-
1.
A novel in vivo test method for evaluating the infrared radiation protection provided by sunscreen products.
Kim, SJ, Bae, J, Lee, SE, Lee, JB, Park, CH, Lim, DH, Park, MS, Ha, J
Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI). 2019;(6):890-895
Abstract
BACKGROUND Infrared radiation (IR) exposure generates reactive oxygen species and induces matrix metalloproteinase-1 expression in human skin. Moreover, while not as acute as ultraviolet radiation, repeated infrared irradiation can result in the photoaging of skin. Broad-spectrum sunscreens can protect skin from IR, but no human in vivo test methods for the evaluation of sunscreens' IR protection effect have been developed. We aimed to develop such a method. MATERIALS AND METHODS We included 155 Korean subjects in our three-part clinical study. The IR reflectance of subjects' skin was measured using a benchtop model of an IR light source and a reflectance measuring probe. We measured the IR reflectance in relation to skin color and hydration level to set up our experimental conditions. We then calculated the infrared protection factors (IPFs) of cosmetic emulsions as the IR reflectance ratio between cosmetic sunscreen-applied skin and non-sunscreen-applied skin and assessed the relationship between IPFs and the amount of sunscreen ingredients. Finally, this method was validated using several commercial sunscreen cosmetics. RESULTS Skin color and hydration level did not influence the IR reflectance of subjects' skin. The IPFs of cosmetic sunscreens showed a positive correlation with the amount of inorganic sunscreen ingredients. CONCLUSION In this study, we developed a simple, fast, and ethically acceptable human in vivo test method for evaluating the IPFs of cosmetic sunscreens.
-
2.
Attenuation of antidepressant and antisuicidal effects of ketamine by opioid receptor antagonism.
Williams, NR, Heifets, BD, Bentzley, BS, Blasey, C, Sudheimer, KD, Hawkins, J, Lyons, DM, Schatzberg, AF
Molecular psychiatry. 2019;(12):1779-1786
Abstract
We recently reported that naltrexone blocks antidepressant effects of ketamine in humans, indicating that antidepressant effects of ketamine require opioid receptor activation. However, it is unknown if opioid receptors are also involved in ketamine's antisuicidality effects. Here, in a secondary analysis of our recent clinical trial, we test whether naltrexone attenuates antisuicidality effects of ketamine. Participants were pretreated with naltrexone or placebo prior to intravenous ketamine in a double-blinded crossover design. Suicidality was measured with the Hamilton Depression Rating Scale item 3, Montgomery-Åsberg Depression Rating Scale item 10, and Columbia Suicide Severity Rating Scale. In the 12 participants who completed naltrexone and placebo conditions, naltrexone attenuated the antisuicidality effects of ketamine on all three suicidality scales/subscales (linear mixed model, fixed pretreatment effect, p < 0.01). Results indicate that opioid receptor activation plays a significant role in the antisuicidality effects of ketamine.
-
3.
Clinical evaluation of performance, biocompatibility, and safety of vitamin E-bonded polysulfone membrane hemodialyzer compared to non-vitamin E-bonded hemodialyzer.
Kiaii, M, Aritomi, M, Nagase, M, Farah, M, Jung, B
Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs. 2019;(4):307-315
-
-
Free full text
-
Abstract
The vitamin E-bonded polysulfone membrane hemodialyzer (ViE™-21) was evaluated in a clinical study for regulatory submission. Seventeen patients on hemodialysis were treated with conventional high-flux hemodialyzers for 2 weeks (Pre-ViE phase) and switched to the ViE-21 for 36 sessions (ViE phase) followed by an additional 2 weeks on conventional hemodialyzers (Post-ViE phase). Reduction ratios of urea, creatinine, beta-2-microglobulin, albumin, and ultrafiltration coefficients (KUF) were measured once during the Pre-ViE phase and twice during the ViE phase. Moreover, biocompatibility markers [leucocyte count, platelet count, and activated complement factor (C3a) levels] were evaluated pre-dialysis, 15 min after initiation, and post-dialysis. During the study, type and number of adverse events (AEs), and device malfunctions were recorded. ViE-21 reduction ratios and KUF were not noticeably different than those of conventional hemodialyzers. Fluctuations of leucocyte counts and C3a concentrations were similar using ViE-21 and conventional hemodialyzers; however, the platelet count fluctuation was lower in ViE-21 sessions. The frequency of episodes of hypotension occurring during the ViE phase was lower than that occurring during the Pre- and Post-ViE phases. In conclusion, this study provided performance and safety data of the ViE-21 for regulatory application. The data suggest that vitamin E-bonded hemodialyzers are beneficial in lowering platelet activation and frequency of intradialytic hypotension. Larger randomized controlled trials are needed to confirm these findings.
-
4.
Folic Acid Reduces Mucositis in Metastatic Renal Cell Carcinoma Patients: A Retrospective Study.
Fristrup, N, Donskov, F
Clinical genitourinary cancer. 2019;(4):254-259
-
-
Free full text
-
Abstract
BACKGROUND Mucositis is often experienced in metastatic renal cell carcinoma (mRCC) patients treated with targeted therapies. This might impair daily quality of life and lead to dose reduction, discontinuation, or treatment shift. We assessed the effect of folic acid to reduce mucositis. PATIENTS AND METHODS Patients treated with systemic therapy for mRCC who developed Grade ≥2 mucositis according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE) received oral folic acid to reduce mucositis. The medical charts were retrospectively reviewed. RESULTS A total of 77 patients had Grade ≥2 mucositis during therapy with sunitinib (n = 29), pazopanib (n = 24), everolimus (n = 10), axitinib (n = 4), temsirolimus (n = 3), interleukin-2/interferon-α (n = 3), cabozantinib (n = 2), bevacizumab (n = 1), and nivolumab (n = 1). Given in doses of 1 to 5 mg daily, folic acid significantly reduced mucositis, mean CTCAE grade 0.88 (95% confidence interval [CI], 0.74-1.03) versus 2.38 (95% CI, 2.26-2.54; P < .0001). Stratified according to treatment, folic acid significantly reduced mucositis grade for sunitinib (0.97 [95% CI, 0.75-1.18] vs. 2.45 [95% CI, 2.23-2.67], P < .0001), pazopanib (0.96 [95% CI, 0.67-1.25] vs. 2.20 [2.03-2.38], P < .0001), everolimus (0.60 [95% CI, 0.10-1.10] vs. 2.60 [95% CI, 2.23-2.97], P < .0001), and other treatments (0.79 [95% CI, 0.38-1.19] vs. 2.36 [95% CI, 2.07-2.64], P < .0001). Of the 77 patients, 8 (10%) patients received dose reduction. Overall progression-free survival was 14 months and overall survival was 31 months. CONCLUSION Folic acid reduced mucositis in mRCC patients receiving systemic therapy. This finding needs prospective validation. A double-blind, placebo-controlled prospective evaluation of folic acid is ongoing (NCT03581773).
-
5.
Thyroid function during the first year of use of the injectable contraceptive depot medroxyprogesterone acetate.
Quintino-Moro, A, Zantut-Wittmann, DE, Silva Dos Santos, PN, Melhado-Kimura, V, da Silva, CA, Bahamondes, L, Fernandes, A
The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception. 2019;(2):102-108
Abstract
PURPOSE The aim of the study was to evaluate thyroid function profile as a possible factor influencing weight and body composition variation in new users of depot medroxyprogesterone acetate (DMPA). MATERIALS AND METHODS A prospective, non-randomised, comparative study was conducted at the University of Campinas, Brazil. Women aged 18-40 years with a body mass index (BMI) less than 30 kg/m2, normal oral glucose tolerance test, no known diseases, and using no medication, who opted to use DMPA were paired by age (±1 year) and BMI (±1 kg/m2) with women initiating copper intrauterine device (IUD) use. The main outcome measures were thyroid function profile, weight, and body composition, as measured by dual-energy X-ray absorptiometry. We used repeated measures ANOVA to perform comparisons between times and groups. RESULTS We evaluated 28 DMPA users and 24 IUD users who completed the 12-month follow-up. We observed that FT4 levels were higher at 12 months (compared to baseline) in the DMPA group (p < .0001) and that FT4/FT3 ratio had increased in both groups. Additionally, at 12 months, total body mass had increased around 2 kg and lean mass increased in the DMPA group compared to the IUD group; there was also an increase in weight, BMI, total body mass, and fat mass when compared to baseline. CONCLUSIONS No changes in thyroid function occurred that could explain the weight increase observed in DMPA users.
-
6.
Half-life of plasma phytosterols in very low birth weight preterm infants on routine parenteral nutrition with vegetable oil-based lipid emulsions.
Pupillo, D, Correani, A, Biagetti, C, D'Ascenzo, R, Simonato, M, Verlato, G, Cogo, P, Rocchi, MBL, Carnielli, VP
Clinical nutrition (Edinburgh, Scotland). 2018;(1):262-269
Abstract
BACKGROUND Phytosterols in vegetable oil (VO)-based lipid emulsions (LE) likely contribute to parenteral nutrition-associated cholestasis (PNAC) in preterm infants. No characterization of plasma phytosterol half-lives has been done in very low birth weight (VLBW) preterm infants receiving parenteral nutrition (PN) with LE. METHODS In a prospective cohort study, 45 VLBW preterm infants who received PN underwent serial blood sample measurements of sitosterol (SITO), campesterol (CAMP), and stigmasterol (STIGM). Plasma phytosterol half-lives were calculated from the phytosterol concentrations-decay curves by using a single-compartment model. RESULTS After the stop of the intravenous LE, study infants had significantly lower plasma total CAMP, STIGM and SITO concentrations. The decay of plasma phytosterol concentrations was monoexponential. Half-life of plasma total CAMP, STIGM and SITO was 13.5 ± 6.9, 10.3 ± 4.5 and 10.3 ± 4.0 days, respectively. Plasma phytosterol half-lives did not correlate with gestational age, birth weight, cumulative phytosterol intakes and plasma conjugated bilirubin. CONCLUSION VLBW preterm infants on PN with LE had rather long plasma phytosterol half-lives similar to hypercholesterolemic adults and phytosterolemic homozygotes patients. We speculate that the accumulation of phytosterols could contribute to their vulnerability to PNAC. CLINICAL TRIAL REGISTRY The Ethics Committee of Marche-Italy (DG/469); www.clinicaltrials.gov (identification number NCT02758834).
-
7.
Scottsdale Magnesium Study: Absorption, Cellular Uptake, and Clinical Effectiveness of a Timed-Release Magnesium Supplement in a Standard Adult Clinical Population.
Weiss, D, Brunk, DK, Goodman, DA
Journal of the American College of Nutrition. 2018;(4):316-327
Abstract
OBJECTIVE Suboptimal magnesium status is likely widespread in the United States and increasing evidence links it to many chronic diseases. Therapeutically addressing magnesium status can be challenging, as higher supplementation often leads to bowel intolerance. This study evaluated the absorption, cellular uptake, and clinical effectiveness of a timed-release formulation containing dimagnesium malate with vitamins B6, B12, and folate (MagSRT™) in a standard clinical population. METHODS A standard clinical population of 91 adults participated in a placebo-controlled study carried out at two clinics; 53 individuals received MagSRT™, containing 500 mg dimagnesium malate and vitamins B6, B12, and folate, while the remaining individuals received a placebo. Baseline serum magnesium, red blood cell (RBC) magnesium, and magnesium status questionnaire scores were collected prior to trial initiation. Serum magnesium was measured 4 and 8 hours after participants ingested 2 supplemental tablets (250 mg magnesium) or 2 placebo tablets. After 30 days, RBC magnesium was evaluated and participants completed the magnesium status questionnaire. A subset of MagSRT™ participants (24) continued the trial for 90 days. Both RBC magnesium and the magnesium status questionnaire were evaluated at 90 days. RESULTS More than 75% of trial participants presented with suboptimal serum and RBC magnesium status at baseline, while the magnesium status questionnaire predicted 100% of participants to have suboptimal magnesium status. MagSRT™ was well tolerated by 91% of magnesium intervention participants. RBC magnesium increased 6% and 30% over 30 and 90 days, respectively, suggesting magnesium absorption and uptake into red blood cells over time. Overall symptomatology, assessed through a magnesium status questionnaire, improved 28% over 30 days and 63% over 90 days. CONCLUSION A standard adult clinical population presented with both qualitative and quantitative evidence of compromised magnesium status at the beginning of the trial. Supplementation with MagSRT™, a timed-release dimagnesium malate supplement containing vitamins B6, B12, and folate, for at least 30 days significantly improved magnesium status symptoms and increased RBC magnesium with minimal gastrointestinal symptoms.
-
8.
Vertebral spine osteoporosis treatment efficacy in local population: A clinical study.
Asadullah, M, Ikram, R, Qazi, S
Pakistan journal of pharmaceutical sciences. 2018;(6):2347-2353
Abstract
In Pakistani population the prevalence of Calcium and vitamin D deficiency is at alarming rate. Previous studies show that globally vertebral osteoporosis is most commonly recognized site causing deterioration to personal life satisfaction. It is very unfortunate that in Pakistan ample amount of research work has not been done in the area, consequently, information on rate of vertebral osteoporosis & fracture are rare in Pakistan. There is no reduction in T-score on supplementation with calcium and vitamin D3 administration. There is reduction in T-score on supplementation with calcium and vitamin D3 administration. The prime objective of the current work was to determine vertebral spine osteoporosis treatment efficacy in local population. This is an intervention experimental study with no control. The study population was selected from the local community; consisting of individuals with vertebral spine osteoporosis, further they were followed for up to 6 months. Data was analyzed by SPSS-22. Tabs Chewable: Calcium: 1250 mg, Cholecalciferol: 125 IU, BD/Day was advised. The mean T-score before and after treatment were recorded as; Mean ±S.D: 2.890 ±1.7217 and Mean ±S.D: -2.456±0.8064 respectively. The findings of the current work do not provide support for routine supplementation with calcium and vitamin D3 orally for osteoporosis.
-
9.
Safety and Effectiveness of Long-Term Treatment with Lurasidone in Older Adults with Bipolar Depression: Post-Hoc Analysis of a 6-Month, Open-Label Study.
Forester, BP, Sajatovic, M, Tsai, J, Pikalov, A, Cucchiaro, J, Loebel, A
The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry. 2018;(2):150-159
Abstract
OBJECTIVE To evaluate the safety and effectiveness of 6 months of treatment with lurasidone in older adults with a diagnosis of bipolar I depression. DESIGN Post-hoc analysis of a multicenter, 6-month, open-label extension study. SETTING Outpatient. PARTICIPANTS Patients aged 55 to 75 years with a DSM-IV-TR diagnosis of bipolar I depression who had completed 6 weeks of double-blind, placebo-controlled treatment with either lurasidone monotherapy (1 study) or adjunctive therapy with lithium or valproate (2 studies). INTERVENTION Flexible doses of lurasidone, 20 to 120 mg/day, either as monotherapy, or adjunctive with lithium or valproate. MEASUREMENTS Effectiveness was assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS; change from open-label-baseline to month-6, observed case analysis). RESULTS A total of 141 older adults entered the extension study (monotherapy, N = 55; 39%; adjunctive therapy, N = 86; 61%). At the end of 6 months of open-label treatment with lurasidone, as monotherapy or adjunctive therapy, minimal changes were observed in the older adult sample in mean weight (-1.0 kg and -0.4 kg, respectively); and median total cholesterol (-2.0 mg/dL and +6.0 md/dL, respectively), triglycerides (+2.5 mg/dL and +6.0 mg/dL, respectively), and HbA1c (0.0% and -0.1%, respectively). Patients treated with 6 months of lurasidone showed a mean improvement on the MADRS in both the monotherapy (-6.2) and adjunctive therapy (-6.7) groups. CONCLUSIONS Results of these post-hoc analyses found that up to 7.5 months of lurasidone treatment for bipolar depression in older adults was associated with minimal effects on weight and metabolic parameters, with low rates of switching to hypomania or mania, and was well tolerated. The antidepressant effectiveness of lurasidone in this age group was maintained over the 6-month treatment period.
-
10.
Role of bisphenol A as environmental factor in the promotion of non-alcoholic fatty liver disease: in vitro and clinical study.
Dallio, M, Masarone, M, Errico, S, Gravina, AG, Nicolucci, C, Di Sarno, R, Gionti, L, Tuccillo, C, Persico, M, Stiuso, P, et al
Alimentary pharmacology & therapeutics. 2018;(6):826-837
Abstract
BACKGROUND Bisphenol A is an endocrine disrupting chemical associated with type 2 diabetes mellitus (T2DM), cardiovascular disease and liver enzyme abnormalities. AIM: To evaluate bisphenol A plasma and urine levels in non-alcoholic fatty liver disease (NAFLD) patients compared to healthy subjects. Furthermore, we evaluated, in human HepG2 cells, the effects of exposure to different concentrations of bisphenol A on both oxidative stress induction and cell proliferation. METHODS We enrolled 60 patients with histological diagnosis of NAFLD with or without T2DM and sixty healthy subjects. In vitro, the proliferation of bisphenol A-exposed HepG2 cells at two different concentrations (0.025 and 0.05 μM) was evaluated, both at high (H-HepG2) and at low (L-HepG2) glucose concentrations for 48 h. Lipoperoxidation was assessed by thiobarbituric acid reactive substances (TBARS) assay. RESULTS Bisphenol A levels were significantly higher in 60 NAFLD subjects, both in urine and in plasma (P < 0.0001) when compared to controls and, in this group, it appeared to be higher in 30 non-alcoholic steatohepatitis patients compared to 30 simple steatosis subjects (P < 0.05), independently from the presence of T2DM. After a bisphenol A-free diet for 1 month, NAFLD patients showed a significant reduction in bisphenol A circulating levels (P < 0.05), without a significant reduction in urine levels. H-HepG2 cells treated with bisphenol A (0.05 μM) increased proliferation compared to controls at 48 h (P < 0.0001). Bisphenol A increased TBARS levels at 48 h versus controls. CONCLUSIONS Our study reveals a possible role of bisphenol A as an environmental factor involved in the promotion of NAFLD, particularly in T2DM patients.