李宗賢Tsung-Hsien Lee陳嬿如Yan-Ru Chen醫學研究所碩士班2026-10-292025-08-2320252025-07-25https://handle.ncl.edu.tw/11296/883zrjhttps://scholars.csmu.edu.tw/handle/123456789/36753中文摘要研究目的：
本研究旨在系統性回顧與統合分析目前文獻中，針對舒更葡糖（Sugammadex）與新斯狄格明（Neostigmine）兩種肌肉鬆弛劑拮抗藥物於末期腎病患者（End-Stage Renal Disease, ESRD）術後使用之安全性差異。由於該族群患者因腎功能嚴重受損，在接受全身麻醉手術時，對於肌肉鬆弛劑的使用與拮抗劑選擇需格外謹慎。傳統上使用新斯狄格明（Neostigmine）作為肌肉鬆弛劑的拮抗劑，但因其代謝與腎功能密切相關，在ESRD患者中可能增加術後併發症風險。舒更葡糖（Sugammadex）為新一代拮抗劑，藉由與羅庫溴鎂（Rocuronium）形成包合物來加速清除，雖主要經腎臟排泄，但其使用安全性在ESRD患者中仍具臨床關注價值。因此本研究期望釐清兩藥物在此特定族群中，對術後腎功能變化與不良臨床結果之影響，並提供麻醉用藥選擇之實證依據。研究方法及資料：
本研究採用系統性文獻回顧與統合分析（Systematic Review and Meta-analysis）之研究設計，資料來源包含PubMed、EMBASE及Cochrane Library等三大資料庫，搜尋時間範圍為2000年至2025年4月1日。納入標準包括以Sugammadex與Neostigmine進行比較之隨機對照試驗或回溯性觀察研究，且研究對象須為接受全身麻醉的末期腎病患者。篩選過程依據PRISMA準則進行，並由兩位研究人員獨立進行納入與排除。品質評估則依研究類型分別使用Cochrane RoB2、ROBINS-I與Newcastle-Ottawa Scale（NOS）進行。統合分析以Review Manager 5.4.1進行，計算標準化平均差（Standardized Mean Difference, SMD）與勝算比（Odds Ratio, OR）進行結果整合。研究主要探討兩組在術後腎功能變化（以Creatinine濃度為指標）及ICU入住率的差異為探討指標。研究結果：
最終共納入八篇符合條件之原始研究文獻，總樣本數達1066人，其中包含兩篇隨機對照試驗與六篇回溯性研究。因一篇研究之品質評估分數未達預設門檻，未納入最終統合分析，因此實際納入分析之研究共七篇。在術後腎功能變化（以血清 Creatinine 濃度為指標）方面，統合分析結果顯示，Sugammadex 組術後 creatinine 升幅顯著低於 Neostigmine 組（SMD = -0.982，95% CI：-1.563 至 -0.401，p = 0.001），差異具有統計與臨床意義。敏感度分析進一步顯示，即使逐一排除單篇研究，效應方向仍保持一致且結果穩健，僅於移除個別研究後統計顯著性略為下降，但整體趨勢不變。在 ICU 入住率方面，統合結果亦顯示 Sugammadex 組的住院風險顯著低於 Neostigmine 組（OR = 10.418，95% CI：1.879–57.765，p = 0.007），顯示 Sugammadex 在 ESRD 病患中可能降低術後需轉入 ICU 的機率，對於減少術後重症風險與醫療資源使用具有潛在的保護效益。結論與建議：
本研究整合目前針對ESRD患者術後使用肌肉鬆弛劑拮抗藥物之文獻，結果顯示Sugammadex相較Neostigmine可能在腎功能保護與降低重大術後不良事件方面更具優勢。儘管最終僅有 7 篇研究納入統合分析，但因排除之文獻並未涉及腎功能變化或 ICU 入住率兩大主要結局，故不影響整體結論之解釋力。建議臨床可在此特殊族群中優先考量Sugammadex之使用，但仍需更多高品質、前瞻性隨機試驗以進一步驗證本研究發現。未來研究亦應考量不同劑量策略與手術類型，以補足現有證據之限制。AbstractObjective：This study aimed to conduct a systematic review and meta-analysis of existing literature to compare the postoperative safety profiles of two neuromuscular blockade reversal agents—Sugammadex and Neostigmine—in patients with end-stage renal disease (ESRD). Due to the markedly impaired renal function in this patient population, anesthetic drug selection, particularly the choice of reversal agents, requires special caution. Neostigmine, traditionally used for neuromuscular blockade reversal, has renal-dependent metabolism and excretion, raising concerns about postoperative complications in ESRD patients. Sugammadex, a newer agent that encapsulates rocuronium for rapid reversal, is primarily renally excreted, yet its safety in ESRD remains a clinical concern. This study therefore sought to clarify the differential impacts of these two agents on postoperative renal function and adverse clinical outcomes in ESRD patients, thereby providing evidence-based guidance for anesthetic management in this high-risk group. Methods and Materials：This study employed a Systematic Review and Meta-analysis research design. Data sources included three major databases: PubMed, EMBASE, and the Cochrane Library, with the search period covering January 2000 to April 1, 2025. Eligible studies were randomized controlled trials (RCTs) or retrospective observational studies that compared Sugammadex with Neostigmine in patients with end-stage renal disease (ESRD) undergoing general anesthesia. The screening process was conducted in accordance with PRISMA guidelines, with two independent reviewers performing study inclusion and exclusion. Quality assessment was performed using Cochrane RoB 2 for RCTs, ROBINS-I for non-randomized studies, and the Newcastle–Ottawa Scale (NOS) as applicable. Meta-analyses were conducted using Review Manager version 5.4.1, calculating Standardized Mean Differences (SMD) and Odds Ratios (OR) for data synthesis. The primary outcomes were postoperative changes in renal function (measured by serum creatinine concentration) and ICU admission rate between the two groups.Results：A total of eight eligible original studies involving 1,066 patients were included, comprising two randomized controlled trials and six retrospective observational studies. One study did not meet the predefined quality threshold and was excluded from the final meta-analysis, resulting in seven studies being included in the pooled analysis. Regarding postoperative renal function, as measured by changes in serum creatinine levels, the meta-analysis demonstrated that the increase in creatinine was significantly lower in the Sugammadex group compared to the Neostigmine group (SMD = -0.982; 95% CI: -1.563 to -0.401; p = 0.001), indicating both statistical and clinical significance. Sensitivity analysis showed consistent and robust results across studies, with only a slight reduction in statistical significance when one study was removed; however, the overall effect direction remained unchanged. In terms of ICU admission rates, the pooled results also revealed a significantly lower risk in the Sugammadex group compared to the Neostigmine group (OR = 10.418; 95% CI: 1.879–57.765; p = 0.007), suggesting that Sugammadex may reduce the likelihood of postoperative ICU transfer in ESRD patients and potentially lower the risk of critical postoperative complications and healthcare resource utilization.Conclusion and Suggestion：This study synthesized the current literature on the use of neuromuscular blockade reversal agents in patients with end-stage renal disease (ESRD) undergoing surgery. The results suggest that Sugammadex, compared with Neostigmine, may offer greater advantages in terms of renal protection and reduction of major postoperative adverse events. Although only seven studies were ultimately included in the meta-analysis, the excluded study did not address the two primary outcomes—renal function changes or ICU admission rates—and thus did not compromise the interpretability of the overall conclusions. Based on the present evidence, Sugammadex may be preferentially considered in this high-risk population; however, further high-quality, prospective randomized trials are needed to confirm these findings. Future research should also investigate different dosing strategies and surgical contexts to address the current limitations in the available evidence.舒更葡糖新斯狄格明末期腎病麻醉安全性腎功能變化系統性回顧統合分析SugammadexNeostigmineEnd-Stage Renal DiseaseAnesthesia SafetyRenal FunctionSystematic ReviewMeta-analysisthesis