Zhu Shixin, Wang Tianyi, Wang Jiahe, Yang Siyuan, Yu Zhengquan, Gao Heng, Chen Gang
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China.
Southeast University, Jiangyin, Jiangsu Province, China.
J Atten Disord. 2023 Mar;27(5):470-487. doi: 10.1177/10870547231153941. Epub 2023 Feb 16.
A new formulation of extended-release methylphenidate (PRC-063) was approved to treat ADHD. This meta-analysis was conducted to study the efficacy and safety of PRC-063 for ADHD.
We searched for published trials to October 2022 in several databases.
A total of 1,215 patients from 5 RCTs were included. We observed significant improvement for PRC-063 in ADHD Rating Scale (ADHD-RS; MD = -6.73, 95% CI [-10.34, -3.12]) compared with placebo. The effect of PRC-063 on the sleep problems due to ADHD was not statistically different from placebo. Six subscales of Pittsburg Sleep Quality Index (PSQI) showed no statistical significance between PRC-063 and placebo. The result showed no significant difference comparing PRC-063 with placebo in serious treatment-emergent adverse events (TEAEs) (RR = 0.80, 95% CI [0.03, 19.34]). In subgroup analysis according to age, PRC-063 was more efficacious in minors compare to adults.
PRC-063 is an efficacious and safe treatment for ADHD, especially in children and adolescents.
一种新的缓释哌甲酯配方（PRC - 063）被批准用于治疗注意力缺陷多动障碍（ADHD）。本荟萃分析旨在研究PRC - 063治疗ADHD的疗效和安全性。
我们检索了多个数据库中截至2022年10月发表的试验。
纳入了来自5项随机对照试验的1215名患者。与安慰剂相比，我们观察到PRC - 063在ADHD评定量表（ADHD - RS；平均差=-6.73，95%置信区间[-10.34，-3.12]）上有显著改善。PRC - 063对ADHD所致睡眠问题的影响与安慰剂无统计学差异。匹兹堡睡眠质量指数（PSQI）的6个分量表在PRC - 063与安慰剂之间无统计学意义。结果显示，在严重治疗中出现的不良事件（TEAE）方面，PRC - 063与安慰剂相比无显著差异（风险比=0.80，95%置信区间[0.03，19.34]）。在按年龄进行的亚组分析中，与成人相比，PRC - 063在未成年人中更有效。
PRC - 063是一种治疗ADHD安全有效的药物，尤其对儿童和青少年有效。
