Laboratory and clinical studies were performed on cefminox (CMNX, MT-141), a new cephamycin antibiotic, and results were as follows.
1. Antimicrobial activities
MICs of CMNX against various clinical isolates were determined with the inoculum size of 10⁶ cells/ml. Percentages of strains susceptible to 12.5μg/ml or less were 4% for S. aureus, 0% for E. faecalis, 100% for E. coli, 81% for K. pneumoniae, 3% for Enterobacter sp., 18% for S. marcescens, 90% for P. mirabilis, 88% for indole-positive Proteus sp. 100% for S. flexneri, 100% for Salmonella sp., 0% for Citrobacter sp. and 0% for P. aeruginosa. Most of those sensitive strains were inhibited by 0.39-0.78μg/ml. These activities were better than those of cefmetazole and cefazolin, but were not as good as those of cefoperazone.
2. Clinical efficacy
Three patients with pneumonia, 1 with pneumonia and sepsis, and 1 with urinary tract infection were treated with CMNX daily dose of 1-4g for 7-31 days. Clinical responses were excellent in 1, good in 3, poor in 2 patients (contained a double case). Bacteriological effects were good for E. coli, K. pneumoniae and S. liquefaciens, poor for P. aeruginosa and P. mirabilis. C. freundii, A. calcoaceticus and E. faecalis were cultured after treatment. No side effect and no abnormal change of laboratory findings were seen in our cases.

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A new cephem cefminox (CMNX, MT-141) was used in the treatment of 22 cases of respiratory tract infections without taking into account background factors of patients. The dosage was 2 to 4g/day in 2 divided doses and the treatment was continued for a period 2 to 17 days. The breakdown of the diseases treated was; pneumonia in 7 cases, secondary lung abscess (rS³)+middle lobe syndrome in 1 case, chronic bronchitis in 3 cases, bronchiectasis in 10 cases and intrapulmonary lymphangitis carcinomatosa (suspected) in 1 case.
The clinical results were rated as excellent in 7 cases, good in 11 cases, fair in 1 case and unknown in 3 cases, with an excellent rate of 36.8% and excellent+good rate of 94.7%.
The causative organisms were identified in 10 cases and included H. influenzae for 8 cases, Klebsiella sp. for 1 case and S. aureus for 1 case. The analysis of bacteriological study revealed disappearance of all of these organisms. However, in 3 out of 8 cases where H. influenzae was isolated and in 1 case where Klebsiella sp. was isolated the changes of organisms to P. aeruginosa were observed.
As the adverse reactions, rashes developed in 1 case and moreover laboratory test results revealed elevation in transaminase in 3 cases. All of these symptoms were mild in nature and none of our cases experienced serious adverse reactions attributable to CMNX.
From these results, we believe that CMNX is one of the useful drugs for the treatment of respiratory tract infections.

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Cefminox sodium (CMNX, MT-141), a new semisynthetic cephamycin, having marked resistance to β-lactamase, and a broad spectrum of antibacterial activity against various bacterial species, including Haemophilus influenzae, Serratia marcescens and Citrobacter freundii, CMNX has higher activity in vivo than in vitro.
For therapeutic purpose, CMNX was given in a daily dose of 0.5g (0.5g×1) to 2g (1×2) by intravenous drip infusion for 4 to 8 days to 24 cases with acute peritonitis (17 cases with acute appendicitis, 1 with localized peritonitis after gastrectomy, 1 with diffuse peritonitis due to perforative duodenal ulcer and 5 with panperitonitis due to intestinal obstruction). The clinical response was rated excellent in 9 cases, good in 14 cases and fair in 1 case and poor in none. No adverse effect was observed.
There were 29 strains isolated organisms included 12 Escherichia coli, some Enterococcus faecalis and Pseudomonas aeruginosa. These isolated organisms were eradicated after CMNX treatment, except a strain of E. faecalis was decreased.
In 19 cases of them, 16 cases with acute peritonitis due to acute appendicitis and 3 cases with acute panperitonitis due to intestinal obstruction, CMNX was administered intravenously in a dose of 1g ( 1 case was 0.5g) before or during the operation, and tissue specimens and body fluids samples were taken during the operation. CMNX concentration was determined to a bioassay with Escherichia coli NIHJ or Vibrio percolans ATCC 8461 as the test organisms.
CMNX concentrations in purulent ascites were 47.2±38.5μg/ml (n=23), those in infected appendix wall were 32.2±21.7μg/g (n=16), that in pus in appendix were 22.1±24.3μg/ml (n=8) and that in other non infected tissues were 24.3±22.0μg/g (n=8). CMNX concentrations in infected tissues were higher than the non infected tissues. In the 3 cases with empyemic appendicitis, CMNX levels in pus in appendix were more higher than that in appendix wall itself.
Therefore, CMNX sodium appears to be a very useful drug when used for chemotherapy on acute peritonitis.

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Cefminox (CMNX, MT-141) was administered to 7 cases with postoperative infections including subphrenic abscess and wound abscess, and the clinical effect was good in 2 cases, fair in 2, poor in 2 and unknown in 1. A daily dose was 2g in 7 cases. The maximum total dose and duration were 22g and 11 days respectively. Side effect which was observed during the test period was 1 case of drug eruption. No abnormal laboratory findings related to this drug were noted.

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Cefminox (CMNX, MT-141), a new cephamycin, was studied of its transfer into the serum and tissues with following results:
1. After an intravenous injection of 1g of CMNX, the serum concentration of the drug achieved in the uterine artery was almost equal to that in the elbow vein, showing good transfer of the drug.
2. After an intravenous injection of 1g of CMNX, favorable results were also obtained for concentrations achieved in all of the adnexal and uterine tissues studied.
3. From the results obtained, it is expected that CMNX is highly effective in particular for infections caused by E. coli, Klebsiella sp. and B. fragilis.

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Clinical and laboratory studies on cefminox (CMNX, MT-141), a new injectable cephamycin antibiotic, were made in the field of obstetrics and gynecology, and following results were obtained.
1. In the clinical trial, 12 cases were treated with CMNX given by intravenous drip infusion. The results were excellent in 2 cases, good in 8 cases and poor in 2 cases. The effectiveness rate was 83.3%.
2. No side effect was recognized.
3. No significant changes of laboratory findings were noticed.

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A total of 15 cases of obstetrical and gynecological infections was treated with cefminox (CMNX, MT-141), a new cephamycin antibiotic, with following results.
The subjects consisted of 3 cases of salpingitis, 2 cases of parametritis, 5 cases of endometritis, and 1 case each of puerperal fever, inflammation of the pelvic dead space, BARTHOLIN'S pyocele, vulvar abscess and suppurative mastitis. In 2 cases of endometritis, pelveoperitonitis and adnexitis were complicated, respectively.
As a rule, CMNX was administered intravenously at a dosage of 1g each twice a day by drip infusion route. The clinical results were rated as excellent in 8 cases, good in 6 cases and poor in 1 case, with an efficacy rate of 93.3%.
No subjective or objective side effects were seen nor any abnormal laboratory test results were found.

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Cefminox (CMNX, MT-141), a new cephamycin antibiotic, was studied in the field of obstetrics and gynecology, and the following results were obtained.
1. The absorption and the penetration of CMNX into pelvic dead space exudate were good. The mean peak serum level after single intravenous injection was 190.8μg/ml. The level in pelvic dead space exudate reached a peak of 36.6μg/ml 4 hours after an intravenous injection of 1g and 6.5μg/ml after 12 hours, thus the level over MIC against main pathogenic organisms was maintained for a long time.
2. CMNX was administered against gyneco-obstetrical infections such as intrauterine, intrapelvic, adnexal infections and postoperative wound infections with daily dose of 2g and was effective in 11 cases out of 12 cases (91.7%), and 81.8% of bacteriological effect was obtained. No side effect was observed.
From the above results the usefulness of CMNX in the field of obstetrics and gynecology was suggested.

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Cefminox (CMNX, MT-141), a new cephamycin antibiotic, was studied both fundamentally and clinically with following results.
1. In 33 cases undergone total hysterectomy and adnexectomy, 1g of CMNX was administered intravenously by the drip infusion route over 1 hour and changes in drug concentration in the venous blood and uterine arterial blood as well as in various uterine tissues including endometrium, myometrium, cervix uteri, portio vaginalis, oviduct and ovary were studied.
In addition, in 3 cases also received 1g of CMNX over 1 hour by the drip infusion route, changes in the concentration of CMNX in the pelvic dead space exudate were investigated.
In each tissue studied, the drug concentration higher than 40μg/g was attained at 20 minutes after completion of drip infusion, showing good transfer of CMNX.
In the pelvic dead space exudate, the peak concentration of 24.7μg/ml appeared at 4 hours after completion of drip infusion and at 12 hours still a concentration of 4.5μg/ml was maintained.
2. In the treatment of 15 cases of obstetrical and gynecological infections, CMNX was used. In all of the cases treated, clinical results better than good were obtained, with excellent results in 2 cases and good results in 13 cases.
In none of the cases side effects or laboratory abnormalities were observed.
From these results CMNX is considered to be a useful drug for the treatment of various infections in the field of obstetrics and gynecology.

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Cefminox (CMNX, MT-141), a new cephem antibiotic, was determined of its antibacterial activity against 304 clinical isolates with following results.
CMNX was inferior to CEZ or CMZ in the activity against 78 isolates of Staphylococcus sp., but it was superior to these antibiotics in the activity against 104 isolates of E. coli.
Against 53 isolates of Bacteroides sp., CMNX showed higher activity than CEZ or CMZ. In the activity against 69 isolates of Peptococcus sp. and Peptostreptococcus sp., CMNX was almost equal to CEZ.

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Intravenous administrations of cefminox (CMNX, MT-141) 1g as both single shot injection and drip infusion were absorbed rapidly. CMNX showed good transference into intrapelvic organs such as uterus, oviduct and ovary, with the tissue/serum ratios of 37.6% for myometrium, 35.1% for endometrium, 41.4% for cervix uteri, 49.5% for portio vaginalis, 54.3% for ovary and 59.7% for oviduct.
From these results, usefulness of CMNX in the field of obstetrics and gynecology was confirmed.

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In order to determine transference of cefminox (CMNX, MT-141) into the female genital organ tissues, the drug concentration in the pelvic dead space exudate was measured in cases undergone radical hysterectomy due to uterocervical cancer. For analysis of data the three-compartment model was used. When CMNX was given at a dose of 1g as an intravenous drip infusion taking 1 hour, the serum concentration of the cubital vein reached its peak of 89.53μg/ml at 1 hour after start of administration. In the pelvic dead space exudate the peak concentration of 39.84μg/ml was reached at 2.55 hours after administration and a concentration higher than 7μg/ml was still detected even at 12 hours. The area under the curve (AUC) for CMNX concentration in the pelvic dead space exudate was 295.63μg·hr/ml. These results suggest that CMNX achieves high concentration in the pelvic dead space exudate and that it is an antibiotic with clinical utility.
CMNX was used in the treatment of 6 cases of obstetrical and gynecological infections. The clinical results were excellent in 1 case, good in 2 cases and poor in 2 cases. In the remaining 1 case the results was unknown.

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Cefminox (CMNX, MT-141) was used in the treatment of obstetrical and gynecological infections with following results.
1. In the treatment of a total of 8 cases including 4 cases of intrauterine infections, 2 cases of pyosalpinx and 2 cases of pelvioperitonitis, clinical results obtained were rated as excellent in 4 cases (50%) and good in 2 cases (25%). When good and excellent results were combined as representing effectiveness, the effective rate was 75% (6/8 cases).
2. The 2 cases, which gave poor results, were under treatment for ovarial carcinoma.
3. CMNX was found effective for intrauterine infections (postpartal) and pyosalpinx, especially those caused by E. coli.
4. None of the cases experienced side effects.

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Fundamental and clinical studies on cefminox (CMNX, MT-141), a new cephamycin antibiotic, were performed and the following results were obtained.
1. Concentration of CMNX was examined in serum, internal genital organs and retroperitoneal fluid after a single intravenous administration of 1. 0 g dose.
The venous serum level of CMNX was 62. ±7. 02μg/ml (Mean±S. D.) at 30 minutes after the administra-tion.
The sufficient transfer of CMNX to internal genital organs and retroperitoneal fluid was demonstrated.
2. In clinical trial, CMNX was given to 10 cases with obstetrical and gynecological infections.
The efficacy was evaluated as excellent in 1 case, good in 8 cases and poor in 1 case.
No side effects were observed in any of the cases treated with CMNX.

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Basic and clinical studies were carried out on cefminox (CMNX, MT-141), a new cephem antibiotic.
Results obtained were as follows.
1. Following each 1g of intravenous drip infusion and intravenous injection, transfer of CMNX to the internal genital organs was good. Transfer of CMNX into exudate of the pelvic dead space was also good and showed high concentration.
2. CMNX was given to 2 cases. Clinical efficacy was good in 1 case, and could not be evaluated in 1 case. No side effects were observed in both cases.
3. The above results show that CMNX is an effective agent.

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Cefminox (CMNX, MT-141) was studied both fundamentally and clinically with following results:
1. In the treatment of 3 cases of BARTHOLIN'S abscess, 2 cases of pyometra, and 1 case each of bartholinitis, inflammation of the pelvic dead space, retroperitoneal abscess and pelvic peritonitis, CMNX was administered at a dosage of 1 g. The global clinical results were rated as good in 9 cases. From these findings it is considered that CMNX is promising as an antibiotic with extremely high efficacy for infections of the field of obstetrics and gynecology. Furthermore, since in none of our cases side effects or laboratory abnormalities were observed, CMNX is considered to be a drug with high efficacy and safety.
2. In 5 cases received 1 g of CMNX intravenously, concentrations of the drug in the serum and tissues of internal genital organs were determined. CMNX was maintained at concentrations higher than 20ug/ml for the serum and 10ug/g for each tissue studied.
In the pelvic dead space exudate 10 to 20ug/ml of the drug was still detected even at 8 hours after the administration. These results obtained by our fundamental study support the efficacy of CMNX demon-strated in the clinical part of our study.

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Human pharmacokinetics and clinical studies of cefminox (CMNX, MT-141) were carried out and the following results were obtained.
1. The concentrations of CMNX transferred to the uterus and its appendages after CMNX 1g intra-venous injection were maintained above 12. 5ug/g during first 3 hours or more.
2. The concentrations of CMNX transferred to the pelvic dead space exudate were above 12. 5ug/ml during 6 hours or more.
3. Those concentrations were sufficiently effective against the major pathogens (Gram-negative and anaerobic bacteria) demonstrated in the field of obstetrics and gynecology.
4. We administered CMNX to 4 cases with postoperative infections at a dose of 2g per day (twice a day) for a period of 4-6 days. The clinical effect was excellent in 3, good in 1 case. No side effect was observed.

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Fundamental and clinical studies on cefminox (CMNX, MT-141), a new cephamycin antibiotic, were carried out and the results were as follows.
After the intravenous one shot administration of 1g CMNX to 17 cases, serum concentrations, tissue concentrations in pelvic organs and protein binding capacities in serum were measured.
Blood concentrations ranged between 100-200ug/ml immediately after the injection and declined gradually. Half-life (T1/2) was 75 minutes.
Tissue concentrations were 30-70ug/g (tissue weight) 10 minutes after injection and declined. Half-life was 90 minutes.
The average serum protein binding rate was 66. 3 ± 8. 4%.
Correlation between tissue concentration (Y) and free serum concentration (X) was expressed as Y=0.42+7. 14X. Correlation coefficient (r) was 0. 80 (r=0. 0).
Correlation coefficient in serum concentrations between HPLC and bioassay was 0. 83 and that in free concentration was 0. 97.
In clinical studies, CMNX was administered to 19 cases of obstetric and gynecological infections. The patients were constituted of 3 with puerperal endometritis, 3 with pyometra, 3 with pelvic peritonitis, 3 with parametritis, 3 with adnexitis, 2 with BARTHOLIN'S abscess and 1 with retroperitoneal abscess and vulva abscess. Over all clinical efficacy was 89. 5% (17/19).
Bacteriologically 26 strains were isolated, 6 strains of E. coli, 4 strains of B. fragilis, 2 strains of P. anaerobius and P. asaccharolyticus and each one of E. faecalis, S. epidermidis, N. gonorrhoeae, S. marcescens, P. maltophilia, A. calcoaceticus, K. pneumoniae, P. mirabilis, H. influenzae, S. intermedius, E. lentum and F. varium.
Twenty of these 24 strains were eliminated after the administration, K. pneumoniae was decreased, E. faecalis, S. marcescens and P. maltophilia remained unaffected.
No side effects were observed but 1 case showed mild elevation of transaminases which normalized 1 week after CMNX was stopped.

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In patients with carcinoma of the uterine cervix, cefminox (CMNX, MT-141) was given intravenously after panhysterectomy and the pelvic dead space exudate and serum levels of the drug were determined at various periods.
The pelvic dead space exudate level reached its peak of 67. 21 ± 39. 81ug/ml at 2 hours, which decreased gradually to 26. 04±6. 66ug/ml at 6 hours. In the serum, the drug level attained the peak of 152. 98±85. 37ug/ml immediately after the injection and thereafter decreased rapidly. However, even at 6 hours level of 7. 26 ± 1. 66ug/ml was still detected.
The pelvic dead space exudate level was much higher than its MIC or 3h-MBC at all periods studied. From these results it was considered that CMNX achieves levels high enough to be expected of clinical efficacy in the pelvic dead space exudate and serum.

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Fundamental and clinical studies on cefminox (CMNX, MT-141), a new cephamycin antibiotic, were carried out and the following results were obtained.
1. When CMNX was administered at a dose of 1g by intravenous drip infusion taking 1 hour, the serum concentrations as high as 20μg/ml and 21μg/ml were detected even at 4 hours after administration for the uterine artery and elbow vein, respectively. From these results, CMNX was supposed to maintain in vivoconcentrations high enough to inhibit 80 to 100% of the growth of bacteria such as S. aureus, E. coli, Klebsiella, Proteus and anaerobic bacteria, B. fragilis, which are the commonest clinical isolates in the field of obstetrics and gynecology.
2. Clinically, in 7 cases of female genital infections (4 cases of parametritis, 1 case of intrauterine infection, 1 case of pyometra and 1 case of pelveoperitonitis), CMNX was administered at a daily dosage of 2 g in 2 divided doses as intravenous drip infusions taking 90 minutes each. The clinical results were excellent in 1 case, good in 3 cases and poor in 3 cases, with an efficacy rate of 57.1%. In 6 out of these 7 cases progressive carcinoma was present as the underlying disease.
3. No side effects nor abnormalities in laboratory findings were observed in any of the 7 cases.
These results suggest that CMNX is effective in the treatment of obstetrical and gynecological infections.

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One gram of cefminox (CMNX, MT-141) was injected intravenously to a total of 29 patients prior to abdominal total hysterectomy and drug levels in the uterine and adnexal tissues were bioassyed. Serum samples and uterine tissues were taken at 0.25, 0.5, 1, 2, 4 or 6 hours after the administration, when bilateral uterine arteries were clamped.
As to serum levels no difference was seen between cubital venous serum and uterine arterial serum, the half-lives being 2.32 hours and 2.22 hours, respectively. The peak level was 66.7μg/ml for both.
The drug level in tissues reached its peak at 15 minutes in the myometrium and cervix uteri, at 30 minutes in the endometrium, portio vaginalis and oviduct and at 1 hour in the ovary. The mean peak level was the highest for the oviduct (55.3μg/g), followed by the portio vaginalis (47.7μg/g), the cervix uteri (46.2μg/g), the myometrium (42.8μg/g), the ovary (37.3μg/g) and the endometrium (34.2μg/g) in this order. After reached the highest levels, the tissue levels decreased gradually in the same manner as the serum levels.
From these results it was shown that CMNX is well transferred into various female genital tissues to achieve concentrations higher than MICs for organisms isolated clinically with high incidences in the field of gynecology and obstetrics. It was assumed from these results that CMNX is clinically useful enough in the treatment of genital organ infections.

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The study was done to evaluate the usefulness of cefminox (CMNX, MT-141) injection for the treatment of infections in the field of obstetrics and gynecology.
Fundamental and clinical studies were made and following results were obtained.
1. When 1 g of CMNX was administered by intravenous single shot, the maximum concentrations in various tissues of female genital organs were as follows: 34.98μg/g in oviduct at 1 hour 10 minutes after the single shot, and 37.11, 28.01, 26.84, 30.01 and 40.06μg/g in ovary, endometrium, myometrium, cervix uteri and portio, respectively, after 1 hour 20 minutes.
2. In the clinical studies, CMNX was given to 13 cases with female genital organ infections and others.
As for the clinical effects, responses were excellent in 1 case, good in 12 cases among 13 cases in total. The efficacy rate was 100%.
As for the clinical effects on causative bacteria, the efficacy rates were 100% (3/3) for single infections due to Gram-negative bacteria, 100% (8/8) for mixed infection cases.
Side effects were not observed. CMNX 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 CMNX will be a useful addition to the antibiotics for the therapy of these infections.

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Clinical efficacy and safety of TMS-19-Q·GC tablet (TMS), a new macrolide preparation, were compared with those of midecamycin (MDM) in superficial suppurative skin and soft tissue infections.
The study was made by the double-blind controled trial at the dosage of daily 600 mg in TMS group and 1,200 mg in MDM group.
Total 218 cases (106 in TMS, 112 in MDM) were analyzed and the final global improvement rating were 82.1% in TMS and 83.9% in MDM.
The clinical effectiveness of TMS was favorable and significantly different from MDM in the aged patients (≥60 years old) and the patients infected with susceptible strains (MIC≤3.13) of Staphylococcus aureus. TMS is prepared with a specific formulation to make the absorption easer in the patients with lower acidity of gastric juice, and the faborable effect of TMS is considered to be a contribution of the devise in older patients.
Slight adverse reactions were observed at 5.0% (6 cases) in TMS and 2.4% (3 cases) in MDM.
In conclusion, TMS at the daily half dose of MDM is as effective as MDM in superficial suppurative skin and soft tissue infections.

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To study current situation of pathogenic bacteria and their drug resistance to macrolide antibiotics in the otorhinolaryngological infections, 609 strains diagnosed as pathogen derived from 463 patients were collected from cohospitals or institutions during the period of 1980-1983.
The results obtained were as follows:
1. Gram-positive cocci (GPC) was dominant (410 strains) and major species wereS. aureus (135 strains), S. pneumoniae (81 strains), S. epidermidis (68 strains) and S. pyogenes (65 strains). In Gram-negative bacteria giving 147 strains and 43 strains, of anaerobes prevailing species were H. influenzae, P. aeruginosa andPeptostreptococcus spp.
2. Representative species in the diseases were S. aureus (26.6%), S. epidermidis (24.5%), and P. aeruginosa (12.8%) in acute otitis media, S. aureus (34.4%), S. epidermidis (17.7%) and P. aeruginosa (14.6%) in acute exacerbation of chronic otitis media, S. epidermidis (17.0%), S. aureus (16.1%) and H. influenzae (13.4%) in acute paranasal sinusitis, S. pyogenes (29.1%), S. pneumoniae (19.6%) and S. aureus (15.1%) in acute tonsillitis.
3. Although most of isolates were susceptible to macrolides, 62 resistant strains to macrolides were found in 501 strains and the resistant rates were 26.7% in S. aureus, 23.1% in S. epidermidis and 6.5% in S. pyogenes. The resistant pattern was somewhat different against each macrolides, resistant strains giving over 100μg/ml in MIC were 55/62 in erythromycin, 35/62 in josamycin and midecamycin and 7/62 in TMS-19-Q, a new macrolide.

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In order to compare the clinical efficacy and safety of TMS-19-Q·GC tablet (TMS) with josamycin tablet (JM) in acute tonsillitis, the double blind trial was carried out with the daily dosage of 200 mg × 3 in TMS and 400 mg × 3 in JM.
Number of cases evaluated for clinical efficacy were 154 cases (73 treated with TMS and 81 treated with JM). The effective rating of TMS and JM were 89.0% and 88.9% judged by doctors in charge, and 82.2% and 85.2% judged by committee respectively. Bacteriological effects were satisfactory to yield the eradica-tion rates of 93.8% in TMS and 94.7% in JM.
Number of cases evaluated for safety were 199 cases (101 treated with TMS and 98 treated with JM). The incidence of side effect was 4.0% (4/101) in TMS and 5.1% (5/98) in JM and most of them were mild gastro-intestinal disorders.
Number of cases evaluated for utility were 156 cases (74 treated with TMS and 82 treated with JM). The usefulness rates were 85.1% in TMS and 86.6% in JM.
There was no significant difference between TMS and JM, in clinical effect, bacteriological effect, safety and utility.
From these results, daily 600 mg dosage of TMS was as useful as daily 1,200 mg dosage of JM in the treatment for acute tonsillitis.

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Clinical efficacy and safety of TMS-19-Q·GC tablet (TMS), a new macrolide antibiotic preparation, were compared with those of josamycin (JM) in the treatment of acute odontogenic infection under multicentered double-blind controlled study at the daily dosage of 600 mg of TMS or 1,200 mg of JM. The results obtained were as follows:
The patients entered into the study were 265 cases and 112 in TMS group and 111 in JM group were adopted to evaluate for the efficacy. The evaluation was made by 2 ways i.e. changes in total clinicalscores of the symptom and the doctors assessment. Efficacy rating of TMS and JM were 81.3 and 82.0% judged by the score and 73.2 and 77.5% judged by doctors in charge respectively.
In the cases with 15 to 20 of total scores at the initial visit, considered to be suitable for the evaluation of antibiotics, the efficacy rating of both drugs were 86.7% in TMS and 84.6% in JM.
Organisms were isolated from 34 cases in TMS and 40 in JM and the clinical effectiveness in those cases were almost the same.
Slight adverse reactions were observed in 6 cases (4.6%) of TMS group and 1 (0.8%) of JM. In 3 cases (4 incidences) of TMS group and 1 of JM slightly abnormal laboratory findings were found. On the statistical analysis of the data regarding efficacy, safety and usefulness, both drugs had no significant difference.
From these results, TMS was considered as effective as JM in the treatment of acute odontogenic infec-tion at a daily half doses of JM.

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