目的 探讨左沙丁胺醇和沙丁胺醇分别联合异丙托溴铵和倍氯米松用于急性加重期慢性阻塞性肺疾病（AECOPD）患者的安全性、有效性差异。方法 采用随机对照、单中心、前瞻性研究方法，选取2022年1月1日—2022年12月31日在合肥市第二人民医院呼吸内科就诊的100例AECOPD住院患者作为研究对象，利用PASS 26.0软件随机分为对照组（n=50）和试验组（n=50）。对照组使用沙丁胺醇、异丙托溴铵和倍氯米松雾化吸入治疗，试验组使用左沙丁胺醇、异丙托溴铵和倍氯米松雾化吸入治疗，比较两组患者治疗前后临床相关指标变化以及不良反应发生情况。结果 试验组治疗总有效率（95.65%）高于对照组（84.00%），差异有统计学意义（P＜0.05）。治疗前两组24 h痰液体积、血气分析指标［动脉血氧分压（paO₂）、动脉血二氧化碳分压（paCO₂）、动脉血氧饱和度（SaO₂）］、肺功能指标［第1秒呼气量（FEV₁）、用力肺活量（FVC）、1秒率（FEV₁/FVC）］、血清炎症因子指标［超敏C反应蛋白（hs-CRP）、白细胞介素-8（IL-8）、肿瘤坏死因子-α（TNF-α）］、氧化应激反应指标［丙二醛（MDA）、谷胱甘肽过氧化物酶（GSH-Px）、超氧化物歧化酶（SOD）］比较，差异无统计学意义（P＞0.05）；治疗后，两组24 h痰液体积、pa（CO₂）、慢阻肺急性加重识别工具（CERT）评分、MDA、hs-CRP、IL-8、TNF-α均较本组治疗前下降，pa（O₂）、FEV₁、FVC、FEV₁/FVC、GSH-Px、SOD较本组治疗前显著升高，差异均有统计学意义（P＜0.05）。治疗后，试验组各项指标改善情况均较对照组明显（P＜0.05）。在治疗过程中，对照组耐受良好，未出现明显不良反应。试验组发生头痛2例、皮疹和腹泻各1例，两组不良反应发生率相比较，差异有统计学差异（P＜0.05）。结论 加入左沙丁胺醇的三联药物方案用于治疗AECOPD患者的临床疗效比沙丁胺醇三联方案更好，但不良反应发生率更高，临床应用需关注其安全性。

Objective To explore the differences in safety and efficacy between levosalbutamol and salbutamol in combination with ipratropium bromide and beclomethasone for patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Methods A randomized controlled, single center, prospective study method was used to select 100 hospitalized AECOPD patients who visited the Department of Respiratory Medicine of the Second People's Hospital of Hefei from January 1, 2022 to December 31, 2022 as the study subjects. PASS 26.0 software was used to randomly divide them into a control group (n=50) and an experimental group (n =50). Patients in the control group were treated with nebulized inhalation of salbutamol, ipratropium bromide, and beclomethasone, while patients in the experimental group were treated with nebulized inhalation of levosalbutamol, ipratropium bromide, and beclomethasone. The changes in clinical indicators and incidence of adverse reactions before and after treatment were compared between the two groups of patients. Results The total effective rate of the experimental group (95.65%) was higher than that of the control group (84.00%), and the difference was statistically significant (P＜0.05). 24 hour sputum volume, blood gas analysis indicators [arterial oxygen partial pressure (paO₂), arterial carbon dioxide partial pressure (paCO₂), arterial oxygen saturation (SaO₂)], lung function indicators (FEV₁, FVC, FEV₁/FVC), serum inflammatory factor indicators (hs-CRP, IL-8, TNF-α) in the two groups before treatment. The comparison of oxidative stress response indicators (MDA, GSH-Px, SOD) showed no statistically significant difference (P＞0.05). After treatment, the 24-hour sputum volume, paCO₂, chronic obstructive pulmonary disease acute exacerbation recognition tool (CERT) score, MDA, hs-CRP, IL-8, TNF-α in both groups. All decreased compared to before treatment in same group, while paO₂, FEV₁, FVC, FEV₁/FVC, GSH-Px, SOD significantly increased compared to before treatment in same group, and the differences were statistically significant (P＜0.05). After treatment, the improvement of various indicators in the experimental group was significantly higher than that in the control group (P＜0.05). During the treatment process, the control group tolerated well and did not experience any significant adverse reactions. There were two cases of headache, one case of rash, and one case of diarrhea in the experimental group. The incidence of adverse reactions between the two groups was statistically different (P＜0.05). Conclusion The clinical efficacy of the triple drug regimen with the addition of levosalbutamol in the treatment of AECOPD patients is better than that of the triple drug regimen with salbutamol, but the incidence of adverse reactions is higher. Clinical application needs to pay attention to its safety.

R974

国家自然科学基金青年基金项目（82003849）；合肥市卫生健康应用医学研究项目（Hwk2021yb010）；安徽省教育厅省级质量工程项目（2019xqsxzx98）；合肥市第二人民医院院级科研项目（1604a0802099）