参附注射液治疗感染性休克的系统评价

Systematic review of Shenfu injection for septic shock

评价参附注射液配合西医常规治疗感染性休克的临床疗效和安全性。计算机检索Cochrane图书馆,Medline,EMbase,CBM,CNKI,VIP,万方数据库,由2位研究者独立筛选和提取资料,根据Cochrane Reviewer's Handbook 5.0评价标准和工具评价纳入文献质量,用RevMan 5.1软件进行数据分析。共纳入6个随机对照试验,共计499名患者。所有研究均未提及随机方法、分配隐藏、盲法及失访。Meta分析结果显示参附注射液加用常规治疗对感染性休克患者的SBP(分别为OR=9.00,95%Cl[3.89,14.11];OR=20.28,95%Cl[16.46,24.10])和DBP(分别为OR=11.25,95%Cl[7.65,14.85];OR=8.17,95%Cl[5.21,11.13])优于单用常规治疗组;对纠正休克(OR=4.60,95%Cl[1.88,11.28];OR=0.88,95%Cl[0.16,4.87];OR=1.02,95%Cl[0.27,3.93];OR=1.65,95%Cl[0.42,6.42])及降低HR(OR=-29.71,95%Cl[-40.51,-18.91];OR=-18.00,95%Cl[-27.16,-8.84];OR=8.00,95%Cl[1.96,14.04])的疗效纳入研究间结果不一致,尚不能得到肯定结论;对提高MAP(OR=-0.10,95%Cl[-2.34,2.14])、降低CI(OR=0.00,95%Cl[-1.24,1.24]),与单用常规组比较未显示出优势。该组纳入研究对参附注射液治疗期间的不良反应/不良事件报告不够;研究可能存在发表偏倚;常规治疗的基础上加用参附注射液可以提高感染性休克患者的血压,但是对于纠正休克有效率及HR尚不能得到肯定结论;而且由于本系统评价纳入研究样本量小且质量较低,上述结论尚需随机双盲对照试验加以证实。

To assess the efficacy and safety of Shenfu injection for septic shock. All clinical studies of Shenfu injection for sep- tic shock were searched from Cochrane library, Medline, EMbase, CBM, CNKI, Wanfang and VIP. Quality assessment and informa- tion extraction were done by two independent screening. The quality of the included documents was evaluated by the Cochrane Collabo- ration＇s tool for assessing risk of bias and allocation concealment. Revman 5.1.4 software was used for data analysis. A total of 6 ran- domized controlled trials were included （499 patients）, in which, 6 studies did not mention allocation concealment, blind and loss-up information. Meta-analysis showed that the Shenfu injection group was better than the conventional treatment group in SBP （ OR = 9. 00,95% CI[ 3.89, 14. 11 ] ; OR = 20. 28,95 % C1[ 16.46, 24. 10 ], respectively） and DBP （ OR = 11.25,95% C1 [ 7.65, 14. 85 ] ; OR = 8.17,95% C1 [ 5.21, 11.13 ], respectively） ; in improving shock symptom （ OR = 4. 60,95% C1 [ 1.88, l 1.28 ] ; OR = O. 88, 95 % C1 [ 0. 16,4. 87 ] ; OR = 1.02,95% C1 [ 0. 27, 3.93 ] ; OR = 1.65,95% C1 [ 0. 42, 6.421 ） and reducing HR （ OR = - 29.71,95 % CI[ - 40. 51, - 18.91 ] ; OR = - 18.00,95% CI[ - 27.16, - $. 84 ] ）, （ OR = 8. O0,95% CI[ 1.96, 14. 04 ] ）, there was inconsisten- cy between the two groups ; the Shenfu injection group showed no advantage in MAP（ OR = -O. 10,95% CI[ -2. 34, 2. 14 ] ）and CI （OR = 0. 00 ,95% Cl[ - 1.24, 1. 241 ）. ADR/AE information of Shenfu injection was not fully reported. This study may exist pubh- cation bias. Shenfu injection on the basis of conventional treatment can improve blood pressure of the treatment of septic shock; we can not get a positive conclusion in improving shock symptom and HR. Also, due to the sample size of included studies were small and of lower quality, conclusions above still need high-qualified randomized, double-blind, controlled trials be confirmed.