肺炎, 肺化膿症を対象としたAmoxycillinと Ampicillinの臨床効果比較試験成績

抄録

One of the characteristics of amoxycillin is said that its absorbency from digestive tract is better than that of ampicillin, and that the blood concentration of amoxycillin is nearly twofold as that of ampicillin. In the purpose to investigate how this good absorbency reflects on the clinical effect, 16 institutions throughout the country have performed the comparative test of the effectiveness by 3 administration methods; amoxycillin 1 g per day, amoxycillin 2 g per day, and ampicillin 2 g per day.
The treated patients consisted of 95 cases of pneumonia and 8 cases of pulmonary purulent inflammation. Having excluded the drop out cases due to various reasons, a statistical analysis was made on the results obtained from cases of pneumonia amoxycillin 2 g in 30 cases, amoxycillin 1 g in 24 cases, and ampicillin 2 g in 16 cases.
The items tested were the symptomatic findings as temperature, pulse rate, respiratory frequency, cough, sputum (amount, Property, and odour), dyspnoea chest pain, breast râles, cyanosis, dehydration symptom and blood pressure, and the clinical test results as thoracic X-ray finding, arterial blood gas, leukocyte count and its classification, erythrocyte count, hemoglobin, hematocrit value, erythrocyte sedimentation rate, CRP, and electrocardiogram. The improvement degree classified by each item above described, was sought from the values obtained before the administration of drug, after 3 days of administration, and after 7 days of administration, and the investigation was made to confirm whether there is a significant difference among three drug methods. As to the finding of thoracic X-ray, the films of each case were collected at a certain place, and they were compared and judged following a fixed standard by a small committee composed of several doctors.
The investigation was made to confirm whether there is a significant difference among three drug methods by comparing the above improvement degrees classified by cases, the judgment results of clinical effects by each physician in charge, and the judgment results of effects in each case by the effect judgment committee composed of several doctors.
The effects classified by causative bacteria were not compared, as there were too few cases in which causative bacteria were determined exactly. The examination was made separately on the cases in which Mycoplasma pneumonia was diagnosed by measuring the value of Mycoplasma CF antibody.
Results : No significant difference was observed among three drug groupes drugs on the improvement degrees of each symptom and finding, although the only degree of CRP tended to be the best with 2 g of amoxycillin at a risk ratio of 10%, while the worst with 2 g of ampicillin. No significant difference was noticed in all the improvement degrees of other symptoms and findings.
No significant difference was observed among three drug groups on the results of effect judgment by each physician in charge and that by effect judgment committee either with all cases and with the cases excluded Mycoplasma pneumonia.
No significant difference was noticed as well among three drug groups on the appearance frequencies of side effects such as digestive tract disorder, allergic reaction, hepatic disorder and renal disorder.
The comparative investigation was not performed on pulmonary purulent inflammation, as the cases of the disease were too few.