围手术期雾化吸入异丙托溴铵治疗胸外科手术合并COPD患者的随机、双盲、安慰剂对照、平行、多中心研究

Perioperative nebulization of ipratropium bromide in patients with chronic obstructive pulmonary disease under thoracic surgery:A randomized,double-blind,placebo-controlled,parallel-group,multi-centre trial

目的评估围手术期雾化吸入异丙托溴铵能否改善胸外科合并慢性阻塞性肺疾病(chronic obstructive pulmonary disease,COPD)进行肺部切除手术患者术前肺功能,降低术后肺部并发症发生率及安全性。方法2013年11月18日—2015年8月12日,10个中心的192例接受全身麻醉下择期肺叶切除术或右肺双叶切除术或肺段切除术的COPD患者按1∶1随机分配至异丙托溴铵组(96例)或安慰剂组(96例),比较两组用药对术前肺功能及术后肺部并发症发生率的影响。其中男168例、女22例,年龄(62.90±6.50)岁。结果两组基线和人口学特征基本均衡。异丙托溴铵组术前第1秒用力呼气容积改变的校正均值高于安慰剂组,差异有统计学意义[(169.90±29.07)mL vs.(15.00±29.35)mL,P<0.05]。异丙托溴铵组术后肺炎发生率下降,差异有统计学意义(2.6%vs.14.1%,P<0.05)。本试验也未观察到任何异丙托溴铵相关的不良事件。结论本研究提示围手术期雾化吸入异丙托溴铵能够显著改善胸外科合并COPD进行肺部切除手术患者的术前肺功能并降低术后肺炎的发生率,且安全性良好。

Objective To evaluate the effect of perioperative nebulization of ipratropium bromide on preoperative pulmonary function and incidence of postoperative pulmonary complications as well as safety in chronic obstructive pulmonary disease(COPD)patients who underwent lung resection in thoracic surgery.Methods During November 18,2013 to August 12,2015,192 COPD patients with a necessity of selective surgical procedures of lobectomy or right bilobectomy or segmentectomy under general anaesthesia in 10 centers were 1:1 randomized to an ipratropium bromide group(96 patients)and a placebo group(96 patients),to compare the effect on preoperative pulmonary function and incidence of postoperative pulmonary complications.The average age of treated patients was 62.90±6.50 years,with168 male patients and 22 female patients.Results The demographic and baseline characteristics were well-balanced between the two groups.The adjusted mean increase of forced expiratory volume in one second(FEV1)in the ipratropium bromide group was significantly higher than that in the placebo group(169.90±29.07 mL vs.15.00±29.35 mL,P<0.05).The perioperative use of ipratropium bromide significantly decreased incidence of postoperative pneumonia(2.6%vs.14.1%,P<0.05).There was no ipratropium bromide related adverse event(AE)observed in this trial.Conclusion This trial indicates that perioperative nebulization of ipratropium bromide significantly improves preoperative lung function and reduces postoperative pneumonia in COPD patients undergoing lung resection in thoracic surgery,and has good safety profile.