Clinical efficacy and resistance of ceftriaxone sodium and sulbactam sodium (2: 1) in the treatment of uncomplicated gonorrhea

Objective To evaluate the clinical efficacy, safety and drug resistance of ceftriaxone sodium and sulbactam sodium for injection (2:1) in the treatment of uncomplicated gonorrhea. Methods It was a single arm, multi-center and open experiment designed study in 7 centers nationwide. A total of 113 subjects were given ceftriaxone sodium and sulbactam sodium (2:1) 3 g for single intravenous infusion. Adverse reactions were monitored, and the bacterial clearance rate in (7±1) days after treatment was used to evaluate the clinical efficacy. The drug susceptibility was detected by Kirby-Bauer method. The minimum inhibitory concentration (MIC) of cephalosporins against the strains of penicillinase-producing Neisseria gonorrhoeae (PPNG) was analyzed. Results A total of 97 subjects were defined as effective analysis cases, and the bacterial clearance rate was 99.0%. No serious adverse events occurred and the incidence of adverse reactions was 4.6% among 108 cases who completed the drug safety analysis. No intermediate or resistant to ceftriaxone sodium and sulbactam sodium (2:1) strain was found among 100 strains isolated from these patients. One out of 18 PPNG strains was low-sensitive to ceftriaxone sodium with the MIC of 0.128 ug/mL. No drug-resistant strain was detected. Conclusions Ceftriaxone sodium sulbactam sodium for injection (2:1) shows effective clinical efficacy, high bacterial clearance rate, good safety and high drug sensitivity for the treatment of uncomplicated gonorrhea. Key words: Gonorrhea; Ceftriaxone; Sulbactam; Bacterial clearance; Adverse reaction