CAJ | 학술논문

目的采用meta分析方法比较6％羟乙基淀粉130/0.4与晶体液在择期手术患者中的安全性及有效性。方法检索Medline、EMBASE、CENTRAL、CNKI以及万方数据库，检索时间自建库至2013年8月，收集择期手术患者中比较6％羟乙基淀粉130/0.4与晶体液的安全性及有效性的随机对照研究。主要评价指标包括：术中出血量、术后透析率和术中低血压发生率。次要评价指标包括：死亡率、围术期恶心呕吐发生率、凝血功能、肾功能和不良事件发生率。两位评价员独立筛查、评价并提取数据，采用RevMan 5.2软件对提取数据进行meta分析。结果共纳入10篇文献，其中英文文献8篇，中文文献2篇，共693例患者。其中7篇文献（共498例患者）比较了6％羟乙基淀粉130/0.4与平衡液的安全性和有效性：结果显示，6％羟乙基淀粉130/0.4可降低腰麻患者术中低血压（OR 0.31，95％ CI 0.13～0.75）及围术期恶心呕吐（OR 0.08，95％ CI 0.01～0.67）的发生率（ P＜0.05）；在全身麻醉或脊椎-硬膜外联合麻醉下，术中低血压、围术期恶心呕吐发生率、死亡率及术中出血量两种液体组比较差异无统计学意义（ P＞0.05）；在全身麻醉下术中尿量的评价上，研究结果间存在明显的异质性（ P＜0.00001，I2＝93％）。其中另3篇文献（共195例患者）比较了6％羟乙基淀粉130/0.4与生理盐水的安全性和有效性：结果显示，在术中出血量、术中低血压、围术期恶心呕吐发生率、凝血功能和肾功能指标及不良事件发生率上，两种液体组比较差异无统计学意义（ P＞0.05）。结论在择期手术患者中应用6％羟乙基淀粉130/0.4是安全有效的。
목적채용meta분석방법비교6％간을기정분130/0.4여정체액재택기수술환자중적안전성급유효성。방법검색Medline、EMBASE、CENTRAL、CNKI이급만방수거고，검색시간자건고지2013년8월，수집택기수술환자중비교6％간을기정분130/0.4여정체액적안전성급유효성적수궤대조연구。주요평개지표포괄：술중출혈량、술후투석솔화술중저혈압발생솔。차요평개지표포괄：사망솔、위술기악심구토발생솔、응혈공능、신공능화불량사건발생솔。량위평개원독립사사、평개병제취수거，채용RevMan 5.2연건대제취수거진행meta분석。결과공납입10편문헌，기중영문문헌8편，중문문헌2편，공693례환자。기중7편문헌（공498례환자）비교료6％간을기정분130/0.4여평형액적안전성화유효성：결과현시，6％간을기정분130/0.4가강저요마환자술중저혈압（OR 0.31，95％ CI 0.13～0.75）급위술기악심구토（OR 0.08，95％ CI 0.01～0.67）적발생솔（ P＜0.05）；재전신마취혹척추-경막외연합마취하，술중저혈압、위술기악심구토발생솔、사망솔급술중출혈량량충액체조비교차이무통계학의의（ P＞0.05）；재전신마취하술중뇨량적평개상，연구결과간존재명현적이질성（ P＜0.00001，I2＝93％）。기중령3편문헌（공195례환자）비교료6％간을기정분130/0.4여생리염수적안전성화유효성：결과현시，재술중출혈량、술중저혈압、위술기악심구토발생솔、응혈공능화신공능지표급불량사건발생솔상，량충액체조비교차이무통계학의의（ P＞0.05）。결론재택기수술환자중응용6％간을기정분130/0.4시안전유효적。
Objective To systematically review the safety and effectiveness of 6% hydroxyethyl starch (HES) 130/0.4 and crystalloid solution for the patients undergoing elective surgery .Methods We searched the Medline , EMBASE , CENTRAL , CNKI and Wanfang databases for randomized controlled trials involving comparison of the safety and effectiveness of 6% HES 130/0.4 and crystalloid solution for the patients undergoing elective surgery . The major evaluation indexes included intraoperative blood loss , postoperative incidence of dialysis and intraoperative incidence of hypotension . The secondary evaluation indexes included mortality , perioperative incidence of nausea and vomiting , coagulation function , renal function and incidence of adverse events .The two reviewers independently screened ,evaluated and extracted the data .Meta-analysis was performed using the Cochrane Collaboration’s RevMan 5.2 software .Results Ten trials involving 693 patients were included in our meta-analysis .Eight trials were in English and 2 trials were in Chinese .Comparison of the safety and effectiveness of 6% HES 130/0.4 and balanced solution was conducted in 7 trials (498 patients in total) ,and the results showed that 6% HES 130/0.4 reduced the intraoperative incidence of hypotension (OR 0.31 ,95% CI 0.13-0.75 ) and perioperative incidence of nausea and vomiting , (OR 0.08 , 95% CI 0.01 to 0.67 ) in the patients undergoing spinal anesthesia ( P< 0.05 );there was no significant difference in the intraoperative incidence of hypotension ,perioperative incidence of nausea and vomiting ,mortality ,and intraoperative blood loss under general anesthesia or combined spinal-epidural anesthesia between the two solution groups ( P> 0.05 );heterogeneity was found in the urine output under general anesthesia ( P<0.000 01 ,I2 =93% ) .The safety and effectiveness were compared between 6% HES 130/0.4 and normal saline in 3 trials (195 patients in total) and the results showed that there was no significant difference in the intraoperative blood loss ,intraoperative incidence of hypotension ,perioperative incidence of nausea and vomiting ,coagulation function ,renal function ,and incidence of adverse events between the two solution groups ( P> 0.05 ) .Conclusion 6% HES 130/0.4 is safe and effective when applied for the patients undergoing elective surgery .