中国临床药学杂志

目的对国外已发表的有关比较两种含地塞米松的预处理方案预防紫杉醇过敏反应效果的高质量的临床研究,用Meta分析的方法进行综合定量分析,选择出一种较为有效的预防方案,为医师选择预防方案时提供参考依据。方法收集PubMed建库日期2000年4月至2010年5月27日发表的有关比较两种含地塞米松的预处理方案对紫杉醇过敏性反应预防效果的文献,根据Meta分析的要求对检索到的原始文献进行质量评估,对符合要求的所有文献研究结果进行Meta分析,评估两种不同预处理方案降低过敏反应和严重过敏反应发生率的优势比(OR),评价两组方案对患者过敏反应发生率的影响。结果符合纳入标准的文献共有4篇,总样本量为666例,其中在紫杉醇用药前2次(12 h和6 h)口服地塞米松组368例,发生过敏反应65例,严重过敏反应8例;在紫杉醇用药前1次(30 rain)静脉注射地塞米松组298例,发生过敏反应70例,严重过敏反应20例;所有过敏反应发生率的合并OR为0.69,95%可信区间为0.46—1.02;严重过敏反应发生率的合并OR为O.32,95%可信区间为0.14～0.75。结论临床进行紫杉醇过敏反应预处理时,应严格按照说明书所给出的经典方案,即采用给药前12 h与给药前6 h均给予口服地塞米松的方案。

AIM All studies that had been published in foreign countries were searched.All these studies were about comparing the preventive effect of two regimens containing dexamethasone to allergy reactions induced by paclitaxel. Then a comprehensive and quantity analysis by means of meta-analysis was made,aiming to choose a effective prevention regimens and provide reference to physicians which could help them to choose prevention regimens.METHODS We screened and evaluated all the studies that have been published in PubMed from April,2000 to May 27,2010 using metaanalysis as a tool.All these studies were regarded to comparing the preventive effect of two regimens containing dexamethasone to allergy reactions induced by paclitaxel.We calculated the odds radio(OR) of the incidence of allergy and serious allergy which could be lowed by two different prevention regimens.RevMan 4.2 software was applied to process data. RESULTS There were four studies with 666 cases meeting our analysis criterion.A total of 368 cases of those cases received two oral doses of dexamethasone prior to administration of paclitaxel,in which 65 cases happened allergy reactions and 8 cases happened serious allergy reactions.While followed by single dose of intravenous dexamethasone,30 min prior to administration of paclitaxel,the number of allergy reaction and serious allergy reaction cases were 70 and 20 respectively. The incorporate OR of allergy reactions was 0.69,witha95%confidence interval(0.46-1.02).The incorporate OR of serious allergy reactions was 0.32,with a 95%confidence interval(0.14 - 0.75).CONCLUSION When using dexamethasone to prevent allergy reactions induced by paclitaxel,the effects have no statistical significances between oral group and intravenous group;but the incidence of serious allergy reactions in oral group are significantly lower than intravenous group(68%lower).