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药械组合产品是由药品、生物制品、医疗器械三者之间任意组合的一类新型医疗产品.由于该类产品包含了隶属于不同监管部门的传统组成部分,这给产品监管、政策的制定以及审评管理带来了一定的挑战.本文介绍了美国、欧盟对药械组合产品的分类管理、审评模式,分析了我国药械组合产品管理现状及存在的问题,并且对该类产品的监管提出一些初浅的意见和建议. 相似文献
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中耳乳突炎并发乙状窦血栓形成1例报道 总被引：1，自引：1，他引：0
<正>患儿男,5岁,因咳嗽7 d,右耳疼痛伴流脓5 d,头痛3 d入院。患儿于7 d前着凉后出现咳嗽,为阵发性单声干咳,无发热、抽搐、鼻塞、流涕等;5 d前出现右耳疼痛、伴流脓性分泌物;3 d前出现头痛,呈阵发性疼痛,以额部及枕后明显,伴呕吐1次,呈非喷射性呕吐,量多,无血丝及咖啡色液体。自行口服"头孢类"消炎药治疗1 d后无明显好转,遂至当地县人民医院就诊,体格检查示:病理征阴性;头部CT平扫检查示: 相似文献
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金莲花药材高效液相色谱指纹图谱研究 总被引：1，自引：0，他引：1
目的：建立金莲花药材高效液相色谱（HPLC）指纹特征图谱的方法.方法：采用Phenomenex GeminiC18柱（4.6 mm ×250 mm,5μm）、乙腈-0.1％磷酸为流动相梯度洗脱,流速1.0 mL/min,柱温35℃,检测波长230 nm,用国家药典委员会颁布的中药色谱指纹图谱相似度评价系统（2004A版）进行相似度评价.结果：建立金莲花药材指纹图谱,确定31个共有峰,指认了5个色谱峰,金莲花各药材指纹图谱与共有模式相似度均在0.85以上.结论：HPLC指纹图谱为金莲花药材质量的更有效控制提供了依据. 相似文献
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Samantha J. LAIN Christine L. ROBERTS Camille H. RAYNES-GREENOW Jonathan MORRIS 《The Australian & New Zealand journal of obstetrics & gynaecology》2010,50(1):25-29
Background: In 2004, the Federal Government introduced the baby bonus, a one-off payment upon the birth of a child.
Aims: To assess the impact of an increase in the number of births on maternity services in New South Wales following the introduction of the baby bonus payment in July 2004.
Methods: A population-based study, using NSW birth records, of 965 635 deliveries from 1998 to 2008 was carried out. The difference between the predicted number of births in 2005–2008, estimated from trends in births from 1998 to 2004, and the observed number of births in NSW hospitals in 2005–2008 were calculated. We also estimated the increase in cost to the health system of births in 2008 compared with previous years.
Results: Compared with trends prior to the introduction of the baby bonus, there were an estimated 11 283 extra singleton births per year in NSW hospitals by 2008. There were significant increases in the number of deliveries performed in tertiary, urban and rural public hospitals; however, the number of deliveries in private hospitals remained stable. Compared with predicted estimates, in 2008, there were over 8700 more vaginal deliveries, over 1000 more preterm births and over 45 000 extra infant hospital days each year. Compared with 2004, in 2008, the estimated cost of births in NSW hospitals increased by $60 million,
Conclusions: The increase in births following the introduction of the baby bonus has significantly impacted maternity services in NSW. 相似文献
Aims: To assess the impact of an increase in the number of births on maternity services in New South Wales following the introduction of the baby bonus payment in July 2004.
Methods: A population-based study, using NSW birth records, of 965 635 deliveries from 1998 to 2008 was carried out. The difference between the predicted number of births in 2005–2008, estimated from trends in births from 1998 to 2004, and the observed number of births in NSW hospitals in 2005–2008 were calculated. We also estimated the increase in cost to the health system of births in 2008 compared with previous years.
Results: Compared with trends prior to the introduction of the baby bonus, there were an estimated 11 283 extra singleton births per year in NSW hospitals by 2008. There were significant increases in the number of deliveries performed in tertiary, urban and rural public hospitals; however, the number of deliveries in private hospitals remained stable. Compared with predicted estimates, in 2008, there were over 8700 more vaginal deliveries, over 1000 more preterm births and over 45 000 extra infant hospital days each year. Compared with 2004, in 2008, the estimated cost of births in NSW hospitals increased by $60 million,
Conclusions: The increase in births following the introduction of the baby bonus has significantly impacted maternity services in NSW. 相似文献
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