论文部分内容阅读
目的评估舌下特异性免疫治疗药物“粉尘螨滴剂”治疗儿童过敏性哮喘及变应性鼻炎的疗效及安全性。方法采用随机双盲、安慰剂平行对照的研究方法,将278例年龄4～18岁粉尘螨过敏的哮喘和(或)鼻炎患儿随机分为治疗组(139例)和安慰剂组(139例),分别给予舌下含服“粉尘螨滴剂”或安慰剂,在治疗第2,3,4,6,10,14,18,22周进行随访,治疗第25周结束临床观察。对两组治疗前后的哮喘和鼻炎症状与体征评分、用药计分、肺功能及各项实验室指标、不良事件进行分析比较,并在试验结束前让患儿进行疾病转归的自我评价。结果 (1)278例研究对象中,共251例完成试验;(2)治疗组过敏性哮喘患者 PEF 日内变异率改变量-1.38,而安慰剂组仅为-0.90(P<0.05);(3)治疗结束后,过敏性哮喘治疗组应急用药改变量较基线有所下降(=-0.08),而安慰剂组用药则有所增加(=0.52),两组用药剂量较基线改变量的差异有显著性(W=-2.45,P<0.05);(4)治疗组鼻炎患者每日症状积分改变量为-1.96,而安慰剂组为-1.03(W=3.90,P<0.01);(5)鼻炎患者安慰剂组应急用药量较基线改变量为0.01,治疗组为-0.25,但两组差异无统计学意义(W=1.40,P>0.05);(6)用药25周以后,两组血清特异性 IgE(sIgE)水平较用药前无显著改变,而治疗组的血清特异性 IgG4平均水平显著增高(P<0.05);(7)试验期间未发生严重不良事件,与研究药物可能有关的不良反应主要表现为哮喘轻度发作和局部皮疹。结论“粉尘螨滴剂”是一种安全有效治疗儿童过敏性哮喘和变应性鼻炎的舌下特异性免疫治疗药物。
Objective To evaluate the efficacy and safety of sublingual immunotherapy drug “dust mites drops” in children with allergic asthma and allergic rhinitis. Methods A randomized, double-blind, placebo-controlled study was conducted in 278 children with asthma and / or rhinitis allergic to dust mites 4 to 18 years old. The children were randomly divided into treatment group (139 cases) and placebo group (139 cases ) Were given sublingual “dust mite drops” or placebo in the treatment of 2,3,4,6,10,14,18,22 weeks were followed up, the end of treatment of the clinical observation of the 25th week. Before and after treatment, the symptoms and signs of asthma and rhinitis, scoring of drugs, pulmonary function and various laboratory indexes and adverse events were analyzed and compared before and after treatment, and children were evaluated for self-evaluation of disease outcome before the end of the experiment. Results (1) 251 of 278 subjects completed the experiment. (2) The intra-day change rate of PEF was 1.38 in the treatment group and -0.90 in the placebo group (P <0.05) ) At the end of treatment, the change in emergency medication for the allergic asthma group decreased from baseline (= -0.08) and increased in the placebo group (= 0.52), with differences in baseline and baseline dose changes between the two groups (W = -2.45, P <0.05). (4) The change of daily symptom score in treatment group was -1.96, and that in placebo group was -1.03 (W = 3.90, P <0.01) The emergency dose of rhinitis patients in placebo group changed from baseline to 0.01 and the treatment group to -0.25, but there was no significant difference between the two groups (W = 1.40, P> 0.05). (6) After 25 weeks of treatment, Specific IgE (sIgE) did not change significantly compared with those before treatment, while the mean level of serum specific IgG4 in the treatment group was significantly increased (P <0.05). (7) No serious adverse events occurred during the trial, which may be related to the study drug The reaction was mainly mild asthma attacks and regional rashes. Conclusion “dust mite drops ” is a safe and effective treatment of children with allergic asthma and allergic rhinitis sublingual specific immunotherapy drugs.