From the Departments of Anesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, China.
From the Departments of Anesthesiology and Critical Care Medicine, Peking University First Hospital, Beijing, China; the Department of Anesthesiology, Aerospace Central Hospital, Peking University Aerospace School of Clinical Medicine, Beijing, China.
Anesthesiology. 2022 Apr 1;136(4):551-566. doi: 10.1097/ALN.0000000000004159.
Postoperative pulmonary complications are common. Aging and respiratory disease provoke airway hyperresponsiveness, high-risk surgery induces diaphragmatic dysfunction, and general anesthesia contributes to atelectasis and peripheral airway injury. This study therefore tested the hypothesis that inhalation of penehyclidine, a long-acting muscarinic antagonist, reduces the incidence of pulmonary complications in high-risk patients over the initial 30 postoperative days.
This single-center double-blind trial enrolled 864 patients age over 50 yr who were scheduled for major upper-abdominal or noncardiac thoracic surgery lasting 2 h or more and who had an Assess Respiratory Risk in Surgical Patients in Catalonia score of 45 or higher. The patients were randomly assigned to placebo or prophylactic penehyclidine inhalation from the night before surgery through postoperative day 2 at 12-h intervals. The primary outcome was the incidence of a composite of pulmonary complications within 30 postoperative days, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonitis.
A total of 826 patients (mean age, 64 yr; 63% male) were included in the intention-to-treat analysis. A composite of pulmonary complications was less common in patients assigned to penehyclidine (18.9% [79 of 417]) than those receiving the placebo (26.4% [108 of 409]; relative risk, 0.72; 95% CI, 0.56 to 0.93; P = 0.010; number needed to treat, 13). Bronchospasm was less common in penehyclidine than placebo patients: 1.4% (6 of 417) versus 4.4% (18 of 409; relative risk, 0.327; 95% CI, 0.131 to 0.82; P = 0.011). None of the other individual pulmonary complications differed significantly. Peak airway pressures greater than 40 cm H2O were also less common in patients given penehyclidine: 1.9% (8 of 432) versus 4.9% (21 of 432; relative risk, 0.381; 95% CI, 0.171 to 0.85; P = 0.014). The incidence of other adverse events, including dry mouth and delirium, that were potentially related to penehyclidine inhalation did not differ between the groups.
In high-risk patients having major upper-abdominal or noncardiac thoracic surgery, prophylactic penehyclidine inhalation reduced the incidence of pulmonary complications without provoking complications.
术后肺部并发症很常见。衰老和呼吸系统疾病会引发气道高反应性，高危手术会导致膈肌功能障碍，全身麻醉会导致肺不张和外周气道损伤。因此，本研究旨在测试这样一个假设，即吸入长效毒蕈碱拮抗剂苯海索可降低高危患者术后 30 天内肺部并发症的发生率。
这项单中心、双盲试验纳入了 864 名年龄在 50 岁以上的患者，他们计划接受持续时间超过 2 小时的上腹部或非心脏胸部大手术，且 Catalonia 手术患者呼吸风险评估评分≥45 分。患者被随机分配至安慰剂或预防性苯海索吸入组，从手术前一晚至术后第 2 天，12 小时一次。主要结局是术后 30 天内肺部并发症的综合发生率，包括呼吸道感染、呼吸衰竭、胸腔积液、肺不张、气胸、支气管痉挛和吸入性肺炎。
共有 826 名患者（平均年龄 64 岁，63%为男性）纳入意向治疗分析。与安慰剂组（26.4%[108/409]）相比，苯海索组（18.9%[79/417]）肺部并发症综合发生率较低（相对风险 0.72；95%CI，0.56 至 0.93；P=0.010；需要治疗的人数 13）。与安慰剂组相比，苯海索组支气管痉挛的发生率较低：1.4%（6/417）vs. 4.4%（18/409；相对风险 0.327；95%CI，0.131 至 0.82；P=0.011）。其他单个肺部并发症的发生率无显著差异。气道峰压大于 40cmH2O 的患者也较少：1.9%（8/432）vs. 4.9%（21/432；相对风险 0.381；95%CI，0.171 至 0.85；P=0.014）。与苯海索吸入相关的其他潜在不良事件，包括口干和谵妄，两组之间的发生率无差异。
对于接受上腹部或非心脏胸部大手术的高危患者，预防性苯海索吸入可降低肺部并发症的发生率，而不会引起并发症。
