Five-year survival of older people with anemia: variation with hemoglobin concentration.

OBJECTIVES: To investigate the significance of low hemoglobin concentration and longevity in older people. DESIGN: Randomized prospective study. SETTING: Nursing home and geriatric hospital ward in a metropolitan welfare center. PARTICIPANTS: Apparently stable older residents from 1990 to 1996. MEASUREMENTS: Survival rates were estimated by statistical analysis. Sixty-three older subjects with low hemoglobin (Hb<11 g/dl) and age/sex-matched normal controls (Hb> or =11 g/dl) were observed for 60 months. Scores of activities of daily living (ADLs) did not significantly differ between the two groups. Cerebrovascular disease was the main complication in both, and malignant neoplasms were not apparent initially. RESULTS: After 60 months, the 5-year survival rate (FSR) of normal controls was significantly higher than that of cases with anemia (P =.0078). FSR was 67% in normal controls and 48% in anemic individuals age 70 to 79. The figures for individuals age 80 to 89 were 62% and 41%, respectively, and for individuals age 90 to 99 were 25% and 13%, respectively, the survival rate significantly decreasing with age in both groups (P <.001). FSR with severe anemia (Hb< or = 8.9 g/dl) was 0% in males, and 27% in females. Values for moderate anemia (9.0 g/dl to 10.9 g/dl) were 25% and 51%, respectively, for normal hemoglobin (11.0 g/dl to 12.9 g/dl) were 44% and 61%, respectively, and for high hemoglobin (13.0 g/dl< or =Hb) were 50% and 70%, respectively. Advanced carcinomas were often detected at autopsy in anemic individuals. No death by cancer occurred in normal controls. CONCLUSION: Low hemoglobin concentration predicts early death in nursing home residents. Anemia-associated conditions that might be life-threatening risks in older people require further investigation.

Coupled transcription-translation of silkworm cytoplasmic polyhedrosis virus injected into oocytes of the frog, Xenopus laevis.

The cytoplasmic polyhedrosis virus of the silkworm, Bombyx mori, contains a ten-segmented, double-stranded RNA genome and five species of polypeptides, V1 (Mr 146,000), V2 (Mr 140,000), V3 (Mr 128,000)), V4 (Mr 62,000), and V5 (Mr 32,000). The virus contains an RNA-dependent RNA polymerase that transcribes the duplex genome RNA to form mRNA either in the infected animals or under appropriate conditions in vitro. We co-microinjected the virus, [alpha-32P]GTP and actinomycin D into oocytes of the frog, Xenopus laevis, and found that at least eight species of mRNA were formed in the oocytes. Virus-injected oocytes were labeled with [35S]methionine and cell extracts were treated with rabbit anti-cytoplasmic polyhedrosis virus immunoglobulin G. Analysis of the immunoprecipitates by sodium dodecyl sulfate polyacrylamide gel electrophoresis revealed that V1, V2, and V3 were produced in the virus-injected oocytes whereas V4 and V5 were not. By injecting the separated double-stranded genome segments immediately after heat-denaturation into oocytes, it was found that V1 was coded for by segment 1 with a chain length of 4.2 kilobase pairs, V2 by segment 2 or 3, whose chain lengths are both 4.0 kilobase pairs, and V3 by segment 4 with a chain length of 3.2 kilobase pairs. These results demonstrate that the Xenopus oocyte is a very useful system for the coupled transcription-translation of double-stranded RNA viruses.

A new apparatus for chronic intravenous infusion in unrestrained rats.

A new apparatus incorporating a unique type of swivel device was devised for chronic intravenous infusion in unrestrained rats. The swivel requires very little torque for rotation, ie, one-fourth that of the standard swivel, yet is 1/30 as expensive. A coil spring tube, located between the swivel and the catheter, allows the rat unhampered movement within the metabolic cage. Because the catheter follows the rats' movements freely, only two silk sutures are required to secure it to the animal. No statistically significant differences between experimental and control rats were observed in terms of body weight gain, food intake, nitrogen balance, or caloric efficiency. This apparatus should prove useful in many areas of research.

[Postoperative enterocolitis and current status of MRSA enterocolitis--the result of a questionnaire survey in Japan].

There is a trend of increase in the number of Staphylococcus aureus infection recently, and postoperative enterocolitis due to methicillin resistant strains is appearing. Because of this, a nation wide questionnaire survey on postoperative enterocolitis was conducted to clarify the status since 1980. Of the 875 major surgical institutes to which we sent the questionnaire, 370 (42.3%) replied and 67 case reports were obtained from 25 institutes. Twenty published reports were added to this and a total of 87 cases were evaluable. The number of postoperative enterocolitis increased after the year 1985, and those resulting from MRSA infection were more frequent in the northern half of Japan including the Kanto area. It was more frequent in males and the mean age was 57.9. Their onset was sudden, beginning with diarrhea and/or fever between the second and fifth postoperative days. In most of the cases, the cephalosporin group of antibiotics, especially of the third generation, were administered preceding the enterocolitis. Six of cases (24%) did not survive, and in some of the institutes they were considered to be hospital infections, as they appeared consecutively between a short period of time.

[A case of psoas abscess associated in the elderly].

A case of psoas abscess associated with diabetes mellitus in the elderly is reported. A 81-year-old male who had been followed for cerebral thrombosis, diabetes mellitus and basal cell carcinoma was admitted to our hospital because of high fever. Leukocytosis, a positive CRP test and pyuria were seen. Proteus mirabilis and Escherichia coli were detected by urine and blood culture, respectively. He was treated with antibiotic therapy for urinary tract infection and sepsis. After starting treatment, a low grade fever continued. On the twenty first hospital day he developed pyrexia again, and a large abscess was demonstrated in the right psoas muscle by pelvic couputed tomography. The abscess was drained and a specimen from it yielded E. coli on culture. Treatment with antibiotics and drainage resulted in symptomatic improvement. In Japan, 82 cases of psoas abscess have been reported from 1990 to 1994. Four cases of these reports were above eighty years old. The experience with this case indicates the necessity of adequate care in cases of elderly diabetes complicated by psoas abscess.

[An outbreak of parainfluenza 3 virus infection in the elderly in a ward].

In the D ward of Nagoyashi-Koseiin geriatric hospital (36-beds), upper respiratory illnesses were recognized in all the inpatients between July and August in 1995, and we studied 7 elderly subjects with parainfluenza 3 infection diagnosed by serology and viral culture. The outbreak of upper respiratory illnesses occurred in the ward during the 17 days from July 21 through August 6, 1996. Fifteen of the 18 elderly persons with upper respiratory illnesses were tested by serology; parainfluenza 3 infection was identified in 7. One of the 7 patients, parainfluenza 3 virus was isolated. Seven elderly subjects with parainfluenza 3 infection were 2 males and 5 females and five of them (71.4%) were bedridden. The most common complaint was fever and coughing in 7/7 (100%), followed by sputum in 5/7 (71.4%), wheezing in 4/7 (42.9%). The pyrexial period in the parainfluenza-infected group ranged from 1 to 4 days (average 3.1 days), and was significantly shorter than that of the influenza group. The maximum recorded temperature in the parainfluenza-infected group ranged from 37.0 to 39.2 degrees C (average 38.1 degrees C), and was significantly lower than that of the influenza group. Two of the 7 patients with parainfluenza 3 virus infection had pneumonia, but nobody died, and all 7 patients recovered without sequele. It is possible that parainfluenza 3 virus infection among elderly subjects cause secondary bacterial infection, so we think that prevention of nosocomial parainfluenza infection should be a high priority in the case of outbreak of such an infection in a ward.

[A questionnaire survey on the theory of postoperative infection prophylaxis in orthopedics].

A questionnaire survey on the theory of postoperative infection prophylaxis was conducted to obtain the consensus on perioperative antimicrobial use among orthopedists in Japan in the period from April to September 2000. Fifty of the 91 orthopedists replied, and the following consensus was obtained. An antimicrobial prophylaxis (AMP) agent should be chosen based on their efficacy against the pathogens expected to be contaminants, such as Staphylococcus spp., and Streptococcus spp., Use an AMP agent that achieves a bactericidal concentration in both the serum and operating site. Use an AMP agent that has little unfavourable side effects. Use an AMP agent that affects minimally the normal bacterial flora. The most commonly used agents are the penicillins and first and second generation cephalosporins. The optimal strategy for most commonly used agents entails infusion of the first dose between approximately 30 minutes pre and post-skin incision and the therapeutic levels should be maintained throughout the operation. The AMP agents having no cross-resistance to the prophylactic agents should be used, if postoperative infection is suspected or developed. The most commonly used agent for both clean operations with or without foreign implants and dirty operations is cefazolin (CEZ), followed by cefotiam (CTM) and flomoxef (FMOX).

[A questionnaire survey on the theory of postoperative infection prophylaxis in gynecology].

A questionnaire survey on the theory of postoperative infection prophylaxis was conducted to obtain the consensus on perioperative antimicrobial use among gynecologists in Japan in the period from April to July 2000. Fifty-six of the 83 gynecologists replied, and the following consensus was obtained. An antimicrobial prophylaxis (AMP) agent should be chosen based on their efficacy against the pathogens expected to be contaminants, such as Staphylococcus spp., Escherichia coli and Bacteroides fragilis group. Use an AMP agent that archives a bactericidal concentrations in both the serum and operating site. Use an AMP agent that has little unfavourable side effects. The newer agents should be considered as a therapeutics for postoperative infections. The therapeutic antimicrobial agents having no cross-resistance to the AMP agents should be used, if postoperative infection is suspected or developed. The most commonly used agent for clean operations are cefazolin (CEZ), followed by cefotiam (CTM) and cefmetazole (CMZ). The most commonly used agent for clean-contaminated operations where low grade level of bacterial invasion expected is CTM, followed by CEZ and CMZ, where as operations where mild grade level of bacterial invasion expected is flomxef (FMOX), followed by CTM and other cephalosporins.

[Efficacy of arbekacin, a new aminoglycoside antibiotic, in surgical patients with MRSA infections].

The clinical efficacy of a new aminoglycoside antibiotic, arbekacin (ABK), was studied in surgical patients who had been infected with methicillin-resistant Staphylococcus aureus (MRSA). Six cases of pneumonia, 2 of wound infections and 2 of intra-abdominal infections were treated by ABK alone or ABK together with beta-lactam antibiotics such as imipenem/cilastatin or cefotiam. The overall clinical efficacies against these MRSA infections were excellent in one case, good in 6 and poor in 3. In six cases treated by ABK alone, good clinical responses were obtained in 4 cases. Among 4 cases that received combination therapy with ABK, good responses were obtained in 3 cases. No adverse reactions were found in ABK monotherapy or in combined therapy. These data suggested that ABK is an effective antibiotic on surgical infections caused by MRSA.

[Clinical evaluation of SM-4300 and antibiotics combinations against severe bacterial infections in surgery].

SM-4300, a newly developed human immunoglobulin preparation for intravenous use, has been evaluated clinically in 11 patients with severe bacterial infections in the combination therapy with antibiotics in the surgery. SM-4300 was administered to the patients, for whom antibiotics alone had not been effective, at a dosage of 2.5 or 5 g/day with continuous use of the same antibiotics. The results obtained were as follows: Clinical effects of SM-4300 were excellent in 1 case, good in 2, fair in 4, poor in 3 and unknown in 2. The efficacy rate was summarized as 30.0%, and the rate including fair response was 70.0%. No subjective and objective clinical side effect was observed. No abnormal laboratory finding was observed. Clinical usefulness of SM-4300 were usefulness in 3 cases, fairly usefulness in 2, useless in 3 and unevaluable in 4. The usefulness rate was 37.5%, and the rate including fairly usefulness was 62.5%. In conclusion, combination therapy with SM-4300 and antibiotics was considered to be safe and effective against severe bacterial infections in the surgery.

[Clinical evaluation of cefpodoxime proxetil in the treatment of skin and soft tissue infections. A double blind comparison of cefpodoxime proxetil and cefaclor].

In order to objectively evaluate the effectiveness, safety and usefulness of the new oral cephem cefpodoxime proxetil (CS-807, CPDX-PR) for the treatment of skin and soft tissue infections, a double-blind comparative study was undertaken using cefaclor (CCL) as the control drug. CPDX-PR and CCL were administered for 7 days at daily doses of 400 mg (divided into 2 portions) and 750 mg (divided into 3 portions), respectively. A total of 243 patients (118 in the CPDX-PR group and 125 in the CCL group) was treated in this study. The effectiveness, safety and usefulness were evaluated in 222 (106 in the CPDX-PR group and 116 in the CCL group), 234 (113 in the CPDX-PR group and 121 in the CCL group) and in 223 patients (107 in the CPDX-PR group and 116 in the CCL group), respectively. There were no differences in patients' backgrounds between the 2 groups, except for the presence or the absence of surgical treatments. The results we obtained are summarized below: 1. In the evaluation of clinical efficacy by the subcommittee, excellent, good, fair and poor efficacy were observed in 36, 43, 17 and 10 patients in the CPDX-PR group, respectively; the efficacy rate was, therefore, calculated to be 74.5%. As for the CCL group, respective results were observed in 50, 39, 17 and 10 patients, indicating an efficacy rate of 76.7%. There was no significant difference between the 2 groups. Improvement rates judged by physicians in charge were 80.2% in the CPDX-PR group and 88.8% in the CCL group. Moreover, no significant difference in diseases or severity were found between the 2 groups. 2. As for the bacteriological efficacy, the 2 groups showed high elimination rates, as 90.1% and 91.6% of the disease causing bacteria were eliminated in the CPDX-PR group and in the CCL group, respectively. Elimination rates in single infections with Staphylococcus aureus were determined to be 85.7% in the CPDX-PR group and 85.0% in the CCL group. 3. Although 6 patients in the CPDX-PR group and 2 patients in the CCL group developed side effects, which were mainly gastrointestinal symptoms, there was no significant difference in the incidence of side effects between the 2 groups. Abnormal laboratory values were found in 5 patients in the CPDX-PR group and 1 patient in the CCL group. 4. There was no significant difference in the usefulness between the 2 groups.(ABSTRACT TRUNCATED AT 400 WORDS)

[Antibiotic susceptibility of bacteria isolated from surgical infection (second report)].

Isolated bacteria from infections in general surgery in 1984 and 1985 have been investigated to find bacterial composition and their susceptibilities to antibiotics in a joint research in which 6 university hospitals in Japan participated. A summary of findings from the investigation is as follows. 1. One hundred and seventy-two (1984) and 211 (1985) cases were included in the study. Cases in which bacteria were detected were 147 and 174 in the respective years. The detection rate was higher than 80% in either year. 2. Total numbers of strains isolated in 1984 and 1985 were 267 and 293, respectively; major sources of these strains were intraperitoneal infection exudates in either year. 3. The most frequent isolate from primary infection cases in both years was Escherichia coli (15-21%), followed by Bacteroides spp. and Staphylococcus spp., in that order. The most frequently isolated from postoperative infection cases were Enterococcus spp. (16-22%), followed by Pseudomonas spp. The diversity of isolated species, as well as the similarity of incidences of different species were noted in cases of postoperative infections. It is suspected that a certain species, even if its pathogenicity is essentially low, may become to be a causative organism once its number increases due to its survival through a perioperative prophylactic use of antibiotics, and also due to the decreased host resistance to infections caused by underlying diseases or surgical stress. 4. Staphylococcus spp. was the most frequent isolate from postoperative infections occurring after clean operations, while Enterococcus spp. and Pseudomonas aeruginosa were major isolates from infections after clean-contaminated operations. Isolates from infections occurring after contaminated operations included Enterococcus spp. greater than E. coli greater than Klebsiella pneumoniae, P. aeruginosa, Bacteroides spp. (1985). 5. In cases without the presence of clinical factors cause by depressed host defense, E. coli and Bacteroides spp. were major isolates, while in cases with the factors, a wide variety of bacterial population tended to be found. 6. Before an administration of antibiotics in primary infections, E. coli, Staphylococcus spp. Bacteroides spp. and Klebsiella spp. were most commonly isolated, while after a chemotherapy, Enterococcus spp. were the most frequent isolates, followed by P. aeruginosa during 1985. These findings reflected the antibacterial spectrum of cephems usually used in surgical field.(ABSTRACT TRUNCATED AT 400 WORDS)

[Penetration of levofloxacin in bile].

The penetration into bile of a new pyridonecarboxylic acid derivative, levofloxacin (LVFX), was studied in a closs-over method with ofloxacin (OFLX) as the control drug in 6 post-operative patients. The lengths of time to the maximum concentrations in bile and the total areas under the curves were both almost the same for these 2 compounds, although the maximum bile concentration of LVFX was slightly lower than that of OFLX. A stability test for LVFX in human bile revealed that over 95.4% of the initial amount was recovered up to 24 hours after commencement of incubation at a room temperature, thus the stability in bile was similar to that in water. The penetration of LVFX which possesses twice as strong antibacterial activities as OFLX was similar to that of OFLX, suggesting that LVFX is useful against bile duct infections.

[Bacteriological and clinical evaluation tazobactam/piperacillin in infectious diseases in surgical field].

We carried out bacteriological and clinical studies on tazobactam/piperacillin (TAZ/PIPC), a combination drug of piperacillin with the new beta-lactamase inhibitor tazobactam, in various infectious diseases in surgical field such as intra-abdominal infections (peritonitis and intra-abdominal abscess), hepatobiliary infections (cholecystitis, cholangitis and hepatic abscess) and secondary infections in wound, etc. The total number of cases treated with the combination drug was 164. Of these cases, 141 cases were assessable for clinical responses including 60 cases with intra-abdominal infections, 38 cases with hepatobiliary infections, and 43 cases with secondary infections. Clinical efficacy rates of the drug were 83.3% in cases with intra-abdominal infections, 86.8% in cases with hepatobiliary infections, and 95.3% in those with secondary infections, hence the overall efficacy rate was 87.9%. In the cases from which beta-lactamase producing strains were isolated, clinical efficacy rates were 84.8% in cases with intra-abdominal infections, 84.6% in those with hepatobiliary infections, and 96.2% in those with secondary infections, hence the overall efficacy rate was 88.9%. Bacteriological efficacy rates were 92.9% in cases with Gram-positive bacterial infections, 64.3% in those with Gram-negative bacterial infections, and 100% in those with anaerobic bacterial infections. Bacteriological efficacy rates were 84.2% in cases with single bacterial infections and 56.5% in those with multi-bacterial infections, and the overall bacteriological efficacy rate was 69.0%. In the cases of infections with beta-lactamase producing strains, bacteriological efficacy rates were 80.0% in cases with Gram-positive bacterial infections, 75.0% in those with Gram-negative bacterial infections, and 100% in those with anaerobic bacterial infections. They were 82.6% in cases with single bacterial infections and 57.9% in those with multi-bacterial infections; the overall bacteriological efficacy rate was 67.2%. The bacterial eradication rate was 79.9% against all the isolates, and it was 79.2% against beta-lactamase producing isolates. In addition, we compared the sensitivity distribution of the isolates to TAZ/PIPC with those to control drugs piperacillin (PIPC), cefotiam (CTM), ceftazidime (CAZ), sulbactam/cefoperazone (SBT/CPZ). The MIC50 and MIC90 values of TAZ/PIPC against all strains were 3.13 micrograms/ml and 50 micrograms/ml, respectively. MIC50 values show that TAZ/PIPC was two times less effective than CAZ and SBT/CPZ but four times more effective than CTM; furthermore, from the MIC90 values, TAZ/PIPC was four times more effective than PIPC, CTM and CAZ. The MIC50 and MIC90 values of TAZ/PIPC against beta-lactamase producing strains were 3.13 micrograms/ml and 50 micrograms/ml, respectively.(ABSTRACT TRUNCATED AT 400 WORDS)

[Antibiotic susceptibility of bacteria isolated from surgical infections (first report)].

In vitro activities of several antimicrobial agents against bacterial pathogens isolated from patients with primary and postoperative infections were investigated in 1982 and 1983. Antimicrobial agents examined were as follows: sulbenicillin (SBPC), piperacillin (PIPC), cephalothin (CET), cefazolin (CEZ), cefmetazole (CMZ), cefotiam (CTM), cefoperazone (CPZ), cefotaxime (CTX), ceftizoxime (CZX), cefmenoxime (CMX), latamoxef (LMOX), lincomycin (LCM), gentamicin (GM) and amikacin (AMK). Specimens for bacterial isolation included plus, fluid drawn by centesis, or bile. Blood samples of septicemia were excluded. The antimicrobial activities of these drugs were determined by the agar plate dilution method of the Japanese Society of Chemotherapy. There were 123 strains obtained in the 1982 survey and 252 strains in the 1983 survey. Little or no differences were seen in frequencies of isolation between the isolates of principal species in 1982 and those in 1983. Isolation frequencies of pathogens in primary infections were, in an order of decreasing frequency, E. coli (25.6%), anaerobes (21.1%), Streptococcus sp. (14.3%), Staphylococcus sp. (11.3%); in postoperative infections, Streptococcus sp. was most frequent (28.6%), followed by Pseudomonas sp. (17.6%), anaerobes (12.6%), E. coli (10.9%), Staphylococcus (10.1%). Against S. aureus, CEZ, CTM, LCM and GM had similar degree of activity with CET being somewhat more active. CMX was the most active drug among the third generation cephems tested against S. aureus. No strain was CTM, CEZ, and LCM-resistant at the same time. Over 90% of E. coli, were sensitive to CTX, CZX and CMX, inhibited by 0.10 microgram/ml, while E. coli were slightly less susceptible to CPZ and LMOX. Penicillins were not very active against K. pneumoniae, and only 60% of K. pneumoniae were inhibited by PIPC at concentrations of 12.5 micrograms/ml. Third generation cephems, CTX, CMX and CZX, proved highly active against K. pneumoniae; over 90% of K. pneumoniae was inhibited by CTX, CMX and CZX at a concentration of 0.10 microgram/ml. About 60% of P. aeruginosa was inhibited by 3.13 micrograms/ml of PIPC and GM but was resistant to SBPC. This survey should be very useful for the selection of an appropriate drug for prophylaxis if the frequencies of incidences of pathogens in postoperative infections are taken into account in selecting the most active antibiotic agent(s) against the most frequent genus, genera and species of pathogens.

[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.

[Fundamental and clinical studies of a sustained release preparation of cefaclor in the surgical field].

Fundamental and clinical studies of S6472 (sustained release preparation of cefaclor (CCL] were conducted in the surgical field and it was confirmed that the preparation is a useful drug. The following is the summary of the results from the fundamental and clinical studies: In vitro antibacterial activity. CCL showed MICs of 0.78 to 6.25 micrograms/ml against almost strains of S. aureus, E. coli and Klebsiella isolated from surgical wound regions, and the antibacterial activities were stronger than those of cephalexin (CEX). Clinical efficacy. S6472 was orally administered to 33 patients with skin and soft tissue infections in 2 divided doses. As a result, excellent clinical response was observed in 13 patients, good response observed in 14 patients, fair in 4 and poor in 1. The clinical efficacy in 1 of the 33 patients was unknown. Overall clinical effective rate was 84.4%. Adverse reaction. In 2 patients, mild gastrointestinal symptoms were observed.

[Clinical evaluation of S6472 (prolonged action preparation of cefaclor) in the treatment of skin and soft tissue infections. A double blind comparison of S6472 and cefaclor].

A double-blind comparative study of S6472 and cefaclor (CCL) was conducted to evaluate the therapeutic efficacy, safety and usefulness in the treatment of skin and soft tissue infections. Either 750 mg b.i.d. of S6472 or 750 mg t.i.d. of CCL was administered orally to patients for a period of 7 consecutive days. Of the 250 cases (123 cases of S6472 group and 127 cases of CCL group) recruited in this trial, 228 cases (114 cases of S6472 and 114 cases of CCL) were adopted by the committee members for the evaluation of therapeutic efficacy, 238 cases (118 cases of S6472 group and 120 cases of CCL group) for usefulness, and 245 cases (121 cases of S6472 group and 124 cases of CCL group) were adopted for the evaluation of side effects. The backgrounds of both patients group were almost similar. The results obtained were as follows: Overall clinical effectiveness Of the 114 patients treated with S6472, excellent clinical responses were obtained in 11 patients, good in 79, fair in 19, poor in 5 (efficacy rate 78.9%), and of the 114 patients treated with CCL, excellent were in 16, good in 78, fair in 13, poor in 7 (efficacy rate 82.5%). There was no statistically significant difference between the 2 groups. Clinical effectiveness classified by initial severity and bacteriological efficacy There was no significant difference between the 2 groups in the clinical effectiveness classified by initial severity and in the bacteriological efficacy. Side effects were noticed in 5 patients of 121 treated with S6472 (4.1%) and in 2 patients of 124 treated with CCL (1.6%), and other 13 patients developed some abnormal laboratory findings. But these undesirable reactions were mild, and developed no significant difference between the 2 groups in the incidence of side effects. There was no significant difference between the 2 groups in the usefulness of the drugs. Conclusively, 750 mg b.i.d. of S6472 is anticipative of the same clinical efficacy, safety and usefulness as compared with that of 750 mg t.i.d. of CCL in the treatment of skin and soft tissue infections.

[Comparative clinical study of aspoxicillin and sulbenicillin in postoperative wound infections].

A well-controlled comparative study was performed to evaluate efficacy, safety and utility of aspoxicillin (ASPC) as compared with sulbenicillin (SBPC) in the treatment of postoperative wound infections. Either 2 g of ASPC or 2 g of SBPC was administered to patients by intravenous drip infusion twice a day for 7 days. The following results were obtained: Overall clinical effectiveness rates were 82.5% (66/80) in ASPC group and 77.0% (57/74) in SBPC group, with no statistically significant difference between 2 groups. Final overall clinical improvement rates were 83.8% (67/80) in ASPC group and 81.1% (60/74) in SBPC group, with no statistically significant difference between 2 groups. As to bacteriological effectiveness, eradication rates of clinical isolates were 70.4% (38/54) in ASPC group and 74.4% (32/43) in SBPC group. There was no statistically significant difference in 2 groups. Side effects and abnormal laboratory findings were observed in 6 cases (6.7%) and 11 cases (12.4%) in ASPC group (89 cases) respectively, and 4 cases (4.4%) and 7 cases (7.8%) in SBPC group (90 cases) respectively. Especially severe adverse reactions were not observed, and there was no significant difference in the incidences of side effects and abnormal laboratory findings between 2 groups. As to overall clinical utility, utility rates were 77.5% (62/80) in ASPC group and 70.3% (52/74) in SBPC group. There was no statistically significant difference between 2 groups. These results may be indicated that ASPC is as useful as SBPC in the treatment of postoperative wound infections.

[Clinical study on fleroxacin in surgical infections].

We conducted clinical studies on fleroxacin (FLRX), a new pyridone carboxylic acid derivative, for the treatment of periproctal abscess, secondary infections (due to wounds, burns or surgical operations), mastitis or areolitis and others with once daily dose of 200 mg or 300 mg. We obtained the following results. Clinical efficacy was evaluated in total 27 cases including periproctal abscess 11, secondary infection 8, mastitis or areolitis 6, phlegmon 1 and infected atheroma 1. Clinical efficacies were rated as excellent in 14, good in 9, fair in 4 cases. The overall efficacy rate was 85.2%. Bacteriological studies identified 14 strains of aerobic Gram-positive organisms, 12 of aerobic Gram-negative organisms and 6 of anaerobic organisms. The overall bacteriological efficacies were: eradicated in 26 strains, unchanged 2 and unidentified 4, hence the eradication rate was 92.9%. As for side effects, anorexia and nausea were observed in one of the 27 cases. In clinical laboratory tests, slight elevations of GPT and BUN were observed in 1 case each. We consider FLRX to be a useful antimicrobial agent at once daily dose for surgical infections.