Clinical evaluation of cefoperazone in lower respiratory tract infections

Clinical evaluation and kinetics in serum of cefoperazone (CPZ) in patients with lower respiratory tract infections have been conducted as a multicenter trial participated by 20 institutions in Kyushu area during a period of 8 months from October 1984 to May 1985. Mean serum CPZ levels up to 4 hours following the end of intravenous infusion of either 1 or 2 g CPZ remained higher than the MIC80 of CPZ against major causative organisms of lower respiratory tract infections such as H. influenzae, P. aeruginosa, K. pneumoniae, and S. pneumoniae. Serum half-lives of CPZ following intravenous infusion were prolonged in the elderly and in patients who showed moderate liver or kidney dysfunction, but did not exceed twofold of normal value. Clinical efficacy rates of CPZ were 82.9% (34/41) against pneumonia, 80% (4/5) against lung abscess, 88.9% (32/36) against acute exacerbation of chronic bronchitis, 66.7% (2/3) against panbronchiolitis, 100% (1/1) against acute bronchitis, and 85.7% (12/14), 64.3% (9/14) and 70.0% (7/10) against infections concurrent to chronic respiratory diseases, pulmonary emphysema and bronchiectasis, respectively. The overall efficacy rate was 81.5% (101/124). Bacteriological eradication rates against P. aeruginosa, H. influenzae and S. pneumoniae were 60% (6/10), 88.9% (8/9) and 100% (3/3), respectively. The overall eradication rate including polymicrobial infection was 67.5% (27/40). The clinical efficacy rate of CPZ in patients with underlying diseases such as lung cancer, pulmonary tuberculosis, and pneumoconiosis, etc. was not significantly different from the efficacy rate in patients without these underlying diseases. Of 20 patients who failed to respond to previous antibiotic treatments, 13 were effectively treated by CPZ. Adverse reactions occurred in 6.7% (11/164) of the patients, and consisted primarily of rash, fever, diarrhea and loose stool. Laboratory abnormalities were seen in 5 patients during the study. These included elevations of S-GOT and S-GPT, eosinophilia and neutropenia. CPZ is a very useful drug in the treatment of lower respiratory tract infections because of its excellent clinical efficacy and rare incidence of abnormal accumulations in sera following the recommended 2-4 g/day administration even in the elderly.     

Experimental and clinical studies of sulbactam/cefoperazone in pediatric field

Clinical trials were carried out with sulbactam/cefoperazone (SBT/CPZ) (combination ratio of 1:1) in pediatric infections. Results were as follows. The mean half-lives of SBT and CPZ in the serum following intravenous injection of SBT/CPZ were about 0.7 and 1.2 hours, respectively. Urinary excretions of SBT and CPZ within 6 hours after intravenous injection of SBT/CPZ were 81.9% and 28.1%, respectively. SBT/CPZ was administered to 33 pediatric patients with various infection; 18 respiratory tract infections, 12 urinary tract infections and 3 Salmonella enterocolitis. The overall efficacy rate was 87.9%. In particular, 7 of 8 urinary tract infections caused by beta-lactamase producing organisms were improved after administration of SBT/CPZ. Diarrhea in 8 and soft stool in 3 of 33 patients occurred, and slight elevation of GOT/GPT was observed in 2 patients.     

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.     

Fundamental and clinical studies of sulbactam/cefoperazone in the field of pediatrics

Sulbactam/cefoperazone (SBT/CPZ) was evaluated in the treatment of pediatric patients to have the following results: Peak serum concentrations which occurred just after the drip infusion of 20 mg/kg SBT/CPZ were 36.4 micrograms/ml and 8.6 micrograms/ml for CPZ and SBT, respectively. The half-life of CPZ was 1.91 hours, and that of SBT, 0.97 hour. Following the 40 mg/kg drip infusion, the peak serum concentration of CPZ was 79.1 micrograms/ml, and that of SBT, 27.0 micrograms/ml. The half-lives were 1.99 hours for CPZ, and 1.07 hours for SBT, respectively. In 6 hours after drip infusion of 20 mg/kg and 40 mg/kg 21.7, 37.0% of CPZ and 41.6, 85.6% of SBT were excreted in urine. Daily doses of about 50-90 mg/kg SBT/CPZ were administered by intravenous or drip infusion to 26 pediatric patients with acute infections such as lacunar tonsillitis, bronchitis, bronchopneumonia, suppurative diseases caused by Staphylococcus (staphylococcal scalded skin syndrome), purulent parotitis, cervical lymphadenitis, phlegmon and acute UTI related with ABPC/CPZ resistant beta lactamase producing E. coli. SBT/CPZ demonstrated the bacteriological effect on all the causative organisms. The clinical efficacy was also confirmed with the efficacy rate of 88.5%. No side effects were observed in all the cases though transient eosinophilia developed in 2 patients.     

Effects of sulbactam/cefoperazone in patients with respiratory infections in aged and/or with underlying respiratory diseases

Sulbactam/cefoperazone (SBT/CPZ), a new antibacterial drug, was administered to 14 cases with respiratory infections for a duration of 5 approximately 13 days at a daily dose of 4 g. Diagnoses of these patients were 7 respiratory tract infections, and 7 bronchopneumonias. The underlying diseases were chronic pulmonary emphysema in 6 cases, bronchial asthma in 2 cases, and one each of bronchiectasis, diffuse panbronchiolitis and lung cancer with bronchoesophageal fistula. All patients had underlying respiratory diseases and/or were more than 70 years old. The rate of clinical efficacy was 78.6%. The incidence of penicillinase production by isolated bacteria was 18.2% and that of cephalosporinase was 63.6%. SBT/CPZ was expected to be more effective than CPZ alone in 3 cases judging from the susceptibility of the bacterial strains concerned, to antibiotics. No side effects were observed. We conclude that SBT/CPZ is useful in the treatment of respiratory infections of patients of advanced age and/or with underlying respiratory diseases.     

Studies on sulbactam/cefoperazone in the field of pediatrics

Microbiological, pharmacokinetic and clinical studies on sulbactam/cefoperazone (SBT/CPZ) were carried out in the field of pediatrics. Antimicrobial activity The MIC80 of SBT/CPZ was 6.25 micrograms/ml for clinically isolated 24 strains of S. aureus (24 beta-lactamase producing strains), 0.39 micrograms/ml for 17 strains of S. pyogenes, 3.13 micrograms/ml for 24 strains of E. coli (22 beta-lactamase producing strains), 3.13 micrograms/ml for 22 strains of K. pneumoniae (22 beta-lactamase producing strains), 1.56 micrograms/ml for 22 strains of P. mirabilis and 0.20 microgram/ml for 15 strains of H. influenzae (13 beta-lactamase producing strains). In comparison with CPZ in respect to the MIC, SBT/CPZ exhibited synergistic effect on 31 strains out of 81 beta-lactamase producing strains (included 6 strains of S. aureus, 9 of E. coli, 5 of K. pneumoniae and 11 of H. influenzae) which was scarcely observed against 43 non-beta-lactamase producing strains. Absorption and excretion Serum levels and urinary excretion of SBT/CPZ were studied in 7 children aged 5 to 12 years. The mean serum concentration of SBT at 15 minutes following a single intravenous injection of 10 mg/kg of SBT/CPZ was 14.2 micrograms/ml and that of CPZ was 30.4 micrograms/ml. The mean urinary recovery rates at 6 hours following the intravenous injection were 57.8% and 18.3%, respectively. The mean serum concentrations of SBT and CPZ after 1-hour infusion of 10 mg/kg of SBT/CPZ were 10.9 micrograms/ml and 17.6 micrograms/ml, respectively. The urinary recovery rates of SBT and CPZ at 7 hours after the infusion were 100.0% and 27.7% on average, respectively. The mean serum levels of SBT and CPZ at 15 minutes after a single intravenous injection of 20 mg/kg of SBT/CPZ were 25.6 micrograms/ml and 66.0 micrograms/ml, respectively and urinary elimination until up to 6 hours were 72.5% on average for SBT and 21.1% for CPZ. Clinical study SBT/CPZ was used for the treatment of a total of 20 pediatric patients aged 1 month to 14 years to evaluate its clinical effectiveness, bacteriological efficacy and adverse effects. The clinical efficacy in 6 patients with acute pneumonia, 3 with staphylococcal scalded skin syndrome, 2 each with acute purulent tonsillitis and acute pyelonephritis, 1 each with acute purulent lymphadenitis, acute sinusitis, acute bronchitis, peritonitis and acute enteritis was judged to be excellent in 15 cases and good in 3 cases with an efficacy ratio of 100%. The clinical efficacy in 6 patients whose infections were caused by beta-lactamase producing strains was judged to be excellent in all the cases.(ABSTRACT TRUNCATED AT 400 WORDS)     

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 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 assessment of sulbactam/cefoperazone in comparison with ceftizoxime in patients with postoperative infections by well controlled method

The clinical effectiveness in postoperative infections of sulbactam/cefoperazone (SBT/CPZ, (SBT 0.5 g+ CPZ 0.5 g) X 2/day) was compared to that of ceftizoxime (CZX, 1.0 g X 2/day) by a well controlled comparative study, to have the following results. The overall effectiveness rate of SBT/CPZ and CZX as judged by Judgement Committee was 84.0% (63/75) and 80.6% (50/62), respectively, and the effectiveness of SBT/CPZ and CZX as assessed by the attending surgeons was 84.0% (63/75) and 71.0% (44/62), respectively. No significant difference was noted in both assessments. In a total of 36 SBT/CPZ-treated patients with intraabdominal infections, the clinical efficacy was judged by attending surgeons to be excellent in 13 patients (36.1%), and to be excellent or good in 31 (86.1%). In the 30 CZX treated patients, it was judged to be excellent in 6 patients (20.0%), and to be excellent or good in 19 (63.3%). These results presented a significant difference (P less than 0.05, U-test) between the 2 drug groups. The final global improvement ratio judged by attending surgeons was 85.3% (64/75) for SBT/CPZ, and 79.0% (49/62) for CZX with no significant difference. In assessment of time-course improvement, the improvement ratio of SBT/CPZ on day 4 was significantly better than that of CZX (P less than 0.05, U-test). The usefulness rate of SBT/CPZ and CZX was 84.0% (63/75) and 73.0% (46/63), respectively. There was no significant difference between the 2 drug groups. To assess the bacteriological efficacy, the eradication rate of SBT/CPZ was compared to that of CZX. There was no significant difference between 85.7% (36/42) for SBT/CPZ and 73.5% (25/34) for CZX. After SBT/CPZ administration, 2 patients (2.5%) complained of side effects. In the clinical laboratory tests, abnormality related to SBT/CPZ medication was observed in 6 patients (7.5%), and that related to CZX, in 5 patients (6.4%). As to the types of side effects and frequency, no significant difference was observed between SBT/CPZ and CZX. It is concluded from the above assessments that SBT/CPZ is a useful drug in the treatment of post-operative infections.     

Treatment with sulbactam/cefoperazone of severe infections in patients with hematological disorders

Infectious episodes in 90 patients with hematological disorders were treated with sulbactam/cefoperazone (SBT/CPZ), a new combination drug of a potent beta-lactamase inhibitor, sodium sulbactam, and a third generation cephalosporin, sodium cefoperazone. Clinical responses to the SBT/CPZ regimen were excellent in 23 cases, good in 30 cases, fair in 11 cases, and poor in 26 cases. The overall efficacy rate (percentage of cases showing excellent or good responses) was 58.9%. Efficacy rates classified according to different infections were: 80% in documented sepsis, 57.6% in suspected sepsis, 61.1% in pneumonia and 50% in other infections. One episode of side effect was encountered with redness and itching of skin. Hepatic disorders were observed in 3 cases. These adverse reactions, however, were not serious. These results indicate that SBT/CPZ has a high therapeutic efficacy to severe infections in patients with hematological disorders.     

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.     

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.     

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 experience with chemotherapy using sulbactam/cefoperazone for severe infections accompanying malignant hematological disorders

Clinical and bacteriological efficacies of sulbactam/cefoperazone (SBT/CPZ) were studied in 44 patients with serious infections associated with hematological malignancy. 1. SBT/CPZ was clinically effective in 33 cases (76.7%). Excellent effects were obtained in 23 cases, good effects in 10 cases and fairly good effects in 7 cases. Clinical effectiveness of SBT/CPZ was not dependent on neutrophil number in peripheral blood. 2. Bacteriologically SBT/CPZ was effective against all of the isolated organisms from 21 cases. 3. Adverse reactions were not significant except one case with eruption, 2 cases with abnormalities in hepatic function tests and 3 cases with abnormalities in renal function tests.     

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 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.     

Bacteriological, pharmacokinetic and clinical studies on sulbactam/cefoperazone in the pediatric field

Bacteriological and clinical effect of a newly developed SBT/CPZ in the treatment for pediatric patients was assessed by a study group consisting of 15 institutions. The results were as follows. Antibacterial effect Susceptibility studies were performed with 93 clinical isolates. The MIC of SBT/CPZ was one-tube inferior or almost similar to that of CPZ in susceptible organisms. In CPZ-resistant organisms at the inoculum of 10(8) cells/ml, however, SBT/CPZ was much superior to CPZ on the basis of the MIC. When the MIC of SBT/CPZ was compared to that of CPZ in 27 strains which have high beta-lactamase-producing activity, it was found that many of CPZ-resistant organisms were susceptible to SBT/CPZ. Serum concentration and urinary excretion The serum concentrations of SBT and CPZ were 33.2 micrograms/ml, respectively at 15 minutes after 20 mg/kg SBT/CPZ was administered by intravenous bolus injection, and those of SBT and CPZ, 51.0 micrograms/ml and 108.3 micrograms/ml, respectively following 40 mg/kg SBT/CPZ therapy. The serum concentrations of CPZ were 2.1-2.4 times as high as those of SBT. The concentrations were dose-related. The half-lives of SBT and CPZ following 20 mg/kg SBT/CPZ administration were 0.94 hour and 1.50 hours, respectively, and those following 40 mg/kg SBT/CPZ were 0.95 hour and 1.53 hours, respectively. There was no significant difference between 20 mg/kg and 40 mg/kg administrations. When compared between SBT and CPZ, CPZ had slightly longer half-lives. At the termination of 1 hour drip infusion of 20 mg/kg SBT/CPZ, the serum concentrations of SBT and CPZ were 16.7 micrograms/ml and 40.1 micrograms/ml, respectively. In the case of 40 mg/kg, the levels of SBT and CPZ were 38.6 micrograms/ml and 94.9 micrograms/ml, respectively. The concentrations were found to be dose-related as were following intravenous bolus injections. The SBT half-lives obtained after 20 mg/kg and 40 mg/kg SBT/CPZ administrations were 1.39 hours and 0.89 hour, respectively; those of CPZ, 2.00 hours and 1.44 hours, respectively. The highest urinary concentration occurred 0-2 hours after intravenous bolus injections of 20 mg/kg or 40 mg/kg SBT/CPZ. Urinary excretion of SBT over 6 hours was 60.0% and 67.7%, and that of CPZ, 21.2% and 25.0%, indicating higher urinary excretion for SBT. When 20 mg/kg SBT/CPZ or 40 mg/kg was administered over 1 hour by drip infusion, urinary excretion became the highest at 1-3 hours after administration. Urinary excretion of SBT over 7 hours following 20 mg/kg and 40 mg/kg SBT/CPZ was 68.8% and 80.3%, respectively, and that of CPZ, 24.4% and 27.3%. The results were similar to those observed following intravenous bolus injections.     

Therapeutic efficacy of imipenem/cilastatin sodium on respiratory tract infections in lung cancer patients]

Imipenem/cilastatin sodium (IPM/CS) was used to treat respiratory tract infections (RTI) in 54 patients with lung cancer. Out of the 54 patients studied, 53 were evaluable for the utility of IPM/CS; 42 had pneumonia, 9 had obstructive pneumonia, 1 had a lung abscess and 1 had acute bronchitis. The efficacy rate was 71.7%. Seventeen causative organisms were isolated from 14 patients. They included Staphylococcus aureus 5 strains, Staphylococcus epidermidis 4 strains, Staphylococcus sp. 2 strains, Enterococcus faecalis 1 strain, Pseudomonas aeruginosa 2 strains, Pseudomonas fluorescens 2 strains, Acinetobacter sp. 1 strain, and the eradication rate was 81.8%. Clinical adverse effects (nausea and vomiting) were observed in 1 patient. Abnormalities in laboratory test results were observed in 3 patients. They disappeared or returned to normal values after completion of therapy or discontinuation of IPM/CS administration. IPM/CS appears to be a useful antibiotic for RTI in patients with lung cancer.     

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 evaluation of sultamicillin in lower respiratory tract infections

Clinical efficacy and safety of sultamicillin (SBTPC) in patients with lower respiratory tract infections, mainly pneumonia and bronchitis, have been evaluated in a multicenter trial by 19 institutions in the Kyushu area during a period of 12 months from December 1988 to November 1989. 1. Clinical evaluation was made in 132 patients and efficacy rates of SBTPC were 80.0% (28/35) for pneumonia, 78.5% (73/93) for bronchitis and 100% for the remaining 1 patient with other respiratory tract infections. The overall efficacy rate was 79.1% (102/129). 2. Clinical efficacy rate of SBTPC for respiratory tract infections in patients with underlying diseases such as chronic bronchitis, old pulmonary tuberculosis etc., was 75.0% (60/80) which was not significantly different from the efficacy rate of 85.7% (42/49) in patients without underlying diseases. 3. Of 13 patients who failed to respond to previous antibiotic treatments, 8 (61.5%) were effectively treated with SBTPC. 4. Clinical efficacy rates against infections caused by single species of organisms were 90.9% (10/11) for Haemophilus influenzae, 100% (8/8) for Streptococcus viridans and 100% (3/3) for Staphylococcus aureus. The overall clinical efficacy rate in all cases of monomicrobial infections was 88.6% (31/35), in polymicrobial infection 45.5% (5/11) and the overall efficacy rate in cases in which causative bacteria were identified was 78.3% (35/46). 5. Adverse reactions occurred in 6.8% (9/132) of the patients. The symptoms included allergic reaction in 1 patient, gastrointestinal system disorders in 7 patients and general fatigability in 1 patient. As abnormalities in laboratory test values, elevations of A1-P, GOT, and GPT were observed in 3 patients during the study, but returned to normal after discontinuation of SBTPC administration. 6. SBTPC is a useful antibiotic in the treatment of lower respiratory tract infections under the current medical environment where resistant organisms which produce beta-lactamases have been increasing.