丹参多酚酸盐静脉滴注联合水化预防造影剂肾病疗效的Meta分析

Meta-analysis on efficacy of salvianolate in prevention of contrast-induced nephropathy

系统评价丹参多酚酸盐静脉滴注联合水化预防造影剂肾病的临床疗效和安全性,以期指导临床用药。通过检索PubMed、EMbase、Cochrane Library、中国生物医学文献数据库、中国知网、维普、万方数据库等,收集丹参多酚酸盐静脉滴注联合常规水化(试验组)对比常规水化(对照组)预防造影剂肾病的随机对照研究(RCT),利用Cochrane 5. 1. 0偏倚风险评估工具对纳入研究的方法学质量进行评价,提取数据并用Rev Man 5. 3软件进行Meta分析。采用Egger’s检验和非参数剪补法评估发表偏倚。纳入9项RCT,共涉及2 186例患者。试验组造影剂肾病的发生率RR=0. 46,95%CI[0. 35,0. 59],P<0. 001,且对于不同类型患者的亚组分析提示,无论是对于年龄≥65岁的患者,接受造影剂剂量≥200 m L的患者,基础肾功能血肌酐(Scr)≥80μmol的患者,接受丹参多酚酸盐术中给药的患者或接受PCI的患者,试验组造影剂肾病的发生率均显著低于对照组,差异均具有统计学意义(P<0. 05),在改善患者术后肾功能各指标方面,实验组均优于对照组,且差异均具有统计学意义(P<0. 05),所有研究均未报告不良反应的发生情况。Egger’s线性回归结果提示存在一定的发表偏倚,敏感性分析、漏斗图法和剪补法分析结果表明稳定、可信。丹参多酚酸盐静脉滴注联合水化预防造影剂肾病具有较好的临床疗效,然而,确切结论有待于更多的高质量、多中心、大规模的随机对照研究证实。

To systemically evaluate the efficacy and safety of salvianolate intravenous drip in combination with hydration against contrast-induced nephropathy(CIN),and guide clinical medication.Chinese and English databases(PubMed,EMbase,the Cochrane Library,CBM,VIP,Wan Fang database,CNKI)were retrieved to collect the randomized controlled trials(RCTs)about the efficacy of salvianolate intravenous drip in combination with hydration(trial group)vs routine hydration(control group)in the prevention of contrastinduced nephropathy.The methodological quality of the RCTs was evaluated by using the Cochrane 5.1.0 Bias Risks Assessment Tool.The data were extracted and Meta-analysis was conducted by Reviewer Manager 5.3.Egger’s test and non-parametric clipping method were used to evaluate publication bias.A total of 9 RCTs with 2 186 participants were included.Results of Meta-analysis showed that the incidence of contrast-induced nephropathy of trial group was significantly higher than that of control group(RR=0.46,95%CI[0.35,0.59],P<0.001).Subgroup analysis showed that the incidences of CIN in patients with acute coronary syndrome(ACS)undergoing PCI,in patients with the average age≥65 years,in patients who received mean contrast volume≥200 m L,in patients with serum creatinine(Scr)≥80μmol,or in patients who received intraoperative administration of salvianolate or PCI were higher than those in control group,with statistically significant differences(P<0.05).The experimental group was superior to the control group in improving the indexes of renal function after operation,and the difference was statistically significant(P<0.05).No study reported the incidence of adverse reactions(ADRs).The funnel plots of the incidence of CIN showed potential publication bias.The results of Egger’s linear regression showed that there was certain publication bias.Sensitivity analysis,funnel plot,and'trim and fill'showed that the results of this study were stable and reliable.Salvianolate combined with routine hydration showed definite clinical efficacy in the prevention of contrast-induced nephropathy.However,exact conclusion should be further verified by additional high-quality,multi-centre,and large-scale RCT studies.