南方医科大学学报

南方医科大学学报 ›› 2019, Vol. 39 ›› Issue (11): 1298-1304.doi: 10.12122/j.issn.1673-4254.2019.11.06

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早期胃肠康复治疗机械通气的脓毒症伴急性胃肠损伤患者的有效性和安全性：34例前瞻性、随机对照、先导试验

刘丹蕾，许卓谦，瞿长春，霍保善，赖汉齐，黎 阳，刘 斌，邓火金，王倩文，李杜娟，常 平，李 沙，王 华   

  • 出版日期:2019-12-05 发布日期:2019-11-20
  • 基金资助:

Efficacy and safety of early physical therapy for acute gastrointestinal injury during mechanical ventilation in patients with sepsis: a randomized controlled pilot trial

  

  • Online:2019-12-05 Published:2019-11-20

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摘要： 目的 探讨早期胃肠康复治疗机械通气的脓毒症伴急性胃肠损伤（AGI）患者的疗效和安全性。方法 采用前瞻性、随机、平行对照的研究方法，开放设计，对康复评定人设盲。筛选2017年5月~2018年3月在广州市一家三级甲等教学医院重症监护病房（ICU）住院的脓毒症患者，符合纳入标准则招募入组。以急性生理和慢性健康状况评分Ⅱ（APACHE Ⅱ）等为平衡因素，区组随机化分为干预组和对照组。两组均按脓毒症标准方案治疗，干预组增加早期胃肠康复。主要研究终点为AGI治愈；次要研究终点包括ICU住院病死率、机械通气预后、ICU住院天数等。数据采集时间点定为入组、呼吸机脱机、转出ICU共3个。结果 共招募 60例患者，34例完成研究。干预组 16例，对照组 18例。结果显示，康复治疗后，干预组和对照组 AGI治愈例数的差异无统计学意义（P>0.05）。比较康复治疗前后两组AGI评分的下降值，分别为（-1.9±2.1）分和（0.9±1.6）分，差异有统计学意义（P<0.05）。早期胃肠康复的不良事件发生率为3.33%，无器官损伤或意外死亡等严重不良事件。两组在ICU住院病死率、机械通气预后、ICU住院天数等指标方面，差异均无统计学意义（P>0.05）。结论 早期胃肠康复不能降低AGI患病率，但降低AGI评分，改善胃肠道症状，安全性好，但需在设计更为合理的大样本多中心临床研究中证实。

Abstract: Objective To investigate the therapeutic effect and safety of early physical therapy for acute gastrointestinal injury (AGI) in septic patients receiving mechanical ventilation. Methods A randomized controlled trial was conducted in the ICU of a tertiary teaching hospital from May, 2017 to March, 2018. The patients diagnosed with sepsis complicated by AGI during mechanical ventilation were recruited and block-randomized into intervention group and control group. Both groups received standard therapy of sepsis, and the patients in the intervention group also received physical therapy as soon as they were hemodynamically stable. The outcome measures included the recovery of AGI, ICU mortality, duration and outcomes of mechanical ventilation and the length of ICU stay. Results A total of 60 patients were initially included, and 34 of them completed the study, including 16 in the intervention group and 18 in the control group. After physical rehabilitation, the number of patients with a cure of AGI did not significantly differ between the two group (P>0.05). Nonetheless, the reduction of AGI scores after the treatments differed significantly between the intervention group and the control group (-1.9±2.1 vs 0.9±1.6, P<0.05). No significant differences were found between the two groups in ICU mortality, duration and outcomes of mechanical ventilation, or the length of ICU stay (P>0.05). In the intervention group, the incidence of exercise-related adverse events was 3.33%, and severe organ injury or death occurred in none of patients. Conclusion Early rehabilitation therapy does not reduce the incidence of AGI but can lower AGI scores and alleviate gastrointestinal symptoms in patients with sepsis during mechanical ventilation.The results still await further verification by welldesigned multicenter clinical trials with large sample sizes.