菊花、党参二氧化硫含量测定方法比较与分析

目的:确定利用《中国药典》收录方法测定中药二氧化硫操作易出问题的环节,提示测定操作的注意事项,以便使测定操作更加完善、结果更加准确。同时了解菊花、党参样品二氧化硫污染状况。方法:以党参和菊花样本为研究材料,利用《中国药典》方法和《欧洲药典》方法测定其中二氧化硫的含量,对比测定结果和测定过程,分析产生误差的原因。结果:按《中国药典》方法测定的结果,20个党参样品中超过400mg·kg-1的样本有6个,10个菊花样本均在30mg·kg-1以下,都符合150mg·kg-1的标准。结论:实验环节中滴定的起点、二氧化硫吸收过程、滴定终点的判断都会影响结果,应严格控制。菊花的二氧化硫污染较少,党参污染相对严重,需要加大监管治理力度,给市场提供合格的药材,保证用药安全。     

Clinical Trials Update from the European Society of Cardiology Congress in Vienna, 2007: PROSPECT,EVEREST, ARISE,ALOFT, FINESSE,Prague-8, CARESS in MI and ACUITY

The Clinical Trials described in this article were presented at the Hotline and Clinical Trial Update Sessions of the European Society of Cardiology Congress held in September 2007 in Vienna, Austria. The sessions chosen for this article represent the scope of interest of Cardiovascular Drugs and Therapy. The presentations should be considered preliminary, as further analyses could alter the final publication of the results of these studies. PROSPECT evaluated echocardiographic criteria for optimal selection of patients with moderate to severe heart failure who may benefit from cardiac resynchronisation therapy, however concluded that no single echocardiographic measure can be recommended. EVEREST found that tolvaptan, a vasopressin V₂ antagonist, resulted in early weight reduction and improvement of dyspnoea in patients with acute heart failure, but lacked long term improvement. In ARISE, the anti-oxidant succinobucal did not affect the primary outcome in high risk cardiovascular patients, but improved the combination of cardiovascular death, myocardial infarction and stroke, and diabetic control in diabetics. ALOFT showed that the addition of the renin inhibitor aliskiren to an ACE inhibitor or ARB and a beta-blocker leads to favourable effects on neurohormonal actions in heart failure. FINESSE markedly improved coronary patency before PCI with half-dose reteplase/abciximab in STEMI patients, however without significantly improving short-term outcome. The Prague-8 Study evaluated whether routine clopidogrel administered >6 h pre-angiography would be a safe way to achieve therapeutic drug levels in case a follow-up intervention would be considered immediately, but appeared not justified because of bleeding complications. CARESS in MI showed that high risk patients with evolving STEMI who undergo thrombolytic therapy should undergo PCI early after the thrombolysis. Finally, the ACUITY trial found that in moderate or high risk Non ST elevation ACS patients triaged to PCI, coronary artery bypass graft (CABG) surgery, or medical management, bivalirudin, with or without associated GPIIb/IIIa inhibitor therapy, resulted in a marked reduction of bleeding at 30 days whilst preserving the ischemic and mortality benefit at 1 year follow up.     

Comparison of Porcine Epidemic Diarrhea Viruses from Germany and the United States, 2014

Since 2013, highly virulent porcine epidemic diarrhea virus has caused considerable economic losses in the United States. To determine the relation of US strains to those recently causing disease in Germany, we compared genomes and found that the strain from Germany is closely related to variants in the United States.     

Analysis of Medicine Prices in New Zealand and 16 European Countries

ObjectiveTo compare prices of medicines, both originators and generics, in New Zealand and 16 European countries.MethodsEx-factory price data as of December 2012 from New Zealand and 16 European countries were compared for a basket of 14 medicines, most of which were at least partially funded by the state in the 17 countries. Five medicines had, at least in some countries, generic versions on the market whose prices were also analyzed. Medicine price data for the 16 European countries were provided by the Pharma Price Information service. New Zealand medicine prices were retrieved from the New Zealand Pharmaceutical Schedule. Unit prices converted into euro were compared at the ex-factory price level.ResultsFor the 14 medicines surveyed, considerable price differences at the ex-factory price level were identified. Within the European countries, prices in Greece, Portugal, the United Kingdom, and Spain ranked at the lower end, whereas prices in Switzerland, Germany, Denmark, and Sweden were at the upper end. The results for New Zealand compared with Europe were variable. New Zealand prices were found in the lowest quartile for five medicines and in the highest quartile for seven other products. Price differences between the originator products and generic versions ranged from 0% to 90% depending on the medicine and the country.ConclusionsMedicine prices varied considerably between European countries and New Zealand as well as among the European countries. These differences are likely to result from national pricing and reimbursement policies.     

Nutrition and health claims in practice

The European Nutrition and Health Claims Regulation ensures that any claims on European Union food labels are substantiated by robust scientific evidence; is this promoting innovation in the food industry and enabling consumers to make meaningful food choices? This paper provides an overview of the Regulation and some of the issues that have arisen since its implementation in 2007, with examples. It also discusses several European Commission‐funded projects that are underway, in particular BACCHUS (FP7/2007–2013; 312090: www.bacchus‐fp7.eu ) that is providing support to small‐ and medium‐sized enterprises that are considering whether to use or apply for health claims.     

The European Medicines Agency Review of Pomalidomide in Combination With Low‐Dose Dexamethasone for the Treatment of Adult Patients With Multiple Myeloma: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use

On August 5, 2013, a marketing authorization valid throughout the European Union (EU) was issued for pomalidomide in combination with dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. Pomalidomide is an immunomodulating agent. The recommended starting dose of pomalidomide is 4 mg once daily taken on days 1–21 of repeated 28‐day cycles. The main evidence of efficacy for pomalidomide in MM was based on a phase III multicenter, randomized, open‐label study (CC‐4047‐MM‐003) in which pomalidomide plus low‐dose dexamethasone therapy (POM+LoDEX) was compared with high‐dose dexamethasone alone (HiDEX) in previously treated adult patients with relapsed and refractory multiple myeloma who had received at least two prior treatment regimens, including both lenalidomide and bortezomib, and had demonstrated disease progression on the last therapy. For the intent‐to‐treat population, median progression‐free survival based on International Myeloma Working Group criteria was 15.7 weeks (95% confidence interval [CI]: 13.0–20.1) in the POM+LoDEX group versus 8.0 weeks (95% CI: 7.0–9.0) in the HiDEX group (log‐rank p value <.001). Overall survival (secondary endpoint) was also different in the two treatment groups (hazard ratio 0.53 [95% CI: 0.37–0.74]). The most commonly reported adverse reactions to pomalidomide in clinical studies were anemia (45.7%), neutropenia (45.3%) and thrombocytopenia (27%), fatigue (28.3%), pyrexia (21%), peripheral edema (13%), and infections including pneumonia (10.7%). Peripheral neuropathy adverse reactions were reported in 12.3% of patients, and venous embolic or thrombotic (VTE) adverse reactions were reported in 3.3% of patients. Pomalidomide is expected to be teratogenic. This paper summarizes the scientific review of the application leading to approval in the EU. The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the EMA website ( http://www.ema.europa.eu ).     

Risk analysis of main mycotoxins occurring in food for children: An overview

Mycotoxins are secondary metabolites produced by fungi contaminating the food chain that are toxic to animals and humans. Children up to 12 years old are recognized as a potentially vulnerable subgroup with respect to consumption of these contaminants. Apart from having a higher exposure per kg body weight, they have a different physiology from that of adults. Therefore they may be more sensitive to neurotoxic, endocrine and immunological effects. For these reasons, a specific and up-to-date risk analysis for this category is of great interest.In this review, an accurate analysis of the main mycotoxins occurring in food intended for children (deoxynivalenol, aflatoxins, ochratoxins, patulin and fumonisins) is presented. In particular, known mechanisms of toxicity and levels of exposure and bioaccessibility in children are shown. In addition, recent discoveries about the strategies of mycotoxins managing are discussed.     

Toxic trace elements at gastrointestinal level

Many trace elements are considered essential [iron (Fe), zinc (Zn), copper (Cu)], whereas others may be harmful [lead (Pb), cadmium (Cd), mercury (Hg), arsenic (As)], depending on their concentration and chemical form. In most cases, the diet is the main pathway by which they enter our organism. The presence of toxic trace elements in food has been known for a long time, and many of the food matrices that carry them have been identified. This has led to the appearance of legislation and recommendations concerning consumption. Given that the main route of exposure is oral, passage through the gastrointestinal tract plays a fundamental role in their entry into the organism, where they exert their toxic effect. Although the digestive system can be considered to be of crucial importance in their toxicity, in most cases we do not know the events that occur during the passage of these elements through the gastrointestinal tract and of ascertaining whether they may have some kind of toxic effect on it. The aim of this review is to summarize available information on this subject, concentrating on the toxic trace elements that are of greatest interest for organizations concerned with food safety and health: Pb, Cd, Hg and As.