摘要
背景与目的 随着单孔胸腔镜技术在肺部小结节诊疗中的广泛应用,术后引流管管理的优化成为胸外科快速康复的关注点。本研究拟探讨单孔胸腔镜肺楔形切除术后免留置胸腔闭式引流管策略的安全性与非劣效性。方法 纳入2023年1月至2025年5月203例符合标准的患者,分为非引流组(n=53)与引流组(n=150),经倾向性评分匹配(propensity score matching, PSM)后获得41对均衡样本,采用非劣效性检验结合贝叶斯分析评估结局。结果 PSM后,非引流组在发热(19.51%vs 26.83%)、胸腔积液(24.39%vs 21.95%)发生率及额外加用镇痛药比例(12.20%vs 9.76%)上达非劣效标准(差值95%CI上限未超10%界值),中位术后住院日(2.00 vs 3.00 d, P<0.001)、术后首日视觉模拟评分(visual analogue scale, VAS)显著优于引流组(P=0.0495)且非劣效性成立;但二次干预(以二次置管为主)率(4.88%vs 0.00%)、影像学并发症(73.17%vs 65.85%)等指标非劣效性检验未成立(差值95%CI上限超10%界值)。贝叶斯分析显示,非引流组影像学相关并发症阳性率高于引流组的概率为77.18%,两组阳性率差异绝对值大于10.0%的概率为44.45%。结论 经严格筛选的低危患者术后免引流管策略可缩短住院时间、减轻疼痛,核心安全性指标达非劣效标准,但二次置管及影像学并发症相关非劣效性未达标,临床应用需加强术后监测以保障安全。
Background and objective With the wide application of uniportal video-assisted thoracoscopy in the diagnosis and treatment of small pulmonary nodules,the optimization of postoperative chest tube management has become a focus of enhanced recovery after thoracic surgery.This study aimed to investigate the safety and non-inferiority of a nodrain strategy following uniportal video-assisted thoracoscopic wedge resection.Methods A total of 203 eligible patients who underwent surgery between January 2023 and May 2025 were enrolled and allocated to the no-drain group(n=53)and the drain group(n=150).After propensity score matching(PSM),41 well-balanced pairs were generated.Non-inferiority testing combined with Bayesian analysis was performed to assess postoperative outcomes.Results After PSM,the no-drain group met the predefined non-inferiority criteria for the incidence of postoperative fever(19.51%vs 26.83%),pleural effusion(24.39%vs 21.95%),and the proportion of patients requiring additional analgesics(12.20%vs 9.76%),with the upper bound of the 95%CI for between-group differences not exceeding the 10%non-inferiority margin.The no-drain group demonstrated a significantly shorter median postoperative length of stay(2.00 vs 3.00 d,P<0.001)and lower visual analogue scale(VAS)scores on postoperative day 1(P=0.0495),with non-inferiority confirmed.However,non-inferiority was not established for secondary intervention rates(primarily chest tube reinsertion,4.88%vs 0.00%)or radiologic complications(73.17%vs 65.85%),as the upper limit of the 95%CI for the between-group differences exceeded the 10%margin.Bayesian analysis showed that the probability that the positive rate of imaging-related complications in the no-drain group was higher than that in the drain group was 77.18%,and the probability that the absolute value of the difference in positive rates between the two groups greater than 10.0%was 44.45%.Conclusion In carefully selected low-risk patients,a no-drain strategy following uniportal thoracoscopic wedge resection may reduce postoperative pain and shorten hospital stay,while meeting non-inferiority criteria for key safety outcomes.However,non-inferiority was not demonstrated for secondary chest tube insertion or radiologic complications.Enhanced postoperative monitoring is therefore essential to ensure clinical safety.
作者
林楚童
宁英泽
马善吴
汤继征
金亮
贺未
何华钰
强光亮
Chutong LIN;Yingze NING;Shanwu MA;Jizheng TANG;Liang JIN;Wei HE;Huayu HE;Guangliang QIANG(Department of Thoracic Surgery,Peking University Third Hospital,Beijing 100191,China)
出处
《中国肺癌杂志》
北大核心
2026年第2期105-114,共10页
Chinese Journal of Lung Cancer
基金
北京市自然科学基金重点研究专项(No.24Z10018)
北京大学第三医院院临床重点项目(No.BYSYRCYJ2023001,No.BYSYZD2025049)资助。
