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.     

Contribution of genetic factors for melanoma susceptibility in sporadic US melanoma patients

Abstract:  The risks of developing malignant melanoma (MM) include ultraviolet irradiation and genetic factors. To examine the contribution of rare and common variation within known MM genes in sporadic US MM patients, coding regions of known MM susceptibility genes [cyclin-dependent kinase inhibitor 2A ( CDKN2A ), cyclin-dependent kinase 4, melanocortin 1 receptor ( MC1R ) and tyrosinase ( TYR )] were resequenced in 109–135 MM cases. The significance of variants was examined by comparing their frequencies in 390 cancer-free controls. Potential deleterious mutations in CDKN2A were found in two patients and two others had variants of unknown significance. Cases were more likely than controls to harbour the MC1R 'R' variants known or predicted to alter its function ( P  = 0.002), particularly the R160W variant ( P  = 0.0035). The associated TYR R402Q variant (rs1126809*A) was found in 29% of cases, similar to what has been described previously. One MM patient with a family history of MM, who had developed other skin cancers, was homozygous for a novel TYR variant (P406L) of unknown significance. Hence, rare variants in TYR may be important risk factors for skin cancer.     

100例性病患者心理健康状况调查分析

目的：探讨性病患者的心理健康状况,为临床治疗和护理提供依据。方法：采用症状自评量表（SCL-90）对100例性病患者的心理健康状况进行测验。结果：100例性病患者SCL-90检测的阳性率为51%,阳性样本因子分居前的是敌对、强迫症状、抑郁、人际敏感。结论：性病患者广泛存在的心理问题,在药用治疗的同时应注意心理方面的治疗和疏导。     

膀胱肿瘤2350例临床病理学特点分析

目的 探讨膀胱肿瘤的发病现状、总体趋势和病理特点.方法 整理1980-2007年2350例膀胱肿瘤病理档案,分为1980-1989、1990-1999和2000-2007年3个时间段.应用SPSS 13.0软件分析3时间段患者性别、年龄及肿瘤组织学类型间的关系.结果 2350例膀胱肿瘤中男1854例,女496例.良性92例,恶性2258例,膀胱恶性肿瘤的发病人数逐年上升.发病高峰年龄从50～69岁推迟到60～79岁.1980-1989、1990-1999和2000-2007年3个时间段中男、女恶性肿瘤病例数分别为524例和113例(4.64:11 00)、589例和164例(3.59:1.00)、675例和193例(3.50:1.00),男性约为女性的3.80倍;3时间段男性发生膀胱尿路上皮癌年龄分别为(57.5±11.7)、(62.6±12.3)、(65.9±11.3)岁,女性分别为(58.7±13.6)、(60.7±12.1)、(65.8±12.0)岁,男女各年龄段分别比较差异有统计学意义(P<0.05).男性发生鳞状细胞癌、尿路上皮癌和腺癌年龄分别为(68.05±9.7)、(59.85±14.1)、(63.4±9.9)岁,差异有统计学意义(P相似文献   

广西边远少数民族学生体型及体质量指数3年追踪**

背景: 前期研究表明广西18~22岁少数民族学生体质量偏轻。 目的：拟进一步了解广西2645名少数民族学生体型及体质健康状况，寻找影响的关联因子。 设计、时间及地点：追踪调查，于2004-12/2007-12在广西民族大学完成。 对象：广西民族大学2003/2005三次体质健康测试的全体学生2 645人。男1 337人，女1308人，年龄为18~20岁，共15个民族。 方法：根据2003年教育部、体育总局《学生体质健康标准（试行方案）》和实施方法分为形态指标、技能指标和身体素质指标3大类。对2 645名少数民族身体机能与体质量指数变化的跟踪调查。 主要观察指标：身高、体质量、肺活量、立定跳远、坐位体前屈、体质量指数。 结果：①广西民族大学2003级学生大学3年期间男生身高、体质量增长率比全国同期多2.45%，身体形态发育正处于高峰期，女生成偏瘦型体型，身体形态发育情况总体欠佳。②男女学生在刚入校时肺活量机能较差，远远低于同期全国平均水平。3年后男生肺活量增长率为11.55%、女生肺活量增长率为27.72%，分别高于全国同期肺活量增长率。③坐位体前屈机能高于同期全国平均水平，男生呈逐年上升趋势，同期全国男性呈下降趋势；同期全国乡村女生均呈逐年上升趋势。④立定跳远机能提高较大，3年后增长率为18.15%，明显高于全国同期立定跳远增长率水平的2.61%。女生立定跳远机能总体不如全国同期水平。⑤体质量指数总体与同期全国乡村男女学生体质量指数比较稍低一些(P < 0.01)。 结论：2 645名少数民族学生发育正处于高峰期；肺活量机能不及全国同期平均水平。男女体质量指数分布有所不同，体质量偏轻者女生多于男生，表明学生营养状况总体欠佳。     

Onychomycosis caused by Fusarium solani in a woman with diabetes

A case of untreated fusarial onychomycosis leading to serious consequences is reported. Fusarium solani is a widespread fungus and an occasional human pathogen. It usually invades rapidly in immunocompromised hosts, and often results in a poor outcome despite treatment. We report a woman with diabetes mellitus who had untreated fusarial infection of the nails, which developed into subcutaneous fusariosis, superinfected by bacteria, and then evolved into osteomyelitis that subsequently resulted in septic shock. Early management of mycotic nails in immunocompromised hosts is crucial to prevent life‐threatening disease.     

Lipid extract from completely sporoderm‐broken germinating Ganoderma sinensis spores elicits potent antitumor immune responses in human macrophages

Ganoderma sinensis has been used widely in Oriental countries for the prevention and treatment of various diseases including cancer. Previous studies have shown that the lipid extract from Ganoderma exhibits direct cytotoxicity against tumor cells. Here, it is reported that the lipid extract from germinating G. sinensis spores, at lower concentrations that have no direct tumoricidal activity, induce potent antitumor immune responses in human monocytes/macrophages. Upon stimulation with the lipid extract, monocytes/macrophages exhibited markedly increased production of proinflammatory cytokines and surface expression of costimulatory molecules. Conditioned medium from stimulated cells effectively suppressed the growth of tumor cells. Apparently, the lipid extract triggered macrophage activation via a mechanism different from that associated with LPS. Moreover, it was observed that the lipid extract could partially re‐establish the antitumor activity of the immunosuppressive tumor‐associated macrophages. These results indicated that in addition to its direct tumoricidal activity, the lipid extract from G. sinensis spores could exert antitumor activity by stimulating the activation of human monocytes/macrophages. Copyright © 2008 John Wiley & Sons, Ltd.