Randomized Trial of Adjunctive Prednisolone for Kawasaki Disease.

Methods

In this multicenter, open-label, randomized, controlled trial in China, we assigned participants with newly diagnosed Kawasaki disease in a 1:1 ratio to receive prednisolone plus standard treatment or standard treatment alone.

在这项中国多中心、开放标签、随机对照试验中，我们将新诊断的川崎病患者以1:1的比例分配接受泼尼松龙加标准治疗或仅接受标准治疗。

The primary outcome was the occurrence of coronary-artery lesions at 1 month after illness onset.

主要结果是疾病发作后1个月冠状动脉病变的发生情况。

Prespecified key secondary outcomes, for which analyses were not controlled for multiplicity, included receipt of rescue therapy, duration of fever, change in the C-reactive protein (CRP) level, and changes in coronary-artery z scores.

未对多重性进行控制的预先设定的关键次要结果包括接受救援治疗、发热持续时间、C反应蛋白（CRP）水平的变化以及冠状动脉Z分数的变化。

Results

A total of 3208 participants underwent randomization, with coronary-artery lesions detected at baseline in 870 of 3184 participants (27.3%).

共有3208名参与者进行了随机分组，其中3184名参与者中有870名（27.3%）在基线时检测出冠状动脉病变。

At 1 month, coronary-artery lesions were detected in 16.0% of the participants receiving prednisolone plus standard treatment and in 13.8% of those receiving standard treatment alone (adjusted risk difference, 1.1 percentage points; 95% confidence interval, -1.0 to 3.4; P = 0.31).

在1个月时，接受泼尼松联合标准治疗的参与者中有16.0%检测出冠状动脉病变，而仅接受标准治疗的参与者中有13.8%检测出病变（调整后的风险差异为1.1个百分点；95%置信区间为-1.0至3.4；P = 0.31）。

Rescue therapy was used in 4.6% of the participants receiving prednisolone plus standard therapy and in 10.1% of those receiving standard treatment alone; the median duration of fever was 8.4 hours and 13.2 hours, respectively, and the reductions in the C-reactive protein level at 72 hours were 67.5 mg per liter and 59.8 mg per liter.

在接受泼尼松龙加标准治疗的参与者中，有4.6%使用了救援治疗，在仅接受标准治疗的参与者中，这一比例为10.1%；发热的中位持续时间分别为8.4小时和13.2小时，而在72小时时C反应蛋白水平的降低分别为每升67.5毫克和59.8毫克。

Decreases in coronary-artery z scores were similar in the two groups.

两组中冠状动脉Z分数的降低相似。

At 3 months, the incidenceof coronary-artery lesions was 12.6% with prednisolone plus standard therapy and 10.5% with standard treatment alone; the percentage of participants with progression of coronary-artery lesions was 28.6% and 28.9%, respectively, and the incidenceof medium-to-giant coronary-artery aneurysms was 1.9% and 1.1%.

在3个月时，联合使用泼尼松和标准治疗的冠状动脉病变发生率为12.6%，仅使用标准治疗的为10.5%；进展为冠状动脉病变的患者比例分别为28.6%和28.9%，中到大型冠状动脉瘤的发生率分别为1.9%和1.1%。

The overall incidenceof adverse events did not differ significantly between the two groups.

两组之间不良事件的总体发生率没有显著差异。

Conclusions

The addition of prednisolone to standard primary treatment for Kawasaki disease did not reduce the incidenceof coronary-artery lesions at 1 month after illness onset.

将泼尼松添加到川崎病的标准一线治疗中，并未在发病后1个月减少冠状动脉病变的发生率。

(Funded by the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences and the National Natural Science Foundation of China; ClinicalTrials.gov number, NCT04078568.).

(该研究由中华医学会医学科学创新基金和国家自然科学基金资助；ClinicalTrials.gov编号，NCT04078568。)