Department of General Surgery, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.
Department of Medical Statistics, Jinling Hospital, Nanjing Medical University, Nanjing, China.
JAMA Surg. 2022 May 1;157(5):384-393. doi: 10.1001/jamasurg.2022.0269.
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.
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.
Random allocation to E-SPN (starting on day 3 after surgery) or L-SPN (starting on day 8 after surgery).
The primary outcome was the incidence of nosocomial infections between postoperative day 3 and hospital discharge.
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).
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.
ClinicalTrials.gov Identifier: NCT03115957.
背景：对于接受大腹部手术后无法通过肠内营养（EN）满足能量目标的患者，补充性肠外营养（SPN）的作用和最佳启动时间仍不清楚。
目的：研究早期补充性肠外营养（E-SPN）（术后第 3 天）或晚期补充性肠外营养（L-SPN）（术后第 8 天）对高营养风险且对 EN 耐受力差的大腹部手术患者发生医院感染的影响。
设计、地点和参与者：这是一项多中心随机临床试验，于 2017 年 4 月 1 日至 2018 年 12 月 31 日在中国 11 家三级医院的普通外科进行。参与者为接受大腹部手术且高营养风险且对 EN 耐受力差的患者（术后第 2 天 EN 能量目标的≤30%，分别计算为女性和男性的理想体重每日 25 和 30kcal/kg），预计住院时间超过 7 天。数据分析于 2020 年 2 月 1 日至 10 月 31 日进行。
干预措施：随机分配至 E-SPN（术后第 3 天开始）或 L-SPN（术后第 8 天开始）。
主要结局和措施：主要结局为术后第 3 天至出院期间的医院感染发生率。
结果：共纳入 230 例患者（平均[标准差]年龄 60.1[11.2]岁；140 例男性[61.1%]；所有患者均为汉族和亚洲人种）随机分为 E-SPN 组（115 例）和 L-SPN 组（115 例）。L-SPN 组中有 1 例患者在干预前撤回了知情同意。与 L-SPN 组相比，E-SPN 组在第 3 天至第 7 天接受的平均（标准差）能量输送更多（26.5[7.4]与 15.1[4.8]kcal/kg/d；P<0.001）。E-SPN 组的医院感染发生率明显低于 L-SPN 组（10/115[8.7%]与 21/114[18.4%]；风险差异 9.7%；95%CI，0.9%-18.5%；P=0.04）。E-SPN 组与 L-SPN 组在非感染性并发症的平均（标准差）数量（31/115[27.0%]与 38/114[33.3%]；风险差异 6.4%；95%CI，-5.5%至 18.2%；P=0.32）、总不良事件（75/115[65.2%]与 82/114[71.9%]；风险差异 6.7%；95%CI，-5.3%至 18.7%；P=0.32）和其他次要结局的发生率方面均无显著差异。E-SPN 组与 L-SPN 组之间治疗性抗生素使用天数的平均（标准差）差异有统计学意义（6.0[0.8]与 7.0[1.1]天；平均差异 1.0 天；95%CI，0.2-1.9 天；P=0.01）。
结论和相关性：在这项随机临床试验中，E-SPN 与腹部手术后的医院感染减少相关，对于高营养风险且对大腹部手术后 EN 耐受力差的患者，E-SPN 似乎是一种有利的策略。
试验注册：ClinicalTrials.gov 标识符：NCT03115957。
