Abstract: AIM: To evaluate the clinical efficacy and safety of domestic cefmenoxime hydrochloride for injection in the treatment of acute bacterial infections.METHODS: A randomized, comparative, single-blind,multicenter clinical trial of domestic cefmenoxime hydrochloride injection (test) and cefmenoxime hydrochloride injection (Bestcall) made in Japan (control) in the treatment of respiratory and urinary tract infections were conducted.The test drug and control drug were administrated intravenously at a dose of 1.0 g bid for 7 to 10 days, re-spectively.Among ITT (intention-to-treat) population,71 patients were enrolled in test grouPand 68 patients in control group.Among PP(per-protocol) population, 68 patients were evaluated in test grouPand 64 patients in control group.RESULTS: All the results were analyzed on the basis of ITT and PPpopulation.The clinical efficacy rates for test and control grouPwere separately 88.7 %(ITT), 92.7 %(PP) and 86.8 %(ITT), 92.2 %(PP).The bacterial eradication rates were 96.7 % and 94.6 %, respectively.The incidences of adverse reaction were 5.6 %and 7.4 %, respectively.There were no significant differences between the two groups (P>0.05).ITT and PPanalysis revealed similar result.CONCLUSION: The domestic cefmenoxime hydrochloride injection has an excellent clinical efficacy and good safety profile in treating patients with acute bacterial infection as the controldrug.

Key words: cefmenoxime hydrochloride injection, bacterial infection, efficacy, safety