Multicentre comparison of azithromycin versus erythromycin in the treatment of paediatric pharyngitis or tonsillitis caused by group A streptococci.

In this open study, 93 children (aged 2-12 years) with a clinical diagnosis of pharyngitis or tonsillitis caused by Streptococcus pyogenes (culture and/or ELISA test positive) were given azithromycin, as a single daily dose of 10 mg/kg (maximum 500 mg) for three days (n = 46); or erythromycin ethylsuccinate, 30-50 mg/kg daily given in three divided doses, for ten days (n = 47). Forty-four of 46 azithromycin patients, and 46 of 47 erythromycin patients, had S. pyogenes isolated at baseline and were included in the clinical and bacteriological analyses. At the end of treatment (day 10-12), 38 (86%) of the 44 azithromycin patients were considered cured, four (9%) improved, one (2%) failed and one relapsed. In the erythromycin group, 30 of 46 (65%) were considered cured, 15 (33%) improved and one (2%) failed. Eradication of S. pyogenes was achieved in 40 of 44 (91%) and 45 of 46 (98%) azithromycin and erythromycin patients, respectively. Re-occurrence of S. pyogenes, assessed 28-32 days after start of treatment, occurred in five of 37 (14%) azithromycin patients (three with clinical symptoms) and five of 39 (13%) erythromycin patients (four with clinical signs). There were no statistically significant differences in clinical or bacteriological efficacy between the two groups. Both drugs were well-tolerated, with side-effects (mainly gastrointestinal) reported in five of 46 (11%) azithromycin patients and in six of 47 (13%) erythromycin patients, one of whom withdrew from treatment. No laboratory abnormalities were observed in the azithromycin patients, but were recorded in two of 43 (5%) erythromycin patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Ceftriaxone monotherapy for bacterial meningitis in children.

A total of 33 patients with bacterial meningitis were treated with single daily doses of ceftriaxone (CTR 100 mg/kg/day i.v.) for a median duration of 13 days. Pathogens isolated by culture and/or determined by latex agglutination were 15 Haemophilus influenzae b, 7 Neisseria meningitidis, 2 Streptococcus pneumoniae, 1 group B streptococcus, 2 Streptococcus viridans and 2 Staphylococcus epidermidis. In 4 cases a diagnosis of purulent meningitis could only be made by means of the inflammatory liquor parameters. All cerebrospinal fluid (CSF) drug levels even at the end of the dosing interval were at least 10-fold higher than the MICs of the respective bacterial isolates. The average penetration of CTR into the CSF was 6.6%. Within 12-46 h after the first dose, control spinal taps were performed. Cultures were sterile in all cases. Side effects encountered were diarrhea, exanthema, neutropenia and transient elevation of glutamic oxaloacetic transaminase, but none caused a change of therapy. One patient developed a biliary concrement. No patient died; 5 patients had prolonged fever (greater than 5 days), and 2 were left with persistent hearing deficiencies. CTR can be recommended as a safe and effective antibiotic agent for once daily treatment of bacterial meningitis in children.

Open study of the clinical effect of suprofen drops in children.

Antipyretic effect, tolerability, and acceptance of alpha-methyl-4-(2-thienyl-carbonyl)phenylacetic acid (suprofen, Suprol) drops were tested within the scope of an open study including a total of 111 children with fever of various etiology; two investigational centers participated in this study. The initial mean rectal temperature averaged 39.3 degrees C. The dosage of suprofen drops depended upon the patient's body weight and age; the drug was administered up to q.i.d., for 4 days at the longest. Body temperature, pulse rate, and respiratory rate were recorded prior to administration and 1/2, 1, 1 1/2, 2, 3, 4, 5 and 6 h after first administration of the drug. The antipyretic effect of the treatment was appreciated good in 89% of the cases. Reduction in temperature was statistically significant at all rating times after first administration of the drops as compared with the initial values. Adverse drug experiences such as vomiting and loose stools were seen in only 5 cases. The tolerability was considered good in 96% and the acceptance in 94% of the cases.

Clinical experience and results of treatment with suprofen in pediatrics. 4th communication: Assessment of pain in babies and infants/Analgesic effect of suprofen syrup in otitis media.

In a study including a total of 175 children, ranging in age from 3 months to 3 years and suffering from otitis media, the analgesic effect of alpha-methyl-4-(2-thienylcarbonyl)-phenyl acetic acid (suprofen, Suprol) syrup was compared with that of lidocaine 0.03 g/6 g + phenazone (phenyl-dimethylpyrazolone) 0.03 g/6 g (L PDP) ear drops. The study was designed as an open controlled trial. The test medications were applied in single doses: suprofen 5-7.5 mg/kg b.w., orally; (L PDP) 1 drop, locally. The severity of pain was assessed in the beginning of the treatment and 2 h following administration of the drugs. The results were indicative of the fact that in children on suprofen syrup marked pain relief was obtained, whereas the painful condition of children on L PDP ear drops even deteriorated.

Clinical experience and results of treatment with suprofen in pediatrics. 1st communication: Suprofen dosage for children/An open and a double-blind study with suprofen syrup.

The antipyretic effect of single doses of alpha-methyl-4-(2-thienylcarbonyl)-phenyl acetic acid (suprofen, Suprol) syrup, administered at dose levels of 1, 2, 3, 4, 5, 7.5, and 10 mg/kg b.w., was tested in a randomized double-blind and a subsequent open study. The test populations consisted of 100 children in the double-blind study and 40 patients in the open test (20 subjects/group). The patients' age ranged from 2 to 12 years; the lowest initial rectal temperature was 39.0 degrees C. The treatment groups were homogeneous as to demographic data. The temperature was reduced in all treatment groups. In the double-blind study the mean value dropped under the subfebrile threshold of 38.0 degrees C only in the group on 5 mg/kg and remained then constant for up to 6 h following administration. No sufficient antipyretic effect was obtained with lower doses. The results of the additional open study with doses of 7.5 and 10 mg/kg indicated good antipyretic effect. This effect was not, however, superior to that obtained with 5 mg/kg. Pulse and respiratory rates returned to normal within 1.5 h following administration, except in patients on 1 mg/kg. A total of 10 patients, homogeneously distributed in the treatment groups, experienced vomiting as an adverse reaction. Short-term hypotonia was seen in one subject on 7.5 mg/kg. The results obtained show that single doses of suprofen upward of 5 mg/kg b.w. exert satisfactory, long-lasting, antipyretic effect on children.

Clinical experience and results of treatment with suprofen in pediatrics. 2nd communication: Use of suprofen suppositories as an antipyretic in children with fever due to acute infections/A single-blind controlled study of suprofen versus paracetamol.

The present randomized single-blind trial was performed to study antipyretic effect and tolerability of alpha-methyl-4-(2-thienylcarbonyl)-phenyl acetic acid (suprofen, Suprol) suppositories versus paracetamol (acetaminophen) suppositories in pediatric patients with fever of various etiology. The study included a population of 120 patients ranging in age from 2 to 12 years; the subjects' mean rectal temperature was 39.3 degrees C in the beginning of the therapy. The dosage of the suppositories depended upon body weight; medication was applied up to 3 times a day. The temperatures were recorded 0.5, 1, 1.5, 2, 3, 4, 5, and 6 h after the preparation was first applied. Pulse rates and respiratory rates were measured at the same rating times. The antipyretic effect of suprofen in younger patients was from 1 through 6 h (except at 3 h) statistically significantly superior to that of paracetamol. In older children, the differences in favor of suprofen were statistically significant only at 1 and 2 h after application of the drug. After the treatment pulse and respiratory rate dropped in both age groups on either treatment. The means were within the normal range at all rating times. The only adverse reaction was vomiting; this phenomenon occurred in 4 cases, i.e., in 2 cases each on either drug.

Clinical experience and results of treatment with suprofen in pediatrics. 3rd communication: Antipyretic effect and tolerability of repeat doses of suprofen and paracetamol syrup in hospitalized children/A single-blind study.

Antipyretic effect and tolerability of alpha-methyl-4-(2-thienylcarbonyl)-phenyl acetic acid (suprofen, Suprol), syrup and paracetamol (acetaminophen) were compared within the scope of the present randomized single-blind study; the test population included a total of 115 children ranging in age from 6 months to 12 years. All patients were admitted to the hospital with an average temperature of 39.3 degrees C, their disease being caused by bacterial or viral infections. The dose levels for treatment with syrup depended upon the children's age and body weight. Treatment was in most cases given for two days; a three-times-a-day schedule was used. The (rectal) temperature as well as pulse and respiratory rates were measured prior to treatment and 0.5, 1, 1.5, 2, 3, 4, 5, 6 h after first administration of the test preparations. The results showed that the antipyretic effect of suprofen was in both age groups at all rating times statistically significantly superior to that of paracetamol. Pulse and respiratory rates dropped in both age groups after treatment; the means were within the normal range at all rating times. Adverse drug reactions were seen in 5 patients on suprofen and in 3 cases on paracetamol. It is, however, questionable whether such reactions are drug-dependent.

Therapeutic approaches to the common cold in children.

In a five-day, randomized, double-blind study, the efficacy and safety of a syrup containing a combination of azatadine maleate, pseudoephedrine sulfate, and dextromethorphan hydrobromide (SCH 399 syrup) were compared with those of an expectorant containing the antihistamine diphenhydramine hydrochloride in 60 children with symptoms of the common cold and associated cough. One-half teaspoonful of assigned medication was administered three or four times daily. The severity of signs and symptoms was graded on days 0, 3, and 5. At days 3 and 5, patients treated with SCH 399 experienced a significantly greater degree of relief (P less than 0.001) than did patients treated with the expectorant product. Differences between treatment groups in overall therapeutic response, as evaluated by the physician, were statistically significant (P less than 0.001) at each visit, favoring patients treated with SCH 399. More than 75% of the patients treated with SCH 399 demonstrated an excellent therapeutic response. Tolerance to both study medications was excellent.

[Acute hemolysis and liver cirrhosis as leading symptoms of Wilson's disease in childhood]. / Akute Hämolyse und Leberzirrhose als führende Symptome eines Morbus Wilson im Kindesalter.

Acute hemolytic anemia and the development of liver cirrhosis with ascites 3 month thereafter suggested Wilson's disease in a 12 years old child, which was confirmed by inappropriate copper metabolism. In addition, neurological symptoms and renal tubular insufficiency characterized the early stage of the disease.

Comparative clinical efficacy and safety of netilmicin and tobramycin in children with serious gram-negative infections.

Thirty children with serious gram-negative infections were treated with either netilmicin, 2 mg/kg, or tobramycin, 1 mg/kg, every eight hours for a minimum of 72 hours. Because of the administration of different doses, a "blind" investigator evaluated treatment response while another investigator adjusted the doses on the basis of each patient's drug serum levels and bacteriological response. Comparisons between the two study groups showed both treatments to be equally effective. All 15 patients treated with netilmicin and 14 of the 15 patients treated with tobramycin experienced complete resolution of clinical signs and symptoms and elimination of pathogens. One child in the tobramycin group was considered a treatment failure because of a persistent urinary tract infection. There were no adverse effects attributable to either drug.

[The significance of serum ferritin determination for the evaluation of preventive iron treatment of anemia in premature infants]. / Die Bedeutung der Serum-Ferritin-Bestimmung für die Beurteilung der Eisenprophylaxe der Frühgeborenenanämie.

The blood values of 36 premature babies were examined for 12 months from the 8th week onwards and the values of the iron metabolism such as serum iron, iron binding capacity, iron saturation and serum ferritin were estimated. All the babies were given 2-3 mg/kg BW/daily Ferro-iron in the form of a ferrous sulphatemucoproteose. When the prophylaxis was begun, the serum ferritin was, as expected in the upper range limit (84 micrograms/l). One year later, it was, at 78 micrograms/l, almost same. These figures demonstrate, that with the beginning of iron prophylaxis in the 8th week of life, the iron reserve in premature babies was kept within the norm.

An antihistamine/decongestant formulation ('Disophrol' Syrup) for relief of symptoms in children with seasonal rhinitis.

An open study was carried out in 30 children with seasonal allergic rhinitis to evaluate the efficacy and tolerance of treatment with a dexbrompheniramine maleate (1.5 mg/5 ml) and pseudoephedrine sulphate (30 mg/5 ml) syrup formulation ('Disophrol' Syrup). Each patient was given 2.5 to 5 ml 4-times daily during the 14-day study period. Relief from signs and symptoms associated with seasonal rhinitis was evaluated on Days 7 and 14 of therapy. By Day 7, 5 patients were considered cured, 22 showed marked improvement and 3 patients had improved. At the Day 14 evaluation, 27 patients had complete clearing of signs and symptoms, 2 patients showed a marked improvement while the remaining patient was considered a treatment failure. Body weight and vital signs remained unaffected. Incidence of adverse reactions was limited to one occurrence of extreme fatigue, which did not necessitate termination of therapy.

[Serum ferritin and iron therapy in childhood. Experiences with iron resin adsorbate (author's transl)]. / Serum-Ferritin und Eisentherapie im Kindesalter. Erfahrungen mit Eisen-Resin-Adsorbat.

In 40 children with iron deficiency anemia and in 15 children with iron deficiency without anemia the diagnosis is made by hemoglobin, red cell count, hematocrit, MCH, serum iron, iron binding capacity, iron saturation and serum ferritin. For treatment an iron resin adsorbate, given one time daily, was used. The average daily increase of hemoglobin in the time of five weeks is 0,71 g/l by an initial value of 91 g/l. In a child with severe anemia (54 g/l) the daily increase was 2,57 g/l Hemoglobin. Serum ferritin increased in 12 weeks from 13 to 51 microgram/l, this normal value shows the filling of the iron reserves.

[Infectious toxic hypotension--effect and dosage of midodrine (author's transl)]. / Infektiös-toxische Hypotension -- Dosierung und Wirkung von Midodrin.

A new alpha-sympathicomimetic drug with peroral effect is midodrine. The effective oral dosage in infancy and childhood is 0.06 mg/kg/dosi. The therapeutic effect, comparing the drug with etilefrin is shown in 120 children with pneumonia, enteritis, meningitis in a random study. The results give an increase in blood pressure and a decrease in heart frequency, statistically proved, on the first day of treatment. Therefore it seems that midodrine is qualified for the treatment of hypotension in infectious diseases.

[Therapy of pneumonia in children with mezlocillin (author's transl)]. / Therapie der Pneumonien im Kindesalter mit Mezlocillin.

Pneumonia in children requires immediate antibiotic treatment. The identification of the causative organism is very difficult and, therefore, of little importance for therapy. A number of simple examinations, such as BSR, neutrophil count and unsegmented neutrophil count, allow to differentiate between bacterial and viral infections. This method is particularly suitable for assessing an antibiotic treatment retrospectively. These considerations were borne in mind when instituting treatment in 72 babies and children suffering from pneumonia. The following diagnoses were established: 12 cases of whooping cough associated with pneumonia, 4 cases of congenital defects and pneumonia, 1 case of rare Salmonella-induced septicopyaemia and pneumonia, 6 cases of pneumonia and reduced defence against infections and 49 cases of primary pneumonia. Except for one child presenting an insufficiently developed immunity system, all the children were rapidly cured within 5-7 days. The only side effect observed was rash in two cases.

[Tetanus antitoxin in serum and cerebral spinal fluid in viral meningitis in children (author's transl)]. / Tetanus-Antitoxin in Serum und Liquor bei Virusmeningitis.

Tetanus antitoxins were measured in serum and cerebro spinal fluid from 58 children--35 boys and 23 girls--with viral meningitis. The concentrations of IgG, IgA and IgM were also determined. The appearance of tetanus antitoxins in cerebral spinal fluid depends on absolute antitoxin levels in serum as well as on the antitoxin/IgG ratio. Antitoxin/IgG ratios in serum and cerebro spinal fluid were in the same order of magnitude. Detection of tetanus antitoxins in the cerebral spinal fluid of children with viral meningitis shows clearly that antibody found in cerebral spinal fluid is not an absolute proof of a certain disease. The results further indicate that local production of IgG antibody cannot be postulated by detecting certain antibodies in the CSF. It is also necessary to prove that antibody/globulin ratios are of significantly different magnitude in serum and CFS.

[Treatment of iron deficiency anemia with ferrosulfate serin komplex (author's transl)]. / Therapie der Eisenmangelanämie Erfahrungen mit einem Serin-Ferrosulfat-Komplex.

The results of treatment of iron deficiency anemia in 217 children and infants (aged 8 months to 12 years) with ferrosulfate serin complex are demonstrated: 208 children with simple iron deficiency anemia with hemoglobin 9.1 g/100 ml before treatment had in the first 4 weeks a daily increase of 0.082 g/10000 ml hemoglobin; in 3 children with severe anemia of chronic blood loss the daily increase was 0.21 mg/100 ml and in 6 children with hypoxic polycythemia with congenital heart disease and so called latent iron deficiency anemia the increse was 0.16 g/100 ml. Through the better absorption of this serin-ferrosulfate complex the required dosis is only 3 mg/kg/d. The benefit of this small dosis is the low rate of side effects.

[Frequency of iron deficiency and iron deficiency anaemia in infancy and childhood (author's transl)]. / Häufigkeit von Eisenmangel und Eisenmangelanämie im Kindesalter.

266 children with iron deficiency were treated over a period of 2 years. The incidence rate and age distribution did not deviate much compared with former results. A different incidence of iron deficiency was found when 120 healthy children from 2 socially and economically different groups were examined. In both groups together the incidence rate of iron deficiency was 19%. But while in the socially higher standing group only 5% were afflicted, the other group showed 33%. This difference questions the value of generally iron medication and favours the opinion that iron deficiency indicates that children have not been looked after properly.

[The importance of immune deficiency for the prognosis of purulent meningitis (author's transl)]. / Bedeutung von Immundefekten für die Prognose der eitrigen Meningitis

Morbidity and mortality of suppurative bacterial meningitis show a very constant behavior over many decades. The introduction of antibiotics certainly lowered the lethality considerably, but since then it has remained fairly unchanged at about 15-20%. However, in the principal groups of pathogens--meningococci, pneumococci, Haemophilus influenzae--antibiotic resistence plays no special role. The significance of disorders of defense against infections for the course of the disease has not yet been investigated. Of 92 children examined with purulent meningitis, 49 showed a selective antibody deficiency syndrome against bacterial antigens, 38 of 48 children investigated showed further disorders of bactericidal activity. The proportion of these disorders is particularly high in children with defective healing of a meningitis.