静脉丙种球蛋白治疗川崎病两种剂量的对照研究

Case-control Evaluation of Two Modalities with Intravenous γ-immunogiobulin Infusion of Kawasaki Disease

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 discuss the best cost-effective of intravenous γ-immunoglobulin（IVIG） in Kawasaki disease by making a case-control with two modalities IVIG infusion. Methods Randomize 60 KD cases were treated by IVIG in our department from 2002 to 2006 were reviewed. The two modalities were as follows：30 cases in 1 g/kg for one day,30 cases in 2 g/kg treatment （for 1 day or 2 days） ,all were treated IVIG in 10 days of the illness onset. The duration of temperature, C-reaction protein and ESR returned to normal time, the general period of fever were compared. The statistics tools was SPSS 12. 0 system. Results To study the compared datum,no differences between the two modalities in the duration of temperature, C-reaction protein and ESR covery, the general period of fever. For coronary artery lesion （CAL） is still in eval- uation. Conclusions It can prevent CAL that treated by IVIG in the early time. The treatment of 2 g/kg had no much be benaficial effects the once treatment （ 1g/kg,for 1 day） in our randomize trials. But it still not enough large cohort of patient in our studies, we still need muhi-center, large cohort of patient and long time research work to make sure of the best IVIG treatment.