The effect of ofloxacin (OFLX: DL-8280), a new oral antibacterial agent, was compared with that of pipemidic acid (PPA) on infectious enteritis (bacillary dysentery, campylobacter enteritis and acute enteritis caused by EPEC and ETEC) by a double-blind method. OFLX was administered in a dose of 600mg/day, and PPA was administered 2, 000mg/day. The duration of the treatment was five days with both drugs. Of 251 cases studied, 107 cases were excluded from the analysis of effectiveness. The effectiveness was evaluated in 144 cases; 77 received OFLX and 67 received PPA. There was no significant difference between both groups in terms of the background factors. The results obtained were as follows: 1) OFLX group was as same as PPA group in clinical effect judged by doctors in charge. 2) There was no significant difference between both groups in defervescence, disappearance of bloody stool, decrease in number of defecation and improvement of stool character. 3) Bacteriological effect of OFLX was superior to that of PPA with Shigella spp. 4) Days required for eradication of organisms were shorter for OFLX group than those for PPA group with significant difference in Shigella cases. 5) Side effects were observed in one case of OFLX group (0.8%) and three cases of PPA group (2.6%). No significant difference was seen in their incidences between both groups. 6) Slightly abnormal laboratory findings were seen in eight cases of OFLX group and three cases of PPA group. 7) OFLX group (88.5%) was superior to PPA group (71.4%) in clinical usefulness judeged by doctors in charge. From these results, OFLX is considered to be very useful medicine in the treatment of patients with bacillary dysentery or carriers.
A newly developed human immunoglobulin preparation for intravenous use, SM-4300, purified by cold ethanol precipitation and ion-exchange adsorption, has been studied in the field of internal medicine. SM-4300 has been evaluated clinically in Japan since 1982 in patients with severe bacterial and/or fungal infections in the combined use with the antibiotics which are resistant to antibiotic therapy. 1. Total number of 199 patients affected with various severe infections were treated with SM-4300 and evaluated by doctors in charge. Clinical effects of SM-4300 were excellent in 15 cases, good in 56, fair in 36, poor in 48 and unknown in 44. The efficacy rate was summarized as 45.8%. 2. Out of 199 cases 117 cases were accepted as the evaluable cases by the committee. The evaluable cases consisted of respiratory infections (62.4%), septicemia including suspicion of septicemia (20.5%), renal and urinary tract infections (8.5%), hepato-biliary tract infections (3.4%) and others. The majority of patients had one or more underlying diseases, mainly including malignant tumor (19.7%), chronic pulmonary disease (10.5%), cerebro-vascular disorder (17.1%), leukemia (10.3%), other diseases (17.9%). The patients without underlying diseases was 10.3%. 3. Clinical effects of SM-4300 were excellent in 15 cases, good in 45, fair in 27 and poor in 30 cases. The efficacy rate was summarized as 51.3%. 71 strains of clinical isolates were obtained from 54 cases. Fifty-nine strains out of them were evaluable for bacteriological effects which were eradicated in 26 strains, decreased in 6 and persisted in 27 strains. The eradication rate was 44.1%. 4. The analysis of the relation between clinical efficacy and underlying diseases, backgroundf actors, isolated organisms or dosage of SM-4300 was done and there was no significant relationship. 5. The rate of appearance of subjective and objective clinical side effects was 1.0%(2 cases). Abnormal laboratory findings because of SM-4300 administration were observed in 3 cases of 199 adopted cases. None of the side effects and abnormal laboratory findings was considered practically important. In conclusion, combination therapy with SM-4300 and antibiotics was considered to be safe and effective against severe bacterial and/or fungal infections in the field of internal medicine.
Ig-100, developed by the Swiss Red Cross, is a human immunoglobulin preparation for i. v. administration prepared by a modification of the Cohn ethanol fractionation process, incorporating mild acid treatment at pH 4. IG-100 has been evaluated clinically in Japan since 1982 in patients with severe bacterial and/or fungal infections which are resistant to antibiotic therapy. Of 340 patients who received IG-100, 332 (97.6%) were adopted for safety evaluation and 183 (53.8%) were considered evaluable for efficacy. The adopted patients consisted of respiratory tract infections (42.2%), septicemia suspect (30.1%), septicemia (8.7%), urinary tract infections (3.0%) and others. The majority of patients had one or more underlying diseases, mainly including leukemia and/or other hematopoietic disorders (51.5%) and malignant tumor (19.9%). Among 183 evaluable patients, clinical responses were excellent in 28, good in 74, fair in 28, poor in 43 and unknown in 10; efficacy rate being 59.0%. Causative organisms were isolated from 128 adopted patients. Among them 66 patients were evaluable for bacteriological effects which were eradicated in 36, partially eradicated in 4, decreased in 3, persisted in 18 and replaced in 5; eradication rate being 62.1%. The analysis of the relation between clinical efficacy and leukocyte counts before and after IG-100 administration revealed that the highest efficacy rate was achieved in the patients whose leukocyte counts after IG-100 administration were in the normal range. The efficacy rate in the patients with lower leukocyte counts was much lower compared with that in the above mentioned patients. It is indicated that neutrophils and other leukocyte populations play an important role in the healing process of severe infections. The rate of appearance of subjective and objective clinical side effects was 0.9% and none of the side effects observed was considered practically important. Abnormal laboratory findings because of IG-100 administration were not observed in 332 adopted patients. In conclusion, combination therapy with IG-100 and antibiotics was considered to be safe and effective against severe bacterial and/or fungal infections.
A survey was conducted on the closure of some or whole classes of a grade in 66 primary and lower secondary schools operated by the Ward of Suginami, Tokyo, during the epidemic period of influenza-like disease in four years, 1979 to 1982. Therefore, the cumulative number of schools surveyed was 264 for the four years. In these schools was surveyed the relationship between the class closure in 1979-1983 and the time of inoculation of influenza vaccine or the rate of inoculation. The results obtained are summarized as follows. 1) In the 264 schools, the second inoculation of influenza vaccine was finished in 203 schools (76.8%) in November and in 61 schools (23.2%) in December. The closure of some or whole classes of a grade occurred in 125 schools (61.6%) of the former 203 schools and in 20 schools (32.7%) of the latter 61 schools. Accordingly, it took place significantly more frequently (p<0.001) in the former than in the latter. 2) Of the 264 schools, 145 schools (54.9%) experienced class closure (group C), but the other 119 schools (45.1%) did not (group N). The average rates of the first and the second inoculation were 86.7% and 77.3%, respectively, in group C and 88.0 and 78.9%, respectively, in group N. Therefore, the average rate of the second inoculation was significantly lower (p<0.01) than that of the first inoculation in both groups. 3) The interval between the two inoculations was 8-14 days in 136 schools (51.5%) and 15-21 days in 90 schools (34.1%) of the 264 schools. From the results mentioned above it was concluded to be necessary for the further enhancement of the immune effect of the existing HA vaccine to make the interval between the first and the second inoculation 4 weeks, to perform the second inoculation about one month prior to the beginning of an epidemic period (from the end of January to that of February), and to increase the rate of the second inoculation.
Herpes zoster infections are frequent in immunosuppressed patients such as Hodgkin's lymphoma and systemic lupus erythematosus. 22 patients with dermatomyositis (DM) and polymyositis (PM) were studied with regard to developement of herpes zoster. Herpes zoster occurred wihh high frequency (22.8%) in patients with DM and PM. Patients had no multiple episodes. The course of herpes zoster was benign: no patients developed disseminated zoster and only one of the five patients had post herpetic neuraligia. Furthermore, patients tended to have mild or inactive stage in DM·PM when herpes zoster affected. The causes that herpes zoster occurred frequently in DM·PM were studied on clinical and laboratory findings of DM·PM patients. Abnormal titer of antinuclear antibody was significantly detected in patients with herpes zoster infection. In addition, two of the five patients with herpes zoster overlapped other collagen diseases. There were no correlation of age at the onset of DM·PM, sex, other clinical and laboratory manifestation between with and without herpes zoster infection. It was no relationship between steroid therapy and herpes zoster infection.
During the period from July to September 1983, 2 outbreaks of acute enteritis had occurred in Gifu. A total of 31 patients were involved in these 2 outbreaks. The major symptoms observed in 31 patients were diarrhea (100%), abdominal pain (93.5%), nausea (80.6%), vomiting (58.1%) and fever (35.5%). In these outbreaks, the vehicles for transmission were confirmed. They were implicated sea bream broiled with salt in outbreak number 1 and tamago-yaki in outbreak number 2. In these food poisoning, Vibrio parahaemolyticus was isolated from 11 (91.7%) out of 12 feces obtained from patients and Vibrio fluvialis was also isolated from 8 (66.7%) cases. The 15 V. parahaemolyticus strains isolated from 5 patients of outbreak number 1 were serologically typed O5: K15 and among the 28 V. parahaemolyticus strains isolated from 7 patients of outbreak number 2 25 were serologically typed O10: K19 and 3 were serologically typed O5: K17. The 8 of the 15 V. fluvialis strains isolated from patients of outbreak number 1, the 12 of the 30 strains isolated from patients of outbreak number 2 and the 1 strain isolated from tamago-yaki of outbreak number 2 were serologically examined by the Tokyo Metropolitan Research Laboratory of Public Health. Among the 8 strain isolated from 3 patients of outbreak number 13 were serologically classified into TFO-12 and the remaining 5 were unable to be classified. Among the 12 strains isolated from 6 patients of outbreak number 2 7 were serologically classified into 2 serovar, i. e., TFO-4 and 17 and the remaining 5 were unable to be classified. The 1 strain isolated from tamago-yaki was also unable to be classified. From above results, it seems likely that V. parahaemolyticus and V. fluvialis were etiological agents of these outbreaks. This was the first report of a bacteriologically and serologically documented mixed food-borne infection with V. parahaemolyticus and V. fluvialis in Japan.
The clinical efficacy and safety of Enoxacin (AT-2266, ENX) were compared with those of cefaclor (CCL) in 188 patients with chronic respiratory tract infections (chronic RTI) and those with exacerbated acute infections by a double-blind study at 40 institutions in Japan. Patients over 16 years old with apparent clinical signs and symptoms were administered ENX or CCL orally for 14 days at a daily dose of 3 tablets or capsules (ENX: on tablet contains 200 mg of ENX; CCL: on capsule contains 250 mg of CCL). The parameters assessed were clinical efficacy, bacteriological response, rate of improvement of clinical signs and symptoms, appearance of side effect, abnormal loboratory findings and clinical usefulness. 1. Clinical efficacy was analysed statistically 166 patients (88 administered ENX., 78 administered CCL) and 22 patients out of a total of 188 patients were excluded. Side effects were also analysed in 179 patients (ENX: 96, CCL 83) in whom judgement was possible. 2. On the basis of committee judgement the overall clinical efficacy rates for all the cases were 56.8% for ENX and 62.8% for CCL, those for chronic RTI were 56.3% for ENX and 62.7% for CCL. No significant difference was observed between the two drug groups. In the evaluation of clinical efficacy by the doctor, the overall efficacy ratesin all the cases were 56.8% for ENX and 55.1% for CCL, those for chronic RTI were 56.3% for ENX and 56.0% for CCL. No significant difference was observed between the two drug groups. 3. The bacteriological eradicated rate of causative organisms was 54.2% out of 48 patients treated with ENX and 50.9% out of 60 treated with CCL and there was no significant differences between the two groups. At showed an eradication rate of 18.2% in S. pneumoniae and that of 84.6% in H influenzae, while the corresponding rates for CCL were 71.4% in S. pneumoniae and 63.2% in H.influenzae. The ENX group was superior to the CCL group in the bacteriological response in H influenzae among causative organisms (p<0.10) and the CCL group was superior to the ENX group in S. pneumoniae (p<0.05). 4. With respect to the rate of improvement of clinical signs and symptoms the ENX group was superior to the CCL group in the improvement for sputum volume five days after treatment (p<0.05). 5. The incidence of side effects was 11.5% for ENX and 2.4% for CCL. The ENX group displayed significantly higher rate of side effects than the CCL group. Abnormal laboratory findings were observed at the rate of 19.7% for ENX and 14.1% for CC1, without significant differences between the two groups. 6. Regarding usefulness as judged by committtee members the respective rate for the ENX group and CCL group were 53.3% and 62.8% and usefulnss as judged by the doctor in charge those were 45.7% for ENX and 48.7% for CCL. These assessements showed no significant differences between the two. From the above results it was concluded that ENX is an equal useful drug to CCL for the treatment of chronic RTI caused by gram negative bacteria.
In order to obtain more effective medium for the selective isolation of strains of Legionella species from environmental water specimens, 18 test media were prepared by adding each one of the 5 antifungal agents, amphotericin B, anisomycin, cycloheximide, nystatin, or miconazole, in various concentrations to GVP (glycine-vancomycin-polymyxin B) medium proposed by Wadowsky and Yee. In a comparative study to isolate legionellae from the water specimens of 15 cooling towers in Fukuoka Prefecture, 15 (100%) specimens were positive on the GVP medium added with either amphotericin B or anisomycin in a concentration of 80μg/ml, 14 (93%) on GVP added with 80μg/ml cycloheximide, whereas 11 (73%) on MWY (modification of Wadowsky-Yee) by Edelstein was the highest and only 1 (7%) on BMPA (buffered cefamandole-polymyxin B-anisomycin) medium was the lowest among the 6 previously reported selective media. All these 24 media were used in combination with acid-buffer treatment of the water specimens. Of these 3 effective antifungal agents, amphotericin B is of cheaper cost and of easier availability than anisomycin in Japan, and is less inhibitory to the growth of legionellae and more inhibitory to candidae than cycloheximide. Thus amphotericin B was chosen as antifungal agent to be incorporated to GVP medium in a concentration of 80pg/ml. This medium in herein named as WYO (Wadowsky-Yee-Okuda) medium and recommended for the selective isolation of legionellae in combination with acidbuffer treatment of the specimen. Growth rates of the 13 test strains of 7 Legionella species on WYO medium were almost similar to those on the original GVP medium. Although the inability of the type strain of L. gormanii to grow on WYO medium would suggests a limitation of such selective isolation device, WYO medium would be helpful for both ecological and epidemiological researches on legionellae and human legionellosis.
The clinical efficacy and safety of Enoxacin (ENX) was objectively compared with those of amoxicillin (AMPC) in patients with bacterial pneumonia by a double blind study. Patients over 16 years old with apparent clinical signs and symptoms caused by pneumonia were administered ENX (at a daily dose of 600mg) or AMPC (at a daily dose of 1, 000mg) orally for 14 days.The results were as follows: 1) Clinical efficacy was analyzed statistically in 139 patients (71 administered ENX, 68 administered AMPC). According to committee judgement on clinical effects, the efficacy rate covering the entire cases treated was 71.8% for the ENX group and 80.9% for the AMPC group. There was no significant difference between the two groups. As for the cases of bacterial pneumonia, the efficacy rate was 71.4% for the ENX group and 84.6% for the AMPC group. A statistical analysis of these results revealed that the efficacy of AMPC tended to be superior to that of ENX. 2) No significant difference was noted between the two groups in the overall clinical efficacy by the attending doctor judgement. 3) There was no significant difference between the two groups for the eradicated rate of causative organisms. 4) The incidence of side effects was 5.5% in the ENX group and 4.2% in the AMPC group, respectively. There was no significant difference between the two groups. 5) There was no significant differene between the two groups for the utility on the basis of committee judgement and the attending doctor judgement.
The clinical usefulness of Enoxacin (ENX, AT-2266), a new oral antibacterial agent, was compared with that of pipemidic acid (PPA) in the treatment of acute infectious diarrhea (bacillary dysentery, Campylobacter enteritis and enteropathogenic and enterotoxigenic E. coli enteritis) by a double-blind method. Daily dosage of ENX and PPA was 600mg and 2000mg, respectively. The duration of the treatment was 5 days. Of 242 cases treated, various statistical analyses were carried out in 146 case, and 96 cases were excluded. Of 146 cases, 73 cases were treated with ENX or PPA respectively. There was no statistical significance between ENX group and PPA group in terms of the background characteristics and MIC distribution against each drug. The results obtained were as follows. 1. The MICs of ENX against the isolates ranged between <0.1 and 1.56μg/ml, whilethose from PPA, between 0.78 and 12.5μg/ml. No resistant strains against ENX and PPA were observed in the causative organisms. 2. In bacillary dysentery, the bacteriological effect of ENX (97.1%) was superiorto that of PPA (83.6%). 3. In bacillary dysentery, the frequency of redischarge of the causative organisms was 2.9% in ENX group and 14.9% in PPA group. A statistically significant difference was observed between ENX group and PPA group. 4. There was no significant difference between ENX group and PPA group in improvement of clinical symptoms by any causative organisms. 5. Side effects were observed in one case of ENX group (0.9%) and 5 cases of PPA group (4.2%). There was no statistically significant difference between both groups. Abnormalities in laboratory tests were slight elevation of s-GPT in ENX group andincrease in eosinophil fraction (percentage) in PPA group. 6. On clinical usefulness judged by the physicians, the ratio of usefulness were 84.6% in ENX group and 66.7% in PPA group in bacillary dysentery. Usefulness of ENX was superior to that of PPA group. 7. The effects on Campylobacter enteritis, enteropathogenic and enterotoxigenic E. coli enteritis could not be assessed because of a small number of cases. As mentioned above, ENX is considered to be useful medication in the treatment of patients with bacillary dysentery and carriers.