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目的系统评价替加环素单药治疗复杂腹腔感染的疗效与安全性,为临床用药提供依据。方法计算机检索Pub Med、Science Direct、The Cocharane Library、Clinical trial、中国知网、万方等大型文献数据库,收集国内外公开发表的关于比较替加环素和其他抗菌药物治疗复杂腹腔感染的疗效和安全性的随机对照试验(RCTs),末次检索时间为2016年3月10日。按Cochrane系统评价方法,采用Rev Man5.2软件进行Meta分析。结果共纳入5项RCTs研究,2775例患者,Meta分析结果显示,替加环素疗效与对照药物相当,CE群体(OR=0.92,95%CI:0.74~1.15,P=0.48)和ME群体(OR=0.91,95%CI:0.70~1.19,P=0.50)的临床治愈率与对照药物比较,差异均无统计学意义;细菌清除率(OR=0.93,95%CI:0.71~1.21,P=0.58)两组间比较差异也无统计学意义。替加环素组的不良反应事件(OR=1.06,95%CI:0.87~1.30,P=0.57)及严重不良反应事件(OR=1.22,95%CI:0.99~1.50,P=0.06)发生率较对照组稍高,但差异无统计学意义;替加环素的不良反应一般为轻中度,常见的不良反应事件为胃肠道反应,其中恶心、呕吐的发生率显著高于对照组;替加环素组因不良反应事件而退出试验的发生率较对照组高,但差异无统计学意义(OR=1.39,95%CI:1.00~1.94,P=0.05);替加环素组死亡率与治疗组比较,差异亦无统计学意义(OR=1.50,95%CI:0.92~2.45,P=0.11)。结论对于复杂腹腔感染,替加环素单药治疗与对照药物比较未显示出优势,不宜首选用于复杂腹腔感染的经验性治疗,但仍是一个效果较好且相对安全的治疗方案。
Objective To evaluate the efficacy and safety of tigecycline monotherapy in the treatment of complicated intra-abdominal infections and provide evidence for clinical use. Methods Large-scale literature databases such as Pub Med, Science Direct, The Cocharane Library, Clinical trial, CNKI and Wanfang were searched and searched. The data of published articles published at home and abroad about the efficacy and safety of tigecycline and other antimicrobial drugs in treating complicated abdominal infection Safety Randomized Controlled Trials (RCTs), last searched on March 10, 2016. According to the Cochrane systematic review method, Rev Man5.2 software was used for meta-analysis. Results A total of 5 RCTs were included in the study. Meta-analysis showed that the efficacy of tigecycline was comparable to that of the control drug. There was no significant difference between the CE group (OR = 0.92, 95% CI: 0.74-1.15, P = 0.48) OR = 0.91, 95% CI: 0.70-1.19, P = 0.50). There was no significant difference in the cure rate between the two groups (OR = 0.93,95% CI: 0.71-1.21, P = 0.58) There was no significant difference between the two groups. The incidence of adverse events (OR = 1.06, 95% CI: 0.87-1.30, P = 0.57) and serious adverse events (OR = 1.22, 95% CI: 0.99-1.50, P = 0.06) in the tigecycline group Slightly higher than the control group, but the difference was not statistically significant. The adverse reactions of tigecycline were generally mild to moderate. The common adverse reactions were gastrointestinal reactions. The incidence of nausea and vomiting was significantly higher than that of the control group. The incidence of withdrawal from adverse reactions in the tigecycline group was higher than that in the control group, but the difference was not statistically significant (OR = 1.39, 95% CI: 1.00-1.94, P = 0.05); death in the tigecycline group There was also no significant difference between the two groups (OR = 1.50, 95% CI: 0.92-2.45, P = 0.11). Conclusion For patients with complicated abdominal infection, tigecycline monotherapy does not show any advantage over the control drugs and is not the first choice for the empirical treatment of complicated intra-abdominal infections. However, it is still a relatively effective and relatively safe treatment.