The impact of adverse reactions to injectable filler substances on quality of life: results from the Berlin Injectable Filler Safety (IFS) - study.

BACKGROUND: Injectable filler substances are commonly used in aesthetic medicine. Adverse reactions are rare, but may cause severe impact on quality of life (QoL). To the best of our knowledge, data on the impact of adverse reactions caused by injectable filler substances on QoL is missing. OBJECTIVE: To evaluate the impact of adverse filler reactions on the QoL. MATERIAL AND METHODS: The Injectable Filler Safety (IFS) - study is a partially population-based registry for adverse reactions due to injectable filler substances. In 2008, the Dermatology Life Quality Index (DLQI) questionnaire was added to the questionnaires of the IFS study. For this analysis, only patients with a completed DLQI were included in the analysis. RESULTS: One hundred and four patients of the IFS study were analysed. A total of 88.5% were female with an average age of 49.2 years. Here, 50.0% were treated with biodegradable and 40.4% with permanent fillers. The most common adverse reactions were nodule formation and hardening. Most patients experienced mild to moderate adverse reactions. Impact on QoL was moderate with an average of 8.9 (±8.4 SD) in patients with adverse reactions to biodegradable and 10.5 (±9.4 SD) to permanent products. However, 24.0% and 13.4% showed a large or a very large impact on QoL. CONCLUSION: Adverse reactions to injectable filler products can have a considerable impact on the QoL, comparable to severe chronic inflammatory skin diseases such as psoriasis.

Adhesive luting of new CAD/CAM materials.

OBJECTIVE: To evaluate the adhesive bonding performance of recently introduced tooth-colored CAD/CAM materials after different pretreatment protocols and using different luting materials. MATERIALS AND METHODS: The CAD/CAM materials under investigation were e.max CAD (lithium disilicate glass ceramic; Ivoclar Vivadent, Schaan, Liechtenstein), Celtra Duo (zirconia-reinforced lithium disilicate ceramic; Dentsply DeTrey, Konstanz, Germany), Lava Ultimate (resin nano ceramic; 3M ESPE, Neuss, Germany), and Enamic (resin infiltrated ceramic; Vita, Bad Säckingen, Germany). A total of 240 blocks (n = 5) received various pretreatments (no pretreatment, silane, sandblasting, sandblasting + silane, hydrofluoric acid, hydrofluoric acid + silane), and then different classes of adhesive luting composites were applied (adhesive: Prime&Bond XP + SCA + Calibra; Dentsply DeTrey; self adhesive: RelyX Unicem; 3M ESPE). After 24 h water storage and 10,000 thermocycles (5°C/55°C), specimens were cut into beams and microtensile bond strengths were recorded. RESULTS: Bonding performance of recent CAD/CAM materials was clearly influenced by the pretreatment method (P < 0.05). In general, significantly higher µ-TBS values were recorded for the ceramic materials compared to the hybrid materials (P < 0.05). Among the hybrid materials, Enamic exhibited higher bond strengths than Lava Ultimate (P < 0.05). However, despite the differences found, all materials showed a high level of bonding performance, being sufficient to withstand intraoral chewing forces during mastication. CONCLUSION: When pretreated as recommended by the manufacturers, recent tooth-colored CAD/CAM materials show an encouraging bonding performance for adhesive luting.

The natural history of actinic keratosis: a systematic review.

Knowledge about the development of untreated actinic keratosis (AK) and risk of progression into squamous cell carcinoma (SCC) is important. Therefore, we set out to synthesize primary data on the natural history of AK. We carried out a systematic literature search (Medline, Medline in Process, Embase, Cochrane) of studies on the natural course of AK, regarding (i) progression and regression rates per lesion-year, (ii) changes in total lesion counts over time, and (iii) spontaneous field regression and recurrence rates, taking into account studies on participants without immunosuppression and history of skin cancer, immunosuppressed patients and participants with a history of skin cancer and sunscreen use. Twenty-four eligible studies were identified providing data on at least one of the outcomes. Progression rates of AK to SCC ranged from 0% to 0·075% per lesion-year, with a risk of up to 0·53% per lesion in patients with prior history of nonmelanoma skin cancer. Rates of regression of single lesions ranged between 15% and 63% after 1 year. The data available on recurrence rates of single lesions 1 year after regression indicate a recurrence rate of 15-53%. Data on the relative change of total AK count over time are heterogeneous, and range from -53% to +99·1%. Spontaneous complete field regression rates range from 0% to 21%, with recurrences in 57%. In general, the available data are limited. Important methodological limitations apply. Currently, no reliable estimates concerning the frequency of AK developing into invasive carcinoma can be given, and further studies are needed.

["Happy shooting" injury of a German KFOR soldier in Kosovo]. / Verletzung eines deutschen KFOR-Soldaten durch "happy shooting" im Kosovo.

In this case report we describe a 24-year-old German KFOR soldier who was injured in the night of New Year's Eve 2009/2010 during the Kosovo Mission by a falling bullet in the right shoulder. The falling bullet was a full metal jacket probably shot during a "happy shooting" by a civilian.

Adverse reactions caused by consecutive injections of different fillers in the same facial region: risk assessment based on the results from the Injectable Filler Safety study.

BACKGROUND: The combination of different injectable fillers in one area is considered to increase the risk of adverse reactions. OBJECTIVES: To characterize adverse reactions in patients who received more than one filler in the same facial region. METHODS: Data (up to July 2009) of the Injectable Filler Safety Study, a German-based registry for adverse filler reactions, was analysed descriptively. All cases were discussed individually. RESULTS: In 22 of the 161 patients (13.7%), two or more different fillers were injected consecutively into the same facial region. All patients were female with an average age of 50.6 (SD 13.6) years. In 12 of the 22 patients (54.5%), a specific filler could be attributed to the adverse reactions whereas in the other 10 patients (45.5%), the filler was not clearly attributable to one filler substance causing the adverse reactions. CONCLUSIONS: With the continuous changes in the filler market, the combination of different fillers in one area becomes more likely. Based on our data, there is not a lot of evidence that the combination of different injectable fillers, specifically biodegradable fillers, in the same region increases the risk of adverse reactions.

[German military surgeons in deployment abroad: life and working conditions]. / Deutsche Militärchirurgen im Auslandseinsatz : Lebens- und Arbeitsbedingungen.

Since 1992 the German Bundeswehr has been deployed for securing peace and peacekeeping abroad. Since then 83 German soldiers have been killed and overall 129 wounded in action as of 07.12.2009. In Northern Afghanistan the German Bundeswehr runs a combat support hospital (role 3) in Mazar-e-Sharif providing a multidisciplinary capability profile. Furthermore, there are two role 2 medical treatment facilities for primary surgical trauma care located in Kunduz and Feyzabad. In these role 2 facilities life saving procedures and damage control operations are performed in order to enable rapid evacuation to a higher level of care. Thereby military surgeons are often confronted with various medical and logistic challenges. The German Navy also has two equivalent role 2 medical treatment facilities (Naval Rescue Centers) aboard its two combat support ships (CSS) "Berlin" and "Frankfurt am Main" to support maritime task groups operating worldwide. These floating field hospitals provide an indispensable asset in the medical emergency care of naval operations with difficult space-time factors. Due to the specific operating alliance between CSS and Naval Rescue Center, special operations as well as evacuation and humanitarian missions following disasters near the coastline can be effectively accomplished.

Effect of diltiazem on histamine- and carbachol-induced bronchospasm in normal and asthmatic subjects.

Recently, several transmembrane calcium-channel blockers have been used in experimental models to investigate the mechanisms through which Ca++ ions contribute to the regulation of the contractile response of airway smooth muscle and to determine the therapeutic use of these drugs in bronchial asthma. Since the data from these studies are inconsistent and inconclusive, we studied the effect of diltiazem, a calcium-channel blocker previously not examined to our knowledge, on histamine- and carbachol-induced bronchoconstriction in healthy and in asymptomatic allergic bronchial asthma. The study was performed in a double-blind, randomized, placebo-controlled fashion, using a single oral dose of 60 mg of diltiazem. Airway reactivity to histamine and carbachol expressed by PD35SGaw was significantly but weakly attenuated by diltiazem in the asthmatic, but not in the normal subjects. Baseline lung function was not significantly influenced by diltiazem. We concluded that the effect of diltiazem on unspecific airway hyperresponsiveness in asthmatic subjects is too weak to justify a recommendation as therapy.

Bronchodilator effect of theophylline preparations and aerosol fenoterol in stable asthma.

To compare the acute bronchodilator effect of increasing doses of intravenous theophylline and inhaled beta adrenergic agonists, we administered intravenous theophylline dissolved in ethylenediamine or proxyphylline and diprophylline or placebo in a double blind fashion to nine asthmatics on three different days. At each session, 100 mg theophylline or placebo were given during each of five subsequent periods of 30 minutes' duration and followed by inhalation of 0.4 mg fenoterol. In contrast to placebo, 500 mg theophylline in ethylenediamine or proxyphylline and diprophylline significantly decreased mean specific airway resistance (SRaw in cmH2O.s) from 31.2 to 23.6 or 34.2 to 23.5 at theophylline serum concentrations of 14.4 or 16.6 mg/L, respectively. Fenoterol lowered SRaw to about 40 percent of the respective baseline values independent of theophylline or placebo pretreatment. We conclude that the acute bronchodilator effect of theophylline is weak in comparison to inhaled beta agonists. Furthermore, proxyphylline and diprophylline cause a weak but not significant bronchodilation when compared to ethylenediamine.

Sterilization of enzyme glucose sensors: problems and concepts.

A useful method of enzyme glucose sensor sterilization has not only to ensure the needs of sterility assurance but has also to guarantee the functional stability of the sensors. The action of 2 or 3% alkalinized glutaraldehyde solution, as well as gamma irradiation with a dose of 25 kGy caused changes of the in vitro functionality and polymer material irritations, respectively. After a combined treatment by 0.6% hydrogen peroxide solution acting over 4 days with 7 kGy gamma irradiation only a slight loss of sensitivity must be registered. The combination of a specially designed universal homogeneous ultraviolet irradiation over 300 s with a 3 days lasting treatment by an inclusion compound of hydrogen peroxide with tensides in urea (0.15% effective hydrogen peroxide concentration) did not cause any influence on the glucose sensor function in vitro. With all methods tested here, a Bacillus subtilis spore reduction over 8 log(10) cycles from 10(6) to 10(-2) spores per test object on an average could be proved experimentally. In general, if non-thermal methods must be used it seems to be impossible to guarantee a sterility assurance level of 10(-6) as it is demanded by the pharmacopoeias. Consequently, effective concepts to produce sterile glucose biosensors for medical and biological applications should be based not only on final product treatments but should include germ reducing measures in every manufacturing step.

The influence of antimicrobial treatments on the cytocompatibility of polyurethane biosensor membranes.

The cytocompatibility of polyurethane membranes was tested following ultraviolet or gamma irradiation as well as treatment with hydrogen peroxide or glutaraldehyde containing solutions. Despite the fact that all of the methods had been recommended for antimicrobial treatment of glucose biosensors, the treatments investigated significantly influenced cytocompatibility characteristics. Cytotoxicity of membrane eluates was not observed following irradiation treatments. This was also the case when the membranes were repeatedly washed following chemical treatment. Cell growth upon the membranes was stimulated to a different extent after gamma and UV irradiation as well as following hydrogen peroxide treatments. Residues of an urea-based hydrogen peroxide inclusion compound caused a restriction in cell growth upon the membranes as was similarly observed with 2 and 4% glutaraldehyde solutions acting over 2 and 4 h, respectively. It is concluded that cytocompatibility in vitro reflecting the host response against a biomaterial in vivo does not only depend upon the material itself but also upon antimicrobial treatments which could have consequences for its bioperformance characteristics.

Oesophageal transport of solid dosage forms depends on body position, swallowing volume and pharyngeal propulsion velocity.

Knowledge about transit of solid dosage forms (SDF) in the gastrointestinal tract is incomplete. Detection of magnetically marked capsules (MMC) via superconducting quantum interference device (SQUID) allows monitoring of oesophageal transport of SDF with high tempospatial resolution. The aim of the study was to investigate the influence of body position, volume at swallowing, and oesophageal motility on orogastric transport of SDF. In 360 measurements we determined tempospatial characteristics of orogastric transit of SDFs by a SQUID device in six volunteers. They swallowed MMCs with various amounts of water in upright and supine position with and without simultaneous oesophageal manometry. Orogastric transit time, oesophageal transport velocity and rate of oesophageal retention of SDF depend on swallowing volume and body position at all experimental conditions. At 50 mL water bolus and in upright position, the retention rate depends on the pharyngeal propulsion velocity, and the transport velocity of MMCs in the oesophageal body are faster than the propulsive oesophageal contractions. Body position, swallowing volume and pharyngeal propulsion velocity markedly influence the oesophageal transport of SDF. They should be taken in upright body position with at least 50 mL of water to minimize entrapment in the oesophagus.

Brain metastases of an amelanotic melanoma as the primary manifestation in a 15-year old boy.

A 15-year old boy was admitted to hospital with an acute left hemiparesis because of a 3.5 cm-diameter-tumor in the right frontoparietal region. In CCT 4 other tumors were to be seen in both hemispheres after giving contrast medium. Upon a diagnostic operation, a hemorrhage into a metastasis of an amelanotic melanoma was found. The boy survived 2.5 months. In the pathological examination the primary tumor was not found, but there were 12 other intracerebral metastases and two metastases in the left lung and the thyroid gland. Histologically it was an amelanotic melanoma.

Determination of the disintegration behavior of magnetically marked tablets.

The disintegration behavior of different tablets that were marked as magnetic dipoles by the incorporation of ferromagnetic black iron oxide and subsequent magnetization was studied using a specially developed measurement setup. This novel apparatus records the magnetic induction generated by the magnetic dipole moment of the tablets during their disintegration. It was found that the observed decrease of the magnetic induction can be used for a quantitative determination of the disintegration of tablets. In particular, it could be shown that the magnetic data provide information about the disintegration mechanism. For tablets with a minor influence of swelling on the disintegration mechanism a linear decline of the magnetic fluxes was observed. After addition of swelling disintegrants (crospovidone) the decline of the magnetic flux could be fitted by an exponential function, indicating the involvement of a disintegration force. Furthermore, the data demonstrate that using modern multichannel biomagnetic measurement equipment the monitoring of the disintegration behavior of magnetically marked tablets in humans will be possible.

Dihydroergotoxine: separation and determination of four components by high-performance liquid chromatography.

The evaluation of a new high-performance liquid chromatographic method is described. It permits the separation and determination of the four components of dihydroergotoxine (dihydroergocristine, dihydroergocornine, dihydro-alpha-ergocryptine, and dihydro-beta-ergocryptine) in a single step. On reversed-phase microparticles, complete baseline separation is possible with different mobile phases containing about 10(-2) M base. The analysis of dihydroergotoxine mesylate drug substance or its dosage forms can be carried out in about 15 min. No reference substance is required for the determination of the proportions of the components. This method is simple and exhibits high accuracy, reproducibility, and selectivity. It permits the analytical control of dosage forms containing dihydroergotoxine mesylate to ensure that they comply with the specifications for the drug substance used in clinical and pharmacological studies.

Physico-chemical, in vitro and in vivo characterisation of polymers for ocular use.

The influence of artificial tear fluid (AT) on ionic and nonionic ophthalmic polymer excipients was rheologically established. In usual concentrations polyvinylalcohol, polyvinylpyrrolidone, dextran, hydroxypropylmethylcellulose, hydroxyethylcellulose and methylcellulose did not show any changes. In contrast, solutions of polyacrylic acid, sodium hyaluronate (S-Hya), sodium alginate (S-Alg) and chitosan decrease the apparent viscosity in contact with AT, while gellan solution increases the viscosity and shows thixotropy. The adhesion of selected polymers (polysaccharides) on mucin was evaluated using a rheological method and resulted in the order S-Hya > Gellan > S-Alg > dextran. Miosis testing of Gellan containing pilocarpine HCl formulations in rabbits shows a possible reduction of drug concentration from 2% to 0.5% obtaining the same bioavailability.

Development of a sterilizing in-place application for a production machine using Vaporized Hydrogen Peroxide.

The use of steam in sterilization processes is limited by the implementation of heat-sensitive components inside the machines to be sterilized. Alternative low-temperature sterilization methods need to be found and their suitability evaluated. Vaporized Hydrogen Peroxide (VHP) technology was adapted for a production machine consisting of highly sensitive pressure sensors and thermo-labile air tube systems. This new kind of "cold" surface sterilization, known from the Barrier Isolator Technology, is based on the controlled release of hydrogen peroxide vapour into sealed enclosures. A mobile VHP generator was used to generate the hydrogen peroxide vapour. The unit was combined with the air conduction system of the production machine. Terminal vacuum pumps were installed to distribute the gas within the production machine and for its elimination. In order to control the sterilization process, different physical process monitors were incorporated. The validation of the process was based on biological indicators (Geobacillus stearothermophilus). The Limited Spearman Karber Method (LSKM) was used to statistically evaluate the sterilization process. The results show that it is possible to sterilize surfaces in a complex tube system with the use of gaseous hydrogen peroxide. A total microbial reduction of 6 log units was reached.

De novo Renal Transplantation after Kaposi Sarcoma: Favorable Outcome in a Patient Receiving Sirolimus and Mycophenolate-Based Immunosuppression.

Immunosuppressive treatment increases the risk of infection and malignancy in organ transplant recipients. We report on a 42-year-old male renal transplant recipient who lost his first graft after reduction of immunosuppressive treatment due to Kaposi sarcoma and who successfully underwent a second renal transplant 10 years later. The patient's current treatment consists of low-dose prednisone, and the two antiproliferative immunosuppressants mycophenolate mofetil and rapamycin. 4.5 years after his second transplant, the serum creatinine is 1 mg/dl and the patient has no signs of recurrent disease.