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目的通过建立两种丙种球蛋白(IVIG)剂量治疗川崎病(KD)的临床对照,探讨一种既适合我国国情,又达到良好疗效的最合理的 IVIG 剂量。方法随机抽取我院2002年～2006年收治的 KD 患儿60例病历,根据 IVIG 治疗情况分为总剂量1 g/kg·d~(-1)单次应用(1g 组)和2 g/kg(2g 组)(包括2 g/kg·d~(-1)单次应用或2 g/kg分2次)两组,每组30例,均于发病10 d 内给予 IVIG,两组对比 IVIG 应用后的退热时间、总热程、C 反应蛋白及血沉恢复正常时间,采用 SPSS 12.0统计软件包进行统计分析。结果两组数据对比后,IVIG 应用后的退热时间、总热程、C 反应蛋白及血沉恢复正常时间指标 P 值均>0.1,不存在统计学差异。用药前1 g 组有2例出现左侧冠状动脉扩张;2 g 组有2例左侧冠状动脉扩张,1例双侧冠状动脉扩张,1例表现为双侧冠状动脉管壁增厚毛糙。治疗后两组冠脉损害病例随访2年内冠状动脉均恢复,恢复时间无明显差别;其余病例亦未见异常,但远期冠脉的预后情况正在随访观察中。结论早期给予 IVIG 治疗 KD,可预防冠脉损害,是目前较为理想的治疗方法。本项对照研究提示,临床上采用2 g/kg 剂量的 IVIG 治疗 KD 并不能较1 g/kg 的剂量更能明显提高临床疗效,反而增加医疗负担,其价值研究有待进一步探讨。但由于本组样本量少,而且有关冠状动脉病变(CAL)的恢复率及预防 CAL 的发生率2年以上的随访资料正在建立中,故目前认为,IVIG 1 g/kg 和2 g/kg 治疗 KD 的疗效在 KD 发病后2年内无显著差异。因此,对于确定国内治疗 KD 合理、经济、有效的最佳 IVIG 剂量,尚有待于多中心、大样本、长时间,按照循证医学原则进行的前瞻性临床研究加以确定。
Objective To establish a clinical control of Kawasaki disease (KD) by establishing two dosages of gamma globulin (IVIG), and to explore a reasonable IVIG dose that is suitable for China’s national conditions and achieves good therapeutic effects. Methods A total of 60 cases of children with KD admitted to our hospital from 2002 to 2006 were randomly divided into two groups according to the treatment of IVIG: single-dose (1g / kg · d -1) and 2g / kg (2g group) (including 2g / kg · d ~ (-1) single application or 2g / kg 2 times), each group of 30 patients were given IVIG within 10 days of onset, the two groups compared with IVIG After application of antipyretic time, total heat, C-reactive protein and erythrocyte sedimentation time, using SPSS 12.0 statistical software package for statistical analysis. Results After the data of two groups were compared, the P values of antipyretic time, total heat stroke, C-reactive protein and ESR index after IVIG application were all> 0.1, no statistical difference existed. Two cases of left coronary artery dilatation occurred in 1 g group before treatment, two cases of left coronary artery dilation in 2 g group, one case of bilateral coronary artery dilatation, and one case of bilateral coronary artery wall thickening and rough. After treatment, the two groups of coronary artery lesions were followed up for 2 years within the recovery of the coronary artery, the recovery time was no significant difference; the other cases were no abnormalities, but the prognosis of long-term coronary artery follow-up observation. Conclusion Early administration of IVIG to treat KD can prevent coronary artery injury and is the ideal treatment. This control study suggests that the clinical use of 2 g / kg dose of IVIG treatment of KD can not be more than 1 g / kg dose significantly improved clinical efficacy, but to increase the medical burden, the value of the study to be further explored. However, because of the small sample size in this group and the fact that follow-up data on the rate of recovery of coronary artery lesions (CALs) and the incidence of CALs more than two years are under development, it is currently believed that IVIG at 1 and 2 g / kg The efficacy of KD was not significantly different within 2 years after onset of KD. Therefore, the determination of the optimal, reasonable and cost-effective IVIG dose for treatment of KD in China has yet to be determined by prospective clinical studies conducted in multicentre, large sample and long-term according to the principles of evidence-based medicine.