头孢曲松钠舒巴坦钠(2:1)治疗无合并症淋病的临床疗效及耐药性研究

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

目的评价注射用头孢曲松钠舒巴坦钠(2:1)治疗无合并症淋病的临床疗效、安全性及菌株耐药性。方法采用单臂、多中心、开放性实验设计,在全国7家单位给予入组的113例无合并症淋病受试者单次静脉滴注头孢曲松舒巴坦钠(2:1)3g,监测不良反应,采用治疗后(7±1)d的细菌学清除率评价临床疗效。采用纸片法(K-B法)进行菌株药敏试验,并对产β-内酰胺酶的淋球菌(PPNG)菌株进行头抱菌素类药物的最低抑菌浓度(MIC)分析。结果在97例完成疗效评价的患者中,细菌学清除率达到99.0%。108例完成安全性分析的患者中不良反应发生率4.6%,未发生严重不良事件。100株临床分离的淋球菌菌株经药敏分析,未发现头孢曲松和头孢曲松舒巴坦钠(2:1)中介或耐药。18株PPNG菌株中发现1株头孢曲松钠低敏株,MIC为0.128μ/mL,未检出耐药菌株。结论注射用头孢曲松钠舒巴坦钠(2:1)治疗无合并症淋病临床疗效明确,细菌清除率高,安全性较好,药物敏感性高。

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.