Abstract：
BACKGROUND: Postoperative ileus, driven by the cholinergic anti-inflammatory pathway, is the most common complication in patients undergoing colorectal surgery. By inhibiting acetylcholinesterase, pyridostigmine can potentially modulate the cholinergic anti-inflammatory pathway and accelerate gastrointestinal recovery. This study aimed to assess the efficacy of pyridostigmine in improving gastrointestinal recovery after colorectal surgery.
METHODS: This double-blinded RCT enrolled adult patients undergoing elective colorectal surgery at two hospitals in South Australia. Patients were randomized to 60 mg oral pyridostigmine or placebo twice daily starting 6 h after surgery until the first passage of stool. The primary outcome was GI-2, a validated composite measure of time to first stool and tolerance of oral diet. Secondary outcomes included incidence of postoperative ileus (defined as GI-2 greater than 4 days), duration of hospital stay, and 30-day complications, evaluated by intention-to-treat univariate analysis.
RESULTS: Of 130 patients recruited (mean(s.d.) age 58.4(16.4) years; 73 men, 56%), 65 were allocated to each arm. The median GI-2 was 1 day shorter with pyridostigmine compared with placebo (2 (i.q.r. 1-3) versus 3 (2-4) days; P = 0.015). However, there were no significant differences in postoperative ileus (17.2 versus 21.5%; P = 0.532) or duration of hospital stay (median 5 (i.q.r. 4-8.75) versus 5 (4-7.5) days; P = 0.921). Similarly, there were no significant differences in overall complications, anastomotic leak, cardiac complications, or patient-reported side effects.
CONCLUSIONS: Pyridostigmine resulted in a quicker return of GI-2 and was well tolerated. Larger multicentre studies are required to determine the optimal dosing and evaluate the impact of pyridostigmine in different surgical settings. Registration number: ACTRN12621000530820 (https://anzctr.org.au).
METHODS: This double-blinded RCT enrolled adult patients undergoing elective colorectal surgery at two hospitals in South Australia. Patients were randomized to 60 mg oral pyridostigmine or placebo twice daily starting 6 h after surgery until the first passage of stool. The primary outcome was GI-2, a validated composite measure of time to first stool and tolerance of oral diet. Secondary outcomes included incidence of postoperative ileus (defined as GI-2 greater than 4 days), duration of hospital stay, and 30-day complications, evaluated by intention-to-treat univariate analysis.
RESULTS: Of 130 patients recruited (mean(s.d.) age 58.4(16.4) years; 73 men, 56%), 65 were allocated to each arm. The median GI-2 was 1 day shorter with pyridostigmine compared with placebo (2 (i.q.r. 1-3) versus 3 (2-4) days; P = 0.015). However, there were no significant differences in postoperative ileus (17.2 versus 21.5%; P = 0.532) or duration of hospital stay (median 5 (i.q.r. 4-8.75) versus 5 (4-7.5) days; P = 0.921). Similarly, there were no significant differences in overall complications, anastomotic leak, cardiac complications, or patient-reported side effects.
CONCLUSIONS: Pyridostigmine resulted in a quicker return of GI-2 and was well tolerated. Larger multicentre studies are required to determine the optimal dosing and evaluate the impact of pyridostigmine in different surgical settings. Registration number: ACTRN12621000530820 (https://anzctr.org.au).
摘要：
背景：术后肠梗阻，由胆碱能抗炎途径驱动，是结直肠手术患者最常见的并发症。通过抑制乙酰胆碱酯酶,吡啶斯的明可以潜在地调节胆碱能抗炎途径并加速胃肠道恢复。本研究旨在评估吡啶斯的明在改善结直肠手术后胃肠道恢复中的疗效。
方法：该双盲RCT招募了在南澳大利亚的两家医院接受择期结直肠手术的成年患者。从手术后6小时开始，患者被随机分为60mg口服吡啶斯的明或安慰剂，每天两次，直到首次排便为止。主要结果是GI-2，这是一种经过验证的首次大便时间和口服饮食耐受性的综合指标。次要结果包括术后肠梗阻的发生率（定义为GI-2超过4天），住院时间,和30天的并发症，通过意向治疗单变量分析进行评估。
结果：招募的130名患者（平均年龄58.4（16.4）岁；73名男性，56%），每个手臂分配了65个。与安慰剂相比，吡啶斯的明的GI-2中位数短1天（2（i.q.r.1-3）比3（2-4）天；P=0.015）。然而,术后肠梗阻(17.2对21.5%;P=0.532)或住院时间(中位数5(i.q.r.4-8.75)对5(4-7.5)天;P=0.921)无显著差异.同样，总体并发症没有显着差异，吻合口漏,心脏并发症,或患者报告的副作用。
结论：吡唑斯的明导致GI-2更快的恢复，并且耐受性良好。需要更大的多中心研究来确定最佳剂量并评估吡啶斯的明在不同手术环境中的影响。注册号:ACTRN12621000530820(https://anzctr.org.au).
方法：该双盲RCT招募了在南澳大利亚的两家医院接受择期结直肠手术的成年患者。从手术后6小时开始，患者被随机分为60mg口服吡啶斯的明或安慰剂，每天两次，直到首次排便为止。主要结果是GI-2，这是一种经过验证的首次大便时间和口服饮食耐受性的综合指标。次要结果包括术后肠梗阻的发生率（定义为GI-2超过4天），住院时间,和30天的并发症，通过意向治疗单变量分析进行评估。
结果：招募的130名患者（平均年龄58.4（16.4）岁；73名男性，56%），每个手臂分配了65个。与安慰剂相比，吡啶斯的明的GI-2中位数短1天（2（i.q.r.1-3）比3（2-4）天；P=0.015）。然而,术后肠梗阻(17.2对21.5%;P=0.532)或住院时间(中位数5(i.q.r.4-8.75)对5(4-7.5)天;P=0.921)无显著差异.同样，总体并发症没有显着差异，吻合口漏,心脏并发症,或患者报告的副作用。
结论：吡唑斯的明导致GI-2更快的恢复，并且耐受性良好。需要更大的多中心研究来确定最佳剂量并评估吡啶斯的明在不同手术环境中的影响。注册号:ACTRN12621000530820(https://anzctr.org.au).
