Clinical trial of immunoglobulin combined with aspirin enteric-coated tablets in the treatment of Kawasaki disease
10.13699/j.cnki.1001-6821.2017.23.006
- VernacularTitle:丙种球蛋白联合阿司匹林肠溶片治疗川崎病的临床研究
- Author:
Yang SHEN
1
,
2
;
Jing SHAN
;
Guang-Hui LIU
;
Wei-Hua XU
;
Yu-Qing CHEN
;
Peng HU
Author Information
1. 安徽医科大学第一附属医院儿科,合肥230022
2. 安徽省儿童医院急救中心,合肥230051
- Keywords:
immunoglobulin;
aspirin enteric-coated tablet;
Kawasaki disease;
safety
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(23):2347-2350
- CountryChina
- Language:Chinese
-
Abstract:
Objective To observe the clinical efficacy and safety of different usage of immunoglobulin combined with aspirin enteric-coated tablets in the treatment of Kawasaki disease.Methods Ninety patients with Kawasaki disease were randomly divided into control group and treatment group with 45 cases per group.Control group was given 1 g · kg-1 immunoglobulin with intravenous injection for 2 days + 40 mg · kg-1 aspirin enteric-coated tablets for 1 month,orally.Treatment group was given 2 g · kg-1 immunoglobulin with one-time intravenous injection + 40 mg · kg-1 aspirin enteric-coated tablets for 1 month,orally.The clinical efficacy,interleukin-6 (IL-6),IL-8,high sensitivity C-reaction protein (hs-CRP),tumor necrosis factor alpha (TNF-α) and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 95.56％ (43/45 cases) and 84.44％ (38/45cases) with significant difference (P ＜0.05).After treatment 1 month,the main indexes in treatment and control groups were compared:IL-6 were (6.18 ±2.10) and (9.10±3.19)pg · mL-1,IL-8 were (5.17 ±1.01) and (10.27 ±2.15)pg · mL-1,hs-CRP were (2.61 ±1.04) and (5.27±0.97)mg· L-1,TNF-α were (13.77 ±0.86) and (16.52 ±1.13)ng· L-1,the differences were statistically significant (all P ＜ 0.05).The adverse drug reactions in treatment group were nausea and headache,which in control group were nausea,headache and chills.The incidences of adverse drug reactions in treatment and control groups were 17.78％ and 13.33％ without significant difference (P ＞0.05).Conclusion Single dose of 2 g · kg-1 immunoglobulin combined aspirin enteric-coated tablets have a better clinical efficacy in the treatment of Kawasaki disease than the double dose of 1 g · kg-1 immunoglobulin combined aspirin enteric-coated tablets,the former can significantly relieve the clinical symptoms and reduce the levels of serum inflammatory factors,without increasing the incidences of adverse drug reactions.
