Evaluation Of Evidence-based Medicine IVIG Combined With Hormone Therapy In IVIG Non-reaction Kawasaki Disease Clinical Efficacy And Safety

Objective: To establish a scientific evaluation system of intravenous immunoglobulin(IVIG)combined with hormone in the treatment of IVIG non-reactive Kawasaki disease,and to provide an evidence for clinical treatment efficacy of children with intravenous immunoglobulin non-reactive Kawasaki disease.Methods: PubMed,EMbase,Medline,Web of Science,OVID,Cochrane Library,Clinical Trials.gov,FDA,CNKI,CBM and VIP were searched to identify relevant studies.Endnote6 X was used to screen the literature;manual retrieval,document tracking and interlibrary borrowing to search for grey documents including unpublished and unpublished data.Subject words were IVIG nonreactive Kawasaki disease,hormone therapy,randomized control,case analysis,clinical observation,IVIG,IVMP,clinical efficacy and safety.The search deadline was October 2017.Two researchers independently and parallelly conducted quantity analysis,data extraction and consistency feasibility assessment of literature,a cross-check of the entry literature was conducted,and the third researcher participated in the consultation andfollowed the principle of quality first..Meta-analysis was performed by RevMan 5.3 software.Results: After screening 79 studies,11 studies were meta-analyzed(8 in Chinese and 3 in English)including 1818 cases in the experimental group and 1724 cases in the control group.The literature type was mainly clinical case analysis,only 3 RCT and NOS scores were B grade.The results showed that the combination treatment of IVIG and hormone is more effective than that of IVIG alone in high-dose impulse therapy.The time of antipyretic [MD =-1.22,95%CI(-1.34 ~-1.10)],regression of mucosal congestion [MD =-0.97,95%CI(-1.12 ~-0.81)],lymph node swelling receding [MD =-1.34,95%CI(-1.91 ~-0.77)],and hand and foot swelling receding [MD =-1.06,95%CI(-1.38 ~-0.74)] was significant declined(P <0.05).The time of antipyretic,regression of mucosal congestion,lymph node swelling receding and hand and foot swelling is shorter in the combination therapy of IVIG and hormone than that of IVIG alone in high-dose impulse therapy.In safety,the incidence of coronary artery disease in the 2 groups during and after treatment was [RR = 0.76,95%CI(0.58 ~ 0.98)] significant differently(P <0.05).The incidence of coronary artery lesions in patients treated with high-dose IVIG alone was higher than that in the trial group(IVIG combined with hormone therapy).Conclusion: As far as available evidence is concerned,(1)the children with IVIG non-reactive Kawasaki disease were treated withmethylprednisolone(methylprednisolone,dexamethasone,etc.)and re-injection of gamma globulin,which could achieve better clinical effect in relief of mucosal congestion,lymph node swelling and hands and feet swelling.(2)The combination of methylprednisolone(methylprednisolone,dexamethasone)and intravenous injection of gamma globulin can reduce the incidence of coronary artery disease in patients with IVIG non-reactive Kawasaki disease.(3)IVIG combined with hormone therapy is effective and safe for patients with IVIG non-reactive Kawasaki disease.It can be used as the first choice in clinical treatment of Kawasaki disease.Limited literature quality and source,we are unable to avoid some objective risk of bias.The system has to be strictly design evaluation results,for a long time and high quality of randomized controlled trials to test and verify.