Comparative test by double blind method were conducted by administering 2 g of CPZ and 4 g of CEZ as a control per day for comparing the actions of both the medicines in order to ascertain the efficacy and safety of CPZ against respiratory tract infection.Clinical examination indicated the effectiveness of CPZ in 75.2% of the cases, while CEZ proved effective in 56.5% of the cases, and showed that CPZ was significantly advantageous over CEZ.CPZ showed a signifficant advantage over CEZ against the individual diseases. In the cases involving bacterial pneumonia, CPZ was effective in 86.2% of the cases, while CEZ was effective in 64.4% and in the cases involving chronic respiratory tract infection, CPZ showed an efficacy of 63.6%, while CEZ was effective in 40.0% of the cases.As regards the bacteriological effects of the medicines, CPZ showed a significantly high efficacy in Gram-negative bacteria. CPZ was effective in 70.6% of the cases, while CEZ was effective in 54.5%, even though Pseudomonas, Enterobacter and H. influenzae having no or very little sensitivity to CEZ were excluded from consideration.No significant difference was observed between the two medicines in the manifestation of any side effect or abnormality in laboratory findings. All of such side effects and abnormalities that were observed were merely of the type usually observed with medicines composed of β-lactam.The utility of CPZ was significantly superior to that of CEZ.In view of the foregoing results, CPZ would be sufficient for effective treatment of respiratory tract infection.
The clinical efficacy and safety of Cefminox (CMNX, MT-141), a new cephamycin, was objectively compared with that of cefotaxime (CTX) in patients with chronic respiratory tract infections, bacterial pneumonia or lung abscess in a well controlled study. Patients over 15 years old with apparent clinical signs and symptoms were administered CMNX or CTX intravenously b.i.d. for 14 days at a daily dose of two grams. The parameters assessed were clinical efficacy, rate of improvement of clinical signs and symptoms, bacteriological response, appearance of side effects, abnormal laboratory findings and clinical usefulness.Clinical efficacy was analyzed statistically in 218 patients (108 administered CMNX, 110 administered CTX) and 42 patients out of a total 260 patients were excluded. Side effects were analyzed in 243 patients (CMNX: 121, CTX: 122) and laboratory abnormalities were also analyzed in 232 patients (CMNX: 116, CTX: 116) in whom judgement was possible.The following results were obtained.1. On the basis of committee judgement the overall clinical efficacy rate was 76.6% for CMNX group and 67.0% for CTX group for total cases. The corresponding figures for patients with pneumonia and lung abscess and those with respiratory tract infections other than pneumonia and lung abscess were 78.9% for CMNX group and 63.2% for CTX group, and 74.0% for CMNX group and 73.2% for CTX group, respectively.2. As to improvement rate of clinical signs and symptoms, significantly higher rate was obtainedwith CMNX in CRP at day 3 in patients with pneumonia and lung abscess, and ESR on day 14 in patients with respiratory tract infections other than pneumonia and lung abscess.3. The bacteriological elimination rate of causative organisms was 91.5% out or 47 pateints treated with CMNX and 80.8% out of 52 patients treated with CTX. No significant difference was observd between the two drug groups.4. Some side effects were observed in 6 patients out of 121 in the CMNX group and 9 out of 122 in the CTX group, with no significant intergroup difference in incidence of these side effects.5. Some abnormal laboratory findings were observed in 26 (22.4%) out of 116 patients in theCMNX group and 42 (36.2%) out of 116 in the CTX group, the difference between these two groups being significant. The observed laboratory abnormalities included eosinophilia in 6 (5.2%) for CMNX group and 16 (13.8%) for CTX group. There was significant difference in incidence of eosinophilia.6. It was found that the clinical usefulness was rated as very useful for 61 patients (55.0%) and useful for 20 patients (18.0%) out of 111 patients in the CMNX group, while in the CTX group the clinical usefulness was rated as very useful for 43 patients (39.1%) and useful for 27 (24.5%) out of 110 patients for total cases. For patients with pneumonia and lung abscess the clinical usefulness was rated as very useful for 34 patients (56.7%) and as useful for 11 (18.3%) out of 60 in the CMNX group and as very useful for 25 patients (36.8%) and useful for 16 (23.5%) out of 68 in the CTX group. In these cases significant difference was observed between the two drug groups (p<0.05), while no significant difference was observed for patients with respiratory tract infections other than pneumonia and lung abscess.From the above results it was concluded that CMNX is a more useful antibiotic than CTX for the treatment of respiratory tract infections.
The therapeutic effectiveness and side effects of CLDM-P were investigated in a series of double blind studies using LCM as control in the treatment of acute pneumonia. These studies were conducted in 25 institutions throughout the country on 119 cases. Twenty-five (25) out of these cases were excepted from evaluation and 94 cases were evaluated. A dose of 600 mg of the compounds were dissolved in 200-300 ml of aqueous sugar solution or normal saline solution and given by drip infusion over an hour twice a day with a 12 hours interval.Evaluation was made on 50 patients treated with CLDM-P and 44 with LCM. General improvement was shown in 88.0% of the CLDM-P group and 93.2% of the LCM group; both drugs proved highly effective, with no significant difference between them.As for symptoms or clinical findings, the CLDM-P group showed significantly better improvement or improving tendency than the other in some evaluation items, probably because CLDM has higher activity than LCM. No significant difference was noted between two treatment groups in the incidences of side effects and abnormal laboratory values. It may be concluded that CLDM-P is effective in treating acute pneumonia.
The efficacy and safety of cefotaxime (CTX, HR 756) and cefazolin (CEZ) were objectively evaluated in a well-controlled study of respiratory tract infections at 38 institutions in Japan. Patients with pneumonia or chronic respiratory tract infections were given intravenous drip infusions of either CTX or CEZ, randomly assigned, at 4 g per day in two divided doses for, in principle, 14 days. The therapeutic efficacy, adverse reactions, and usefulness of the drugs were evaluated by intergroup comparison.The following results were obtained:1.There was no statistically significant intergroup difference in therapeutic efficacy.2.Among patients in which the causative organisms were able to be determined, the bacteriological efficacy of CTX, in terms of eradication rate, was significantly superiorto that of CEZ.3.There was no significant intergroup difference in the incidence of side effects4.There was no significant intergroup difference in usefulness.
The clinical effectiveness and side effects of TMS-19-Q (TMS) in the patients with respiratory tract infections, mainly mild bacterial pneumonia, mycoplasmal pneumonia and PAP, were compared with those of midecamycin (MDM) by means of double-blind controled stiudy. TMS or MDM was orally administered 600 or 1200mg per day respectively. Total 185 cases (94 in TMS and 91 in MDM) were analyzed and the results obtained were as follows:Overall clinical efficacy ratings of TMS and MDM groups were 84.4% and 90.6% in pneumonia, and 85.7% and 78.9% in airway tract infections. Bacteria isolated and defined as the pathogen were 28 strains mainly consisting of Streptococcus pneumoniae and Haemophilus influenzae.The side effects were observed 1.1% in TMS group and 4.6% in MDM group, and abnormal changes of laboratory findings were noted 15.2% in TMS and 13.2% in MDM.In respect to clinical effectiveness and side effects, statistical analysis showed that the data on both drugs were not significantly different.From these results, daily 600mg dosage of TMS was as useful as daily 1200mg dosage of MDM in the treatment for mild and moderate respiratory tract infections.
For the purpose of evaluating the efficacy, safety and usefulness of ceftriaxone (CTRX), a cephem antibiotic, in respiratory tract infections, a well-controlled comparative study was carried out with cefotaxime (CTX) for a reference.One (1) gm of either CTRX or CTX was administered by drip infusion twice a day for 7 to 14 days in principle into patients with chronic bronchitis and diffuse panbronchiolitis aggravated with infections, chronic respiratory diseases accompanied with infections in the lower respiratory tract like bronchiectasis, bronchial asthma, pulmonary emphysema, pulmonary fibrosis, obsolete pulmonary tuberculosis, lung cancer, etc. and bacterial pneumonia.Results were as follows:1) Clinical efficacy: The efficacy rate was 81%(100/124) with CTRX and 74%(94/127) with CTX, with no statistically significant difference between the two drugs. The efficacy rate in the moderately infected patients was 81%(54/67) with CTRX and 62%(37/60) with CTX, CTRX being significantly superior to CTX.If cases infected with P. aerugirrosa were excluded, CTRX was higher in efficacy than CTX.2) Bacteriological effects: The bacterial eradication occurred in 35 patients out of 44 (80%) with CTRX and in 42 out of 54 (78%) with CTX, with no statistically significant difference. There was no significant difference in efficacy between the two, whether according to strains of isolates or types of infections (single or mixed).3) Adverse reactions: The incidence of adverse reactions was 10.5%(14/133) to CTRX and 6.3%(9/143) to CTX, no statistically significant difference being noticed. The incidence of skin rash was significantly higher with CTRX. In the clinical laboratory test, abnormal signs were observed in 37 out of 130 (28.5%) with CTRX and in 36 out of 137 (26.3%) with CTX, no significant difference being detected.4) Usefulness: CTRX was evaluated to be very useful in 3 out of 133, useful in 94, slightly useful in 13 and useless in 20. There were 3 unevaluable cases.CTX was very useful in 2 out of 143, useful in 90, slightly useful in 14 and useless in 28. Evaluation was impossible in 9 cases.There was no significant difference in usefulness between CTRX and CTX.5) Conclusion: From the above, CTRX was considered to be clinically very useful for the treatment of infections of the lower respiratory tract like chronic respiratory tract infections and pneumonia.
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.
