FDA’S Perspectives on Cardiovascular Devices

The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, §903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 ). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA’s review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.     

妇女叶酸增补中需要关注的问题

妇女围孕期增补叶酸能够有效预防神经管缺陷等疾病的发生。随着对叶酸研究的不断深入，叶酸补充中出现了诸多问题。本文简要综述了叶酸在服用方式以及基础和临床研究中出现的值得讨论、已经引起关注和需要进一步研究探讨的问题，并提出了深入研究叶酸可能的发展趋势。     

肝硬化患者凝血障碍与内毒素血症

本文通过多项止凝血实验指标和鲎试验对20例失代偿性肝硬化患者进行动态观察,发现血浆内毒素水平和ⅧR:Ag均增高.其他凝血因子和ATⅢ减低.纤维蛋白连接素减低.结果提示:(1)止凝血功能障碍与内毒素血症(ETM)并存,并与疾病的进展密切有关;(2)ETM的发生率和严重程度与肝硬化失代偿的程度有关;(3)ETM和止凝血功能异常的动态观察可作为判断预后的一项参考指标     

心血管疾病并发焦虑抑郁症状2050例心理干预治疗分析

目的:了解心血管疾病并发焦虑抑郁症状的情况并探讨心理干预等对焦虑抑郁症状的影响。方法:对住院的2050例心血管疾病并发焦虑抑郁症状的患者进行回顾性分析。结果:心血管疾病患者中并发有焦虑抑郁症状者占56%;其常表现为类似心绞痛、左心衰竭症状,可并发有心律失常;高血压病并发有焦虑抑郁患者对血压升高的耐受性差,动态血压检查以非勺型改变者居多;单纯使用心血管药物治疗效果欠佳,心理干预,焦虑抑郁症状严重者结合抗焦虑抑郁药物疗效显著。结论:心血管疾病患者常并发焦虑抑郁症状,心理干预治疗等可有效改善患者的症状。     

Overview of the Clinical Efficacy of Lamotrigine

Summary: Testing the efficacy of lamotrigine (LTG) in epileptic patients has been approached in several ways. The first pilot study examined the effect of a single dose of LTG in patients with frequent interictal spikes, and a reduction in spike frequency was observed. Subsequently, single doses reduced photosensitivity in appropriate patients. Single-blind administration of LTG for 1 week in addition to the patients' regular antiepileptic drugs (AEDs), in patients with refractory seizures, reduced seizures despite the short duration of therapy. This regimen was continued using a placebo-controlled crossover study with 1-week duration of treatment. Efficacy in partial and tonic-clonic seizures was subsequently confirmed in four double-blind crossover studies; a meta-analysis of these four studies showed a 30% reduction in partial seizures despite the intractable nature of the seizures in the patients included. Current studies aim at evaluating the drug as monotherapy and in different seizure types.     

血管介入仿真模拟器在心血管医生冠状动脉介入技术规范化培训中的作用

目的明确Angiomemor（美国Simbionix公司生产）血管介入仿真模拟器是否有助于冠状动脉造影技术的掌握和提高。方法选取16名无血管放射介入经验的心血管医生，接受相同课时的冠状动脉介入造影理论培训后，按随机表编码随机分为模拟器培训组与非培训组各8名，模拟器培训组8名医生接受Angiomemor血管介入仿真模拟器培训，模拟冠状动脉造影操作，非培训组8名心血管医生未接受仿真模拟器培训。在随后的真实临床环境中操作冠状动脉造影时，评价2组医生冠状动脉造影操作过程中错误的频数、平均造影时间、造影剂使用量及术中放射线剂量。结果相对于非培训组，模拟器培训组医生在冠状动脉造影操作中错误频数减少62．5％、平均造影时间减少44．0％、造影剂使用量减少44．0％，术中平均放射线曝光时间减少了57．7％，平均X线累计曝光剂量减少51．6％，单位面积X线累计曝光剂量减少了52．4％。结论Angiomemor血管介入仿真模拟器有助于医生较快地熟练掌握冠状动脉造影技术，是冠状动脉介入规范化培训的重要辅助手段之一。     

冠状动脉搭桥术193例经验总结

目的:探讨冠状动脉搭桥术的病例选择、手术方法和治疗效果。方法:回顾性分析1997年1月～至2003年12月齐鲁医院施行的体外循环下冠状动脉搭桥术穴CPBCABG雪99例,非体外循环冠状动脉搭桥术穴OPCABG雪74例,冠状动脉搭桥加瓣膜置换术穴CABG VP雪20例的临床资料。结果:手术死亡6例,死亡率3.1%。体外循环下单纯冠状动脉搭桥术死亡率为2%,非体外循环冠状动脉搭桥术死亡率为2.7%,冠状动脉搭桥加瓣膜置换术死亡率为10%。短期随访3～6个月,症状消失占93.0%,症状明显减轻占5.4%。结论:患者近期随访效果良好,3组的手术死亡率差异无统计学意义穴P>0.05雪。     

Reproductive Function in Epilepsy

Summary: : The hypothalamic-pituitary-gonadal axis is a complex system within which both positive and negative feedback occur among its elements and higher brain systems. The occurrence of seizures and changes in the secretion of pituitary hormones can affect the feedback loop. Both seizures and antiepileptic drugs can affect the hypothalamic-pituitary-gonadal axis of males and females and cause changes in hormones and sexuality. Reproductive dysfunction has a social impact because of reduced fertility. Once conception occurs, live birth rates are not diminished. Prospective studies of men and women with epilepsy are needed.     

The Prospective Assessment of Autonomic Nerve Function by Pupillometry in Adolescents with Type 1 Diabetes Mellitus

The study aimed to compare the longitudinal assessment of autonomic nerve function by computerized infrared pupillometry and standard cardiovascular tests in adolescents with diabetes. Adolescents (n = 150) were assessed at two time points (T1 and T2). The median time interval between assessments was 1.5 (range 0.9–3) years. At T1 the median age was 14.5 (range 8.3–19.5) years and the median duration was 6.5 (range 1.1–16) years. The pupillary variables assessed included the resting pupil diameter, the maximum constriction velocity, and the reflex amplitude of constriction. Heart rate reflexes were assessed in response to deep breathing, the Valsalva manoeuvre, and on standing from a lying position (30/15 ratio). Between visits there was a significant decrease in maximum constriction velocity (6.0 mm s^?1 vs 6.3 mm s^?1, p = 0.0001) and resting pupil diameter (6.2 mm vs 6.3 mm, p = 0.001). At reassessment pupillary abnormalities increased from 32 (21 %) to 45 (30%), with 17 (54 %) of the initial abnormalities persisting. Adolescents with abnormally slow maximum constriction velocity compared to those with normal maximum constriction velocity had a higher glycated haemoglobin (HbA_1c%) at T2 (p = 0.02) and between assessments (p = 0.01). Cardiovascular test abnormalities did not increase between visits and the persistence of initial abnormalities was low (21 %). In summary, pupillometry appears a more sensitive test of autonomic nerve dysfunction in adolescents with diabetes than assessment of cardiovascular reflexes.     

OSAS患者循环ICAM-1,VCAM-1及L-选择素水平与心血管疾病的研究

目的 :探讨阻塞性睡眠呼吸暂停综合征 (OSAS)患者循环细胞间黏附分子 - 1(intercellularadhesionmolecule 1,ICAM - 1)、血管细胞黏附分子 - 1(vasculaecelladhesionmolecule 1,VCAM -l)及L -选择素 (L -selection)水平及与心血管疾病的相关性。方法 :选取OSAS患者 12例 (男性 9例 ,女性 3例 ,平均年龄 5 1.6±4 .8岁 )及 12例年龄相匹配的健康对照者。采用ELISA法检测OSAS患者入睡前、睡醒后血浆ICAM - 1、VCAM - 1及L -选择素水平 ,并与正常对照组比较。结果 :OSAS患者入睡前ICAM - 1,VCAM - 1及L -选择素水平较正常对照组升高 (ICAM - 1:4 0 2 .8± 4 8.2vs 2 0 8.4± 5 6 ,P <0 .0 5 ;VCAM - 1:814± 88.9vs 5 82±4 4 .5 ,P <0 .0 5 ;L -选择素 :1390 .4± 76 .8vs 10 4 4 .3± 80 .2 ,P <0 .0 1) ,睡醒后ICAM - 1及L -选择素水平较正常对照组明显升高 (ICAM - 1:395± 4 5vs 2 0 5± 5 0 ,P <0 .0 5 ;L -选择素 :114 3.5± 196 .2vs 10 2 5 .6±5 0 .3,(P <0 .0 5 )。结论 :OSAS所致的低氧血症激活了循环黏附分子 ,参与了心血管疾病的发生与发展。