摘要目的 系统评价(Meta分析)奥马珠单抗治疗慢性自发性荨麻疹(CSU)的疗效及安全性.方法 在PubMed、Clinicaltrials.gov、the Cochrane Database of Systematic Reviews和the Cochrane Central Register of Controlled Trials等数据库搜索关于奥马珠单抗治疗CSU疗效和安全性的随机对照临床试验(RCT).2位系统评价员根据纳入与排除标准独立筛选文献,提取资料并评价纳入RCT的质量后,采用RevMan 5.3软件进行Meta分析,比较奥马珠单抗75、150、300、600 mg(1个月)剂量亚组与安慰剂组之间及合并剂量后的奥马珠单抗组与安慰剂组之间的疗效及安全性.结果 共纳入7个RCT,共1 365例病例.结果显示,奥马珠单抗组及各剂量亚组在改善1周荨麻疹活动评分(UAS7)、1周风团数量评分方面均优于安慰剂组(P＜0.05);奥马珠单抗组及75、150、300 mg亚组在改善1周瘙痒严重程度评分(ISS)、主要症状完全控制率方面优于安慰剂组(P＜0.05),尚不能认为600 mg亚组优于安慰剂组(P=0.07);奥马珠单抗组及150、300 mg亚组在改善皮肤病生活质量指数(DLQI)方面均优于安慰剂组(P＜0.05),尚不能认为75 mg亚组优于安慰剂组(P=0.50).奥马珠单抗组及各剂量亚组的一般不良事件发生率、严重不良事件发生率与安慰剂组差异均无统计学意义(P＞0.05).结论 奥马珠单抗可改善CSU患者的临床症状及生活质量,在改善UAS、ISS、风团数量评分、DLQI和控制主要症状(UAS=0)方面均有效,安全性高;皮下注射150 mg/月或300 mg/月奥马珠单抗改善CSU患者临床症状及生活质量的效果最佳.

abstractsObjective To evaluate the efficacy and safety of omalizumab on the treatment of chronic spontaneous urticaria (CSU) by systemic review and meta-analysis.Methods Electronic databases,such as PubMed,Clinicaltrials.gov,the Cochrane Database of Systematic Reviews,and the Cochrane Central Register of Controlled Trials,were searched to collect randomized controlled trials (RCTs) about the efficacy and safety of omalizumab in the treatment of CSU.Two reviewers independently screened RCTs according to the inclusion and exclusion criteria,extracted data,and assessed the quality of the included RCTs.And then,a meta-analysis was carried out by using RevMan 5.3 software for comparisons of the efficacy and safety of the 75-,150-,300-,600-mg omalizumab groups versus the placebo group after 1-month treatment,as well as the total omalizumab group versus the placebo group.Results A total of 7 RCTs involving 1 365 patients were included in this meta-analysis.The results showed that the total omalizumab group and different omalizumab subgroups were superior in improving the urticaria activity score of 7 days (UAS7) and wheal number score of 7 days to the placebo group (all P ＜ 0.05).For the improvement in the itch severity score (ISS) of 7 days and complete response rate for main symptoms (UAS7 =0),the total omalizumab group,75-,150-and 300-mg omalizumab groups were superior to the placebo group (all P ＜ 0.05),but there were no significant differences between the 600-mg omalizumab group and the placebo group (P =0.07).The dermatology life quality index (DLQI) was better in the total omalizumab group,150-and 300-mg omalizumab groups than in the placebo group (all P ＜ 0.05),but no significant difference was observed between the 75-mg omalizumab group and the placebo group (P =0.50).There were no significant differences in the incidence of common adverse events or serious adverse events between the total omalizumab group as well as the 75-,150-and 300-mg omalizumab subgroups and the placebo subgroup (all P ＞ 0.05).Conclusions Omalizumab can improve clinical symptoms and life quality of patients with CSU,and is effective in improving the UAS,ISS,wheal number score,DLQI and complete response rate for main symptoms (UAS =0) with high safety.Subcutaneous injection of omalizumab at a dose of 150 or 300 mg/month shows the best efficacy in improving the clinical symptoms and life quality of patients with CSU.