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A Real-World Study of the Efficacy and Safety of the Use of Structural Fat Emulsion Three-Chamber Bags in Perioperative Patients

author:Pharmaceutical Health
A Real-World Study of the Efficacy and Safety of the Use of Structural Fat Emulsion Three-Chamber Bags in Perioperative Patients

XIONG Chao-gang1, ZHAO Ning2(1.Xi'an Chest Hospital; 2.Peking University First Hospital)

【Abstract】Objective: To understand the clinical nutritional status of perioperative patients and to provide a reference for the rational use of parenteral nutrition preparations in clinical practice. Methods: The survey was carried out by online questionnaire, which was composed of four modules: questionnaire information, patient information, prescription research and postoperative observation, body weight and ALB were selected as the effect indicators to evaluate parenteral nutrition, and CRP, ALT and TG were selected as the safety indicators to evaluate parenteral nutrition, and SPSS 18.0 software was used for statistical analysis. Results: The course of parenteral nutrition used in perioperative patients was 6.12±2.91 days, which was shorter than that of non-structural fat emulsion three-chamber pockets. After parenteral nutrition, the levels of ALB in the perioperative period increased significantly (P<0.01), and the levels of CRP and ALT decreased significantly (P<0.01), but there was no significant effect on body weight and TG levels. Compared with the three-chamber bag of non-structured fat emulsion, the ability of structured fat emulsion to increase ALB was more significant (P<0.01) and the level of ALT was more significant (P<0.01)). Conclusion: For perioperative patients with parenteral nutrition requirements, the clinical benefit of structured lipid emulsion is more obvious.

In order to gain an in-depth understanding of the clinical nutritional status of perioperative patients, the Nutrition Therapy Standardization Special Fund of China Medical and Health Development Foundation commissioned Beijing Yaoshi Health Management Co., Ltd. to carry out the public welfare project of "Online Questionnaire Survey on Perioperative Clinical Nutritional Status". The results of the first phase of the investigation were published online on the pharmaceutical affairs website platform on December 22, 2022, and the results showed that industrial three-chamber bag infusion is the most commonly used form of parenteral nutrition (PN) in clinical practice, and structural lipid emulsion is suitable for perioperative patients. From March 2023 to October 2023, Beijing Yaoshi Health Management Co., Ltd. carried out the second phase of the "Online Questionnaire Survey on Perioperative Clinical Nutritional Status", aiming to further expand the sample size of the study and provide a reference for the rational use of parenteral nutrition preparations in perioperative patients.

1 Objects and Methods

1.1 Survey Respondents

A total of 10,937 survey forms were received from 205 hospitals, which were filled in online by 817 doctors, and 2,547 forms with incomplete data, irregular filling and abnormal values were excluded, and a total of 8,390 survey data were included in the analysis.

1.2 Survey Methodology

In order to facilitate the data filling and subsequent summary analysis, and ensure the authenticity and accuracy of the data, the survey was carried out through an online questionnaire, and Beijing Yaoshi Health Management Co., Ltd. cooperated with Wuxi Keaisi Information Technology Co., Ltd. to establish an online questionnaire survey data filling website (https://pms.kuai-info.com/), and the website designated a special person as the administrator, and the doctor logged in, filled in and submitted online according to the user name assigned by the administrator, and completed the survey.

The questionnaire consisted of four modules: questionnaire information, patient information, prescription research and postoperative observation. Among them, the questionnaire information includes the questionnaire number and the doctor's name; Patient information includes patient code, age, gender, height, diagnosis; The prescription survey consisted of two single-choice questions: "parenteral nutrition prescription form" and "parenteral nutrition days". Postoperative observation includes observation of body weight, albumin, alanine aminotransferase, and serum triglyceride levels on the first day after surgery and after the end of parenteral nutrition.

1.3 Statistics and Analysis

In this study, body weight and ALB were selected as the performance indicators to evaluate parenteral nutrition, and CRP, ALT and TG were selected as the safety indicators to evaluate parenteral nutrition. SPSS 18.0 software was used to analyze, the mean ± standard deviation ('x ± s) was used for continuous data analysis, and the analysis of variance was used for comparison between groups, P>0.05, the difference was not statistically significant, and P<0.05, the difference was statistically significant.

2 Results

2.1 Patient Information

本次调研对围手术期使用肠外营养患者的年龄、性别、身高及肠外营养天数进行了调查,同时收集了术后第一天的体重、白蛋白(Albumin,ALB)、C反应蛋白(C-reactive protein,CRP)、谷丙转氨酶(Alanine aminotransferase,ALT)和血清甘油三酯(Triglyceride,TG)水平,组间水平无统计学差异(P<0.05),具体结果见表1。

A Real-World Study of the Efficacy and Safety of the Use of Structural Fat Emulsion Three-Chamber Bags in Perioperative Patients

2.2 Days of parenteral nutrition

This survey found that the number of days of parenteral nutrition in the perioperative period was 6.12±2.91 days. Among them, the course of parenteral nutrition with three-chamber bags of structured fat emulsion was 6.06±2.83 days, and the duration of treatment with three-chamber bags of non-structured fat emulsion was 6.43±3.31 days. Compared with the non-structural fat emulsion three-chamber pockets, the treatment course of the structural fat emulsion three-chamber bags was shorter (P<0.01).

A Real-World Study of the Efficacy and Safety of the Use of Structural Fat Emulsion Three-Chamber Bags in Perioperative Patients

2.3 Evaluation of the efficacy and safety of parenteral nutrition

In terms of efficacy, the use of parenteral nutrition in the perioperative period showed a decrease in body weight (>0.05) and a significant increase in ALB (<0.01). Compared with the three-chamber bag of non-structured fat emulsion, structured fat emulsion significantly increased ALB levels (<0.01)). In terms of safety, CRP and ALT were significantly decreased (<0.01) and TG (<0.01) in perioperative patients. Compared with the three-chamber bag of non-structural fat emulsion, the reduction of ALT level was more pronounced by structured fat emulsion (<0.01)). See Table 3 and Figure 1.

A Real-World Study of the Efficacy and Safety of the Use of Structural Fat Emulsion Three-Chamber Bags in Perioperative Patients

3 Discussion

Parenteral nutrition refers to nutritional support therapy that provides the required nutrients for human metabolism through the intravenous route, and is an important part of surgical perioperative treatment. [1] Especially for gastrointestinal surgery patients who cannot eat orally, parenteral nutrition can provide patients with the nutrient metabolism substrates required by the human body, maintain organ function, reduce weight loss, and promote wound healing. [2]

In parenteral nutrition emulsions, fat emulsion and glucose are the most important energy supply substances, and fat energy supply generally accounts for 30%~50% of non-protein energy supply, and an appropriate proportion of fat energy supply can reduce glucose utilization, which is conducive to blood glucose regulation in perioperative patients in a state of stress[1].

At present, the commonly used fat emulsions in clinical practice are mainly long-chain fat emulsions, medium/long-chain fat emulsions, and structural fat emulsions. This survey found that the proportion of patients who chose structured fat emulsion was the highest in clinical practice, reaching 84.48%, which was the most widely used parenteral nutrition preparation in clinical practice. Structural fat emulsions are hydrolyzed and re-esterified by medium/long-chain fat emulsions, which makes the hydrolysis rate of fatty acids more uniform, which is conducive to fat clearance, which will bring additional clinical benefits compared with traditional medium/long-chain fat emulsions. A meta-analysis of 32 studies[3] showed that structured lipid emulsions improved liver function, nutritional status, and immune function, reduced inflammation, shortened hospital stays, and reduced rates of adverse events compared with medium- and long-chain lipid milks.

Another meta-analysis of 21 studies[4] showed that structured fat emulsions were more beneficial for ALB elevation, liver tolerance, and triglyceride elimination than medium- to long-chain emulsions after surgery and/or in critically ill patients. In this study, structured fat emulsion had the most significant effect on ALB levels and ALT levels compared with the three-chamber pockets of non-structural fat emulsions, which increased ALB levels by 2.18 g/L and decreased ALT levels by 6.45 U/L in perioperative patients, and the observed results were similar to those of the above two meta-analyses.

In summary, for perioperative patients with parenteral nutrition needs, the clinical benefit of structured lipid emulsion is more obvious than that of non-structural fat emulsion three-chamber pockets, which is suitable for perioperative patients.

bibliography

[1] Chinese Society of Parenteral and Enteral Nutrition. Expert consensus on the clinical application of multi-lumen bags for parenteral nutrition (2022)[J]. Chin J Surg,2022,60(4):321-328.

[2] Nursing Group, Parenteral and Enteral Nutrition Branch, Chinese Medical Association. Expert consensus on safe infusion of parenteral nutrition[J]. Chinese Journal of Nursing,2022,57(12):1421-1426.

[3] Li C, Ni Q, Pei Y, et al. Meta‐analysis of the efficacy and safety of structured triglyceride lipid emulsions in parenteral nutrition therapy in China[J]. Clin Nutr, 2019,38(4):1524‐1535.

[4] Wu GH, Zaniolo O, Schuster H, et al. Structured triglycerides versus physical mixtures of medium- and long-chain triglycerides for parenteral nutrition in surgical or critically ill adult patients: Systematic review and meta-analysis[J]. Clin Nutr. 2017 Feb; 36(1):150-161.

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