| Objective:Bronchial asthma is one of the most common respiratory diseases in children and adults worldwide,and its pathogenesis is related to Immunoglobulin E(IgE).IgE prom-otes the release of inflammatory cytokines by binding to relevant receptors of inflamm-atory cells and airway structure cells,leading to increased airway inflammation.Anti-IgE monoclonal antibody blocks the downstream inflammatory signaling pathway by competitively binding IgE,reduces the release of inflammatory mediators,and achieves the role of reducing airway inflammation and slowing airway remodeling.This paper intends to systematically evaluate the efficacy and safety of anti-IgE monoclonal anti-body in escalation therapy of patients with bronchial asthma through Meta-analysis in order to provide evidence-based medical evidence for relevant clinical decisions.Methods:CNKI,Wanfang Database,VIP,SinoMed,PubMed and Web of Science were sea-rched systematically for relevant clinical randomized controlled trials(RCTs)from the database establishment to January 2023.The improved Jadad scale was used to evaluate the methodological quality of the included literatures,and the Cochrane systematic re-view tool was used to assess the risk of bias in the included studies.Data such as total clinical effective rate,ACT,ACQ,AQLQ,IgE,Fe NO,Increased value of FEV1,Increased value of FEV1%Pred,number of acute exacerbation of asthma,frequency of acute exacerbation of asthma and adverse reactions were extracted from literatures mee-ting inclusion and exclusion criteria.Meta-analysis was performed using Rev Man5.4software.χ~2test was used to detect and analyse the heterogeneity of included each study,and Graphpad Prism9.5 software was used to describe the heterogeneity and statistical significance of each subgroup.Results:Atotal of 11 RCTswere included,enrolling 1956 patients with moderate to severe asthma.The Jadad score was 4 to 7,and the risk of bias was assessed aslow to moderate risk.The results of Meta-analysis showed that there was statistically significant differe-nces in the total clinical effective rates between the experimental group and the control group[RR=1.39,95%CI(1.02,1.89),P=0.04].In addition,the results of subgroup analys-is also showed that there was statistically significant differences in total clinical effecti-ve rates in OMA+SIT group[RR=1.40,95%CI(1.02,1.94),P=0.04].However,There w-as no significant differences in total clinical effective rate in OMA+ICS+LABA group[RR=1.45,95%CI(0.94,2.22),P=0.09].There was statistically significant differences in ACT between the experimental group and the control group[MD=3.41,95%CI(3.04,3.79),P<0.00001].There was no statistically significant differences in ACQ between the experimental group and the control group[MD=-0.66,95%CI(-1.50,0.17),P=0.12].The results of subgroup analysis also showed that there was no statistically significant diff-erences in ACQ in OMA+ICS+LABA group[MD=0.00,95%CI(-0.67,0.67),P=1.00].However,the results of subgroup analysis showed that the difference of ACQ in OMA+OCS group and OMA+ICS group was statistically significant[MD=-1.50,95%CI(-1.87,-1.13),P<0.00001;MD=-0.41,95%CI(-0.65,-0.17),P=0.0007].There was no statistically significant differences in AQLQ between the experimental group and the control group[MD=0.66,95%CI(-0.28,1.60),P=0.17].The results of subgroup analysis showed that there was no statistically significant differences in AQLQ between OMA+LABA group and OMA+ICS+LABA group[MD=-0.48,95%CI(-2.62,1.66),P=0.66;MD=0.84,95%CI(-0.21,1.89),P=0.12].IgE value of the experimental group and the co-ntrol group was statistically significantly different[MD=-139.79,95%CI(-247.64,-31.55),P=0.01].The results of subgroup analysis also showed that IgE value in OMA+ICS group and OMA+ICS+LABA group were statistically significantly different[MD=-391.50,95%CI(-489.34,-293.66),P<0.00001;MD=72.69,95%CI(132.40,12.97),P=0.02).However,the differences of IgE value in OMA+OCS group had no statistical significa-nce[MD=68.20,95%CI(145.63,9.23),P=0.08].There was statistically significant differ-ence in Fe NO value between the experimental group and the control group[MD=-11.81,95%CI(-23.30,-0.33),P=0.04].The differences of increased value of FEV1 between the experimental group and the control group was statistically significant[MD=0.19,95%CI(0.08,0.30),P=0.0005].In addition,the results of subgroup analysis also showed that t-he differences of increased value of FEV1 in OMA+ICS+LABA group was statistically significant[MD=0.19,95%CI(0.07,0.30),P=0.001].However,there was no significant differences in increased value of FEV1 of OMA+LABA group[MD=0.26,95%CI(-0.22,0.74),P=0.29].There was statistically significant differences between the experimental group and the control group in increased value of FEV1%Pred[MD=6.43,95%CI(0.94,11.93),P=0.02].In addition,the results of subgroup analysis also showed that there was also significant difference in increased value of FEV1%Pred in OMA+OCS group,OMA+LABA group,OMA+ICS group and OMA+ICS+LABA group[MD=10.60,95%CI(3.11,18.09),P=0.006;MD=2.0,95%CI(0.45,3.55),P=0.01;MD=1.10,95%CI(1.04,1.16),P<0.00001;MD=9.70,95%CI(9.58,9.82),P<0.00001].There was statistically sig-nificant differences in the number of acute exacerbation of asthma between the experi-mental group and the control group[RR=0.85,95%CI(0.75,0.95),P=0.004].In addition,the results of subgroup analysis also showed that there was statistically significant differences in the number of acute exacerbation of asthma in OMA+ICS+LABA group[RR=0.85,95%CI(0.76,0.96),P=0.006].However,there was no significant difference in the number of acute exacerbation of asthma in OMA+ICS group[RR=0.71,95%CI(0.34,1.52),P=0.38].There was statistically significant differences in the number of acute ex-acerbation of asthma between the experimental group and the control group[MD=-0.70,95%CI(-1.33,-0.07),P=0.03].However,the results of subgroup analysis showed that the difference of frequency of acute exacerbation of asthma in OMA+OCS group and OMA+ICS+LABA group were not statistically significant[MD=0.60,95%CI(1.44,0.24),P=0.16;MD=-0.82,95%CI(-1.77,0.13),P=0.09).The difference of AR between the experimental group and the control group was statistically significant[RR=0.84,95%CI(0.74,0.97),P=0.01].In addition,the results of subgroup analysis also showed that t-he differences of ARin OMA+ICS+LABAgroup was statistically significant[RR=0.86,95%CI(0.75,0.98),P=0.03].However,there was no significant differences in ARbetw-een OMA+ICS group and OMA+SIT group[RR=0.20,95%CI(0.01,4.11),P=0.30;RR=0.65,95%CI(0.24,1.71),P=0.38].The differences of AR in OMA+ICS+LABA group was significantly different in that of the control group[RR=0.86,95%CI(0.75,0.98),P=0.03].Subgroup analysis was conducted on OMA+ICS+LABA group according to the intervention course,and the results showed that the difference of AR in OMA+ICS+LABA group was statistically significant compared to that of the control group after 24weeks of treatment[RR=0.80,95%CI(0.70,0.92),P=0.002],and there was no significant differences in AR between OMA+ICS+LABA group and the control group after 16 or20 or 48 weeks of treatment[RR=1.09,95%CI(0.76,1.56),P=0.65;RR=2.47,95%CI(0.12,50.18),P=0.56;RR=0.87,95%CI(0.67,1.13),P=0.30].Conclusion:On the basis of conventional treatment,omalizumab can improve the total clinical effective rate,ACT,increased value of FEV1,increased value of FEV1%Pred in patien-ts with moderate to severe asthma,and reduce the level of IgE,the level of FeNO,the number of acute exacerbation of asthma and the frequency of acute exacerbation of asthma.Omalizumab combined with conventional treatment do not significantly chang-e ACQ and AQLQin patients with moderate to severe asthma.In terms of safety,Omali-zumab can reduce AR in patients with moderate to severe asthma.In addition,OMA can significantly reduce AR inpatients with asthma based on ICS+LABA treatment for up to 24 weeks. |
PDF Full Text Request