头孢他啶/阿维巴坦与碳青霉烯类疗效和安全性比较

Comparison of the efficacy and safety between ceftazidime/avibactam and carbapenems

目的:系统性评价比较头孢他啶/阿维巴坦(ceftazidime/avibactam, CAZ/AVI)与碳青霉烯类用于治疗革兰阴性菌(Gram-negative bacteria, GNB)引起感染的有效性和安全性,为临床合理用药提供参考。方法:计算机检索PubMed, EMBASE,Cochrane library, CNKI及万方、维普、CBM,检索时限为各数据库建库起至2020年12月,纳入CAZ/AVI与碳青霉烯类比较用于治疗GNB感染的随机对照临床试验。对纳入文献进行资料提取,采用Rev Man 5.3统计软件分析结果。结果:共纳入10篇文献,合计3 983例患者。结果显示,CAZ/AVI与碳青霉烯类相比,用于治疗由GNB引起的复杂性腹腔感染(cIAIs)、复杂性尿路感染(cUTIs)及医院获得性肺炎和呼吸机相关性肺炎(HAP/VAP)时,两者临床治愈率相当(P>0.05)。对于由头孢他啶不敏感和产超广谱β-内酰胺酶/头孢菌素酶(ESBLs/AmpC)的GNB引起的感染,两组的临床治愈率相当[相对危险度(RR)=1.01,95%置信区间(CI)为(0.94~1.09),P=0.78;RR=1.04, 95%CI为(0.97~1.12),P=0.26]。对于患有cUTIs的患者,CAZ/AVI具有更高的细菌清除率[RR=1.14, 95%CI(1.02~1.27),P=0.02]。两组的死亡率和不良事件发生率相似(P≥0.05)。结论:CAZ/AVI与碳青霉烯类相比,用于治疗由GNB引起的复杂性感染时的有效性和安全性相似,CAZ/AVI在治疗由耐药GNB引起感染的患者中可能具有潜在优势。

Objective: To systematically evaluate the efficacy and safety of ceftazidime/avibactam(CAZ/AVI) and carbapenems in patients with infections caused by Gram-negative bacteria(GNB), in order to provide evidence-cased reference in clinic. Methods: Databases including PubMed, EMBASE, Cochrane library, CNKI, WanFang Data, VIP, and CBM database were retrieved for randomized controlled trials about CAZ/AVI versus carbapenems for the treatment of infection from the time that they were established to December 2020. The data were exracted from clinical studies, and analyzed using Rev Man 5.3 statistical software. Results: A total of ten papers including 3 983 patients were adopted. The results turns out to be a comparable clinical response of CAZ/AVI to carbapenems in the treatment of GNB infections include complicated intra-abdominal infections(cIAIs), complicated urinary tract infections(cUTIs), hospital-acquired pneumonia/ventilator-associated pneumonia(HAP/VAP),P>0.05. In patients with infections caused by resistant GNB(including CAZ non-susceptible organisms and ESBLs/AmpC-positive organisms), both groups showed a similar clinical response, without significant heterogeneity [RR=1.01, 95%CI(0.94,1.09), P=0.78;RR=1.04, 95%CI(0.97,1.12), P=0.26]. Higher microbiological response rate was demonstrated with CAZ/AVI in patients with cUTIs, with significant heterogeneity [RR=1.14, 95%CI(1.02,1.27), P=0.02]. No significant difference was detected between the two groups regarding mortality and adverse events(P≥0.05). Conclusion: CAZ-AVI exhibited comparable efficacy and safety with carbapenems in complicated infectious diseases caused by GNB. This agent may become a potential powerful agent for patients with resistant Gram-negative bacterial infections.