[Studies and Publication Practice in Pediatric Hematology and Oncology in Germany--An Analysis of the Period 1970-2006]. / Studien und Publikationspraxis in der PädiatrischenHämatologie und Onkologie in Deutschland--Analyseder Jahre 1970­2006.

BACKGROUND: Several therapy optimization studies (TOSs) for the treatment of hematologic and oncologic disorders in children and adolescents have been conducted in Germany. The publication of research results is necessary to ensure that future studies are well designed and based on relevant and unanswered questions. This retrospective cohort study was conducted to analyze the study- and publication practice in this field. METHODS: All study protocols in the field of the pediatric oncology and hematology in Germany were collected. Relevant data from study protocols were extracted, beginning with 1) general information about the study protocol, and 2) information about each methodological trial. In a second step, the publication practice was characterized by searching in electronic databases and by contacting principal investigators. Relevant Data of each publication was extracted. RESULTS: The research activity has increased significantly in the past few years. The found publication rate of 85% represents an outstanding publication practice. Additionally, German, as being the main publication language a few decades ago, has been almost completely replaced with English. An acceptable methodological conduct was observed in the analyzed study protocols. DISCUSSION AND CONCLUSION: Studies have been principally based on the concept of TOS, without considering a detailed breakdown into each methodological trial. A markedly subdivision of studies into methodologically identifiable trials would allow a clear definition of their parameters, while increasing transparency of the study conduct and its results.

[Importance of long chain omega-3 fatty acids in prostate cancer]. / Stellenwert von langkettigen Omega-3-Fettsäuren bei Prostatakrebs.

The benefits of long chain polyunsaturated omega-3 fatty acids (n-3 PUFA) from fish or administered as supplements remain controversial regarding prostate cancer (PCa). Based on the currently available evidence no clear benefit of n-3 PUFA intake to generally reduce PCa incidence has been found. On the other hand n-3 PUFAs have a clear influence on the development of already existing PCa. The intake of n-3-PUFAs considerably reduces the risk of metastasis and PCa-related mortality.

Determination of CGS 16617 and stable isotope-labeled CGS 16617, an angiotensin-converting enzyme inhibitor, in human plasma by gas chromatography/mass spectrometry.

An analytical method has been developed for the simultaneous determination of a novel orally active angiotensin-converting enzyme inhibitor (CGS 16617) and a stable isotope-labeled analog. Both compounds are isolated from human plasma using an ion-exchange column, derivatized with pentafluoropropionic anhydride and pentafluoropropanol, and analyzed by gas chromatography/mass spectrometry. After splitless injection on a methyl-silicon column, the compound is detected using negative ion chemical ionization with nitrous oxide as a reagent gas. CGS 16617 labeled with four deuteriums and two 13C is used as an internal standard. The accuracy and precision of the method, expressed as the overall mean +/- SD recovery obtained from two sets of 36 quality-control samples used during a clinical study (concentration range 0.2-100 ng ml-1 plasma), was 96.1 +/- 16.2% for unlabeled drug and 97.6 +/- 14.4% for the D4-labeled drug (concentration range 0.2-100 ng ml-1 plasma). The limit of quantification using 1 ml plasma is 0.2 ng ml-1 for both labeled and unlabeled drug.

France: late abortion.

PIP: In France, under the terms of a law passed by Parliament in 1975, a woman may have an abortion up to 12 weeks of pregnancy if she is a French resident and, in the event that she is a minor, she has parental consent. The woman must also have 2 medical consultations, a week apart. The woman is reimbursed by the state up to 70% of the cost of the abortion. After 12 weeks, abortion, except for therapeutic abortion, under the terms of Article 317 of the Criminal Code, is a crime, punishable by 6 months to 10 years in prison, a fine of between 1800 and 250,000 Francs, and loss of professional license. Moreover, Article 647 of the Health Code bans any advertising, incitement or propaganda for abortion or abortion-inducing products. Many French women go to Britain or Holland for abortions after 12 weeks, but they face the financial burden of traveling as well as the difficulties of getting help in a strange country and the stigma of having done something illegal. The Mouvement Francais pour le Planning Familial, which won the legalization of contraception in 1967, is now fighting for legal abortion as well as the distribution of information about sexuality, contraception, and abortion in the schools. 2 charges of incitement to abortion have been brought against the organization.^ieng

Simultaneous determination of oxprenolol and 2H6-labelled oxprenolol in human plasma by gas chromatography/mass spectrometry.

A gas chromatographic/mass spectrometric method for the specific determination of oxprenolol and 2H6-labelled oxprenolol when both are present in the same sample is described. After addition of 13C3-labelled oxprenolol as internal standard, plasma is alkalized and extracted by a mixture of dichloromethane and diethyl ether. The residue following evaporation of the organic phase is derivatized with heptafluorobutyric anhydride. Negative ion detection with N2O as reagent gas is used for the measurements at m/z 488, 491 and 494 for oxprenolol, the 13C3-labelled internal standard and 2H6-labelled oxprenolol, respectively. The precision and accuracy of the analytical method were investigated using samples containing both unlabelled and 2H6-labelled oxprenolol. The overall mean recovery (% +/- SD, n = 70) in the concentration range 20-1500 nmol l-1 (around 6-450 ng ml-1 of the hydrochloride salts) was 100.6 +/- 3.3 and 101.0 +/- 3.5 for oxprenolol and 2H6-labelled oxprenolol, respectively. The limit of quantification was around 20 nmol l-1 for both compounds.

Glycerol trinitrate (nitroglycerin) plasma concentrations achieved after application of transdermal therapeutic systems to healthy volunteers.

Glycerol trinitrate (nitroglycerin, in the following briefly called GTN) plasma concentrations achieved upon application of a commercial scale produced transdermal therapeutic system containing GTN (TTS-GTN, Nitroderm-TTS) were compared to those induced by 2 TTS-GTN prototypes previously used for clinical trials. Each system was applied to the chest, lateral aspect, of 14 healthy volunteers for 24 h, in a 3-period change-over study. GTN in plasma was determined by gas chromatography-mass spectrometry. The 3 systems released the drug continuously over 24 h. The mean plasma concentrations for all subjects and all sampling times (nmol/l) +/- SE were 0.92 +/- 0.18, 0.80 +/- 0.12 and 0.97 +/- 0.18 for the commercial scale TTS and the 2 other systems, respectively. No significant differences were demonstrated. The mean delivery rate of GTN calculated from the initial and residual contents of the TTS was 6.8 micrograms/min as a mean for the 3 systems. In another study, three different application sites were compared (chest, upper arm and pelvis). The results did not demonstrate significantly different GTN plasma levels. A comparison with published data after intravenous infusion showed a good availability of GTN administered transdermally by means of TTS. Its magnitude seems comparable to that of the intravenous route.

Quantitative determination of nitroglycerol in human plasma by gas chromatography negative ion mass spectrometry using 15N labelled nitroglycerol as internal standard.

Negative ionization resulted in the simplification of a previously published method. The new method permits the determination of 0.25 nmol l-1 nitroglycerol in plasma with a coefficient of variation of 9.1%.

Gas chromatographic mass spectrometric determination of 1,2,3-propanetrioltrinitrate (nitroglycerin) in human plasma using the nitrogen-15 labelled compound as internal standard.

A method for the quantitative determinatio of 1,2,3-propanetrioltrinitrate (nitroglycerin) in human plasma by gas chromatography mass spectrometry has been developed. After addition of 1,2,3 and methyl acetate (90 : 10). The extracts are purified by partition between, first, the extraction solvent and a mixture of acetonitrile and water (60 : 40) and, secondly, the resultant aqueous phase and benzene. THe solvent is evaporated to a small volume before injection. The fragment ions at m/z 46 and 47 are monitored for the measurement of the [NO2]+ and [15NO2]+ ions using electron impact ionization. The mean recovery (%) +/- SD in blind plasma samples spiked with amounts in the concentration range 0.35-3.52 nmol 1(-1), was 97.4 +/- 9.0 (n = 58). Within a day, recovery experiments gave rise to coefficients of variation of 9.6, 6.4 and 2.7% at the levels 0.44, 0.88 and 11 nmol 1(-1), respectively. Concentrations in plasma down to about 0.2 nmol 1(-1) (50 pg ml-1) could be estimated. Percent recovery of duplicate determinations in the range 0.5-1.96 nmol 1(-1) +/- SD was 99.4 +/- 6.0 (n = 80).

Malabsorption syndrome in broiler chickens.

A disease syndrome of broiler chickens is described. Affected birds exhibited poor pigmentation of the shanks, decreased weight gains, elevated feed conversions, poor feathering, enlargement of the proventriculus, and a decrease in the size of the gizzard. Reoviruses were isolated from affected chickens from several farms. Signs and lesions similar to those seen in chickens with the field syndrome were reproduced when these isolates were inoculated into day-old chicks with low levels of maternal antibody against viral arthritis. The pathogenicity of the viral isolates was variable. The incidence of lameness was much higher in those groups of chicks injected with these viruses than in the control groups.

Characterization of a papovavirus isolated from fledgling budgerigars.

A virus suspected of causing high death rates in fledgling budgerigars in Georgia and Texas aviaries was isolated in budgerigar embryo fibroblasts inoculated with tissue homogenates from affected birds. Virus was most easily recovered from tissues containing many intranuclear inclusion bodies. Cytopathic effect on fibroblasts of all four isolates was characterized by a swollen nucleus followed by rounding and detachment of the affected cell from the monolayer. Properties suggesting the B-931 isolate belongs to the papovaviridae family are (1) presence of DNA; (2) insensitivity to treatment with CHCl3; and (3) presence of cubic viral particles 42 to 49 nm in diameter in the nucleus of infected chicken embryo fibroblasts. The isolate did not hemagglutinate erythrocytes of chickens, turkeys, budgerigars, guinea pigs, or type O humans and was basically stable against heating and freeze-thawing. An examination of fledgling budgerigars from infected aviaries demonstrated that sick birds carried more virus than healthy birds.

A viral disease of fledgling budgerigars.

Fledgling budgerigars from aviaries in Georgia and Texas were reported to have high rates of mortality. Affected birds died acutely and exhibited abdominal distention and reddening of the skin. Postmortem lesions were hydropericardium, enlarged heart and liver with areas of necrosis, and swollen, congested kidneys. Histologic examination of a variety of tissues revealed cells with enlarged nuclei containing inclusions. Electron micrographs revealed the presence of viral particles 42 to 49 nm in diameter in the nuclei of epithelial cells of the renal tubule.

Report of IABS committee on avian product standardization.

The International Association of Biological Standardization (IABS) organized an international symposium in August 1973 on the "Requirements for Poultry Virus Vaccines" at Lyon (France). The Proceedings of this symposium were subsequently published as "Developments in Biological Standardization", volume 25. At the conclusion of this symposium, it was resolved that an Avian Biological Products Standardization Committee should be established, this committee including four subcommittees, each under the direction of a chairman who would be responsible to make a report on his own subject. The four subjects are: specific pathogen freedom (SPF), infectious bronchitis, Marek's disease, Newcastle disease. The work established by the Committee is presented.

Vaccination of one-day-old chicks against newcastle disease using inactivated oil adjuvant vaccine and/or live vaccine.

One-day-old chicks, with or without maternal antibodies against Newcastle disease, were vaccinated by different methods: one group received a live vaccine (Hitchner B1 strain), the second group an oil-adjuvant vaccine, and the third group both vaccines simultaneously. The serological response and the protection of the chicks against challenge were evaluated regularly up to 80 days of age. The best results were obtained when using both vaccines, which induced a good level of protection against the challenge virus strain.

[Biosynthesis of thiazole from thiamine in Escherichia coli]. / Biosynthèse du thiazole de la thiamine chez Escherichia coli.

The incorporation into the thiazole moiety of thiamine of several labeled compounds has been studied on short time incubations of washed-cells suspensions. No incorporation of radioactivity from [G-14C] methionine was found in a mutant auxotrophic for methionine. No radioactivity was incorporated from [U-14C] aspartate or from [U-14C] serine. The incorporation of 35S from sulphate was lowered by cysteine or glutathione but was unaffected by methionine or homocystine. Although the synthesis of thiazole is dependent on methionine, neither the sulphur atom nor the carbon chain of thiazole originate from methonine in E. coli. No carbon originates from cysteine which is the likely direct donor of sulphur.

Dry aerosol vaccination against Newcastle disease. I. Safety and activity controls on chickens.

A new technic or immunization against Newcastle disease in chicken was developed: this method consists of dispersing lyophilized products by aerosols. One to fourteen day old chickens, with and without parental antibodies, were vaccinated with increasing amounts (10(-1) to 10(5)EID50) of HB1 and LaSota attenuated viruses. 10(4)EID50, inhaled theoretical dose, gave better results when the animals were challenged with the virulent strain. Under laboratory conditions, no respiratory problems occurred in vaccinated animals; but there is 10 to 20% mortality among animals treated by aerosols in poultry houses, because of respiratory diseases developed after vaccination.

Dry aerosol vaccination against Newcastle disease: II. Serological response in chicks.

Day-old chickens with Newcastle disease maternal antibodies are separated in two batches. One batch (S) is vaccinated by liquid spray method with HB1 strain: the other one (NS) is not vaccinated. At 2, 3 or 4 weeks subgroups from S and NS batches are vaccinated with HB1 strain by dry aerosol method. Serological controls reveal an important increase of Newcastle antibodies within two weeks after dry aerosol vaccination. Then a drop of the antibody quantities is observed during weeks 2 to 4 post dry aerosol vaccination. In the following weeks, the antibody level increases very slowly.