中国循证医学杂志

中国循证医学杂志

抗生素降阶梯方案治疗重症肺炎有效性和安全性的 Meta 分析

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目的 系统评价抗生素降阶梯方案治疗重症肺炎患者的有效性与安全性。 方法 计算机检索 PubMed、EMbase、The Cochrane Library、CBM、CNKI、VIP 和 WanFang Data 数据库,同时检索中国临床试验注册中心(www.chictr.org.cn),搜集关于抗生素降阶梯方案治疗重症肺炎患者的随机对照试验(RCT),检索时限均从建库至 2017 年 6 月。由 2 名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用 RevMan 5.3 软件进行 Meta 分析。 结果 共纳入 13 个 RCT,包括 1 860 例患者。Meta 分析结果显示:与对照组相比,抗生素降阶梯组的临床治愈率明显更高[RR=1.28,95%CI(1.20,1.35),P<0.000 01],总住院时间[MD=–6.74,95%CI(–8.65,–4.82),P<0.000 01]、并发症控制时间[MD=–6.86,95%CI(–9.12,–4.59),P<0.000 01]明显缩短,死亡率明显降低[RR=0.48,95%CI(0.28,0.82),P=0.008],两组差异均有统计学意义。纳入研究报道的不良反应较少,且程度均为轻、中度,安全性尚可。 结论 当前证据表明,抗生素降阶梯治疗方案在重症肺炎患者治疗过程中相比常规治疗疗效更佳,能够显著缩短总住院时间、降低病死率。受纳入研究质量和数量限制,上述结论尚待更多高质量研究予以验证。

Objective To systematically review the efficacy and safety of de-escalation therapy for severe pneumonia. Methods We searched PubMed, EMbase, The Cochrane Library, CBM, CNKI, VIP and WanFang Data databases and the China Clinical Trials Registry (www.chictr.org.cn) to collect randomized controlled trials (RCTs) of de-escalation therapy for the patients with severe pneumonia from inception to June, 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed using RevMan 5.3 software. Results A total of 13 RCTs involving 1 860 patients were included. The results of meta-analysis showed that: the de-escalation therapy group was superior to the control group on the clinical cure rate (RR=1.28, 95%CI 1.20 to 1.35, P<0.000 01), the total hospitalization time (MD=–6.86, 95%CI –9.12 to –4.59,P<0.000 01), remission time of complications (MD=–6.26, 95%CI –8.43 to –4.10,P<0.000 01) and death rate (RR=0.48, 95%CI 0.28 to 0.82,P=0.001), the differences were statistically significant. The reported adverse reactions were rare, and the degree of adverse reaction was mild to moderate. Conclusion Current evidence shows that de-escalation therapy for patients with severe pneumonia has a certain advantage compared with conventional treatment, and can significantly shorten the total hospitalization time and reduce mortality. Due to the limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.

关键词: 降阶梯治疗; 抗生素; 重症肺炎; 系统评价; Meta 分析; 随机对照试验

Key words: De-escalation therapy; Antibiotic; Severe pneumonia; Systematic review; Meta-analysis; Randomized controlled trial

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