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PubMed1985

[Pharmacokinetics of aztreonam in peripheral venous serum, uterine arterial serum and intrapelvic female organs].

The concentrations of aztreonam (SQ 26,776, AZT, Squibb) in peripheral venous serum, uterine arterial serum and intrapelvic female organs were determined by bioassay, using the cylinder-plate diffusion method, in 27 women with simple total hysterectomy. With an intravenous injection of AZT 1 g, the maximum levels of peripheral venous serum and uterine arterial serum were 76.39 micrograms/ml and 76.38 micrograms/ml, respectively. Also, the biological half-life (T1/2) was 1.56 hours in peripheral venous serum and 1.54 hours in uterine arterial serum. The concentration in uterine arterial serum was more than 1.8 micrograms/ml at 8 hours after injection and maintained at a high level than the minimal inhibitory concentration necessary for most Gram-negative bacteria for at least 8 hours. The concentrations of AZT in female genital organs were kept higher than the minimal inhibitory concentration against E. coli at 4 hours after injection, and the ratios of the concentrations in uterine tube and endometrium to that in peripheral venous serum were 0.40 +/- 0.18 and 0.30 +/- 0.20, respectively. Since AZT is characterized by more potent antibacterial activity against Gram-negative bacteria and the minimal side effects, intravenous administration of AZT at 1 g or 2 g per day may be an adequate dose for infections of the female urogenital tract.

Adult↗

PubMed1985

[Clinical evaluation of aztreonam in the field of obstetrics and gynecology].

Aztreonam (AZT) was evaluated for its clinical efficacy in a total of 10 cases, namely 3 cases of endometritis, 6 cases of intrapelvic infections, 1 case of puerperal pyelonephritis. The clinical results of AZT were as follows; excellent in 5 cases and moderate in 5 cases, the overall efficacy rate was 100%. No clinical side effect was observed, however in laboratory finding slightly elevated transaminase (GOT, GPT) was observed in 1 case.

Adult↗

PubMed1985

[Fundamental and clinical studies on aztreonam in obstetrics and gynecology].

Fundamental and clinical studies on gynecological use of aztreonam (AZT), a new monobactam, were performed with following results. Following the intravenous administration of 1 g dose of AZT, the transfer of AZT to pelvic dead space exudate was good, in which the concentration of that was 14.9 micrograms/ml (2 hours), 15.3 micrograms/ml (3 hours) after injection. The transfer of AZT to serum of umbilical cord and amniotic fluid was excellent. In a clinical trial, AZT was given to 5 patients with obstetric and gynecological infections. The clinical efficacy was evaluated as excellent in 1 case and good in the other 4 cases. No adverse effects were observed in any of the patients treated with AZT.

Adult↗

PubMed1985

[Clinical review and antibacterial effect of aztreonam in infections in obstetrics and gynecology].

Clinical effect in obstetrics and gynecology was studied on aztreonam (AZT), a potent monobactam antibiotic for Gram-negative bacteria. AZT was tested for 7 cases and effective for all of them with quite a high effective rate of 100%. Neither side effect nor abnormal laboratory findings were noted and it sufficiently proves the property of AZT, a totally chemical-synthesized product with lower incidence of allergic reaction. The above results suggest that AZT is useful for obstetrics and gynecologic infections in view of its high stability to beta-lactamase and dehydropeptidase and high potency against Gram-negative bacteria.

Adult↗

PubMed1985

[Basic and clinical trials of aztreonam in the field of pediatrics].

Serum and urinary concentrations and recovery rates of aztreonam (SQ26,776, AZT), a newly developed antibiotic, were studied for a total of 20 pediatric cases by one-shot intravenous injections of 10, 20 and 40 mg/kg to 3, 4 and 3 cases, respectively, and by intravenous drip infusion of 10, 20 and 40 mg/kg to 3, 4 and 3 cases for 1 hour, respectively. Clinical and bacterial effects of AZT were studied by administering 76.7 mg/kg per day on average for a total of 36 cases of tonsillitis (6), pneumonia (13), otitis media and pneumonia complication (1), pleurisy (1), sinusitis (1) and UTI (14). The above daily dose was given t.i.d. (9 cases) or q.i.d. (27 cases), by intravenous drip infusion for 30 minutes for one t.i.d. case and by one-shot intravenous injection for 7 days for the remaining 35 cases. Also, side effect and laboratory values were examined for 43 cases including 7 dropouts. Serum concentration of AZT in 10 pediatric cases were measured by dosing 10, 20 and 40 mg/kg by one-shot intravenous injection to 3, 4 and 3 cases, respectively. In every dosage group, the serum concentrations were highest 5 minutes after the intravenous injection with average values of 91.0, 174.0 and 175.3 mcg/ml, respectively. Dose response was observed between 10 mg/kg dose group and 20, 40 mg/kg dose groups, but it was not between 20 mg/kg group and 40 mg/kg group. This was considered to be attributable to the individual case-fluctuations in the 2 groups and to a high concentration case of 240.0 mcg/ml in the 20 mg/kg group. Half-life of each dosage group was 1.55, 1.65 and 1.93 hours. Serum concentrations of AZT in 10 pediatric cases at the dosage level of 10, 20 and 40 mg/kg for 3, 4 and 3 cases, respectively, by 1 hour intravenous drip infusion were highest at the end of the administration with average values of 95.7, 126.0 and 170.7 mcg/ml, respectively. There was a dose response among the 3 groups and the half-life of them were 1.02, 1.41 and 2.48 hours, respectively. A longer half-life of the 3rd group with 40 mg/kg administration than the other 2 groups was due to 1 particular case of 4.44 hours with unknown cause of such an exceptional extension.(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗

PubMed1985

[Clinical study of aztreonam on respiratory tract infections caused by gram-negative pathogens].

Aztreonam (E-0734, AZT) was administered to pneumonia and chronic respiratory tract infections. The results were as follows: AZT was administered to 29 patients. Twenty-six cases were evaluable and 3 cases were excluded from evaluation of efficacy because 1 was Gram-positive infection, 2 were unclear symptom of infection. Pneumonia was 4 cases. Chronic respiratory tract infections were 22 cases. Clinical efficacy was judged as follows; excellent in 7 cases, good in 10 cases, fair in 5 cases and poor in 4 cases, then the efficacy rate was 65.4%. Efficacy rate in pneumonia, acute aggravation of diffuse panbronchiolitis and bronchiectasis with infection was 50%, 67% and 83%, respectively. Bacteriological response was judged on 21 cases with eradication rate was 66.7%. Bacteriological response classified by pathogen was as follows: All 6 isolates of H. influenzae, 2 in 6 isolates of P. aeruginosa, 4 in 5 isolates of H. parainfluenzae and all 3 isolates of K. pneumoniae were cleared. Total eradicated rate was 74.1%. Eruption was observed in 1 case as side effect. Abnormal laboratory findings were observed in 4 cases. Elevation of GOT and GPT was in 3 cases. Increase of eosinophil and basophil was in 1 case. AZT was considered to be a useful antibiotic for the treatment of respiratory tract infections, especially chronic respiratory tract infections, caused by Gram-negative pathogens.

Adult↗

PubMed1985

[Epidemiologic and therapeutic study on gonorrheal infections--one shot therapy by aztreonam].

A clinical study of a new monocyclic beta-lactam antibiotic, AZTREONAM (hereafter referred to as AZT) for gonorrheal infections as well as epidemiologic study of gonorrheal infections were made Epidemiology: There was a reflection of the increasing sexual activity of the younger generation; both male and female patients in their twenties were most frequent (male 49.5%, female 43.7%) and the percent of teen age patients was 15.1% (male) and 34.4% (female). Forty two strains (17.2%) out of 244 clinically isolated gonococci were PPNG. Residue of serious secretion was observed in a little less than 20% suggesting a complication by Chlamydia trachomatis. Clinical Result: One shot (1-2 g) therapy by AZT was given to 244 gonorrheal infection cases (212 urethritis cases of males. 32 cervicitis cases of females) with the following highly effective rate. Although beta-lactamase producing MIC of AZT at 10(6) CFU/ml showed a peak of 0.025 microgram/ml and ranged between less than 0.0125 microgram/ml to 0.2 microgram/ml. The time required for the elimination of gonococci was studied by the administration of 1 g and 2 g AZT. Gonococci became extinct in 1-8 hours or 4-4.5 hours on average. The difference between n 1 g and 2 g was scarcely observed. Clinical effect of 1 g one shot and 2 g one shot AZT was examined on the 3rd treatment day for 244 male and females cases. The effective rate was high; 90.7% by 1 g, 97.1% by 2 g for male urethritis, 100% by 1 g also by 2 g for female cervicitis. This therapeutic efficacy was kept even in PPNG, isolated cases. There were two side effects (0.8%), one case each of numbness and, redness and swelling of both hands, out of 244 cases, but both of them were minor ones without clinical complication.

Adolescent↗

PubMed1985

[Clinical studies on aztreonam following intravenous drip infusion].

Aztreonam (AZT), a new synthetic monocyclic beta-lactam antibiotic, which is resistant to beta-lactamase and has a strong and specific activity against aerobic Gram-negative bacteria including Pseudomonas aeruginosa. The patients of 13 cases with localized peritonitis due to acute appendicitis, 3 cases with panperitonitis (1 case with perforative appendicitis, 1 with acute cholecystitis and 1 with pancreatic necrosis) and 4 cases with skin and soft tissue infection (anal fistula and abdominal abscess etc.) were treated by AZT. AZT was administered in a dose of 1 g twice a day by intravenous drip infusion using 100 ml-volume bottle preparation with saline for 4 to 10 days. Clinical efficacy was rated excellent in 2 cases, good in 16 cases, fair in 1 case and poor in 1 case (efficacy rate 90.0%). Adverse effects were small skin rash in 1 case, and increased GOT and GPT in 1 case. No adverse effect was recognized in other cases. Therefore, AZT appears to be very useful drug when used for chemotherapy of infectious diseases in surgery.

Adolescent↗

PubMed1985

[Therapeutic effectiveness of aztreonam on severe infections associated with hematologic disorders. Hanshin Infection Study Group].

One hundred and nine patients with infection accompanying hematologic disorders including leukemia and lymphoma were treated with aztreonam (AZT). Of the 90 patients in whom the efficacy could be evaluated, 17 (18.9%) responded markedly and 29 (32.2%) moderately, the effective rate being 51.1%. The efficacy rate classified according to infections was 25% in septicemia, 46.3% in suspected septicemia, 57.1% in pneumonia and 100% in urinary tract infection. The efficacy rate to the Gram-negative bacteria was 78.9% and to the Gram-positive bacteria was 20.0%. In 4 (66.7%) out of 6 patients in whom P. aeruginosa was the causative organism, AZT was effective. The efficacy rate was 52.2% in the 23 patients whose causative organisms were identified and 50.7% in 67 patients whose causative organisms were not identified. There was no significant difference in the efficacy rate between the patients who failed to respond to prior antibiotic therapy (53.6%) and those treated with AZT from the beginning. The initial neutrophil count did not affect the efficacy rate. Side effects which might have been caused by AZT were eruption and fever in 4 patients. Hepatic disorders and eosinophilia were observed in 7 patients. However, the relationship between AZT and these abnormal findings was not established. These results indicate that AZT is an effective and safe antibiotic for the treatment of infections accompanying hematologic disorders.

Adolescent↗

PubMed1985

[Clinical and pharmacokinetic evaluations of aztreonam in children].

Aztreonam (AZT) was evaluated for its safety, clinical efficacy and pharmacokinetics in children. AZT was effective in all the 16 children with Gram-negative bacterial infections. The diagnoses included acute bronchitis and pneumonia (11), UTI (2), UTI with bacteremia (1), purulent meningitis (1) and acute mucositis (1). The etiologic agents were H. influenzae (10), B. catarrhalis (1), N. meningitidis group C (1), E. coli (3) and P. aeruginosa (2). The serum half-life was approximately 1.2 hours after intravenous bolus injection. Penetration into the inflamed cerebrospinal fluid was good not only in acute purulent meningitis but also in viral meningitis. From the present study, AZT is a safe and effective antibiotic when used in children with Gram-negative bacterial infections.

Age Factors↗

PubMed1985

[Fundamental and clinical studies of aztreonam in the field of pediatric].

The fundamental and clinical studies of aztreonam (AZT) were performed. The results were as follows: The MICs of AZT for E. coli and Salmonella sp. which were recently isolated in the pediatric field were less than 0.78 micrograms/ml. AZT also was effective against ABPC/PIPC-resistant bacteria. The MIC of AZT for V. parahaemolyticus was less than 1.56 micrograms/ml. The peak serum levels of AZT which were occurred just after the 1 hour drip infusion of 10-30 mg/kg were 60.5-136.8 micrograms/ml, and at 6 hours after infusion the serum levels were 1.3-6.1 micrograms/ml; therefore, the dose response was proved. The mean half-lives (T 1/2) were between 1.21 and 1.36 hours. The excretion rates in urine up to 6 hours after intravenous drip infusion were between 32.7 and 77.5%. The ratio of the cerebrospinal fluid concentration to serum in the child with purulent meningitis was 3.5% at 1 hour after the intravenous injection at the dose of 69 mg/kg, and the ratios of the subdural fluid levels to serum were 31.3-37.5%. The levels of AZT into the feces by the multiple dosage were 0-840 micrograms/g. Twenty-five pediatric patients with acute infections had been treated by intravenous injection or drip infusion at the doses of 49-120 mg/kg/day (almost 50-100 mg/kg/day) for 4 to 13 days. The efficacy rate of excellent + good was 84% and that of excellent + good + fair was 96%. The efficacy rate of excellent + good was 100% in all cases with upper/lower respiratory tract infection, bronchopneumonia, and acute urinary tract infection caused by Gram-negative rods. The clinical efficacy was observed in all cases with acute bacterial enteritis. Although AZT was clinically effective against Salmonella enteritis, bacteriological efficacy on the causative organisms was not observed in some cases. Although AZT was bacteriologically effective in 1 patient with typhoid, it did not alleviated fever. AZT showed activity to 9 strains isolated from the culture of throat swab, urine and feces. No side effects were clinically observed in all cases, while slight elevations of laboratory findings were observed in 4 cases.

Age Factors↗

PubMed1985

[Fundamental and clinical studies of aztreonam in pediatric infections].

Fundamental and clinical studies were carried out with aztreonam (AZT), a new monocyclic beta-lactam antibiotic, in pediatric infections. Results were as follows. The mean half-lives in the vein blood were 1.09 hours, 1.18 hours, 1.22 hours after injection, when the doses were 10, 20 and 40 mg/kg, respectively. Dose response was observed. The average recovery rates in the urine between 0 and 6 hours were 40.2%, 42.3%, 50.8% when the doses were 10, 20 and 40 mg/kg, respectively. The antibacterial activity of AZT against 16 clinical isolates were determined in comparison with those of ABPC, CPZ, LMOX and CTX. Against 8 clinical isolates of E. coli and 3 of H. influenzae, the activity of AZT was equal or superior to that of CPZ, LMOX and CTX, and way by far superior to that of ABPC. Twenty-three pediatric patients received AZT in doses ranging from 48 to 79 mg/kg divided 3 times a day; 12 cases of urinary tract infection, 9 cases of respiratory tract infection and 2 cases of bacterial enterocolitis. The rate of clinical effectiveness was 100%. No side effect was observed. Slight elevation of GOT and GPT were observed in 2 cases, increase of platelet count in 2. All were considered to be transient and mild.

Age Factors↗

PubMed1985

[Fundamental and clinical studies on aztreonam in the pediatric field].

Fundamental and clinical studies on aztreonam (AZT), a new monobactam antibiotic, were performed in the pediatric field. The MICs of AZT were assessed against the clinically isolated strains in the pediatric infections. AZT showed an excellent antibacterial activity against Gram-negative bacteria, i.e., against E. coli (20 strains), K. pneumoniae (9), P. mirabilis (16), P. vulgaris (5), P. aeruginosa (10), S. typhimurium (4) and H. influenzae (11); the MICs of AZT against the above strains were less than 0.39 microgram/ml, 0.10 microgram/ml, 0.024 microgram/ml, 0.024 microgram/ml, 6.25 micrograms/ml, 0.10 microgram/ml and 0.10 microgram/ml, respectively. However, antibacterial activity of AZT against Gram-positive bacteria was inferior to that against Gram-negative bacteria, i.e., against the strains of S. aureus (16) and S. pyogenes (4), those MICs were more than 400 micrograms/ml and 3.13 micrograms/ml, respectively. Serum concentrations and urinary excretion of AZT were measured in 2 children aged 7 and 11 years after a single intravenous injection at the dose of 20 mg/kg. The mean serum concentration of AZT followed by the injection 62.5 micrograms/ml at 1/4 hour, 28.5 micrograms/ml at 1/2 hour, 16.5 micrograms/ml at 1 hour, 12.0 micrograms/ml at 2 hours, 3.6 micrograms/ml at 4 hours and 1.1 micrograms/ml at 6 hours, respectively. The mean half-life (beta-phase) was 1.24 hours. The mean urinary concentrations after the injection were 5,000 micrograms/ml in 0-2 hours, 1,650 micrograms/ml in 2-4 hours and 611 micrograms/ml in 4-6 hours and the mean urinary recovery rate up to 6 hours was 61.2%. These results in our studies were considered to be comparable with those reported in adults. In our clinical studies, AZT was administered to a total of 14 cases, i.e., acute pneumonia (4 cases), acute pyelonephritis (4), acute enteritis (5) and acute sppurative cholangitis (1). Clinical effect of AZT was excellent or good in 13 cases except fair in 1 case with acute enteritis and the efficacy rate (excellent and good) was 92.9%. With regard to bacteriological effect, all the strains of H. influenzae (3), E. coli (2), P. mirabilis (1) and P. vulgaris (1) were eradicated, but, S. typhimurium (4) was not eradicated. Neither side effect nor abnormal laboratory findings were observed during the study.

Age Factors↗

PubMed1985

[Clinical evaluation of aztreonam in children].

Clinical usage of aztreonam (AZT), a newly synthesized antibiotic which belongs to monobactam, was evaluated for its efficacy and safety in 22 patients aged from 1 month-old to 13 year-5 month-old with bacterial infections and the following results were obtained. AZT was administered to 4 patients with pyelonephritis and 10 patients with tonsillitis at a daily dosage of 40.4-120.9 mg/kg and to 5 patients with clinical sepsis associated with agranulocytosis caused by intensive antileukemic therapy at a daily dosage of 142.4-171.4 mg/kg, divided into 3 or 4, by intravenous injection or by 30 minutes drip infusion. The clinical results of these 19 evaluable patients were as follows: excellent; 10 cases, good; 5 cases, fair; 2 cases, poor; 2 cases. The over all efficacy rate was 78.9% and that of pyelonephritis and tonsillitis was 100.0%. No clinical side effects were observed in any 23 patients, including a patient who proved to be suffering from Mycoplasma pneumoniae infection, and no abnormal laboratory findings caused by AZT was noticed. The MICs of AZT against 9 strains isolated from patients with pyelonephritis and those with tonsillitis were as follows: MICs against all of 3 strains of K. pneumoniae were less than 0.05 microgram/ml. MICs against 2 out of 4 strains of H. influenzae were less than 0.05 microgram/ml and those of the remaining 2 strains were 0.10 microgram/ml. MIC against 1 strain of S. aureus was 1.56 microgram/ml. MIC against 1 strain of S. epidermidis was more than 100 micrograms/ml.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

PubMed1985

[Pharmacokinetics and clinical evaluation of aztreonam in pediatrics].

Pharmacokinetics, in vitro, and in vivo effect of aztreonam (SQ 26,776, AZT), a newly synthesized monobactam antibiotic, were investigated in pediatric patients. The pharmacokinetics were studied in 12 children without renal or hepatic impairment, each of whom received single 10, 20 and 40 mg/kg intravenous doses of drug. Serial samples of serum and urine were assayed for AZT. Serum pharmacokinetics of AZT were described by an open, linear, two-compartment kinetic model. After intravenous administration, AZT was eliminated primarily by urinary excretion of unchanged drug (60.4%). The average biological half-lives of AZT in serum were 1.33 (10 mg/kg, n = 1), 1.69 +/- 0.40 (20 mg/kg, n = 8), and 1.51 +/- 0.61 (40 mg/kg, n = 3) hours. The antibacterial activity of AZT against E. coli and P. aeruginosa was equal or slightly stronger than that of CPZ, LMOX, and CTX. It had no antimicrobial activity against Gram-positive cocci. In vivo effect of AZT was evaluated in 13 children with various infections. The result was excellent in 7 cases, good in 1 case, fair in 3 cases and poor in 1 case, with effective ratio of 66.7%. Exanthema or elevation of GOT and GPT were noticed in 3 patients.

Adolescent↗

PubMed1985

[Laboratory and clinical studies of aztreonam in the pediatric field].

The authors have carried out the laboratory and clinical studies of aztreonam (AZT) and obtained the following results. The antibacterial activities of AZT against the clinical isolates of E. coli, K. pneumoniae and P. aeruginosa were measured by the agar dilution method with inoculum size of 10(6) cells/ml. The susceptibility distribution of E. coli to AZT ranged from 0.025 or lower to 1.56 microgram/ml, and the peak of distribution was 0.05 microgram/ml. The peak of susceptibility distribution of K. pneumoniae was 0.025 microgram/ml or lower, and the distribution of P. aeruginosa ranged from 0.1 to 100 micrograms/ml higher and the peak of distribution was 3.13 micrograms/ml. After intravenous bolus injection of 20 mg of AZT in 4 children, the mean peak serum level was 117 +/- 35.1 micrograms/ml at 15 minutes after injection, and half-life time was 1.42 hours. The mean urinary excretion rates was 63.2 +/- 30.6% up to 6 hours after bolus injection of 20 mg/kg of AZT. AZT was given 11 cases with bacterial injection. Daily doses of AZT were from 41.7 to 94.9 mg/kg. Clinical results obtained were excellent and good responses in 8 of 11 cases (72.7%). No side effect was observed.

Age Factors↗

PubMed1985

[Clinical evaluation of aztreonam in pediatrics].

Clinical studies of aztreonam (AZT) were performed in 10 pediatric cases. One transient pyuria case with 10(3)/ml E. faecalis detected in urine was excluded from clinical evaluation, because the presence of infection was unclear. Results were as follows: AZT was effective on 1 patient with meningitis (causative organism: H. influenzae), who was treated with 41.7 mg/kg 4 times a day. Results of administration of 58.1-78.9 mg/kg 3 or 4 times a day by intravenous injection for 1 E. coli sepsis-and-pyelonephritis complication case and 7 pyelonephritis cases (causative organisms: E. coli in 1, E. coli + E. faecalis in 1, E. faecalis in 1, P. aeruginosa in 3 and unknown in 1) were excellent in 4, good in 2 and poor in 2 cases. The pathogens of the 2 poor cases were E. faecalis and P. aeruginosa, respectively. Six of the pyelonephritis cases had vesicoureteral refluxes as an underlying condition. Clinical and microbiological effects of AZT were considered to be closely correlated with its MIC values. No side effect was recognized. Though abnormal laboratory findings were obtained in 4 cases, including elevations of GOT X GPT in 2 cases, GPT elevation in 1 case and plateletcount increase in 1 case. All of these abnormalities were minor and transient. The serum concentrations of AZT for a two-month-old patient with pyelonephritis were 65, 50, 35, 22.8 and 12.4 micrograms/ml at 1/2, 1, 2, 4 and 6 hours, respectively and T1/2 was 2.42 hours after injecting AZT 20 mg/kg by intravenous injection.(ABSTRACT TRUNCATED AT 250 WORDS)

Age Factors↗

PubMed1985

[Clinical experience with aztreonam in the pediatric field].

Aztreonam (AZT) was given intravenously to 20 children with the following acute bacterial infections: 13 cases of bronchopneumonia, 5 cases of urinary tract infection, 1 case of cervical lymphadenitis with acute tonsillitis and 1 case of acute enteritis. Clinical effectiveness was obtained in 17 cases of 20 cases and bacteriological effectiveness in 10 strains out of 11 strains. No side effect was observed except for 2 cases with eruption, 1 case with slight elevation of GPT, 1 case with slight elevation of GOT and 1 case with slight elevation of GOT and GPT. From the above clinical results, it is apparent that AZT is a useful antibiotic for treating pediatric patients with various kinds of bacterial infections.

Acute Disease↗