比较肺癌围手术期患者使用 acapella、主动呼吸循环技术和体外膈肌起搏不同组合方案的疗效：一项随机对照试验。
Comparative efficacy of different combinations of acapella, active cycle of breathing technique, and external diaphragmatic pacing in perioperative patients with lung cancer: a randomised controlled trial.
机构信息
Department of Thoracic Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, No. 651, Road Dongfengdong, Yuexiu District, Guangzhou, Guangzhou, Guangdong, China.
出版信息
BMC Cancer. 2023 Mar 28;23(1):282. doi: 10.1186/s12885-023-10750-4.
BACKGROUND
Acapella plus active cycle of breathing technique (ACBT), external diaphragm pacemaker (EDP) plus ACBT have been shown to facilitate the recovery of functional capacity and lung function in patients suffering from airway obstruction but the efficacy in perioperative patients with lung cancer has not been proven.
METHODS
We conducted a three-arm, prospective, randomized, assessor-blinded, controlled trial in patients with lung cancer who underwent thoracoscopic lobectomy or segmentectomy in the department of thoracic surgery, China. Patients were randomly assigned (1:1:1) to receive Acapella plus ACBT, EDP plus ACBT, or ACBT group (control group) using SAS software. The primary outcome was functional capacity, measured by the 6-minute walk test (6MWT).
RESULTS
We recruited 363 participants over 17 months: 123 assigned to the Acapella plus ACBT group, 119 to the EDP plus ACBT group, and 121 to the ACBT group. Statistically significant differences were noted for functional capacity between the EDP plus ACBT and control groups at each follow-up time (1-week follow-up: difference = 47.25 m, 95% CI, 31.56-62.93; P < 0.001; and 1-month follow-up: difference = 49.72 m, 95% CI, 34.04-65.41; P < 0.001), between the Acapella plus ACBT and control groups at postoperative week 1 (difference = 35.23 m, 95% CI, 19.30-51.16; P < 0.001) and postoperative month 1 (difference = 34.96 m, 95% CI, 19.03-50.89; P < 0.001), and between the EDP plus ACBT and Acapella plus ACBT groups at 1-month follow-up (difference = 14.76 m, 95% CI, 1.34-28.19; P = 0.0316).
CONCLUSION
EDP plus ACBT and Acapella plus ACBT significantly improved functional capacity and lung function in perioperative patients with lung cancer, compared with single-model ACBT, and the effects of EDP plus ACBT were clearly superior to those of other programs.
TRIAL REGISTRATION
The study was registered in the clinical trial database (clinicaltrials.gov) on June 4, 2021 (No. NCT04914624).
背景
声乐呼吸技术（ACBT）加主动呼吸循环技术（ACBT）、外部膈肌起搏器（EDP）加 ACBT 已被证明可促进气道阻塞患者的功能容量和肺功能恢复，但在肺癌围手术期患者中的疗效尚未得到证实。
方法
我们在中国胸外科部门对接受胸腔镜肺叶切除术或肺段切除术的肺癌患者进行了一项三臂、前瞻性、随机、评估者设盲、对照试验。使用 SAS 软件将患者随机分配（1:1:1）至声乐呼吸技术加 ACBT 组、EDP 加 ACBT 组或 ACBT 组（对照组）。主要结局是由 6 分钟步行试验（6MWT）测量的功能容量。
结果
在 17 个月的时间里，我们共招募了 363 名参与者：123 名分配到声乐呼吸技术加 ACBT 组，119 名分配到 EDP 加 ACBT 组，121 名分配到 ACBT 组。在每次随访时间（1 周随访：差异=47.25 米，95%置信区间，31.56-62.93；P<0.001；1 个月随访：差异=49.72 米，95%置信区间，34.04-65.41；P<0.001）、术后第 1 周（差异=35.23 米，95%置信区间，19.30-51.16；P<0.001）和术后第 1 个月（差异=34.96 米，95%置信区间，19.03-50.89；P<0.001），EDP 加 ACBT 组与对照组之间以及 EDP 加 ACBT 组与声乐呼吸技术加 ACBT 组之间的功能容量均存在统计学显著差异，在 1 个月随访时（差异=14.76 米，95%置信区间，1.34-28.19；P=0.0316），EDP 加 ACBT 组与声乐呼吸技术加 ACBT 组之间的功能容量也存在统计学显著差异。
结论
与单一模式 ACBT 相比，EDP 加 ACBT 和声乐呼吸技术加 ACBT 可显著改善肺癌围手术期患者的功能容量和肺功能，而 EDP 加 ACBT 的效果明显优于其他方案。
试验注册
该研究于 2021 年 6 月 4 日在临床试验数据库（clinicaltrials.gov）注册（注册号：NCT04914624）。
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