Clarithromycin Plus Intravenous Immunoglobulin Therapy Can Reduce the Relapse Rate of Kawasaki Disease: A Phase 2, Open-Label, Randomized Control Study.
Clarithromycin Plus Intravenous Immunoglobulin Therapy Can Reduce the Relapse Rate of Kawasaki Disease: A Phase 2, Open-Label, Randomized Control Study.
复制标题
DOI：
10.1161/jaha.116.005370
复制
发表时间：
2017-07-06
影响因子：
5.4
通讯作者：
Hara T
中科院分区：
文献类型：
--
作者：
Nanishi E;Nishio H;Takada H;Yamamura K;Fukazawa M;Furuno K;Mizuno Y;Saigo K;Kadoya R;Ohbuchi N;Onoe Y;Yamashita H;Nakayama H;Hara T;Ohno T;Takahashi Y;Hatae K;Harada T;Shimose T;Kishimoto J;Ohga S;Hara T
我们以前报道过，生物膜和先天免疫参与了川崎病的发病。因此，我们的目标是评估克拉霉素，一种抗生物被膜剂，对川崎病患者的疗效。我们在日本的8家医院进行了一项开放标签、多中心、随机的2期试验。符合条件的患者包括4个月至5岁的儿童，他们是在患病4至8天内登记的。参与者被随机分配接受静脉注射免疫球蛋白(IVIG)或IVIG+克拉霉素。主要终点是IVIG治疗开始后发烧的持续时间。81名符合条件的患者被随机分组。两组发热持续时间差异无统计学意义(IVIG+克拉霉素组和IVIG组分别为34.3±32.4和31.1±31.1小时，P=0.66)。丙种球蛋白联合克拉霉素组复发率为12.5%，明显低于丙种球蛋白组的30.8%(P=0.046)。在研究期间没有发生严重的不良反应。在一项特殊分析中，静脉注射丙种球蛋白+克拉霉素组的患者平均住院时间明显少于静脉注射丙种球蛋白组(8.9亿天对10.3百万天，P=0.049)。IVIG联合克拉霉素治疗虽然不能缩短发热时间，但降低了川崎病患者的复发率，缩短了住院时间。网址：http://www.umin.ac.jp/ctr/index.htm.唯一标识：UMIN000015437。
We previously reported that biofilms and innate immunity contribute to the pathogenesis of Kawasaki disease. Therefore, we aimed to assess the efficacy of clarithromycin, an antibiofilm agent, in patients with Kawasaki disease. We conducted an open‐label, multicenter, randomized, phase 2 trial at 8 hospitals in Japan. Eligible patients included children aged between 4 months and 5 years who were enrolled between days 4 and 8 of illness. Participants were randomly allocated to receive either intravenous immunoglobulin (IVIG) or IVIG plus clarithromycin. The primary end point was the duration of fever after the initiation of IVIG treatment. Eighty‐one eligible patients were randomized. The duration of the fever did not differ between the 2 groups (mean±SD, 34.3±32.4 and 31.1±31.1 hours in the IVIG plus clarithromycin group and the IVIG group, respectively [P=0.66]). The relapse rate of patients in the IVIG plus clarithromycin group was significantly lower than that in the IVIG group (12.5% versus 30.8%, P=0.046). No serious adverse events occurred during the study period. In a post hoc analysis, the patients in the IVIG plus clarithromycin group required significantly shorter mean lengths of hospital stays than those in the IVIG group (8.9 days versus 10.3 days, P=0.049). Although IVIG plus clarithromycin therapy failed to shorten the duration of fever, it reduced the relapse rate and shortened the duration of hospitalization in patients with Kawasaki disease. URL: http://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000015437.