Novità nel mondo di Medicina di Laboratorio

Alnylam Pharmaceuticals Inc priced its gene silencing drug to treat patients with a rare genetic disorder that can cause severe pain at $575,000 per year after receiving an early U.S. approval on Wednesday.
Reuters Health Information

A new analysis in more than 5 million women has identified starting ages for breast cancer screening based on family history of the disease.
Reuters Health Information

Algorithms that combine a clinical decision rule (CDR) and highly sensitive D-dimer are widely recommended for identifying patients in whom pulmonary embolism can be safely excluded without further studies, but these algorithms appear to be underused, according to a survey of practitioners in the Veterans Administration (VA) healthcare system.
Reuters Health Information

Levels of influenza-like illness activity have exceeded the baseline for 2 weeks running, according to the latest report from the Centers for Disease Control and Prevention.
Medscape Medical News

Unlike some previous evidence, a new study finds no association between statins and cognitive changes and even suggests statins may have a protective effect in certain populations.
Medscape Medical News

Three medical stories that we didn't cover, explained.
Medscape

A new artificial intelligence algorithm uses peripheral retinal field images to predict how quickly diabetic retinopathy will progress and which patients need immediate attention.
Medscape Medical News

BACKGROUND:

Laboratory medicine, like other areas of medicine, is obliged to adhere to high ethical standards. There are particular ethical issues that are unique to laboratory medicine and other areas in which ethical issues uniquely impact laboratory practice. Despite this, there is variability in ethics education within the profession. This review provides a foundation for the study of ethics within laboratory medicine.

CONTENT:

The Belmont Report identifies 3 core principles in biomedical ethics: respect for persons (including autonomy), beneficence (and its corollary nonmalfeasance), and justice. These core principles must be adhered to in laboratory medicine. Informed consent is vital to maintain patient autonomy. However, balancing patient autonomy with the desire for beneficence can sometimes be difficult when patients refuse testing or treatment. The use of leftover or banked samples is fundamental to the ability to do research, create reference intervals, and develop new tests, but it creates problems with consent. Advances in genetic testing have created unique ethical issues regarding privacy, incidental findings, and informed consent. As in other professions, the emergence of highly contagious and deadly infectious diseases poses a difficult ethical dilemma of helping patients while protecting healthcare workers.

CONCLUSIONS:

Although many clinical laboratorians do not see or treat patients, they must be held accountable to the highest ethical and professional behavior. Recognition and understanding of ethical issues are essential to ethical practice of laboratory medicine.

BACKGROUND:

Observational studies suggest vitamin D and marine -3 fatty acid (n-3 FA) supplements are associated with lower systemic inflammation. However, past trials have been inconsistent.

METHODS:

The randomized, double-blind, placebo-controlled VITamin D and OmegA-3 TriaL (VITAL) tested vitamin D (2000 IU/day) and/or n-3 FA (1 g/day) supplementation in a 2 x 2 factorial design among women ≥55 and men ≥50 years of age. We assessed changes in interleukin (IL)-6, tumor necrosis factor receptor 2 (TNFR2), and high-sensitivity C-reactive protein (hsCRP) concentrations from baseline to 1 year among participants randomized to vitamin D + n-3 FA (392), vitamin D (392), n-3 FA (392), or placebo only (385). Geometric means and percent changes were compared, adjusting for baseline factors.

RESULTS:

Baseline characteristics were well balanced. In the active arms, 25-OH vitamin D rose 39% and n-3 FA rose 55% vs minimal change in placebo arms. Neither supplement reduced biomarkers at 1 year. Vitamin D resulted in 8.2% higher IL-6 (95% CI, 1.5%–15.3%; adjusted P = 0.02), but TNFR2 and hsCRP did not. Among 784 receiving vitamin D, hsCRP increased 35.7% (7.8%–70.9%) in those with low (<20 ng/mL) but not with higher baseline serum 25(OH) vitamin D [0.45% (–8.9% to 10.8%); P interaction = 0.02]. Among 777 randomized to n-3 FA, hsCRP declined [–10.5% (–20.4% to 0.8%)] in those with baseline low (<1.5 servings/week), but not with higher fish intake [6.4% (95% CI, –7.11% to 21.8%); P interaction = 0.06].

CONCLUSIONS:

In this large sample from a population-based randomized controlled trial, neither vitamin D nor n-3 FA supplementation over 1 year decreased these biomarkers of inflammation.

ClinicalTrials.gov Identifier:

NCT01169259; NCT01351805