Objective To evaluate the efficacy and safety of domestic amoxicillin clavulanate (16∶1) sustained-release tablet in the treatment of acute bacterial infections.   Methods A multicenter double-blind randomized clinical trail was conducted. A total of 286 patients were enrolled in the study. There were 284 patients for FAS(Full Analysis Set) analysis

including 141 in the treatment group and 143 in control group. While 266 patients were enrolled in PPS（Per-Protocol Set） analysis

and there were 133 patients in each group. Amoxicillin clavulanate (16∶1) and amoxicillin clavulanate (4∶1) were given orally at a dose of 500 mg/31.25 mg or 500 mg/125 mg respectively twice one day for 5-10 d.   Results  At the end of treatment

the cure rates and efficacy rates were 68.79% and 92.91% in the treatment group

while 74.83% and 92.31% in the control group. The bacterial eradication rates were 96.51% for each group. Adverse reactions were 9.93% in the treatment group and 8.39% in the control group

and the drugrelated clinical adverse were 7.80% and 2.78%

respectively. No statistical difference between the 2 groups was observed (P0.05).    Conclusion  Domestic amoxicillin clavulanate (16∶1) sustained-release tablet is as effective and safe as amoxicillin clavulanate (4∶1) in the treatment of acute bacterial infections.