different medication-dispensing systems, the stages of occurrence, and contributing factors.</p></div><div><h3>Methodology</h3><p>Prospective observational study. The staging of the dispensing process were reviewed in five dispensing systems: Stock, Unitary-Dose dispensing systems (UDDS) without Computerised Prescription Order Entry (CPOE), CPOE-UDDS, Automated Dispensing Systems (ADS) without CPOE and CPOE-ADS. Dispensing errors were identified, together with the stages of occurrence of such errors and their contributing factors.</p></div><div><h3>Results</h3><p>Two thousand one hundred eighty one errors were detected among 54,169 opportunities of error. Error-rate: Stock, 10.7%; no-CPOE-UDDS, 3.7%, CPOE-UDDS, 2.2%, no-CPOE-ADS, 20.7%; CPOE-ADS, 2.9%. Most frequent stage when error occurs: Stock, preparation of order; no-CPOEUDDS and CPOE-UDDS, filling of the unit dose cart; no-CPOE-ADS and CPOE-ADS, filling of the ADS. Most frequent error: Stock, no-CPOE-ADS and CPOE-ADS, omission; CPOE-UDDS, different amount of drug and no-CPOE-UDDS, extra medication. Contributing factor: Stock, CPOE-ADS and no-CPOE-ADS, stock out/supply problems; CPOE-UDDS, inexperienced personnel and deficient communication system between professionals; no-CPOE-UDDS, deficient communication system between professionals.</p></div><div><h3>Conclusions</h3><p>Applying new technologies to the dispensing process has increased its safety, particularly, implementation of CPOE has enabled to reduce dispensing errors.</p></div>","PeriodicalId":100521,"journal":{"name":"Farmacia Hospitalaria (English Edition)","volume":"34 2","pages":"Pages 59-67"},"PeriodicalIF":0.0,"publicationDate":"2010-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/S2173-5085(10)70001-0","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"56620874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 3
Pharmaceutical intervention with parenteral nutrition 药物干预与肠外营养
Pub Date : 2010-01-01 DOI: 10.1016/S2173-5085(10)70059-9
D. Sevilla Sánchez, M.M. Placeres Alsina, M.T. Miana Mena, E. López Suñé, C. Codina Jané, J. Ribas Sala

Objective

Description and analysis of pharmaceutical interventions for patients with parenteral nutrition and an assessment of the degree of acceptance.

Method

Prospective six-month study. Design of a data collection sheet (with personal data, the indication for parenteral nutrition, hospital area, nutrition type, time and type of intervention, type of notification, acceptance) for recording interventions carried out based on normal activities: complete review of pharmacotherapy and clinical history.

Results

A total of 265 interventions were carried out during the study period (1.5 interventions/day) with a mean of 2.1 interventions/patient. The overall degree of acceptance was 83.77%; significant differences were found between type of communication for the intervention (oral and/or written) and the degree of acceptance.

Conclusions

Adding a pharmacist to the care team permits direct intervention in partnership with the doctor, and it is an effective method for preventing and resolving the complications, generally metabolic, that are associated with parenteral nutrition. Using this process for resolving medication-related problems in hospitalised patients, principally in surgical areas, is an addition to the pharmacist's activities in the area of nutritional support.

目的对肠外营养患者的药物干预进行描述和分析,并评价其接受程度。方法前瞻性研究。设计一份数据收集表(包括个人资料、肠外营养适应证、医院面积、营养类型、干预时间和类型、通知类型、接受情况),记录在正常活动基础上开展的干预措施:对药物治疗和临床病史的完整回顾。结果研究期间共进行了265次干预(1.5次/d),平均2.1次干预/患者。总体接受度为83.77%;干预的沟通类型(口头和/或书面)和接受程度之间存在显著差异。结论在护理团队中增加一名药剂师,可以在医生的配合下进行直接干预,是预防和解决肠外营养相关并发症(通常是代谢并发症)的有效方法。利用这一过程解决住院病人(主要是外科病人)与药物有关的问题,是药剂师在营养支持领域活动的补充。
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引用次数: 4
Resistance to aspirin: Prevalence, mechanisms of action and association with thromboembolic events. A narrative review 阿司匹林抵抗:患病率,作用机制和与血栓栓塞事件的关联。叙述性回顾
Pub Date : 2010-01-01 DOI: 10.1016/S2173-5085(10)70062-9
L. Cañivano Petreñas , C. García Yubero

Objectives

The purpose of this study is to review the prevalence of aspirin resistance in patients with a high risk of cardiovascular events, and secondly, to investigate its epidemiology and mechanism of action, and the clinical consequences it can provoke.

Material and methods

A search was run on PubMed, EMBASE and Reviews Database for English or Spanish articles on aspirin resistance published up to November 2008. Additional studies were obtained by searching the reference lists in the selected articles for articles relevant to our secondary objectives.

Results

Aspirin resistance is described as affecting 0% to 57% of the population, and is related to a decreased protective effect against strokes and cardiovascular events. Many modifiable and unmodifiable factors can affect the efficacy of antiplatelet drugs. Possible strategies for overcoming this decreased antiaggregant effect include increasing the aspirin dosage or dual therapy with another antiplatelet agent.

Conclusions

Lack of response to aspirin decreases its protective effects. However, lack of a standard definition for aspirin resistance, the absence of diagnostic reference methods to identify resistant patients, and the different mechanisms of action involved in platelet aggregation call the clinical importance of this fact into question. Additional well-designed studies are needed to detect patients with real resistance in order to have more effective prevention of cardiovascular morbidity and mortality.

目的回顾心血管事件高危患者阿司匹林抵抗的流行情况,探讨阿司匹林抵抗的流行病学、作用机制及其可能引起的临床后果。材料和方法在PubMed、EMBASE和综述数据库上搜索2008年11月前发表的关于阿司匹林耐药性的英文或西班牙文文章。通过在选定文章的参考文献列表中搜索与我们次要目标相关的文章,获得了其他研究。结果阿司匹林抵抗影响了0%至57%的人群,并与中风和心血管事件的保护作用下降有关。许多可改变和不可改变的因素都会影响抗血小板药物的疗效。克服这种降低的抗聚集作用的可能策略包括增加阿司匹林的剂量或与另一种抗血小板药物的双重治疗。结论对阿司匹林反应的降低降低了其保护作用。然而,由于缺乏阿司匹林耐药的标准定义,缺乏识别耐药患者的诊断参考方法,以及血小板聚集所涉及的不同作用机制,这一事实的临床重要性受到质疑。需要更多设计良好的研究来发现真正耐药的患者,以便更有效地预防心血管疾病的发病率和死亡率。
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引用次数: 2
Compliance of prescriptions for chronic obstructive pulmonary disease patients given upon hospital discharge 慢性阻塞性肺疾病患者出院时处方的依从性
Pub Date : 2010-01-01 DOI: 10.1016/S2173-5085(10)70012-5
B. García Robredo , M.A. Calleja Hernández , M.I. Luque Vega , R. Ubago Pérez , M.J. Faus Dáder

Objective

Measure the degree of compliance of prescriptions given to chronic obstructive pulmonary disorder (COPD) patients upon hospital discharge by comparing them to international recommendations. Identify factors that influence the degree of compliance. Evaluate the effect of that degree of compliance on the number of COPD exacerbations.

Method

Retrospective observational study. We selected all episodes identified as COPD in a tertiary hospital during 2006. By consulting the clinical history database, we accessed the hospital discharge report and calculated the treatment's degree of proximity to the recommendations issued in the Global Initiative for Chronic Obstructive Lung Disease (GOLD). For each episode, we calculated the number of exacerbations in the six following months. Descriptive, bivariate statistical analysis.

Results

We obtained 365 episodes. The mean degree of compliance was 82% (SD = 15.9). The patient's age and the severity of the disease did not influence the degree of compliance. We observed an inverse correlation between the hospital stay and the degree of compliance (P = .026). Discharge reports issued by the Pneumonology Department had a significantly higher degree of compliance (P < .001). No statistically significant relationship was found between the degree of compliance and the number of exacerbations.

Conclusions

The degree of compliance is high according to the GOLD recommendations. The Pneumology Department had the highest degree of compliance, and a higher degree of compliance was related to a shorter hospital stay. The treatment compliance had no effect on the number of exacerbations of the disease.

目的比较慢性阻塞性肺疾病(COPD)患者出院时处方的依从性,并与国际推荐处方进行比较。确定影响遵守程度的因素。评估该依从性程度对COPD加重次数的影响。方法回顾性观察研究。我们选择了2006年在一家三级医院确诊为COPD的所有病例。通过查阅临床病史数据库,我们访问了出院报告,并计算了治疗与全球慢性阻塞性肺疾病倡议(GOLD)中发布的建议的接近程度。对于每一次发作,我们计算了接下来6个月的加重次数。描述性、双变量统计分析。结果共获得365例病例。平均依从度为82% (SD = 15.9)。患者的年龄和疾病的严重程度不影响依从性。我们观察到住院时间与依从程度呈负相关(P = 0.026)。由肺内科出具的出院报告的依从性明显较高(P <措施)。依从性与加重次数之间无统计学意义的关系。结论按照GOLD推荐的用药依从度高。肺内科的依从性最高,且依从性越高,住院时间越短。治疗依从性对疾病加重次数没有影响。
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引用次数: 2
Meta-analysis of the effectiveness of the strategy of monotherapy with boosted protease inhibitors in HIV+ patients 增强蛋白酶抑制剂单药治疗HIV+患者有效性的meta分析
Pub Date : 2010-01-01 DOI: 10.1016/S2173-5085(10)70018-6
J. Saez de la Fuente, A. Such Díaz, C. Sánchez Gil, C. Esteban Alba, I. Escobar Rodríguez

Introduction

The objective of this study is to analyse the available evidence regarding the effectiveness of the strategy of induction maintenance with boosted protease inhibitors with ritonavir in adult HIV patients as compared to conventional treatment.

Methods

We performed a meta-analysis of randomised controlled trials in HIV patients to compare the efficacy of a monotherapy strategy of boosted protease inhibitors as compared with conventional antiretroviral therapy. The literature search was conducted in PubMed, EMBASE (September 1999-September 2009) and in conference abstracts of the last 5 years. The Odds Ratio of treatment failure and their 95% confidence intervals were calculated. To combine the results of individual studies selected, a fixed effects model based on the Mantel-Haenszel method or random effects was used, depending on whether or not the results were heterogeneous.

Results

Initially a total of 1510 publications were found, of which just 8 studies met the criteria for inclusion in the meta-analysis. The combined Odds Ratio of the 8 studies is 1.39 (95% CI 1.02–1.90) for the treatment group with conventional antiretroviral treatment, but with a confidence interval close to the limits of statistical non-significance.

Conclusion

The results of the combined effectiveness analysis in the meta-analysis found no significant differences between the conventional strategy and monotherapy. This strategy is considered recommended (level A evidence) in patients with no history of previous failure of protease inhibitor, with undetectable plasma viral load and signs or symptoms of nucleoside/nucleotide toxicity.

本研究的目的是分析与传统治疗相比,利托那韦增强蛋白酶抑制剂诱导维持策略在成年HIV患者中的有效性的现有证据。方法:我们对HIV患者的随机对照试验进行了荟萃分析,以比较增强蛋白酶抑制剂单一治疗策略与常规抗逆转录病毒治疗的疗效。检索PubMed、EMBASE(1999年9月- 2009年9月)和近5年的会议摘要。计算治疗失败的优势比及其95%置信区间。为了结合所选择的单个研究的结果,根据结果是否异质性,使用基于Mantel-Haenszel方法的固定效应模型或随机效应。结果最初共发现1510篇出版物,其中只有8篇研究符合纳入meta分析的标准。接受常规抗逆转录病毒治疗的治疗组,8项研究的综合优势比为1.39 (95% CI 1.02-1.90),但置信区间接近无统计学意义的极限。结论meta分析的综合疗效分析结果显示,常规策略与单药治疗之间无显著差异。对于没有蛋白酶抑制剂失效史、血浆病毒载量检测不到、核苷/核苷酸毒性体征或症状的患者,推荐使用该策略(A级证据)。
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引用次数: 2
Detecting adverse drug events during the hospital stay 在住院期间检测药物不良事件
Pub Date : 2009-01-01 DOI: 10.1016/S2173-5085(09)70095-4
C. Berga Culleré , M.Q. Gorgas Torner , J. Altimiras Ruiz , M. Tuset Creus , M. Besalduch Martín , M. Capdevila Sunyer , M. Torres Gubert , M.T. Casajoana Cortinas , E. Baró Sabaté , J.R. Fernández Solà , A. Moron i Besolí , E. Òdena Estradé , J. Serrais Benavente , M.T. Vitales Farrero , C. Codina Jané , Representing the Working Group for the Catalan Society of Clinical Pharmacy

Introduction

The principal objective was to determine the incidence rate of adverse drug events (ADEs) in hospitalised patients and evaluate the event prevention percentage.

Methods

Multi-centre, prospective observational study lasting 4 months, performed in 5 hospitals providing different levels of care. We included all adult patients who were admitted to one of the selected centres for longer than 48 hours and who required pharmacological treatment. ADEs were identified by direct observation and the use of previously defined alarm signals. The Karch-Lasagna scale was used to determine the causality relationship, and the Schumock and Thornton questionnaire adapted by Otero was used to evaluate ADE preventability. Preventable drug-induced adverse events were classified according to the taxonomy that the Ruiz-Jarabo 2000 group defined, and coordinated by ISMP-Spain.

Results

We included 1550 patients, 159 of whom experienced at least one ADE (10.3%). The preventability percentage was 51.6%, which represented 5.3% of the total sample. The endocrine system (34.8%) and the cardiovascular system (20.7%) were the most affected by preventable ADEs. Antibiotics were responsible for 16.5% of all ADEs. Nine point three percent of all preventable ADEs were triggered by use of opiates. The vast majority of preventable ADEs (36.3%) resulted from omitting a necessary medication. Only 4.4% of preventable ADEs are considered to be serious.

Conclusions

There is a high incidence rate of ADEs during patients’ hospital stay (10.3%), and half of them (51.6%) could have been prevented. Implementation of an automatic alarm system and certain best practices for problem spots along the care circuit will help detect and avoid preventable ADEs.

主要目的是确定住院患者药物不良事件(ADEs)的发生率,并评估事件预防百分比。方法在5家提供不同护理水平的医院进行为期4个月的多中心前瞻性观察研究。我们纳入了所有在选定的中心之一住院超过48小时且需要药物治疗的成年患者。通过直接观察和使用预先定义的警报信号来识别ade。采用Karch-Lasagna量表确定因果关系,采用Otero改编的Schumock和Thornton问卷评估ADE的可预防性。根据Ruiz-Jarabo 2000组定义的分类法对可预防的药物引起的不良事件进行分类,并由ISMP-Spain进行协调。结果纳入1550例患者,其中159例至少发生一次ADE(10.3%)。可预防率为51.6%,占总样本的5.3%。可预防的ade对内分泌系统(34.8%)和心血管系统(20.7%)的影响最大。抗生素占所有ade的16.5%。在所有可预防的ade中,9.3%是由使用阿片类药物引发的。绝大多数可预防的ade(36.3%)是由于遗漏了必要的药物。只有4.4%的可预防ade被认为是严重的。结论住院期间不良事件发生率较高(10.3%),其中一半(51.6%)是可以预防的。实施自动报警系统和针对护理电路中的问题点的某些最佳做法将有助于发现和避免可预防的ade。
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引用次数: 17
期刊
Farmacia Hospitalaria (English Edition)
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