ABSTRACT
OBJECTIVE: To assess the effect of ranitidine on cellular immune response (and postoperative infective morbidity) in a homogeneous group of patients. DESIGN: Prospective randomized controlled trial. SETTING: University hospital, Italy. SUBJECTS: 42 patients about to undergo curative resection for carcinoma of the colon, rectum, or stomach. INTERVENTIONS: Cell mediated immunity was tested 3 days before, and 4 days after, operation by reactions to 7 recall antigens (Multitest, Merieux). 21 patients were randomly allocated to receive ranitidine 100 mg twice daily intravenously from the day before operation until the third postoperative day. MAIN OUTCOME MEASURES: Comparison of the number of reactive patients and number of positive antigens before and after operation; and correlation between reactivity and incidence of postoperative infective complications. RESULTS: The median (range) skin test scores preoperatively were: ranitidine group 8.5 (0-17), and control group 10 (0-19). The postoperative figures were 7 (0-28) and 4.5 (0-15.5) respectively. The corresponding numbers of positive antigens were 1 (0-4) and 3 (0-4) compared with 1 (0-5) and 1 (0-3). The changes in the scores did not seem to be influenced by blood transfusion, serum albumin concentration, age of the patient, or type of tumour. Two patients died in the ranitidine group (pulmonary embulus, n = 1, necrotising pancreatitis, n = 1) and there were 4 wound infections. There were no deaths in the control group, one intra-abdominal abscess, and 8 wound infections. Median hospital stay was similar, 10 (8-16) in the ranitidine group, and 11 (5-20) in the control group. CONCLUSION: Ranitidine had a beneficial effect on cell-mediated immunity as it seemed to prevent the usual postoperative reduction in reactivity, but there was no significant difference in the incidence of infective complications though it was lower in the ranitidine group.
