[Amoxicillin/clavulanic acid in therapy of bacterial infections of the diabetic foot. Results of an observational study]. / Amoxicillin/Clavulansäure in der Therapie des bakteriell infizierten diabetischen Fusses. Ergebnisse einer Anwendungsbeobachtung.

The results of an observational study of amoxicillin/clavulanic acid (Augmentan) in 191 patients are presented. The average duration of treatment was 15 days (median). Healing or improvement was observed in 76% of the cases. In view of the fact that the condition often has a multifactorial genesis and neural and vascular changes impair healing, this result must be considered a clinical success. Variables with an influence on the efficacy of the treatment were the incidence of manifestation and pathogenesis of the ulcer, renal function, blood pressure and smoking. Amoxicillin/clavulanic acid was well tolerated, with adverse events being observed in only 9 out of 193 patients (4.7%). Treatment was abandoned because of adverse events in 3 out of 193 patients (1.6%). Overall, treatment of the infected diabetic foot with amoxicillin/clavulanic acid was well tolerated and effective.

A prognostic score for postherpetic neuralgia in ambulatory patients.

The main objective was to develop a scoring system for easy use by the physician in daily clinical practice in deciding the appropriate treatment for his herpes zoster patient. Data from 635 patients who did not receive antiviral therapy were included in this analysis. Of these, 131 developed postherpetic neuralgia (PHN). Of the 29 variables tested univariately in this study, 15 showed a significant correlation with the incidence of PHN, but only six proved to contribute to the overall predictive power in the multivariate approach. Using two independent approaches, the model showed a very satisfactory performance in the validation sample. Patients without acute pain rarely developed PHN. In those with acute pain, being female, being over 50 years of age, having more than 50 lesions, having lesions of a hemorrhagic nature, having cranial or sacral localisation of the rash or having pain in the prodromal phase proved to be significant, multivariate factors. An easy-to-use scoring system used in a risk graph is proposed. These data should be useful in the individual treatment decision as well as in the design and analysis of therapeutic trials in herpes zoster.

Demography, symptomatology, and course of disease in ambulatory zoster patients. A physician-based survey in Germany.

This survey summarises the observations of physicians who prospectively recorded clinically relevant data on their patients with an episode of herpes zoster. These included demography of patients, signs and symptoms during the prodromal phase, relevant history, description of disease at the first visit, therapeutic measures and description of disease, and occurrence of postherpetic neuralgia (pain 4-5 weeks after crusting) at the second visit. A total of 2,063 patients were reported to the data management centre. The age distribution resembles that reported in the literature including the notable increase in zoster frequency with advancing age. Almost 20% of the patients, however, were 30 years old or less, and this contrasts markedly with the published literature. Age modifies the frequency of the dermatome afflicted: more cranial and less thoracic manifestations were observed with increasing age. Almost all patients reported symptoms which may be attributed to a prodromal phase, especially pain in the affected dermatome (82%). The incidence of postherpetic neuralgia was 28%. A complicated disease course such as visceral, ocular, or otological involvement, or progression to additional dermatomes was seen in almost 10% of the patients.

Booster immunization of low- and non-responders after a standard three dose hepatitis B vaccine schedule--results of a post-marketing surveillance.

Seventy-nine low-responders and 83 non-responders after a previous three-dose hepatitis B (HB) vaccine course at 0.1, and 6 months were enrolled to receive additional 20 micrograms recombinant HB vaccine doses every 2 months until all had anti-HBs levels > or = 100 mIU ml-1. After the first booster, 65.4% had anti-HBs levels > or = 100 mIU ml-1, 17.9% were low-responders (10-99 mIU ml-1), and 16.7% remained non-responders (< 10 mIU ml-1). All complying non-responders developed anti-HBs levels > or = 100 mIU ml-1 after the third booster at the latest, whereas all low-responders reached this level after the second booster. Although body mass index affected the response to the first hepatitis B booster, when full compliance to regular revaccination was ensured, all non- and low-responders eventually reached sufficient anti-HBs levels.

Immunogenicity of a recombinant hepatitis B vaccine in adults.

OBJECTIVES: To evaluate the immunogenicity and reactogenicity of a recombinant hepatitis B vaccine in health care staff under routine use and unselected conditions and to investigate factors that influence the response to vaccination. METHODS: This prospective postmarketing surveillance study was performed in unselected health care staff and their relatives (age range, 12-60 years) at 58 hospitals. Overall, 880 subjects were administered a 20-microgram dose of a vaccine at 0, 1, and 6 months according to the prescribing information and under routine hospital practice, and they were tested for antibody to hepatitis B surface antigen after the third dose at the hospitals routine laboratory. The principal outcome measures were antibody to hepatitis B surface antigen titers that were expressed as the seroprotection rate (SPR) (SPR [given as a percentage], > or = 10 mlU/ mL), spontaneously reported adverse events, and geometric mean titers (in milli-international units per milliliter). RESULTS: The compliance to the 3-dose schedule under routine hospital practice was 98.1%. The immune response was good in all age groups, and the overall SPR was 97.8% at 1 month after the third dose in field conditions with unselected health care workers. The SPR in vaccinees (age range, 40-59 years) was close to 95%. Age (P < .001), smoking (> or = 10 cigarettes per day) (P < .001), Broca index (> 110%) (P < .001), antibody to hepatitis B surface antigen testing (> 8 weeks after the last dose) (P = .03), chronic underlying disease (P = .04), and male gender (P = .04) were factors associated with lower geometric mean titers in routine vaccine use. No serious adverse events were reported. CONCLUSION: The large immune response that was elicited by this hepatitis B vaccine in adults under daily routine field conditions reflected reality, with a high SPR also found in elderly and other persons with risk factors associated with a lower immune response.

Software FIACRE: bioprocess monitoring on the basis of flow injection analysis using simultaneously a urea optode and a glucose luminescence sensor.

Various computer programs for large-scale bioprocess control and optimization have been developed as well as software for simple laboratory routine analysis. In comparison, software can hardly be found that works on laboratory scale and provides the control of complex flow injection analysis (FIA) systems, multisubstrate determination, data evaluation as well as minimal process control abilities. The sensors applied can be of different type (luminometric or other optical as well as electrochemical biosensors). The development of such a software may be very helpful for the transfer of FIA/biosensor systems from the state of development to industrial processes. Hence, each analysing system--even a well established biosensor--has to be individually adapted to the process, a task which is best done under laboratory conditions. Such a flexible, computer-controlled FIA system for research level based on the software FIACRE is presented. Five FIA/(bio)sensor system can be controlled simultaneously. Additionally, common temperature and pH recordings are possible. Determinations of substrate concentrations are performed by means of calibration curves which can be recorded at different times. This allows supervising the activities of the sensors during a cell cultivation and controlling the bioprocess, e.g. by adding substrate to a cell culture. The automated monitoring of the degradation of glucose and urea by two different optical sensing principles during a cell cultivation under the control of one microcomputer is presented for the first time. For this purpose, already well examined biosensors (a urease optode and a luminometric glucose sensor) were employed and their properties discussed under the aspect of working in real cultivation media. It will also be shown that substrates being of interest for bioprocess control can be detected by slight modifications of known reactions. For example, substrates of NADH-dependent enzymatic reactions can be detected by the luminol chemiluminescence system, and optodes can be employed for pH, penicillin and glucose determination.

Cimetidine suspension in patients with stage 0 gastro-oesophageal reflux disease.

One hundred and twenty-five patients with symptoms of heartburn and acid regurgitation but without endoscopic abnormalities were randomized to receive 200 mg cimetidine suspension four times daily or placebo for two weeks. Daily dairy cards were kept to evaluate the frequency and degree of symptoms. At two weeks cimetidine was significantly more effective than placebo. It is concluded that placebo suspension has a considerable effect on gastro-oesophageal reflux disease symptoms, but cimetidine suspension provides significantly better relief.

[Treatment of uncomplicated duodenal ulcer using cimetidine alone and in combination with pirenzepine. A comparative study]. / Behandlung des unkomplizierten Ulcus duodeni mit Cimetidin allein und kombiniert mit Pirenzepin. Eine Vergleichsstudie.

In a double-blind, randomised trial two drug regimens were compared in a group of 129 patients with uncomplicated duodenal ulcers, 64 receiving cimetidine (800 mg) and pirenzepine (50 mg) at bed-time, 65 receiving cimetidine (800 mg) and a placebo at bed-time. Neither statistically nor clinically was there an important difference in effectiveness and tolerance between the two drug regimens.

Double-dummy comparison of suprofen and indometacin sustained release formulations.

In a randomized double-dummy study a new dosage form of alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid (suprofen, Suprol), i.e., suprofen sustained release 600 mg tablets, was compared with indometacin sustained release 75 mg capsules. The test population included 60 hospitalized subjects in severe chronic pain requiring analgesic treatment. The treatment groups were homogeneous as to their anamnestic data. Treatment was given for 3 weeks; the drugs were uniformly administered in the morning and in the evening. The intensity of pain was assessed using a visual analog scale (VAS) prior to administration of the first dose on day 1 of the therapy, and then for up to 10 h. Further assessments of pain intensity and pain relief were obtained after 1, 2, and 3 weeks of therapy. Comparison of the mean pain intensity (VAS) at the individual rating times revealed statistically significant better pain relief with suprofen than with indometacin already 1 h after the administration (p less than 0.05, multivariate analysis of variance). This statistically significant difference as compared with indometacin was confirmed at all subsequent time points. The weekly assessments of pain intensity showed that the results obtained with suprofen were superior to those with indometacin, although they were not statistically significant. However, pain relief after 2 weeks' treatment with suprofen was significantly superior (p = 0.0061, exact test) to the result observed with indometacin. The results obtained with suprofen in weeks 1 and 3 were superior to those with indometacin, but they were not statistically significant.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical effect of rectal application of suprofen in children. An open controlled study.

Antipyretic effect, tolerability, and acceptance of alpha-methyl-4-(2-thienylcarbonyl)-phenyl acetic acid (suprofen, Suprol) suppositories were tested in an open study including 90 hospitalized children with fever of various etiology. The mean rectal temperature prior to treatment was 39.3 degrees C. The dose regimen was chosen depending upon the body weight: Up to 4 suppositories were administered for maximally 4 days. Body temperature as well as pulse and respiratory rates were recorded prior to insertion of the suppository and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 h following first application of the preparation. Regardless of sex and age the temperature was reduced in 85.5% of the cases; as compared to the initial values this reduction was after first application statistically significant at all rating times. The only adverse reaction - vomiting - was seen in 3 cases.

Effect of thymopentin on the mortality and immune response after an experimental herpes simplex infection in mice.

The effect of thymopentin on the mortality rate of mice treated with lethal doses (LD90) of herpes virus 2 and on the cytotoxic T cell activity after sublethal doses (LD10) of herpes virus was investigated in two series of experiments. Doses of 1, 0.1 or 0.01 ng of thymopentin per g/mouse were administered i.p. in each experiment, either 3 days before, 3 days (66 h) after, or 3 and 6 days after the herpes virus infection. The cumulative mortality rate was evaluated 10 days after the infection. Cytotoxic T cell activity was measured 3, 7 and 14 days after the infection. The 0.1-ng dose of thymopentin reduced the mortality rate to less than 50% (p = 0.0000) if it was administered 3 days before the infection. A single injection of any dose after infection did not reduce the mortality at all, while two injections of 0.1 ng reduced it by about 25% (p = 0.0038). A 1-ng dose showed a mild but significant reduction (p = 0.0313) if it was applied 3 days before the infection. The cytotoxic T cell activity was either not influenced or significantly modified (p less than 0.05), i.e. increased or decreased as compared to the control, depending on the dose and timing of thymopentin. A correlation between increased cytotoxic T cell activity and protection against mortality can be demonstrated, while no protection was observed in dose regimens where the cytotoxic T cell activity became reduced. The results are discussed in connection with earlier clinical studies in which the beneficial effect of thymopentin has been demonstrated in frequently relapsing herpes labialis and herpes genitalis patients.

Comparison of Papanicolaou staining and Feulgen staining for automated prescreening.

Feulgen staining is considered to be a quantitative DNA-specific cytochemical procedure. The applicability of this staining in high-resolution cytometry was tested in comparison with a regressive Papanicolaou staining. Papanicolaou-stained or Feulgen-stained intermediate and carcinoma cells selected by a cytologist were examined with a Zeiss scanning microscope photometer at 546 and 560 nm, respectively. After cell image segmentation and feature extraction, a statistical data evaluation was carried out by computer. Cell distributions with respect to four selected nuclear features demonstrated the influence of the staining procedure on cell feature measurements. The discriminatory power of the classification system as related to both staining procedures was studied using discriminant analysis. Using only nuclear features, a 7.3% improvement of the overall correct classification rate (from 85.0% to 92.3%) was achieved using Feulgen staining. The misclassification rate was simultaneously reduced by 50%. Using cytoplasmic as well as nuclear features, a 98% rate of correct classification was achieved.

Reappraisal of the clinical and etiologic significance of immunoglobulin deviations in autoimmune hemolytic anemia ('warm type').

56 patients with autoimmune hemolytic anemia ('warm type') (AIHA) were investigated for immunoglobulin deviations. Of these, 43 were repeatedly analyzed (mean 4 times). The mean observation time was 20 months. The immunoglobulin values were correlated with clinical (degree of hemolysis) and serological (immunoglobulin class of autoantibodies; strength of antiglobulin reaction) parameters and statistically evaluated by variance analysis. Although no significant deviations of immunoglobulins in AIHA were found as compared to a normal control group, the immunoglobulin disturbance most frequently seen was an elevation of IgM. This is interpreted as a possible lack or functional impairment of immunoregulatory T cells in AIHA.

[The lh-rh-test in men with fertility disorders (author's transl)]. / Der LH-RH-Test bei Störungen der männlichen Fertilität

89 mal patients with fertility disorders underwent a test with 50 mug synthetic LH-RH. The basal levels of FSH and LH are elevated in patients with azoospermia, with testicular atrophy, varicocele and Klinefelters syndrome. They increase with age. After stimulation with LH-RH the highest relative peaks (maximal value divided by control value) of LH are seen younger patients, in those with varicocele, and oligozoospermia. The FSH-values do not differ significantly between these groups. Low relative peaks of LH are seen in older patients. In Klinefelter's syndrome the relative peaks of FSH and LH are significantly lowered.

Activation of intravascular coagulation by endotoxin: the significance of granulocytes and platelets.

The importance of granulocytes and/or platelets in endotoxin-induced generalized intravascular coagulation was studied as well as thrombocytopenic rabbits. Neutropenia and thrombocytopenia were induced by oral administration of busulphan. Generalized intravascular coagulation, as indicated by renal glomerular microclot formation, was initiated by two intravenous injections of endotoxin. Granulocyte counts before the second injection of endotoxin were most significantly related to activation of intravascular coagulation whereas platelet counts either before the first or second injection of endotoxin were not definitely related to the activation process. Renal glomerular microclots occurred in rabbits after two injections of endotoxin even when the platelet counts were between 500 and 5000/mul. These experiments indicated that granulocytes but not platelets are essential to the activation of endotoxin-induced intravascular coagulation.

Oxygen consumption, heart rate, respiratory rate and rectal temperature in healthy newborns during the first two hours after birth.

A report is made on the continuous registration of oxygen consumption, heart rate, respiratory rate and rectal temperature in 32 neonates during the first two hours of life. A short account of the registration technique is given. A comparative study shows, that oxygen consumption, heart rate and respiratory rate fall during the period of observation, whereas the rectal temperature rises. 26 out of the 32 neonates demonstrated a approximately linear fall of each of the oxygen consumption values during the period of observation. There is a similar relationship, which is statistically verified, between the oxygen uptake and heart rate. Oxygen consumption and heart rate can be correlated with each other after the first 60 minutes of life. This close and direct relationship between the oxygen consumption and the heart rate, an important parameter of the heart and circulatory system, stresses clearly the importance of the continuous registration of oxygen consumption for monitoring the general condition of the neonate. A change from this situation means a risk for the neonate which must be clarified by blood-gas analysis. A continuous registration of oxygen uptake for the surveillance of the neonate includes numerous vital functions and appears to be a more suitable parameter than single parameters which include only partial functions. The application of the method is simple and safe for the infant.