Skin sensitivity and intolerance in Shanghai: cumulative influence of different meteorological parameters

Background: Although Sensitive skin (SS) conditions are reported to be affected by climate changes, the correlations with meteorological parameters remain mostly unclear.

Objective: To investigate the changes of facial skin conditions in different seasons in Shanghai, including the speed and severity of the influences imposed by different meteorological parameters.

Methods: Totally eighty-one healthy female volunteers completed the study in both spring (May) and summer (August). Evaluations of facial skin conditions included stimulating sensory test, clinical grading and biophysical measurements. Correlations between the meteorological parameters and ΔTEWL as well as clinical parameters were analyzed.

Results: There was no significant difference between two seasons in lactic acid sting test. The stimulation sensations felt by Vitamin B3 (VB3) containing cream was significantly higher in May than that in August. In accordance, baseline visual scores for erythema and scaliness in May were also significantly higher than those scores in August. The baseline transepidermal water loss (TEWL) value was significantly higher in May than that in August. Positive correlations were detected between ΔTEWL and atmospheric pressure on the test day, adjust 3-day and 7-day mean of daily solar radiation respectively. There were negative correlations between ΔTEWL and temperature outside on the test day, adjust 3-day mean as well as adjust 7-day mean of relative humidity.

Conclusions: Facial skin conditions in summer are better than that in spring in Shanghai. The influences from atmospheric pressure and temperature are relatively quick in speed, while the influences from relative humidity and solar radiation are slow but cumulative.     

Short term study of human skin irritation by single application closed patch test: assessment of four multiple emulsion formulations loaded with botanical extracts

Background: Assessment of skin irritation potential is a major concern in safety assessment of cosmetics, when long-term use of these products are expected. Non-invasive bioengineering probes have been used previously to measure skin irritation potential of cosmetic ingredients.

Objectives: Experimentation carried out to weigh up the skin irritation potential of four multiple emulsion formulations via visual and non-invasive measurements. Immediate effects of formulations and comparison of two assessment techniques were also tried to establish.

Methods: Four multiple emulsion formulations one control (without botanical active) and three containing the functional botanical actives plus additives were tested in this study using the following techniques: transepidermal water loss (TEWL), COLIPA visual scoring method (CVSM), Mexameter MPA 5 (Courage + Khazaka, Germany) and capacitance [Corneometer MPA 5 (Courage + Khazaka, Germany)]. Visual examination and non-invasive measurements were performed at baseline and after 24?h. The formulations were applied on the forearm of 12 healthy volunteers of same sexes aged 20–25 years.

Results: We found that none of the formulation produced irritation both on visual and instrumental evaluation. However, formulations MeB and MeC have comparable immediate effects on dryness, erythema, melanin and TEWL. Formulation MeC produced more effective results on different parameters, may be due to synergistic effect of two extracts, while MeA failed to produce any immediate effects on skin parameters. Moreover results of both assessment methods are parallel to each other.

Conclusions: None of the formulation produce irritant effects, barrier impairment effects or immediate effects except for the formulation MeC which produced appreciable results than other formulations but statistically these results were insignificant (p?>?0.05). Based on these results, it could be concluded that formulations may be implied safely as skin rejuvenating candidates.     

Efficacy and safety of 2% supramolecular salicylic acid compared with 5% benzoyl peroxide/0.1% adapalene in the acne treatment: a randomized,split-face,open-label,single-center study

Background: Topical drugs for mild to moderate acne include adapalene (ADA) and benzoyl peroxide(BPO). Supramolecular salicylic acid (SSA), a modified SA preparation, is considered as a new effective therapeutic scheme.

Objectives: To compare the safety and efficacy of 2% supramolecular SA (2% SSA) with 0.01% adapalene plus 5% benzoyl peroxide (5%BPO +0.1%ADA) for treatment of facial acne.

Materials and methods: This was an open-label, split face, randomized and single-centre clinical trial. Subjects with mild to moderate acne were enrolled. Two percent SSA cream were randomly applied on one side of the face while 5%BPO +0.1%ADA gel was applied on the opposite side for 28?days. The numbers of acne lesions, along with side effects of the targeted area were evaluated by the investigators at day 0, day 14, and day 28. Skin water content, TEWL and skin lightening indexes were measured at the same time.

Results: A total of 31 of acne patients completed the trial. Dates showed that 2% SSA had similar effects to 5%BPO +0.1%ADA in reducing papules/pustules (47.9% vs. 49.8%), non-inflammatory lesions (43.1% vs. 42.7%) and total lesions (44.1% vs. 45.6%; all p?>?0.05) at day 28. The skin barrier (skin hydration value and TEWL value), skin brightness (L* value) and erythema (a* values) indicators showed no statistical differences in the left and right sides of the face (p?>?0.05).

Conclusion: This study demonstrated that 2% SSA has a similar efficacy with 5%BPO +0.1%ADA in mild to moderate acne treatment. This might be a useful pilot study that could be used to support further larger clinical trials.     

CPT,the main test method of skin neuronal sensitivity

Background: Many scholars concentrate on skin barrier disruption of sensitive skin, but few focus on its increased neuronal sensitivity.

Objective: To study the possibility of using current perception threshold (CPT) measurement for the quantitative evaluation of skin neuronal sensitivity combined with stinging test.

Methods: The amount of 50?μL 10% lactic acid was applied on each side of the nasolabial fold at random. Subjects assessed stinging based on a 4-point scale at 30?s, 2.5?min and 5.0?min. CPT and transepidermal water loss (TEWL) were measured before and after stinging test. Subjects were divided into different groups based on their response to lactic acid.

Results: There was a positive correlation between CPT_before and the sum of clinical scores (CSs). While the beginning time of stinging (BT) was shortened, the CPT_before decreased and TEWL increased.

Conclusion: Different degrees of skin susceptibility can be reflected by BT. CPT can be useful for the quantitative evaluation of skin neuronal sensitivity.     

In vivo antibacterial activity of Garcinia mangostana pericarp extract against methicillin-resistant Staphylococcus aureus in a mouse superficial skin infection model

Context: Garcinia mangostana Linn. (Guttiferae) (GM) pericarp has been shown to exhibit good in vitro antibacterial activity against methicillin-resistant Staphylococcus aureus (MRSA); however, there is currently no available information regarding its in vivo antibacterial activity.

Objective: To examine in vivo antibacterial activity of G. mangostana extract against MRSA.

Materials and methods: GM pericarp was extracted by ethanol (GM-EtOH) and methanol (GM-MeOH). The crude extracts were examined for in vitro antibacterial activity against MRSA using broth microdilution assay. The in vivo antibacterial activity of 10% GM-EtOH against MRSA was determined in a tape stripping mouse model of superficial skin infection for 9 days by evaluating transepidermal water loss (TEWL) and performing colony counts from cultured swabs.

Results: GM-EtOH showed greater in vitro activity against MRSA than GM-MeOH in broth microdilution assay with minimum inhibitory concentration 17 versus 20?μg/mL and minimum bactericidal concentration 30 versus 35?μg/mL, respectively. The GM-EtOH (13.20?±?0.49%) contained α-mangostin more than the GM-MeOH (9.83?±?0.30%). In the tape stripping mouse model, 10% GM-EtOH reduced the number of MRSA colonies (0–1) recovered from infected wounds (>100 colonies) on the first day of treatment, restored TEWL to normal levels on the fourth day, and had completely healed the wounds by day 9.

Conclusion: GM-EtOH showed promising in vivo antibacterial activity against MRSA in a superficial skin infection model in mice. It is of interest to develop a topical formulation of GM-EtOH to further study its potential as a novel antibacterial agent.     

Optimization of Impedance Spectroscopy Techniques for Measuring Cutaneous Micropore Formation after Microneedle Treatment in an Elderly Population

Purpose

The objective of this study was to optimize a reproducible impedance spectroscopy method in elderly subjects as a means to evaluate the effects of microneedles on aging skin.

Methods

Human volunteers were treated with microneedles at six sites on the upper arm. Repeated impedance measurements were taken pre- and post-microneedle insertion. Two electrode types were evaluated (dry vs. gel), using either light or direct pressure to maintain contact between the electrode and skin surface. Transepidermal water loss (TEWL) was measured as a complementary technique.

Results

Five control subjects and nine elderly subjects completed the study. Microneedle insertion produced a significant decrease in impedance from baseline in all subjects (p?p? Conclusions Impedance spectroscopy reproducibly measures micropore formation in elderly subjects, which will be essential for future studies describing microneedle-assisted transdermal delivery in aging populations.     

Can levothyroxine treatment reduce urinary albumin excretion rate in patients with early type 2 diabetic nephropathy and subclinical hypothyroidism? A randomized double-blind and placebo-controlled study

Objective:

To investigate the effect of levothyroxine (LT₄) therapy on urinary albumin excretion rate (UAER) in early type 2 diabetic nephropathy (DN) and subclinical hypothyroidism (SCH) patients with mildly increased thyroid stimulating hormone (TSH) levels and serum thyroid peroxidase antibody (TPO-Ab) positivity.

Methods:

Application of randomized double-blind and placebo-controlled methods. A total of 136 normotensive patients with early type 2 DN and SCH (TSH 4.0–7.0 mIU/L and TPO-Ab positive) were selected, and were randomly divided into two groups for LT₄ or placebo treatments, respectively. Changes in UAER, serum creatinine, glomerular filtration rate (GFR), blood pressure, serum uric acid and lipids in patients before and after 48 weeks of treatment were examined and compared between groups.

Results:

There were no statistically significant differences in the baseline characteristics of study participants between two treatment groups (p?>?0.05 for all). After 48 weeks of treatment, compared to the placebo treatment, the LT₄ treatment was more effective in reducing total cholesterol (p?4 treatment was better in reducing UAER, low-density lipoprotein cholesterol and uric acid than the placebo group (p?Conclusion:

The LT₄ treatment may decrease UAER and exert kidney protection effects in early type 2 DN and SCH patients with mildly increased TSH levels and serum TPO-Ab positivity. However, due to the short duration of follow-up and small number of cases, the results of this study need future trials with larger numbers of patients and longer follow-up periods to verify whether such a strategy can provide durable benefits.     

Has dry/cold weather an impact on the skin condition of cleanroom workers?

ABSTRACT

In previous epidemiological studies irritant skin changes were reported significantly more frequently under dry/cold ambient air conditions. The aim of this study was to assess whether a similar effect might be observed in cleanroom workers, occupationally exposed to strictly controlled ambient conditions. This investigation examined 690 employees of a semiconductor production company in Germany, one half in winter (n = 358) and the other half in spring (n = 332). In both waves, both cleanroom workers, who used occlusive gloves predominantly during the entire shift, and employees in the administration, serving as the control group, were included. Ambient outdoor temperature and relative humidity (RH) were measured and absolute humidity (AH) was calculated. Hands were dermatologically examined with quantitative clinical skin score HEROS, supplemented by transepidermal water loss (TEWL) and stratum corneum hydration measurements. Temperature ranged from –5.41 to 6.51°C in winter (RH 71.04–92.38%; AH 2.85–6.7 g/m³) and from 6.35 to 10.26°C in spring (RH 76.17–82.79%; AH 5.66–7.92 g/m³). Regarding HEROS, TEWL, and corneometry, no marked consistent pattern regarding an enhanced or decreased risk of irritant skin changes was found. Work in a strictly controlled environment with prolonged wearing of occlusive gloves, with clean hands and without exposure to additional hazardous substances, did not seem to negatively affect the skin. In this particular setting, meteorological conditions also did not appear to adversely affect the skin. It is conceivable that wearing of gloves and air conditioning in the plant protect skin of the hands from adverse effects due to dry and cold air encountered when not working.     

Assessing the dermal compatibility of a new female incontinence product line

Context: We have developed a line of products designed to better meet the overall needs of women suffering from urinary incontinence. The products are more discrete and contain a unique odor neutralizing technology (ONT).

Objective: This paper describes the overall skin compatibility program for this product line in which the new products were compared to negative controls and/or commercially marketed reference products with an established history of safe use.

Materials and methods: Test products consisted of several product forms (light pads/pantiliners, moderate pads, briefs and taped diapers) with ONT and having various degrees of protection. Studies were conducted using standard protocols for 4-day and 21-day cumulative irritation, the Human Repeat Insult Patch Test (HRIPT), and the Behind-the-Knee (BTK) test for mechanical and chemical irritation. In one 4-day irritation study and one HRIPT, test subjects consisted of individuals with self-assessed sensitive skin. In addition, one 4-day study was conducted using normal skin sites, and sites compromised by tape stripping. Nonirritant controls were physiologic saline and/or current, commercially marketed incontinence products. All responses were evaluated by visual scoring of erythema. In addition, in the BTK, transepidermal water loss (TEWL) and adverse sensory effects collected from panelists’ daily diaries were also evaluated.

Results and discussion: Two 4-day cumulative irritation studies and one 21-day study demonstrated that a wide range of product forms (liners, light and moderate pads, briefs and adult diapers) produced skin reactions similar to the nonirritant controls. The 4-day study conducted using sensitive skin subjects showed good skin compatibility, and the test products were comparable to the nonirritant controls. In the 4-day study with both normal and compromised skin sites, test products produced mean erythema scores similar to the nonirritant controls. Three HRIPT separate studies confirm that the products do not induce contact sensitization, including one study conducted on individuals with self-assessed sensitive skin. In the BTK, test and control products produced similar irritation, as assessed by erythema, TEWL and sensory effects.

Conclusion: The results from the patch tests and mechanical irritation test demonstrate good skin compatibility of the new line of products with the unique ONT. In addition, the forms of the product (i.e. liner, pad or brief), were equally compatible with skin.     

Characterization of dry skin associating with type 2 diabetes mellitus using a KK-Ay/TaJcl mouse model

Purpose: Type 2 diabetes mellitus (DM) induces various dermatological conditions that can affect patient quality of life, including increased susceptibility to skin infections and dry skin. While the mechanisms that underlie the causes of dry skin in type 1?DM have been widely studied, how type 2?DM elicits similar effects is unclear. The purpose of this study was therefore to evaluate skin barrier and hydration function using a KK-A^y/TaJcl mouse model of type 2?DM.

Materials and methods: KK-A^y/TaJcl and control mice were housed separately for 4 weeks and then body weight, water intake, urine production, and blood glucose levels were measured. Skin barrier function was estimated by assessing transepidermal water loss (TEWL) and hydration levels of the stratum corneum. The expression levels of various skin biochemical factors were also examined by western blot, including type 1 collagen, mast cell tryptase, hyaluronic acid binding protein (HABP), and fibroblast protein S100A4.

Results: Compared to control mice, there was a marked increase in body weight, water intake, urine production, and blood glucose levels in the KK-A^y/TaJcl mice over the length of the experiment. Hydration levels in the stratum corneum were lower in KK-A^y/TaJcl mice compared to control mice, although TEWL was not significantly different between groups. We also found that hyaluronic acid binding protein expression was higher in KK-A^y/TaJcl mice, although other biochemical factors were the same.

Conclusions: These findings suggest that hyaluronic acid associates with the dry skin caused by type 2?DM. This contributes to understanding this phenomenon and may lead to better treatment options for patients in the future.     

Role of mast cells in the induction of dry skin in a mouse model of rheumatoid arthritis

Purpose: Rheumatoid arthritis (RA) is known to induce dry skin as an extra-articular symptom. However, the mechanisms behind the induction are unclear. In this study, we utilized an arthritis mouse model to simulate RA to reveal the relationship between arthritis and dry skin.

Materials and methods: DBA/1JJmsSlc control mice (n?=?5) and DBA/1JJmsSlc collagen-induced arthritis mouse model (arthritis mice; n?=?5) were used. We measured transepidermal water loss (TEWL) and capacitance to reveal the effect of arthritis on skin barrier function. In addition, we measured the expression of biomarkers of skin barrier function.

Results: We found that the hind limb volume of the arthritis mice was higher than that of the control mice. Our results showed that the arthritis mice had higher TEWL and lower capacitance when compared to the control mice. When compared to that of the control mice, the skin of the arthritis mice was thicker with more leukocyte infiltration. In the skin of arthritis mice, we observed lower expression of type I and IV collagens, but higher expression of matrix metalloproteinases (MMP)-1 and -9 when compared to that of the control mice. The levels of mast cells, histamine, substance P, and tryptase were higher in the arthritis mice than in the control mice. This study showed that the arthritis mice exhibited a disruption of skin barrier function (i.e. dry skin), which was improved following treatment with a mast cell inhibitor.

Conclusions: Our results on mast cells suggested that an improvement of dry skin is important for RA management.     

Solid lipid nanoparticles-loaded topical gel containing combination drugs: an approach to offset psoriasis

Aim: The primary aim of present work was to develop effective combination drug therapy for topical treatment of psoriasis.

Methods: Betamethasone dipropionate and calcipotriol loaded solid lipid nanoparticles (CT-BD-SLNs) were prepared by hot melt high shear homogenization technique, which were then incorporated in Carbopol gel matrix. The anti-psoriatic potential was tested by sequential in vitro (skin permeation and dermal distribution, anti-proliferative effect in HaCaT cells) and in vivo (Draize patch irritation, transepidermal water loss (TEWL) and anti-psoriatic mouse tail studies) experiments.

Results: A negligible amount in receptor compartment, yet confined distribution of drugs to epidermal and dermal region of skin was observed in case of SLNs, which is essential for safe and effective anti-psoriatic therapy. Draize patch test and TEWL demonstrated negligible skin irritation and better skin tolerability of SLNs. The in vitro HaCaT cell line study demonstrated that SLNs delayed the abrupt growth of keratinocytes, while in vivo mouse tail model showed that SLNs gel significantly decreased the epidermal thickness and increased melanocyte count in comparison to commercial Daivobet® ointment.

Conclusions: The developed SLNs gel is expected to be potential strategies for treatment of psoriasis and other topical diseases.     

Evolution of the percutaneous penetration and distribution of uranyl nitrate as a function of skin-barrier integrity: an in vitro assessment

As recommended by OECD Guidelines, percutaneous penetration studies consider intact skin, but rarely injured skin. Recent years have witnessed a growing concern for these two types of dermal exposure in the industry, particularly in the nuclear industry. The aim of this study was to show that a method based on an in vitro device can be used to realistically assess how skin-barrier alterations caused by occupational accidents can modify the percutaneous penetration and distribution of radionuclides, particularly uranium. Wounds encountered in the nuclear industry (i.e., nitric acid burns and abrasion) were simulated on hairless rat skin. Skin-barrier alterations were characterized by means of a histological study and by measuring transepidermal water loss (TEWL) and skin thickness. The percutaneous penetration of uranyl nitrate through intact or injured skin biopsies was then measured in vitro. The maximum uranium flux values obtained for intact skin, skin abrasion with stratum corneum removal, and skin exposed to 2 N HNO₃, 5 N HNO₃, and 14 N HNO₃ were, respectively, 0.6?±?0.02, 1.2?±?0.03, 1.2?±?0.04, 42.0?±?1.0, and 174.0?±?8.7?ng.cm^?2.h^?1. These results demonstrated that the percutaneous absorption of uranium increased with the increased impairment of the stratum corneum. TEWL, combined with maximum uranium flux values measured in vitro, yielded a good prediction of the percutaneous penetration of uranium through injured skin, previously observed in vivo. To conclude, this in vitro assay provides a conservative estimate of the percutaneous diffusion of uranium through intact or injured skin, making it a good alternative method for toxicological studies and risk assessments.     

Evaluation of the efficacy of polydeoxyribonucleotides in the healing process of autologous skin graft donor sites: a pilot study

Objective: The article presents the results of a pilot study performed to evaluate the efficacy of polydeoxyribonucleotides (PDRNs) in shortening the healing times of autologous skin graft donor sites. Research design, methods: Two groups of patients were studied, the PDRN group (n?=?20) and a control group (n?=?20). In the control group dressings were performed with non-adherent gauzes and bulky gauzes with cloramine solution, whereas in the PDRN group a PDRN ointment was spread under the same medication as the controls.

Results: In the PDRN group, dressing procedures were not painful (whereas in the controls they often were), re-epithelialisation occurred earlier (12.5 vs 24.45 days) and there were no infections (9 in the controls).

Conclusions: Results are encouraging for the use of PDRNs in shortening the healing times of autologous skin graft donor sites, although further studies are necessary to obtain clinically relevant results.     

Influence of temperature and soil moisture on the toxic potential of clothianidin to collembolan Folsomia candida in a tropical field soil

Climate change can alter the toxic effects of pesticides on soil invertebrates. However, the nature and magnitude of the influence of climatic factors on clothianidin impacts in tropical soils are still unknown. The influence of increasing atmospheric temperature and the reduction in soil moisture on the toxicity and risk of clothianidin (seed dressing formulation Inside FS^®) were assessed through chronic toxicity tests with collembolans Folsomia candida in a tropical field soil (Entisol). The risk of clothianidin for collembolans was estimated using the Toxicity-Exposure Ratio (TER) approach. Organisms were exposed to increasing clothianidin concentrations at 20, 25 and 27?°C in combination with two soil moisture conditions (30 and 60% of the maximum water holding capacity—WHC). The effect of temperature and soil moisture content on clothianidin toxicity was verified through the number of F. candida juveniles generated after 28 days of exposure to the spiked soil. The toxicities estimated at 25?°C (EC₅₀__30%WHC?=?0.014?mg?kg^?1; EC_{50_60%WHC}?=?0.010?mg?kg^?1) and 27?°C (EC_{50_30%WHC}?=?0.006?mg?kg^?1; EC_{50_60%WHC}?=?0.007?mg?kg^?1) were 2.9–3.0-fold (25?°C) and 4.3–6.7-fold (27?°C) higher than those found at 20?°C (EC_{50_30%WHC}?=?0.040?mg?kg^?1; EC_{50_60%WHC}?=?0.030?mg?kg^?1), indicating that clothianidin toxicity increases with temperature. No clear influence of soil moisture content on clothianidin toxicity could be observed once the EC₅₀ values estimated at 30% and 60% WHC, within the same temperature, did not significantly differ. A significant risk was detected in all temperatures and soil moisture scenarios studied, and the TER values indicate that the risk can increase with increasing temperatures. Our results revealed that temperature could overlap with soil moisture in regulating clothianidin toxicity and reinforce the importance of including climatic factors in the prospective risk assessment of pesticides.

     

Comparison of TLR-2, TLR-4, and antimicrobial peptide levels in different lesions of acne vulgaris

Context: Recent studies have shown that tolls like receptors (TLRs) and antimicrobial peptides (hBD-1, cathelicidin) play an important role in the pathogenesis of acne vulgaris (AV).

Objective: To evaluate and report the expression of TLR-2, TLR-4, hBD-1 and cathelicidin in different regions of skin in AV.

Participants: This study was performed in 80 patients with AV and a control group of 20 healthy individuals.

Material and methods: Skin biopsies were performed from 20 papular, 20 pustular, 20 comedonal and 20 nodular lesions of patients and 20 healthy volunteers. Expression levels of TLR-2, TLR-4, hBD-1 and cathelicidin in four separate areas (epidermis, dermis, inflammation region and skin appendages) were evaluated by immunohistochemical method. Further, these parameters were compared between different skin lesions.

Results: A significant difference was found between the levels of staining of TLR-2, TLR-4 and hBD-1 from the epidermis, inflammation region, dermis and skin appendages (p?<?0.05). Levels of cathelicidin were different in only the inflammation region (p?<?0.05). The level of TLR-2 in the epidermis with nodules was lower than the papules and comedones (p?<?0.05). Levels of TLR-2 in the inflammation and dermis of the cases with papules were significantly higher when compared to pustules (p?<?0.05). The levels of staining of TLR-4 in the dermis with comedones were significantly lower compared to the cases with papules (p?<?005). The level of hBD-1 in the epidermis region of comedones was significantly higher compared to nodules (p?<?0.05). The expression of cathelicidin in the inflammation region of comedones was significantly low (p?<?0.05).

Conclusion: It is thought that TLR-2, TLR-4, hBD-1 and cathelicidin play an important role in the pathogenesis of AV and in the development of different acne types. We think that, better results could be obtained in treatment of AV with different treatment options targeted in regulation of TLR-2, TLR-4, hBD-1 and cathelicidin release.     

Secondary prevention of diabetic patients with coronary artery disease in cardiac rehabilitation: risk factors,treatment and target level attainment*

ABSTRACT

Introduction: Diabetic patients who have suffered from an acute coronary syndrome (ACS) or have had coronary artery bypass graft (CABG) surgery are at very high risk of recurrent cardiovascular events. Their prognosis, however, can be improved if the target values for blood pressure (BP?<?130/80?mmHg) or low density lipoprotein cholesterol [LDL-C?<?2.6?mmol/L (100?mg/dl), optionally?<?1.8?mmol/L (70?mg/dl)] are achieved. It is not known what proportion of diabetic patients receives such stringent secondary prevention measures and achieves target level attainment for BP, lipids and glucose in cardiac rehabilitation (CR).

Methods: During 2003 to 2005, 11?973 diabetic (29.7%) and 28?370 non-diabetic patients (70.3%), predominantly after ACS (74 and 80%), were included in a nationwide registry. At entry and at discharge, patient characteristics, pharmacotherapy and blood pressure, lipids and blood glucose were recorded. In a mixed model approach, temporal changes between centres and within centres, respectively, were analysed.

Results: At discharge, a lower proportion of diabetic patients achieved normalisation of BP (in 2005: <140/90?mmHg: 78.4 vs. 82.9% in non-diabetic patients, p?<?0.001) or <130/80?mmHg (45.5 vs. 49.8%), respectively. LDL-C?<?2.6?mmol/L was more frequently attained in diabetic patients (68.2 vs. 66.5%), as was LDL-C?<?1.8?mmol/L (28.8 vs. 23.0%). Fasting blood glucose was not changed during the observation period, as at discharge almost a quarter of all diabetic patients exceeded the threshold value of 7.0?mmol/L (126?mg/dl). In 2005 at discharge, statin therapy was administered in 93% in both diabetics and non-diabetics, acetylic salicylic acid in 79% in diabetics vs. 80% in non-diabetic patients (clopidogrel: 41 vs. 45%).

Conclusion: Generally there is room for improvement in the management of cardiac risk factors for both patients groups. In diabetic patients in CR at high risk for recurrent cardiac events, in recent years an improvement of the lipid profile has been observed. Hypertension and glycaemia are still not optimally addressed.     

Influence of prenatal waterpipe tobacco smoke exposure on renal biomarkers in adult offspring rats

Background: Waterpipe tobacco smoke (WTS) is a popular form of tobacco consumption. Prenatal exposure to cigarette smoke altered kidney function and oxidative stress balance in offspring. However, the effect of prenatal WTS exposure on kidney function parameters, blood pressure and oxidative stress in adult offspring rats were unknown.

Methods: Pregnant Wister rats were exposed to either WTS for 2?hours per day utilizing a whole body exposure system or fresh air from day 0 of gestation to day 21. Systolic blood pressure, histological analysis of kidney, kidney function biomarkers [angiotensin converting enzyme (ACE), angiotensin I, angiotensin II, urea nitrogen, creatinine and albumin], and oxidative stress biomarkers (glutathione peroxidase (GPx), catalase and thiobarbituric acid reactive substances (TBARS)) were measured in male- and female- offspring rats on week 20.

Results: Prenatal exposure to WTS significantly decreased kidneys’ weight and glomeruli area (p?<?0.05) in offspring rats. Prenatal WTS exposure increased blood pressure in offspring rats (p?<?0.05). Further, prenatal WTS exposure increased the level of urine albumin (p?<?0.05) in offspring rats. Prenatal WTS exposure increased the level of ACE and angiotensin I (p?<?0.05) in female offspring rats. Prenatal WTS exposure increased the level of TBARS (p?<?0.05) in female offspring rats and there was a trend of decreased activity of GPx in male and female offspring rats, but was not significant (p?>?0.05).

Conclusions: Maternal WTS exposure during pregnancy resulted in detrimental effects on the renal system as indicated by altered kidney parameters and function, increased systolic blood pressure and oxidative stress in adult offspring rats.     

Comparison of PLGA and lecithin/chitosan nanoparticles for dermal targeting of betamethasone valerate

Abstract

Poly(lactide-co-glycolide) (PLGA) and lecithin/chitosan (LC) nanoparticles were prepared to evaluate the difference in the behavior upon administration on skin, for steroidal treatment. For this purpose, betamethasone-17-valerate (BMV)-loaded nanoparticles with a narrow size distribution and high entrapment efficiency were prepared. Permeation studies showed that both polymeric nanoparticles enhanced the amount of BMV in epidermis, which is the target site of topical steroidal treatment, when compared with commercial formulation. 1.58-Fold increase was determined in the epidermis concentration of BMV by LC nanoparticles with respect to PLGA nanoparticles. Nanoparticles were diluted in chitosan gel (10%, w/w) to prepare suitable formulation for topical application. Accumulation from both gel formulations were found significantly higher than commercial formulation in skin layers (p?<?0.05). In addition, pharmacodynamic responses were also investigated as anti-inflammatory and skin-blanching parameters. Both formulations significantly improved these parameters although they contained 10 times less amount of BMV than commercial cream. Moreover, TEWL measurement exhibited no barrier function changes upon the application of nanoparticles on skin. Overall, both nanoparticles improved the localization of BMV within skin layers; but when compared with PLGA nanoparticles, the LC nanoparticles could be classified as a better candidate for topical delivery vehicle in the treatment of various dermatological inflammatory diseases.     

Clinical Evaluation of the Trophic Effect of Polydeoxyribonucleotide (PDRN) in Patients Undergoing Skin Explants. A Pilot Study

SUMMARY

Objective: The purpose of this double-blind, randomised, placebo-controlled study was to assess the effects of intramuscular and subcutaneous PDRN in favouring the wound-healing process in donor sites of grafts.

Methods: 26 adult patients of both sexes (15 males and 11 females; mean age: 68.2?±?16.1 years) subjected to skin explants due to plastic surgery were eligible to participate in this double-blind, placebo-controlled study. Patients were randomly allocated into the PDRN group (14 subjects) or the placebo group (12 subjects). PDRN (5625?mg/vial) or placebo were administered by the intramuscular route once daily, associated with a subcutaneous administration of the same dosage form (2 vials every 3 days) for 10 consecutive days.

The primary end point for efficacy was the evolution of wound healing in donor sites, which was evaluated measuring wound surface area and then calculating percentage re-epithelialisation. Secondary end points were local subjective symptoms, such as pain and itching, and objective signs such as perilesional erythema and blisters. Signs and symptoms were quantified through an analogue scale.

Results: At day 7 of the treatment period, the difference in percentage of re-epithelialisation was statistically significant (p?<?0.008) in; favour of the PDRN group. At the end of the observational period, between-group comparison demonstrated that patients treated: with PDRN had a more prompt trophic effect.

No adverse events were reported during the trial.

Conclusions: The findings of our study demonstrated that PDRN is able to modify positively the repair processes in donor sites of autologous skin grafts. This could improve the clinical outcome and decrease the need for additional therapies or hospital stay.