Wang Jiahe, Yang Siyuan, Li Xiang, Wang Tianyi, Xu Zhongmou, Xu Xiang, Gao Heng, Chen Gang
Department of Neurosurgery & Brain and Nerve Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China.
Department of Neurosurgery & Brain and Nerve Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China.
Sleep Med. 2021 Mar;79:40-47. doi: 10.1016/j.sleep.2020.12.039. Epub 2021 Jan 2.
Solriamfetol is developed for the treatment of excessive sleepiness in adult patients with narcolepsy and obstructive sleep apnea (OSA). No systematic review of existing literature has been investigated before. Therefore, the meta-analysis is conducted to assess the efficacy and safety of solriamfetol for excessive sleepiness in narcolepsy and OSA.
PubMed, Embase and Cochrane Library databases were searched from earliest date to July 2020 for randomized controlled trials (RCTs) and the primary outcomes were change from baseline in mean sleep latency and Epworth Sleepiness Scale (ESS).
We pooled 1177 patients from five RCTs and found solriamfetol led to a significant increment in mean sleep latency (MD = 9.52, 95% CI: 7.60 to 11.44, P < 0.00001) and a reduction in ESS score (MD = -3.74, 95% CI: -4.38 to -3.09, P < 0.00001) compared with placebo. The proportion of patients with at least one adverse event was significantly increased in solriamfetol group (RR = 1.42, 95% CI: 1.24 to 1.64, P < 0.00001), while no statistical differences existed in the risk of at least one serious adverse event between solriamfetol and controlled group (RR = 0.95, 95% CI: 0.24 to 3.77, P = 0.39).
A dose of 150 mg solriamfetol is proved to be the appropriate and stable dose for excessive sleepiness. In addition, solriamfetol showed good efficacy for excessive sleepiness in narcolepsy and OSA but also significantly increases the risk of adverse events.
索利那非托用于治疗发作性睡病和阻塞性睡眠呼吸暂停（OSA）成年患者的过度嗜睡。此前尚未对现有文献进行系统综述。因此，进行荟萃分析以评估索利那非托治疗发作性睡病和OSA患者过度嗜睡的疗效和安全性。
检索PubMed、Embase和Cochrane图书馆数据库，从最早日期至2020年7月，查找随机对照试验（RCT），主要结局指标为平均睡眠潜伏期和爱泼沃斯嗜睡量表（ESS）相对于基线的变化。
我们汇总了来自五项RCT的1177例患者，发现与安慰剂相比，索利那非托可使平均睡眠潜伏期显著增加（MD = 9.52，95%CI：7.60至11.44，P < 0.00001），ESS评分降低（MD = -3.74，95%CI：-4.38至-3.09，P < 0.00001）。索利那非托组至少发生一次不良事件的患者比例显著增加（RR = 1.42，95%CI：1.24至1.64，P < 0.00001），而索利那非托组与对照组至少发生一次严重不良事件的风险无统计学差异（RR = 0.95，95%CI：0.24至3.77，P = 0.39）。
150mg索利那非托被证明是治疗过度嗜睡的合适且稳定剂量。此外，索利那非托对发作性睡病和OSA的过度嗜睡显示出良好疗效，但也显著增加了不良事件风险。
