The efficacy and safety of morinidazole combined with appendectomy in treating purulent or gangrenous appendicitis: a randomized, controlled, double-blind, multi-center clinical trial

Abstract

Objective To assess the efficacy and safety of morinidazole combined with appendectomy in treating purulent or gangrenous appendicitis. Methods Double-blind randomized controlled multicenter clinical trial was designed and conducted. Totally 437 patients were included, 219 in the control group and 218 in the experimental group. Cases of purulent or gangrenous appendicitis were enrolled and assigned to each of the two groups. The control group received ornidazole injection for 5 to 7 days while the experimental group received morinidazole injection. Both groups underwent appendectomy. Clinical response, micrombiological outcomes, overall response were evaluated. Adverse events and side effects were recorded. Results No significant difference was observed between the two groups regarding the clinical healing rate at 5-10 days after medicine withdrawal, anaerobia clearance and overall healing rates. Adverse events occurred in 140 patients (32.1%). Incidence of adverse events in the control group and the experimental group was 34.7% and 29.4%, respectively (P>0.05). The overall incidence of side effects was 15.1% (66 cases). Side effects were less seen in the experimental group compared with that in the control group (11.5% vs. 18.7%, P<0.05). The most frequent side effects were aminotransferase rising, thrombocytosis, nausea, vomiting and electrocardiographic abnormality. Conclusions The effect of morinidazole plus operation was comparable with ornidazole in treating purulent or gangrenous appendicitis. The safety of morinidazole is better than ornidazole. Key words: Appendicitis; Ornidazole; Morinidazole