【摘要】 目的系统荟萃分析奥马珠单克隆抗体(单抗)治疗慢性特发性荨麻疹的疗效与安全性。方法采用Pub Med数据库、Cochrane图书馆临床对照试验数据库、中国生物医学文献数据库、中国知网全文数据库及万方科技期刊全文数据库等收集文献,研究文献为奥马珠单抗治疗慢性特发性荨麻疹的随机双盲对照试验,观察对象为年龄大于12岁,经抗H1受体拮抗剂治疗未达到满意效果的慢性特发性荨麻疹患者。应用Rev Man5.0.24软件对数据进行meta分析,评价奥马珠单抗的疗效及安全性。结果共纳入4项随机双盲对照试验,1 128例患者。各组7 d荨麻疹活动性评分(UAS7)<6分的病例数比较:75 mg奥马珠单抗治疗组优于安慰剂对照组,差异有统计学意义[相对危险度(RR)=1.73,95%可信区间(95%CI):1.10~2.71,P=0.020],300 mg奥马珠单抗治疗组优于75 mg奥马珠单抗治疗组,差异有统计学意义(RR=0.45,95%CI:0.33~0.60,P=0.001);各组治疗后UAS7降低值比较:75 mg奥马珠单抗治疗组优于安慰剂对照组,差异有统计学意义[均方差(MD)=5.03,95%CI:1.72~8.34,P=0.003],300 mg奥马珠单抗治疗组优于75 mg奥马珠单抗治疗组,差异有统计学意义(MD=-7.73,95%CI:-11.15~-4.30,P=0.001);各组1周瘙痒严重程度评分比较:75 mg奥马珠单抗治疗组优于安慰剂对照组,差异有统计学意义(MD=1.75,95%CI:0.55~2.95,P=0.004),300 mg奥马珠单抗治疗组优于75 mg奥马珠单抗治疗组,差异有统计学意义(MD=-3.35,95%CI:-4.97~-1.73,P=0.001)。300 mg奥马珠单抗治疗组总的不良反应和严重不良反应发生情况与安慰剂对照组比较,差异均无统计学意义(RR=1.07、0.39,95%CI:0.97~1.18、0.39~1.38,P=0.200、0.340)。75 mg奥马珠单抗治疗组总的不良反应发生情况与300 mg奥马珠单抗治疗组比较,差异也无统计学意义[RR=0.91,95%CI:0.78~1.06,P=0.240]。结论慢性特发性荨麻疹患者在常规治疗未奏效时加用奥马珠单抗治疗可改善疗效,且安全性高。更多还原

【Abstract】 Objective To perform the systematical meta analysis on the efficacy and safety of omalizumab for treating chronic idiopathic urticaria(CIU). Methods The double blind randomized controlled trials(RCT) on omalizumab for treating CIU were retrieved from the Cochrane Central Register of Controlled Trials,Pub Med,CBM,CNKI and Wanfang database. The observation subjects were the CIU patients aged over 12 years old without satisfactory effect to the H1 receptor antagonist therapy.The obtained data were performed the meta analysis by using the Rev Man 5.0 software. The curative effect and safety of omalizumab were evaluated. Results 4 double blind RCT were included involving 1 128 patients. In the comparison of urticaria activity score on 7 d(UAS7) <6 points among various groups,the omalizumab 75 mg group was superior to the placebo group and the control group[RR=1.73,95%CI(1.10~2.71),P=0.020] and the omalizumab 300 mg group was superior to the omalizumab 75 mg group,the differences were statistically significant[RR=0.45,95%CI(0.33~0.60),P=0.001];in the comparison of UAS7 decreased values after treatment among various groups,the omalizumab 75 mg group was superior to the placebo group and the control group[MD=5.03,95%CI(1.72~8.34),P=0.003] and the omalizumab 300 mg group was superior to the omalizumab 75 mg group,the differences were statistically significant[MD=-7.73,95%CI(-11.15~-4.30),P<0.001];in the comparison of 1-week itching degrees among various groups,the omalizumab 75 mg group was superior to the placebo group and the control group[MD=1.75,95%CI(0.55~2.95),P=0.004] the omalizumab 300 mg group was superior to the omalizumab 75 mg group,the differences were statistically significant[MD=-3.35,95%CI(-4.97~-1.73),P<0.00]. The total adverse reactions and severe adverse reactions had no statistical difference between the omalizumab 300 mg group with the placebo group and the control group(RR=1.07,0.39,95%CI:0.97~1.18,0.39~1.38,P=0.200,0.340). Furthermore,the occurrence situation of the total adverse reactions also had no statistical difference between the omalizumab 75 mg group and omalizumab 300 mg group[RR=0.91,95%CI(0.78~1.06),P=0.240]. Conclusion Adding omalizumab in CIU patients without effect to the conventional therapy can improve the curative effect with high safety.更多还原