【罂粟摘要】早期肠外营养和晚期肠外营养对腹部手术患者的影响：一项随机临床试验

早期肠外营养和晚期肠外营养对腹部手术患者的影响：一项随机临床试验

贵州医科大学     麻醉与心脏电生理课题组

翻译：宋雨婷  编辑：陈锐 审核：曹莹

罂 粟 摘 要   

重要性：对于腹部大手术后不能仅通过肠内营养达到能量目标值的患者来说，肠外营养的效果和最佳时机仍不清楚。

目的：检测营养风险发生率高且对肠内营养不耐受的腹部大手术患者早期肠内营养（术后3天）和晚期肠外营养（术后8天）对院内感染发生率的影响

试验设计、地点及参与者：2017年4月1日至2018年12月31日期间，在中国11所三甲医院普外科开展一项多中心随机临床试验。本试验的参与者为营养风险发生率高且对肠内营养不耐受（男性和女性分别通过每日每公斤理想体重30千卡和25千卡进行计算，术后2日肠内营养能量目标值≤30%），预计术后住院时间超过7天的腹部手术患者。数据分析于2020年2月1日至10月1日进行。

干预措施：随机分为早期肠外营养（术后3天开始）和晚期肠外营养（术后8天开始）

主要指标和测量方法：主要指标为术后3天到出院期间的院内感染发生率

结果：共有230名患者（均数[标准差]年龄，60.1[11.2]岁；140名男性[61.1%]；所有患者均为汉族和亚裔）随机分为早期肠外营养组（115例）和晚期肠外营养组（115例）。晚期肠外营养组中的1名患者在干预前退出本试验。与晚期肠外营养组相比（均数[标准差]能量，26.5[7.4]比15.1[4.8]千卡/公斤·天；P＜.001），早期肠外营养组在术后3-7天获得更多能量。与晚期肠外营养组相比（10/115[8.7%]比21/114[18.4%]；风险差异，9.7%；95%置信区间，0.9%-18.5%；P＝.04），早期肠外营养组院内感染的发生率明显较小。早期肠外营养组与晚期肠外营养组非感染性并发症 (31/115 [27.0%]比38/114 [33.3%]；风险差异, 6.4%; 95%置信区间, −5.5% 至 18.2%; P = .32), 总的不良事件(75/115 [65.2%] 比 82/114 [71.9%]；风险差异, 6.7%; 95% 置信区间, −5.3% 至 18.7%; P = .32)和其他次要指标的数据无明显差异。早期肠外营养组和晚期肠外营养组(6.0 [0.8]比7.0 [1.1]天；平均差异，1.0 天；95% 置信区间，0.2-1.9天； P = .01)抗生素治疗天数有显著差异。

结论和相关性：在本次随机临床试验中，早期肠内营养与腹部手术病人院内感染减少有关。早期肠外营养对腹部大手术术后高营养风险且肠内营养耐受差的患者似乎是个有利的治疗策略。

原始文献来源：

Gao X, Liu Y, Zhang L, et al. Effect of Early vs Late Supplemental Parenteral Nutrition in Patients Undergoing Abdominal Surgery: A Randomized Clinical Trial.[J].JAMA Surg. 2022;157(5):384–393.

英文原文

Effect of Early vs Late Supplemental Parenteral Nutritionin Patients Undergoing Abdominal SurgeryA Randomized Clinical Trial

ABSTRACT

IMPORTANCE The effect of and optimal timing for initiating supplemental parenteral nutrition

(SPN) remain unclear after major abdominal surgery for patients in whom energy targets

cannot be met by enteral nutrition (EN) alone.

OBJECTIVE To examine the effect of early supplemental parenteral nutrition (E-SPN) (day 3

after surgery) or late supplemental parenteral nutrition (L-SPN) (day 8 after surgery) on the

incidence of nosocomial infections in patients undergoing major abdominal surgery who are

at high nutritional risk and have poor tolerance to EN.

DESIGN, SETTING, AND PARTICIPANTS A multicenter randomized clinical trial was conducted

from April 1, 2017, to December 31, 2018, in the general surgery department of 11 tertiary

hospitals in China. Participants were those undergoing major abdominal surgery with high

nutritional risk and poor tolerance to EN ( 30% of energy targets from EN on postoperative

day 2, calculated as 25 and 30 kcal/kg of ideal body weight daily for women and men,

respectively) and an expected postoperative hospital stay longer than 7 days. Data analysis

was performed from February 1 to October 31, 2020.

INTERVENTIONS Random allocation to E-SPN (starting on day 3 after surgery) or L-SPN

(starting on day 8 after surgery).

MAIN OUTCOMES AND MEASURES The primary outcome was the incidence of nosocomial

infections between postoperative day 3 and hospital discharge.

RESULTS A total of 230 patients (mean [SD] age, 60.1 [11.2] years; 140 men [61.1%]; all

patients were of Han race and Asian ethnicity) were randomized (115 to the E-SPN group and

115 to the L-SPN group). One patient in the L-SPN group withdrew informed consent before

the intervention. The E-SPN group received more mean (SD) energy delivery between days 3

and 7 compared with the L-SPN group (26.5 [7.4] vs 15.1 [4.8] kcal/kg daily; P < .001). The

E-SPN group had significantly fewer nosocomial infections compared with the L-SPN group

(10/115 [8.7%] vs 21/114 [18.4%]; risk difference, 9.7%; 95% CI, 0.9%-18.5%; P = .04).

No significant differences were found between the E-SPN group and the L-SPN group in the

mean (SD) number of noninfectious complications (31/115 [27.0%] vs 38/114 [33.3%]; risk

difference, 6.4%; 95% CI, −5.5% to 18.2%; P = .32), total adverse events (75/115 [65.2%] vs

82/114 [71.9%]; risk difference, 6.7%; 95% CI, −5.3% to 18.7%; P = .32), and rates of other

secondary outcomes. A significant difference was found in the mean (SD) number of

therapeutic antibiotic days between the E-SPN group and the L-SPN group (6.0 [0.8] vs

7.0 [1.1] days; mean difference, 1.0 days; 95% CI, 0.2-1.9 days; P = .01).

CONCLUSION AND RELEVANCE In this randomized clinical trial, E-SPN was associated with

reduced nosocomial infections in patients undergoing abdominal surgery and seems to be a

favorable strategy for patients with high nutritional risk and poor tolerance to EN after major

abdominal surgery.

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