Cefpiramide (CPM) was administrated intramuscularly to 27 cases of gynecological infections to evaluate its clinical efficacy and safety and the following results were obtained.
1. CPM was effective to all the cases of gynecological infections, and excellent was seen in 14 cases and good was seen in 13 cases.
2. CPM eliminated 75% of clinical isolates.
3. Laboratory tests were performed to blood samples and functions of liver and kidney before and after CPM treatment.
Elevation of GPT was observed in 2 cases but required no treatment.

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A new cephalosporin, cefpiramide was administered to 12 patients with gynecological infections and the clinical effects obtained were good in 11 cases and poor in 1 (effective ratio: 91.7%).
No side effects were observed except for eruption in 1 case, however, the relationship between the drug and eruption was unknown.
No abnormalities were observed in hematological, hepatic and renal tests.

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One hundred and nine patients with infection accompanying hematologic disorders including leukemia and lymphoma were treated with aztreonam (AZT). Of the 90 patients in whom the efficacy could be evaluated, 17 (18.9%) responded markedly and 29 (32.2%) moderately, the effective rate being 51.1%.
The efficacy rate classified according to infections was 25% in septicemia, 46.3% in suspected septicemia, 57.1% in pneumonia and 100% in urinary tract infection. The efficacy rate to the Gram-negative bacteria was 78.9% and to the Gram-positive bacteria was 20.0%. In 4 (66.7%) out of 6 patients in whom P. aeruginosa was the causative organism, AZT was effective. The efficacy rate was 52.2% in the 23 patients whosecausative organisms were identified and 50.7% in 67 patients whose causative organisms were not identified.
There was no significant difference in the efficacy rate between the patients who failed to respond to prior antibiotic therapy (53.6%) and those treated with AZT from the beginning.
The initial neutrophil count did not affect the efficacy rate.
Side effects which might have been caused by AZT were eruption and fever in 4 patients. Hepatic disorders and eosinophilia were observed in 7 patients. However, the relationship between AZT and these abnormal findings was not established.
These results indicate that AZT is an effective and safe antibiotic for the treatment of infections accompanying hematologic disorders.

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A study of serum and atrial muscle concentration of ceftizoxime (CZX) was performed in 28 adult patients having cardiac surgery. Patients were administrated a single dose of CZX 2g intravenously. Serum and atrial muscle samples were obtained at suitable intervals before extracorporeal circulation, and assayed CZX concentration.
Serum concentrations were 54.5μg/ml at 60 minutes, and 21.8μg/ml at 180 minutes. Atrial tissue levels were 29.9μg/g at 60 minutes, and 14.8μg/g at 180 minutes. Tissue/serum concentration ratio was high value; 0.549 at 60 minutes, 0.679 at 180 minutes.
Judging from its favorable transfer into atrial muscle and MIC₈₀ against the suspected pathogen, CZX seemed to be clinically useful in the treatment of infection after cardiac surgery.

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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 2g of ASPC or 2g of SBPC was administered to patients by intravenous drip infusion twice a day for 7 days.
The following results were obtained:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.

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Fundamental and clinical studies on S 6472 were carried out and following results were obtained.
1. Serum concentrations after single oral administration showed 2 peaks at 1 or 2 hours and 5 or 6 hours in the cases with normal meal. Namely this drug has much more maintenance of serum concentration than normal cefaclor.
2. In maintenance of serum concentrations after the administration, there were no obviously difference between normal and heavy meal.
3. S 6472 was administered twice a day to 7 patients with various infections (bronchopneumonia 2 cases, acute bronchitis 1 case, purulent tonsillitis 4 cases) and clinical responses were all effective results. Pathogenic bacteria of S. aureus, S. pneumoniae, S. pyogenes and H. influenzae were completely eliminated in all cases.
4. No significant side effects were observed.
On the above results, this administration method of S 6472 twice a day was considered to be good response against mild or moderate bacterial infections in children.

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A comparative double blind study of lenampicillin (LAPC, KBT-1585) and talampicillin (TAPC) was carried out in order to objectively evaluate efficacy, safety and utility of LAPC in treatment of 238 patients with oral infections.
1. Cases accepted by the Central Committee for evaluation of efficacy and utility were 218, consisting of 101 of the LAPC group and 117 of the TAPC group; safety were 234, consisting of 110 of LAPC and 124 of TAPC. Clinical effectiveness as rated by attending doctor was 84.2% for the LAPC group and 82.9% for the TAPC group. The clinical utility rating was 82.2% in the LAPC group and 82.1% in the TAPC group, showing no significant difference between the 2 drugs.
Adverse reactions were found in 6 cases (5.5%) in the LAPC group and 5 cases (4.0%) in the TAPC group, showing no significant difference between the 2 drugs.
Cases accepted by the controllers for evaluation of efficacy and utility were 236, consisting of 111 cases of LAPC and 125 cases of TAPC. Those for safety were 236, consisting of 111 cases of LAPC and 125 of TAPC. The clinical effectiveness rating was 77.5% in the LAPC group and 79.2% in the TAPC group. Clinical utility rating was 75.7% in the LAPC group and 78.4% in the TAPC group.
Rate of adverse reactions was 5.4% in the LAPC group and 4.0% in the TAPC group, showing no significant difference between the 2 drugs.
2. Cases evaluated for efficacy according to numerical rating on the 3rd day were 200 cases, consisting of 93 of LAPC and 107 of TAPC. The effectiveness rate was 83.9% in the LAPC group and 95.3% in the TAPC group, showing a significant difference between the 2 drugs.
On the other hand, taking into consideration evaluation scores of the 5th day, the effectiveness rate was 88.7% in the LAPC group and 96.1% in the TAPC group, showing no significant difference between the 2 drugs.
3. The effectiveness rate in cases of isolated organisms was 84.9% in the LAPC group and 79.7% in the TAPC group, showing no significant difference between the 2 drugs.
4. Adverse reactions were mostly of gastrointestinal origin. Symptoms were not serious and disappeared soon after administration was discontinued or immediately after administration was completed.
5. Abnormal laboratory findings were observed in 9 cases, consisting of 3 in the LAPC group and 6 in the TAPC group, but none were serious.
The results indicated that LAPC was almost equal to TAPC in utility evaluations in the treatment of oral infections.

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Clinical efficacy and safety of SM-4300, a newly developed human immunoglobulin preparation for intravenous use, were evaluated in 11 patients with severe infectious disease which are resistant to antibiotic therapy in the combined use with the antibiotics.
1. Clinical effects of SM-4300 were excellent in 1 case, good in 5 cases, fair in 1 case, poor in 1 case and unevaluable in 3 cases. The efficacy rate was summarized as 75%.
2. Bacteriological responses were eradicated in 1 case and unknown in 10 cases.
3. No side effects and abnormal laboratory findings due to SM-4300 were observed in this investigation.

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A newly developed human immunoglobulin preparation for intravenous administration (SM-4300) was applied to the severe bacterial infections in the field of internal medicine.
Nine cases of severe infections were treated with SM-4300 and antibiotics combination. Clinical effects of SM-4300 were excellent in 1 case, good in 5, poor in 1 and unknown in 2. The efficacy rate was summarized as 86%, and no side effects were observed.

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Unmodified intravenous dried ion-exchange resin treated human normal immunoglobulin, SM-4300, was administered to 4 patients with severely intractable infectious diseases. Obvious antipyretic effect, opsonic effect and investigational findings on healing are not observed. However, in both subjective and objective clinical effects, we obtained the following test results, that is, 1 case of effective and 2 cases of rather effective. No side effects by SM-4300 were observed.

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A new human gamma-globulin for intravenous use, SM-4300, was administered to 13 patients with infectious diseases.
Five grams of SM-4300 was drip infused to each patient whose infection was not controlled by previous administered antibiotics. All of 13 patients had primary diseases besides infections. Thirteen patients were composed of 4 with pyelonephritis, 2 with pneumonia, 1 with bronchopneumonia, 1 with bronchitis, 1 with pyothorax, 2 with sepsis and 2 with cholecystitis.
The results obtained were good in 3 cases, fair in 2 cases and poor in 7 cases. The results of a patient was not determined.
No side effect was found including in laboratory findings.

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A newly developed human immunoglobulin preparation for intravenous use, SM-4300, has been studied in Nagoyashi-Koseiin Geriatric Hospital on the effects of 14 cases of the various severe infections in the combined use with antibiotics.
The following results were obtained:
1. The patients had many kinds of underlying diseases. Cerebral vascular disease was the most frequent underlying disease, and found in 79% of 14 patients, followed by heart failure.
2. Among them 8 cases were chosen for the clinical evaluation by doctors in charge. SM-4300 effected good in 1 case, fairly 3 and poorly 4. The efficacy rate was summarized as 12.5%.
3. In all cases, there were no significant side effects regarding symptoms, hematological analysis, renal and liver functions.
Based on these results, SM-4300 may be safe and a drug worth to try in treatment of severe infections.

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Eighteen cases of various infections, mostly having severe underlying diseases and showing no or insufficient responses to antibacterial chemotherapy, were treated with additional intravenous drip infusion of SM-4300 (2.5 or 5g, once a day, for 1-3 days). Eight of the cases were excluded from the assessment of the effectiveness, as they died too early, or as their fever was supposed to have been “tumor fever” retrospectively.
SM-4300 was found to be effective in 2 out of 5 septicemia cases, in 3 pneumonia cases, including 1 complicated with septicemia, out of 4, and also in 1 patient with liver abscess, as well as in another of meningitis caused by Campylobacter fetus; i. e. the efficacy rate was estimated as 60% in total.
Any side effects attributable to SM-4300 were observed in none of the 18 cases.
These results obtained seem to endorse the usefulness of the preparation.

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SM-4300, a newly developed human immunoglobulin for intravenous use, has been studied for the safety and effectiveness/efficacy in the 7 patients with severe respiratory infections and a patient with fever of undetermined origin.
1. Severe infections in the patients considered of 3 cases of pneumonia, 2 of obstructive pneumonia due to lung cancer, 2 of diffuse panbronchiolitis and 1 of fever of undetermined origin. Clinical effects of SM-4300 were excellent in 1 case, good in 1, fair in 2 and poor in 4. The efficacy rate was 25.0%.
2. The appearance of subjective and objective clinical side effects and abnormal laboratory findings related to SM-4300 administration were not noted.

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A new drug of human intact immunoglobulin, SM-4300 was applied to the acute respiratory infections in the field of internal medicine. SM-4300 was administered intravenously for 1 or 3 days at a daily dose of 2.5g to 4 patients suffering from respiratory infections.
We have obtained the results as follows.
Clinical effects of SM-4300 were good in 2 cases, fair in 1 case, unknown in 1 case, and no side effects were observed.

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Use of SM-4300, which is a newly developed human immunoglobulin preparation for intravenous administration, has clinically been evaluated in the patients with severe or intractable bacterial infections.
Of total 13 cases of the admitted patients at the 1st department of internal medicine, faculty of medicine, Kyushu university, 10-pneumonia case were associated with blood diseases like acute myelocytic leukemia (AML) and multiple myeloma (MM), and in addition, with other underlying diseases like lung cancer and bronchiectasis, 1 was prosthetic valve endocarditis, 1 cholecystitis associated with pericarditis and 1 fever of undetermined origin (FUO). SM-4300 of 5g single bolus or 3 daily doses of 2.5g per day were infused with chemotherapy drugs precedingly administered for more than 3 days and the results were evaluated; good in 4, fair 4, poor 2 and unknown 3, and the efficacy rate was 40%.
Bacteriologically, the results were decreased in 1, persisted 1 and the majority was unknown. Observed were no side reactions nor the changes in clinical examination variables incurred by this drug.
It is therefore considered that SM-4300 is of use for the treatment of intractable bacterial infections when used with antibiotics.

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With the recent development of new potential antibiotics, it has become easier to treat patients with common bacterial infections. However we find it difficult to handle severe infections due to opportunistic pathogens, developed in the so-called immunocompromised patients.
SM-4300 is a newly developed intravenous human gamma-globulin, which is said to be intact without conventional enzyme-treatment and sulfonization. SM-4300 is also free from large molecules of aggregated gamma-globulin.
SM-4300 was administered in combination with antibiotics to 2 patients of severe respiratory infections, having refractory underlying diseases.
Case No.1 was a 65-year-old female with bronchopneumonia, who had been suffering from pulmonary fibrosis, chronic bronchitis, chronic congestive heart failure and tricuspid insufficiency for several years. During her hospitalization because of these diseases, she developed cough with slight sputum and exertional dyspnea accompanied by high body temperature of 38° on January 1983. Chest X-ray revealed infiltration in the right lung field which was compatible with bronchopneumonia. SM-4300 of 5g was added intravenously on 5th day after 4 day-cefotiam treatment with no improvement. High body temperature subsided and laboratory data became normal around 3 days after single SM-4300 injection.
Case No.2 was a 68-year-old male patient of chronic bronchitis with chronic pulmonary emphysema and bronchial asthma.
Around the end of May 1983, he complained of dyspnea on exertion and had mucopurulent sputum, more than 100ml daily, from which Pseudomonas aeruginosa was cultured in large number. He was afebrile.
Intravenous cefsulodin (CFS), 2-4g daily started to eradicate P. aeruginosa. SM-4300 of 2.5g was injected daily for consecutive 3 days from 7 to 9, June, as no reduction of sputum volume was noted 4 days after CFS therapy.
Transient reduction of sputum in amount and P. aeruginosa in number were obtained, however dyspnea did not improved afterwards.
There were no remarkable side effects.
SM-4300 is considered to be very useful drug in the treatment of infections developed in immunocompromised conditions.

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Twenty-six patients with bacterial infections, mainly respiratory infections, were treated with newly developed gamma-globulin preparation (SM-4300), as a combination therapy with some antibiotics. The result was as follows.
1. Clinical effects of 18 cases evaluated were excellent in 1 case (5.6%), good in 10 (55.6%), fair in 4 (22.2%) and poor in 3 (16.7%).
2. No remarkable adverse reactions and abnormal value in laboratory data due to administration of SM-4300 were observed.
3. Significant changes of complement system before and after administration of SM-4300 were not observed.
4. It was considered that SM-4300 was effective as a combination therapy with some antibiotics for the treatment of severe or refractory bacterial infections.

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The intravenous human gamma-globulin (SM-4300) was used with antibiotics for 9 patients who had severe bacterial infections resisted to the antibiotics. All of these patients had underlying hematological diseases, acute leukemia, aplastic anemia, malignant lymphoma and pure red cell aplasia. In many of the cases the leucocyte counts were extremely decreased.
In 11 episodes of the infections, 4 cases were successfully treated by SM-4300 and 4 cases were not. No adverse reaction was found.
It seems that the use of SM-4300 is effective for the treatment of these severe infections.

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In vitro experiment with phagocytic and bactericidal activity of human neutrophils, SM-4300 augmented opsonic activity against Pseudomonas aeruginosa.
After a single dose of 200mg/kg body weight SM-4300 to a child with common variable immunodeficiency (CVI), serum IgG concentration/time curve was similar to that after PEG-Ig administration.
In combination therapies with SM-4300 and antibiotics in 8 children with bacterial infections, beneficial efficacy of SM-4300 was observed.
There was no adverse reaction in 16 times injections to 9 children with bacterial infections and 5 times to a child with CVI.

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Ten cases of bacterial infections, showing no or insufficient response to antibacterial chemotherapy, were treated with a new intravenous human γ-globulin (SM-4300).
SM-4300 was administered intravenously (68-172mg/kg/day) once a day for 1-3 days.
SM-4300 was effective in 6 out of 8 pneumonia cases and also in 1 out of 2 septicemia cases. In none of the 10 cases, any side effects were observed.

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Six cases of severe infections in pediatrics, which showed no or insufficient responses to treatment with antibiotics, were treated with additional intravenous infusion of SM-4300. Results were as follows.
1. Three cases of bacterial infections with high fever, showing no response to chemotherapy, were treated with SM-4300 (68-135mg/kg). Administration of SM-4300 resulted in defervescence, decreasing pain and swelling and showing a trend for improvement in CRP values.
2. Administrations of SM-4300 (61-100mg/kg) against pleurisy caused by Mycoplasma were effective in defervescence and improvement in chest findings.
3. Clinical effects of SM-4300 were excellent in 2 cases, good in 3 and fair in 1.
4. In this study, no clinical side reactions nor abnormal laboratory values in blood, liver or renal functions were observed.

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SM-4300, a new developed immunoglobulin preparation with ion-exchange treatment, was used intravenously for 12 infectious diseases. These 12 cases (under 10 years old) were including 4 sepsises, 3 pneumonias, 1 pyothorax, 1 ventriculitis, 1 purulent meningitis, 1 aseptic meningitis and 1 cellulitis.
To evaluate the effect of SM-4300, 2 cases were excluded from evaluation bacause of blood transfusion or immediately death. Since antibiotics were used at the same time, it was surely difficult to evaluate the effect of SM-4300. In 10 cases, 2 cases were excellent effective, 4 cases were fairly effective and others were no effective. Including fairly effective cases, the rate of efficacy was 60%.
In all cases, there were no significant side effects regarding clinical findings and laboratory examinations.
SM-4300 may be available for severe infectious diseases with antibiotics therapy.

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The authors have carried out the laboratory and clinical studies of SM-4300 and obtained the following results.
1. Serum level of IgG before and after administration of SM-4300 was observed in a case with agammaglobulinemia. The serum level reached the peak at 30 minutes after administration of SM-4300 and the half-life was about 25 days.
2. SM-4300 enhanced the opsonic activity of human neutrophils to Pseudomonas aeruginosa in vitro.
3. In substitution therapy against agammaglobulinemia, the clinical effect of SM-4300 was observed.
4. Four patients with severe infections were treated with SM-4300 and antibiotics and evaluated. Clinical effects of SM-4300 in combination therapy with antibiotics were excellent in 2 cases, good in 1 case and poor in 1 case. The subjective and objective clinical side effects and abnormal laboratory findings were not noted.

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SM-4300, a newly developed human immunoglobulin for intravenous use, was administered to 6 patients in the pediatric field.
Two cases out of 3 cases with immunodeficiency syndrome were studied in terms of absorption and excretion of SM-4300 and all of them were observed effect of preventive bacterial infection.
Three cases were administered combination therapy with SM-4300 and antibiotics. Two cases were pneumonia and 1 case was pleurisy.
The following results were obtained.
1. Two cases with immunodeficiency syndrome were observed serum levels of immuno gammaglobulin before and after administration of SM-4300. At 2-3 hours after the administration of SM-4300, the serum levels got to peak and the half-lives were 22.1 days and 22.6 days, respectively. The half-lives of SM-4300 were similar to plasmin or polyethylene glycol treated and sulfonated human immunoglobulin.
2. The clinical effects of substitution therapy against 3 patients with immunodeficiency syndrome were observed.
Through the administration of SM-4300 every 18 to 21 days for 6 months, 1 case was doing well.
One case with chronic bronchitis and otitis media was hanging in the balance as well as she has been administered other immunoglobulin preparations.
The last case didn't control the serum levels of immunoglobulin because he did not visit a hospital until incidence of infectious disease.

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The human immunoglobulin (SM-4300), which was developed by Travenol Laboratories, Inc. U. S. A., was used with antibiotics on 12 cases of severe surgical infectious disease.
The method of administration and the evaluation of clinical effect of gammaglobulin (SM-4300) were made based upon the criteria of the SM-4300 study group. The clinical evaluation of the effect was classified in 5 grades; excellent, good, fair, poor and unknown.
Three types of administration dose schedules were employed.
Severe surgical infections were 3 cases of postoperative pneumonia, 3 cases of sepsis with pneumonia, 3 cases of peritonitis, 1 case of cholangitis, 1 case of sepsis with perinephritis and 1 case of subphrenic abscess.
Bacterial and immunological examination were also performed before and after the administration of SM-4300.
Evaluable cases were 10 cases out of 12 cases. Clinical effects of the administration of SM-4300 were evaluated as excellent in 1 case, good in 3, fair in 2 and poor in 4.

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A newly developed human immunoglobulin preparation for intravenous use, SM-4300, had been studied in the field of surgery. SM-4300 was administered to 2 patients with severe infection in the combined use with antibiotics. SM-4300 was considered to be a safe and effectively useful drug.
One case with suspicious of septicaemia was excellent response to SM-4300, at a dosage of 2.5 g/day×3, and another case with postoperative diffuse peritonitis was not effective at a dosage of 5.0 g/day×1.
No objective and subjective side effect and abnormal laboratory finding was observed in 2 cases.

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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:
1. 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%.
2. No subjective and objective clinical side effect was observed. No abnormal laboratory finding was observed.
3. 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.

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Clinical efficacy and safety of SM-4300, a newly developed human immunoglobulin, have been studied in 7 episodes of severe infections complicated with advanced cancer.
1. Clinical effect of SM-4300 was good in 1 case, fair in 5 and poor in 1. The efficacy rate was summarized as 14.3%, and the rate including fair response was 85.7%.
2. No subjective and objective clinical side effect was observed and abnormal laboratory findings were not noted.
In conclusion, combination therapy with SM-4300 and antibiotics was considered to be safe and effective against the patients with severe infections complicated with advanced cancer.

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A newly developed human immunoglobulin for intravenous use, SM-4300, purified by cold ethanol precipitation and ion exchange resin, has been studied in the surgery.
SM-4300 has been evaluated clinically against inpatients with severe bacterial and/or fungal infections in the combined use with the antibiotics which are resistant to antibiotic therapy.
Total number of 13 patients affected with various severe infections were treated with SM-4300. Clinical effects of SM-4300 were excellent in 2 cases, good in 6, fair in 3 and poor in 2. The efficacy rate was summarized as 61.5%.
No subjective and objective clinical side effects and abnormal laboratory findings were observed.
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 surgery.

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SM-4300, a newly developed human immunoglobulin for intravenous use, has been evaluated clinically in combination with the antibiotics in the patients with severe bacterial, fungal or viral infections which are resistant to antibiotic therapy in the surgery.
1. Total number of 26 patients affected with various severe infections were treated with SM-4300. Clinical effects of SM-4300 were good in 10 cases, fair in 7 cases, poor in 7 cases and unknown in 2 cases. The efficacy rate was 41.7%.
2. Severe infections in these 26 patients consisted of 14 cases of peritonitis, 5 cases of intrathoracic infections, 4 cases of sepsis suspected and 3 cases others. Twenty-tree patients had underlying diseases, in which 15 cases were patients with cancer.
3. Clinically isolated organisms were obtained from 12 cases, of 26 strains were evaluated for bacterio-logical effects which were eradicated in 10 strains, decreased in 3 and persisted in 13 strains, the eradication rate being 38.5%.
4. The subjective and objective clinical side effects were not noted.

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The beneficial effects of γ-globulin, which were used for agammaglobulinemia and severe infectious disease as an adjuvant or combination therapy in conjunction with antibiotics, are well known.
In this study, a new intravenous human γ-globulin (SM-4300) was administered to 5 patients with bacterial infection and 2 patients with viral infection.
In 4 out of 7 patients (57.1%), several symptoms such as high fever, general fatigue and pain were improved clinically.
Furthermore, there were no side effects due to SM-4300 either in clinical findings or in laboratory examinations.

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SM-4300, a newly developed human immunoglobulin preparation, has been studied for the safety and effectiveness/efficacy in the 16 patients with severe bacterial and/or fungal infections which are resistant to antibiotic therapy.
1. Clinical effect of 16 cases were excellent 1 case, good 4, fair 4, poor 4 and unknown 3. The efficacy rate was 38.5% and the efficacy rate including fair was 69.2%.
2. No remarkable adverse reaction due to administration of SM-4300 were observed.

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SM-4300, a newly developed human immunoglobulin preparation was evaluated in 24 patients with severe bacterial infections and the following results were obtained.
1. The clinical efficacy was excellent in 4 cases, good in 7, fair in 5, poor in 3 and unknown in 5 with the effective rate of 57.9%.
2. No serious side effect nor abnormalities in laboratory findings due to administration of SM-4300 were observed except 1 case with slight elevation of GOT and GPT.

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Intact γ-globulin (SM-4300) was studied for its clinical efficacy in 13 of 23 cases of surgical severe bacterial infections. The drug was administered intravenously either 2.5 g/day for 3 days or 5 g for a day and the results were as follows.
1. Clinical effects of SM-4300 in 13 cases of surgical severe bacterial infections were excellent in 1 case, good in 3, fair in 3 and poor in 6.
2. SM-4300 was effective in all of 5 cases of intraperitoneal abscess.
3. The elevation of serum IgG was observed after the administration of SM-4300 in all cases tested.
4. As to complement, the slight elevation of serum CHSO was observed in the half of cases documented.
5. Clinical side effects were not confirmed in any case. These results suggest that intac γ r-globulin (SM-4300) was effective in combination with antibiotics.

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Evaluation of SM-4300, a new intact gammaglobulin for peritoneal use, about antimicrobial titers and prophylactic effects on bacterial infections in mice was performed. The results are as follows:
1. The antimicrobial titers of SM-4300 against bacteria, protozoa, and virus were almost the same as those of venoglobulin-I, another intact gammaglobulin.
2. The difference in antimicrobial titers among several lots of SM-4300 was unrecognizable.
3. Prophylactic effects of SM-4300 on systemic infections in granulocytopenic mice were remarkable and were comparable to those of venoglobulin-I.
4. About 9% of venoglobulin-I treated mice were died within 24 hours after the injection. On the contrary, no mice was died by SM-4300 treatment.

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