Significant differences in functional outcome between upper and lower limbs after vascular trauma of the extremities.

BACKGROUND: This study aimed to compare the functional results between upper (UE) and lower extremity (LE) following arterial reconstruction due to vascular trauma. METHODS: Patients treated for arterial injuries with vascular reconstruction at two centres between 2005 and 2014 were assessed. The physical fitness questionnaire - Fitnessfragebogen (FFB-Mot) - was evaluated. The differences between pre- and post-traumatic values were compared statistically for UE and LE. Inability to return to the preoperative workplace or postoperative loss of at least 10% of the FFB-Mot were defined as the primary outcome events. RESULTS: Twenty-seven patients could be re-evaluated. The primary outcome event occurred in 52% (14/27) without significant difference between UE (43%) and LE (62%) (p = 0.45). The difference between the pre- and post-traumatic FFB-Mot scores showed a significantly poorer functional outcome after LE vascular injury (p = 0.012). CONCLUSION: Results indicate a poorer functional outcome after vascular extremity trauma to the LE than to the UE.

Daylight photodynamic therapy versus cryosurgery for the treatment and prophylaxis of actinic keratoses of the face - protocol of a multicenter, prospective, randomized, controlled, two-armed study.

BACKGROUND: Photodynamic therapy with daylight (DL-PDT) is efficacious in treating actinic keratosis (AK), but the efficacy of field-directed, repetitive DL-PDT for the treatment and prophylaxis of AK in photodamaged facial skin has not yet been investigated. METHODS/DESIGN: In this multicenter, prospective, randomized, controlled, two-armed, observer-blinded trial, patients with a minimum of 5 mild-to-moderate AK lesions on photodamaged facial skin are randomly allocated to two treatment groups: DL-PDT with methyl aminolevulinate (MAL) and cryosurgery. In the DL-PDT group (experimental group), 5 treatments of the entire face are conducted over the course of 18 months. After preparation of the lesion and within 30 min after MAL application, patients expose themselves to daylight for 2 h. In the control group, lesion-directed cryosurgery is conducted at the first visit and, in the case of uncleared or new AK lesions, also at visits 2 to 5. The efficacy of the treatment is evaluated at visits 2 to 6 by documenting all existing and new AK lesions in the face. Cosmetic results and improvement of photoaging parameters are evaluated by means of a modified Dover scale. Primary outcome parameter is the cumulative number of AK lesions observed between visits 2 and 6. Secondary outcome parameters are complete clearance of AK, new AK lesions since the previous visit, cosmetic results independently evaluated by both patient and physician, patient-reported pain (visual analogue scale), patient and physician satisfaction scores with cosmetic results, and patient-reported quality of life (Dermatology Life Quality Index). Safety parameters are also documented (adverse events and serious adverse events). DISCUSSION: This clinical trial will assess the efficacy of repetitive DL-PDT in preventing AK and investigate possible rejuvenating effects of this treatment. (Trial registration: ClinicalTrials.gov Identifier: NCT02736760). TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02736760 . Study Code Daylight_01. EudraCT 2014-005121-13.

Patient satisfaction after the treatment of glabellar lines with Botulinum toxin type A (Speywood Unit): a multi-centre European observational study.

BACKGROUND: Whilst the efficacy and safety of glabella complex treatment with botulinum toxin type A (Speywood Unit) [BoNT-A (s.U)] has been comprehensively studied, there are very few trials on patient-reported outcomes and patient satisfaction associated with this treatment. OBJECTIVE: To assess the level of patient satisfaction 3 weeks and 4 months after the treatment of glabellar lines with BoNT-A (s.U). METHODS: This is a multi-centre, prospective, non-interventional observational study carried out in France, Germany, Spain and the United Kingdom. Subjects were eligible if the investigator had already decided to prescribe BoNT-A (s.U), according to the labelling. Subjects completed a questionnaire at both 3 weeks and 4 months after treatment. RESULTS: About 533 subjects completed at least one of the two questionnaires. About half of the subjects (47.9%) were naive to BoNT-A treatment of the glabella, while 50.6% had previously received another product. A high level of satisfaction was observed after the treatment, with 94.7% and 89.6% of subjects being satisfied or very satisfied with the aesthetic outcome at week 3 and month 4, respectively. Treatment was safe and well tolerated, as directly determined in the survey. Major reasons for satisfaction included the positive aesthetic outcome, a natural appearance, a rested look and comfort of injection. Most subjects felt the treatment brought them 'harmony', 'self-esteem/confidence' or 'youth'. Of the subjects who had previously been treated with another product, 51.2% considered the results obtained in the present study with BoNT-A (s.U) were better. CONCLUSION: Treatment of the glabellar lines with BoNT-A (s.U) led to a high level of patient satisfaction and a more positive self-perception up to 4 months after the treatment, regardless of whether the patients were naive or not to BoNT-A treatment.

[Treatment of crow's feet with two different botulinum toxin type A preparations in split-face technique]. / Botulinumtoxin Typ A im Halbseitenvergleich. Wirksamkeit und Verträglichkeit bei der Behandlung von Krähenfüßen.

BACKGROUND: For the first time, the effectiveness of Xeomin®, and Dysport® in an dose-ratio of 1:3 treating crow's feet (FWS 2-3) was evaluated in a double-blind randomized pilot study. PATIENTS AND METHOD: Xeomin® (12 units) was compared to Dysport® (36 units) in an intra-individual split-face technique in 22 patients over a period of 4 months. According to the facial-wrinkle-scale (FWS) patients were rated as responders with an improvement of at least 1 point in FWS. RESULTS: One month after treatment significantly more than 80% of patients were rated as responders. The different products proved to be equivalent in response rate and effectiveness with no significant difference after 4 weeks and 4 months in statistical analysis. Surprisingly the decrease in FWS of crows' feet at rest was more pronounced. CONCLUSION: The different botulinum toxin type A formulations proved to be equivalent in effectiveness and tolerability in a dose ratio of 1:3 (Xeomin®: Dysport®) The more pronounced decrease of crow's feet at rest points out the importance of muscle insertion into the skin for the cosmetic result in the periorbital region.

[Does dilution have an impact on cosmetic results with BoNT/A? Complex-protein-free BoNT/A for treatment of glabella lines]. / Beeinflusst die Verdünnung das kosmetische Ergebnis von BoNT/A? Komplexproteinfreies BoNT/A zur Behandlung der Glabellafalte.

BACKGROUND: In this 2-armed, randomized study we investigated the efficacy and tolerability of complex-protein-free botulinum neurotoxin type A (BoNT/A), applied in two different dilution volumes for treatment of glabellar lines. PATIENTS AND METHODS: 40 patients with grade 2-3 glabellar lines (Facial Wrinkle Scale) received treatment with 25U BoNT/A (Xeomin). 100U of botulinum neurotoxin were diluted in 2.5 ml (group I) or 4 ml sodium chloride solution (group II). Responders showed an improvement in the wrinkle score (independent rater) of at least one point. RESULTS. Response rates two weeks after treatment were 100% / 89.5%, at 3 months 84.2% / 64.7% and at 4 months 53.3% / 61.5% (groups I / II respectively). There was no significant difference between the two dilutions. CONCLUSION: Complex-protein-free botulinum neurotoxin type A in both dilutions effectively reduced severity of glabellar lines. There was no statistically significant difference in efficacy between the two dilutions.

[Significance of blepharoplasty in dermatologic surgery]. / Stellenwert der Oberlidkorrektur in der Dermatochirurgie.

Upper eye lid blepharoplasty is one of the most commonly practiced surgical treatments in aesthetic medicine. Careful patient selection, thorough preoperative planing, and exact surgical treatment lead to optimal results. CO(2) laser assisted surgery provides a dry and clear surgical field, allowing precise tissue control. On the other hand CO(2) laser subsurfacing leads due to thermal effect to a shrinking of the lax orbital septum, and reduces the need for orbital fat resection or even allows one to avoid fat resection. Periorbital combination treatments in most cases allow smaller or less invasive procedures, reducing risk factors. Additionally they adapt to individual anatomic structures, different needs in outcome and show synergistic effects. Aesthetic dermatology incorporates many conservative and invasive approaches, so that upper eyelid blepharoplasty in dermatologic surgery is widely accepted and well-established.

[The indications for and results of HDR afterloading therapy in diseases of the skin and mucosa with standardized surface applicators (the Leipzig applicator)]. / Indikationen und Ergebnisse der HDR-Afterloading-Therapie bei Erkrankungen der Haut und Schleimhaut mit standardisierten Oberflächenapplikatoren (Leipzig-Applikator).

BACKGROUND: In our department we have developed a standardized applicator for HDR brachytherapy of surface lesions, the so called Leipzig-applicator. We have used this method since September 1987, initially with a Decatron remote afterloading machine, but more recently from November 1990 with a microSelectron-HDR. We report about our experience of 10 years. PATIENTS AND METHOD: Since 1987 we treated 520 patients in 3,026 fractions with this method. In most of the cases we irradiated tumors of the skin of the face, but we also treated tumors of the mouth, of the tongue, of the perianal region and the external genitalia. The histological types were in most of the cases squamous cell carcinomas and basal cell carcinomas, but we also treated tumors like Kaposi-sarcomas, melanomas and skin manifestations of lymphomas and solid organ tumors. We also irradiated benign lesions like keloids after excision. We use single doses between 5 and 10 Gy once to twice a week. The isodose distribution was depending of the tissue infiltration of the tumor. The total dose was 30 to 40 Gy. RESULTS: In 91% of the cases we obtained a complete remission of the tumor, in 6% a partial remission. Recurrences appeared in 8% of the patients. In most cases the reason of the recurrence was a lower brachytherapy dose because of a prior radiotherapy. We didn't observe any severe late radiation reaction. CONCLUSION: We consider that our series of patients treated with HDR brachytherapy and a range of standardized applicators demonstrates that this is a successful method of treating surface lesions.

[The initial results on the radiobiological comparability of continuous LDR irradiation and PDR irradiation using a guinea pig skin animal model]. / Erste Ergebnisse zur strahlenbiologischen Vergleichbarkeit einer kontinuierlichen LDR-Bestrahlung und einer PDR-Bestrahlung mit Hilfe des Tiermodells Meerschweinchenhaut.

AIMS: The classic continuous low dose rate (LDR) brachytherapy was very important in such cases with a higher risk of severe especially late radiation reactions. From clinical experiences and radiobiological considerations it is known, that the therapeutic ratio of LDR is higher than HDR. Another way to combine the therapeutic ratio of LDR and the possibility of optimisation is the use of pulse dose rate (PDR) technique. The PDR-technique is a method, which can be compared with continuous LDR-therapy. PDR should have biological effects equivalent to conventional LDR. MATERIAL AND METHODS: We have tried to compare the classic continuous LDR-technique with 2 PDR-regimes by means of the guinea pig skin model. In this test series we involved 20 female animals with an initial weight of 400 to 500 g. We compared radiation reactions of following regimes: 1. Continuous LDR regimen with a cobalt-60 source with an activity of 5.5 mCi 30 Gy in 60 hours. 2. PDR regimen 0.5 Gy hourly, pulse length minimal 10 minutes, 30 Gy in 60 hours with an Ir-192 source with an activity of nearly 40 mCi. 3. PDR-regimen 0.8 Gy hourly with 9 hours night break (10.00 p. m. to 7.00 a. m.). The radiation reaction was controlled by the help of an evaluation table in which the criteria of radiation reaction were classified according to the degree of seriousness. The observation time is now minimal 14 and maximal 24 months. RESULTS: The findings shows a significant coincidence of early and late radiation reactions of the skin fields irradiated with the continuous LDR-technique and fields irradiated with the PDR-technique. There was not a difference of the radiation reactions between PDR-irradiation with and without night break. CONCLUSIONS: Generally it is possible to compare the radiation reactions of PDR-irradiation and the classic continuous LDR-brachytherapy. It is also possible to use a PDR-regimen with a night break of 9 hours. But results must be calculated for each tissue of interest, in our test consequently for guinea pig skin.

[The methods and results of simultaneous radiochemotherapy with carboplatin in advanced cervical carcinomas]. / Methode und Ergebnisse der simultanen Radiochemotherapie mit Carboplatin bei fortgeschrittenen Zervixkarzinomen.

PURPOSE: The frequency and the poor therapeutic results in advanced cervical cancer establish the demand for effectiveness of treatment. Recent clinical data have shown that simultaneous radiochemotherapy may yield high remission rates in squamous cell carcinomas of other organs. PATIENTS AND METHODS: In our Department of Radiotherapy and Radiooncology of the University of Leipzig we treated since 1.6.1991 17 patients with advanced cancer of the uterine cervix with a simultaneous radiochemotherapy with carboplatin. RESULTS: The rate of complete remission was 76%. Follow-up is available from six to 24 months. Severe or toxic side effects of the treatment we didn't observe. Eight (47%) patients live relapse-free. CONCLUSIONS: In our opinion randomized studies are required to determine: What is better? Simultaneous radiochemotherapy or radiotherapy?

[Radiobiological research to optimize high-dose-rate afterloading therapy with Ir-192 in extragenital tumors]. / Strahlenbiologische Untersuchungen zur Optimierung der High-dose-rate-Afterloadingtherapie mit Ir-192 bei extragenitalen Tumoren.

Since the introduction of the high-dose rate afterloading therapy a higher biological effectivity of this method has been well known in comparison with the low-dose contact therapy. This will practically taken into account by reducing the dose and more fractionating of the total dose. With our test we want: firstly to prove the influence of the therapy break on the duration of the radiation reaction. Secondly we want to prove the influence of the dose rate on the efficiency of the radiation reaction. We have tried to answer the question by the animal model guinea pig skin. We examined early reactions as well late reactions.

[Examination of the differential hematocrit and the plasma viscosity under the influence of ionizing radiation]. / Orientierende Untersuchungen zum Differentialhämatokrit und zur Plasmaviskosität unter dem Einfluss ionisierender Strahlen.

Systematic investigations into the impact of haemorheological parameters through ionizing rays are not available in literature. The main factors influencing the flow capacity of the blood were determined in vitro by using a set of special methods. Even by using high dosages of irradiation (600 R) only those changes in the flow capacity of the blood could be identified which lay in or near the dispersion area of the methods. These investigations carried out in vitro only take into account the immediate effect of the blood and not rheological changes caused by the intact organism after irradiation.

Effect of beta-adrenergic blockade on the circadian rhythm of myocardial ischemia in ambulatory patients with stable angina.

The antiischemic efficacy of the beta 1-selective blocker Bisoprolol at a dose of 10 mg daily was examined in an open pilot study during steady state. ST-segment analysis was obtained during a 14-day treatment period by means of Holter monitoring in 13 patients with documented stable coronary heart disease (CHD) and an average age of 61 years. beta-Blockade produced a 30% reduction in the frequency of ischemic episodes. There were statistically significant reductions in the mean duration of the ischemic episodes from 19 to 12 min, in the sum of ST-segment deviations in all episodes from 1.35 to 1.0 mV, and in the mean number of ischemic episodes per day from 7 to 5. The intensity of the ischemic episodes (mV x s) was reduced by two-thirds. The circadian distribution of ischemic episodes was linked to the circadian rhythm of heart rate (HR), and the antiischemic effect paralleled the negative chronotropic effect of beta-blockade. beta-Blockade had a greater effect on HR during the day (-20 beats/min) than during the night (-10 beats/min). A possible secondary antiarrhythmic effect was the 80% decrease in ventricular extrasystoles.

[Initial results of high-dose-rate afterloading treatment of tumors in the head and neck region]. / Erste Ergebnisse der High-dose-rate-Afterloading-Behandlung von Tumoren im Kopf-Hals-Bereich.

First results of high-dose-rate afterloading therapy in the head-neck area are encouraging. The procedure is not very invasive and is suitable especially for older patients, not tolerating much, who can be hardly submitted another therapeutic method. The limited spatial dose distribution allows a careful treatment of the surrounding tissue in spite of the application of high single doses, however limits the size of tumors too, that the afterloading therapy is possible in (max. 2 cm). The method represents an alternative of the much more complicated procedure of the low-dose contact therapy, that affects the patients in a stronger way like interstitial therapy and moulage treatment. No tumor recurrences or metastasis were seen in our patients. Influence of alteration in fractionation rhythm and of application of sources with very high dose capacity will be the subject of further studies.

[Effectiveness of programme for early detection of recurrence of endometrial carcinoma (author's transl)]. / Zur Effektivität eines Programmes der Rezidivfrüherkennung beim Endometriumkarzinom.

An intensive after-care programme for early detection of recurrence was applied to 340 patients with endometrial carcinoma. This approach proved to be effective by comparison with a control group, since 26 cases of recurrence (7.6 per cent), largely without symptoms, were identified sooner after primary therapy. While only some of the author's efforts for early recurrence detection were translatable into recurrence therapy, they feel that they should continue their after-care programme within justifiable limits. More information on therapeutic results regarding recurrence of endometrial carcinoma is expected to become available in the forthcoming years. Programme effectiveness must be judged by survival result rather than by expenses.

[Effectiveness of programme for early detection of recurrence of cervical carcinoma (author's transl)]. / Zur Effektivität eines Programmes zur Rezidivfrüherkennung beim Zervixkarzinom.

Various diagnostic methods, generally suitable for early diagnosis of carcinoma recurrence, were used in a systematic localised search programme on 799 patients with invasive cervical carcinoma. The practicability of a concept for early detection of recurrence was verified and established by shortening of latency from first manifestation to recurrence and by more frequent detection of recurrent processes even without symptoms. Reported are methods selected from the programme for their suitability for early recurrence detection. These were necessarily restricted to detection of localised recurrence, following radiological or combined treatment, whereas early detection of parametrial and pelvic wall recurrences seemed to be purposeful, too, when preceded exclusively by primary surgical therapy. Rates of survival, following at least one year of recurrence observation, were encouraging and the support of the view that early detection of recurrence might help to improve the chance of healing.