静脉注射免疫球蛋白治疗婴幼儿毛细支气管炎的临床研究

Clinical Study of Intravenous Immunoglobulin in the Treatment of Bronchiolitis in Infants

目的探讨静脉注射免疫球蛋白（intravenous immune globulin，IVIG）治疗婴幼儿毛细支气管炎（bronchiolitis）的临床效果。方法选择2005年6月至2009年8月确诊为毛细支气管炎的患儿88伊为研究对象。采用前瞻性研究方法，依照患儿就诊的先后顺序将其随机分为研究组（n=42）和对照组（n=46）。对两组患儿在采取抗炎、平喘和改善通气等毛细支气管炎常规治疗措施的同时，研究组给予静脉输沿免疫球蛋白，剂量为400mg／（kg·d），连续用（3～5）d；对照组除常规治疗外，不采取其他任何处理措施再根据临床经验，将研究组患儿按照接受静脉注射免疫球蛋白治疗的时间分为早用IVIG组（n=20，病秸≤5d时应用静脉注射免疫球蛋白治疗）和晚用IVIG组（n=22，病程〉5d时应用静脉注射免疫球蛋白涯疗）。研究组和对照组、早用和晚用IVIG组患儿性别、年龄和病情分度等一般临床资料比较，差异无显藿意义（P〉0．05）（本研究遵循的程序符合本院人体试验委员会制定的伦理学标准，分组征得受试对象监拶人的知情同意，并与其签署知情同意书）。结果研究组患儿急性期喘憋及咳嗽持续时间、肺部哮鸣音消彗时间和住院时间均较对照组明显缩短，两组比较，差异有显著意义（P〈0．01）；病程中早用IVIG组较晚片IVIG组患儿喘憋及咳嗽持续时间、肺部哮呜消失时间和住院时间明显缩短，两组比较，差异有显著意史（p〈O．01）。研究组不良反应发生率低，仅为4．8％（2／42）。结论静脉注射免疫球蛋白治疗婴幼儿毛细曼气管炎疗效显著，临床应用相对安全，且应尽早使用（病程≤5d时应用）。

Objective To investigate the effects of intravenous immunoglobulin （WIG） in the treatment of bronchiolitis in infants. Methods From June 2005 to August 2009, a total of 88 infants with bronchiolitis were enrolled in the study. By the method of randomized controlled trial, they were randomly divided into two groups according to visiting sequence, research group （n=42） and control group （n=46）. Infants were all treated with routine programs. Research group also were treated by intravenous infusion with intravenous immunoglobulin 400 mg/（kg · d）, 3-5 days. Based on the clinical experience, infants in research group were further divided into two groups according to time of accepting intravenous infusion with intravenous immunoglobulin： Early use of IVIG groups （n= 20, patients whose disease course was≤5 days accepted IVIG） and late use of IVIG group （n= 22, patients whose disease course was〉5 days accepted IVIG）. There were no significance between infants in research and control groups, and in early and late use of IVIG group among sexuality, age, and degree of bronchiolitis （P〉0. 05）. The study protocol was approved by the Ethical Review Board of Investigation in Human Being of First Peopler s Hospital of Longquanyi. Informed consent was obtained from the parents of each participating infant. Results There were significant difference between research and control groups in duration of clinical symptoms in acute stage and in-hospital time （P〈0.01）. There were significant difference between early and late use of IVIG groups in duration of clinical symptoms in acute stage and in-hospital time （P〈0. 01）. Adverse effect incidence rate of intravenous immunoglobulin in treating of bronchiolitis was low, only 4. 8% （2/42）. Conclusion Intravenous immunoglobulin has satisfactory therapeutic effect for treating bronchiolitis of infants and reducing recurrence and avoid forming asthma. It is worth popularizing and applied as soon as possible （the patient whose disease course was≤5 days accepted intravenous immunoglobulin）.