Attack on Sunscreens Continues.

The Food and Drug Administration (FDA) was required to issue and put into effect a final sunscreen monograph by November 26, 2019. On March 27, 2020, President Donald Trump signed into effect H.R. 748, the "Coronavirus Aid, Relief, and Economic Security Act" (CARES). This bill eliminated the November 2019 requirement. The CARES Act includes legislative reforms that modernize the way over-the-counter (OTC) monograph drugs are regulated in the United States. Under this Act, sunscreens will be considered generally recognized as safe and effective (GRASE), if they meet conditions newly defined by the FDA. In addition, the FDA is required to issue a proposal to revise the sun-screen requirements for GRASE not later than 18 months after enactment and will sunset by the end of the fiscal year 2022. The CARES Act also addresses the requirement for a new drug application (NDA).1-7.

Multicenter methodology comparison of the FDA and ISO standard for measurement of in vitro UVA protection of sunscreen products.

In vitro standard methods are available and accepted worldwide to assess UVA protection of sunscreen products. Though, harmonisation of methods has made progress in the last decade, still two differing methods - one by FDA the other by ISO - are in use. In a multicentre study including 9 centres in Germany, 4 different commercial sunscreen products were assessed using both methods to discover their similarities and differences. UVA protection factor and Critical Wavelength were detected at various substrate type (sandblasted versus moulded PMMA plates), at different surface roughness of the plates as well as at different product application dose using two different irradiation spectra. Results: The strongest influence on UVA protection factor results from the surface roughness of the plates. Depending on the roughness (accepted range of 2 to 7 µm in the FDA method) a variability in the UVA protection factor of up to 25% was observed, while the much narrower definition of plate roughness by ISO (4.5 to 5.2 µm) had no relevant influence on the test results. Sandblasted plates in our assessment led to higher UVA protection factors and produced less scattered results compared to moulded plates. These differences were not pronounced. Application dose and spectra of the irradiation source were of negligible influence on UVA protection factor results for the investigated UV-filter combinations. The UVA protection factor which is the endpoint of the ISO method was found to be a parameter with a high potential to differentiate among different test products. The endpoint of the FDA method - the Critical Wavelength - was found to be an unambitious endpoint. Insensitivity to all described modifications of the method was observed. All investigated products performed similar and passed the Critical Wavelength criteria independent of method and parameters.

Current guidelines for the management of non-alcoholic fatty liver disease: A systematic review with comparative analysis.

The current epidemic of non-alcoholic fatty liver disease (NAFLD) is reshaping the field of hepatology all around the world. The widespread diffusion of metabolic risk factors such as obesity, type2-diabetes mellitus, and dyslipidemia has led to a worldwide diffusion of NAFLD. In parallel to the increased availability of effective anti-viral agents, NAFLD is rapidly becoming the most common cause of chronic liver disease in Western Countries, and a similar trend is expected in Eastern Countries in the next years. This epidemic and its consequences have prompted experts from all over the word in identifying effective strategies for the diagnosis, management, and treatment of NAFLD. Different scientific societies from Europe, America, and Asia-Pacific regions have proposed guidelines based on the most recent evidence about NAFLD. These guidelines are consistent with the key elements in the management of NAFLD, but still, show significant difference about some critical points. We reviewed the current literature in English language to identify the most recent scientific guidelines about NAFLD with the aim to find and critically analyse the main differences. We distinguished guidelines from 5 different scientific societies whose reputation is worldwide recognised and who are representative of the clinical practice in different geographical regions. Differences were noted in: the definition of NAFLD, the opportunity of NAFLD screening in high-risk patients, the non-invasive test proposed for the diagnosis of NAFLD and the identification of NAFLD patients with advanced fibrosis, in the follow-up protocols and, finally, in the treatment strategy (especially in the proposed pharmacological management). These difference have been discussed in the light of the possible evolution of the scenario of NAFLD in the next years.

Renoprotective Effect of Angiotensin-Converting Enzyme Inhibitors and Angiotensin II Receptor Blockers in Diabetic Patients with Proteinuria.

BACKGROUND/AIMS: Limited evidence exists on the choice of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) in diabetic patients with nephropathy. We aim to assess the renal effectiveness and safety of these drugs among diabetic nephropathy patients. METHODS: This retrospective cohort study was conducted with diabetic nephropathy patients who initiated ACEI or ARB monotherapy. The primary outcome was a composite of end stage of renal disease and renal transplantation, and the secondary outcome was all-cause mortality. The safety endpoint was hyperkalemia. RESULTS: Three thousand seven hundred and thirty-nine ACEI users and 3,316 ARB users were identified. ARBs seemed to be inferior to ACEIs given their poorer renal outcome (HR 1.31; 95% CI, 1.15-1.50) and higher risk of hyperkalemia (HR 1.17; 95% CI, 1.04-1.32). Among the four ACEIs compared, captopril was an inferior treatment choice given its poorer renal outcomes (HR 1.42; 95% CI, 1.05-1.93) and higher mortality rate (HR 1.25; 95% CI, 1.01-1.55). Irbesartan appeared to be a poorer treatment choice among the three ARBs compared, given its inferior renal protective effect (HR 1.35; 95% CI, 1.03-1.78). CONCLUSIONS: Our findings suggest ACEIs as a relatively more renoprotective and safer treatment as compared to ARBs. Captopril and irbesartan may be inferior to the other ACEIs and ARBs respectively.

Sun exposure behavior and protection: recommendations for travelers.

BACKGROUND: Although there have been recent advances in the development of photoprotective clothing and broad-spectrum sunscreens, few peer-reviewed publications have focused on photoprotection recommendations for travelers. METHODS: In order to describe the adverse health effects of excessive ultraviolet (UV) radiation exposures; review recent studies of public perceptions regarding photoprotection and sun exposure behaviors; identify special populations at increased risks of drug-induced photosensitivity reactions and UV-induced skin cancers; and recommend several effective photoprotection strategies for travelers, Internet search engines were queried with the key words as search terms to examine the latest references on photoprotection and the epidemiology of UV-associated skin cancers. RESULTS: Observational studies have demonstrated that the public knows little about proper sunscreen protection, selection, and use, and often abuses sunscreens for intentional UV overexposures. Cohort studies have identified special populations at increased risks of UV-associated skin cancers without the proper use of sunscreens and photoprotective clothing including children, fair-skinned persons, patients taking photosensitizing drugs, and organ transplant recipients (OTRs). Clinical investigations support the regular use of broad-spectrum sunscreens to prevent the development of premalignant actinic keratoses (AK) in all sun-exposed subjects, especially OTRs; to prevent the development of squamous cell carcinomas from new AK in sun-exposed subjects, especially OTRs; to possibly prevent the development of cutaneous malignant melanomas in children and adults; and to possibly prevent the development of basal cell carcinomas in OTRs. CONCLUSIONS: Recommended photoprotection strategies for travelers should include avoiding intense sunlight, wearing photoprotective clothing, wearing sunglasses, and selecting the right sunscreen for their skin type. Travel medicine practitioners should counsel travelers about photoprotection and encourage travelers to take advantage of recent advances in the development of more effective broad-spectrum sunscreens and photoprotective clothing for themselves and their children.

Cardioprotective effect of HPLC standardized ethanolic extract of Terminalia pallida fruits against isoproterenol-induced myocardial infarction in albino rats.

ETHNOPHARMACOLOGICAL RELEVANCE: Terminalia pallida is an evergreen endemic tree, mentioned in Ayurveda as the fruits of Terminalia pallida are excellent in cardioprotective property. Tribal people use Terminalia pallida fruit for the treatment of diabetes and this plant widely used in many other disorders. AIM OF STUDY: The present investigation was to evaluate the antioxidant, biochemical profile and histological studies of qualitatively standardized ethanolic extract of Terminalia pallida fruits (TpFE) against isoproterenol-induced myocardial infarction in rats. MATERIALS AND METHODS: TpFE was standardized by high performance liquid chromatography (HPLC) and mass spectroscopy (MS). Rats were pretreated orally with different doses of TpFE (100, 300, and 500mgkg(-1) body weight) and cardioprotective positive control gallic acid (GA) for 30 days prior to isoproterenol (ISO) induced myocardial infarction. The rats were sacrificed, hearts were collected and homogenized for biochemical analysis. The effects on total cholesterol (TC), triglycerides (TG), low density lipoprotein cholesterol (LDL-C) and very low density lipoprotein cholesterol (VLDL-C), high density lipoprotein cholesterol (HDL-C), lipid peroxidation (LPO) marker, malondialdehyde (MDA), creatine kinase (CK), lactate dehydrogenase (LDH), alanine transaminase (ALT), aspartate transaminase (AST), catalase (CAT), glutathione peroxidase (GPx), sodium potassium (Na(+)/K(+)), calcium (Ca(2+)) and magnesium (Mg(2+)) adenosine triphosphatases (ATPases) were estimated in heart tissue homogenate. RESULTS: Rats administered with ISO showed a significant increase in TC, TG, LDL-C, VLDL-C, and MDA and a significant decrease in HDL-C, cardiac marker enzymes - CK, LDH, ALT and AST. ISO significantly reduced antioxidants - CAT, GPx, and membrane bound enzymes - Na(+)/K(+), Ca(2+) and Mg(2+) ATPases. Pretreatment with TpFE (100, 300, and 500mgkg(-1) bw) and GA (15mgkg(-1) bw) for a period of 30 days significantly inhibited the effects of ISO. Moreover, biochemical findings were supported by histopathological observations. CONCLUSION: The present study provide evidence for the first time, that TpFE pretreatment ameliorated myocardial injury in ISO-induced myocardial infarcted rats and exhibited cardioprotective activity.

[Towards the estimation of survival curves parameters and geroprotectors classification].

The following parameters are proposed to estimate in survival curves analysis: Median Life Span, Hill slope, Expected Maximal Life Span. Those estimates enable to classify geroprotectors as weak, moderate and strong.

[Effectiveness of new preventive means for maintaining the functional state of organism in air operators].

The study was designed to assess the psycho-physiological and immune status in 60 male aviation specialists aged 24-45 years given biologically active food additives "Intra" and "Adaptol" It was shown that regular consumption of these additives promoted mobilization of functional reserves of the organism, improved time-related activity of nervous processes, increased lability of the central part of the visual analyzer, and improved results of subjective assessment of postural equilibrium control. Results of the study indicate that food additives "Intra", "Adaptol" possess immunocorrective potential and may be used to restore functions of various organs and their systems in a human operator under extreme conditions.

Evaluation of coated oxygenators in cardiopulmonary-bypass systems and their impact on neurocognitive function.

INTRODUCTION: Coronary artery bypass graft surgery (CABG) using cardiopulmonary bypass (CPB) is assumed to be associated with a decline of neurocognitive functions. This study was designed to analyse the neurocognitive function of patients with coronary heart disease before and after CABG and to determine possible protective effects of oxygenator surface coating on neurological outcome. METHODS: Forty patients scheduled for selective CABG were prospectively randomized into two groups of 20 patients each according to the type of hollow-fibre membrane oxygenator used. Non-coated oxygenators (Group A) were compared to phosphorylcholine (PC)coated oxygenators (Group B). A battery of six neurological tests was administered preoperatively, 7-10 days and 4-6 months after surgery. RESULTS: One patient of Group A suffered from a perioperative stroke and died on postoperative day 3, presumably because of sudden heart failure. Two patients of Group A (10%) developed a symptomatic transitory delirious psychotic syndrome (STPT) on postoperative days 3 and 5. None of the patients of Group B had perioperative complications. The test analysis revealed a trend of declined neurocognitive function early after CABG, but did not show any difference in neurocognitive outcome between the two groups. DISCUSSION: PC coating of the oxygenators did not show any significant benefit on neurocognitive function after CABG using CPB.