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胰腺癌患者的肠外营养支持。Ⅱ期研究结果。

Parenteral nutrition support for patients with pancreatic cancer. Results of a phase II study.

机构信息

Universitätsmedizin Berlin, Charité Centrum für Tumormedizin, CONKO - Study Group, Augustenburger Platz 1, Berlin, Germany.

出版信息

BMC Cancer. 2010 Mar 9;10:86. doi: 10.1186/1471-2407-10-86.

DOI:10.1186/1471-2407-10-86
PMID:20214798
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2841666/
Abstract

BACKGROUND

Cachexia is a common problem in patients (pts) suffering from upper gastrointestinal cancer. In addition, most of these patients suffer from malabsorption and stenosis of the gastrointestinal tract due to their illness. Various methods of supplementary nutrition (enteral, parenteral) are practised. In patients with advanced pancreatic cancer (APC), phase angle, determined by bio-electrical impedance analysis (BIA), seems to be a survival predictor. The positive influence of BIA determinate predictors by additional nutrition is currently under discussion.

METHODS

To examine the impact of additional parenteral nutrition (APN) we assessed outpatients suffering from APC and progressive cachexia. The assessment based on the BIA method. Assessment parameters were phase angle, ECM/BCM index (ratio of extracellular mass to body cell mass), and BMI (body mass index). Patients suffering from progressive weight loss in spite of additional enteral nutritional support were eligible for the study.

RESULTS

Median treatment duration in 32 pts was 18 [8-35] weeks. Response evaluation showed a benefit in 27 pts (84%) in at least one parameter. 14 pts (43.7%) improved or stabilised in all three parameters. The median ECM/BCM index was 1.7 [1.11-3.14] at start of APN and improved down to 1.5 [1.12-3.36] during therapy. The median BMI increased from 19.7 [14.4-25.9] to 20.5 [15.4-25.0]. The median phase angle improved by 10% from 3.6 [2.3-5.1] to 3.9 [2.2-5.1].

CONCLUSIONS

We demonstrated the positive impact of APN on the assessed parameters, first of all the phase angle, and we observed at least a temporary benefit or stabilisation of the nutritional status in the majority of the investigated patients. Based on these findings we are currently investigating the impact of APN on survival in a larger patient cohort.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT00919659.

摘要

背景

恶病质是上消化道癌症患者常见的问题。此外,由于疾病的原因,这些患者大多存在胃肠道吸收不良和狭窄。因此采用了各种补充营养的方法(肠内、肠外)。在晚期胰腺癌(APC)患者中,生物电阻抗分析(BIA)确定的相位角似乎是一个生存预测指标。目前正在讨论肠外营养(APN)对 BIA 确定预测指标的积极影响。

方法

为了研究额外的肠外营养(APN)的影响,我们评估了患有 APC 和进行性恶病质的门诊患者。评估基于 BIA 方法。评估参数包括相位角、细胞外液/细胞内液指数(细胞外液与细胞内液的比值)和 BMI(体重指数)。尽管接受了额外的肠内营养支持,但仍持续出现体重减轻的患者符合研究条件。

结果

32 名患者的中位治疗时间为 18 [8-35] 周。疗效评估显示 27 名患者(84%)至少有一个参数受益。14 名患者(43.7%)在所有三个参数中都得到改善或稳定。APN 开始时 ECM/BCM 指数中位数为 1.7 [1.11-3.14],治疗期间降至 1.5 [1.12-3.36]。BMI 中位数从 19.7 [14.4-25.9]增加到 20.5 [15.4-25.0]。相位角中位数提高了 10%,从 3.6 [2.3-5.1]提高到 3.9 [2.2-5.1]。

结论

我们证明了 APN 对评估参数的积极影响,首先是相位角,我们观察到大多数研究患者的营养状况至少暂时得到改善或稳定。基于这些发现,我们目前正在更大的患者队列中研究 APN 对生存的影响。

试验注册

ClinicalTrials.gov 标识符:NCT00919659。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/739f/2841666/210a08e905f0/1471-2407-10-86-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/739f/2841666/d8b0d8bce76f/1471-2407-10-86-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/739f/2841666/210a08e905f0/1471-2407-10-86-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/739f/2841666/d8b0d8bce76f/1471-2407-10-86-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/739f/2841666/210a08e905f0/1471-2407-10-86-2.jpg

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