Division of Neurology, Department of Pediatrics, Kalawati Saran Children's Hospital and Lady Hardinge Medical College, New Delhi, 110001, India.
Department of Neurology, Smt. Sucheta Kriplani Hospital and Lady Hardinge Medical College, New Delhi, India.
Indian J Pediatr. 2021 Aug;88(8):778-784. doi: 10.1007/s12098-020-03630-3. Epub 2021 Feb 11.
To compare intravenous methylprednisolone (IVMP) with oral prednisolone (OP) for the treatment of West syndrome.
In this randomized, open-label trial, children aged 2 to 30 mo presenting with epileptic spasms with hypsarrhythmia or its variants on EEG were randomized to receive either IVMP (30 mg/kg/d for 3 d followed by oral prednisolone taper) or OP (4 mg/kg/d for two weeks followed by taper). The primary outcome measure was spasms cessation on day 14. Secondary outcomes included time to response, electroclinical remission at 2 and 6 wk, and frequency of adverse effects. ( ClinicalTrials.gov Identifier: NCT03876444).
Sixty children were enrolled; 31 in the IVMP and 29 in the OP arm. Proportion of children achieving spasms cessation at day 14 was similar in both groups (54.8% versus 68.9%, p = 0.26). Time to achieve remission was lower in the IVMP group (mean 5.4 ± 0.9 versus 9.5 ± 2.6 d, p < 0.0001). Electroclinical remission at 2 wk was similar in both groups (51.6% versus 44.8%, p = 0.59) but lower at 6 wk in the IVMP group (45.2% versus 75.9%, p < 0.015). Adverse effects like sleep disturbance, irritability and hypertension were more common in IVMP group whereas weight gain was more common in the OP group.
There was no significant difference in spasms cessation between the groups on day 14 although remission was higher at 6 wk in OP group. Our study suggests that OP was better than IVMP in efficacy and sustained remission with fewer adverse effects.
比较静脉注射甲泼尼龙（IVMP）与口服泼尼松龙（OP）治疗婴儿痉挛症的疗效。
本随机、开放标签试验纳入了年龄在 2 至 30 月龄、脑电图显示有癫痫性痉挛伴高度失律或其变异型的患儿，将其随机分为 IVMP 组（30mg/kg/d，连用 3d 后口服泼尼松龙逐渐减量）或 OP 组（4mg/kg/d，连用 2 周后逐渐减量）。主要结局指标为第 14 天痉挛停止。次要结局指标包括反应时间、2 周和 6 周时的临床电缓解率，以及不良反应的发生频率。（ClinicalTrials.gov 标识符：NCT03876444）。
共有 60 例患儿入组，其中 IVMP 组 31 例，OP 组 29 例。两组患儿第 14 天痉挛停止的比例相似（54.8%对 68.9%，p=0.26）。IVMP 组达到缓解的时间更短（平均 5.4±0.9 对 9.5±2.6 d，p<0.0001）。两组患儿第 2 周的临床电缓解率相似（51.6%对 44.8%，p=0.59），但第 6 周时 IVMP 组的缓解率较低（45.2%对 75.9%，p<0.015）。IVMP 组不良反应如睡眠障碍、烦躁和高血压更为常见，而 OP 组体重增加更为常见。
两组患儿在第 14 天的痉挛停止率没有显著差异，尽管 OP 组在第 6 周的缓解率更高。我们的研究表明，OP 在疗效和持续缓解方面优于 IVMP，且不良反应更少。
