Clinical evaluation of sulbactam/cefoperazone in the field of obstetrics and gynecology

One or 2 grams of sulbactam/cefoperazone (SBT/CPZ) in 250 ml of 5% glucose solution was administered twice daily by drip infusion to 10 patients with female genital organ infections. The clinical effectiveness was seen in 8 patients but not in 2 patients associated with emergence of replaced organism or non-eradicated causative organism. Antibacterial activity of SBT/CPZ vs. CPZ in the 20 clinical isolates revealed that SBT/CPZ was 1 or 3 tubes superior to CPZ alone in the beta-lactamase producing organisms, but, 1 or 2 tubes inferior to CPZ in the beta-lactamase non-producing organisms. In 1 case increases in GOT and GPT, and in another increases in GOT and GPT, and a decrease in platelets were observed even though their degrees were mild.     

Clinical trial of sulbactam/cefoperazone in the field of obstetrics and gynecology

Sulbactam/cefoperazone (SBT/CPZ) was administered to 19 patients with various infections in the field of obstetrics and gynecology. The clinical efficacy was judged as excellent in 1 case and as good in 16 cases; hence, the efficacy rate was 89.5%. SBT/CPZ was not effective in a patient with end-stage carcinomatous peritonitis and nor in a patient with pyosalpinx caused by E. coli and Peptococcus magnus. Except a case by E. coli, SBT/CPZ was highly effective for pyosalpinx and pelvic peritonitis where E. coli or K. pneumoniae was the causative organism. No side effects were observed.     

Clinical studies on sulbactam/cefoperazone in the field of obstetrics and gynecology

Efficacy and safety of sulbactam/cefoperazone (SBT/CPZ) was studied on gynecological infections. The results obtained are as follows: In the treatment of 31 cases of gynecological infections, the clinical efficacy of SBT/CPZ was assessed as excellent in 9 cases and effective in 22 cases. As for the bacteriological effects of SBT/CPZ, clinically isolated organisms were completely (100%) eradicated. In comparison with MICs of CPZ, SBT/CPZ was found to show a combined effect on Gram-negative and Gram-positive organisms in the order mentioned, but this effect was not observed against anaerobes. The combined effect of SBT/CPZ on beta-lactamase producing bacteria was also investigated in the same manner. As a result, SBT/CPZ was found to exert a combined effect on beta-lactamase strains of S. aureus, S. epidermidis, E. coli, B. catarrhalis and B. fragilis. The laboratory tests performed before and after administration of SBT/CPZ revealed rise in GOT and GPT values in 1 case, GPT values in 2 cases and eosinophil in 1 case. However, these rises were all mild and required no particular measures.     

Clinical studies on sulbactam/cefoperazone in the field of obstetrics and gynecology

Sulbactam (SBT), a new beta-lactamase inhibitor, in combination with cefoperazone (CPZ) was studied for the clinical efficacy in the field of obstetrics and gynecology. SBT/CPZ was given to 5 cases with the following infections; 2 of pyometra, 2 of endometritis and 1 of abscess of adnexa. Clinical efficacy was good in 3 cases and poor in 2 cases. Bacteriologically, only 1 strain of P. vulgaris was beta-lactamase producer but was persisted after treatment. Neither side effects nor abnormal laboratory findings was observed.     

Experience with sulbactam/cefoperazone in the field of obstetrics and gynecology

Sulbactam/cefoperazone (SBT/CPZ) was studied for clinical efficacy in the field of obstetrics and gynecology, and following results were obtained: In the treatment of 6 cases of gynecological infection, the clinical efficacy of SBT/CPZ was assessed as excellent in 1 case and effective in 5 cases. Neither adverse effects nor abnormalities in laboratory findings due to SBT/CPZ were observed. Based on these results, SBT/CPZ is considered to be a highly effective antibiotic with clinical efficacy in obstetric and gynecological infections in the daily dosage of 2 g given in two divided doses.     

Fundamental and clinical studies on sulbactam/cefoperazone in the field of obstetrics and gynecology

Fundamental and clinical studies on sulbactam/cefoperazone (SBT/CPZ), a combination drug of sulbactam and cefoperazone, were carried out in the field of obstetrics and gynecology. The following results were obtained: Transfer into female genital organ tissues Following 1 hour intravenous drip infusion of SBT/CPZ, favourable transfers of both of SBT and CPZ to female genital organ tissues and pelvic dead space exudate were observed. Clinical evaluation A total of 12 cases comprising 6 with intrauterine infection, 1 with pyometra, 1 with abscess of portio vaginalis, 2 with parametritis, 1 with pelvioperitonitis and 1 with purulent lymphocyst was treated with SBT/CPZ. Clinical efficacy was excellent in 6 cases, good in 5 cases and poor in 1 case, with overall efficacy rate of 92%. The bacteriological efficacy was judged as eradicated in 3, and as decreased in 2 out of 5 evaluable cases. In all of the 5 cases, isolated organisms were beta-lactamase producing organisms. No notable side effects or abnormal laboratory findings were observed except 1 case with elevations of GOT and GPT.     

Fundamental and clinical studies on sulbactam/cefoperazone in the field of obstetrics and gynecology

A combination of sulbactam, a beta-lactamase inhibitor, plus cefoperazone (SBT/CPZ = 1/1) was studied in the field of obstetrics and gynecology, and the results were following: Absorption and transfer into genital organ tissues were good. With the 1g intravenous injection the maximum serum concentrations in the uterine artery were 88.6 micrograms/ml for CPZ and 50.0 micrograms/ml for SBT, and the maximum tissue concentrations were 12.2-17.4 micrograms/g for CPZ and 9.8-21.4 micrograms/g for SBT. When the 2 g was administered, the maximum tissue concentrations were 11.9-26.7 micrograms/g for CPZ and 6.0-8.0 micrograms/g for SBT. These elimination showed the similar trend as their serum levels, and their tissue levels were higher than MIC80 for the main organisms. Their penetration into the intrapelvic dead space exudate was also good and showed that the peak levels were 30.1 micrograms/ml for CPZ and 17.4 micrograms/ml for SBT at 2 hours after the 2 g intravenous injection. The peak levels of 34.4 micrograms/ml for CPZ and 8.8 micrograms/ml for SBT at 6 hours after 2 g intravenous drip infusion were obtained. Their elimination was slow, and the concentration higher than MIC80 for main organisms was maintained for a long period of time. For gyneco-obstetrical infections such as adnexitis, intrauterine, intrapelvic and external genital organ infections, a daily dose of 2-4 g of SBT/CPZ produced a 100% clinical efficacy in 10 patients and a 88.9% bacteriological effect. The eradication ratio was more than 80% against beta-lactamase producing organisms. Side effects were few. The above results indicated that SBT/CPZ was useful in the field of obstetrics and gynecology.     

Clinical evaluation of sulbactam/cefoperazone in the pediatric infections

Sulbactam/cefoperazone (SBT/CPZ), a fifty-fifty combination of a beta-lactamase inhibitor, SBT, and an already marketed broad spectrum cephalosporin, CPZ, was evaluated for its efficacy and safety in 25 children. The diagnoses included purulent lymphadenitis, pneumonia, acute UTI, bacteremia and purulent meningitis. SBT/CPZ was effective in all the 20 cases with bacterial infections, but strains highly resistant to CPZ were not isolated in this study. The serum and cerebrospinal-fluid levels of SBT were grossly parallel with those of CPZ, and the half-life of the serum SBT was 0.754 hour. Although severe adverse reactions were not encountered with SBT/CPZ therapy, loose stools in 20% and diarrhea in 16% of the cases were observed.     

Fundamental and clinical studies of sulbactam/cefoperazone in obstetrics and gynecology

The study was done to evaluate the usefulness of sulbactam/cefoperazone (SBT/CPZ) injection for the treatment of infections in the field of obstetrics and gynecology. Fundamental and clinical studies were made and the following results were obtained. In the clinical studies, SBT/CPZ was given to 19 cases with female genital organ infections. As for the clinical effects, responses were excellent in 4 cases, good in 15 cases among 19 cases in total. The efficacy rate was 100%. The efficacy rate on disease was 100% in all cases (9 cases of puerperal uterine infection, 1 case of endometritis, 1 case of pyometra, 5 cases of adnexitis, 2 cases of pelveoperitonitis and 1 case of abscess of vulva). As for causative bacteria, the efficacy rate was 100% for all infections due to single or mixed infection, due to aerobic Gram-negative, -positive or anaerobic bacteria. Side effect was observed in 1 case with diarrhea. SBT/CPZ showed a satisfactory clinical efficacy and a potent bacteriological effect in treatment of the infection in the field of obstetrics and gynecology, and it has been concluded that SBT/CPZ will be a useful addition to the antibiotics for the therapy of these infections.     

Clinical evaluation of sulbactam/cefoperazone in lower respiratory tract infections

Clinical evaluation, safety and kinetics in serum of sulbactam/cefoperazone (SBT/CPZ) in patients with lower respiratory tract infections have been studied in a multicenter trial participated by 28 institutions in Kyushu area during a period of 13 months from March 1987 to March 1988. 1. Mean peak serum levels of SBT and CPZ in 35 patients up to 4 hours after intravenous infusion of 2 g of SBT/CPZ were 38.2 +/- 17.3 micrograms/ml for SBT and 104.3 +/- 31.4 micrograms/ml for CPZ. Serum half-lives of SBT and CPZ were 0.76 hour and 1.53 hours, respectively. These results were in similar ranges to those reported elsewhere for SBT/CPZ. 2. Serum half-lives of SBT and CPZ after intravenous infusion of 2 g of SBT/CPZ were not significantly prolonged in patients with moderate liver or kidney dysfunctions. 3. Clinical efficacy rates of SBT/CPZ in 217 patients were 93.1% (81/87) for pneumonia, 93.3% (14/15) for lung abscess, 78.9% (15/19) for acute exacerbation of chronic bronchitis, 57.1% (4/7) for diffuse panbronchiolitis, 72.4% (21/29), 74.4% (32/43) and 100% (9/9) for infections concurrent to bronchiectasis, chronic respiratory disease and pulmonary emphysema, respectively. Those were 50% (1/2) for bronchitis associated with lung cancer and 66.7% (4/6) for empyema. The overall efficacy rate was 83.4% (181/217). 4. Clinical efficacy rate of SBT/CPZ for pneumonia in patients with underlying diseases such as lung cancer, pulmonary tuberculosis and pneumoconiosis, etc, was 85.3% (29/34) and was not significantly different from the efficacy rate of 98.1% (52/53) in patients without these underlying diseases. 5. Of 30 patients who failed to respond of previous antibiotic treatments, 21 were effectively treated by SBT/CPZ. 6. Bacteriological eradication rates against Pseudomonas aeruginosa, Haemophilus influenzae and Streptococcus pneumoniae were 42.9% (9/21), 87.5% (14/16) and 100% (5/5), respectively. The overall eradication rate in all cases including polymicrobial infections was 72.8% (67/92). 7. The high levels of peak serum concentration of CPZ, and the difference between serum levels of SBT and of CPZ seemed to contribute to the high clinical efficacy. 8. Adverse reactions occurred in 2.8% (6/217) of the patients, and consisted primarily of rash and diarrhea. Laboratory abnormalities were observed in 8 patients during the study. These were elevations of S-GOT and S-GPT, and eosinophilia. 9. SBT/CPZ is a very useful drug in the treatment of lower respiratory tract infections as it has become available just in time when increase in resistant organisms to beta-lactams is notable.     

头孢哌酮钠／舒巴坦钠防治妇产科感染临床比较研究

目的评价注射用头孢哌酮钠／舒巴坦钠预防和治疗妇产科感染的安全性和有效性。方法按照卫生部颁发的《抗菌药物临床研究指导原则》进行临床观察,用随机对照方法,比较注射用头孢哌酮钠／舒巴坦钠每次1．5g每12h（轻度）1次,1．5g每8h（中度）1次或3．0g每8h（重度）1次,预防治疗妇产科感染的临床疗效和安全性。结果试验组的临床痊愈率54．16％（267／493）高于对照组51．38％（223／434）,其差异无统计学意义（P〉0．05）,两组有效率分别为91．08％（449／493）和91．01％（395／434）,细菌清除率分别为86．85％（370／426）和81．04％（295／364）,（P〉0．05）,临床研究中未发现试验药物的严重不良反应。结论注射用头孢哌酮钠／舒巴坦钠对预防和治疗妇产科感染和手术后预防感染是安全有效药物。     

Clinical evaluation of sulbactam/cefoperazone for severe infections associated with hematological disorders

The effectiveness of sulbactam/cefoperazone (SBT/CPZ) on severe infections associated with hematological diseases was evaluated in a nation-wide multicenter clinical study. SBT/CPZ (4-6 g/day), a 1:1 combination of SBT and CPZ, was given intravenously to 437 patients with hematological disorders. The underlying diseases included acute nonlymphocytic leukemia, acute lymphocytic leukemia, malignant lymphoma, multiple myeloma, myelodysplastic syndrome and others. Thus, 94.3% of the patients had hematological malignancies. The complicating infections included sepsis in 41 cases; sepsis suspected in 205; pneumonia in 47; urinary tract infection in 15; fever of unknown origin in 59; and others in 70. Clinical efficacies of SBT/CPZ were as follows; markedly effective, 83 cases; effective, 170; fairly effective, 59; and ineffective, 110. The efficacy rate (markedly effective plus effective) was 60.0% as a whole. The efficacy rate of SBT/CPZ in sepsis and suspected cases, which accounted for 56.3% of the infections, was 59%. Mild side effects such as skin rash were observed in 15 patients (3.1%). As for abnormal laboratory test results, transient increases in GOT, GPT, A1-P, LDH, etc. were observed in 42 patients (8.6%). Therefore, SBT/CPZ is considered to be a useful drug in empiric therapy for severe infections associated with hematological diseases.     

Clinical evaluation of tinidazole on anaerobic infections in the field of obstetrics and gynecology

The bacteriological and clinical effect of tinidazole (TDZ) was evaluated in 16 cases of intrauterine, intrapelvic and vulvar infection caused by anaerobic organisms and the following results were obtained. Anaerobes were detected in 16 cases, including 1 case with anaerobes alone and 15 cases with mixed anaerobes and aerobes. Eight different species and 24 strains were detected. A single species was isolated from 9 cases, 2 species from 6 cases and 3 species from 1 case. The main species detected were Bacteroides fragilis and Peptostreptococcus spp. of which 9 strains (37.5%) each were isolated. Escherichia coli and B. fragilis was the most frequently occurring combination. The peak MIC values of TDZ were 0.78 micrograms/ml for B. fragilis and 1.56 micrograms/ml for Peptostreptococcus spp. Most other organisms were also sensitive to TDZ. The bacteriological response of the anaerobic infections to TDZ was 87.5% and overall clinical efficacy was 87.5%. Few side effects were observed.     

Clinical evaluation of sulbactam/cefoperazone for severe infections associated with hematological disorders]

The combination therapy of sulbactam/cefoperazone (SBT/CPZ) and piperacillin (PIPC) was evaluated in 49 patients with severe infections associated with hematological disorders. Clinical responses in 43 evaluable patients out of the 49 patients were excellent in 12, good in 18, thus, overall efficacy rate was 69.8% (excellent plus good). Efficacy rates of this combination therapy were 60% (3/5) for sepsis, 75% (21/28) for suspected sepsis, and 50% (4/8) for pneumonia. The efficacy rate was 71.4% (10/14) in patients with neutrophil counts less than 200/microliters; this combination therapy was highly effective even in the neutropenic patients. Transient increases in hepatic function test values were observed in 2 patients, but no other side effects were observed during the combination therapy. From these observations it appears that the combination therapy of SBT/CPZ and PIPC is a very useful empiric therapy for severe infections associated with hematological diseases.     

Clinical experience on sulbactam/cefoperazone in the pediatric field

Approximately 20 mg/kg/day of sulbactam/cefoperazone (SBT/CPZ) was given by one shot intravenous injection to 16 pediatric inpatients with respiratory tract infections (13 cases), urinary tract infection (1 case), skin infection (1 case) or gastrointestinal tract infection (1 case). An excellent efficacy in 6 cases and a good efficacy in 10 cases were observed. Causative organisms were not identified in the respiratory tract infections, even though the efficacy was excellent or good. Side effects were not noticed in particular and SBT/CPZ was judged as safe enough agent. Concentrations of SBT/CPZ in the spinal fluid were determined in 3 patients. Their low concentrations suggested the poor transfer into the spinal fluid. Finally, SBT/CPZ is a very useful agent since it is effective also against resistant organisms which produce penicillinase-type beta-lactamases.     

Clinical studies on sulbactam/cefoperazone in the pediatric field

Sulbactam, a new beta-lactamase inhibitor, in combination with cefoperazone was administered to 18 pediatric patients, 7 months to 10 years 6 months of age, at a daily dose of 56-320 mg/kg divided into 4 times by intravenous bolus infusion for 3 to 11 days, and the sum of 2.6-74.0 g of the drug was given. A total of 18 cases comprised 8 with RTI, 1 with gastric tract infection, 4 with UTI and 5 with sepsis (suspected). Clinical efficacy was excellent in 10 cases, good in 3 cases, fair in 1 case and poor in 4 cases, and efficacy rate was 72.2%. Out of 8 strains (1 of S. aureus, 1 of P. aeruginosa, 1 of Salmonella subgenus I, 2 of E. coli, 2 of P. mirabilis and 1 of K. pneumoniae), possible causative organisms isolated before the treatment, 6 strains were disappeared, 1 strain of K. pneumoniae persisted, and 1 strain of P. aeruginosa was replaced by S. aureus. Diarrhea was noted in 1 case as subjective side effect, and as abnormal laboratory findings, GOT and GPT elevations in 1 case, GPT elevation in 1 case and eosinophil elevation in 1 case were observed.     

Clinical study on sulbactam/cefoperazone in the field of pediatrics

Sulbactam/cefoperazone (SBT/CPZ) was used in pediatric patients with acute infections, and the following results were obtained. SBT/CPZ was administered to 18 pediatric patients with acute infections. Out of them, 14 patients, i.e., 3 with acute tonsillitis, 1 with acute laryngitis, 1 with acute bronchitis, 4 with acute pneumonia, 4 with bronchopneumonia, 1 with pyothorax, were adopted for the evaluation, and the other 4 were excluded because they were judged inadequate for clinical efficacy evaluation. The clinical efficacy of SBT/CPZ was assessed as excellent in 4, good in 9 and fair in 1. The effective rate was 92.9%. In 6 cases causative organisms were detected, i.e., Haemophilus influenzae in 3, Klebsiella in 1 and Staphylococcus aureus in 2 cases. Eradication of these organisms was confirmed in all cases except for 1 patient with pyothorax caused by S. aureus. The doses used in 12 out of the evaluated 14 cases ranged from 58.4 to 80 mg/kg/day, 84.1 mg/kg/day was used in 1 case and 101.4 mg/kg/day was used in 1 case with pyothorax. Patients with severe infections were generally given large doses. The frequency of administration was 3 times per day except 1 case, and intravenous drip infusion was used in all cases. The duration of treatment was 2- less than 3 days for 7 cases, 3-5 days for 6 cases and 9 days for 1 case (pyothorax). No clinical side effects were observed in any case. In laboratory examinations, a slight elevation of GOT was observed in 1 case, but no abnormal findings in the other cases. From the above results, SBT/CPZ was considered to be a highly useful drug in the treatment of pediatric infections.     

Clinical evaluation of cefroxadine in the field of obstetrics and gynecology

Cefroxadine (CXD), an oral cephalosporin antibiotic was studied in the field of obstetrics and gynecology and the following results were obtained. CXD was orally given to 22 cases at daily dose of 1,500 mg 3 times a day. CXD administration was given to 22 cases in all; 4 with cervicitis, 6 with endometritis, 2 with puerperal fever, 4 with bartholinitis, 5 with adnexitis and 1 with vulvitis, respectively. Overall efficacy rate was 77.3% (17/22) (excellent 4, good 13, fair 5). As for side effects, a slight diarrhea was observed. CXD was considered to be a useful antibiotic in the field of obstetrics and gynecology by above the results.     

Clinical studies of sulbactam/cefoperazone therapy in pediatric bacterial infections

Sulbactam/cefoperazone (SBT/CPZ) was administered intravenously to 9 patients with respiratory infections (H. influenzae 6 cases, pathogens unknown 3 cases), 2 patients with urinary tract infection (E. coli and C. freundii; both cases had VUR), and 1 patient with staphylococcal bacteremia. In these causative bacteria, 5 strains (H. influenzae 3, E. coli 1 and S. aureus 1) were beta-lactamase producers. Bacteriological efficacy (eradication rate) was complete (9/9, 100%) and clinical efficacy was also complete (12/12, 100%). In comparison with CPZ alone, MICs of SBT/CPZ against beta-lactamase producing bacteria were superior. Although mild side effect was observed in 1 case (eosinophilia), no other severe form of adverse reaction were encountered. It was concluded that SBT/CPZ was an useful antibiotic for the treatment of pediatric bacterial infections, especially caused by beta-lactamase (penicillinase) producing bacteria.     

Clinical evaluation of aztreonam in the field of obstetrics and gynecology

Aztreonam (AZT), a new monobactam antibiotic was evaluated on clinical efficacy and bacteriological response in gynecological and obstetrical infections, and the following results were obtained. AZT was given to 22 cases with obstetrical and gynecological infections at a dose of 1 g X 2 times daily and 86.4% of clinical efficacy, 45.5% of eradicated rate on diagnosis, 52.5% of bacteriological response on isolated organisms and 83.3% of bacteriological effect on cases isolated Gram-negative bacteria were assessed. Side effect incidence was very low.