对我国药品定价引入经济性指标的思考

目的:为提高我国药品定价的科学性和合理性提供参考。方法:分析我国药品定价引入经济性指标方面的已有研究成果的合理性及存在的问题并提出较为合理的定价办法。结果:笔者认为合理的定价方法应为:首先,确定每一类治疗相同适应证下不同通用名药品中满足临床需要的最低价格品种为该类药品的代表品,然后以代表品的价格为基准,对待定价药品与代表品的功能进行倍比打分,以此作为分子,再将待定价药品的价格与代表品药品价格之比作分母,通过两者之比所得值对1的偏离程度,确定待定价药品应提价还是降价及价格涨落幅度。而代表品的定价可采用成本加成法确定。结论:本研究提出的方法可通过将定价目标与药品临床效果紧密结合实现价值定价,可科学、合理、经济、高效地同时满足药品定价目标及我国"批量式"定价的客观要求。     

注射剂原研药与仿制药的政府定价比较

目的:为完善药品政府定价,特别是对于原研药的定价提供参考。方法:通过统计国家发改委药品定价目录中的价格数据,计算注射剂中原研药与仿制药价格的差价率。结果:满足《药品政府定价办法》中对于差价率规定(注射剂差价率35%)的药品仅占总数的26%,且最高的一个差价率超过500%。结论:建议政府采用逐步降价等较温和方法,控制给予原研药的价格优惠程度,并建立动态的价格调控机制,使原研药生产企业与仿制药生产企业利益趋于平衡。     

医保目录重梳理，发改委酝酿药价再调整

继2005年10月国家发改委对22种抗生素药物实施大幅度降价之后，发改委新一轮价格调整又在酝酿之中。据中国化学制药工业协会人士介绍，此次价格调整实际上是去年年底国家发改委继扩大政府定价药品范围后又一次价格调整动作，将重新对医保目录内药品价格进行梳理，调整比价关系，而事实上，这一工作早在去年即已开始。     

国外药物经济学在药品定价管制中的应用及对我国的启示

目前，药品价格已成为政府和公众共同关注的话题，政府进行的十几次药品降价亦未从根本上解决药品价格虚高问题。从国际惯例以及我国的药品价格改革实践来看，政府对具有一定社会公益性的药品进行监管是必需的，而政府行为的科学性是干预效果的保证，药物经济学（Pharmacoeconomics，PE）就是对药品进行合理定价的一个科学依据。     

“坚持”降价

“涉及循环系统、心脑血管用药的700个药品品种的价格调整将于今年12月份公布执行。”在11月12日的中国自我药疗大会上,国家发改委价格司有关人士透露。至于具体降价力度与幅度,将于前几批“大致相似”。这也是国家发改委的“第20次降价”。该人士介绍,目前,政府定价药品数量约2400种,占流通药品品种数量的20%,但占销售金额的60%。2400种政府定价药品中包括1700种列入医保目录的处方药及部分垄断性、特殊性药品和700种列入医保目录的非处方药及地方调剂进入医保的品种,对于前述的1700种药品除特殊药品外,将于今年内分三批全部核定零售价格。…     

信息广场

国家发改委重新修订政府定价的药品目录国家发改委公布了新的《国家发展改革委定价药品目录》,对政府制定价格的药品范围、形式和权限进行了调整,并将于今年8月1日起正式执行。根据《药品管理法实施条例》的规定,纳入国家基本医疗保险报销药品品种应实行政府指导价或政府定价。     

国家计委出台药价管理新规定：规范药品价格秩序 制止虚高定价高额折扣

国家计委发布《关于完善药品价格政策改进药品价格管理工作的通知》,进一步规范药品价格秩序,制止药品经销中的高额折扣,减轻社会医药费负担,同时适当放宽科技含量高的药品利润率限制。1996年以来,国家计委先后颁布了《药品价格管理暂行办法》、《药品价格管理暂行办法的补充规定》等一系列法规文件,并对列入政府定价的国产、进口药品进行了全面审价,国产药品销售价格平均降低了15％左右,降价总额约40亿元左右;进口药品价格平均降低了10％左右,降价总额20亿元左右。各地也对列入省管目录的药品价格进行了整顿。通过整顿,有效地遏…     

我国药品价格改革探析

目的探讨我国药品价格改革的思路、方法与成效。方法分析我国药品价格改革的特点、趋势及存在的问题,并参考国外药品价格改革的经验。结果与结论我国的药品价格改革以降价为主线,在一定程度上抑制了药品的虚高定价;药品定价更加趋于合理,包括合理升高普药的价格,定价程序更加规范以及行政定价转向专家定价等,但仍存在一些值得探讨的问题。     

警戒

广东药品差别定价办法颁布实施 8月10日起，《广东省物价局药品差别定价办法》开始试行。根据该项政策，在目前纳入政府限价管理的2889种药品之中，将有3大类11项药品享受单独定价待遇，此举在全国还是首创。     

英国药品定价方法的调整趋势及对我国的启示

目的:为我国政府部门制定和调整药品价格提供参考。方法:明晰英国药品定价的目标,分析其定价方法对定价目标的支撑和吻合情况,介绍和分析其新的调整趋势——价值定价法。结果与结论:英国药品定价方法在不断调整和完善,价值定价法更加符合价格管理目标的客观要求。我国政府定价部门应及早予以深入研究和尝试此类方法,通过对药品的成本-效果进行评估、确定药品间功能差异指标、确定指标权重、评价药品的价值,进行合理的药品定价。     

Quantitative in vivo and in vitro sex differences in artemisinin metabolism in rat

1. The pharmacokinetics of the antimalarial compound artemisinin were compared in the male and female Sprague-Dawley rat after single dose i.v. (20 mg.kg) or i.p. (50 mg.kg) administration of an emulsion formulation. 2. Plasma clearance of artemisinin was 12.0 (95% confidence interval: 10.4, 13.0) l.h. kg in the male rat and 10.6 (95% CI: 7.5, 15.0) l.h. kg in the female rat suggesting high hepatic extraction in combination with erythrocyte uptake or clearance. Artemisinin half-life was 0.5 h after both routes of administration in both sexes. Values for plasma clearance and half-lives did not statistically differ between the sexes. 3. After i.p. administration artemisinin AUCs were 2-fold higher in the female compared with male rat (p 0.001). Artemisinin disappearance was 3.9-fold greater in microsomes from male compared with female livers and it was inhibited in male microsomes by goat or rabbit serum containing antibodies against CYP2C11 and CYP3A2 but not CYP2B1 or CYP2E1. 4. The unbound fraction of artemisinin in plasma was lower (p 0.001) in plasma obtained from the male (8.8 2.0%) compared with the female rat (11.7 2.2%). 5. The possibility of a marked sex difference, dependent on the route of administration, has to be taken into account in the design and interpretation of toxicological studies of artemisinin in this species.     

Interindividual variability in metabolic activation in humans in vivo

In assessing interindividual variability in metabolic activation, the toxic metabolite is often too unstable for conventional analysis. Possible alternatives include a stable product of the reactive metabolite e.g. cysteinyl derivatives of N-acetyl-4-benzoquinoneimine, the toxic metabolite of paracetamol, adducts with DNA or protein, and indirect measurement of the activity of the enzyme(s) producing the active metabolite. An example of the last approach is the use of furafylline, a highly specific inhibitor of human CYP1A2, to determine the extent of the metabolic activation of the cooked food mutagens PhIP and MeIQx. The extent of inhibition, determined from levels of unchanged amine in urine, is an indirect measure of the activity of the activation pathway. Further refinement of this approach, allied to improved measures of the biological process of interest should prove of value in evaluating interindividual variability and its role in the risk assessment process.     

Theophylline kinetics in peripheral tissues in vivo in humans

Several biochemical and cellular effects have been described for methylxanthines under in vitro conditions. However, it is unknown, whether threshold concentrations required to exert these effects are attained in target tissues in vivo. We therefore employed the microdialysis technique for measuring theophylline concentrations in peripheral tissues under in vivo conditions.Following in vitro and in vivo calibration, microdialysis probes were inserted into the medial vastus muscle and into the periumbilical subcutaneous adipose layer of healthy volunteers. Following single oral dose administration of 300 mg or i.v. infusion of 240 mg theophylline, in vivo time courses of theophylline concentrations were monitored in tissues and plasma. Major pharmacokinetic parameters (c_max, t_max, AUC) were calculated for plasma and tissue time courses. The mean AUC_tissue /AUC_plasma-ratio was 0.56 (p.o.) and 0.55 (i.v.) for muscle and 0.55 (p.o.) and 0.72 (i.v.) for subcutaneous adipose tissue.We conclude that microdialysis provides important information on the distribution and the tissue pharmacokinetics of theophylline.Abbreviations FPIA Fluorescence polarisation immuno assay - AUC Area under the curve - t_max Time to peak concentration - c_max Peak concentration     

Quantitative in vivo and in vitro sex differences in artemisinin metabolism in rat

1. The pharmacokinetics of the antimalarial compound artemisinin were compared in the male and female Sprague-Dawley rat after single dose i.v. (20 mg x kg(-1)) or i.p. (50 mg x kg(-1)) administration of an emulsion formulation. 2. Plasma clearance of artemisinin was 12.0 (95% confidence interval: 10.4, 13.0) 1 x h(-1) x kg(-1) in the male rat and 10.6 (95% CI: 7.5, 15.0) 1 x h(-1) x kg(-1) in the female rat suggesting high hepatic extraction in combination with erythrocyte uptake or clearance. Artemisinin half-life was approximately 0.5 h after both routes of administration in both sexes. Values for plasma clearance and half-lives did not statistically differ between the sexes. 3. After i.p. administration artemisinin AUCs were 2-fold higher in the female compared with male rat (p < 0.001). Artemisinin disappearance was 3.9-fold greater in microsomes from male compared with female livers and it was inhibited in male microsomes by goat or rabbit serum containing antibodies against CYP2C11 and CYP3A2 but not CYP2B1 or CYP2E1. 4. The unbound fraction of artemisinin in plasma was lower (p < 0.001) in plasma obtained from the male (8.8 +/- 2.0%) compared with the female rat (11.7 +/- 2.2%). 5. The possibility of a marked sex difference, dependent on the route of administration, has to be taken into account in the design and interpretation of toxicological studies of artemisinin in this species.     

休克时血中氧自由基的变化

本实验测定10名休克患者血浆和红细胞的丙二醛(MDA)、血浆总抗的氧化活性(AOA)的含量。结果表明:休克病人红细胞膜和血浆 MDA 含量(4.298±0.722;5.348±0.834)与对照组(3.235±0.682;4.356±1.081)比较明显增高(P<0.05);血浆 AOA(39.65±7.858)与对照组(48.21±10.81)比较明显降低(P<0.01)。提示:休克时,患者机体内自由基反应增强是引起组织细胞损伤的原因之一。     

Trichinellosis in immigrants in Switzerland

We describe a case of trichinellosis diagnosed at the Division of Infectious Diseases, Hospital of Lugano, in January 2009. This case was associated with a cluster of cases and was traced to the consumption of contaminated meat after a wild boar hunt in Bosnia.     

Hyperkalaemia in patients in hospital

A survey of all laboratory blood specimens with a plasma potassium concentration greater than or equal to 5.5 mmol/L was conducted over a three month period. Of 331 specimens with hyperkalaemia, 71 were excluded because the specimens was haemolysed, old or contaminated. The laboratory served a population of 348,561 and during this time measured the plasma potassium on 25,016 occasions. Sixty-six outpatients and 20 neonates were not evaluated. The survey was undertaken on 86 of 102 inpatients (46 males), 48 of whom were over 66 years of age. Fifty-seven patients were admitted under a medical service and 29 under a surgical service. Fifty-nine had a single episode of hyperkalaemia. Thirty-two underwent a surgical procedure. The commonest contributing factor was impaired renal function which was present in 71 (83%) patients. Although a definitive causative role for drugs could be identified in only five patients, in 52 (60%) patients drugs were a contributing factor (potassium supplements 24, ACE inhibitors 16, nonsteroidal antiinflammatory drugs 12). Thirty-five of the 86 (41%) patients died during their hospital admission. Nineteen of the 35 deaths occurred within three days of the hyperkalaemia being recorded. A normal plasma potassium was eventually documented in 50 of the 86 patients. Of the remaining 36 patients, 25 (69%) subsequently died. In general the treatment of patients with hyperkalaemia focused on identifying and treating the underlying cause. Hyperkalaemia must always be considered seriously and regard given to the overall clinical status of the patient, with particular attention to drug therapy, renal and cardiac function, acid base status and the possibility of sepsis.