丙种球蛋白联合阿司匹林肠溶片治疗川崎病的临床研究

Clinical trial of immunoglobulin combined with aspirin enteric-coated tablets in the treatment of Kawasaki disease

目的比较不同用法的丙种球蛋白联合阿司匹林肠溶片治疗川崎病的临床疗效及安全性。方法将90例川崎病患儿随机分为对照组45例和试验组45例。对照组予以1 g·kg^(-1)丙种球蛋白,静脉注射,连续2 d+40 mg·kg^(-1)阿司匹林肠溶片,qd,口服,持续1个月;试验组予以2 g·kg^(-1)丙种球蛋白,一次性静脉注射+40 mg·kg^(-1)阿司匹林肠溶片,qd,口服,持续1个月。比较2组患儿的临床疗效、白细胞介素-6(IL-6)、IL-8、超敏C-反应蛋白(hs-CRP)和肿瘤坏死因子-α(TNF-α),以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为95.56%(43例/45例))和84.44%(38例/45例),差异有统计学意义(P<0.05)。治疗后1个月,试验组和对照组的IL-6分别为(6.18±2.10)和(9.10±3.19)pg·m L^(-1),IL-8分别为(5.17±1.01)和(10.27±2.15)pg·m L^(-1),hs-CRP分别为(2.61±1.04)和(5.27±0.97)mg·L^(-1),TNF-α分别为(13.77±0.86)和(16.52±1.13)ng·L^(-1),差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有恶心和头痛,对照组的药物不良反应主要有恶心、头痛和寒战。试验组和对照组的总药物不良反应发生率分别为17.78%和13.33%,差异无统计学意义(P>0.05)。结论单次2 g·kg^(-1)丙种球蛋白联合阿司匹林肠溶片方案治疗川崎病的临床疗效明显优于1 g·kg^(-1)丙种球蛋白2 d联合阿司匹林肠溶片方案,前者可更快地缓解患儿的临床病症情况,降低血清炎症因子的水平,且不增加药物不良反应的发生率。

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 given1 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 treatmentand control groups were 95. 56%（ 43/45 cases） and 84. 44%（ 38/45 cases） 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 · m L-1,IL-8 were（ 5. 17 ± 1. 01） and（ 10. 27 ± 2. 15） pg · m L-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 of2 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.