头孢他啶阿维巴坦治疗革兰阴性菌感染的快速卫生技术评估

Ceftazidime-avibactam for the Treatment of Gram-negative Bacterial Infections:A Rapid Health Technology Assessment

目的通过快速卫生技术评估,对头孢他啶阿维巴坦治疗革兰阴性菌感染的有效性、安全性、经济性进行评价,为临床实践与决策者提供循证依据。方法计算机检索Pubmed、The Cochrane Library、中国知网、万方数据库、维普数据库及CRD、INAHTA、CADTH、HTAi、NICE网站,检索时限均从建库至2021年5月20日,仅纳入头孢他啶阿维巴坦治疗革兰阴性菌感染的系统评价、Meta分析、卫生技术评估和药物经济学研究,由2名评价者独立筛选文献及提取数据结果,并对结果进行综合分析。结果共纳入15篇文献,其中10篇为系统评价/Meta分析,4篇为药物经济学研究,1篇为系统评价/Meta分析合并药物经济学研究。有效性研究结果显示头孢他啶阿维巴坦对于产超广谱β-内酰胺(ESBL)酶肠杆菌的轻中度复杂尿路感染和复杂腹腔感染、产肺炎克雷伯杆菌碳青霉烯(KPC)酶耐碳青霉烯肠杆菌感染、血流感染、多重耐药铜绿假单胞菌引起的复杂尿路感染等是较优选择,但对于医院获得性肺炎的疗效不优于其他抗菌药物。安全性研究显示头孢他啶阿维巴坦与其他治疗药物比较死亡率没有显著性差异,但不良事件发生率较高,尤其在腹腔感染患者中胃肠道反应、肌酐升高、因不良事件停药的发生率明显高于对照组。经济学研究显示头孢他啶阿维巴坦在欧美国家具有较好的经济性,但缺乏中国人群的相关经济学研究。结论头孢他啶阿维巴坦治疗革兰阴性菌感染有较好的有效性、安全性和经济性,有必要开展中国人群的药物经济学评价。

Objective To evaluate the efficacy,safety,and cost-effectiveness of ceftazidime-avibactam for the treatment of Gram-negative bacterial infections in a rapid health technology assessment,so as to provide the latest evidence-based basis for health providers and decision makers.Methods Pubmed,the Cochrane Library,CNKI,WanFang,VIP database and University of York Centre for Reviews and Dissemination(CRD)Web,International Network of Agencies for Health Technology Assessment(INAHTA)Web,Canadian Agency for Drugs and Technologies in Health(CADTH)Web,Health Technology Assessment international(HTAi)Web,National Institute for Health and Care Excellence(NICE)Web were searched.The retrieval time limit was from the establishment of the database to May 20,2021.Only the systematic review,meta-analysis,health technology assessment and pharmacoeconomic research of ceftazidime avibactam in the treatment of gram-negative bacterial infections were included.Two reviewers independently screened the literature and extracted the data results,and comprehensively analyzed the results.Results A total of 15 literatures were included,including 10 systematic reviews/meta-analyses,4 pharmacoeconomic studies,and 1 systematic review/meta-analysis combined with pharmacoeconomic studies.This study shows that Ceftazidime-avibactam is a good option for the treatment of mild to moderate complicated urinary tract and intra-abdominal infections caused by ESBL-producing Enterobacteriaceae,infections caused by KPC-producing carbapenem-resistant Enterobacteriaceae,bacteremia and complicated urinary tract infections caused by multi-resistant P.aeruginosa,but the curative effect on hospital acquired pneumonia was not better than other antibiotics.The safety studies show that there is no significant difference in mortality between ceftazidime-avibactam and other therapeutic drugs,but the incidence of AEs was higher,especially in patients with abdominal infection,the incidence of gastrointestinal reaction,elevated creatinine and withdrawal due to adverse events were significantly higher than those in the control group.Foreign pharmacoeconomic studies show that Ceftazidime-avibactam is a cost-effective treatment for Gram-negative bacterial infections compared with other antibiotic treatment options in Europe and the United States,while there is no relevant research on Chinese population.Conclusion Ceftazidime-avibactam is effective,safe and cost-effective for the treatment of Gram-negative bacterial infections.Pharmacoeconomic studies focusing on Chinese populations are needed to provide more evidence for local healthcare decision makers.