头孢匹罗药物利用评价标准的建立与应用

目的建立头孢匹罗药物利用评价(DUE)标准,为临床合理用药提供参考。方法以头孢匹罗药品说明书为基础,参考相关规定及文献制定标准草案,经专家修订确定头孢匹罗DUE标准,依据此标准对本院2016年1月-2017年12月使用头孢匹罗的131例住院患者进行回顾性分析。结果 (1)用药指征:有适应证占98.5%,无禁忌证占100.0%;(2)用药过程:生命体征与实验室指标监测符合标准率为55.0%,特殊人群用药符合标准率为90.6%,用法用量符合标准率为92.4%,联合用药符合标准率为96.9%,药物相互作用符合标准率为98.5%,溶媒、疗程符合标准率为100.0%;(3)用药结果:治疗有效率为81.7%,不良反应监测符合标准率为92.4%;(4)管理指标:病程记录符合标准率为98.5%,会诊、处方权符合标准率为100.0%。结论本研究建立的头孢匹罗DUE标准可以为规范头孢匹罗在临床中的应用提供参考。     

Outcomes in elderly patients following surgery for colorectal cancer in the veterans affairs health care system

AIM: To compare 30-day and 5-year mortality in elderly vs. younger patients following surgical resection for colorectal cancer. METHODS: A cohort study of patients admitted to VA hospitals with a new diagnosis of colorectal cancer who underwent surgical resection between October 1990 and September 2000. Cumulative survival rates (30-day and 5-year) were calculated from Kaplan-Meier estimates and adjusted risks of death were estimated using Cox proportional hazards models. RESULTS: We identified 34,888 individuals with a new diagnosis of colorectal cancer between October 1990 and September 2000, of whom 22 633 (65%) underwent surgical resection. The 30-day mortality following resection for rectal and colon cancer, respectively, for patients <65 years was 2.1 and 2.8% compared with 4.9 and 5.6% for those > or =65 years. The 5-year cumulative survival for rectal and colon cancer for patients <65 years was 54.0 and 57.6% compared with 44.5 and 46.6% for those > or =65 years. In patients > or =65 years with rectal or colon cancer, after adjustment, 30-day mortality was 2 times greater and 5-year mortality was 1 times greater than in younger patients. CONCLUSIONS: Older age is an independent predictor of increased short-term and long-term mortality following surgery in patients with rectal and colon cancer.     

天津市眼科医院眼科药物评价标准的建立与应用

目的 建立眼科药物评价标准并将其应用于天津市眼科医院眼科临时采购药品评价。方法 围绕药品的安全性、有效性、经济性、创新性、适宜性和可及性6个维度,制定眼科药物评价标准,并对天津市眼科医院2021—2022年临时采购的眼用药品进行回顾性评价。结果 制定了百分制“眼科药品临床综合评价表”,临时采购的9种眼用药品评分均高于60分。结论 “眼科药品临床综合评价表”可作为天津市眼科医院药品临床评价的参考依据,有助于提高医院药事管理能力及合理用药水平。     

比阿培南的药物利用回顾性分析及干预措施

摘要：目的 建立比阿培南的药物利用评价(DUE)标准,评价我院比阿培南的用药合理性并提出干预措施。 方法 采用回顾性调查方法,对照比阿培南的DUE标准,查阅我院2013年1月至2013年6月共75例使用比阿培南医嘱的情况,进行当前用药分析,并根据评价结果提出整改意见。 结果 根据所建立的DUE标准,从用药指征、用药过程、用药结果3方面综合评价,有些指标还不能达到期望目标值,仍有可以改进的地方。结论 DUE是临床药师进行用药合理性干预的有效手段之一。运用所制定的比阿培南的DUE标准,可以更好地促进比阿培南的临床合理应用。     

利奈唑胺葡萄糖注射液药物利用评价标准的建立及在重症医学科的应用

目的 建立利奈唑胺葡萄糖注射液的药物利用评价（DUE）标准,评价利奈唑胺葡萄糖注射液在重症医学科（ICU）的应用情况,为临床合理用药提供参考。方法 参考药品说明书、抗菌药物临床应用指导原则、相关管理规范,建立利奈唑胺葡萄糖注射液的DUE标准,并对2020年7月至2021年12月合肥市第二人民医院ICU使用利奈唑胺葡萄糖注射液的病历进行回顾性分析。结果 共纳入应用利奈唑胺葡萄糖注射液的病人82例,临床有效率52.44%(43/82)、药品不良反应（ADR）发生率4.88%(4/82),经评估该院ICU的利奈唑胺葡萄糖注射液应用在剂量、处方权限、病程记录、不良反应监测方面均符合评价标准要求,但仍有一些指标存在问题,如经验性用药较多89.02%(73/82)、用药前病原学检查率较低48.78%(40/82)、药物疗程不足45.12%(37/82),主要由病人出院或发生ADR造成。结论 建立的利奈唑胺葡萄糖注射液的DUE标准实用性较强,可及时发现利奈唑胺葡萄糖注射液在使用过程中的问题。     

日本抗菌药物临床评价指导原则介绍

抗菌药物是一类具有独特治疗学特点的药物,其临床评价存在诸多不同于一般药物评价的考虑,本文通过介绍日本"抗菌药物临床评价指导原则",以期为相关药物研发和评价人员提供参考。     

Development and evaluation of an artificial membrane for determination of drug availability

Various artificial membranes (e.g. PAMPA) and cellular-based membranes (e.g. Caco-2) are used for screening during early stages of drug discovery. However, these methods are not well suited for evaluation of pharmaceutical formulations and the effects of various excipients on drug availability. When drug molecules permeate biological membranes they encounter two types of permeation resistance, a membrane resistance in the lipophilic membrane and diffusion resistance in the unstirred water layers adjacent to both surfaces of the lipophilic membrane. We have developed an artificial membrane that is cheap and simple to prepare. The unstirred water layer consists of a hydrated semi-permeable cellophane membrane with a molecular weight cutoff (MWCO) of 12,000-14,000 Da and a lipophilic membrane of pure n-octanol in a nitrocellulose matrix. In the diffusion cell the hydrated cellophane membrane (thickness 210-230 microm) is on the donor side and the lipophilic octanol membrane (thickness about 120 microm) on the receptor side. Permeation of ionizable lipophilic drug molecules was diffusion-controlled when the drug was unionized but lipophilic membrane controlled when the drug was ionized. Drug permeation patterns from cyclodextrin containing formulations through the membrane were similar to those previously observed for biological membranes such as hairless mouse skin and the eye cornea.     

二甲双胍药物利用评价标准的建立与应用

目的 建立二甲双胍药物利用评价标准,评价临床使用的合理性。方法 以盐酸二甲双胍片和盐酸二甲双胍缓释片药品说明书为基础,参考相关指南和专家共识,建立评价标准。利用AHP加权TOPSIS法评价医院2023年1月～12月242份病例二甲双胍使用的合理性。结果 242份病例中,74份使用合理（占比30.58%）;153份使用基本合理（占比63.22%）;15份使用不合理（占比6.20%）。结论 建立的二甲双胍药物利用评价标准和AHP加权TOPSIS法可用于二甲双胍的合理性评价,评价结果显示该药的使用基本合理。     

达比加群酯药物利用评价标准的建立与回顾性分析

目的:建立达比加群酯药物利用评价标准(drug use evaluation, DUE),为临床合理应用达比加群酯提供参考。方法:以达比加群酯药品说明书为基础,参考相关指南和文献,通过专家咨询法制订达比加群酯药物利用评价标准,并采用回顾性研究方法,对湖北省某大型三甲医院2021年1-6月使用达比加群酯的住院患者用药进行合理性评价,具体包括适应证、用法用量、联合用药、禁忌证、不良反应监测及药物转换等。结果:共纳入501份病例,完全符合评价标准的合理率为91.42%,不合理应用常见于适应证不适宜(2.2%)和用法用量不适宜(2.0%),同时存在30.3%的联合用药的高风险。结论:建立的达比加群酯的DUE具有较强的科学性、实用性和可行性,该院达比加群酯临床应用中尚存在一些问题,应进一步加强干预,促进临床合理用药。     

公共卫生事件中FDA应对短缺药品指导原则介绍

为应对新型冠状病毒肺炎（COVID-19）突发公共卫生事件,2020年3月,FDA发布“FD&C法案506C规定的永久停产和生产中断报告指导原则”。该指导原则为申请人和生产企业及时和详尽地报告药品和生物制品生产变化提出建议,以便FDA采取及时有效的措施应对可能的短缺药品,保障美国药品供应链稳定。该指导原则对完善我国药品生产中断报告制度具有参考价值。     

HCV eradication in veterans with underlying mental health disorders and substance use

ObjectiveHepatitis C virus (HCV) disproportionately affects those with mental health disorders and those with substance use, and the increasing HCV transmission in the United States is driven by the opioid epidemic. However, patients with a mental health disorder, substance use, or combination of both historically have had limited access to HCV treatment. The goal of our study was to compare sustained virologic response (SVR) rates of HCV treatment with direct-acting antivirals (DAAs) between subjects with and without a mental health disorder, substance use, or combination of both.MethodsWe performed a retrospective chart review at 1 Veterans affairs medical center of patients enrolled in the hepatitis C pharmacy clinic who completed DAA treatment from August 17, 2013 to August 17, 2017. The participants (N = 833 patients) were categorized into 2 groups: those with at least 1 mental health disorder, substance use, or combination of both and those without. Baseline variables relevant to HCV treatment, DAA regimen, number of documented efforts to engage patients, and SVR data were collected.ResultsOf the 833 study participants, 579 patients had a mental health disorder, substance use, or combination of both. The 3 most prevalent disorders were patient-reported substance use (n = 333), substance-related and addictive disorders (n = 176), and depressive disorders (n = 159). The SVR rates and number of documented efforts to engage patients before and during treatment through SVR laboratory completion between those with a mental health disorder, substance use, or combination of both and those without were not statically significant.ConclusionDAA-based HCV treatment is highly effective with SVR rates exceeding 95% in the entire study cohort, including patients with or without mental health disorders, substance use, or combination of both.     

Development and evaluation of a gastroretentive drug delivery system for the low-absorption-window drug celecoxib

The objective of the present study is to develop microspheres for celecoxib to enhance its bioavailability by increasing its gastric residence time. Four different polymers-polyethylene oxide, Eudragit S, cellulose acetate, and Eudragit RL-were used to form the floating microspheres using an emulsion-solvent diffusion technique. The use of two different solvents (dichloromethane and ethanol) that differed in the rate of diffusion led to formation of a hollow core in the microspheres, which was partially responsible for the flotation ability. The formulation was optimized on the basis of in vitro buoyancy and in vitro release in simulated gastric fluid at pH 3. Scanning electron microscopy revealed differences between the formulations in terms of their topography. X-ray diffractometry and differential scanning calorimetry examination showed the amorphous nature of the drug. Microspheres prepared with polyethylene oxide:Eudragit S:celecoxib (2:2:1) gave the best in vitro percentage release and was taken as the optimized formulation. By fitting the data into zero order, first order, and Higuchi model, it could be concluded that the release followed first-order release kinetics. The correlation coefficient (R2 value) was obtained upon fitting the data to Higuchi equation, which signifies that the mechanism of release of celecoxib from the microspheres was diffusion rate-limited.     

Perceptions of behavioral health care among veterans with substance use disorders: Results from a national evaluation of mental health services in the Veterans Health Administration

Understanding patients' perceptions of care is essential for health care systems. We examined predictors of perceptions of behavioral health care (satisfaction with care, helpfulness of care, and perceived improvement) among veterans with substance use disorders (SUD; n = 1,581) who participated in a phone survey as part of a national evaluation of mental health services in the U.S. Veterans Health Administration. In multivariate analyses, SUD specialty care utilization and higher mental health functioning were associated positively with all perceptions of care, and comorbid schizophrenia, bipolar, and PTSD were associated positively with multiple perceptions of care. Perceived helpfulness of care was associated with receipt of SUD specialty care in the prior 12 months (adjusted OR = 1.77, p < .001). Controlling for patient characteristics, satisfaction with care exhibited strong associations with perceptions of staff as supportive and empathic, whereas perceived improvement was strongly linked to the perception that staff helped patients develop goals beyond symptom management. Survey responses that account for variation in SUD patients' perceptions of care could inform and guide quality improvement efforts with this population.