摘要
目的系统评价单用呼吸喹诺酮类与β-内酰胺类联合大环内酯类比较治疗非ICU住院社区获得性肺炎(CAP)患者的有效性与安全性。方法计算机检索Pub Med、The Cochrane Library(2015年第3期)、EMbase、CNKI、Wan Fang Data、VIP和CBM数据库,搜集使用呼吸喹诺酮类与β-内酰胺类联合大环内酯类治疗非ICU住院CAP患者的相关随机对照试验(RCT),检索时限均为从建库截至2015年4月。由2位研究者按照纳入与排除标准筛选文献、提取资料和评价纳入研究的偏倚风险后,采用Rev Man 5.0软件进行Meta分析。结果共纳入17个RCT,共5 423例患者。Meta分析结果显示:在病死率上,两组差异无统计学意义;在临床有效率上,基于ITT和PP分析数据的Meta分析结果均显示两组差异无统计学意义,但对类型不清楚数据的Meta分析结果显示,呼吸喹诺酮组的临床有效率更高[RR=1.08,95%CI(1.01,1.18),P=0.02],且这种差异主要来自亚洲人群[RR=1.10,95%CI(1.02,1.18),P=0.01];在不良反应上,呼吸喹诺酮组的不良反应发生率更低[RR=0.81,95%CI(0.73,0.90),P<0.000 1],且这种差异主要来自高加索人群[RR=0.64,95%CI(0.36,1.14),P=0.13]。结论当前证据显示,在非ICU住院CAP患者中,单用呼吸喹诺酮与β-内酰胺类联用大环内酯类相比,其临床疗效相当,但前者安全性更好。受纳入研究数量和质量所限,本研究结论尚需进一步开展大样本高质量RCT进行验证。
Objective To systematically review the efficacy and safety of respiratory fluoroquinolones monotherapy versus β-lactams plus macrolides combination therapy for non-ICU hospitalized community acquired pneumonia (CAP) patients. Methods We searched databases including PubMed, the Cochrane Library (Issue 3, 2015), EMbase, CNKI, WanFang Data, VIP and CBM to identify randomized controlled trials (RCTs) involving the comparison of fluoroquinolones monotherapy with β-lactarns plus macrolides combination treatment for the non-ICU hospitalized patients with CAP up to April 2015. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, assessed the risk bias of included studies, and then meta-analysis was performed using the RevMan 5.0 software. Results A total of 17 RCTs involving 5 423 patients were included. The results of meta-analysis showed that there was no significant difference between the two therapy groups on the mortality. For the clinical treatment success rates, no significant differences between the two groups were found based on the data of intention-to-treat (ITT) and per-protocol (PP) analyses. However, respiratory fluoroquinolones monotherapy was associated with higher clinical treatment success rates based on the data that it was unclear whether ITT or PP analysis was used (RR=I.08, 95% CI 1.01 to 1.18, P=0.02), especially in Asians (RR=I.10, 95%CI 1.02 to 1.18, P=0.01). Additionally, respiratory fluoroquinolones monotherapy was associated with less adverse events (RR=0.81, 95%CI 0.73 to 0.90, P〈0.000 1), especially in Caucasians (RR=0.64, 95%CI 0.36 to 1.14, P=0.13). Condusion Current evidence shows that the efficacy of respiratory fluoroquinolones monotherapy may be similar to β-lactams plus macrolides combination treatment for non-ICU hospitalized CAP patients. Since the limitation of quantity and quality of included studies, large-scale high-quality RCTs are needed to verify the above conclusion.
出处
《中国循证医学杂志》
CSCD
2015年第7期824-832,共9页
Chinese Journal of Evidence-based Medicine