| 摘要: |
| 目的 探讨一次性使用干封式胸腔闭式引流装置的安全性及有效性。方法 本研究为前瞻性、单中心、随机、平行对照、非盲的非劣效性临床试验，采用区组随机化方法进行随机化分组。选择2017年1月至2019年6月在上海交通大学附属胸科医院接受肺叶切除术治疗且术后进行胸腔闭式引流的患者72例作为研究对象，根据随机化要求随机分配进入试验组与对照组，各36例。试验组采用一次性使用干封式胸腔闭式引流装置、对照组采用一次性使用胸腔闭式引流水封瓶进行胸膜腔内气体和/或液体引流，建立全分析集（FAS）、符合方案集（PPS）、安全数据集（SS）评价两组的引液效果（胸腔积液恢复良好率）、引气效果（肺膨胀恢复良好率）及安全性。结果 入组的72例病例中，有3例患者因住院年龄超出了入选标准予以剔除，剔除率为4.17%（3/72）。FAS将所有72例受试者全部纳入，对照组和试验组各36例；PPS受试者共69例，对照组36例、试验组33例；SS受试者72例，对照组和试验组各36例。FAS分析结果显示对照组和试验组胸腔积液恢复良好率均为100.00%（36/36），非劣效性界值为7.00%，两组间差值为0.00%（95% CI 0.00%~0.00%），其下限的绝对值低于非劣效性界值；对照组与试验组肺膨胀恢复良好率分别为69.44%（25/36）和72.22%（26/36），两组间的差值为2.78%（95% CI-18.21%~23.77%），差异无统计学意义（P>0.05）。PPS分析结果显示，对照组胸腔积液恢复良好率为100.00%（36/36），试验组为100.00%（33/33），两组间差值为0.00%（95% CI 0.00%~0.00%），其下限的绝对值低于非劣效性界值；对照组与试验组肺膨胀恢复良好率分别为69.44%（25/36）和69.70%（23/33），两组间的差值为0.25%（95% CI-21.48%~21.98%），差异无统计学意义（P>0.05）。SS分析结果显示，整个试验过程中试验组所用的一次性使用干封式胸腔闭式引流装置和对照组所用的胸腔闭式引流水封瓶密封性均良好，连接口均未发生脱落，临床上均未发生不良反应事件。结论 胸外科手术患者术后应用一次性使用干封式胸腔闭式引流装置的引液、引气效果良好，安全性好，是胸腔闭式引流水封瓶引流方法很好的补充，值得推广。 |
| 关键词: 胸外科手术 引流术 干封式引流瓶 水封式引流瓶 |
| DOI：10.16781/j.CN31-2187/R.20201377 |
| 投稿时间：2020-11-18修订日期：2021-03-04 |
| 基金项目:上海申康医院发展中心专科疾病临床“五新”转化项目（16CR3115B）. |
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| Clinical effect of a disposable dry-sealed thoracic drainage device after thoracic surgery |
| ZHOU Hai-yan,YIN Qing,ZHOU Ming-zhou,FAN Li-min* |
(Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China
*Corresponding author) |
| Abstract: |
| Objective To verify the safety and efficacy of a dry-sealed thoracic drainage device. Methods This study was a prospective, single-center, randomized, parallel controlled, non-blind and non-inferiority clinical trial. Block randomization was used. A total of 72 patients who received lobotomy and postoperative thoracic drainage in Shanghai Chest Hospital of Shanghai Jiao Tong University from Jan. 2017 to Jun. 2019 were selected and randomly assigned to experimental group and control group, with 36 patients in each group. The experimental group used a disposable dry-sealed thoracic drainage device, and the control group used a disposable thoracic drainage bottle for gas and/or fluid drainage in the pleural cavity. Full analysis set (FAS), per-protocol set (PPS) and safety set (SS) were set up to evaluate the effect of fluid drainage (recovery rate of pleural effusion), ventilation effect (good recovery rate of lung inflation) and safety in the 2 groups. Results Among the 72 cases, 3 patients were excluded because their hospitalization age exceeded the inclusion criteria, and the exclusion rate was 4.17% (3/72). FAS included all 72 subjects, 36 in the control group and 36 in the experimental group; 69 subjects in PPS, 36 in the control group and 33 in the experimental group; and 72 subjects in the SS, 36 in the control group and 36 in the experimental group. The results of FAS analysis showed that the good recovery rate of pleural effusion was 100.00% (36/36) in the control group, and that in the experimental group was 100.00% (36/36); the non-inferiority margin was 7.00%, the difference between the 2 groups was 0.00% (95% confidence interval[CI] 0.00%-0.00%), and its lower limit absolute value was lower than the non-inferiority margin. The good recovery rate of lung inflation was 69.44% (25/36) in the control group and 77.22% (26/36) in the experimental group, and the difference between the 2 groups was 2.78% (95% CI -18.21%-23.77%), showing no significant difference (P>0.05). The results of PPS analysis showed that the good recovery rate of pleural effusion was 100.00% (36/36) in the control group, and that in the experimental group was 100.00% (33/33), with the difference between the 2 groups being 0.00% (95% CI 0.00%-0.00%) and the lower limit absolute value being lower than the non-inferiority margin; the good recovery rate of lung inflation was 69.44% (25/36) in the control group and 69.70% (23/33) in the experimental group, and the difference between the 2 groups was 0.25% (95% CI -21.48%-21.98%), showing no significant difference (P>0.05). SS analysis results showed that the dry-sealed thoracic drainage device and the closed thoracic drainage bottle both had good sealing performance during the whole experiment, the connecting port did not fall off, and there were no clinical adverse events. Conclusion The application of dry-sealed thoracic drainage device in postoperative patients plays positive roles in fluid and/or gas drainage with good safety. It is a good supplement to the drainage method of water-sealed thoracic bottle and worthy popularizing. |
| Key words: thoracic surgical procedures drainage dry-sealed drainage bottle water-sealed drainage bottle |
