中药在欧美国家注册管理概况

参阅美国食品药品监督管理局（FDA，Food and Drug Administration）；欧盟委员会（EC，European Commission）；欧盟药品审评局（EMEA，The European Agency for the Evaluation of Medicinal Products）及欧盟食品兽医办公室（FVO，Foodand Veterinary Office）有关法律法规文件，就中药在欧美国家申请上市注册的基本要求做简要介绍。     

对医药代表注册制度的思考与建议

目的:促进医药流通领域健康、有序发展。方法:借鉴国内、外相关经验并提出规范医药代表行为的建议方案。结果与结论:我国应建立医药代表注册制度,规范医药代表的行为,使之发挥应有作用。     

模拟人联合多媒体在医学英语教学中的应用

本文通过医学模拟人结合多媒体技术建构的资源库,对我校侨生在外科临床实习阶段进行专业英语教学进行探索,结果表明该教学模式为侨生提供了轻松自主的学习环境和丰富多样的语言载体,收到了良好的教学效果.     

Quality of perinatal death registration

The quality of national perinatal mortality statistics was evaluated from a survey in nine maternity hospitals in Hainaut, Belgium (total births: 7862). The overall completeness of perinatal death registration was 86%. Under-registration was especially frequent in low birth weight babies. In 69% of cases, the birth weight value reported on death certificates was in exact agreement with the value in hospital records. Using detailed categories of causes, there was, in 37% of cases, agreement between the underlying cause on death certificates and the main cause identified in hospital records. Using gross categories of causes, the level of agreement was 56%. Disagreement was mostly due to the lack of specificity of the underlying cause on death certificates. The authors suggest ways to improve the quality of registration.Abbreviation ICD International classification of diseases The study was supported by a research grant of the Fonds de la Recherche Scientifique Medicale No 3.9002.85     

山东省乳山市1970—1992年恶性肿瘤流行病学调查报告

目的：研究乳山市人口常见恶性肿瘤流行特征。方法：收集乳山市1970-1974年全人口死亡回顾调查资料、1985-1989年的1／10人口的全死因抽样调查及1990-1992的连续调查资料，进行统计、分析。结果：近22年来，乳山市居民胃癌死亡率仍处于高水平，肝癌、肺癌的死亡率则逐年上升。结论：建立全市人民的标准化癌症登记报告系统，对于了解和掌握本市恶性肿瘤流行动态及进行肿瘤防治都是非常必要的。     

关于医疗器械注册相关文件的若干理解

为了整顿和加强医疗器械注册环节工作，国家近两年相继下发了一系列医疗器械注册及再注册的相关文件。如何正确理解既有法规、文件与后续发布的注册有关文件以及相互之间的关系，对于从事注册的医疗器械生产企业和代理机构准确提供相关材料、顺利通过注册非常重要。就医疗器械再注册期问原注册证延期、注册证变更、生产企业以及代理人等相关角色的含义和关系等几个问题提出了一些理解，以供参考。     

Additional information from parental questionnaires and pharmacy records for registration of birth defects

EUROCAT Northern Netherlands registers children born with a birth defect in the Northern Netherlands. Data used to be collected via a notification form, which is filled out by the notifier and, if necessary, completed by the general practitioner. To increase the amount of information, EUROCAT started using new methodology in July 1997. The new procedure consists of three additional steps. Firstly, a parental questionnaire with 43 questions concerning pregnancy and medical history is sent to the parents. Also, the pharmacist is approached to provide information on the drugs that were dispensed to the mother in the period from three months before until the end of the pregnancy. The last step is a telephone interview with the mother. In this study the old and new method are compared with respect to response, quality and quantity of the data. Of the 198 parental questionnaires included in this study, 179 (90.4%) were returned. The pharmacists returned 173 out of 179 requests for information (96.6%). The parental information is more complete for ethnicity and serum screening. The quality of the drug exposure data is much better using the new methodology. The general practitioner's input is still necessary for specification and verification of the diagnosis.     

Pre-hospital trauma care: a proposal for more efficient evaluation

Although mortality is an important outcome parameter for pre-hospital trauma care, it is influenced by many factors other than pre-hospital trauma care alone. We therefore studied an alternative method to evaluate pre-hospital trauma care by calculating the change in probability of survival (Ps) according to the TRISS methodology, before and directly after the pre-hospital trauma care. Correlations between patient characteristics and a change in Ps were assessed. Further, required sample sizes were calculated for an 80% power to detect a hypothetical 3% reduction in mortality and the corresponding change in Ps. In 140 of 191 patients with an Injury Severity Score > or =16, the Ps did not change. In 36, the Ps increased and in 15 patients, the Ps decreased. Between these three groups, significant differences were found in Revised Trauma Score and age, but no clear differences in Injury Severity Score or mortality. A 3% difference in mortality would require 6800 patients, in contrast to 3500 when the change in Ps was the primary outcome parameter. A change in Ps is a promising outcome parameter for a more efficient evaluation of pre-hospital trauma care. A good collaboration is, however, required between ambulance services and the trauma center for reliable registration.     

欧美原料药进口注册文件中的分析方法验证

目的:促进我国企业原料药的国际注册工作。方法:结合欧美原料药注册管理的要求,对其中的分析方法验证部分进行全面阐述,并提出具体的操作方法。结果与结论:分析方法验证无论在质量控制中,还是在国际药品注册活动中,都是非常重要的内容,我国企业必须给予高度的重视。     

Medical tourism: Assessing the evidence on treatment abroad

The review focuses on one growing dimension of health care globalisation – medical tourism, whereby consumers elect to travel across borders or to overseas destinations to receive their treatment. Such treatments include cosmetic and dental surgery; cardio, orthopaedic and bariatric surgery; IVF treatment; and organ and tissue transplantation. The review sought to identify the medical tourist literature for out-of-pocket payments, focusing wherever possible on evidence and experience pertaining to patients in mid-life and beyond.