头孢曲松联合甲硝唑治疗复杂腹腔感染疗效与安全性的Meta分析

Efficacy and safety of ceftriaxone plus metronidazole for treating complicated intra-abdominal infections:a Meta-analysis

目的:评价头孢曲松联合甲硝唑治疗复杂腹腔感染的疗效与安全性。方法:计算机检索Pubmed、Science Direct、Clinical trials.gov、Cochrane library、中国知网(CNKI)和中国生物医学数据库(CBM),收集国内外公开发表的关于头孢曲松联合甲硝唑治疗复杂腹腔感染的临床随机对照试验(RCTs)(检索时间截止到2013年12月30),采用RevMan 5.2软件进行Meta分析。结果:共纳入8项RCTs研究,3 214例患者,Meta分析结果显示,头孢曲松联合甲硝唑在治疗复杂腹腔感染的疗效及安全性上,均不亚于对照抗菌药物。临床治愈率(OR=1.04,95%CI:0.84-1.30,P=0.72),细菌清除率(OR=1.04,95%CI:0.80-1.36,P=0.76)均无统计学差异;在安全性方面,头孢曲松联合甲硝唑治疗组总的不良事件发生率(OR=0.89,95%CI:0.74-1.07,P=0.20),严重不良事件发生率(OR=0.79,95%CI:0.62-1.01,P=0.06),药物相关性不良事件发生率(OR=0.88,95%CI:0.67-1.15,P=0.34)以及死亡率(OR=0.90,95%CI:0.60-1.36,P=0.63)均较对照组低,但无统计学差异。结论:头孢曲松联合甲硝唑治疗复杂腹腔感染疗效及安全性并不亚于对照的其他抗菌药物,可作为复杂性腹腔感染的优选治疗方案之一。

OBJECTIVE To evaluate the efficacy and safety of ceftriaxone plus metronidazole for treatment of complicated intraabdominal infections.METHODS Pubmed,Science Direct,Clinical trials.gov,Cochrane library,CNKI and CBM were searched to retrieve randomized controlled trials（RCTs） compared ceftriaxone plus metronidazole with other antibiotics in the treatment of complicated intra-abdominal infections（last search time：December 30 th,2013）.Meta-analysis was performed with the RevMan 5.2 software supplied by Cochrane Collaboration.RESULTS Eight randomized controlled trials included a total of 3214 patients with complicated intra-abdominal infections were included for Meta-analysis.The results of the Meta-analysis indicated that the group of ceftriaxone /metronidazole combination was as good as the control group,with similar clinical cure rate（eight RCTs,2736 patients,OR = 1.04,95%CI：0.84-1.30,P = 0.72）,bacteriological success rate（seven RCTs,1814 patients,OR = 1.04,95% CI：0.80-1.36,P = 0.76）;The overall incidence of adverse events（six RCTs,2159 patients,OR = 0.89,95% CI：0.74-1.07,P = 0.20）,serious adverse events（six RCTs,2410 patients,OR = 0.79,95% CI：0.62-1.01,P = 0.06）,drug-related adverse events（six RCTs,2276 patients,OR = 0.88,95% CI：0.67-1.15,P = 0.34） and mortality（seven RCTs,2853 patients,OR = 0.90,95% CI：0.60-1.36,P =0.63） of ceftriaxone /metronidazole combination group were also similar between the compared treatment groups.CONCLUSION Ceftriaxone / metronidazole combination can be used as effectively and safely,as other recommended antimicrobial regimens,for the treatment of complicated intra-abdominal infections.