BACKGROUND: Efforts to replace the rabbit skin irritation test have been underway for many years, encouraged by the EU Cosmetics Directive and REACH. Recently various in vitro tests have been developed, evaluated and validated. OBJECTIVE: A key difficulty in confirming the validity of in vitro methods is that animal data are scarce and of limited utility for prediction of human effects, which adversely impacts their acceptance. This study examines whether in vivo or in vitro data most accurately predicted human effects. METHODS: Using the 4-hr human patch test (HPT) we examined a number of chemicals whose EU classification of skin irritancy is known to be borderline, or where in vitro methods provided conflicting results. RESULTS: Of the 16 chemicals classified as irritants in the rabbit, only five substances were found to be significantly irritating to human skin. Concordance of the rabbit test with the 4-hr HPT was only 56%, whereas concordance of human epidermis models with human data was 76% (EpiDerm) and 70% (EPISKIN). CONCLUSIONS: The results confirm observations that rabbits overpredict skin effects in humans. Therefore, when validating in vitro methods, all available information, including human data, should be taken into account before making conclusions about their predictive capacity.

• MeSH
• alternativy testů na zvířatech normy   MeSH
• biotest normy   MeSH
• dráždivé látky škodlivé účinky   MeSH
• falešně pozitivní reakce MeSH
• kosmetické přípravky škodlivé účinky   MeSH
• králíci MeSH
• kůže účinky léků   MeSH
• lidé MeSH
• náplasťové testy normy   MeSH
• prediktivní hodnota testů MeSH
• testy kožní dráždivosti normy   MeSH
• zvířata MeSH
• Check Tag
• králíci MeSH
• lidé MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• srovnávací studie MeSH
• validační studie MeSH
• Názvy látek
• dráždivé látky MeSH
• kosmetické přípravky MeSH

Several irritants were used in the in vitro irritation medical device round robin. The objective of this study was to verify their irritation potential using the human patch test (HPT), an in vitro assay, and in vivo data. The irritants were lactic acid (LA), heptanoic acid (HA), sodium dodecyl sulfate (SDS), Genapol® X-80 (GP), and Y-4 polymer. Dilute saline and sesame seed oil (SSO) solutions of each were evaluated using a 4 and 18 h HPT and the EpiDerm™ SIT-MD RhE assay; results were then compared to existing rabbit skin irritation test data. Results from the 4 h HPT were negative in most cases except for GP and SDS, while the 18 h HPT also identified some LA, HA, and GP samples as irritants. EpiDerm™ SIT-MD correctly identified all irritants except GP in SSO due to limited solubility. Data from cutaneous rabbit irritation tests were negative, while all intracutaneous results were strongly or weakly positive except for the most dilute GP solutions. These findings indicate that EpiDerm™ SIT-MD results correlate with those from the rabbit intracutaneous test and confirm that RhE assays are suitable replacements for animals in evaluating the tissue irritation potential of medical devices.

• Klíčová slova
• EpiDerm SIT-MD, Human patch test, ISO 10993-10, Medical devices, Skin irritation,
• MeSH
• alternativy testů na zvířatech MeSH
• benchmarking MeSH
• dodecylsíran sodný toxicita   MeSH
• dráždivé látky toxicita   MeSH
• králíci MeSH
• kůže účinky léků   MeSH
• kyselina mléčná toxicita   MeSH
• kyseliny heptylové toxicita   MeSH
• lidé MeSH
• náplasťové testy metody   MeSH
• polyethylenglykoly toxicita   MeSH
• polyvinylchlorid toxicita   MeSH
• reprodukovatelnost výsledků MeSH
• testy kožní dráždivosti metody   MeSH
• zdravotnické prostředky * MeSH
• zvířata MeSH
• Check Tag
• králíci MeSH
• lidé MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• dodecylsíran sodný MeSH
• dráždivé látky MeSH
• genapol X 080 MeSH Prohlížeč
• kyselina mléčná MeSH
• kyseliny heptylové MeSH
• polyethylenglykoly MeSH
• polyvinylchlorid MeSH

Most modern wound dressings assist the wound-healing process. In contrast, conventional wound dressings have limited antibacterial activity and promote sporadic fibroblast growth. Therefore, wound dressings with prolonged substance release must be improved. This research aimed to develop hydrogel films. These were synthesized from alginate and pectin, incorporated with mangosteen extract (ME), and encapsulated in niosomes (ME-loaded niosomes). Subsequently, we examined the in vitro release and physical characteristics of ME-loaded niosomes. These characteristics included particle pH, size, charge, polydispersity index (PDI), and drug loading properties. These properties included drug loading content (DLC), entrapment efficiency (EE), and yield (Y). Additionally, we examined the swelling ratio and biological characteristics of the hydrogel film. These characteristics included antibacterial activity, cytotoxicity (L929), cell attachment to the tested materials, cell migration, hemocompatibility, and in vivo irritation. Significant results were obtained using a 2:1 niosome preparation containing Span60 and cholesterol. Ratio influenced size, charge, PDI, DLC, EE, and Y. The results were 225.5 ± 5.83 nm, negatively charged, 0.38, 16.2 ± 0.87%, 64.8 ± 3.49%, and 87.3 ± 3.09%, respectively. Additionally, the release of encapsulated ME was pH sensitive because 85% of the ME can be released at a pH of 5.5 within seven days and decrease to 70% at a pH of 7.4. The maximum swelling ratios of patches with 0.5% and 1% Ca2+ crosslinking were 867 wt% and 1,025 wt%, respectively, after 30 min. These results suggested that a medium dose (15 mg) of niosomal ME incorporated in a hydrogel film provided better bacterial inhibition, cell migration, and cell adhesion in an in vitro model. Additionally, no toxicity was observed in the fibroblasts and red blood cells. Therefore, given the above-mentioned advantages, this product can be a promising candidate for wound dressing applications.

• Klíčová slova
• Hydrogel, Mangosteen extract, Niosome, Skin irritation,
• Publikační typ
• časopisecké články MeSH

2-Hydroxyethyl methacrylate (HEMA) monomer and sodium benzoate, diluted with saline in the range 0-20%, were tested for intradermal irritation in rats. Radioactive indicator (113mIn) was used to quantify this biological response. At low concentrations (up to 1%) only a little irritation was recorded, while at higher levels (5% or more) a significant adverse reaction developed. The degree of irritation was dose dependent. In the concentration range 0-10%, the response was exponential. Model decomposition products derived from three different polymerization initiators were also tested. How the results obtained with the model irritants relate to real polymerization systems is discussed.

• MeSH
• dráždivé látky * MeSH
• inbrední kmeny potkanů MeSH
• krysa rodu Rattus MeSH
• kůže účinky léků   patologie   MeSH
• kyseliny polymethakrylové * toxicita   MeSH
• polyhydroxyethylmethakrylát analogy a deriváty   toxicita   MeSH
• radioizotopy india MeSH
• zvířata MeSH
• Check Tag
• krysa rodu Rattus MeSH
• mužské pohlaví MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• dráždivé látky * MeSH
• kyseliny polymethakrylové * MeSH
• polyhydroxyethylmethakrylát MeSH
• radioizotopy india MeSH

Samples of poly(2-hydroxyethyl methacrylate) p(HEMA) hydrogels were prepared using three different polymerization initiators. The gels were washed in water under standard conditions. The extracts were then examined for intradermal irritation in rats using a radioactive indicator (113mIn). The irritation effects were dependent on the concentrations of the irritating substances and also on the gel type. Solid discs made of the gels, washed to varying degrees of purity, were also implanted into rats. Tissue irritation, as well as some other biological responses, were followed in situ using the radioindicator and common histological techniques. The irritation effects were very mild (even with the unextracted gel material). A possible explanation for the events taking place at the site of implantation is presented.

• MeSH
• biokompatibilní materiály * MeSH
• dráždivé látky * MeSH
• exsudáty a transsudáty analýza   MeSH
• fibrin analýza   MeSH
• inbrední kmeny potkanů MeSH
• krevní proteiny metabolismus   MeSH
• krysa rodu Rattus MeSH
• kůže účinky léků   patologie   MeSH
• kyseliny polymethakrylové toxicita   MeSH
• polyhydroxyethylmethakrylát toxicita   MeSH
• protézy a implantáty MeSH
• radioizotopy india MeSH
• zánět MeSH
• zvířata MeSH
• Check Tag
• krysa rodu Rattus MeSH
• mužské pohlaví MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• biokompatibilní materiály * MeSH
• dráždivé látky * MeSH
• fibrin MeSH
• krevní proteiny MeSH
• kyseliny polymethakrylové MeSH
• polyhydroxyethylmethakrylát MeSH
• radioizotopy india MeSH

UNLABELLED: PURPOSE OF THE STUDY With the concept of the lateral compression plate (LLCP) a technique has been available designed to combine the advantages of a fixed-angle fixation with a complete sinking of the implant into the proximal bone. The objective of the present study was to investigate the results of the LLCP compared with classical screw osteosynthesis (SO). MATERIAL AND METHODS 31 patients with pes planovalgus who received calcaneal displacement osteotomy and osteosyntheses with screws (n = 17) or LLCP (n = 14) between 2010 and 2015 were investigated retrospectively.The ankle-hindfoot scale, Kaikkonen score, VAS, and the SF-36 were determined preoperatively as well as at the last clinical follow-up. In addition, a radiological control of osseous integration was performed in all patients 12 weeks after surgery. RESULTS With regard to clinical scores both methods depicted significant improvement. In the overall cohort there were no pseudarthroses. In the SO group 5 cases (29%) showed hardware irritation, in the LLCP group there were none. Results in the LLCP group were significantly superior in the area of the physical section of the SF 36. CONCLUSIONS Based on the results of our study, surgical treatment of stage II pes planovalgus by means of calcaneal displacement osteotomy using the LLCP is equivalent to SO with a lower incidence of hardware irritation. Key words:pes planovalgus, lateral compression plate, osteosynthesis, screw, hardware irritation. LEVEL OF EVIDENCE: Level IV, retrospective case serie.

• MeSH
• hodnocení výsledků zdravotní péče MeSH
• kostní destičky MeSH
• kostní šrouby MeSH
• kostní svalek diagnostické zobrazování   MeSH
• lidé středního věku MeSH
• lidé MeSH
• osteotomie * škodlivé účinky   přístrojové vybavení   metody   MeSH
• patní kost chirurgie   MeSH
• plochá noha diagnóza   chirurgie   MeSH
• pooperační komplikace * diagnóza   etiologie   prevence a kontrola   MeSH
• poranění měkkých tkání * diagnóza   etiologie   prevence a kontrola   MeSH
• srovnávací výzkum účinnosti MeSH
• vnitřní fixace fraktury * škodlivé účinky   přístrojové vybavení   metody   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• srovnávací studie MeSH
• Geografické názvy
• Německo MeSH

Irritable bowel syndrome is a frequent functional disorder of gastrointestinal tract. Its high incidence represents an important socioeconomic concern. The diagnosis of irritable bowel syndrome is indirect and requires exclusion of an organic lesion within as well as outside the gastrointestinal tract. No algorithms--so called treatment guidelines--are available for pharmacological or non-pharmacological treatment of the irritable bowel syndrome. Long-term and comprehensive care of patients with functional diseases is an important component of the management of patients with irritable bowel syndrome.

• MeSH
• lidé MeSH
• syndrom dráždivého tračníku * diagnóza   farmakoterapie   etiologie   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• anglický abstrakt MeSH
• časopisecké články MeSH
• přehledy MeSH

• Klíčová slova
• MENINGIOMA/cerebrospinal fluid *, PROTEINS/cerebrospinal fluid *, SPINAL CORD/neoplasms *,
• MeSH
• lidé MeSH
• meningeální nádory * MeSH
• meningeom mozkomíšní mok   MeSH
• meningismus * MeSH
• nádory míchy * MeSH
• proteiny v mozkomíšním moku * MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• proteiny v mozkomíšním moku * MeSH

• Klíčová slova
• REFLEX *, SYMPATHETIC NERVOUS SYSTEM/physiology *,
• MeSH
• nervový systém - fyziologické jevy * MeSH
• reflex * MeSH
• splanchnické nervy * MeSH
• sympatický nervový systém fyziologie   MeSH
• Publikační typ
• časopisecké články MeSH

• Klíčová slova
• CAROTID SINUS/physiology *,
• MeSH
• kožní nemoci * MeSH
• sinus caroticus fyziologie   MeSH
• Publikační typ
• časopisecké články MeSH