Abstract：
BACKGROUND: Efficacy and safety of sugammadex for the reversal of neuromuscular blocking agents (NMBAs) in patients with neuromuscular diseases remains unclear. We summarised the available evidence and evaluated the quality of data reporting and the validity of published reports.
METHODS: We searched for reports (any design) on the usage of sugammadex (any regimen) for the reversal of an NMBA in patients (any age) with any neuromuscular disease. We used a modified CARE checklist (maximum score 23) to assess the quality of data reporting and an original specific validity checklist (maximum score 41) that was developed through a Delphi process.
RESULTS: We retrieved 126 observational reports (386 patients). Most dealt with myasthenia gravis patients receiving rocuronium. The train-of-four ratio returned to ≥0.9 in 258 of 265 (97.4%) patients in whom neuromonitoring was used. Adverse events occurred in 14 of 332 (4.2%) patients in whom adverse events were reported as present or absent. In 90 case reports, the median score of the 23-point CARE checklist was 13.5 (inter-quartile range [IQR] 11-16). In all 126 reports, the median score of the 41-point validity checklist was 23 (IQR 20-27). Scores were positively correlated.
CONCLUSIONS: These uncontrolled observations (of mainly low to moderate quality and validity) do not allow confident assessment of the efficacy and safety of sugammadex for the reversal of NMBAs in patients with neuromuscular diseases. Reporting of observational data should follow established guidelines, include specific information to ensure validity, and emphasise what the new data add to current knowledge.
UNASSIGNED: PROSPERO 2019 (CRD42019119924).
METHODS: We searched for reports (any design) on the usage of sugammadex (any regimen) for the reversal of an NMBA in patients (any age) with any neuromuscular disease. We used a modified CARE checklist (maximum score 23) to assess the quality of data reporting and an original specific validity checklist (maximum score 41) that was developed through a Delphi process.
RESULTS: We retrieved 126 observational reports (386 patients). Most dealt with myasthenia gravis patients receiving rocuronium. The train-of-four ratio returned to ≥0.9 in 258 of 265 (97.4%) patients in whom neuromonitoring was used. Adverse events occurred in 14 of 332 (4.2%) patients in whom adverse events were reported as present or absent. In 90 case reports, the median score of the 23-point CARE checklist was 13.5 (inter-quartile range [IQR] 11-16). In all 126 reports, the median score of the 41-point validity checklist was 23 (IQR 20-27). Scores were positively correlated.
CONCLUSIONS: These uncontrolled observations (of mainly low to moderate quality and validity) do not allow confident assessment of the efficacy and safety of sugammadex for the reversal of NMBAs in patients with neuromuscular diseases. Reporting of observational data should follow established guidelines, include specific information to ensure validity, and emphasise what the new data add to current knowledge.
UNASSIGNED: PROSPERO 2019 (CRD42019119924).
摘要：
背景：Sugammadex在神经肌肉疾病患者中逆转神经肌肉阻断剂（NMBAs）的有效性和安全性尚不清楚。我们总结了现有证据，并评估了数据报告的质量和已发布报告的有效性。
方法：我们搜索了关于sugammadex（任何方案）在患有任何神经肌肉疾病的患者（任何年龄）中使用NMBA逆转的报告（任何设计）。我们使用修改后的CARE检查表（最高分23）来评估数据报告的质量，并使用通过Delphi过程开发的原始特定有效性检查表（最高分41）。
结果：我们检索了126份观察性报告（386例患者）。大多数治疗重症肌无力患者接受罗库溴铵。在265名使用神经监测的患者中，有258名（97.4％）的四组比率恢复到≥0.9。在332例患者中，有14例（4.2%）发生了不良事件，其中不良事件报告为存在或不存在。在90个病例报告中，23分的CARE检查表的中位评分为13.5分(四分位距[IQR]11~16分).在所有126份报告中，41分有效性检查表的中位得分为23分(IQR20-27).分数呈正相关。
结论：这些不受控制的观察结果（主要是低到中等质量和有效性）无法可靠地评估sugammadex逆转神经肌肉疾病患者NMBA的疗效和安全性。观测数据的报告应遵循既定的指导方针，包括特定信息以确保有效性，并强调新数据对当前知识的补充。
■PROSPERO2019（CRD42019119924）。
方法：我们搜索了关于sugammadex（任何方案）在患有任何神经肌肉疾病的患者（任何年龄）中使用NMBA逆转的报告（任何设计）。我们使用修改后的CARE检查表（最高分23）来评估数据报告的质量，并使用通过Delphi过程开发的原始特定有效性检查表（最高分41）。
结果：我们检索了126份观察性报告（386例患者）。大多数治疗重症肌无力患者接受罗库溴铵。在265名使用神经监测的患者中，有258名（97.4％）的四组比率恢复到≥0.9。在332例患者中，有14例（4.2%）发生了不良事件，其中不良事件报告为存在或不存在。在90个病例报告中，23分的CARE检查表的中位评分为13.5分(四分位距[IQR]11~16分).在所有126份报告中，41分有效性检查表的中位得分为23分(IQR20-27).分数呈正相关。
结论：这些不受控制的观察结果（主要是低到中等质量和有效性）无法可靠地评估sugammadex逆转神经肌肉疾病患者NMBA的疗效和安全性。观测数据的报告应遵循既定的指导方针，包括特定信息以确保有效性，并强调新数据对当前知识的补充。
■PROSPERO2019（CRD42019119924）。
