Abrishami Amir, Ho Joyce, Wong Jean, Yin Ling, Chung Frances
Department of Anesthesia, Toronto Western Hospital, University Health Network, University of Toronto, 399 Bathurst Street, 2-241A McLaughlin Wing, Toronto, Ontario, Canada, M5T 2S8.
Cochrane Database Syst Rev. 2009 Oct 7(4):CD007362. doi: 10.1002/14651858.CD007362.pub2.
Sugammadex is the first selective relaxant binding agent that has been studied for reversal of neuromuscular blockade induced by rocuronium and other steroidal non-depolarizing neuromuscular blocking agents (NMBAs).
To assess the efficacy and safety of sugammadex in reversing neuromuscular blockade induced by steroidal non-depolarizing NMBAs and in preventing postoperative residual neuromuscular blockade.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, Issue 3), MEDLINE (1950 to August 2008), and EMBASE (1980 to August 2008). In addition, we handsearched reference lists of relevant articles and meeting abstracts. Furthermore, we contacted the medication's manufacturer for more information.
All randomized controlled trials (RCTs) on adult patients (>/= 18 years old) in which sugammadex was compared with placebo or other medications, or in which different doses of sugammadex were compared with each other. We excluded non-randomized trials and studies on healthy volunteers.
We independently performed determination of trial inclusion, quality assessment, and data extraction. We applied standard meta-analytic techniques.
We included18 RCTs (n = 1321 patients). Seven trials were published as full-text papers, and 11 trials only as meeting abstracts. All the included trials had adequate methods of randomization and allocation concealment. The results suggest that, compared with placebo or neostigmine, sugammadex can more rapidly reverse rocuronium-induced neuromuscular blockade regardless of the depth of the block. We identified 2, 4, and 16 mg/kg of sugammadex for reversal of rocuronium-induced neuromuscular blockade at T(2) reappearance , 1 to 2 post-tetanic counts, and 3 to 5 minutes after rocuronium, respectively. The number of trials are very limited regarding vecuronium and pancuronium. Serious adverse events occurred in < 1% of all patients who received the medication. There was no significant difference between sugammadex and placebo in terms of the prevalence of drug-related adverse events (RR 1.20, 95% CI 0.61 to 2.37; P = 0.59, I(2) = 0%, 5 RCTs). Also, no significant difference was found between sugammadex and neostigmine for adverse events (RR 0.98, 95% CI 0.48 to1.98; P = 0.95, I(2) = 43%, 3 RCTs).
AUTHORS' CONCLUSIONS: Sugammadex was shown to be effective in reversing rocuronium-induced neuromuscular blockade. This review has found no evidence of a difference in the instance of unwanted effects between sugammadex, placebo or neostigmine. These results need to be confirmed by future trials on larger patient populations and with more focus on patient-related outcomes.
舒更葡糖钠是首个用于逆转罗库溴铵及其他甾体类非去极化神经肌肉阻滞剂（NMBA）所致神经肌肉阻滞的选择性肌松药结合剂。
评估舒更葡糖钠逆转甾体类非去极化NMBA所致神经肌肉阻滞及预防术后残余神经肌肉阻滞的有效性和安全性。
我们检索了Cochrane对照试验中心注册库（CENTRAL）（Cochrane图书馆2008年第3期）、MEDLINE（1950年至2008年8月）和EMBASE（1980年至2008年8月）。此外，我们手工检索了相关文章的参考文献列表和会议摘要。此外，我们还联系了该药物的制造商以获取更多信息。
所有针对成年患者（≥18岁）的随机对照试验（RCT），其中将舒更葡糖钠与安慰剂或其他药物进行比较，或比较不同剂量的舒更葡糖钠。我们排除了非随机试验和针对健康志愿者的研究。
我们独立进行试验纳入的判定、质量评估和数据提取。我们应用了标准的荟萃分析技术。
我们纳入了18项RCT（n = 1321例患者）。7项试验以全文形式发表，11项试验仅以会议摘要形式发表。所有纳入试验均有充分的随机化和分配隐藏方法。结果表明，与安慰剂或新斯的明相比，无论阻滞深度如何，舒更葡糖钠都能更迅速地逆转罗库溴铵所致的神经肌肉阻滞。我们确定分别给予2、4和16mg/kg舒更葡糖钠可在T2恢复、强直后计数1至2次以及罗库溴铵给药后3至5分钟时逆转罗库溴铵所致的神经肌肉阻滞。关于维库溴铵和泮库溴铵的试验数量非常有限。在所有接受该药物治疗的患者中，严重不良事件的发生率<1%。在药物相关不良事件的发生率方面，舒更葡糖钠与安慰剂之间无显著差异（RR 1.20，95%CI 0.61至2.37；P = 0.59，I2 = 0%，5项RCT）。此外，在不良事件方面，舒更葡糖钠与新斯的明之间也未发现显著差异（RR 0.98，95%CI 0.48至1.98；P = 0.95，I2 = 43%，3项RCT）。
已证明舒更葡糖钠可有效逆转罗库溴铵所致的神经肌肉阻滞。本综述未发现舒更葡糖钠、安慰剂或新斯的明在不良反应发生率方面存在差异的证据。这些结果需要通过未来针对更大患者群体且更关注患者相关结局的试验来证实。
