CN106668835A - 一种用于肿瘤治疗的肠内营养剂及其制备方法 - Google Patents
一种用于肿瘤治疗的肠内营养剂及其制备方法 Download PDFInfo
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- CN106668835A CN106668835A CN201610082049.5A CN201610082049A CN106668835A CN 106668835 A CN106668835 A CN 106668835A CN 201610082049 A CN201610082049 A CN 201610082049A CN 106668835 A CN106668835 A CN 106668835A
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- chloride
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Abstract
本发明提供一种用于肿瘤治疗的肠内营养剂,按所述营养剂1000mL计,所述营养剂成分包含:蛋白质70~95g、脂肪54~74g、碳水化合物77~115g、膳食纤维20~50g、牛磺酸171~319mg、肉碱100~156mg、酵母抽出物300~419mg、维生素0.5~2g、无机盐4~9g、水650~710g;本发明高蛋白、高脂肪、低碳水化合物的肠内营养剂符合肿瘤患者代谢特点,可选择性饥饿肿瘤细胞而不影响正常细胞功能,尤其适用于肿瘤伴发糖尿病患者,有效扭转营养不良,提高肿瘤患者生活质量。
Description
本申请要求于2015年11月6日提交的申请号为201510753312.4、标题为“一种用于肿瘤治疗的肠内营养剂及其制备方法”的中国专利申请的优先权的全部权益,该中国专利申请的全部内容以引用方式并入本文。
技术领域
本发明属于医药技术领域,具体涉及一种用于肿瘤治疗的肠内营养剂及其制备方法。
背景技术
研究发现,40~80%的肿瘤患者都会出现营养不良。恶性肿瘤本身的代谢异常及相关治疗措施会导致或加重营养不良,这会显著增加恶性肿瘤的死亡率及医疗费用,从而导致恶性肿瘤患者的治疗效果、生活质量及生存时间的明显降低。因此,应该高度重视肿瘤患者的营养不良问题。
肠内营养是临床营养支持的重要手段,有助于维持肠粘膜细胞结构与功能的完整。当患者需要营养支持且具有完整或者部分胃肠道功能时,应首选肠内营养途径。由于肿瘤细胞的营养物质代谢显著区别于正常细胞,且手术、化疗、放疗等治疗手段对正常细胞具有巨大的破坏性,因此,肿瘤患者围治疗期的营养支持应符合肿瘤患者代谢特点才能真正发挥作用。例如,正常细胞主要通过有氧氧化来获得能量,而肿瘤细胞50%的能量来源于糖酵解;肿瘤患者体内蛋白质消耗增加,骨骼肌不断降解;肿瘤发生常伴有炎症反应。因此,降低碳水化合物供能、提高蛋白质供给、提高抑炎多不饱和脂肪酸ω-3脂肪酸的比例已经成为符合肿瘤患者代谢特点的营养制剂配方技术。特别地,基础研究表明:ω-3脂肪酸可以治疗动物乳腺癌骨转移病灶,抑制肿瘤细胞的转移;临床研究表明:ω-3脂肪酸可以抑制甚至逆转胰腺癌患者的体重下降,增加瘦体重,改善体能。
恶性肿瘤患者的临床表现除本身疾病外,尚有肿瘤的副综合征表现,其中伴发糖尿病已非常常见。因此,在治疗肿瘤的同时也应该兼顾副综合征的治疗,营养支持时也应综合考虑营养制剂对肿瘤患者血糖的影响。
目前,市场上已有“安素”、“能全素”、“能全力”、“百普素”等多种肠内营养制剂,但普遍适用于营养不良或摄入障碍的患者,适用于肿瘤患者围治疗期的肠内营养制剂种类较少,特别是对于恶性肿瘤伴发糖尿病的患者,尚无肠内营养制剂。
发明内容
本发明的目的是提供一种高蛋白、高脂肪、低碳水化合物的肠内营养剂,其符合肿瘤患者代谢特点,可选择性饥饿肿瘤细胞而不影响正常细胞功能,适用于肿瘤伴发糖尿病的患者,能够有效扭转营养不良,提高肿瘤患者生活质量;尤其有助于维持食管癌放疗患者的营养状况,并且患者对其的耐受性较好。
本发明的上述目的是通过以下技术方案实现的:
本发明提供一种用于肿瘤治疗的肠内营养剂,所述营养剂包含蛋白质、脂肪、碳水化合物、膳食纤维、牛磺酸、L-肉碱、酵母抽出物、维生素、无机盐和水;
其中,所述蛋白质包含酪蛋白、大豆蛋白和乳清蛋白;
所述脂肪包含大豆油、芥花油、中链(C6-C12)脂肪酸甘油三酯和亚麻籽油;
所述碳水化合物包含麦芽糊精、果糖和异麦芽酮糖;
所述膳食纤维包含难消化性麦芽糊精、果寡糖和菊粉;
所述维生素包含维生素A、维生素D、维生素E、维生素K1、维生素B1、维生素B2、维生素B6、维生素B12、维生素C、生物素、氯化胆碱、烟酸、叶酸和泛酸;
所述无机盐包含碳酸钙、柠檬酸钠、氯化镁、氯化钠、磷酸氢二钾、氯化钾、氧化镁、柠檬酸钾、硫酸锌、硫酸亚铁、硫酸锰、硫酸铜、氯化铬、钼酸钠、硒酸钠和碘化钾;
优选地,按所述营养剂1000mL计,所述营养剂包含:蛋白质70-95g、脂肪54-74g、碳水化合物77-115g、膳食纤维20-50g、牛磺酸171-319mg、L-肉碱100-156mg、酵母抽出物300-419mg、维生素0.5-2g、无机盐13.8-25.8g、水650-710g;
优选地,按所述营养剂1000mL计,所述营养剂包含:蛋白质87g、脂肪65g、碳水化合物107g、膳食纤维36g、牛磺酸200mg、L-肉碱130mg、酵母抽出物320mg、维生素1g、无机盐18.9g、水695g。
按所述营养剂1000mL计,所述蛋白质包含酪蛋白52.3-65.2g、大豆蛋白10.6-17.5g、乳清蛋白7.1-12.3g;优选地,所述蛋白质包含酪蛋白62.0g、大豆蛋白15.0g、乳清蛋白10.0g。
按所述营养剂1000mL计,所述脂肪包含大豆油18.0-23.8g、芥花油16.2-19.4g、中链脂肪酸甘油三酯13.3-16.4g、亚麻籽油6.5-14.4g;优选地,所述脂肪包含大豆油21.0g、芥花油18.0g、中链脂肪酸甘油三酯16.0g、亚麻籽油10g。
按所述营养剂1000mL计,所述碳水化合物包含麦芽糊精36.4-51.4g、果糖10.4-20.3g、异麦芽酮糖30.2-43.3g;
优选地,所述碳水化合物包含麦芽糊精40.0、果糖15.0g、异麦芽酮糖32.0g。
按所述营养剂1000mL计,所述膳食纤维包含难消化性麦芽糊精8.9-21.2g、果寡糖6.1-17.6g、菊粉5.0-11.2g;优选地,所述膳食纤维包含难消化性麦芽糊精14.0g、果寡糖12.0g、菊粉10.0g。
按所述营养剂1000mL计,所述维生素包含维生素A 1.05-3mg RE、维生素D 19.2-20.1μg、维生素E 45-51mgα-TE、维生素K185-120μg、维生素B11-4mg、维生素B21.2-3.1mg、维生素B62-5.3mg、维生素B123.2-7.3μg、维生素C 401-443mg、生物素41-63μg、氯化胆碱472-543mg、烟酸22.3-28mg、叶酸344-410μg、泛酸9.2-13.1mg;
优选地,所述维生素包含维生素A 2.05mg RE、维生素D 17.2μg、维生素E 47.8mgα-TE、维生素K1100μg、维生素B12.5mg、维生素B22.9mg、维生素B63.4mg、维生素B125.2μg、维生素C 432mg、生物素52μg、氯化胆碱512mg、烟酸25.2mg、叶酸390μg、泛酸11.2mg。
按所述营养剂1000mL计,所述无机盐包含碳酸钙5-8g、柠檬酸钠3-7g、氯化镁2-4g、氯化钠1-2.5g、磷酸氢二钾0.8-2g、氯化钾0.3-0.8g、氧化镁0.3-0.7g、柠檬酸钾0.2-0.6g、硫酸锌60-80mg、硫酸亚铁60-80mg、硫酸锰10-30mg、硫酸铜5-9mg、氯化铬4-8mg、钼酸钠0.4-0.7mg、硒酸钠0.2-0.5mg、碘化钾0.2-0.5mg;
优选地,按所述营养剂1000mL计,所述无机盐包含碳酸钙6.5g、柠檬酸钠5g、氯化镁3g、氯化钠1.5g、磷酸氢二钾1.3g、氯化钾0.54g、氧化镁0.5g、柠檬酸钾0.4g、硫酸锌70mg、硫酸亚铁70mg、硫酸锰20mg、硫酸铜7mg、氯化铬6mg、钼酸钠0.6mg、硒酸钠0.35mg、碘化钾0.3mg;
优选地,按所述营养剂1000mL计,所述无机盐中包含钠1-1.5g、钾1-3g、铜1.2-3mg、镁400-440mg、铁16.2-18mg、锌22-27mg、锰3-5.5mg、钙1-3g、磷0.8-1.4g、碘140-170μg、氯1.2-1.9g、硒79-85μg、铬90-110μg、钼130-150μg;
优选地,按所述营养剂1000mL计,所述无机盐中包含钠1.3g、钾2g、铜2.3mg、镁420mg、铁17.2mg、锌25mg、锰4.4mg、钙1.5g、磷1.1g、碘160μg、氯1.6g、硒81μg、铬100μg、钼140μg;
优选地,所述营养剂还包含乳化剂,其选自卵磷脂、脂肪酸甘油酯和琥珀酸甘油酯中的一种或多种;
优选地,按所述营养剂1000mL计,所述营养剂包含乳化剂3.3g;
优选地,所述营养剂还包含调味品,其选自天然香草和人工香草中的一种或两种。
本发明所述营养剂包含的中链脂肪酸、单不饱和脂肪酸、ω-3脂肪酸和ω-6脂肪酸的供能比为2:2:1:2。
本发明所述营养剂包含的蛋白质、脂肪和碳水化合物的供能比为22-27%:36-53%:20-44%,优选地,所述营养剂包含的蛋白质、脂肪和碳水化合物的供能比为22%:45%:33%。
本发明还提供一种本发明所述肠内营养剂的制备方法,制备方法包括将上述各成分混合均匀;
优选地,本发明所述肠内营养剂的制备方法包括以下步骤:
(1)制备以下溶液:
溶液A:由脂肪(中链脂肪酸甘油三酯、大豆油、芥花油、亚麻籽油)、乳化剂和脂溶性维生素预混料组成,其中脂溶性维生素预混料由维生素A、维生素D、维生素E、维生素K1组成;
溶液B:由蛋白质(酪蛋白、乳清蛋白、大豆蛋白)和水组成;
溶液C:由水、碳水化合物(麦芽糊精、果糖、异麦芽酮糖)、膳食纤维(难消化性麦芽糊精、果寡糖、菊粉)和浓度为40重量%的氢氧化钾组成;
溶液D:由非脂溶性维生素(维生素C、氯化胆碱、烟酸、维生素B12、泛酸、维生素B1、维生素B6、维生素B2、叶酸、生物素)、酵母抽出物、牛磺酸、L-肉碱和水组成;
溶液E:由无机盐和水组成,优选由碳酸钙、柠檬酸钠、氯化镁、氯化钠、磷酸氢二钾、氯化钾、氧化镁、柠檬酸钾、硫酸锌、硫酸亚铁、硫酸锰、硫酸铜、氯化铬、钼酸钠、硒酸钠、碘化钾和水组成;
溶液F:由水和调味剂组成,优选由水、天然香草和/或人工香草组成;
将溶液A、B、C、D、E和F混合后在55-65℃下搅拌,调节pH至6.5-6.8;
(2)将步骤(1)得到的混合物加热至70-75℃,0.1-0.2MPa下脱气,后于8-10MPa下乳化后加热至98-102℃,后加热至146-147℃,保持3-8秒;
(3)将步骤(2)得到的混合物冷却至98-102℃;后基板散热降温至70-75℃。
(4)在氮气的保护下,将步骤(3)得到的混合物在30-50MPa压力下均质,后在70-80℃下保持13-20秒,后冷却至2-6℃,即得。
本发明所述肠内营养剂在制备治疗肿瘤的药物或者制备肿瘤患者营养食品中的用途。优选地,所述肿瘤为恶性肿瘤,进一步优选为食管癌;更优选地,所述肿瘤患者为食管癌放疗患者。
本发明所述肠内营养剂中,所述营养剂包含的中链脂肪酸、单不饱和脂肪酸、ω-3脂肪酸和ω-6脂肪酸的供能比为2:2:1:2。其中,中链脂肪酸主要来源于本发明所述的中链脂肪酸甘油三酯,具有吸收速度快的优势,是一种能快速提供能量的养分,通常仅需几分钟中链脂肪酸就能直接从肠道上皮细胞吸收,再通过肝门静脉进入血液循环。相比之下,长链脂肪酸要在肠道上皮细胞里重新与甘油结合成甘油三酯,再与载脂蛋白、磷脂和胆固醇形成乳糜微粒,而后才能经淋巴系统进入血液循环,需3~4个小时才能完成。单不饱和脂肪酸主要来源于芥花油,是一种人体必需脂肪酸。此外,芥花油不只提供单不饱和脂肪酸,同时含有丰富的必需脂肪酸—亚麻油酸和次亚麻油酸,都是人体不能自行合成,需要由食物中摄取而来的。ω-3脂肪酸和ω-6脂肪酸的主要来源分别为亚麻籽油和大豆油,本发明所述营养剂中提高了ω-3脂肪酸的含量,使ω-3脂肪酸和ω-6脂肪酸的比例为1:2(正常饮食两者的比例在1:4-1:6范围内)。根据脂肪酸与炎症的关系,ω-6脂肪酸属于致炎脂肪酸,ω-3脂肪酸属于抑炎脂肪酸,提高ω-3脂肪酸的含量有助于抑制肿瘤患者的体重下降,增加瘦体重,改善机能。
本发明所述肠内营养剂包含人体需要的七大营养素,即碳水化合物、脂类、蛋白质、维生素、无机盐、水和膳食纤维,符合肿瘤患者代谢特点,具有高蛋白、高脂肪和低碳水化合物,其中,蛋白质、脂肪和碳水化合物的供能比为22%:45%:33%。
本发明所述肠内营养剂的蛋白质100%来源于优质蛋白质,包含有动物蛋白(酪蛋白和乳清蛋白)与植物蛋白(大豆蛋白),其中富含精氨酸和支链氨基酸,有助于增加蛋白质合成、预防分解代谢,促进细胞与组织的修复,有利于增强机体免疫力,降低术后感染风险,改善肿瘤恶液质等虚弱症状。
恶性肿瘤本质上属于慢性低度炎症,本发明所述营养剂中提高了ω-3脂肪酸的含量,其来源于亚麻籽油。世界卫生组织(WHO)推荐人类膳食用油脂肪酸的标准为:饱和脂肪酸、单不饱和脂肪酸与多不饱和脂肪酸三者的供能比例为1:1:1,而多不饱和脂肪酸中ω-3脂肪酸与ω-6脂肪酸比例为1:4-6。根据肿瘤患者代谢特点,本发明所述营养剂优化了脂肪酸供能比例,中链脂肪酸(MCT):单不饱和脂肪酸(来源于芥花油):ω-3脂肪酸:ω-6脂肪酸(来源于大豆油)=2:2:1:2。其中,MCT供能占脂肪供能的20%以上,MCT具有高能量、易吸收的特点,可为肿瘤患者快速供能。
与高糖配方的其它营养剂相比,本发明肠内营养剂不仅有助于降低血糖浓度,减少了感染风险。同时,本发明中碳水化合物来源包含低升糖指数的异麦芽酮糖、果糖,有利于患者平稳血糖,特别适合于肿瘤伴发糖尿病患者,且有助于降低肿瘤的转移。
本发明肠内营养剂包含多样性膳食纤维,包括难消化性麦芽糊精、果寡糖、菊糖,维持胃肠道功能的同时减缓葡糖糖的吸收。
本发明肠内营养剂包含牛磺酸。牛磺酸是人体不可缺少的氨基酸,具有维持正常视觉功能、维持渗透压平衡、维持细胞膜稳定、降血糖、保护组织缺血再灌注损伤、提高机体免疫力、调节脂类分泌、保护心肌细胞等广泛的生物学作用。牛磺酸可增强机体免疫力以及影响抗肿瘤药物的细胞摄入和外排,继而减少因抗肿瘤药物而产生的不良反应。此外,牛磺酸还有助于帮助细胞膜形成及胆酸进行脂肪乳化。
本发明肠内营养剂包含L-肉碱,在高脂配方中有利于促进脂肪酸的氧化利用,提高脂肪供能比例,同时可以显著改善肿瘤患者的疲劳感,从而提高肿瘤患者的生活质量。
本发明肠内营养剂包含核苷酸(来源于酵母抽提物),其通过参与细胞代谢与更新,有利于增强机体免疫力、维持肠道正常菌群的消化和吸收的功能,此外,还具有明显的抗辐射、明显增强机体对外界的应激能力。
因此,本发明所述肠内营养剂为高蛋白、高脂肪、低碳水化合物的肠内营养剂,其符合肿瘤患者代谢特点,可选择性饥饿肿瘤细胞而不影响正常细胞功能,尤其适用于肿瘤伴发糖尿病患者,有效扭转营养不良,提高肿瘤患者生活质量。特别是研究证明,本发明的肠内营养剂有助于维持食管癌放疗患者的营养状态,降低放疗相关毒副反应发生率,帮助患者顺利完成治疗,改善临床结局;并且患者对本发明的肠内营养剂有良好的耐受性。
具体实施方式
下面结合具体实施方式对本发明进行进一步的详细描述,给出的实施例仅为了阐明本发明,而不是为了限制本发明的范围。
实施例1:本发明所述营养剂的制备
1、原料如表1所示:
表1:本发明所述营养剂的制备原料
2、制备方法:
(1)制备以下溶液:
溶液A:由中链甘油三酯、大豆油、芥花油、亚麻籽油、乳化剂(卵磷脂、脂肪酸甘油酯、琥珀酸甘油酯)和脂溶性维生素预混料(维生素A、维生素D、维生素E、维生素K)组成;
溶液B:由酪蛋白、乳清蛋白、大豆蛋白和水组成;
溶液C:由水、果糖、难消化性麦芽糊精、麦芽糊精、果寡糖、菊粉、异麦芽酮糖和浓度为40重量%的氢氧化钾组成;
溶液D:由非脂溶性维生素(维生素C、氯化胆碱、烟酸、维生素B12、泛酸、维生素B1、维生素B6、维生素B2、叶酸、生物素)、酵母抽出物、牛磺酸、L-肉碱和水组成;
溶液E:由碳酸钙、柠檬酸钠、氯化镁、氯化钠、磷酸氢二钾、氯化钾、氧化镁、柠檬酸钾、硫酸锌、硫酸亚铁、硫酸锰、硫酸铜、氯化铬、钼酸钠、硒酸钠、碘化钾和水组成;
溶液F:由水、天然香草和人工香草组成;
将溶液A、B、C、D、E和F混合后在55-65℃下搅拌,调节pH至6.5-6.8;
(2)将步骤(1)得到的混合物加热至70-75℃,0.1-0.2MPa下脱气,后于8-10MPa下乳化后加热至98℃,后加热至146-147℃,保持3-8秒;
(3)将步骤(2)得到的混合物冷却至98-102℃;后基板散热降温至70-75℃。
(4)氮气保护下,将步骤(3)得到的混合物在30-50MPa压力下均质,后在70-80℃下保持13-20秒,后冷却至2-6℃后放入接收罐储存;通过灌装机,将接收罐内溶液灌入瓶中,并密封其灌入口;对产品进行灭菌、液位打查、真空度检查,然后包装,得到本品。
本实施例制备得到的肠内营养剂检测结果如表2:
表2:本发明所述营养剂检测结果
经计算,本发明所述营养剂每100ml的能量为135kcal,即:
6.72*9+7.35*4+11.19*4=134.64kcal,其中:
蛋白质供能为7.35*4=29.4kcal,占总能量的22%;
脂肪供能为6.72*9=60.48kcal,占总能量的45%;
碳水化合物供能为11.19*4=44.76kcal,占总能量的33%。
表3:本发明所述营养剂各脂肪原料的不同脂肪酸的组成比例
经计算,本发明所述营养剂中每1000m中各脂肪酸的含量如下:
单不饱和脂肪酸:21g*20%+18g*57%+10g*15%=15.96克;
ω-3多不饱和脂肪酸:21g*4%+18g*7.5%+10g*58%=7.99克;
ω-6多不饱和脂肪酸:21g*56%+18g*16%+10g*13.5%=15.99克;
中链脂肪酸:16克。
因此,从上述可以得出,本发明所述营养剂中的中链脂肪酸、单不饱和脂肪酸、ω-3脂肪酸和ω-6脂肪酸的供能比为2:2:1:2。
相比于ω-3脂肪酸与ω-6脂肪酸比例为1:4的营养剂,本发明所述营养剂中ω-3脂肪酸与ω-6脂肪酸比例为1:2的组方能够更有效的降低葡聚糖硫酸钠(DSS)诱导的小鼠结肠炎的炎症反应,其相关机制是提高ω-3脂肪酸的供能比能够上调过氧化物酶体增殖物激活受体(peroxisome proliferator-activated receptor,PPAR),降低核转录因子kappaB(NF-κB),随后减少炎症介质的产生。此外,相比于长链脂肪酸,中链脂肪酸更容易被人体消化、吸收,其吸收后被直接运输到肝脏,被迅速β-氧化,快速产热供能。因此,该脂肪酸配比中,既能提供患者必需脂肪酸,更能够恰当快速供能。
实施例2:本发明所述营养剂的制备
1、原料如表4所示:
表4:本发明所述营养剂的制备原料
2、制备方法:
(1)制备以下溶液:
溶液A:由中链甘油三酯、大豆油、芥花油、亚麻籽油、乳化剂(卵磷脂、脂肪酸甘油酯、琥珀酸甘油酯)和脂溶性维生素预混料(维生素A、维生素D、维生素E、维生素K)组成;
溶液B:由酪蛋白、乳清蛋白、大豆蛋白和水组成;
溶液C:由水、果糖、难消化性麦芽糊精、麦芽糊精、果寡糖、菊粉、异麦芽酮糖和浓度为40重量%的氢氧化钾组成;
溶液D:由非脂溶性维生素(维生素C、氯化胆碱、烟酸、维生素B12、泛酸、维生素B1、维生素B6、维生素B2、叶酸、生物素)、酵母抽出物、牛磺酸、L-肉碱和水组成;
溶液E:由碳酸钙、柠檬酸钠、氯化镁、氯化钠、磷酸氢二钾、氯化钾、氧化镁、柠檬酸钾、硫酸锌、硫酸亚铁、硫酸锰、硫酸铜、氯化铬、钼酸钠、硒酸钠、碘化钾和水组成;
溶液F:由水、天然香草和人工香草组成;
将溶液A、B、C、D、E和F混合后在55-65℃下搅拌,调节pH至6.5-6.8;
(2)将步骤(1)得到的混合物加热至70-75℃,0.1-0.2MPa下脱气,后于8-10MPa下乳化后加热至98℃,后加热至146-147℃,保持3-8秒;
(3)将步骤(2)得到的混合物冷却至98-102℃;后基板散热降温至70-75℃。
(4)氮气保护下,将步骤(3)得到的混合物在30-50MPa压力下均质,后在70-80℃下保持13-20秒,后冷却至2-6℃后放入接收罐储存;通过灌装机,将接收罐内溶液灌入瓶中,并密封其灌入口;对产品进行灭菌、液位打查、真空度检查,然后包装,得到本品。
本实施例制备得到的肠内营养剂检测结果如表5:
表5:本发明所述营养剂检测结果
检测项目 | 单位 | 结果 |
总碳水化合物 | g/100ml | 11.17 |
热量 | kcal/100ml | 1.33 |
水分 | g/100ml | 80 |
灰分 | g/100ml | 1.1 |
粗脂肪 | g/100ml | 6.58 |
粗蛋白质 | g/100ml | 7.45 |
重量体重比 | g/ml | 1.0548 |
钠 | mg/100ml | 134.5 |
铁 | mg/100ml | 1.6 |
锌 | mg/100ml | 2.86 |
硒 | μg/100ml | 8.02 |
维生素D | μg/100ml | 2.08 |
牛磺酸 | mg/100ml | 16.38 |
钙 | mg/100ml | 280 |
经计算,本产品每100ml的能量为133.7kcal,即:
蛋白质供能为29.8kcal,占总能量的22.3%;
脂肪供能为59.22kcal,占总能量的44.3%;
碳水化合物供能为44.68kcal,占总能量的33.4%。
表6:本发明所述营养剂各脂肪原料中不同脂肪酸的组成比例:
经计算,本发明所述营养剂每1000ml中各脂肪酸的含量如下:
单不饱和脂肪酸:21g*20%+18g*57%+10g*15%=15.96克;
ω-3多不饱和脂肪酸:21g*4%+18g*7.5%+10g*58%=7.99克;
ω-6多不饱和脂肪酸:21g*56%+18g*16%+10g*13.5%=15.99克;
中链脂肪酸:16克。
从上述内容可以得出:本发明所述营养剂中的链脂肪酸、单不饱和脂肪酸、ω-3脂肪酸和ω-6脂肪酸的供能比为2:2:1:2。
实施例3:本发明所述营养剂在放疗食管癌患者的临床应用及耐受性
放疗是食管癌患者中晚期的主要治疗方式之一,而放疗常导致严重的粘膜炎,出现吞咽疼痛使吞咽困难加重,从而引起能量和蛋白质摄入不足。营养不良会影响恶性肿瘤患者的治疗效果,降低生活质量,缩短生存时间的,增加医疗费用。特殊医学用途的配方食品,是为了满足进食受限、消化吸收障碍、代谢紊乱或特定疾病状态人群对营养素或膳食的特殊需要,专门加工配制而成的配方食品,起着重要的营养支持作用。本发明所述营养剂是高能量、高蛋白、高脂肪、低碳水化合物配方,含有多种维生素、矿物质,富含膳食纤维,特别添加牛磺酸、核苷酸和左旋肉碱的肿瘤全营养配方食品。
对于PG-SGA≥4分的放疗食管癌患者,评估本发明所述营养剂对食管癌患者营养状态、放疗副反应发生率、胃肠道症状发生率的影响。
35例食管癌患者在放疗过程中,采用本发明所述营养剂作为营养支持补充。患者平均年龄是60.86±9.88岁,PG-SGA平均评分为8.16±2.98分。放疗过程中,14名患者采取口服补充途径,21名患者采用管饲补充途径,本发明所述营养剂(实施例1)的平均使用量为1137.5kcal/天。35名患者均按计划完成放疗,患者前白蛋白和转铁蛋白显著升高(P<0.05),总蛋白、白蛋白、白细胞、血红蛋白、血小板与放疗前相比均没有特异性差异;C-反应蛋白检测值有所降低,但没有显著性差异。此外,恶心、腹胀、腹泻的发生率只有17.1%、5.7%、5.7%,没有严重的放疗副反应出现。
因此,本发明所述营养剂的应用有助于维持食管癌放疗患者的营养状况,且患者对其的耐受性较好。
一、方法
1、治疗对象
选择年龄在18-80岁之间、经病理诊断为食管癌、PG-SGA评分≥4分、入院前6个月内体重丢失≥10%、拟进行放疗的患者进行观察研究。
共纳入35例食管癌患者,其中,男26例,女9例,平均年龄为60.86±9.88岁,平均体重为56.28±7.22kg,平均PG-SGA评分为8.16±2.98分,平均KPS评分为81.9±5.12分。肿瘤分期情况如下:2例II期;30例III期;3例IV期。放疗过程中,14例患者通过本发明所述营养剂(实施例1)进行营养补充,21例患者通过管饲途径补充。患者的一般临床资料详见表7。
表7:患者的一般临床资料
2、治疗实施
根据临床营养诊治流程进行治疗,包括筛查、评价、营养治疗计划制定、实施、监测、方案调整。所有患者均采用本发明所述营养剂(实施例1)进行营养支持治疗。
3、检测指标
上述患者在放疗治疗前后检测如下指标:白细胞、血红蛋白、血小板、总蛋白、白蛋白、前白蛋白、转铁蛋白、谷丙转氨酶、谷草转氨酶、肌酐、甘油三酯、C-反应蛋白;在营养治疗过程中,观察并记录患者胃肠道症状,包括:恶心、呕吐、腹胀、腹泻、腹痛的发生情况。毒副反应的评价参考美国国立癌症研究所《常见不良事件评价标准》(CTCAE v3.0)。
统计学方法:采用SPSS 20.0软件对数据进行统计学分析,对计数资料以率表示,计量资料以表示,分析时采用t检验,P<0.05为差异具有统计学意义。
二、测试
1、放疗前后患者各项指标对比
所有患者均按计划完成放疗,对比放疗前后各项指标的变化,结果发现:(1)血液学指标(白细胞、血红蛋白、血小板)与治疗前相比有所下降,但没有统计学意义(P>0.05);(2)治疗后,前白蛋白和转铁蛋白显著升高(P<0.05),总蛋白和白蛋白水平保持稳定(P>0.05);(3)此外,谷丙转氨酶、谷草转氨酶、肌酐、甘油三酯和C-反应蛋白变化与治疗前相比差异无显著性意义(P>0.05),见表8。
表8:放疗前后各项指标的变化
2、放疗毒副反应症状
所有患者均未出现严重放疗毒副不良反应,均未终止或延迟放疗,轻度放疗毒副反应发生率详见表9。
表9:放疗毒副反应发生率
1、胃肠道耐受情况
放疗过程中,35例患者的本发明所述营养剂(实施例1)的平均使用量为1137.5kcal/天,平均使用时间为22天。恶心、腹胀、腹泻的发生率分别为17.1%、5.7%、5.7%,无呕吐和腹痛症状。详见表10。
表10:胃肠道症状发生率
症状 | 恶心症状 | 呕吐症状 | 腹胀症状 | 腹泻症状 | 腹痛症状 |
n(%) | 6(17.1) | 0 | 2(5.7) | 2(5.7) | 0 |
三、结论
本发明人经研究发现,食管癌患者营养不足是其不良预后的独立危险因素。食管癌患者由于吞咽功能障碍及不合理饮食,在治疗前往往已出现体重下降、营养不足。在治疗过程中,由于疾病本身因素及治疗因素导致患者摄入量进一步下降,从而逐步加重已经发生的营养不足,部分患者因为营养不足/恶病质导致其他并发症,影响治疗进程,影响治疗效果。因此,营养支持治疗已成为改善营养不良患者临床结局的重要治疗措施。本发明所述营养剂以乳清蛋白、大豆蛋白、酪蛋白为蛋白质来源,氨基酸模式更优化,蛋白质生物利用率更高;脂肪以植物油为主,亚麻籽油提供n-3脂肪酸,其有助于维持患者体重,改善体能;添加多种维生素、矿物质和膳食纤维,可以满足患者全部营养需要。本研究采用本发明所述营养剂提供营养补充,研究结果表明,本发明所述营养剂的应用有助于维持食管癌放疗患者的营养状态、帮助患者顺利完成治疗,且患者对其耐受性较好。
恶性肿瘤患者由于营养物质代谢异常及治疗相关因素常导致能量、蛋白质、维生素、矿物质等缺乏,使治疗相关并发症增加,治疗顺应性降低。本发明发现通过营养支持小组的早期介入,合理的营养补充可以为骨髓造血提供更多的底物,维持血细胞水平的相对稳定。
此外,肿瘤患者由于蛋白质代谢异常、骨骼肌蛋白质消耗增加,常出现负氮平衡,肝脏对于各种蛋白(白蛋白、前白蛋白、转铁蛋白等)的合成量减少,这些指标随即出现不同程度的降低。低白蛋白血症将加剧代谢紊乱、增加感染并发症、延长住院时间,与患者不良预后直接相关,是影响预后的独立因素。本发明所述营养剂及时充足的补充,可以升高患者的前白蛋白和转铁蛋白水平,有助于改善负氮平衡。
本发明人还发现,患者营养不足与感染等并发症发生率升高显著相关,对于局部晚期食管癌患者而言,接受放化疗的治疗效果与营养状况、放化疗剂量相关,肿瘤放化疗患者常常由于并发症的发生而暂停或终止治疗,严重影响治疗效果。本发明通过对35例PG-SGA评分≥4分的食管癌放疗患者进行营养干预后,患者全部按计划完成治疗,且没有严重的放疗副反应发生。
在本发明中,大多数患者对于本发明所述营养剂的耐受性较好,每天平均使用量为1137.5kcal/天,谷丙转氨酶、谷草转氨酶、肌酐、甘油三酯水平在治疗前后没有显著性差异,胃肠道不良反应(恶心、呕吐、腹胀、腹泻、腹痛)的发生率较低,表明本发明营养剂用于放疗食管癌患者短期内对肝肾功能影响不大,对胃肠道有较好的耐受性。
实施例4:本发明所述营养剂在放疗食管癌患者的临床应用及耐受性
评价本发明所述营养剂补充高脂肪、高蛋白肿瘤全营养配方食品对食管癌放疗患者营养状况和临床结局的影响。
选取80例能够经口进食且NRS2002≥3分的食管癌放疗患者,随机分为研究组(n=41,服用本发明所述营养剂(实施例2))和对照组(n=39,不服用营养剂),比较放疗前后两组患者的能量摄入、营养状况、放疗副反应发生率等情况。
研究组患者每日口服本发明所述营养剂能量显著增加(418±109kcal增加至585±164kcal,P<0.05),放疗前后对比,研究组患者前白蛋白和转铁蛋白水平显著升高(17.35±5.83mg/L增加至20.15±6.02mg/L,P<0.05;213.74±52.66mg/L增加至264.19±43.78mg/L,P<0.05)。此外,相比于对照组,研究组患者发生III级放射性食管炎、III级放射性皮肤损伤的发生率显著降低(38%降低至24%,P<0.05;41%降低至27%,P<0.05)。
本发明所述营养剂营养补充可改善食管癌放疗患者的营养状况,降低放疗相关毒副反应发生率,有助于改善临床结局。
一、方法
1、治疗对象
选择食管癌患者80例,其中男性59例,女性21例;年龄48-74岁,平均年龄59.39±10.72岁。所有患者均经病理诊断为食管癌、营养风险筛查(Nutritional risk screening2002,NRS2002)评分≥3分、能够经口进食、拟进行放射治疗。患者于放疗前随机分为研究组(n=41,服用本发明所述营养剂(实施例2))和对照组对照组(n=39,不服用营养剂),详见表11。
表11:患者的一般临床资料
2、治疗实施
根据临床营养诊治流程进行治疗,包括筛查、评价、营养治疗计划制定、实施、监测、方案调整。所有患者均采用本发明所述营养剂(实施例2)进行营养支持治疗。
患者采用本发明所述营养剂进行口服营养。正常情况下至少放疗前3天即开始给予补充。
二、测试
两组患者于放疗前、放疗后检测相关指标,以及记录相关数据。(1)能量摄入:采用24h回顾法每周进行一次膳食调查,分析患者每日能量和蛋白质摄入量,每周测量一次体重。(2)血液学测定:空腹状态下静脉采血后检测患者白细胞、血红蛋白、血小板、总蛋白、白蛋白、前白蛋白、转铁蛋白。(3)毒副反应观察:毒副反应的评价参考美国国立癌症研究所《常见不良事件评价标准》(CTCAE v3.0)。
统计学方法:采用SPSS 20.0软件对数据进行统计学分析,对计数资料以率表示,采用χ2检验,计量资料以表示,分析时采用t检验,P<0.05为差异具有统计学意义。
1、放疗前后患者能量及蛋白质摄入量对比
通过24h回顾法调查膳食的种类和数量,根据《中国食物成分表2002》计算各营养素每日摄入量,放疗前每日膳食平均摄入能量为1394±148kcal,与放疗前相比,放疗后膳食能量以及蛋白质摄入量均有所减少,没有显著性差异。研究组患者每日通过ONS补充,放疗前平均每日补充418kcal(1.29罐,占总能量的23%),随着放疗的进行到放疗结束后平均每日补充585kcal,存在显著性差异(P<0.05),详见表12。
表12:放疗前后能量和蛋白摄入量变化
注:*P<0.05,研究组与对照组比较;P<0.05,组内放疗前与放疗后比较。
2、放疗前后两组各项指标对比
比较放疗前后各项指标的变化,结果表明:(1)研究组患者体重维持稳定,对照组患者体重下降,但均无显著性差异(P>0.05);(2)相比于放疗前,两组患者白细胞、血红蛋白、血小板、总蛋白水平有所降低,但均无显著性差异(P>0.05);(3)研究组前白蛋白和转铁蛋白水平显著升高(P<0.05),对照组患者白蛋白水平显著降低,详见表13。
表13:放疗前后各项指标的变化
注:*P<0.05,研究组与对照组比较;P<0.05,组内放疗前与放疗后比较。
3、两组放疗相关毒副反应对比
放疗结束后,比较两组患者放疗相关毒副不良反应发生率,相比于对照组,研究组患者出现III级放射性食管炎、III级放射性皮肤损伤的发生率显著降低,III级放射性肺炎发生率,对照组与研究组之间无显著性差异(5%vs5%,P>0.05)。详见表14。
表14:放疗相关毒副反应发生率比较
注:*P<0.05,相比于对照组。
三、结论
放疗在杀伤肿瘤细胞的同时会损伤周围的正常组织和器官,食管癌放疗患者常发生放射性食管炎、吞咽困难和疼痛等症状,出现营养不良,影响治疗进程,影响治疗效果。本发明证实了本发明所述营养剂可维持食管癌放疗患者的体重,改善其营养状况。
本发明还针对100例肿瘤放疗患者随机对照研究发现,本发明所述营养剂能明显改善放疗患者的营养状况,相比于对照组,接受本发明所述营养剂的肿瘤患者在饮食摄入量、食物种类及膳食结构上更加合理,患者的营养状况、体重及饮食摄入量都能够明显恢复到正常水平,患者白蛋白水平显著性下降,显著性提高前白蛋白和转铁蛋白水平,利于患者改善临床结局。
本发明经研究发现,营养不足与感染等并发症发生率升高显著相关,食管癌放疗患者常出现放射性食管炎、皮肤损伤等放疗相关毒副反应,而本发明所述营养剂能够有效降低放化疗毒副反应。
总之,以上对本发明具体实施方式的描述并不限制本发明,本领域技术人员可以根据本发明作出各种改变或变形,只要不脱离本发明的精神,均应属于本发明所附权利要求的范围。
Claims (11)
1.一种用于肿瘤治疗的肠内营养剂,所述营养剂包含蛋白质、脂肪、碳水化合物、膳食纤维、牛磺酸、L-肉碱、酵母抽出物、维生素、无机盐和水;
其中,所述蛋白质包含酪蛋白、大豆蛋白和乳清蛋白;
所述脂肪包含大豆油、芥花油、中链(C6-C12)脂肪酸甘油三酯和亚麻籽油;
所述碳水化合物包含麦芽糊精、果糖和异麦芽酮糖;
所述膳食纤维包含难消化性麦芽糊精、果寡糖和菊粉;
所述维生素包含维生素A、维生素D、维生素E、维生素K1、维生素B1、维生素B2、维生素B6、维生素B12、维生素C、生物素、氯化胆碱、烟酸、叶酸和泛酸;
所述无机盐包含碳酸钙、柠檬酸钠、氯化镁、氯化钠、磷酸氢二钾、氯化钾、氧化镁、柠檬酸钾、硫酸锌、硫酸亚铁、硫酸锰、硫酸铜、氯化铬、钼酸钠、硒酸钠、碘化钾;
优选地,按所述营养剂1000mL计,所述营养剂包含:蛋白质70-95g、脂肪54-74g、碳水化合物77-115g、膳食纤维20-50g、牛磺酸171-319mg、L-肉碱100-156mg、酵母抽出物300-419mg、维生素0.5-2g、无机盐13.8-25.8g、水650-710g;
优选地,按所述营养剂1000mL计,所述营养剂包含:蛋白质87g、脂肪65g、碳水化合物107g、膳食纤维36g、牛磺酸200mg、L-肉碱130mg、酵母抽出物320mg、维生素1g、无机盐18.9g、水695g。
2.根据权利要求1所述的肠内营养剂,其特征在于,按所述营养剂1000mL计,所述蛋白质包含酪蛋白52.3-65.2g、大豆蛋白10.6-17.5g、乳清蛋白7.1-12.3g;优选地,所述蛋白质包含酪蛋白62.0g、大豆蛋白15.0g、乳清蛋白10.0g。
3.根据权利要求1或2所述的肠内营养剂,其特征在于,按所述营养剂1000mL计,所述脂肪包含大豆油18.0-23.8g、芥花油16.2-19.4g、中链脂肪酸甘油三酯13.3-16.4g、亚麻籽油6.5-14.4g;优选地,所述脂肪包含大豆油21.0g、芥花油18.0g、中链脂肪酸甘油三酯16.0g、亚麻籽油10g。
4.根据权利要求1至3中任一项所述的肠内营养剂,其特征在于,按所述营养剂1000mL计,所述碳水化合物包含麦芽糊精36.4-51.4g、果糖10.4-20.3g、异麦芽酮糖30.2-43.3g;
优选地,所述碳水化合物包含麦芽糊精40.0、果糖15.0g、异麦芽酮糖32.0g。
5.根据权利要求1至4中任一项所述的肠内营养剂,其特征在于,按所述营养剂1000mL计,所述膳食纤维包含难消化性麦芽糊精8.9-21.2g、果寡糖6.1-17.6g、菊粉5.0-11.2g;优选地,所述膳食纤维包含难消化性麦芽糊精14.0g、果寡糖12.0g、菊粉10.0g。
6.根据权利要求1至5中任一项所述的肠内营养剂,其特征在于,按所述营养剂1000mL计,所述维生素包含维生素A 1.05-3mg RE、维生素D 19.2-20.1μg、维生素E 45-51mgα-TE、维生素K1 85-120μg、维生素B1 1-4mg、维生素B2 1.2-3.1mg、维生素B6 2-5.3mg、维生素B123.2-7.3μg、维生素C 401-443mg、生物素41-63μg、氯化胆碱472-543mg、烟酸22.3-28mg、叶酸344-410μg、泛酸9.2-13.1mg;
优选地,所述维生素包含维生素A 2.05mg RE、维生素D 17.2μg、维生素E 47.8mgα-TE、维生素K1 100μg、维生素B1 2.5mg、维生素B2 2.9mg、维生素B6 3.4mg、维生素B12 5.2μg、维生素C 432mg、生物素52μg、氯化胆碱512mg、烟酸25.2mg、叶酸390μg、泛酸11.2mg。
7.根据权利要求1至6中任一项所述的肠内营养剂,其特征在于,按所述营养剂1000mL计,所述无机盐包含碳酸钙5-8g、柠檬酸钠3-7g、氯化镁2-4g、氯化钠1-2.5g、磷酸氢二钾0.8-2g、氯化钾0.3-0.8g、氧化镁0.3-0.7g、柠檬酸钾0.2-0.6g、硫酸锌60-80mg、硫酸亚铁60-80mg、硫酸锰10-30mg、硫酸铜5-9mg、氯化铬4-8mg、钼酸钠0.4-0.7mg、硒酸钠0.2-0.5mg、碘化钾0.2-0.5mg;
优选地,按所述营养剂1000mL计,所述无机盐包含碳酸钙6.5g、柠檬酸钠5g、氯化镁3g、氯化钠1.5g、磷酸氢二钾1.3g、氯化钾0.54g、氧化镁0.5g、柠檬酸钾0.4g、硫酸锌70mg、硫酸亚铁70mg、硫酸锰20mg、硫酸铜7mg、氯化铬6mg、钼酸钠0.6mg、硒酸钠0.35mg、碘化钾0.3mg;
优选地,按所述营养剂1000mL计,所述无机盐中包含钠1-1.5g、钾1-3g、铜1.2-3mg、镁400-440mg、铁16.2-18mg、锌22-27mg、锰3-5.5mg、钙1-3g、磷0.8-1.4g、碘140-170μg、氯1.2-1.9g、硒79-85μg、铬90-110μg、钼130-150μg;
优选地,按所述营养剂1000mL计,所述无机盐中包含钠1.3g、钾2g、铜2.3mg、镁420mg、铁17.2mg、锌25mg、锰4.4mg、钙1.5g、磷1.1g、碘160μg、氯1.6g、硒81μg、铬100μg、钼140μg;
优选地,所述营养剂还包含乳化剂,其选自卵磷脂、脂肪酸甘油酯、琥珀酸甘油酯中的一种或多种;
优选地,按所述营养剂1000mL计,所述营养剂包含乳化剂3.3g;
优选地,所述营养剂还包含调味品,其选自天然香草和人工香草中的一种或两种。
8.根据权利要求1至7中任一项所述的肠内营养剂,其特征在于,所述营养剂包含的中链脂肪酸、单不饱和脂肪酸、ω-3脂肪酸和ω-6脂肪酸的供能比为2:2:1:2。
9.根据权利要求1至8中任一项所述的肠内营养剂,其特征在于,所述营养剂包含的蛋白质、脂肪和碳水化合物的供能比为22-27%:36-53%:20-44%,优选地,所述营养剂包含的蛋白质、脂肪和碳水化合物的供能比为22%:45%:33%。
10.权利要求1至9中任一项所述的肠内营养剂的制备方法,制备方法包括将上述各成分混合均匀;
优选地,所述肠内营养剂的制备方法包括以下步骤:
(1)制备以下溶液:
溶液A:由脂肪(中链脂肪酸甘油三酯、大豆油、芥花油、亚麻籽油)、乳化剂和脂溶性维生素预混料组成,其中脂溶性维生素预混料由维生素A、维生素D、维生素E、维生素K1组成;
溶液B:由蛋白质(酪蛋白、乳清蛋白、大豆蛋白)和水组成;
溶液C:由水、碳水化合物(麦芽糊精、果糖、异麦芽酮糖)、膳食纤维(难消化性麦芽糊精、果寡糖、菊粉)和浓度为40重量%的氢氧化钾组成;
溶液D:由非脂溶性维生素(维生素C、氯化胆碱、烟酸、维生素B12、泛酸、维生素B1、维生素B6、维生素B2、叶酸、生物素)、酵母抽出物、牛磺酸、L-肉碱和水组成;
溶液E:由无机盐和水组成,优选由碳酸钙、柠檬酸钠、氯化镁、氯化钠、磷酸氢二钾、氯化钾、氧化镁、柠檬酸钾、硫酸锌、硫酸亚铁、硫酸锰、硫酸铜、氯化铬、钼酸钠、硒酸钠、碘化钾和水组成;
溶液F:由水和调味剂组成,优选由水、天然香草和/或人工香草组成;
将溶液A、B、C、D、E和F混合后在55-65℃下搅拌,调节pH至6.5-6.8;
(2)将步骤(1)得到的混合物加热至70-75℃,0.1-0.2MPa下脱气,后于8-10MPa下乳化后加热至98-102℃,后加热至146-147℃,保持3-8秒;
(3)将步骤(2)得到的混合物冷却至98-102℃;后基板散热降温至70-75℃;
(4)在氮气的保护下,将步骤(3)得到的混合物在30-50MPa压力下均质,后在70-80℃下保持13-20秒,后冷却至2-6℃,即得。
11.权利要求1至9中任一项所述的肠内营养剂在制备治疗肿瘤的药物或制备肿瘤患者营养食品中的用途;
优选地,所述肿瘤为恶性肿瘤,进一步优选为食管癌;
更优选地,所述肿瘤患者为食管癌放疗患者。
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