Analysis of systemic adverse reactions in patients with simple allergic rhinitis after subcutaneous immunotherapy with standardized dicid allergen injection
10.3760/cma.j.cn114015-20200813-00868
- VernacularTitle:单纯变应性鼻炎患者接受螨变应原注射液皮下免疫治疗后全身不良反应发生情况分析
- Author:
Min PAN
1
;
Zhengda FAN
;
Jianrong XUE
;
Zhibang HU
;
Jing MA
Author Information
1. 常州市第三人民医院药事科，常州 213001
- Publication Type:Journal Article
- Keywords:
Rhinitis, allergic, perennial;
Allergens;
Mites;
Immunity, active;
Drug-related side effects and adverse reactions
- From:
Adverse Drug Reactions Journal
2021;23(4):190-195
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To understand the occurrence of systemic adverse reactions in patients with simple allergic rhinitis (AR) after receiving subcutaneous immunotherapy (SCIT) with standardized dicid allergen injection.Methods:The clinical data of AR patients who completed the whole course of SCIT with standardized mite allergen injection in AR Diagnosis and Treatment Center in Department of Otolaryngology, the Third People′s Hospital of Changzhou from August 1st, 2015 to July 31st, 2020 were analyzed retrospectively. The course of SCIT was 156 weeks, comprising 4 stages. The first 14 weeks was the dose increase phase, in which standardized mite allergen injection was given once a week and the dose was gradually increased from 5 TU in the 1st week to 5 000 TU in the 14th week; the weeks 15-52, 53-104, and 105-156 were the dose maintenance phase, in which the injection was given once every 5 weeks at the dose of 5 000 TU. According to the number of injections, the incidence of systemic adverse reactions in patients of different gender and age at different stages of the course of treatment and after injection at different doses were counted, and the types [according to the time of occurrence, the adverse reactions were divided into immediate type(≤30 min) and delayed type(>30 min)], classification (grade 1-5), clinical manifestations, and outcome of adverse reactions were analyzed.Results:A total of 302 patients were enrolled in the study, including 175 males and 127 females, aged from 5 to 60 years. Of them, 187 patients were ≤14 years old and 115 were>14 years old. Three hundred and two patients received 13 687 subcutaneous injections totally and 46 patients in 120 times of injection had systemic adverse reactions. The incidence of adverse reactions was 15.23% (46/302) according to the number of cases and 0.88% (120/13 687) according to the number of injections. Among the 120 times of systemic adverse reactions, 55 (45.83%) were immediate type and 65 (54.17%) were delayed type. The adverse reactions belonged to grade 1 in 94 times of injections (78.33%, mainly manifested as nasal itching, eye itching, cough, pruritus, etc), grade 2 in 23 times of injections (19.17%, mainly manifested as asthma, diarrhea, etc), and grade 3 in 3 times of injections (2.50%, 2 mainly manifested as no response to inhaled bronchodilator and 1 as laryngeal edema). There was no significant difference in the incidences of systemic adverse reactions between the male and female patients [0.94% (76/8 091) vs. 0.79% (44/5 596), χ2=0.89, P=0.35]. The incidence of systemic adverse reactions in patients ≤14 years old was higher than that in patients >14 years old [1.14% (97/8 536) vs. 0.45% (23/5 151), χ2=17.59, P<0.01]. The incidence of systemic adverse reactions in weeks 16-52 [1.86% (40/2 153) ] was higher than those in the first 14 weeks [0.99% (51/5 169)], weeks 53-104 [0.72% (23/3 194) ], and weeks 105-156 [0.19% (6/3 171) ], and the differences were statistically significant ( χ2=9.40, P<0.01; χ2=14.30, P<0.01; χ2=41.69, P<0.01). The incidence of systemic adverse reactions at the injection dose o f <5 000 TU was higher than that at the injection dose of 5 000 TU [1.11% (51/4 579) vs. 0.76% (69/9 108) , χ2=4.45, P=0.04]. The systemic adverse reactions were self-relieved or could be relieved after the intervention and the outcome was good. Conclusions:The incidence of systemic adverse reactions in AR patients who completed the whole course of SCIT with standardized dicid allergen injection was 0.88%, which mainly belonged to grade 1 adverse reactions. Children of ≤14 years old, during the week 16 to 52 of treatment, at the injection dose of <5 000 TU were more likely to have systemic adverse reactions.
