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.     

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。     

Energy recommendations for normal weight,overweight and obese children and adolescents: are different equations necessary?

In 2002/2005, separate energy requirement equations were generated by the Institute of Medicine's (IOM) Dietary Reference Intake process for normal weight and overweight/obese children and adolescents. The current paper questions the theoretical rationale of having two sets of equations (based solely on body-weight classification): when body weight is considered, overweight and obese children and adolescents do not seem to differ from their normal weight counterparts in energy expended for basal metabolism or physical activity tasks. However, energy needs for weight maintenance among overweight/obese girls were consistently higher when predicted using the equations for overweight/obese individuals compared with those developed for normal weight individuals. In contrast, among overweight/obese boys, they were consistently lower . Although the differences are within the variability of the estimates, even theoretical support for a higher energy intake (as occurs in girls) seems unwise because of the potential contribution to a higher body mass in children who are already at risk. It is the opinion of the authors that the IOM revisit the use of two separate equations and generate one set that is appropriate for all children and adolescents.     

Gerontology in the developing Brazil: Achievements and challenges in public policies

Aim:   In the last three decades, the segment of population aged 60 years and older has more than doubled in Brazil. People aged 80 years and older are expected to be the fastest-growing segment in the near future. This aim of this study was to analyze the legal structures currently in place in Brazil and to provide a framework for care policies and practices towards older-adults.
Methods:   This article focuses on past and present major socioeconomic burdens on this segment of the Brazilian population as well as on public achievements to overcome inequities.
Results:   Both the public health and the social security systems have been directed to provide preferential assistance to the aged. Nonetheless, the elderly remain the most impoverished segment of Brazil and carry the burden of an overall lack of specialized services. Moreover, socioeconomic inequalities and population diversity in Brazil affects elderly care, adding complexity to this unique scenario.
Conclusion:   Brazil has adopted legal hallmarks that substantially shifted public practices towards the elderly segment from a philanthropic status to a legitimate right for care and assistance. The demographic transition that took place provides an opportunity for innovative solutions in public policies for older adults in a developing economic environment.     

Statistical clues to postoperative blood loss: Moving averages applied to medical data

With the advent of computerized databases, medical data has become easy to accumulate; however, effective use of this data continues to pose significant problems. In other circumstances, smoothing algorithms have been used to uncover non-obvious correlations, trends and relationships in noisy data. We have applied four such algorithms to a large dataset of postoperative blood replacement in cardiopulmonary bypass patients. When applied to this dataset, one of the algorithms proved surprisingly effective. It confirmed several previously observed correlations, and also provided an additional series of counterintuitive and apparently unrelated associations. These associations have been explored in an accompanying paper.     

使用便携式微量输液泵持续输注氟尿嘧啶的临床观察及护理

目的：探讨使用便携式微量输液泵在肿瘤化疗中持续输注氟尿嘧啶的应用效果。方法：选取我科2006年3月-2008年7月96例癌症化疗病人按入院先后顺序分为对照组和实验组,每组48例。对照组采用传统的化疗方式,采用浅静脉留置针直接从外周静脉输注氟尿嘧啶（5-Fu）连续5天,每天维持6-8小时。实验组采用浅静脉留置针连接便携式微量输液泵持续泵入氟尿嘧啶（5-Fu）120h～135h,两组均以21天为1个周期,观察两组病人化疗毒副反应发生情况。结果：实验组化疗毒副反应发生率明显低于对照组,平均住院时间明显缩短,两组比较差异有统计学意义（P〈0.01）。结论：使用便携式微量输液泵持续泵入氟尿嘧啶能减轻病人的毒副反应,缩短住院时间,提高肿瘤病人生活质量,有效减轻护士的工作负担。     

Partner- and partnership-related risk factors for preterm birth among low-income women in Lima,Peru

A woman's partner and the characteristics of their partnership can play an important role in the health of her pregnancy. Yet, with the notable exception of intimate partner violence, there has been little previous research addressing the associations between partner- or partnership-related factors and birth outcomes. This analysis tested the hypothesis that risk factors related specifically to partner or partnership characteristics increased the risk for preterm birth. Between 2003 and 2005, a total of 580 preterm cases (20–36 weeks gestational age at delivery) and 633 term controls (≥37 weeks) were selected from women delivering at an obstetric hospital in Lima, Peru. Each woman completed a confidential, structured interview and provided biological specimens within 48 h after delivery. Multivariable logistic regression was used to assess associations between partner and partnership characteristics and preterm birth. After adjustment for behavioral, demographic, and obstetric risk factors, ever having had a partner with a history of drug use (aOR = 1.91, 95% CI 1.22–2.99), ever having had anal sex (aOR = 1.40, 95% CI 1.07–1.84), having a current partner with a history of visiting prostitutes (aOR = 1.69, 95% CI 1.22–2.33), and perceiving one's current partner as a “womanizer” (aOR = 1.34, 95% CI 1.02–1.77) were significantly associated with an elevated risk of preterm birth when tested in separate models. These four factors were then used to create a composite partnership risk score, which showed an increasing dose-response relationship with preterm birth risk (per additional partner risk factor: aOR = 1.31, 95% CI 1.16–1.49). These results highlight the importance of considering a broader set of risk factors for preterm birth, specifically those related to a woman's partner and partnership characteristics. Further research could clarify the specific mechanisms through which these partner and partnership characteristics may increase the risk of preterm birth.