摘要
目的:系统评价奥马珠单抗在儿童中重度过敏性哮喘治疗中的有效性和安全性。方法:计算机检索中国知网、万方数据库、PubMed、Cochrane Controlled Register of Trials(CENTRAL)及Embase数据库,检索时间均为建库至2021年3月,纳入奥马珠单抗治疗儿童中重度过敏性哮喘的随机对照试验(研究组患儿使用奥马珠单抗治疗;对照组患儿使用其他治疗过敏性哮喘的药物或安慰剂),由2名评价员按纳入与排除标准筛选文献、提取资料,采用Rev Man 5.3软件进行荟萃分析(Meta分析)。结果:最终纳入8篇文献,包括1756例患儿。Meta分析结果显示,有效性方面,研究组患儿的哮喘恶化发生率(以恶化风险人日数表示恶化发生率:RR=0.68,95%CI=0.55~0.85,P=0.0007;以发生恶化患儿所占百分比表示恶化发生率:RR=0.54,95%CI=0.45~0.66,P<0.00001)显著低于对照组,哮喘全球疗效评估(GETE)优良率(RR=1.39,95%CI=1.23~1.58,P<0.00001)、儿童控制哮喘测试(C-ACT)评分(MD=0.76,95%CI=0.31~1.21,P=0.001)显著高于对照组,上述差异均有统计学意义;但两组患儿的第1秒用力呼气容积占预计值百分比(FEV_(1)%)(MD=0.62,95%CI=-0.89~2.13,P=0.42)、第1秒用力呼气容积占用力肺活量百分比(FEV_(1)/FVC)(MD=-0.10,95%CI=-0.98~0.79,P=0.83)比较,差异均无统计学意义。安全性方面,研究组患儿的严重不良事件发生率显著低于对照组(RR=0.54,95%CI=0.39~0.76,P=0.0004),缺课时间(MD=-0.30,95%CI=-0.57~-0.02,P=0.04)显著少于对照组,差异均有统计学意义。结论:奥马珠单抗可有效改善儿童中重度过敏性哮喘患者的临床指标,显著降低严重不良事件发生率,改善患儿的生活质量。
OBJECTIVE:To systematically evaluate the efficacy and safety of omalizumab in the treatment of children with moderate-to-severe allergic asthma.METHODS:CNKI,Wanfang Data,PubMed,Cochrane Controlled Register of Trials(CENTRAL)and Embase database were retrieved to collect the randomized controlled trial of omalizumab in the treatment of children with moderate-to-severe allergic asthma(the study group was treated with omalizumab,while the control group received other drugs or placebos for the treatment of allergic asthma).The retrieval time was from the establishment of the database to Mar.2021.Two reviewers screened the literature and extracted data according to the inclusion and exclusion criteria,Meta-analysis was performed by using RevMan 5.4 software.RESULTS:Totally 8 randomized controlled trials were collected,including 1756 children.Meta-analysis results showed that the incidence of asthma exacerbation(exacerbation incidence expressed as number of person-days at risk of exacerbation:RR=0.68,95%CI=0.55-0.85,P=0.0007;exacerbation incidence expressed as percentage of children with exacerbation:RR=0.54,95%CI=0.45-0.66,P<0.00001)in the study group was significantly lower than those in the control group,and the excellent rate of Global Evaluation of Asthma Effectiveness(GETE)(RR=1.39,95%CI=1.23-1.58,P<0.00001),Children’s Asthma Control Test(C-ACT)score(MD=0.76,95%CI=0.31-1.21,P=0.001)were significantly higher than those in the control group,and the differences were statistically significant.The difference of percentage of forced expiratory volume in one second to estimated value(FEV_(1)%)(MD=0.62,95%CI=-0.89-2.13,P=0.42),and the forced expiratory volume in the first second to the forced vital capacity(FEV_(1)/FVC)(MD=-0.10,95%CI=-0.98-0.79,P=0.83)was not statistically significant.The incidence of severe adverse events in the study group was significantly lower than that in the control group(RR=0.54,95%CI=0.39-0.76,P=0.0004),and time of absence from school(MD=-0.30,95%CI=-0.57--0.02,P=0.04)was significantly shorter
作者
姜红玉
李娟
胡文凤
顾锦华
张琳
张海波
JIANG Hongyu;LI Juan;HU Wenfeng;GU Jinhua;ZHANG Lin;ZHANG Haibo(Dept.of Emergency,Maternity and Child Health Hospital Affiliated to Nantong University,Jiangsu Nantong 226018,China;Dept.of Pharmacy,Maternity and Child Health Hospital Affiliated to Nantong University,Jiangsu Nantong 226018,China)
出处
《中国医院用药评价与分析》
2021年第9期1091-1096,共6页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
国家自然科学基金项目(No.81870941)
南通市卫生健康委科研项目(No.MB2020043)。
