Cost-Effectiveness of Thrombolytics: A Simplified Model

Objective of the study: To construct a simple model for an internal, retrospective cost-effectiveness analysis and to calculate the incremental cost-effectiveness of tissue plasminogen activator (TPA) over streptokinase (SK) in Turkey.Setting: Koşuyolu Heart, Education and Research Hospital, Istanbul, Turkey.Method: Among patients who were hospitalized for treatment of acute myocardial infarction (AMI), 196 were randomly selected. One-year mortality rates according to the treatment groups (TPA, SK, other) were determined. Among surviving patients, 28 from TPA and another 28 from SK group were randomly selected for the pharmacoeconomic analysis. Patient treatment data were taken from medical records while data regarding to costs were taken from hospital bills.Main outcome measures: Incremental cost-effectiveness ratio (ICER). The cost part of the ratio was considered as ‘the overall-costs’, while the effectiveness part was considered as ‘lives saved’ per treatment group.Results: With an increased one-year survival rate of 2.37% and an increased cost of €1120.8 ($1165.6) per patient in the TPA group, the ICER for the use of TPA instead of SK was €47,289 ($49,180.6) per life saved.Conclusion: This model can be a guide for similar analyses. The results of our study (the incremental cost-effectiveness of TPA over SK) will be informative for the decision-makers in Turkey, by whom the medical benefit for money spent would be assessed and judged. We believe that our results make a contribution to similar studies in the literature.     

三种非甾体抗炎药治疗骨关节炎的成本-效果分析

目的：评价3种非甾体抗炎药治疗骨关节炎的经济效果。方法：从2002年5月10日至2002年12月10日对152例骨关节炎患者口服3种不同非甾体抗炎药治疗方案，运用药物经济学成本．效果分析方法进行比较。结果：3种方案治疗骨关节炎的成本分别为171．88元，231．35元，170．20元；有效率分别为82．0％，66．0％，65．4％。每获得一个单位效果，3种方案所需花费的成本分别为2．10元，3．51元，2．60元。在方案C的效果基础上，每获得1个单位效果，方案A、B所花费的成本分别为0．1元，101．9元。结论：方案C为成本最低的方案，但有效率不高；方案A有效率有较大提高，而且增加相同的效果所需的成本也最低。因此，方案A为最佳治疗方案。     

3种用药方案治疗幽门螺杆菌感染的成本-效果分析

目的:评价3种用药方案治疗幽门螺杆菌(Hp)感染的成本-效果。方法:441例Hp感染的消化性溃疡患者随机分为3组,分别服用雷贝拉唑+克拉霉素+阿莫西林(A组)、奥美拉唑+克拉霉素+替硝唑(B组)、奥美拉唑+克拉霉素+阿莫西林(C组),各组疗程均为1周,观察疗效并进行成本-效果分析。结果:A、B、C组成本分别为325.04、221.30、211.64元,Hp根除率分别为92.2%、89.2%、79.1%,成本-效果比分别为352.54、248.09、267.56;A、B方案相对于C方案的增量成本-效果比分别为865.65、95.64。结论:B方案治疗幽门螺杆菌感染较为经济、合理。     

The Value of Vocational Rehabilitation in Substance User Treatment: A Cost-Effectiveness Framework

Vocational rehabilitation (VR) programs within addiction treatment traditionally consider employment as the desired outcome. This singular focus ignores other benefits, such as reduced substance use. A framework for evaluating the cost-effectiveness of VR within addiction treatment is presented and illustrated with data from the Alcohol and Drug Services Study (ADSS, 1996–1999). VR was associated with a 2.5% increase in probability of abstinence at an $883 increase in cost per admission. Thus, the estimated cost-effectiveness of VR in promoting abstinence is $35,000 per additional abstinent client ($883/0.025), indicating that VR is a cost-effective contributor to other goals of addiction treatment.     

3种血栓素A_2抑制剂用于不稳定型心绞痛的成本-效果分析

目的比较3种血栓素A2（TXA2）抑制剂奥扎格雷钠（丹奥）、丙酯（宁阳欣）、阿魏酸钠（尤尼林）联合常规疗法治疗不稳定型心绞痛的成本与效果。方法随机抽取符合诊断标准的患者128例,在常规治疗基础上分别给予奥扎格雷钠80mg（每天2次静脉滴注,方案A）、丙酯180mg以及阿魏酸钠0.3g（每天1次静脉滴注,方案B和方案C）,治疗14d后对疗效和成本进行分析。结果 3组心绞痛改善总有效率分别为92.50%,83.72%,82.22%,组间比较均无统计学意义（P〉0.05）;人均治疗总成本分别为（4384.51±405.95）元、（4428.35±360.12）元、（4148.22±267.75）元,成本-效果比分别为4740.01,5289.48,5045.27。在方案C的基础上,每获得1个单位效果,方案A和方案B所需追加的成本分别为2298.54元和18675.33元。结论奥扎格雷钠联合常规疗法治疗不稳定型心绞痛的方案相对较优。     

4种抗生素治疗非淋菌性尿道(宫颈)炎的成本-效果分析

目的:评价4种口服抗生素治疗非淋菌性尿道(宫颈)炎(NGU)的成本-效果。方法:收集口服国产阿奇霉素与司帕沙星、进口阿奇霉素与司帕沙星治疗NGU的临床资料,进行成本-效果分析。结果:国产阿奇霉素与司帕沙星、进口阿奇霉素与司帕沙星治疗NGU的治愈率分别为89.6%与83.2%、95.5%与88.3%;成本-效果比分别为39与139、140与220。结论:国产与进口阿奇霉素、国产与进口司帕沙星均能有效治疗NGU,但国产阿奇霉素的成本-效果优于国产司帕沙星,进口阿奇霉素的成本-效果亦优于进口司帕沙星。     

3种短程三联疗法根除幽门螺杆菌感染的成本-效果分析

目的:对3种短程三联疗法根除幽门螺杆菌(Hp)感染进行成本-效果分析。方法:278例Hp阳性的消化性溃疡或慢性糜烂性胃窦炎患者随机分为A、B、C组,分别服用奥美拉唑、兰索拉唑及泮托拉唑,3组均同时加用阿莫西林及甲硝唑,疗程7d。疗程结束1mo后,观察疗效,并进行成本-效果分析。结果:A、B、C组的Hp根除率分别为85·11%、87·80%、89·22%(P>0·05),愈合率分别为92·55%、87·80%、90·20%(P>0·05),不良反应发生率分别为27·66%、24·39%、30·39%(P>0·05),药品成本分别为234·73、123·36、116·64元。结论:C组方案较优,但B、C组的成本差别不大。     

The Value of U.S. Pharmacopeial Standards: A Review of the Literature

While there are many standard-setting health care organizations, the United States Pharmacopeial Convention's (USP) role includes the creation of documentary and physical standards for therapeutics, including chemical drugs, excipients, and biologics. Despite the ubiquity of these standards, little work has been carried out to characterize and quantify their value. We reviewed the peer-reviewed and gray literature relevant to such evaluations. The review yielded 36 articles, focused variously on accreditation and other standards in health care, the broad impact of pharmacopeial standards and evaluations of specific USP standards. We did not find any study quantifying the impact of USP or other pharmacopeial standards, but many reports have been published that suggest the utility of USP standards to drug development, quality assurance, and public health. Frequently cited areas of impact include equitably advancing the analytical capabilities of manufacturers; enabling the creation of legally enforceable naming conventions; detecting mislabeled and substandard drugs in the marketplace, especially in the context of increased globalization of drug markets; and facilitating the harmonization of diverse international drug quality standards. Our insights provide opportunities for empiric assessments of the effects of USP standards on important outcomes including their promotion of efficient drug development, market competition, drug quality, and patient safety.     

Statistical Monitoring of Safety in Clinical Trials

Appropriate monitoring of safety data during the conduct of a clinical trial can ensure timely alteration or termination of the trial to protect patients from potentially harmful treatment. Quantitative evaluation in safety monitoring is important for the study team and the data monitoring committee to make timely recommendations. This article provides an overview of statistical methods for monitoring a prespecified adverse event of interest in a single-arm or controlled clinical trial, including those described in the literature and two proposed methods following a general Bayesian framework using conjugate families. The implementation of statistical methods on safety monitoring is illustrated through clinical trial examples. Practical challenges and considerations are also discussed via simulation studies.     

A New Hydrate of Cyclosporine: Structural and Physicochemical Characterization

This work highlights a new orthorhombic hydrate (Form 2) of cyclosporine (CsA), a widely used immunosuppressant. The uniqueness of this new form was established by powder X-ray diffractometry, solid-state nuclear magnetic resonance spectroscopy, and single crystal X-ray diffraction analysis. The crystal structure of this form was solved (P2₁2₁2₁, a = 12.639 Å, b = 19.758 Å, c = 29.568 Å, Z = 4). In addition, the solid-state properties of Form 2 were compared with other known crystalline forms of CsA by thermal analysis, water vapor sorption analysis, Fourier-transform infrared spectroscopy, and so on. These studies suggest that Form 2 is a nonstoichiometric hydrate with distinctive hydrogen bonding modes. More importantly, Form 2 is about an order of magnitude less soluble than the commercially available tetragonal form (Form 1). An interconversion map among various CsA solid forms was built by slurry experiments. Form 2 was the most stable form in aqueous systems, whereas the previously known orthorhombic hydrate (Form 3) was the predominant form in nonaqueous vehicles. While Form 2 as a lower solubility form poses greater challenge in bioavailability enhancement, the solid-state properties of this unique hydrate may provide new drug delivery opportunities.     

Effects of Nitro-L-Arginine on Blood Pressure and Cardiac Index in Anesthetized Rats: A Pharmacokinetic-Pharmacodynamic Analysis

Purpose. Nitric oxide synthase (NOS) inhibitors such as Nitro-L-arginine (L-NA) are being considered for the management of hypotension observed in septic shock. However, little information is available regarding the pharmacokinetic and pharmacodynamic properties of these agents. Our objective was to examine the relationships between L-NA plasma concentration and various hemodynamic effects such as cardiac index (CI), mean arterial pressure (MAP), and heart rate (HR) elicited by L-NA administration in rats. Methods. L-NA was infused at doses between 2.5 – 20 mg/kg/hr in anesthetized rats over one hour. Hemodynamic effects and plasma L-NA levels were determined. Results. Infusion of L-NA resulted in dose-dependent increases in MAP and systemic vascular resistance (SVR), decreases in CI, and minimal change in HR. The relationships between the hemodynamic effects and plasma L-NA levels were not monotonic, and hysteresis was observed. Using nonparametric analysis, the equilibration half-time (t_1/2,keo) between plasma L-NA and the hypothetical effect site was determined to be 51.5 ± 6.6 min, 42.4 ± 10.1 min, 43.4 ± 9.0 min for MAP, CI, and SVR, respectively (n = 14). The E_max and EC₅₀ values obtained were + 32.5 ± 8.4 and 2.6 ± 1.3 g/ml for MAP and –52.9 ± 15.6 and 3.7 ± 1.8 g/ml for CI, respectively. Conclusions. Although L-NA can bring about beneficial elevation of MAP, such effect is always accompanied by a stronger effect on CI depression. Dose escalation of L-NA may bring about detrimental negative inotropic effect and loss of therapeutic efficacy.     

Gliptins: A New Class of Oral Antidiabetic Agents

India has the largest population of patients with type 2 diabetes mellitus. The conventional agents used to treat type 2 diabetes frequently exhibit reduced efficacy over time leading to inadequate glycaemic control and are also associated with adverse effects. Hence, there is a need for alternative therapies that can overcome the limitations associated with conventional antidiabetic agents. This review focuses on Gliptins, which have become a research area of intense focus and present an alternative therapeutic strategy for patients with type 2 diabetes. Gliptins show significant improvements in glycaemic control and are well tolerated, particularly with regard to weight change and hypoglycemia. Hence, gliptins are considered as useful agents for the treatment of type 2 diabetes mellitus.     

我院中药房门诊1120例患者药物咨询工作统计与分析

目的：了解患者用药情况,更好地开展中药临床药学工作,促进合理用药。方法：对2008年8月~2009年8月我院中药房1 120例咨询记录进行回顾性分析。结果：用药咨询中,药物的相互作用、用法用量及不良反应等问题分别占药物咨询的37.59%、30.27%、9.38%;所咨询疾病的种类以循环系统最多,占23.21%,其他系统所占比例均匀。结论：开展合理用药咨询,对于保证药物疗效、保障用药安全、促进合理用药是十分必要的,对药物的作用及相互作用的解释是临床药师工作重心,多药联合应用更需关注;同时也对药师提出了更高要求。     

Evaluation of a pharmacist vs. Haematologist-managed anticoagulation clinic: A retrospective cohort study

IntroductionWarfarin is the core component in the management of various thromboembolic disorders, which requires specialized expertise to optimize outcomes. There is limited data comparing a pharmacist vs. a haematologist-managed anticoagulation clinic in our setting, and in the Middle East. We aimed to evaluate the effectiveness and safety of a pharmacist vs. a haematologist-managed anticoagulation clinic in the Ambulatory Care Center at King Abdulaziz Medical City, Jeddah, Saudi Arabia.MethodsA retrospective cohort study was conducted from 2016 to 2018, which included adult patients who have been followed-up for at least six months and who received warfarin for an extended period. The primary outcome was the proportion of time the patients in the two arms were in the therapeutic range. The secondary outcomes were the differences in expanded time in the therapeutic range, as well as the frequency of bleeding and thromboembolic events between the two arms.ResultsWe enrolled 104 and 124 patients in the pharmacist and haematologist arms respectively. The median time in the therapeutic range for the pharmacist arm was 71.4%, IQR (60.8–83.8) vs. 65%, IQR (43.5–79.1), in the haematologist arm (p = 0.0049). The median expanded time in the therapeutic range was 86.4%, IQR (77.5–95.3) vs. 81.21%, IQR (67.1–93.3) in the pharmacist vs. haematologist arm (p = 0.015) respectively. Major bleeding events occurred in 5.7 % vs. 3.2 %, and thromboembolic events in 5.7% vs. 4%, in the pharmacist vs. haematologist arm respectively.ConclusionsOur results demonstrated that the time in the therapeutic range was significantly higher in the pharmacist arm, with no significant difference in bleeding and thromboembolic events compared to the haematologist arm.     

抗癌药物新剂型—白蛋白微球5—氟脲嘧啶白蛋白微球的稳定性考查

本文报告了5—氟脲嘧啶白蛋白微球(5—FUAM)注射液的物理稳定性。以5—FUAM,吐温80及生理盐水组成的处方,在观察期限内沉降缓慢;经离心沉降后也易于分散。流通蒸气灭菌30min 及室温贮存50d 后,微球粒度略有增大。     

对集体所有乡镇企业从业人员数量统计偏差的研究

乡镇企业统计数据的质量关系到很多国民经济指标的测算 ,因而有着十分重要的意义。将乡镇企业中集体企业从业人员数量的统计数据与第一次全国农业普查结果相比较 ,发现二者有较大的差距。该研究通过定性和定量分析 ,测定了这一统计偏差的幅度 ,并尝试找出集体所有乡镇企业从业人员数量的统计偏差与影响因素之间的关系 ,根据该项研究结果 ,最后提出了一些政策建议     

The pharmacy care plan service: Evaluation and estimate of cost-effectiveness

Background

The UK Community Pharmacy Future group developed the Pharmacy Care Plan (PCP) service with a focus on patient activation, goal setting and therapy management.

用高效液相色谱-蒸发光散射检测法测定注射剂中乙酰谷酰胺的含量

目的:建立乙酰谷酰胺的含量测定方法,为该类药物提供质量控制标准.方法:采用Phenomenex C18色谱柱(250mm×4.6mm,5μm),柱温35℃;以0.01mol·L-1醋酸铵溶液(用冰醋酸调节pH值至4.5)为流动相,流速为0.6ml·min-1,蒸发光散射检测器检测,漂移管温度为115℃,气体流量为3.2L·min 1.结果:乙酰谷酰胺在0.198～0.991mg·mL-1范围内呈良好的线性关系,r=0.9993;平均回收率为98.9%,RSD=1.7%,n=6;最低检出量为50ng.结论:本方法简便、快速,结果准确、可靠,重现性好.     

2007—2010年我院国家基本药物使用情况统计与分析

目的:分析2007—2010年我院使用国家基本药物的情况,为我院今后贯彻执行国家基本药物制度,并进一步推广使用国家基本药物的工作提供必要的理论数据。方法:从我院的医院信息系统数据库中,调出各药品组使用国家基本药物的品种、数量、金额的相关数据,用Excel 2003办公软件进行处理,得出统计结果并分析。结果:我院使用的国家基本药物品种比率为:药库4年平均为26.75%;中心药房4年平均为34.73%;门诊药房4年平均为28.45%;社区药房4年平均为33.51%。我院使用的国家基本药物金额比率为:药库4年平均为25.28%;中心药房4年平均为31.61%;门诊药房4年平均为22.49%;社区药房4年平均为26.76%。结论:从统计结果看我院在使用国家基本药物的品种比率和金额比率上都是偏低的,与国家基本药物制度实施要求差距较大。还需在我院加大国家基本药物的宣传、培训和教育力度,将基本药物作为首选药优先合理地使用。     

我院150例药品不良反应报告分析

目的:了解我院药品不良反应(ADR)发生的特点并评价ADR报告质量,促进临床合理用药,提高ADR监测工作质量。方法:收集到我院2005～2006年上报的ADR病例150例,并应用Excel软件对性别、年龄、涉及的药品种类、涉及的器官或系统及临床表现、ADR报告质量等进行分类统计。结果:由抗微生物药引起的ADR所占比例最高,ADR损害的器官或系统以皮肤及其附件最为常见,ADR上报率偏低,报告质量需提高。结论:应进一步加强我院ADR的监测和宣传工作,提高专业人员责任意识,减少ADR发生。