Biomedical subjects

A Kramer

Publications and source records attributed to A Kramer.

At least 19 recordsLinked to original sources

PubMed2007

The peritoneal explant test for evaluating tissue tolerance to mouthrinses.

The tissue cultures of explants of neonatal rat peritoneum have been demonstrated to be a sensitive test for tissue compatibility with wound antiseptics. The present study investigated the suitability of this method to assess the relative toxicity of mouthrinses to tissue. Mouthrinses containing 0.1% chlorhexidine (Chlorhexamed Fluid 0.1%) (A), 0.3% triclosan (Colgate) (B), essential oil in ethanolic solution (Listerine) (C), and amine/stannous fluoride (Meridol) (D) were tested at use concentration and in dilutions of 10, 1, and 0.1% with exposure times of 1, 10, and 30 min, respectively. The mouthrinses (test) and Ringer's solutions (control) were applied to opened rat peritoneum. After thorough irrigation with Ringer's solution, a piece of peritoneum was removed and 1 x 1 mm explants were cut. The explants were cultivated with a bovine serum culture medium in 24-well plates at 37 degrees C in a CO2 incubator (95% air, 5% CO2). After 10 days, the tissue proliferation for the explants was assessed by a stereo microscope at 10x magnification after ethanol fixing and hemalaun staining. With 24 grafts per test, the proliferation rate was calculated relative to a control, which was run for each mouthrinse and concentration/time combination. Data were analyzed using ANOVA (SPSS 11.0) and post-hoc paired t test. Statistical significance of all correlations was tested by setting the significance level at p < 0.05. At most concentrations, D caused significantly less tissue damage than A or B. There was no difference between C and A or C and B at 100%. However, the toxicity of C was significantly less than A or B at 10, 1, and 0.1%. C and D behaved similarly except for the 10% (30 min) and the 1% (10 min) solutions in which C was significantly less toxic. We concluded that the rat peritoneum explant test was demonstrated to be a sensitive test to assess the relative toxicity of mouthrinses to tissue.

Amines↗

PubMed2006

In vitro antibacterial activity of Lucilia sericata maggot secretions.

Maggots of the green blowfly, Lucilia sericata, are used as an alternative to surgical intervention and long-term antiseptic therapy for the treatment of chronic wounds. The secretions of maggots are known to have antibacterial properties. To quantify the bactericidal effect of secretions from larvae of L. sericata, an in vitro test model based on the modified European quantitative suspension test (EN 1040) was developed, in which a co-culture of maggots and bacteria (Micrococcus luteus,Escherichia coli, methicillin-sensitive Staphylo-coccus aureus) in tryptic soy broth was tested. The numbers of bacterial colonies with and without maggot exposure were compared after 24, 48 and 72 h of exposure. The mean log(10) reduction factor (RF) for bacterial elimination per maggot was >4 at all examined times for all tested bacteria. Thus, maggot secretion fulfilled the required definitions of an antiseptic. In addition, the maggots' ability to ingest bacteria was also evaluated. Maggots contained viable bacteria after 48 h of contact with the respective organisms. These maggots also continued excreting bacteria. Therefore, maggots should be disposed of after use as they must be regarded as medical waste.

Animals↗

PubMed2006

In vitro activity of linezolid against clinical isolates of Fusobacterium spp.

OBJECTIVES: Although most susceptibility studies for linezolid have investigated aerobic bacteria, only a few have investigated anaerobe isolates. The aim of the present study was to determine the antibacterial activity of linezolid against a larger sample of clinical isolates of Fusobacterium spp. and to report on the detailed susceptibility, stratified by species. METHODS: The in vitro susceptibility of 80 clinical isolates of Fusobacterium (Fusobacterium necrophorum, n = 34; Fusobacterium nucleatum, n = 20; Fusobacterium varium, n = 18; Fusobacterium mortiferum; n = 8) was tested and compared with the activity of the older compounds amoxicillin and amoxicillin/clavulanic acid. RESULTS: The MIC of linezolid ranged from 0.016 to 1.0 mg/L, with the MIC(90) being 0.5 mg/L. The highest MIC obtained for linezolid (1.0 mg/L) was measured for an F. varium isolate. The MIC(90) for both, amoxicillin (range: 0.016-0.75 mg/L) and amoxicillin/clavulanic acid (range: 0.047-0.75 mg/L), was 0.5 mg/L. Overall, no resistant strains were found in the study. CONCLUSIONS: Compared with amoxicillin and amoxicillin/clavulanic acid, linezolid was less active against F. necrophorum (MIC(90) 0.25 mg/L) and F. nucleatum (MIC(90) 0.25 mg/L), equally active against F. varium (MIC(90) 0.75 mg/L) and slightly more active against F. mortiferum (MIC(90) 0.19 mg/L).

Acetamides↗

PubMed2006

Multi-site quantitative ultrasound compared to dual energy X-ray absorptiometry in rheumatoid arthritis: effects of body mass index and inflamed soft tissue on reproducibility.

The objective of the study is to evaluate multi-site quantitative ultrasound (QUS) in comparison to dual energy X-ray absorptiometry (DXA) considering the effects of body mass index (BMI) and disease activity on measurements in patients suffering from rheumatoid arthritis (RA). Sixty-eight patients underwent a cross-sectional analysis of bone mineral density measured by DXA (lumbar spine, total femur) and speed of sound estimated by QUS (phalanx III, distal radius). The short-term precision of QUS was investigated with regard to BMI of healthy individuals and with regard to the level of disease activity in patients suffering from RA. The patients with RA were divided into two BMI groups as well as into low and advanced disease activity groups. The short-term precision of QUS-SOS ranged from 0.90 to 2.55% (healthy controls) and from 0.64 to 1.89% (patients with RA). The association between DXA and QUS parameters were limited in the case of advanced disease activity and pronounced BMI. Low QUS-SOS was observed for advanced disease activity group (QUS-SOS phalanx: -2.5%; QUS-SOS distal radius: -2.1%) in comparison to low disease activity group, whereas only a slight change of DXA parameters was observed. DXA-BMD and QUS parameters revealed higher values with pronounced BMI. The system shows only a short-term precision with limitations in healthy controls with accentuated BMI, as well as in patients with active RA. The application of multi-site QUS seems to be restricted for patients with active inflammation based on soft tissue alteration in RA and for healthy individuals with pronounced body mass.

Absorptiometry, Photon↗

PubMed2006

Risk factors for Staphylococcus aureus nasal carriage in residents of three nursing homes in Germany.

The prevalence of Staphylococcus aureus nasal carriage in three nursing homes (N=500) was 36.6%. No meticillin-resistant S. aureus (MRSA) was detected. The following significant risk factors for S. aureus nasal carriage were identified: vascular cognitive impairment [odds ratio (OR)=0.31]; diabetes mellitus (OR=1.82); hypertension (OR=0.30); chronic obstructive pulmonary disease (OR=1.86); stroke (OR=3.31); antibiotic therapy within the previous three months (OR=2.10); and level 2 care (defined as highly dependent, needing help in activities of daily living for up to 4h/day) (OR=1.97). Compared with other countries, the prevalence of MRSA nasal carriage in residents of German nursing homes is low.

Adult↗

PubMed2006

Peripheral bone status in rheumatoid arthritis evaluated by digital X-ray radiogrammetry and compared with multisite quantitative ultrasound.

The development of secondary osteoporosis in rheumatoid arthritis (RA) has recently become well recognized, characterized by demineralization at axial and in particular periarticular peripheral bone sites. Our aim was to evaluate multisite quantitative ultrasound (QUS) compared to digital X-ray radiogrammetry (DXR) by the quantification of cortical bone loss dependent on the severity of RA. Fifty-three patients with verified RA underwent QUS measurements (Sunlight Omnisense 7000) with estimation of the speed of sound (QUS-SOS) at the distal radius and at the phalanx of the third digit. Also, bone mineral density (DXR-BMD) and metacarpal index (DXR-MCI) were estimated on metacarpals II-IV using DXR technology. Additionally, Larsen score and Steinbroker stage were assessed. Disease activity of RA was estimated by disease activity score 28 (DAS 28). For the group with minor disease activity (3.2 5.1), QUS-SOS of the radius revealed a significant correlation to DXR-BMD (R = 0.71) and DXR-MCI (R = 0.84), whereas for QUS-SOS (phalanx) no significant association to the DXR parameters was shown. The DXR parameters and, to a lesser extent, the QUS data also demonstrated pronounced declines in the case of accentuated disease activity (DAS > 5.1). Both DXR-BMD (-25.9 %, P < 0.01) and DXR-MCI (-38.6 %, P < 0.01) revealed a notable reduction dependent on the severity of RA. Otherwise, QUS-SOS marginally decreased, with -2.6% (radius) and -3.9% (phalanx). DXR revealed a significant reduction of DXR-BMD as well as DXR-MCI dependent on the severity of RA and surpassed multisite QUS as a promising diagnostic tool.

Absorptiometry, Photon↗

PubMed2006

Multiplex PCR-ELISA for direct detection of MRSA in nasal swabs advantageous for rapid identification of non-MRSA carriers.

In the study presented here 251 nasal swabs obtained from medical staff were directly investigated for MRSA using a commercial multiplex PCR system in parallel with conventional culture methods to determine the usefulness of PCR for rapid screening. Both methods identified 3.2% (8/251) of specimens as MRSA-positive; one sample was culture-positive only, and three were PCR-positive only. PCR correctly identified 215 of 239 (90%) negative swab samples, but one sample with weak cultural growth was not detected and was therefore considered false negative. The comparative sensitivity of culture versus PCR was 75% (9/12) versus 91.6% (11/12). Although PCR had a low positive predictive value (31.4%) its negative predictive value was high (99.5%). The results of this study indicate the multiplex PCR is suitable for the rapid identification of MRSA-negative individuals directly from nasal swabs in populations with a low MRSA prevalence, but positive results need to be confirmed by culture.

Enzyme-Linked Immunosorbent Assay↗

PubMed2006

Association between cardiac disorders and a decades-previous history of diphtheria.

A long, prior history of diphtheria is common among middle-aged and elder European adults. The aim of the present study was to determine whether the risk of reduced ventricular function and impaired intraventricular conduction is increased in individuals with a history of diphtheria. A study population of 2,480 subjects (1,222 women) aged 45 years or older who were recruited for the Study of Health in Pomerania were available for the present analyses. Left ventricular function was assessed by echocardiography. Intraventricular conduction blocks were diagnosed using electrocardiograms. Multivariable analyses revealed that individuals with a history of diphtheria had neither an increased odds for reduced fractional shortening (OR 1.21, 95% CI 0.69-2.11; p=0.51) nor an increased odds for intraventricular conduction blocks (OR 0.90, 95% CI 0.55-1.46; p=0.67). However, regression models revealed two-way interactions between the exposure variable and hypertension with respect to both endpoints. A history of diphtheria increased the odds for both endpoints in normotensive but not in hypertensive individuals. The findings show that a history of diphtheria several decades previously in a patient is a risk marker for reduced cardiac function and impaired intraventricular conduction in individuals at low risk for these disorders.

Adult↗

PubMed2006

[Optimizing surgical hand disinfection].

For more than 110 years hands of surgeons have been treated before a surgical procedure in order to reduce the bacterial density. The kind and duration of treatment, however, has changed significantly over time. Recent scientific evidence suggests a few changes with the aim to optimize both the efficacy and the dermal tolerance. Aim of this article is the presentation and discussion of new insights in surgical hand disinfection. A hand wash should be performed before the first disinfection of a day, ideally at least 10 min before the beginning of the disinfection as it has been shown that a 1 min hand wash significantly increases skin hydration for up to 10 min. The application time may be as short as 1.5 min depending on the type of hand rub. Hands and forearms should be kept wet with the hand rub for the recommended application time in any case. A specific rub-in procedure according to EN 12791 has been found to be suitable in order to avoid untreated skin areas. The alcohol-based hand rub should have a proven excellent dermal tolerance in order to ensure appropriate compliance. Considering these elements in clinical practice can have a significant impact to optimize the high quality of surgical hand disinfection for prevention of surgical site infections.

Disinfectants↗

PubMed2006

Inverse association between periodontitis and respiratory allergies.

BACKGROUND: Periodontitis is an infection with systemic effects and a high prevalence among adults. In the aetiology of allergic diseases the hygiene hypothesis claims that infections in early infancy may protect against allergic diseases. OBJECTIVE: The aim of the present analyses was to investigate the independent relation between periodontitis and respiratory allergies such as hayfever, house dust mite (HDM) allergy and asthma. METHODS: From the Study of Health in Pomerania (SHIP) a total number of 2837 subjects aged 20 to 59 years were included in the analysis. In our study population 326, 111 and 114 subjects were classified as suffering from hayfever, HDM allergy or asthma, respectively. The attachment loss (AL) were measured. Periodontitis was defined according to the percentage of surfaces which exceeded 3 mm AL [healthy: 0-7.7%, mild: 7.8-28.6%, moderate: 28.7-63.9%, severe: >63.9%]. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using logistic regression. RESULTS: After adjustment for confounding factors these analyses revealed inverse associations between periodontitis and hayfever as well as periodontitis and HDM allergy. For increasing AL, a trend of decreasing risk could be observed for hayfever (healthy: reference; mild AL: OR 0.87 [95%-CI 0.6-1.2]; moderate AL: OR 0.80 [95% CI 0.6-1.2]; server AL: OR 0.53 [95% CI 0.3-0.9]; P(trend)=0.01) and for HDM allergy (healthy: reference; mild AL: OR 0.80 [95% CI 0.5-1.3]; moderate AL: OR 0.64 [95% CI 0.3-1.2]; server AL: OR 0.39 [95% CI 0.2-0.9]; P(trend)=0.02). Furthermore, for asthma were observed a slightly inverse association in the full-adjusted model (healthy: reference; mild AL: OR 1.10 [95% CI 0.6-2.0]; moderate AL: OR 0.96 [95% CI 0.5-1.8]; server AL: OR 0.48 [95% CI 0.2-1.0]; P(trend)=0.11). CONCLUSION: There is an inverse association between periodontitis and respiratory allergies. Our results might support the hygiene hypothesis.

Adult↗

PubMed2006

Susceptibility to diphtheria in adults: prevalence and relationship to gender and social variables.

Recent outbreaks of diphtheria have drawn attention to the re-emergence of this disease. This study investigated susceptibility to diphtheria in north-east Germany and its relationship to gender and social factors. A study population of 4275 individuals recruited for the population-based Study of Health in Pomerania (SHIP) was available for analysis. IgG antibodies against diphtheria toxin were determined by ELISA and were used to define susceptibility to diphtheria (i.e., IgG titres < 0.1 IU/mL). The prevalence of susceptibility to diphtheria was 32.4%. Multivariate analysis revealed 45% increased odds of women being susceptible to diphtheria. Women who had not received diphtheria toxoid vaccination during the previous 10 years had four-fold increased odds of being susceptible to diphtheria toxin compared with unvaccinated men. None of the social factors investigated was associated with susceptibility status. It was concluded that a high proportion of middle-aged adults was susceptible to diphtheria. Women lacked seroprotection more often than men, which might be explained, in part, by gender-specific immune responses following vaccination. There is a need for information campaigns to improve public awareness of these problems.

Adult↗

PubMed2006

Systemic iodine absorption after preoperative antisepsis using povidone-iodine in cataract surgery-- an open controlled study.

After preoperative conjunctival and periorbital antisepsis with povidone-iodine (PVP-I), the systemic absorption of iodine after cataract surgery was measured to evaluate the risk of thyroid side effects. Five different combinations of PVP-I alone or in combination with PVP-I-free antiseptics were applied to the conjunctiva and periorbital skin. An iodine-free product served as control. Iodide and creatinine in urine were analyzed before intervention and 24 and 48 h postoperatively. Depending on the concentration and application site, 0.3-4.5% of the total applied iodine or 3.6-45.4% of the free iodine were absorbed. The range of urine iodine excretion was between 11.7 and 71.0 mug iodine/g creatinine, depending on the PVP-I concentration and the site of application. The increase in iodine excretion was significant at 24 h postoperatively in trials receiving PVP-I both periorbitally and conjunctivally, depending of the concentration used. Because the iodine absorption is only slight and of doubtful clinical relevance, presurgical conjunctival antisepsis can be achieved with 1.25% PVP-I; so far clinically manifest anamnestic thyroid disorders are excluded. Presently, periorbital skin antisepsis with PVP-I cannot be recommended until data on thyroid metabolism in the population have been collected and evaluated, especially in a region currently or previously deficient in iodine.

Absorption↗

PubMed2006

Comparative study of in vitro cytotoxicity of povidone-iodine in solution, in ointment or in a liposomal formulation (Repithel) and selected antiseptics.

The cytotoxicity of povidone-iodine in Repithel, Betaisodona ointment and Betaisodona solution was investigated using CHO-K1 cells. To estimate the vitality of test cells after 30 min contact time using vital dye neutral red, the following IC(50) were determined: 16-18% Repithel, 8-9% Betaisodona ointment and 1.8-2% Betaisodona solution; using MTT for detecting vitality, the IC(50) were: 5-10% Repithel, 1.3-2.5% Betaisodona ointment and 0.6-1.3% Betaisodona solution. Therefore, the first attack of the antiseptic agent iodine to mammalian cells is carried out on enzymes, perhaps by oxidation, followed by membrane attack. Murine fibroblasts were used to compare the cytotoxic impact of povidone-iodine with those of chlorhexidine digluconate (CHex), octenidine dihydrochloride (Oct) and polyhexamethylene biguanide (PHMB). On the base of molecular concentration, povidone-iodine is more than 20 times better tolerated by L929 cells than CHex, Oct or PHMB. Moreover, after 30 min contact of L929 cells with povidone-iodine, there is a temporarily cytotoxic reaction, which leads after 24 h culture to an unexpected revitalisation of murine fibroblasts. This phenomenon was not detected using CHex, Oct or PHMB. Povidone-iodine seems to be the most tolerated antiseptic in comparison with CHex, Oct or PHMB.

Administration, Topical↗

PubMed2006

Lack of in vitro genotoxicity of povidone-iodine in solution, in ointment or in a liposomal formulation (Repithel).

The in vitro genotoxicity of povidone-iodine in Repithel, Betaisodona ointment and Betaisodona solution was investigated using CHO-K1 cells. The comet assay and chromosome aberration test were used to characterise the genotoxic potency of povidone-iodine within 4 h of contact with test cells. Methyl methanesulphonate without S9 activation and benzo[a]pyrene with S9 activation were used as positive controls. No higher concentrations than 6% Repithel, 5% Betaisodona ointment and 2% Betaisodona solution in culture medium with 10% fetal bovine serum were tested within 4 h of contact with CHO-K1 cells for the comet assay, because higher concentrations will provide >60% cytotoxicity. All tested concentrations of povidone-iodine formulations (4-6% Repithel, 3-5% Betaisodona ointment and 1-2% Betaisodona solution) are not genotoxic in the comet assay. 10% Repithel, 5% Betaisodona ointment and 2.5% Betaisodona solution in culture medium with 10% fetal bovine serum were final concentrations in the chromosome aberration test, which provide <60% cytotoxicity within 4 h of contact with CHO-K1 cells. All tested concentrations of povidone- iodine formulations (5-10% Repithel, 2.5-5% Betaisodona ointment and 1.25-2.5% Betaisodona solution) are not genotoxic in the chromosome aberration test. Using the comet assay and chromosome aberration test to characterise the genotoxic potency of povidone-iodine within 4 h of contact with CHO-K1 cells, there was no chromosome damage detected.

Animals↗

PubMed2006

Hygienic relevance and risk assessment of antimicrobial-impregnated textiles.

The antimicrobial impregnation of textiles is intended to provide protection of textiles against microbial corrosion, prevention of malodor or prophylaxis and therapy of infections, respectively. For every biocidal product a careful risk assessment for humans and the environment has to be performed. The advantage of antimicrobially active textiles has to be documented for every agent as well as for every application, and a balance has to be found between a textile's quality rating and the potential risks, e.g. sensitization, disturbance of the ecology of the skin, toxic side effects by means of systemic absorption, cytotoxicity, genotoxicity, carcinogenicity, teratogenicity and ecotoxicity. This article evaluates the applicability of silver compounds as well as the classic antimicrobials triclosan, quaternary ammonium compounds, copper and further new options like chitosan and zeolite. It has to be emphasized that there are no objections against the use of antimicrobially active textiles if their use is equal or superior to other preventive or therapeutic measures. This applies to the amelioration of the course of dermatological diseases with disturbed skin flora, in particular atopic dermatitis, the prevention and therapy of acute and chronic wound infections by wound dressings, the use of impregnated surgical suture material as well as special indications in the prevention of infection in medical facilities. The use of antimicrobial textiles for the prevention of dermatomycosis by antifungal impregnation is of questionable use; the antimicrobial impregnation of textiles for deodorization purposes has to be avoided. Presently, from a hygienic point of view, the following questions have to be clearly determined: declaration of any antimicrobial impregnation; development of international standards for in vitro testing and preclinical evaluation of efficacy and tolerance; evaluation of the advantage of the antimicrobial properties for the intended use including the risk-benefit assessment.

Anti-Infective Agents↗

PubMed2006

Efficacy and safety of silver textile in the treatment of atopic dermatitis (AD).

BACKGROUND: Patients with atopic dermatitis (AD) have an increased tendency to develop bacterial skin infections. Colonization with Staphylococcus aureus is known to be a major trigger and might also play a pathophysiological role. Because of their antiseptic action, silver-coated textiles suppress S. aureus colonization and toxin formation, thus damping the inflammatory reaction. OBJECTIVES: To evaluate the clinical effectiveness and safety of a special silver textile in the treatment of patients suffering from acute AD. METHODS: In a randomized phase II monocenter parallel-group comparative study 30 patients were recruited (average age 25.5 years, min. 4 years, max. 70 years) who were affected by AD in an acute phase. During the first study phase from Day 1 to Day 14, 10 patients received a silver textile (Group 1), 10 a silver-free textile (Group 2), and 10 prednicarbate ointment (Group 3). In the second phase from Day 15 to Day 28 all patients wore the silver textile, and during the follow-up period from Day 28 to Day 56 no textiles were used. Prednicarbate ointment was allowed as emergency medication, but ointment consumption was measured. The overall severity of the disease was evaluated using the SCORAD index as the primary efficacy parameter. Secondary parameters included severity of pruritus and the patients' assessment of their disease control (uncontrolled, limited, good or complete). Safety tests included hematology, blood chemistry, urinalysis for silver, and physical examination for silver deposits in the skin and mucous membranes. RESULTS: The initial SCORAD was 61.6 (IQR 26.6, min. 30.6, max. 99.9). At the end of the Study Phase 1 the SCORAD had improved significantly in the patients of Groups 1 (74.6-29.9, p = 0.005) and 3 (57.8-24.0, p = 0.009). During Study Phase 2 healing of eczema continued in Group 1 (SCORAD 29.9-18.1, p = 0.037), was observed in Group 2 (48.2-24.1, p = 0.015), and remained at an improved level in Group 3 (SCORAD 24-23.5). Consumption of prednicarbate ointment (Phase 1, Phase 2, follow-up period, medians are given): Group 1: 135 g, 10 g, 45 g; Group 2: 13 g, 0 g, 0 g; Group 3: 145 g, 30 g, 90 g. Silver textiles reduced the severity of the pruritus (p = 0.031); silver-free textiles (n.s.) and prednicarbate (n.s.) were less effective. No undesired events were observed. CONCLUSION: The elastic silver textile worn directly against the skin led to an impressive improvement of AD and a reduction in the use of prednicarbate ointment.

Adolescent↗

PubMed2006

The role of thiocyanate in the etiology of goiter in an industrial metropolitan area.

OBJECTIVE: Thiocyanate (SCN-) has concentration dependent antithyroid properties and a role in the etiology of goiter has been suggested in several studies. In 1991 an epidemiological survey conducted in the region of Halle/Leipzig (Saxony), an area with significant air pollution, suggested an inverse relationship between urinary iodine (I-)/SCN- excretion and goiter prevalence. 10 years later, we reinvestigated the same industrial area to clarify if the situation has changed after the elimination of most industrial waste products and moreover, if SCN- excretion levels alone or in combination with air pollution or smoking as a SCN- source are critical for thyroid function. DESIGN AND METHODS: We investigated a cohort of 708 probands for I-, SCN- and creatinine excretion in spot urine samples and determined the prevalence of goiter and thyroid nodules by high resolution ultrasonography. RESULTS: Probands with goiter (n = 79, 11%) had significantly higher urinary SCN- excretions than probands without (3.9 +/- 2.8 vs 3.1 +/- 3.4 mg SCN-/g creatinine) and significantly lower urinary I-/SCN- ratios than patients without thyroid disorders (41 +/- 38 vs 61 +/- 71 microg I-/mg SCN-/l). Mean urinary I- excretions were not different between probands with or without goiter. Smokers showed significantly elevated urinary SCN-/creatinine ratios in comparison to non-smokers (4.3 +/- 4.3 vs 2.4 +/- 2.1 mg SCN-/g creatinine). ANOVA revealed a prediction of thyroid volume through age (P < 0.001), gender (P < 0.001), body weight (P < 0.05) and smoking (P < 0.05). CONCLUSIONS: In our investigation, age, gender and smoking (raising SCN- levels by CN- inhalation) were predictive for thyroid volume and the urinary I-/SCN- ratios were able to detect probands with an increased risk of developing goiter in contrast to urinary I- excretion levels alone. These data suggest, that in an era and area of decreased cyanide pollution, SCN- may remain a cofactor in the multifactorial aetiology of goiter.

Adult↗

PubMed2006

The classification of antiseptic products to be administered to wounds--another borderline case between medicinal products and medical devices?

The importance of a correct demarcation between a Medicinal Product (MP) and a Medical Device (MD) is undisputedly one of the major topics related to the development and launch of a new healthcare product. However, for some products the correct demarcation between MPs and MDs can turn out to be somewhat complicated. This article aims to provide an overview on the existing legislation and its adequate application based on a suitable example at hand. Article 2 (2) of the European Directive 2001/83/EC as amended by Directive 2004/27/EC on the Community code relating to medicinal products for human use stipulates that the respective Medicinal Products Legislation must be applied whenever a product can be covered by both the definitions for MPs and for products regulated by other legal provisions enacted by the European Community, e.g. Cosmetic Products (CPs) or MDs. This basic principle implies that the decision to base the risk-benefit assessment of the product in question on the Medical Device Directive (MDD) would contradict the aforementioned constitutional principle, pursuant to which the stricter of the regulatory procedures theoretically possible is to apply in cases of doubt. In contrast to the approval procedure established for MPs, the MDD requires a Conformity Assessment Procedure to be performed by the manufacturer himself and a "Notified Body". Thus, in the majority of cases the responsibility for the risk assessment of MDs lies solely with the manufacturer and is prior to launch not subject to further scrutiny by regulators. Only in specific cases, i.e. for the Conformity Assessment Procedure of Class III MDs which contain an Active Pharmaceutical Ingredient one of the Member States competent authorities designated in accordance with Directive 65/ 65/EEC has to be involved before taking a decision. It is therefore important that the classification of the product is carried out carefully in full compliance with existing legal provisions, also taking into account the related guidance documents issued by the European Commission. The adequate application of these rules is explained using the example of the antiseptic compound polihexanide, which is used both in approved medicinal products (wound antiseptics) and wound irrigation solutions labelled as medical devices.

Animals↗