肾上腺糖皮质激素联合乌司他丁治疗儿童川崎病的非随机对照临床研究

Glucocorticoid combined with ulinastatin in treatment of Kawasaki disease in children: a non-randomized controlled clinical trial

目的探讨肾上腺糖皮质激素联合乌司他丁治疗儿童川崎病的临床疗效。方法根据患儿病情和家长意愿,将2011年1月至2013年12月入院确诊为典型川崎病(KD)的104例患儿分为乌司他丁组(甲基强的松龙+乌司他丁,n=46)和静脉注射丙种球蛋白(IVIG)组(n=58)。观察两组患儿治疗前、治疗后1周、3个月及6个月时的冠状动脉内径的变化,热退时间,再次治疗情况,治疗前、治疗后1周及3周时白细胞(WBC)、血小板(PLT)、血红蛋白(HB)、C反应蛋白(CRP)、血沉的变化以及住院总费用。结果两组患儿在治疗前、治疗后1周、3个月及6个月时冠状动脉内径比较差异均无统计学意义(P>0.05)。治疗48 h乌司他丁组患儿体温均正常(100%),正常率高于IVIG组(83%)(P<0.01)。乌司他丁组和IVIG组各有2例(4%)和10例(17%)给予再次治疗。不同治疗方案对两组患儿血沉、WBC及HB水平的影响差异有统计学意义(P<0.01)。乌司他丁组患儿平均住院总费用低于IVIG组(P<0.01)。结论甲基强的松龙联合乌司他丁治疗儿童KD没有增加冠状动脉瘤的发生风险;并能大大降低住院费用;与IVIG治疗相比,在KD急性期能更好的控制患儿的实验室指标,缩短发热时间。

Objective To investigate the clinical efficacy of glucocorticoid combined with ulinastatin in the treatment of Kawasaki disease（KD） in children. Methods A total of 104 children who were admitted and diagnosed with typical KD between January 2011 and December 2013 were assigned to ulinastatin group（methylprednisolone ＋ ulinastatin; n=46） and intravenous immunoglobulin（IVIG） group（n=58） according to the severity of KD and the willingness of their parents. Observations for the two groups were performed to compare the changes in coronary artery diameter before and at 1 week, 3 months, and 6 months after treatment, fever clearance time, retreatment condition, changes in white blood cells（WBC）, platelets（PLT）, hemoglobin（HB）, C-reactive protein（CRP）, and erythrocyte sedimentation rate（ESR） at 1 week and 3 weeks after treatment, and total in-hospital cost. Results There was no significant difference in the coronary artery diameter between the two groups before or at 1 week, 3 months or 6 months after treatment（P0.05）. All the patients（100%） in the ulinastatin group vs 83% in the IVIG group had a normal body temperature after 48 hours of treatment（P0.01）. Two patients（4%） in the ulinastatin group and 10 patients（17%） in the IVIG group received retreatment. Significant differences were observed in ESR, WBC, and HB between them（P0.01）. The total in-hospital cost in the ulinastatin group was significantly lower than that in the IVIG group（P0.01）. Conclusions For children with KD, methylprednisolone combined with ulinastatin does not increase the risk of coronary artery aneurysm, decreases in-hospital costs, is superior in controlling laboratory markers and shortening the duration of fever during the acute phase compared with the IVIG therapy.