Li Jinling, He Lu, Tang Hongmei, Peng Tingting, Long Yao, Zeng Peishan, Huang Yuan, Chen Zhaofang, Han Mingshan, Xu Kaishou
Department of Rehabilitation, Guangzhou Women and Children's Medical Centre, Guangzhou Medical University, Guangzhou.
School of Medicine, South China University of Technology, Guangzhou, China.
Dev Med Child Neurol. 2023 Jan;65(1):86-93. doi: 10.1111/dmcn.15305. Epub 2022 Jun 8.
To compare the risks of adverse events 3 months after Onabotulinumtoxin-A and Lanbotulinumtoxin-A injections in children with cerebral palsy (CP) and to identify risk factors and associations.
A total of 1037 children (682 males, 355 females; mean age 5 years 2 months [SD 3 years]; age range 2 years-17 years 10 months) with CP underwent 1013 Onabotulinumtoxin-A injections and 418 Lanbotulinumtoxin-A injections from 2012 to 2021. Information was recorded in a purpose-built database.
The adverse event rates of Onabotulinumtoxin-A and Lanbotulinumtoxin-A were reported as 13.92% and 11.96% respectively. Most adverse events were mild and self-limiting. Children in Gross Motor Function Classification System (GMFCS) levels IV to V had a higher risk of adverse events than those in GMFCS levels I to III (odds ratio [OR] [95% confidence interval {CI}] = 3.65 [1.56, 5.40], p < 0.01). The history of recent illness and higher dose increased the likelihood of adverse events (OR [95% CI] = 2.00 [1.55, 3.00] and 2.20 [1.53, 3.07] respectively, p < 0.01). Sex, age, and the number of injections had no significant effect on adverse event rates (p > 0.05). The incidence of upper respiratory tract infection and lower respiratory tract infection after injections was weakly correlated with the incidence before injections (r = 0.36 and r = 0.27 respectively, p < 0.01).
Occurrence of adverse events was similar between Onabotulinumtoxin-A and Lanbotulinumtoxin-A in children with CP. Dose, GMFCS level, and health background were risk factors.
The prevalence of adverse events was similar between Onabotulinumtoxin-A and Lanbotulinumtoxin-A in children with cerebral palsy (CP). The prevalence of adverse events increased with the severity of CP and the injected dose. Sex, age, and number of injections had no significant effect on the prevalence of adverse events.
比较注射A型肉毒毒素（Onabotulinumtoxin-A）和A型澜肉毒素（Lanbotulinumtoxin-A）3个月后脑瘫（CP）患儿发生不良事件的风险，并确定风险因素及相关性。
2012年至2021年期间，共有1037例CP患儿（男682例，女355例；平均年龄5岁2个月[标准差3岁]；年龄范围2岁至17岁10个月）接受了1013次A型肉毒毒素（Onabotulinumtoxin-A）注射和418次A型澜肉毒素（Lanbotulinumtoxin-A）注射。相关信息记录于一个专门构建的数据库中。
A型肉毒毒素（Onabotulinumtoxin-A）和A型澜肉毒素（Lanbotulinumtoxin-A）的不良事件发生率分别为13.92%和11.96%。大多数不良事件为轻度且具有自限性。粗大运动功能分级系统（GMFCS）IV至V级的患儿发生不良事件的风险高于GMFCS I至III级的患儿（优势比[OR][95%置信区间{CI}]=3.65[1.56，5.40]，p<0.01）。近期患病史和较高剂量会增加不良事件发生的可能性（OR[95%CI]分别为2.00[1.55，3.00]和2.20[1.53，3.07]，p<0.01）。性别、年龄和注射次数对不良事件发生率无显著影响（p>0.05）。注射后上呼吸道感染和下呼吸道感染的发生率与注射前的发生率呈弱相关（r分别为0.36和0.27，p<0.01）。
CP患儿中，A型肉毒毒素（Onabotulinumtoxin-A）和A型澜肉毒素（Lanbotulinumtoxin-A）不良事件的发生情况相似。剂量、GMFCS分级水平和健康背景是风险因素。
脑瘫（CP）患儿中，A型肉毒毒素（Onabotulinumtoxin-A）和A型澜肉毒素（Lanbotulinumtoxin-A）不良事件的发生率相似。不良事件的发生率随CP严重程度和注射剂量的增加而升高。性别、年龄和注射次数对不良事件的发生率无显著影响。
