目的系统评价非索非那定改善变应性鼻炎症状的有效性及评价用药安全性。方法计算机检索OVID、The Cochrane Library、Pub Med、EMbase、CNKI和万方数据库,收集有关非索非那定对变应性鼻炎(过敏性鼻炎)疗效的随机对照试验(RCT),检索日期截止到2014年12月31日。按Cochrane系统评价方法,评价所纳入研究的文献质量,并提取有效数据后采用Rev Man5.1软件进行Meta分析。结果最终共纳入9个RCT研究,合计3776患者。Meta分析结果显示:非索非那定可明显改善变应性鼻炎总症状(TSS)[SMD=-0.42;95%CI(-0.49,-0.36),〈0.00001];改善清晨瞬总症状[SMD=-0.29;95%CI(-0.37,-0.22),p〈0.00001];改善单个鼻症状:鼻塞[SMD=-0.24;95%CI(-0.21,-0.07),p〈0.0001],流涕[SMD=-0.24;95%CI(-0.31,-0.17),p〈0.00001],打喷嚏[SMD=-0.37;95%CI(-0.44,-0.30),p〈0.00001],鼻痒[SMD=-0.31;95%CI(-0.38,-0.24),p〈0.00001]。非索非那定的不良反应发生率与安慰剂组相似,无统计学差异[OR=1.02;95%CI(.86,1.21),p=0.84]。结论非索非那定治疗变应性鼻炎安全有效,可明显改善变应性鼻炎总体症状,改善生活质量。
Objective To evaluate the effectiveness of Fexofenadine in the treatment of allergic rhinitis(AR),so as to providehigh quality evidence for formulating the rational AR therapy. Methods:Databases including OVID,The Cochrane Library(Issue 3,2012),Pub Med,EMbase,CNKI and Wan Fang Data were searched to collect randomized controlled trials(RCTs)on Fexofenadinein AR published before december 2014. Two reviewers independently screened literature according to the inclusion and exclusion crite-ria,extracted data,and evaluated the methodological quality of the included studies. Then the meta-analysis was conducted usingRev Man5.1 software. Results:A total of 9 trials involving 3776 patients were included. The results of meta-analyses showed that:asignificant reduction of the daily reflective total symptom scores(TSS)[SMD=-0.42;95%CI(-0.49,-0.35),p 0.00001];Positiveresults were also found for morning instantaneous TSS[SMD=-0.28;95%CI(-0.36,-0.21),p〈0.00001];and individual nasal symp-tom scores{congestion[SMD=-0.17;95%CI(- 0.24,0.10),p〈0.00001],rhinorrhea[SMD=-0.24;95% CI(-0.31,-0.17),p〈0.00001],sneezing[SMD=-0.37;95% CI(-0.44,-0.30),p〈0.00001],and itching[SMD =-0.31;95% CI(-0.38,-0.24),p〈0.00001]}. Conclusion:This study has major strengths to evaluate the efficacy and safety of fexofenadine in the treatment of AR bymeans of a meta-analysis of RCTs;All of these values encourage the recommendation of fexofenadine for AR. Further research fo-cused on the benefits and disadvantages for a pediatric population is needed.