[Changes in the recurrence rate of neurotic symptoms]. / Zmiany czestosci wystepowania objawów nerwicowych.

The frequency of neurotic disorders' symptoms measured by symptom check-list in those admitted for specialist treatment, varied significantly even in a time-span of more than ten months (studies 1979-1999).

[Neurotic symptoms frequency]. / Czestosc objawów nerwicowych.

The analysis of symptom checklists completed by 3196 patients before treatment--1970 females and 1226 males starting the therapy due to neurotic disorders--revealed that 12 symptoms occur im more than 80% of patients; 9 symptoms in 70-80%, 18 dysfunctions in 70-60% and 17 other dysfunctions in 60-50% of examined population. This means that a large number of symptoms including tension, mood depression an anxiety as well as difficulties in concentration, lack of self-confidence, sense of tiredness, loss of energy, persistent thoughts and images, constant fear, absent-mindedness, motor tensions, pessimism, thought flood, the sense of difficulty in thinking and tachycardia occur in almost all patients suffering from neurotic disorders, mo matter what these disorders are. Tle largest group consisted of patients with the diagnosis of anxiety disorders like phobias and the like (ca. 25%). Results of the study suggest the necessity of verification of the present views on the picture of dysfunctions combining into neurotic disorders. A similar occurrence rate of ca. 30% of the 95 analysed dysfunctions in the subgroups of females and males as well as a higher occurrence rate of 10% of the dysfunctions in the male group also make it necessary to verify the prevalent convictions about the sex-dependent differences in the picture and course of neurotic disorders.

[S-II symptom questionnaire]. / Kwestionariusz objawowy S-II.

"S-II" Symptom Check-list which allows for a fast diagnosis of neurotic disorders. A result of 165 points suggests the incidence of such disorders with the probability of 90%. The methodology of the construction of the check-list intends for the application of questions most common in those ill due to neurotic disorders (owing to the change in frequency) and the most possibly equal amount of questions on the symptoms common to women and men. Thanks to this the norm for women and men is identical. SCL S-II Symptom Check-list is a shortened and actualised version of the "O" Symptom Check-list, developed in 1975. It is similar to the SCL-90 and highly correlated with it, but it does not contain the variables concerning the psychotic symptoms. Thanks to this, its' accuracy (specificity) in the diagnosis of neurotic disorders is high. 4 pairs of questions allow for the judgement of answer reliability. 10 scales were singled out in the questionnaire. They are only of a helpful value and do not allow for a one-sided diagnosis of the type of the disorder, listed in the ICD-10. The scale results can, however make the correct diagnosis easier.

Effects of various aluminium compounds given orally to mice on Al tissue distribution and tissue concentrations of essential elements.

To evaluate the risk of gastrointestinal long-term aluminium (Al) exposure, aluminium distribution and the levels of the following essential elements: Ca, Mg, Zn, Cu, and Fe in tissue were studied. Aluminium was administered in drinking water as aluminium chloride, dihydroxyaluminium sodium carbonate or aluminium hydroxide. Mice (strain Pzh:SFIS) were exposed to a total dose of 700 mg Al in long-term treatment (for each Al compound n = 15). Concentrations of Al, Ca, Mg, Zn, Cu, and Fe in stomach, kidneys, bone and liver were analyzed by atomic absorption spectrometry. After AlCl3 treatment, aluminium was found to accumulate in all tested tissues. A significant decrease in Fe concentration in liver and Zn in kidneys was observed in comparison to concentrations of these elements in the control group. In the Al(OH)3-treated group, accumulation of aluminium was observed in bone only and decline of Fe concentration in stomach and Cu in liver and kidney. In the NaAl(OH)2CO3-treated group the increase in Al concentration was significant in bone; there was no change in concentration of essential elements in the examined tissues. The observed aluminium accumulation was not accompanied by changes in Ca and Mg concentration except for bone. This study showed that oral administration as a route of Al exposure can result in diverging accumulation of aluminium in tissues, the concentration depending on the chemical form.

[Drug resistance of Enterococcus species isolated from the urogenital system]. / Lekoopornosc szczepów Enterococcus sp. izolowanych z ukladu moczowo-plciowego.

Despite low virulence of enterococci, they have become important nosocomial pathogens. This has been correlated with the increased use of broad-spectrum antibiotics, particularly cephalosporins. Many strains of enterococci exhibit multiple drug resistance; the most important being high-level resistance (HLR) to penicillin (MIC > 100 mg/l) and gentamicin (MIC > 500 mg/l and 2000 mg/l) and/or streptomycin (MIC > 2000 mg/l). The investigation was performed on 92 strains, isolated from genito-urinary tract and recognised as Enterococcus sp. All strains were obtained from several microbiological laboratories of Gdansk, Gdynia and Tczew. On biochemical reaction profiles species of enterococci were identified as: E. faecalis (72.8%), E. faecalis varians (9.8%), E. durans (7.6%) and E. faecium (9.8%). The minimal inhibitory concentration (MICs) of penicillin, ampicillin, azlocillin, imipenem, gentamicin, amicacin, ciprofioxacin and vancomycin were determined by the agar dilution method. None of these 92 enterococcal strains was vancomycin resistant. 22.2% of E. faecium and 7.5% of E. faecalis showed high-level resistance to penicillin. None of these strains were produced beta-lactamase. High-level resistance to streptomycin and gentamicin was detected. Both--high-level resistance to streptomycin and gentamicin--were found in 6% E. faecalis; 11.1% E. faecalis varians and 22.2% E. faecium.

[Examination of protein MPB 70 properties in BCG substrains used for the production of Polish antituberculosis vaccines]. / Badanie obecnosci bialka MPB 70 w podszczepie BCG uzywanym do produkcji Polskiej szczepionki przeciwgruzliczej.

The aim of the study was examination of MPB70 protein production by different BCG substrains and testing this protein as reagent in allergenic skin test on BCG vaccinated guinea pigs. Three BCG substrains: Danish 1331 (D), Japanese 172 (J) and Polish BCG Moreau (P) were used for the study. The protein MPB70 received from dr Nagai from Osaka University was used as reference preparation. It has been shown that MPB70 protein of molecular weight about 21,500 Da was present only in BCG Moreau (P) and Japanese (J) substrains. In immunoblotting test monoclonal antibodies reacted additionally with 43,000 Da protein in all tested substrains. We suspect that the detected additional molecule was a dimer of MPB70 protein. The development of skin reactions to MPB70 protein was seen in guinea pigs vaccinated with J and P substrains. The peak of alergy to MPB70 protein was observed 9 weeks after vaccination. In sera of vaccinated animals antibodies against MPB70 protein were detected by ELISA method. The possibility of using MPB70 protein for diagnostic purpose is discussed.

The level of endotoxin contamination in biopreparations.

Bacterial endotoxins as contamination of biopreparations have been estimated by chromogenic LAL test. Study on some compounds (aluminium hydroxide, formaldehyde and merthiolate) being components of vaccines showed no effect on the result of LAL test. The level of endotoxins in virus vaccines with the limits defined in producers certificate was adequate, the level of endotoxin was also low in virus vaccines of undefined requirements. The concentration of endotoxin in bacterial vaccines was differentiated. Considering the results of our experiments, as well as the fact, that the requirements for endotoxin contamination of bacterial vaccines are not available it seems necessary to establish the limits for these group of biopreparations.

[Level of bacterial endotoxins in Haemophilus influenzae type b vaccines conjugated with toxoids (td, Di)]. / Poziom endotoksyny bakteryjnej w szczepionkach Haemophilus influenzae typ b skoniugowanych z toksoidami (Te, Di).

Quantitative evaluation of bacterial endotoxin was performed in the following vaccines: Act-Hib, Hiberix, Hib-Titer. The aim of this study was to assess the accuracy and precision of chromogenic LAL test with S-2423 substrate for this particular biopreparations and after that to determine the amounts of endotoxin as a factor of vaccine safety. Because of the lack of information concerning the presence of endotoxin in Act-Hib vaccine, we also tried to establish the limits for the presence of endotoxin in this type of vaccine. The estimated level of endotoxin was as follows: 110 EU/ml in Act-Hib, 1.64 EU/ml in Hiberix and 2.4 EU/ml in Hib-Titer. The results of this study showed that the amounts of endotoxin was dependent on the molecular size of polysaccharide PRP and on the presence of protein component. The limit of endotoxin presence in Act-Hib vaccine recommended by us is max. 150 EU/ml.

[LAL (Limulus Amoebocyte Lysate) test as applied to the safety evaluation of biological preparations]. / Test LAL (Limulus Amoebocyte Lysate) w zastosowaniu do oceny bezpieczenstwa biopreparatów.

In the paper some problems concerning of pyrogen testing were described. The risk of reactions after administration parenteral preparations contaminated pyrogenic substances give the cause for searching sensitive, repeated methods of their designation. The paper is review of the adaptation Limulus Amoebocyte Lysate (LAL) test for the estimation of endotoxin in biological preparations. The paper overview, chemical structure of endotoxin the characteristic of Limulus polyphemus, principle basis of the LAL test and general remarks of application. The LAL test according to the opinion of many authors is more sensitive in comparing with the pyrogen rabbit test.

[Use of the LAL test for quantitative determination of Bacteroids fragilis endotoxin]. / Zastosowanie testu LAL do ilosciowego oznaczania endotoksyny Bacteroides fragilis.

The aim of this study was the evaluation of LAL test with chromogenic substrate usefulness for the quantitative detection of B. fragilis endotoxin and the determination of the amount of endotoxin in culture filtrates of the strains of this species. Also, the trial was undertaken to determine the influence of clindamycin on endotoxin release from B. fragilis rods to the culture medium. Four B. fragilis strains were examined: one nonenterotoxigenic (NTBF) and three enterotoxigenic (ETBF). The growth of cultures was determined and endotoxin liberated to the culture medium during growth of strains was detected. BHI broth and BHI broth with addition of sub inhibitory doses (sub-MIC) of clindamycin were applied. Bacterial cultures were incubated for 48 hours at 37 degrees C. Samples of bacterial cultures were collected after 4, 8, 16, 24 and 48 hours of cultivation, and the optical density was measured. Then the samples were centrifuged, supernatants were filtered through 0.45 micron filters and concentrated three times with 5000 D ultrafilters. Prepared samples were kept frozen at -70 degrees C until used. The amount of endotoxin in samples was determined using quantitative LAL test with chromogenic substrate S-2423. The results of the experiments indicate that LAL test is the useful method for determination of B. fragilis endotoxin concentration. This endotoxin activates the enzymatic system present in Limulus polyphemus amebocyte lysate. Endotoxin is shed spontaneously by B. fragilis rods to the culture medium during growth. Clindamycin at subinhibitory concentrations (sub-MIC) inhibits the growth of cultures of examined strains. The antibiotic caused increase in endotoxin amount in culture medium.

[LAL test used for detection of undesirable biologically active substances in biopreparations]. / Test LAL w zastosowaniu do wykrywania niepozadanych biologicznie czynnych substancji w biopreparatach.

Detection of bacterial endotoxin was performed in four groups of biopreparations: IVIG, virus and bacterial vaccines and antibiotics. The 44 samples of biopreparations were tested by the qualitative LAL-test (gel-clot) and some of them (22 samples) by the quantitative, LAL-test (chromogenic end-point). The concentration of endotoxin in 10 samples of IVIG was in the range from 0.457 EU/ml to 19.46 EU/ml. Only 4 of them did not exceed the limit recommended by FDA for human globulins (5 EU/ml). In the 9 samples out of 10 samples of virus vaccines the presence of endotoxin was in the range from 0.06 to 0.15 EU/ml. The concentration of endotoxin in 10 samples of bacterial vaccines determined by gel- clot method was below sensitivity of test (2 EU/ml). In antibiotics we did not find the presence of endotoxin in the range recommended by Ph. Eur. 1995 limits (0.1-0.2 EU/ml). The presented data show the necessity for requirements elaboration for each type of biopreparations.

[The immunochemical characteristics of adult sera after Td vaccination]. / Charakterystyka immunochemiczna surowic osób doroslych szczepionych przeciw blonicy i tezcowi.

The results of immunochemical test of 29 adults sera before and after Td vaccination were presented. The level of 12 protein fractions was in normal range value in 26 of examined sera. There was IgA deficiency in one serum, in two others haptoglobin deficiency and high levels of transferrin and IgM were observed.

[Symptom check-lists in the diagnosis and epidemiology of neurotic disorders]. / Kwestionariusze objawowe w diagnozie i w badaniach epidemiologicznych zaburzen nerwicowych.

Epidemiological studies related to the occurrence of neurotic disorders commonly use symptom check-lists. The results of such studies depend on, amongst others, the construction of the questionnaire and especially on the specification of the value of the questionnaire (GSI) which is determined as the boundary between the "psychophysiological" or organic symptoms and neurotic symptoms. A control study was carried out on the norms of two symptom checklists which have been used for many years in Poland: SCL-"S" (73 symptoms), most often diagnosed in neurotic patients, at the time of constructing the questionnaire and the SCL-"O" (the same 73 + 62 other symptoms). The criterion population was made up of 843 untreated subjects and 2026 patients of day-hospitals. The norms specified by the method of finding the "optimal cut-off point" were approx. 5% in the SCL-"S" and 3% in the SCL-"O" higher for the cohort of women than for men. According to those norms, about 30% of the untreated population gains the same result of Global Severity Index (GSI) as about 90% of patients treated for neurotic disorders and could be diagnosed as neurotic disorders. The GSI norms for the SCL-"S" more often indicated the existence of these disorders in the group of untreated women than in the men's group, while the norms of SCL-"O" indicate a similar frequency of the disease independently of the gender. The symptom frequency analysis presenting differences in the women (1165 ss.) and men (861 ss.) patient groups and lead also to the hypothesis on the dependency of such epidemiological data on the construction of the symptom check-lists--especially the number of variables concerning symptoms more frequent in the female and/or in the male populations.

[Evaluation of contamination of serum derived intravenous preparations]. / Ocena stopnia zanieczyszczenia glinem wybranych preparatów osoczopochodnych do stosowania dozylnego.

The concentration of Al in 4 lots of 5% Albumina and in 14 lots of 5% immunoglobulins were estimated by adsorptive stripping voltammetric method. Mean Al concentrations amounted to 142.6 micrograms/l in 5% Albumina and to 202 micrograms/l in IVIG preparations produced in Poland. Al concentrations in foreign IVIG preparations ranged from 14 to 54 micrograms/l. These data show the need to consider setting an upper limit of microgram Al/l in i.v. drug products produced or registered in Poland.

[Aluminum as an adjuvant in vaccines and post-vaccine reactions]. / Glin jako adiuwant w szczepionkach i reakcje poszczepienne.

Aluminium compounds have been widely used as adjuvants in prophylactic and therapeutic vaccines. Adjuvants are able to stimulate the immune system in a nonspecific manner, i.e. high antibody level can be obtained with minimal dose of the antigen and with reduced number of inoculations. Adjuvants use has been mostly empirically determined by such factors as efficacy and safety. The mechanism of action of the aluminium adjuvants is not completely understood and is very complex. The basic factors of the mode of action: 1) the complex of antigen and aluminium gel is more immunogenic in structure than free antigen, 2) effect "depot"--The antigen stimulus last longer, 3) the production of local granulomas. Vaccines adsorbed onto aluminium salts are a more frequent cause of local post-vaccinal reactions than plain vaccines. 5-10% those vaccinated can develop a nodule lasting several weeks at the injection site. In some rare cases the nodules may become inflammatory and even turn into an aseptic abscess. The nodules persisting more than 6 weeks may indicate development of aluminium hypersensitivity. Finally aluminium adjuvant immunogens induce the production of IgE antibodies.

Dissolution and relative bioavailability of two carbamazepine preparations for children with epilepsy.

The in-vitro dissolution profiles of two carbamazepine formulations (Tegretol and a generic carbamazepine) have been assessed and the bioavailability of carbamazepine compared in 12 epileptic children at steady-state. Dissolution from the generic formulation (100 and 200 mg tablets) tended to be greater than for the proprietary tablets. However, the bioavailability and pharmacokinetics of carbamazepine when assessed at steady-state were similar for the two formulations. It appears, therefore, that the breakthrough seizures and higher incidence of neurological side-effects observed when children were given generic carbamazepine in place of the proprietary formulation cannot be accounted for by differences in bioavailability or pharmacokinetics.