3种方案治疗非淋菌性尿道（宫颈）炎的决策树分析

目的：评价3种方案治疗非淋菌性尿道（宫颈）炎的经济学效果。方法：运用药物经济学决策树分析原理,分别对左氧氟沙星序贯疗法、阿奇霉素静脉滴注疗法和依诺沙星静脉滴注疗法进行回顾性分析、评价。结果：3种治疗方案的总成本依次为114.60、474.53和379.33元,总有效率为86.20%、88.35%和87.50%。每治愈1例非淋菌性尿道（宫颈）炎患者所期望的成本分别为132.95、537.10和433.52元。结论：3种治疗方案中以左氧氟沙星序贯疗法为优。     

盐酸小檗碱与环孢素合用的药物经济学研究

目的：了解盐酸小檗碱与环孢素合用能否降低环孢素的费用。方法：采用回顾性调查方法,进行盐酸小檗碱与环孢素合用的药物经济学评估。结果：盐酸小檗碱可显著增加环孢素的血药浓度。在满足正常疗效的同时,可降低环孢素的药物费用,每个每年可节约药费6000-8000元。结论：小檗碱与环孢素合用能降低费用,减轻病人和社会的经济负担。     

棕榈酸帕利哌酮PP1M治疗精神分裂症的药物经济学研究进展

目的系统总结棕榈酸帕利哌酮(PP1M)治疗精神分裂症的药物经济学相关研究结果,为抗精神病药的临床应用提供依据。方法系统检索Taylor&Francis、ScienceDirect、PubMed、Embase、CBM、中国知网和万方数据库等,检索时间从建库至2019年12月,纳入2015~2019年棕榈酸帕利哌酮(PP1M)药物经济学相关的文献,并参照综合卫生经济学评价报告准则(CHEERS)量表评估文献质量。结果共纳入14篇对照研究,主要评价内容包括棕榈酸帕利哌酮(PP1M)相比其他抗精神病药在疗效、成本节约和质量调整生命年(QALYs)等方面的差异。多数研究结果支持棕榈酸帕利哌酮(PP1M)更具优效性,且通过敏感性分析验证了结果的稳定性。结论当前抗精神病药物中,棕榈酸帕利哌酮(PP1M)在治疗精神分裂症方面具有良好的药物经济学优势,同时棕榈酸帕利哌酮(PP3M)的成本效果优势较为明显。     

Étude coût-efficacité du pamoate d’olanzapine : analyse en miroir sur un an

IntroductionOlanzapine pamoate has a higher cost of treatment than the oral form and requires administration in a hospital setting (unlike other long-acting antipsychotics), and the cost-effectiveness of this treatment may be questioned. Many scientific societies and national health systems are increasingly interested in the pharmacoeconomic impact of health products. The search for efficacy of a treatment can be done in two ways: medico-economic modeling studies or observational studies i.e. randomized controlled trials or mirror studies. The models are based on theoretical models from published clinical data simulating the course and evolution of patient health conditions, which benefit from a particular therapeutic strategy. Even if the design of observational mirror studies makes it possible to get closer to the clinical reality by observing the patient before and after the initiation of the treatment, the majority of the pharmacoeconomic studies published on olanzapine pamoate are modeling works that do not reflect actual conditions of care. The Guillaume Régnier Hospital Center in Rennes has a large cohort of patients treated with olanzapine pamoate: 121 instauration treatments are recorded from April 1, 2010 to Mars 1, 2015. The objective of this study is to evaluate the cost-effectiveness of olanzapine pamoate in actual clinical practice.MethodsThis is a one-year cost-effectiveness retrospective observational mirror-image study of a cohort of 52 patients with schizophrenia who were treated for at least three months with olanzapine pamoate. The primary efficacy endpoint is the differential in the number of full-time hospitalizations before and after the introduction of olanzapine pamoate versus the hospital cost differential. The secondary criteria are the difference of the number of the days spent in hospital and the number of outpatient consultations between the year preceding the injection and the year following it. The results were calculated on the general cohort and within 2 subgroups: patients treated for more than one year and those receiving less than one year of treatment with olanzapine pamoate.ResultsFifty-two patients were included (median age = 35 years, sex ratio H/F = 2.7) and only 38.5% discontinued treatment. For patients who maintained long-acting treatment, they received a dosage of 25 mg oral olanzapine (min = 7.5 mg, max = 60 mg), 5 mg more medially than the group having stopped the olanzapine pamoate (20 mg; min = 10 mg, max = 40 mg). The majority of these patients were receiving off-label authorized marketing doses of oral olanzapine, whereas 22% of them had off-label dosages of olanzapine pamoate. The main causes of discontinuation were symptom persistence, loss of vision and the occurrence of adverse effects (including weight gain and sedation). Olanzapine pamoate significantly reduced the number of hospitalizations compared to the previous management strategy (1 less hospitalization, P < 0.001 in patients treated more than one year and in the general cohort). As a logical consequence the number of hospitalization days in day care increased after the establishment of this long-acting antipsychotic with hospital reserve status (18 in median; min = 0, max = 159). We observed a non-statistically significant tendency of decrease in the number of days of full-time hospitalization and an increase in the number of ambulatory procedures, particularly in patients who have maintained the treatment for one year. This efficiency had a non-significant additional cost of €3361 per year. There was an average multiplication by 8,5 of the drug cost a year later in the general cohort (5.5 in the group of patients treated less than one year and 10.4 in the group of patients who maintained it a year). There was a 23,2% average increase in the cost of hospitalization in the general cohort (3.75 % in patients who maintained treatment compared to 48.9% in patients who discontinued treatment).ConclusionBy its mirror design, the study was placed in real conditions of care of the patient with schizophrenia. A total of 61.5% of patients maintained treatment with olanzapine pamoate for a minimum of one year. This APAP is more effective without significantly increasing the cost compared to the previous therapeutic strategy (including oral olanzapine). The additional cost is partly due to the administration restriction in a hospital setting in relation to risk of Post-Injection Delirium/Sedation Syndrom (PDSS). There is currently no acceptable efficiency limit. The results of this cost-effectiveness analysis cannot be extrapolated to the other long-acting antipsychotics since it is the only one with hospital reserve status. The current limitations of medico-economics in psychiatry derive from the heterogeneity of clinical forms and the management of mental pathologies.     

医保药品目录调整之退出机制的国际经验借鉴

近期国家医保局发布的《基本医疗保险用药管理暂行办法》和《2020年国家医保药品目录调整工作方案》中将拟调整的药品分为新增纳入、直接调出、可以调出及调整限定支付范围四类,并首次明确支付标准调整和调出药品的条件。医保目录动态调整、有进有出体现中国医保管理水平的进一步提升,但目前调整退出机制和具体操作办法尚有待健全完善。该研究对欧洲部分有代表性的国家和美国医保目录调整,特别是退出机制进行梳理,从决策机制、调整频次和路径、评审方法和标准、以及实施效果和影响等多个维度展开分析论述,对退出机制关键步骤和主要考虑因素进行归纳总结。在对国际经验和操作模式分析总结的基础上,进一步提出针对中国医保目录药品调整和退出机制建立健全的政策建议,以期为优化医保管理、提高医保运行效率提供参考。     

药物经济学在医保药品谈判中的角色--以丙型肝炎直接抗病毒药物为例

目的:以参加2019年国家医保药品谈判的丙型肝炎治疗药物为例,探讨药物经济学在医保药品谈判中的作用,为医保药品目录调整和同类药品谈判提供参考。方法:通过成本效用分析和阈值分析,测算丙肝治疗药物的降价幅度并与实际降价幅度进行对比,结合具体谈判方式探讨相关影响因素。结果:2019年丙肝药品谈判采用了竞争性谈判和比价磋商谈判两种方式。竞争性谈判纳入的基因1b型药品艾尔巴韦格拉瑞韦和来迪派韦索磷布韦测算降价幅度(50.7%和32.8%)低于实际降价幅度(89.0%和89.9%),比价磋商谈判纳入的非基因1b型药品索磷布韦维帕他韦测算降价幅度(36.7%)也低于实际降价幅度(81.2%),竞争性谈判降价幅度高于比价磋商谈判。结论:药物经济学、预算影响、国际参考价格和疾病市场特征等可为谈判提供依据,优化参照选择和成本计算可提高药物经济学证据的决策利用度,但谈判起决定性作用的还是支付者意愿。竞争性谈判不宜针对创新药物,易打击企业研发积极性。     

Quality of Life as an Outcome Measure for Epilepsy Clinical Trials.

Assessment of health-related quality of life (HRQOL) has been developed to the point where wellvalidated instruments are being used in clinical trials. Data on the impact of new treatments can be used for formulary and regulatory decisions if the clinical trials are designed with appropriate instruments and sample sizes. However, more information is needed about the clinical significance of small differences in total or scale scores. Similarly, pharmacoeconomic studies should be prospective assessments that include evaluation of HRQOL as well as cost. In the future, these new aspects of outcome assessment are expected to be used as an adjunct to traditional seizure frequency and adverse effect reports in the selection of antiepileptic drugs.     

4种质子泵抑制药治疗十二指肠溃疡伴出血的疗效及药物经济学研究

摘 要 目的：对比奥美拉唑、泮托拉唑、兰索拉唑及埃索美拉唑四种质子泵抑制药治疗十二指肠溃疡伴出血的疗效和安全性,并进行药物经济学研究。 方法: 采用回顾性分析方法,收集90例十二指肠溃疡伴出血的患者,按使用质子泵抑制药品种的不同分为奥美拉唑组、泮托拉唑组、兰索拉唑组及埃索美拉唑组等4组。比较各组疗效及安全性,并采用药物经济学方法进行评估。结果: 4组的治疗总有效率比较,差异无统计学意义(P>0.05)。4组患者的平均止血时间、止血率,药品不良反应发生率比较,差异均无统计学意义(P>0.05)。采用最小成本分析法,泮托拉唑组治疗成本显著低于其他3组。结论:4组治疗方案的疗效和安全性基本相当,而泮托拉唑成本最低,是药物经济学最优方案。     

Comparison of methods for measuring antibiotic consumption in an intensive care unit

Hospitals worldwide are working on minimizing unnecessary use of antimicrobials. To assess actual changes of antimicrobial usage, correct and precise measurements are necessary. This study aimed to compare data on the purchase of antibiotics from the pharmacy and the administration of antibiotics to patients, respectively, in an intensive care unit (ICU). Data were obtained from the Neurointensive Care Unit (NICU) at Rigshospitalet, Denmark. During a 23‐month period, comprising 10 770 bed‐days (BD), the ward purchased 16 908 defined daily doses (DDD) of antibiotics from the pharmacy, and 15 130 DDD and 41 304 individual doses were administered. Intraclass correlation coefficients (ICCs) were calculated; control and runcharts and a Bland–Altman plot were constructed. Pharmacy sales and drug administration data showed no systematic variation over time with a monthly overestimation of pharmacy sales data of 10% (95% confidence interval (CI), 6.20–14.3%) for all antibiotics, and 7% (95% CI: 1.81–11.1%) for broad‐spectrum antibiotics. The antibiotic consumption, without bed‐days, has a clinically acceptable ICC of >0.70 and no systematic difference is suggested by the Bland–Altman plot. In this study of a large NICU, whose antibiotic consumption varied at random, pharmacy sales data were an acceptable approximation of the actual summarized drug consumption.