间歇充气加压联合低分子肝素预防静脉血栓栓塞症效果的系统评价和试验序贯分析

Effects of Intermittent Pneumatic Compression Combined with Low Molecular Weight Heparin on Prevention of Deep Venous Thrombosis: A Meta-analysis with Trial Sequential Analysis

目的系统评价间歇充气加压联合低分子肝素用于预防静脉血栓栓塞症的效果。方法计算机检索Pub Med、EMBASE、Web of Science、CENTRAL和知网、万方及CBM中,关于间歇充气加压联合低分子肝素预防静脉血栓栓塞症的随机对照试验,并追溯合格研究、主题相关研究及综述的参考文献。2名评价者独立检索、筛查文献、提取数据、评价纳入文献的方法学质量并交叉核对后,用Rev Man 5.3进行Meta分析,试验序贯分析软件估算各结局指标需求样本量。结果共纳入23项随机对照试验,包括5 257例研究对象。Meta分析结果显示,亚组分析表明间歇加压充气联合低分子肝素与常规护理、单用低分子肝素或单用间歇充气加压相比,有助于预防住院患者深静脉血栓形成的发生(RR=0.16,95%CI:0.06~0.41,P<0.001),(RR=0.32,95%CI:0.22~0.46,P<0.001),(RR=0.37,95%CI:0.25~0.53,P<0.001),降低肺栓塞发生率(RR=0.16,95%CI:0.06~0.47,P<0.001),但可能会增加出血等不良反应的发生(RR=5.97,95%CI:1.75~20.40,P=0.004),且间歇充气加压联合低分子肝素与单用低分子肝素相比,并不能降低肺栓塞发生率(RR=0.72,95%CI:0.16~3.18,P=0.67)。敏感性分析和试验序贯分析证实主要结局指标合并结果可信。结论间歇加压充气联合低分子肝素能有效降低静脉血栓栓塞症的发生,建议临床推广使用,但应注意出血等并发症的发生。

Objective To systematically assess the effects of intermittent pneumatic compression combined with low molecular weight heparin on the prevention of deep venous thrombosis in inpatients. Methods A computerized search in PubMed, EMBASE, Web of Science, CENTRAL, CNKI, WanFang and VIP was performed for relevant randomized trials （RCTs） focusing the effects of intermittent pneumatic compression combined with low molecular weight heparin on the preJention of deep Jenous thrombosis in inpatients. Methodological quality of all eligible studies was assessed accordingly by two independent investigators. Then, meta-analysis and trial sequential analysis were performed by using RevMan 5.3 and TSA software, respectively. Results Totally 23 RCTs including 5,257 participants were concluded into the Meta-analysis. Meta-analysis results suggested that when compared to routine nursing, low molecular weight heparin or intermittent pneumatic compression, intermittent pneumatic compression combined with low molecular weight heparin was conducive to reducing the incidence rates of deep venous thrombosis（RR=0.16,95%CI：0.06～0.41,P〈0.001 ）,（RR= 0.32, 95%CI：0.22～0.46, P〈0.001）,（RR=0.37,95%CI：0.25～0.53,P〈0.001）andpulmonary embolism（RR=0.16,95%CI：0.06～0.47,P〈 0.001）, but it may increase the incidence of adverse reactions such as bleeding（RR=5.97, 95%C/：1.75～20.40, P=0.004）. Intermittent pneumatic compression combined with low molecular weight heparin, when compared with use low molecular weight heparin alone, did not reduce the incidence of PE （RR =0.72, 95%C/：0.16～3.18, P=0.67）. Meanwhile, sensitivity analysis and TSA confirmed the robustness of all pooled results. Conclusion Intermittent pneumatic compression combined with low molecular weight heparin is effective for preventing deep venous thrombosis and pulmonary embolism in inpatients, and could be promoted clinically, but the occurrence of complications such as bleeding should be noted.