药物不良反应杂志
藥物不良反應雜誌
약물불량반응잡지
ADVERSE DRUG REACTIONS JOURNAL
2014年
2期
100-106
,共7页
白蛋白%肝硬化%腹水%Meta分析
白蛋白%肝硬化%腹水%Meta分析
백단백%간경화%복수%Meta분석
Albumins%Cirrhosis%Ascites%Meta-analysis
目的 评价人血白蛋白治疗肝硬化腹水的疗效与安全性. 方法 以“cirrhosis”、“ascites”、“albumin”、“randomized controlled trials”和“肝硬化”、“腹水”、“人血白蛋白”、“随机对照试验”为检索词,检索Cochrane图书馆、PubMed、EMBase、Web of Science、中国生物医学文献数据库、中国知网、维普数据库和万方数据库,收集用人血白蛋白治疗肝硬化腹水的随机对照试验并全文发表的论文.根据纳入标准对文献进行筛选和评估,采用RevMan 5.2软件进行统计分析,计算相对危险度(RR)和95％置信区间(CI).试验组静脉滴注人血白蛋白,对照组静脉滴注等容积0.9％氯化钠注射液或人工胶体液(如羟乙基淀粉、葡聚糖、聚明胶肽等)或不用药.比较试验组与对照组的疗效与安全性. 结果 共检索到相关文献688篇,筛选后最终纳入13篇,英文11篇,中文2篇,共1 152例患者.Meta分析结果显示,试验组低钠血症发生率(7.67％)低于对照组(14.66％),差异有统计学意义(RR =0.60,95％CI:0.41 ～0.88,P=0.008);试验组和对照组腹水消退率(91.67％比88.44％)、肾损伤发生率(5.12％比6.93％)、感染发生率(5.04％比4.93％)、肝性脑病发生率(5.90％比5.00％)、消化道出血发生率(2.57％比2.73％)、高钾血症发生率(1.09％比6.45％)、再住院率(52.15％比61.82％)、因腹水再住院率(38.68％比41.85％)、住院病死率(3.80％比4.54％)、总病死率(21.40％比24.83％)差异均无统计学意义(均P＞0.05).试验组与对照组不良反应发生率(3.13％比3.05％)差异无统计学意义(P=0.97). 结论 目前的研究未证明使用人血白蛋白与人工胶体液或晶体液治疗肝硬化腹水的疗效及安全性有明显差异.
目的 評價人血白蛋白治療肝硬化腹水的療效與安全性. 方法 以“cirrhosis”、“ascites”、“albumin”、“randomized controlled trials”和“肝硬化”、“腹水”、“人血白蛋白”、“隨機對照試驗”為檢索詞,檢索Cochrane圖書館、PubMed、EMBase、Web of Science、中國生物醫學文獻數據庫、中國知網、維普數據庫和萬方數據庫,收集用人血白蛋白治療肝硬化腹水的隨機對照試驗併全文髮錶的論文.根據納入標準對文獻進行篩選和評估,採用RevMan 5.2軟件進行統計分析,計算相對危險度(RR)和95％置信區間(CI).試驗組靜脈滴註人血白蛋白,對照組靜脈滴註等容積0.9％氯化鈉註射液或人工膠體液(如羥乙基澱粉、葡聚糖、聚明膠肽等)或不用藥.比較試驗組與對照組的療效與安全性. 結果 共檢索到相關文獻688篇,篩選後最終納入13篇,英文11篇,中文2篇,共1 152例患者.Meta分析結果顯示,試驗組低鈉血癥髮生率(7.67％)低于對照組(14.66％),差異有統計學意義(RR =0.60,95％CI:0.41 ～0.88,P=0.008);試驗組和對照組腹水消退率(91.67％比88.44％)、腎損傷髮生率(5.12％比6.93％)、感染髮生率(5.04％比4.93％)、肝性腦病髮生率(5.90％比5.00％)、消化道齣血髮生率(2.57％比2.73％)、高鉀血癥髮生率(1.09％比6.45％)、再住院率(52.15％比61.82％)、因腹水再住院率(38.68％比41.85％)、住院病死率(3.80％比4.54％)、總病死率(21.40％比24.83％)差異均無統計學意義(均P＞0.05).試驗組與對照組不良反應髮生率(3.13％比3.05％)差異無統計學意義(P=0.97). 結論 目前的研究未證明使用人血白蛋白與人工膠體液或晶體液治療肝硬化腹水的療效及安全性有明顯差異.
목적 평개인혈백단백치료간경화복수적료효여안전성. 방법 이“cirrhosis”、“ascites”、“albumin”、“randomized controlled trials”화“간경화”、“복수”、“인혈백단백”、“수궤대조시험”위검색사,검색Cochrane도서관、PubMed、EMBase、Web of Science、중국생물의학문헌수거고、중국지망、유보수거고화만방수거고,수집용인혈백단백치료간경화복수적수궤대조시험병전문발표적논문.근거납입표준대문헌진행사선화평고,채용RevMan 5.2연건진행통계분석,계산상대위험도(RR)화95％치신구간(CI).시험조정맥적주인혈백단백,대조조정맥적주등용적0.9％록화납주사액혹인공효체액(여간을기정분、포취당、취명효태등)혹불용약.비교시험조여대조조적료효여안전성. 결과 공검색도상관문헌688편,사선후최종납입13편,영문11편,중문2편,공1 152례환자.Meta분석결과현시,시험조저납혈증발생솔(7.67％)저우대조조(14.66％),차이유통계학의의(RR =0.60,95％CI:0.41 ～0.88,P=0.008);시험조화대조조복수소퇴솔(91.67％비88.44％)、신손상발생솔(5.12％비6.93％)、감염발생솔(5.04％비4.93％)、간성뇌병발생솔(5.90％비5.00％)、소화도출혈발생솔(2.57％비2.73％)、고갑혈증발생솔(1.09％비6.45％)、재주원솔(52.15％비61.82％)、인복수재주원솔(38.68％비41.85％)、주원병사솔(3.80％비4.54％)、총병사솔(21.40％비24.83％)차이균무통계학의의(균P＞0.05).시험조여대조조불량반응발생솔(3.13％비3.05％)차이무통계학의의(P=0.97). 결론 목전적연구미증명사용인혈백단백여인공효체액혹정체액치료간경화복수적료효급안전성유명현차이.
Objective To evaluate the efficacy and safety of human serum albumin in treatment of patients with ascites due to cirrhosis.Methods Cochrane Library,PubMed,EMBase,Web of Science,CBM,CNKI,VIP,Wanfang Database were searched by using keywords "ascites","albumin","cirrhosis" and "randomized controlled trials".The full text papers of randomized controlled trials (RCT) about human albumin treatment in patients with ascites due to cirrhosis were collected.The articles were selected and evaluated according to the inclusion criteria.The related information was statistically analyzed with RevMan 5.2 software,the relative risk (RR) and 95％ confidence intervals (CI) were calculated.The patients in experimental group received Ⅳ infusion of human serum albumin.The patients in control group received isotonic 0.9％ sodium chloride injection or artificial colloid (such as hetastarch,dextran,polygeline etc.) or no drugs.The efficacy and safety were compared between the 2 groups.Results A total of 688 related articles were searched and 13 RCT were enrolled into the study finally.There were 11 articles in English and 2 in Chinese.A total of 1 152 patients were entered in the study.The results of Meta-analysis showed that the incidence of hyponatremia in the experimental group (7.67％) was lower than that in the control group (14.66％),the difference was statistically significant(RR =0.60,95％ CI:0.41 ～ 0.88,P =0.008).The differences of the ascites regression rates (91.67％ vs.88.44％),the incidences of renal injury (5.12％ vs.6.93％),the incidences of infection (5.04％ vs.4.93％),the incidences of hepatic encephalopathy (5.90％ vs.5.00％),the incidences of hemorrhage of digestive tract (2.57％ vs.2.73％),the incidences of hyperpotassemia (1.09％ vs.6.45％),the rehospitalization rates (52.15％ vs.61.82％),the rehospitalization rates due to ascites (38.68％ vs.41.85％),the hospital mortality (3.80％ vs.4.54％),and the total mortality rates (21.40％ vs.24.83％) between the experimental group and the control group were not statistically significant (all P ＞ 0.05).The difference of incidence of adverse reactions between the experimental group and the control group (3.13％ vs.3.05％) was not statistically significant (P =0.97).Conclusion The present study can not demonstrate the obvious differences in curative effect and safety between the therapies of Ⅳ infusion of human serum albumin and artifical colloid or chloride in treatment of patients with ascites due to cirrhosis.
