A comparative study of cefotaxime sodium versus a combination of cefapirin and gentamicin in the prophylactic treatment of patients undergoing cholecystectomy

Abstract

This was a randomized open evaluation of claforan vs. combination treatment of cefapirin + gentamicin. Patients taking part in the study were randomized in 3 parallel groups: 3 x 1 g claforan given during a period of 24 h (regimen I) was compared to 1 x 1 g claforan given at the time of incision (regimen II) and to a combination of cefapirin + gentamicin given in divided doses for 5 days (regimen III). Sixty-five patients (31 males and 34 females) aged between 23 and 76 years, who underwent cholecystectomy, were included in the study. There were no significant differences between the study groups in terms of sex, age, height, weight, diagnosis, aggravating factors and clinical condition of patients. Sixty of sixty-five patients noted "cholelithiasis" as diagnosis. The majority of patients documented an acute exacerbation of chronic condition. Twenty-three patients documented concomitant diseases/conditions or aggravating factors. The most frequent were: Diabetes mellitus, jaundice and clonorchiasis. During the study no additional administration of antibiotics or other concurrent treatment was recorded. Tolerance of the test substances was noted as "good" by 63 patients and satisfactory in 2 patients. In 3 patients (one patient in each treatment group) a postoperative wound infection was documented. One patient from regimen II with wound infection, therefore, received more than 1 g claforan. Postoperative hemoglobin decreased in all 3 groups (p less than 0.05). BUN decreased in the regimen group I (p less than 0.05) and increased together with creatinine in the group of regimen III (p less than 0.05). No side effects were documented in any treatment groups. The use of a single or three doses of claforan was more convenient and simple than the combination regimen. Less laboratory adverse effects (renal function) were also noted in claforan treated patients than the combination of cefapirin + gentamicin group.