[Responsibility and function of Research Ethics Committees]. / Aufgaben und Arbeitsweise Medizinischer Ethik-Kommissionen.

In Germany, only Research Ethics Committees (REC) set up according to States law at Faculties of Medicine, Medical Associations or States authorities are entitled to assess all areas of biomedical research. In a multidisciplinary review, research projects are evaluated using the criteria "scientific quality", "accordance with law" and "ethical acceptability". Since 2004, the "favorable opinion" of a REC is together with the approval by the competent Federal Authority a legal requirement for drug trials. For all other fields of biomedical research, the opinion of a REC is considered legally not binding advice for the researcher. For sharing of experiences, for harmonization of their work and for partnership with the public, the local-independent RECs established the "Permanent Working Group of German Research Ethics Committees". This group functions to a certain degree like central RECs in other States.

[Reorganization of the procedures and the tasks of the responsible ethics committees after the 12th AMG amendment. Concepts of the permanent working group of the medical ethics committees in Germany]. / Neuordnung des Verfahrens und der Aufgaben der zuständigen Ethik-Kommissionen Konzepte des Arbeitskreises der medizinischen Ethik-Kommissionen in der Bundesrepublik nach der 12. AMG-Novelle.

Since 12(th) of August 2004 the EU Directive 2001/20/EG has been implemented into the national law. The 12th AMG amendment of 30 July 2004 and the good clinical practice decree on the conduct of clinical trials on drugs for human use of 9 August 2004 have been authorized and must be considered for new clinical trials with investigational medical products (drugs). The scope of the changes are to increase the quality of clinical trials and to continue the process of harmonization within the European Community. Based on the new law the sponsor has to apply for approval by the competent authority and for a favourable opinion by the responsible ethics committee. Both procedures are independent; a favourable opinion of the responsible ethics committee is a necessary condition before starting the trial. Thus, the role of the ethics committees has been changed; the committees are considered as an institution comparable to an authority to protect the rights and safety of human subjects involved in clinical trials. The permanent working group of the medical ethics committees in Germany has established a procedure to meet these requirements, particularly in the case of multicentre clinical trials, where only a single opinion shall be given for each member state. This article describes this procedure (application, process of ethical consideration among the leading and local ethics committees in multicentre trials, responsibilities during the trial).

[Animal experiment studies on the functional evaluation of hydronephrosis with non-catheter unilateral determination of 131I-hippuran clearance]. / Tierexperimentelle Studien zur Funktionsbeurteilung von Harnstauungsnieren mit der katheterlosen seitengetrennten Bestimmung der 131J-Hippuran-Clearance.

In 64 dogs the influence of a sudden unilateral ureteral obstruction on renal blood flow (RBF), on renal extraction of PAH and 131I-hippurate and on kidney function as determined by clearance methods was studied. By measuring the venous blood flow, using the method of Bretschneider, a decrease of the RBF was observed generally although in some cases the RBF remained constant or even increased. The arterial blood flow, controlled by electromagnetic means, showed a tendency to increase but in some cases remained constant or decreased. In all cases, independent of the reaction of the RBF to acute ureteral obstruction, a significant decrease of the renal extraction of PAH as well as of 131I-hippurate was observed. This decrease of kidney function was found by conventional methods (PAH- and 125I-hippurate clearance in "steady state" technique), whereas by external measurement of the 131I-hippurate clearance different results were obtained leading to the assumption of an increase of renal function. Only if urinary flow was free, the three methods agreed in their results. In kidneys damaged by a longer period of ureteral obstruction, these function tests yielded corresponding values only in the case of unimpaired urinary flow. Following repeated ureteral obstruction, external measurement and conventional methods no longer agreed in kidney function determination. In some cases, by external measurement renal function was determined to be higher before opening the ligation of the ureter as compared to the result achieved thereafter.

[Endoprosthetic treatment of a solitary femoral metastasis in follicular carcinoma of the thyroid (author's transl)]. / Endoprothetische Behandlung einer solitären Femurmetastase bei follikulärem Schilddrüsenkarzinom.

A radical surgical resection of a metastasis in the upper part of the femur is paradigmatically discussed. The implantation of a so-called tumour endoprothesis yields a functionally sufficient long-time substitute without local relapsing of tumour during time of observation. Further short-term investigation for tumour spreading is necessary.

[Investigations on 131I-hippurate-clearance in obstructive-uropathy; extraction of para-aminohippuric acid and 131I-hippurate in the acutely obstructed canine kidney (author's transl)]. / Untersuchungen zur 131J-Hippuran-Clearance bei der Stauungsniere; Die Extraktion von Para-Amino-Hippursäure und 131J-Hippuran in der akut gestauten Hundeniere.

The results of more recent clinical and experimental investigations have thrown doubt on the usefulness of determining the individual 131I-hippurate clearance for evaluation of the function of acutely obstructed kidneys. There is a significant difference (5% level) between the kidney performance determined with external measurement on the one hand and with PAH and 125I-hippurate clearance in the steady state on the other. With the steady state method, the restriction of function to be expected in consequence of urinary obstruction is demonstrated, whereas with simultaneous measurement with catheterless 131I-hippurate clearance, an increase in function is detected. In the clearance studies carried out in the conventional way with PAH and 125I-hippurate, it was difficult to determine quantitatively the urine produced during urinary obstruction. The renal extraction of p-aminohippuric acid and 131I-hippurate was therefore determined in simultaneous measurement in six dogs before and after acute urinary obstruction with a constant plasma level of the test substances. The results obtained with this very elaborate method which is, however, independent of urine collection show that an acute urinary obstruction leads to a decrease of renal extraction both of PAH and of 131I-hippurate. Since with conventional clearance, the measurement result is proportional to the amount of substance excreted with the urine, a restriction of function must also result with the steady state methods in determining the performance of acutely obstructed kidneys. The results of the extraction investigations hence confirm the results of the clearance studies mentioned. In addition, they show that the "increase" of renal performance immediately after an experimentally induced urinary obstruction repeatedly found with catheterless determination of 131I-hippurate-clearance cannot be explained by a different kinetic behavior of PAH and 131I-hippurate in the acutely obstructed kidney.

[The effect of urinary obstruction on the results of catheterless divided 131I hippuran clearance studies (author's transl)]. / Einfluss von Harnabflussstörungen auf Ergebnisse der katheterlosen seitengetrennten Bestimmung der J-131-Hippuran-Clearance.

During catheterless renal 131I Hippuran clearance studies, the function of each kidney can be calculated from the area integral, which is derived from the total body curve and to segments of phase II of each nephrographic curve measured for 120 seconds after the injection. For this it is assumed that the course of this phase depends entirely on the function of the renal parenchyma and is not affected by other factors such as urinary obstruction. During investigations of obstructed kidneys, considerable discrepancies were found repeatedly between clearances calculated by this method and the operative findings of a paper thin renal parenchyma of the kidney in question. In two cases it has been shown for the first time that there is an unexpected and surprising change in phase II. It follows that urinary obstruction falsifies the results of 131I Hippuran clearance tests, leading to an overestimate of the function of the obstructed kidney.

[Treatment of chronic arterial occlusive disease. Clinical study with a new galenic preparation of Pentoxifyllin (Trental 400) (author's transl)]. / Zur Behandlung der chronischen arteriellen Verschlusskrankheit Klinische Studie mit einer neuen galenischen Zubereitung von Pentoxifyllin (Trental 400).

26 patients suffering from arterial occlusive disease in the legs, stages IIa to IV according to Fontaine classification, and 7 patients with serious vascular disorders in the arm, were treated with daily 3- to 4 X 1 tablet Trental 400 (400 mg Pentoxifylline per tablet) over extended periods. In order to establish the therapeutic efficacy of the drug, influence on microcirculation (133Xenon-muscle clearance), poststenotic blood pressure (Doppler ultrasonic technique), oscillography, walking distance and alteration of clinical stage (following Fontaine classification) were studied. The medication resulted in a significant increase in muscular capillary flow whereby more affected legs showed better response than those initially less impaired. The poststenotic pressure increased significantly in initially more affected arteries and elevation of oscillographic amplitudes was found, too. The walking distance increased markedly, rest pain was removed and the clinical stage according to Fontaine classification changed on a linear scale from the more severe to the light stages of impairment. The patients with vascular disorders in the arms showed good improvement of their condition.

[Studies on renal clearance measurements by nuclear medicine methods (author's transl)]. / Untersuchunge zur nuklearmedizinische Bestimmung der Nierenclearance.

Two mathematical models are employed to describe and interpret the time-activity course in the human body outside the reno-vesical compartment of a tracer that has been injected intravenously by the single-shot method and is excreted via the kidneys. From the results a method is derived which permits a practical determination of total clearance. The individual clearance of each kidney is calculated using a simplified method of background (EPA) correction.

[The aid of bone scans in diagnosis of fibrous dysplasia (author's transl)]. / Uber den Wert der Skeletzintigraphie für die Diagnose der fibrösen Knochendysplasie.

Fibrous dysplasia of the bone does not only occur in childhood as commonly believed, but may also be diagnosed during adult life as a stepwise progressing disease. Bone scans are useful to differentiate active from non-active disease. Suspicious accumulations of the radio-pharmaceutical which may be detected by total body scanning, should be confirmed by roentgen examination as a more specific method. Bone scan is helpful in early detection of focal disease and may visualize lesions in wide-spread disease for further radiological workup.

Renal function after ligation of the left renal vein.

In animal experiments the ligation of the left renal vein after nephrectomy on the right side and the ligation of the suprarenal inferior vena cava is explored by four different methods. Degree and length of postoperative renal dysfunction depend on the preliminary ligation or the narrowing of the suprarenal inferior vena cava. The period of adaptation is correlated to the development of a collateral circulation of the left renal vein.

[Therapy simulator for radiotherapy planning]. / Erfahrungen beim Einsatz eines Therapiesimulators zur Bestrahlungsplanung

The ideas prevailing so far with regard to therapy simulators are represented and the type of the simulator used is described; after that, the range of problems a simulator is applied to, is being analysed more detailedly. The use of the simulator is necessary within two phases of irradiation planning: Firstly, to trace that cross-sectional view of the body which is best adapted to dosage planning along with a preliminary adjustment informing upon the beam directions and the field sizes needed. Secondly, to accomplish the final fixation of the needed beam directions and field sizes inclusively the marking of cutaneous fields, a definitive schedule of doses having been laid down before. The requirements, therapy simulators have to meet according to these considerations, are discussed.

[Results of radiotherapy of bronchial carcinoma (author's transl)]. / Ergebnisse der Strahlenbehandlung des Bronchialkarzinoms

In a joint retrospective study by 17 radiotherapy clinics in German-speaking countries the results of treatment of bronchial carcinoma after radiotherapy were analysed in 7503 cases. The age peak was between the 60th and 70th year. Squamous-cell carcinoma was the most frequent histological type, followed by anaplastic carcinoma, with adenocarcinoma being rare. There was a high proportion of histologically not clearly identified cases (27% in central and 35% in peripheral carcinomas). Survival rate at one year was 31% for central (3662 patients) and peripheral (961 patients) tumours, but only 2% at five years. Prognostically there was no difference between histological types and kind of radiotherapy or technique, but total dose affected survival rate. At a total dose of less than 5000 rd the survival rate at five years was minimal. The prognosis of combined surgical and radiotherapeutic measures was slightly better than with a radiotherapy alone, but results were unpredictable for the individual case. It is concluded that radiotherapy aiming at cure should be used in imoperable bronchial carcinoma if the tumour state and general condition of the patient appear to make a cure possible. But if this is not the case, radiotherapy should be used only palliatively, i.e. only to ameliorate symptoms.

[Radiological diagnosis of echinococcus disease in man (author's transl)]. / Radiologische Diagnostik bei der Echinokokkus-Erkrankung des Menschen

The position of radiological diagnostics in the context of the diagnosis of echinococcosis was discussed on the basis of 11 examined cases of Echinococcus cysticus (9) and Echinococcus alveolaris (2). General thoracic x-rays as well as radiological examination of the gastrointestinal track and the kidneys were used to establish the extent of echinococcosis and to determine the involvement of neighboring organs. Diagnosis of the liver is generally of major interest diagnostically. With a scintigram of the liver, parenchymatous lesions of 2-4 cm and larger can be diagnosed with an optimal examination technique. The scintigram used in connection with the arteriogram can clarify the extent of the parenchymatous lesions. The celiacogram is the most important of the morphological liver diagnostic methods. It can be augmented by the selective hepaticogramm. An exact localization and the relationship of the process to the vessels is possible only with the celiacogram. In addition, the exclusion of other liver processes for the differential diagnosis is possible with the angiogram. The direct splenoportography is for the most part, replaced today by the indirect splenoportogram, it is only used now for special problems.

[Transferrin variants: significance and identification in paternity cases (author's transl)]. / Die Bedeutung und Zuordnung von Transferrin-Varianten in der Abstammungsbegutachtung

Transferrin phenotypes were determined in 3380 sera of unrelated persons of the western region of Germany with 97.60 percent for TfC and 2.40 percent for Tf variants. Identification was achieved by immunochemical means or through autoradiography. Relative mobilities in some variants were measured using Tf B2C (0.7) as reference. Application of Tf variants is demonstrated in paternity cases.