摘要
目的评价依拉环素治疗复杂性腹腔感染(cIAI)的有效性和安全性。方法采用计算机检索中国知网、维普、PubMed、Web of Science、The Cochrane Library、ClinicalTrials.gov数据库中使用依拉环素(试验组)与碳青霉烯类抗菌药物(厄他培南钠、美罗培南,对照组)治疗成人cIAI的随机对照试验(RCT)中英文文献,检索时限为各数据库自建库起至2024年6月,使用Cochrane 5.1.0版评价手册评价纳入RCT的质量,使用Jadad量表评价纳入文献的质量,使用RevMan 5.3软件对治疗的有效性和安全性进行Meta分析。结果纳入4篇文献(中文文献1篇,英文文献3篇),包含5项研究,Jadad量表评分均为5分。试验组在改良意向治疗(MITT)、微生物学改良意向治疗(micro-MITT)、临床可评价和微生物可评价人群的结束治疗、疗效判断(TOC)和晚期随访访视时的临床治愈率与对照组均相当(P>0.05)。试验组在TOC访视时的micro-MITT人群中对革兰阴性菌(含肠杆菌科细菌、大肠埃希菌、肺炎克雷伯菌和非肠杆菌科细菌)、革兰阳性菌(含链球菌、粪肠球菌和屎肠球菌)及厌氧菌(含脆弱拟杆菌和多形拟杆菌)的清除率与对照组均相当(P>0.05),对卵形拟杆菌的清除率显著低于对照组[OR=0.17,95%CI(0.04,0.72),P=0.02]。试验组患者药物相关不良事件发生率[OR=1.63,95%CI(1.23,2.15),P=0.00020],胃肠道反应发生率[OR=2.80,95%CI(1.83,4.29),P<0.00001],恶心发生率[OR=8.07,95%CI(3.32,19.63),P<0.00001]均显著高于对照组;两组患者严重不良事件发生率、全因死亡率和呕吐发生率均相当(P>0.05)。结论依拉环素治疗成人cIAI患者的临床疗效和微生物清除率(除卵形拟杆菌)与碳青霉烯类抗菌药物相当,但药物相关不良事件尤其是恶心的发生率更高。
Objective To evaluate the efficacy and safety of eravacycline in the treatment of complicated intra-abdominal infection(cIAI).Methods Randomized controlled trials(RCTs)in both Chinese and English for eravacycline(the experimental group)and carbapenems(ertapenem sodium,meropenem,the control group)in the treatment of adult cIAI in the CNKI,VIP,PubMed,Web of Science,The Cochrane Library,ClinicalTrials.gov databases were searched from the inception of each database to June 2024.The Cochrane Handbook(version 5.1.0)was used to evaluate the quality of the inclued RCTs,and the Jadad scale was used to evaluate the quality of the included studies.RevMan 5.3 software was used for Meta-analysis of efficacy and safety.Results Four articles(one in Chinese and three in English)were included,including five studies.The Jadad scale score of four articles was five points.The clinical cure rates at the end-of-treatment visit,test-of-cure(TOC)visit,and late follow-up visit in the population of modified intent-to-treat(MITT),microbiological modified intent-to-treat(micro-MITT),clinically evaluable(CE),and microbiologically evaluable(ME)in the experimental group were comparable to those in the control group(P>0.05).The clearance rates of Gram-negative bacteria(including Enterobacteriaceae,Escherichia coli,Klebsiella pneumoniae,and non-Enterobacteriaceae),Gram-positive bacteria(including Streptococcus,Enterococcus faecalis,and Enterococcus faecium),and anaerobic bacteria(including Bacteroides fragilis and Bacteroides thetaiotaomicron)in the micro-ITT population in the experimental group were comparable to those in the control group during the TOC visit(P>0.05),and the clearance rate of Bacteroides ovatus in the experimental group was significantly lower than that in the control group[OR=0.17,95%CI(0.04,0.72),P=0.02].The incidence of drug-related adverse events[OR=1.63,95%CI(1.23,2.15),P=0.0002],gastrointestinal reactions[OR=2.80,95%CI(1.83,4.29),P<0.00001]and nausea[OR=8.07,95%CI(3.32,19.63),P<0.00001]in the experimental group were significantly higher than those in the control group.The incidence of serious adverse events,all-cause mortality,and vomiting were comparable between the two groups(P>0.05).Conclusion The clinical efficacy and microbial clearance rate(except for Bacteroides ovatus)of eravacycline in the treatment of adult patients with cIAI are comparable to those of carbapenems,but the incidence of drug-related adverse events(especially nausea)of eravacycline is higher.
作者
吕珊
高倩
何菊英
枉前
岑菁
LYU Shan;GAO Qian;HE Juying;WANG Qian;CEN Jing(The First Affiliated Hospital of Army Medical University,Chongqing,China 400038)
出处
《中国药业》
2025年第17期118-123,共6页
China Pharmaceuticals
基金
重庆市临床药学重点专科建设项目[渝卫办发[2021]52号]。
