白三烯受体拮抗剂孟鲁司特对皮肤斑贴试验反应的影响

Effect of a leukotriene receptor antagonist, montelukast, on skin patch test reactions

目的 探究白三烯受体拮抗剂孟鲁司特对甲醛阳性皮肤斑贴试验的影响.方法 采用随机、双盲、安慰剂对照试验.147例1％甲醛斑贴试验阳性（＋＋）患者随机分为两组,孟鲁司特组77例患者口服孟鲁司特10mg每日1次,连续14 d,安慰剂组70例口服安慰剂1片每日1次,连续14 d.在用药第11天进行再次斑贴试验,服药后第14天判读斑贴试验结果.数据分析在意向性分析人群中进行.统计学分析采用采用SPSS 17.0版软件x2检验及连续性校正检验.结果 孟鲁司特组完成试验75例,安慰剂组完成试验67例.阳性程度改变：孟鲁司特组有70例患者斑贴试验反应程度没有改变,安慰剂组有60例患者反应程度没有改变,两组差异无统计学意义（x2=0.968,P＞ 0.05）.阳性率改变：孟鲁司特组有75例患者经干预后斑贴试验反应仍呈阳性表现,安慰剂组有67例患者经干预后斑贴试验反应仍呈阳性表现（75/77比67/70,x2=0.012,P＞0.05）.结论 白三烯受体拮抗剂孟鲁司特对甲醛阳性皮肤斑贴试验反应无抑制作用.

Objective To evaluate the effect of a leukotriene receptor antagonist,montelukast,on positive skin patch test reactions to formaldehyde.Methods A randomized,double-blind,placebo-controlled trial was conducted.Totally,147 patients with positive （＋＋） patch test reactions to 1% formaldehyde were recruited in this study,and randomly divided into two groups：montelukast group （n =77） and placebo group （n =70）.Patients in the montelukast group took montelukast 10 mg once daily for 14 days,and those in the placebo group took placebo 10 mg once daily for 14 days.Patch tests were conducted again at day 11,and the results of patch tests were read at day 14.Data analysis was carried out on the intention-to-treat （ITT） population,and statistical analysis was done by chi-square test and continuitycorrected chi-square test with the SPSS software version 17.0.Results Seventy-five out of 77 patients in the montelukast group and 67 out of 70 patients in the placebo group completed the trial.There was no significant difference in the proportion of patients experiencing no changes in the degree of positive reactions to formaldehyde between the montelukast group and placebo group （70/77 vs.60/70,x2 =0.968,P 〉 0.05）.Similarly,no statistical difference was observed in the percentage of patients experiencing no changes in positive patch test reactions to formaldehyde between the montelukast group and placebo group （75/77 vs.67/70,x2 =0.012,P 〉 0.05）.Conclusion The leukotriene receptor antagonist montelukast exerts no inhibiting effect on positive patch test reactions to formaldehyde.