注射用七叶皂苷钠治疗术后肿胀疗效和安全性的Meta分析  

Meta-analysis of Efficacy and Safety of Sodium Aescinate for Injection in the Treatment of Postoperative Swelling

作　　者：赵新才 杨全军[1] 卢进[1] 郭澄[1] 徐嵘[1] ZHAO Xincai;YANG Quanjun;LU Jin;GUO Cheng;XU Rong(Dept.of Pharmacy,Shanghai Municipal Sixth People’s Hospital,Shanghai 200233,China)

机构地区：[1]上海市第六人民医院药剂科,上海200233

出　　处：《中国药房》2018年第14期1983-1987,共5页China Pharmacy

基　　金：上海市临床药学重点专科建设项目(No.2017-373);上海市卫生计生系统重要薄弱学科建设计划项目(No.2016ZB0302-01);上海交通大学医学院医院药学科研基金项目(No.JDYX2017ZD001)

摘　　要：目的:系统评价注射用七叶皂苷钠治疗术后肿胀的疗效和安全性,为临床治疗提供循证参考。方法:计算机检索Cochrane图书馆、Pub Med、Web of Science、Embase、中国期刊全文数据库、中国生物医学文献数据库、万方数据库等,纳入常规治疗+注射用七叶皂苷钠(试验组)对比常规治疗+甘露醇或激素等(对照组)治疗术后肿胀的随机对照试验(RCT),提取相关资料并按照Cochrane系统评价员手册5.1.0评价质量后,采用Rev Man 5.3统计软件对数据进行Meta分析。结果:共纳入12项研究,合计1 615例患者。Meta分析结果显示,试验组患者总有效率[RR=1.23,95%CI(1.15,1.32),P<0.001]、术后肿胀程度评分[MD=-0.62,95%CI(-0.91,-0.33),P<0.001]、术后肿胀时间[MD=-3.65,95%CI(-4.10,-3.20),P<0.001]、术后VAS评分[MD=-1.24,95%CI(-2.06,-0.42),P=0.003]、不良反应发生率[RR=0.39,95%CI(0.17,0.89),P=0.02]均显著优于对照组,差异均有统计学意义;两组患者术后CRP水平比较,差异无统计学意义[MD=-0.92,95%CI(-2.51,0.67),P=0.26]。结论:在常规治疗的基础上给予注射用七叶皂苷钠治疗术后肿胀疗效显著,可降低术后肿胀程度,缩短术后肿胀时间,减轻术后疼痛,且不增加不良反应。OBJECTIVE:To systematically evaluate the efficacy and safety of Sodium aescinate for injection in the treatment of postoperative swelling,and to provide evidence-based reference for the clinical treatment.METHODS:Retrieved from Cochrane Library,PubMed,Web of Science,Embase,CNKI,CBM and Wanfang database,randomized controlled trials(RCTs)about routine treatment+Sodium aescinate for injection(test group)vs.routine treatment+mannitol or hormone(control group)in the treatment of postoperative swelling were collected.After data extraction and quality evaluation with Cochrane system evaluator manual 5.1.0,Meta-analysis was conducted by using Rev Man 5.3 statistical software.RESULTS:Totally 12 studies were included,involving 1 615 patients.Results of Meta-analysis showed that the total response rate[RR=1.23,95%CI(1.15,1.32),P<0.001],postoperative swelling score[MD=-0.62,95%CI(-0.91,-0.33),P<0.001],swelling time[MD=-3.65,95%CI(-4.10,-3.20),P<0.001],VAS score[MD=-1.24,95%CI(-2.06,-0.42),P=0.003]and the incidence of ADR[RR=0.39,95%CI(0.17,0.89),P=0.02]of trial group were significantly better than those of control group,with statistical significance.There was no statistical significance in the level of CRP between 2 groups after surgery[MD=-0.92,95%CI(-2.51,0.67),P=0.26].CONCLUSIONS:Based on routine treatment,Sodium aescinate for injection has good efficacy for postoperative swelling,can relieve postoperative swelling,shorten the duration of postoperative swelling and relieve postoperative pain but not increacing ADR.

关 键 词：注射用七叶皂苷钠 术后肿胀 疗效 安全性 META分析 

分 类 号：R969[医药卫生—药理学]