Won Young Ju, Lim Byung Gun, Lee Dong Kyu, Kim Heezoo, Kong Myoung Hoon, Lee Il Ok
Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea.
Medicine (Baltimore). 2016 Aug;95(34):e4678. doi: 10.1097/MD.0000000000004678.
Previous studies have shown that sugammadex, a modified γ-cyclodextrin, is a well-tolerated agent for the reversal of neuromuscular blockade (NMB) induced by a steroidal neuromuscular blocking drug in adult patients. However, its use has not been reviewed in pediatric patients. The aim of this meta-analysis was to evaluate the efficacy and safety of sugammadex in the reversal of rocuronium-induced NMB during surgery under general anesthesia in pediatric patients.
A literature search was performed using the Pubmed, EMBASE: Drugs and pharmacology, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews. Analysis was conducted using RevMan 5.3. Data collected from different trials were pooled; the weighted mean difference or the pooled risk ratio and the corresponding 95% confidence interval (CI) were used for analysis, and heterogeneity (I) assessment was performed.
Six randomized controlled trials comparing 253 pediatric patients (age range, 2-18 years) were included in the final analysis. The mean time taken to reach a train-of-four ratio of ≥0.9 was significantly shorter in the sugammadex groups (2 and 4 mg/kg) than in the control group (neostigmine or placebo), although the heterogeneity was high. The weighted mean differences of the 2 and 4 mg/kg sugammadex groups were -7.15 (95% CI: -10.77 to -3.54; I = 96%; P = 0.0001) and -17.32 (95% CI: -29.31 to -5.32; I = 98%; P = 0.005), respectively. The extubation time in the sugammadex group was shorter than that in the control group; the weighted mean difference of the sugammadex group was -6.00 (95% CI: -11.46 to -0.53; I = 99%; P = 0.03). There was no significant difference between the groups in terms of the incidence of postanesthetic adverse events; the pooled risk ratio was 0.67 (95% CI: 0.27-1.71; I = 59%; P = 0.41).
We suggest that sugammadex is fast and effective in reversing rocuronium-induced NMB in pediatric patients. Although there was no evidence of a higher incidence of adverse events with sugammadex compared to that with neostigmine or placebo, much more data regarding the safety of sugammadex in pediatric patients may be still required.
既往研究表明，舒更葡糖钠是一种改性γ-环糊精，对于成年患者甾体类神经肌肉阻滞药诱导的神经肌肉阻滞（NMB）的逆转是一种耐受性良好的药物。然而，其在儿科患者中的应用尚未得到综述。本荟萃分析的目的是评估舒更葡糖钠在小儿全身麻醉手术期间逆转罗库溴铵诱导的NMB的有效性和安全性。
使用PubMed、EMBASE：药物与药理学、Cochrane对照试验中心注册库和Cochrane系统评价数据库进行文献检索。使用RevMan 5.3进行分析。汇总从不同试验收集的数据；采用加权均数差或合并风险比及相应的95%置信区间（CI）进行分析，并进行异质性（I²）评估。
最终分析纳入了比较253例儿科患者（年龄范围2至18岁）的6项随机对照试验。舒更葡糖钠组（2mg/kg和4mg/kg）达到四个成串刺激比值≥0.9的平均时间显著短于对照组（新斯的明或安慰剂），尽管异质性较高。2mg/kg和4mg/kg舒更葡糖钠组的加权均数差分别为-7.15（95%CI：-10.77至-3.54；I²=96%；P=0.0001）和-17.32（95%CI：-29.31至-5.32；I²=98%；P=0.005）。舒更葡糖钠组的拔管时间短于对照组；舒更葡糖钠组的加权均数差为-6.00（95%CI：-11.46至-0.53；I²=99%；P=0.03）。两组在麻醉后不良事件发生率方面无显著差异；合并风险比为0.67（95%CI：0.27-1.71；I²=59%；P=0.41）。
我们认为舒更葡糖钠在逆转小儿患者罗库溴铵诱导的NMB方面快速且有效。虽然没有证据表明舒更葡糖钠与新斯的明或安慰剂相比不良事件发生率更高，但可能仍需要更多关于舒更葡糖钠在儿科患者中安全性的数据。
