ICU, The First Affiliated Hospital, Zhejiang Chinese Medical University, Hangzhou, China.
ICU, Xinhua Hospital of Zhejiang Province, Hangzhou, China.
Complement Ther Med. 2019 Dec;47:102194. doi: 10.1016/j.ctim.2019.102194. Epub 2019 Sep 11.
Current conventional treatments for sepsis associated with acute gastrointestinal injury (AGI) have limited efficacy. This study aimed to study traditional Chinese medicine (TCM) bundle therapy (based on TCM syndrome differentiation) as add-on to conventional treatments on the incidence of AGI and on the prognosis of patients with sepsis.
This was a prospective multicenter randomized single-blind controlled trial.
Intensive care units (ICUs) of five university teaching hospitals in Zhejiang Province (China) from December 2012 to December 2014.
The control group received conventional treatment for sepsis and AGI. The intervention group received the conventional treatment combined with TCM bundle therapy.
The primary outcome was 28-day mortality. The secondary outcomes included the clinical indicators of sepsis. The 28-day mortality (35.3% vs. 48.3%, P = 0.01) and AGI-attributable mortality (15.1% vs. 36.2%, P = 0.02) in the intervention group were significantly lower than in controls. Duration of mechanical ventilation (17.4 ± 10.4 vs. 19.9 ± 11.1 days, P = 0.049) and duration of ICU stay (17.3 ± 10.2 vs. 20.1 ± 11.5 days) were significantly shorter in the intervention group compared with controls. On days 7 and 14, D-lactate, diamine oxidase, lipopolysaccharides, tumor necrosis factor-α, intra-abdominal pressure, and abdominal circumference in the intervention group were significantly lower than in controls, and serum MTL levels and bowel sounds were significantly higher (all P < 0.05).
TCM bundle therapy in the early stage of sepsis can improve survival and the markers of gastrointestinal function in patients with sepsis associated with AGI.
目前针对伴有急性胃肠损伤（AGI）的脓毒症的常规治疗方法疗效有限。本研究旨在研究基于中医证型辨证的中医综合治疗（TCM 套餐疗法）对脓毒症相关 AGI 的发生率及脓毒症患者预后的影响。
这是一项前瞻性、多中心、随机、单盲对照试验。
中国浙江省五所大学教学医院的重症监护病房（ICU）（2012 年 12 月至 2014 年 12 月）。
对照组接受脓毒症和 AGI 的常规治疗。干预组接受常规治疗加 TCM 套餐疗法。
主要结局为 28 天死亡率。次要结局包括脓毒症的临床指标。干预组 28 天死亡率（35.3%比 48.3%，P=0.01）和 AGI 相关死亡率（15.1%比 36.2%，P=0.02）明显低于对照组。干预组机械通气时间（17.4±10.4 比 19.9±11.1 天，P=0.049）和 ICU 入住时间（17.3±10.2 比 20.1±11.5 天）明显短于对照组。与对照组相比，干预组在第 7 天和第 14 天的 D-乳酸、二胺氧化酶、脂多糖、肿瘤坏死因子-α、腹腔内压和腹围明显降低，血清 MTL 水平和肠鸣音明显升高（均 P<0.05）。
脓毒症早期应用 TCM 套餐疗法可改善脓毒症相关 AGI 患者的生存率和胃肠功能标志物。
