参附注射液用于成人脓毒性休克患者早期复苏的Meta分析

Meta-analysis of the Clinical Efficacy of Shenfu Injection in the Treatment of Septic Shock

目的:采用Meta分析方法评价参附注射液用于成人脓毒性休克患者早期复苏的疗效。方法:计算机检索The Cochrane Library(2017年3期)、PubMed、Embase、CNKI、VIP、万方数据库(Wan Fang Data)中关于参附注射液治疗成人脓毒性休克的随机对照试验(RCTs),检索时间为建库至2017年3月。由两位评价者按照纳入与排除标准独立筛选文献、提取资料并评价偏倚风险后,采用RevMan 5.3软件进行统计分析。结果:共纳入8个RCTs,包括587例患者。Meta分析结果显示:(1)治疗组(常规疗法+参附注射液)与对照组(常规疗法)相比,28 d病死率的差异无统计学意义[OR=0.73,95%CI(0.44,1.21),P=0.22];(2)两组提高治疗后6 h的平均动脉压(MAP)的差异无统计学意义[MD=7.12,95%CI(-3.08,17.31),P=0.17];(3)与对照组相比,治疗组可显著改善治疗后6h的血乳酸值(Lac)[MD=-1.92,95%CI(-3.34,-0.51),P=0.008]。5个结局指标因文献间存在临床异质性或仅1项研究提及,仅作描述性分析,结果显示:(1)与对照组相比,治疗组可显著增加治疗后6 h的尿量(P<0.05);(2)与对照组相比,治疗组可显著提高治疗后6 h的中心静脉压(CVP)(P<0.05);(3)3项研究比较了治疗后6 h的上腔静脉血氧饱和度(ScvO_2)或混合静脉血氧饱和度(SvO_2),综合结果尚不能得出肯定结论(P>0.05);(4)2项研究治疗组6 h的乳酸清除率(LAC)均高于对照组,差异均有统计学意义(P<0.05);(5)1项研究提及不良反应发生情况,结果显示两组均无不良发应发生。结论:参附注射液联合常规疗法治疗脓毒性休克患者对提高治疗后6h的CVP、尿量,降低Lac,提高LAC均优于单用常规疗法;对提高治疗后6 h的ScvO_2或SvO_2,尚不能得出肯定结论;对降低28 d病死率,提高治疗后6 h的MAP与单用常规疗法比较未显示出优势。受纳入研究数量和治疗所限,上述结论需开展更多高质量研究予以验证。

Objective： To systematically evaluate the clinical efficacy of Shenfu injection in the treatment of septic shock. Methods： We electronically searched databases including Pub Med,The Cochrane Library（ Issue 3,2017）,Embase,CNKI,VIP,and Wan Fang Data to collect randomized controlled trials（ RCTs） about shenfu injection for septic shock from inception to March 2017. Two reviewers independently screened literature,extracted data and assessed the risk of bias of included studies. Then,Meta-analysis was performed using Rev Man 5. 3 software. Results： Eight RCTs involving587 patients were included. The results of Meta-analysis showed that：（ 1） no statistical difference was found between two groups of death in 28 days [OR = 0. 73,95% CI（ 0. 44,1. 21）,P = 0. 22].（ 2） no statistical difference was found between two groups of improving MAP（ 6 h after treatment） [MD = 7. 12,95% CI（-3. 08,17. 31）,P = 0. 17].（ 3） the statistical differences were found between two groups of improving Lac（ 6 h after treatment） [MD =-1. 92,95% CI（-3. 34,-0. 51）,P = 0. 008]. Due to the clinical heterogeneity,three outcome indexes were only descriptive analysis.The results showed that：（ 1） compared with control group,treatment group could significantly improve urinary volume（ 6 h after treatment）（ P 0. 05）;（ 2） treatment group could significantly improve CVP（ 6 h after treatment）（ P 0. 05）.（ 3）no sure conclusion was made for treatment group of ScvO_2 or SvO_2（ P 0. 05）.（ 4） treatment group could significantly improve LAC（ 6 h after treatment）（ P 0. 05）.（ 5） only one study referred to the occurrence of adverse reactions,and the results showed that no adverse events occurred in either group. Conclusion： Current evidence shows,Shenfu injection could effectively improve CVP,urinary volume,LAC（ 6 h after treatment） and reduce Lac（ 6 h after treatment）. For improving ScvO_2 or SvO_2（ 6 h after treatment）,no sure conclusion was made. Compared with the conventional treatment,combined Shenfu injection did not show the advantage for death in 28 days and MAP（ 6 h after treatment）. Due to limited quality and quantity of the included studies,more high quality studies are needed to verify the above conclusion.