CN108185437A - 一种肿瘤全营养配方粉及其制备方法 - Google Patents
一种肿瘤全营养配方粉及其制备方法 Download PDFInfo
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- CN108185437A CN108185437A CN201711457284.7A CN201711457284A CN108185437A CN 108185437 A CN108185437 A CN 108185437A CN 201711457284 A CN201711457284 A CN 201711457284A CN 108185437 A CN108185437 A CN 108185437A
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- vitamin
- powder
- nutrient formulation
- protein
- formulation powder
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- 238000009472 formulation Methods 0.000 title claims abstract description 42
- 238000002360 preparation method Methods 0.000 title claims abstract description 10
- 102000004169 proteins and genes Human genes 0.000 claims abstract description 29
- 108090000623 proteins and genes Proteins 0.000 claims abstract description 29
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Abstract
本发明涉及一种适用于肿瘤患者的全营养配方粉及其制备方法,所述的全营养配方粉以总重量100g计,组分包括:5g~30g蛋白质、4g~26g脂肪、30g~80g碳水化合物、1g~10g膳食纤维、190mg~970mg维生素、1.30g~5.65g矿物质、1g~10g调味剂和0.1g~0.5g特异性营养补充剂,其中脂肪组分包含0.1g~2.5g鱼油,所述特异性营养补充剂为大豆卵磷质、酵母提取物、牛磺酸和左旋肉碱的混合物。本发明的产品便于携带,可提供全面的营养支持,富含ω‑3不饱和脂肪酸,特别是鱼油成分提供丰富的EPA和DHA有益成分,和植物油组成合理的搭配,促进患者的身体恢复。
Description
技术领域
本发明涉及特殊医学用途配方食品领域,具体涉及一种适用于肿瘤患者的粉剂类全营养配方产品及其制备方法。
背景技术
癌症统计资料显示,在中国,每年新发癌症病例达429万,占全球新发病例的20%,死亡281万例。癌症防治已成为我国重要公共卫生问题。其中消化道癌症是我国居民发病和死亡的主要负担,占男性全部癌症的50%左右。
数据显示,我国40%~80%的肿瘤患者存在营养不良,体质量减轻常是癌症病人的首发症状,在消化道癌症中体质量减轻的发生率最高。癌症病人体质量减轻的原因主要包括摄入减少及代谢异常。营养不良状态可导致癌症治疗获益减少,化疗相关毒性风险增加,术后并发症增多,生存质量降低,从而一定程度上影响疾病预后。
放射治疗(radiotherapy,RT)是治疗癌症的主要手段,约70%的癌症患者在整个病程中会接受放疗。接受头颈部或食管放疗的患者中,高达80%者会出现黏膜炎、摄入减少和体重下降;接受盆腔区域放疗的患者中,有近80%会出现胃肠道反应。而营养支持可以改善放疗患者营养摄入、体重和生活质量,减轻放疗对营养状况的负面影响,使患者能够顺利完成放疗计划而避免中断治疗。
特殊医学用途配方食品(foods for special medical purposes,FSMP)是指为了满足进食受限、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。在营养支持产品中,全营养配方产品是可作为单一营养来源满足目标人群营养需求的特殊医学用途配方食品。肿瘤患者在摄入减少及代谢异常等情况下,特别是在化疗过程中出现摄入障碍时,为患者提供全营养配方产品,可以满足患者的能量需求,改善代谢,有助于维持肠粘膜细胞结构与功能的完整。
目前,国外一些公司的相关产品在中国已申请专利或上市。比如美国雅培公司的安素,荷兰纽迪希亚公司的能全力,德国的瑞素和瑞能,日本的味之素等。由于人种、饮食结构、地理位置等的不同,中国人与其它地域人群的膳食营养存在一定差异,上述国外公司研发的配方不能有效的解决中国人的营养支持问题。特别的,对于肿瘤患者来说,肠道功能较为脆弱,更加需要针对性的营养产品。中国专利申请CN1257731A和CN1321431A提供的营养素形态为各种食物粉末,残渣量大,只能采用分次推注的方法,用量大时容易出现返流,造成吸入性肺炎等并发症,此外,这类食物需要接近正常的消化、吸收功能,否则容易出现腹胀、腹泻等并发症。因此,危重病人单独使用难以达到营养需求,营养状况不佳。专利申请CN106668835A提供了一种用于肿瘤治疗的肠内营养剂,提供高蛋白、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。但是,该产品为液体,不利于存储和运输,包装成本较高,且口味较为单调,不利于肿瘤患者进食。另外,对于肿瘤患者缺乏的一些特异性营养物质,缺乏有效的补充。专利申请CN106890312A提供了一种适用于肝癌患者的肠内营养剂,包含人体所需的七大营养素,同时含有药食同源-枸杞子中的生物活性成分,多种药理营养素,适合肝癌患者食用。但是,该产品的适用范围仅限于肝癌,且补充的营养物质侧重在多糖和蛋白质方面,对于脂肪和其它特殊营养物质的补充不足。
由此可见,目前国产的各种天然食物粉或营养素,大多不是全能营养素,单独使用不能完全满足营养需求;而全能的营养产品,多数为液体,不利于存储和运输;口味较为单调,不利于进食。针对肿瘤患者,特别是对于放疗过程中的肿瘤患者,目前缺乏针对性的全能营养产品,更缺乏对某些特异性营养物质的补充。
发明内容
本发明提供一种肿瘤全营养配方粉,可以完全满足肿瘤患者对于蛋白质、脂肪、碳水化合物、矿物质等必备营养素的需求,并特别添加了鱼油成分,弥补了亚麻仁油粉等无法提供的二十碳五稀酸(EPA)和二十二碳六稀酸(DHA),舒缓患者压力,促进心血管健全,减轻偏头痛等并发症,特别适合接受放疗治疗的患者食用。本发明提供的肿瘤全营养配方粉通过调整各物质的用量,提供更加适宜的口感。制成粉剂有利于包装和运输,降低成本。
本发明的上述目的是通过以下技术方案实现的:
本申请提供一种用于肿瘤治疗的全营养配方粉,以总重量100g计,所述的全营养配方粉包含5g~30g蛋白质、4g~26g脂肪、30g~80g碳水化合物、1g~10g膳食纤维、190mg~970mg维生素、1.30g~5.65g矿物质、1g~10g调味剂和0.1g~0.5g特异性营养补充剂。各组分优选为粉剂。
其中,所述蛋白质包括大豆蛋白和乳清蛋白,其中乳清蛋白可以选择水解乳清蛋白;
所述脂肪包含菜籽油粉、葵花籽油粉、中链甘油三酸酯、鱼油粉和亚麻仁油粉;
所述碳水化合物包含麦芽糊精和赤藻糖醇;
所述膳食纤维包含抗性糊精、低聚果糖和菊粉;
所述维生素包含重酒石酸胆碱、维生素C(L-抗坏血酸)、维生素E(d1-α-醋酸生育酚)、维生素A(醋酸维生素A)、烟酸、D-泛酸钙、维生素B12(氰钴胺)、维生素B6(盐酸吡哆醇)、维生素B2(核黄素)、维生素B1(盐酸硫胺素)、维生素D3(胆钙化醇)、维生素K(植物甲萘醌)、叶酸、生物素和肌醇;
所述矿物质包含氯化钾、柠檬酸钠、碳酸钙、磷酸三钙、氯化镁、磷酸氢二钾、焦磷酸铁、氧化镁、柠檬酸钾、氯化钠、硫酸锌、硫酸锰、硫酸铜、三氯化铬、钼酸钠、碘化钾和硒酸钠;
所述调味剂包含食用香料和三氯蔗糖;
所述特异性营养补充剂包含大豆卵磷质、酵母提取物(含核苷酸)、牛磺酸和左旋肉碱。
其中所述的大豆蛋白优选蛋白质含量在60wt%以上的大豆蛋白粉。大豆蛋白的氨基酸成分与牛奶相近,必须氨基酸的含量丰富,是植物性完全蛋白质,可以为肿瘤患者提供蛋白质营养。其中所述的乳清蛋白具有吸收性强,氨基酸成分完整等特点,可以促进肌肉合成,调节免疫力。
菜籽油粉被人体吸收的比率很高,可达99%,因此它所包含的亚油酸等不饱和脂肪酸和维生素E等维生素营养成分能被很好地吸收,具有较好的延缓衰老、软化血管的功效。菜籽油粉的胆固醇含量很低,所以不适宜摄入胆固醇的人群也可放心食用,另外其ω-3不饱和脂肪酸的含量也较高。葵花籽油粉含有植物甾醇、亚油酸、维生素等多种对人类有益的物质,其中维生素E的含量在所有主要植物油中是含量最高的;亚油酸的含量也达到70%左右。经常食用葵花籽油粉能降低血清胆固醇水平和甘油三酯水平,具有降血压的功效。
中链甘油三酸酯又称为中链脂肪酸甘油三酯,具有饱和度高,氧化稳定性好,脂肪酸碳链适中等特点,可以快速吸收,改善吸收不良症状,具有调节代谢的功效。
亚麻仁油富含植物性ω-3不饱和脂肪酸和木酵素,是人体无法合成的必须营养素,可抑制强力的雌激素以及前列腺素,可以预防肿瘤的生长,可以促进心脑系统健康,避免心脏病和中风,促进肌肉、骨骼等的生长。
鱼油中富含ω-3多元不饱和脂肪酸例如二十碳五稀酸(EPA)和二十二碳六稀酸(DHA)。由于鱼油易氧化变质,鱼油本身的味道较重,过去往往制成软胶囊供人们食用摄取。近年来鱼油粉、DHA粉已经有了革命性的突破技术,让消费者能够在日常饮食中就能摄取到ω-3多元不饱和脂肪酸。
作为优选技术方案之一,以全营养配方粉的总量为100g计,其包含:蛋白质10~28g、脂肪10~25g、碳水化合物35~60g、膳食纤维3~5g、维生素305~855mg、矿物质2.00~4.45g、调味剂2~8g和特异性营养补充剂0.1g~0.4g。
作为优选方案之一,以全营养配方粉的总量为100g计,其包含:蛋白质18~27g(优选为26.8g)、脂肪18~24g(优选为23g)、碳水化合物38~50g(优选为41g)、膳食纤维3.4~4.5g(优选为3.5g)、维生素718~850mg(优选827mg)、无机盐2.00~4.00(优选为2.05g)、调味剂2.2~5.0g(优选为2.6g)和特异性营养补充剂0.1g~0.3g(优选0.22g)。
作为优选方案之一,以全营养配方粉的总量为100g计,所述蛋白质包含:大豆蛋白13~22g(优选为22.0g)和乳清蛋白1~5g(优选为4.8g)。
作为优选方案之一,以全营养配方粉的总量为100g计,所述脂肪包含:菜籽油粉1.0g~12.0g(优选为10.0g)、葵花籽油粉2.1g~12.6g(优选为9.6g)、中链甘油三酸酯0.5~1.5g(优选为0.7g)、鱼油粉0.1g~2.5g(优选为0.6g)和亚麻仁油粉1.0g~8.0g(优选为2.1g)。
作为优选方案之一,以全营养配方粉的总量为100g计,所述碳水化合物包含:麦芽糊精30g~50g(优选为30g)和赤藻糖醇10g~20g(优选为11g)。
作为优选方案之一,以全营养配方粉的总量为100g计,所述膳食纤维包含:抗性糊精0.68~2.04g(优选为1.5g)、菊粉0.68~2.04g(优选为1.5g)和低聚果糖0.64~1.92g(优选为0.5g)。
作为优选方案之一,以全营养配方粉的总量为100g计,所述维生素包含:重酒石酸胆碱100~200mg(优选为183mg)、维生素C(L-抗坏血酸)42.5~182.5mg(优选为154.3mg)、维生素E(d1-α-醋酸生育酚)3~23mgα-TE(优选为17.1mgα-TE)、维生素A(醋酸维生素A)0.1~1mgRE(优选为0.732mgRE)、烟酸3~13mg(优选为9mg)、D-泛酸钙2~6mg(优选为4mg)、维生素B12(氰钴胺)1~2μg(优选为1.9μg)、维生素B6(盐酸吡哆醇)0.5~1.5mg(优选为1.21mg)、维生素B2(核黄素)0.5~1.5mg(优选为1.04mg)、维生素B1(盐酸硫胺素)0.5~1.5mg(优选为0.89mg)、维生素D3(胆钙化醇)1~10μg(优选为6.1μg)、维生素K(植物甲萘醌)28~48μg(优选为36μg)、叶酸100~150μg(优选为140μg)、生物素8~28μg(优选为18.6μg)和肌醇200~550mg(优选为455mg)。
作为优选方案之一,以全营养配方粉的总量为100g计,所述无机盐包含:氯化钾0.5~1.5g、磷酸氢二钾、柠檬酸钾0.1~0.4g(含钾量优选为0.714mg)、氯化钠0.01~0.1g、柠檬酸钠0.2~1.2g(含钠量优选为0.464g)、碳酸钙0.5~1.5g、磷酸三钙磷酸钙0.1~0.5g(含钙量优选为528mg)、氯化镁、氧化镁0.1~0.2g(含镁量优选为150mg)、焦磷酸铁0.01~0.02g(含铁量优选为6.1mg)、硫酸锌0.01~0.02g(含锌量优选为8.92mg)、硫酸锰0.01~0.03g(含锰量优选为1.57mg)、硫酸铜0.5~1.5mg(含铜量优选为0.82mg)、三氯化铬0.05~0.15mg(含铬量优选为35.7μg)、钼酸钠0.05~0.15mg(含钼量优选为0.05mg)、碘化钾0.05~0.15mg(含碘量优选为0.057mg)、硒酸钠20~100μg(含硒量优选为29μg),其中氯含量优选为582mg,磷含量优选为376mg。
作为优选方案之一,以全营养配方粉的总量为100g计,所述调味剂包含:食用香料1~5g(优选为1g)和三氯蔗糖1~5g(优选为1.6g)。
第二方面,本发明提供一种肿瘤全营养配方粉的制备方法,其包括下述步骤:
(1)称量:将所有原料辅料进行称量;
(2)预混:先将各维生素、各矿物质进行预混,预混约15~40min(优选25min),直至均匀;
(3)过筛:将蛋白质、脂肪、碳水化合物、膳食纤维、调味剂和特异性营养补充剂和上述步骤(2)中得到的预混料各自过10目筛,过筛的条件为温度不大于30℃且湿度不大于50%;
(4)总混:将步骤(2)中过筛得到的组分混合15~45min(优选30min),直至均匀,混合的条件为不大于30℃且湿度不大于50%;
(5)填充、包装:将得到的总混合粉以需要的规格进行填充罐装。
本发明的效果
本发明所述全营养配方粉中,包含人体所需的各种营养素,即蛋白质、脂类、碳水化合物、维生素、矿物质和膳食纤维,提供全营养支持。以高含量含有碳水化合物,能迅速及时补充人体所需能量。
本发明的脂肪类组分中含有菜籽油粉、葵花籽油粉、中链甘油三酸酯、鱼油粉和亚麻仁油粉等多种脂类,富含ω-3不饱和脂肪酸。特别是鱼油成分,富含EPA和DHA两种有益成分,和植物油组成合理的搭配,促进患者的身体恢复。本发明产品还含有中链甘油三酸酯,供能迅速,且不包含反式脂肪。
本发明产品的膳食纤维含量高且膳食纤维种类多样,包含麦芽糊精、赤藻糖醇,能够有效促进消化、调节血糖。
本发明产品还含有重酒石酸胆碱和肌醇,二者配合可以降低胆固醇。另外,还包含多种多样的人体所需维生素,如维生素A和维生素B1和维生素B2和维生素B6和维生素B12和维生素C和维生素D和维生素E和维生素K和生物素和烟酸和叶酸等,上述维生素复配,搭配合理,全面补充人体所需。
本发明产品中的蛋白质100%来源于优质蛋白质,包含有动物蛋白(乳清蛋白)和植物蛋白(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。
所述特异性营养补充剂包含大豆卵磷质、酵母提取物(含核苷酸)、牛磺酸和左旋肉碱。大豆卵磷质可以有效调节血脂和胆固醇,改善大脑功能,提高记忆力,一般对肿瘤起到预防的作用。酵母提取物有抑制肿瘤生长的作用。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、维持细胞膜温度、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。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。左旋肉碱的主要生理功能是促进脂肪转化成能量。这些特异性营养补充剂可以调理患者身体,提供针对性的营养支持,抑制肿瘤再生。
本发明产品中还包含食用香料和三氯蔗糖等调味品,能够改善口感,提高患者的进食欲望。
本发明生产工艺简单,原料来源广泛,携带方便,食用简便;且针对肿瘤患者有针对性的营养支持,并且添加抑制肿瘤生长的成分,可作为肿瘤患者单一营养来源食用。
由此可见,本发明的肿瘤全营养配方粉能够提供安全均衡、符合生理需要的各种营养素和微量元素,能够改善患者整体营养状况,并且对肝肾功能没有损害。
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:本发明肿瘤全营养配方粉的制备
1、原料配方如表1所示:
表1 本发明所述肿瘤全营养配方粉的制备原料
2、制备方法
(1)称量:将所有原料辅料进行称量;
(2)预混:先将各维生素、各矿物质进行预混,预混约15~40min(优选25min),直至均匀;
(3)过筛:将蛋白质、脂肪、碳水化合物、膳食纤维、调味剂和特异性营养补充剂和上述步骤(2)中得到的预混料各自过10目筛,过筛的条件为温度不大于30℃且湿度不大于50%;
(4)总混:将步骤(2)中过筛得到的组分混合15~45min(优选30min),直至均匀,混合的条件为不大于30℃且湿度不大于50%;
(5)填充、包装:将得到的总混合粉以需要的规格进行填充罐装。
本实施例制备得到的全营养配方粉的检测结果如表2:
表2 实施例1全营养配方粉的营养成分表
效果评价
1、营养指标评价
以实施例1和2得到的全营养配方粉为例,将其与《食品安全国家标准特殊医学用途配方食品通则》GB 29922-2013规定的各项指标逐一对照,发现均符合要求。
2、本发明的肿瘤全营养配方粉的临床试验
根据欧洲临床营养和代谢学会(ESPEN)2016年发布的《癌症患者营养管理指南》,肿瘤患者在不同阶段有不同的营养需求。根据该指南,肿瘤患者的能量需求应该类似于健康人群,介于25~30kCal/(kg·d)。对于卧床患者可按20~25kCal/(kg·d)估算能量需求。癌症患者蛋白质的合成、分解均增加,但分解速度高于合成速度,故机体蛋白减少,血浆蛋白水平降低。蛋白质摄入不足会使体内蛋白质消耗增加,导致骨骼肌消耗。故癌症患者应及时补充蛋白质和氨基酸,以纠正体内负氮平衡。蛋白质的摄入量应不少于1g/(kg·d)。对于正在接受化疗并存在体重下降或营养不良风险的癌症晚期患者,可以补充ω-3长链脂肪酸或鱼油,以稳定或改善食欲、进食量和体重。
患者在接受营养支持前均接受营养咨询师的营养咨询。通过咨询,评价患者营养不良的严重程度和类别,分析导致患者营养不良的社会、家庭、疾病、心理和生理因素(如疼痛、厌食、吞咽困难、药物影响等),提出有针对性、个体化的营养教育计划。
(1)研究对象
以接受放疗治疗的胃癌患者为试验对象。选择标准是:经过评估后患者可以自主进食,大于20岁,小于80岁。性别不限。共90名,包括59名男性及31名女性,编号后分别进入实验组30人、对照组130人,对照组230人。患者平均年龄61.17±9.76岁,均采用口服补充途径。
(2)测试配方
实验组口服实施例1的全营养配方粉,对照组1口服实施例1除去鱼油组分的全营养配方粉,对照组2按照原有习惯日常进食。
(3)试验流程
30例实验组胃癌患者在放疗过程中,饮食供应方式由营养师评估每位受试者能量需要量,至少给于每位受试者25~30kCal/(kg·d)的能量。供给方式为根据被试者的体重,换算得到需要的能量,得到需要的全营养粉质量,每餐给予根据本发明实施例1的全营养配方粉,1天6餐。试验时间为放疗期间。
30例对照组1的胃癌患者按照上述方法口服不含鱼油成分的实施例1的全营养配方粉。
30例对照组2的胃癌患者由营养师评估每位受试者能量需要量,至少给于每位受试者25~30kCal/(kg·d)的能量。供给方式为正常进食,一日三餐。
实验开始前,记录个人基本资料,包括:年龄、性别、疾病史、卧床年数。测量其升高、体重,计算身体质量指数、测量血压及收集血液,进行生化值检验。
化疗开始后,记录受试者饮食摄取量、消化情况、排便情况(是否出现腹泻或腹胀情况)。90名患者均按照计划完成放疗。
(4)生化检验
抽取受试者餐前静脉血,经3000rpm、10min离心后,分离出血清、血浆,进行血球与生化等测定,血液检验委托专业检验所进行。
生化分析包括:炎症分析(白细胞计数、C反应蛋白)、血液脂质指标(甘油三酯)、肾功能指标(肌酸酐)、肝功能指标(丙氨酸转氨酶、天冬氨酸转氨酶)、营养状态指标(总蛋白、前清蛋白、转铁蛋白)。观察并记录患者肠胃道症状,包括: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)。
(5)统计分析
使用统计分析软件SPSS20.0版对数据进行统计学分析,对计数资料以率表示,分析时采用t检验,当p<0.05具有统计上的差异。
(6)结果
①放疗前后实验组患者的各项指标对比
实验组受试者在介入前、中、后,给予1个月的本发明全营养配方粉的白细胞计数有一定下降、血红蛋白和血小板指数有所上升,但是无显著差异。血液脂质指标:甘油三酯有下降趋势,但不具显著意义;肝功能指标:丙氨酸转氨酶和天冬氨酸转氨酶有上升趋势,但不具显著意义;肾功能:肌酸酐略有上升,但不具显著意义。C反应蛋白与治疗前基本一致,无统计学差异。总蛋白、前白蛋白和转铁蛋白含量有一定升高,均在正常范围内,无统计学差异。
表3 实验组放疗前后各项指标的变化
项目 | 治疗前(n=30) | 治疗后(n=30) | P |
白细胞计数(109/L) | 8.385±3.25 | 8.171±3.47 | >0.05 |
血红蛋白(g/L) | 145.5±17.35 | 148.2±18.21 | >0.05 |
血小板容积分布宽度(fL) | 13.5±1.5 | 14.7±2.1 | >0.05 |
总蛋白(g/L) | 65.22±5.10 | 67.48±4.89 | >0.05 |
前清蛋白(mg/L) | 16.52±4.87 | 17.85±4.53 | >0.05 |
转铁蛋白(mg/L) | 216.45±43.36 | 221.47±38.56 | >0.05 |
丙氨酸转氨酶(U/L) | 18.98±1.87 | 19.52±2.01 | >0.05 |
天冬氨酸转氨酶(U/L) | 16.37±1.74 | 17.84±1.58 | >0.05 |
肌酸酐(U/L) | 65.23±14.52 | 66.32±12.85 | >0.05 |
甘油三酯(mmol/L) | 1.21±0.35 | 1.09±0.24 | >0.05 |
C反应蛋白(g/L) | 18.04±14.26 | 17.99±12.85 | >0.05 |
②放疗后实验组和对照组1的结果对比
结果表明,实验组相对于对照组1,白细胞计数、C反应蛋白、血小板容积分布宽度和甘油三脂有一定程度的降低,存在统计学差异。丙氨酸转氨酶和天冬氨酸转氨酶、肌酸酐有一定程度降低,总蛋白增加,但是无统计学差异。由此可见,鱼油可以降低胃癌患者血脂含量、消炎和抗凝的作用。具有潜在的改善肝功能和肾功能的作用。
表4 实验组和对照组1放疗后各项指标的变化
②放疗后实验组和对照组2的结果对比
结果表明,实验组相比于对照组2,总蛋白含量增加,前清蛋白和转铁蛋白含量增加,白细胞计数和C反应蛋白减少,具有统计学差异。可见,本发明的全营养配方粉具有提高蛋白质吸收、消炎的效果。和对照组2相比,实验组的平均体重更高,具有显著性差异,可见相比于正常进食,食用本发明实施例1的全营养粉可以提供更稳定的营养供给。
表5 实验组和对照组2放疗后各项指标的变化
项目 | 实验组(n=30) | 对照组2(n=30) | P |
白细胞计数(109/L) | 8.171±3.47 | 10.587±5.12 | 0.148 |
总蛋白(g/L) | 67.48±4.89 | 60.12±3.85 | 0.176 |
前清蛋白(mg/L) | 17.85±4.53 | 14.39±3.34 | 0.133 |
转铁蛋白(mg/L) | 221.47±38.56 | 180.25±38.64 | 0.141 |
C反应蛋白(g/L) | 17.99±12.85 | 23.12±13.73 | 0.137 |
体重(kg) | 63.2±10.3 | 60.6±12.3 | 0.103 |
3、放疗毒副反应症状
所有患者均未出现严重的放疗毒副反应。均未终止或者延迟放疗。对照组1和2出现轻度放疗毒副反应8例,5例为放射性肺炎,3例为放射性皮肤损伤。实验组患者没有出现毒副反应。
4、肠道耐受情况
放疗过程中,30例实验组患者的本发明所述营养剂(实施例1)的平均使用天数为25天。恶心、腹胀、腹泻、呕吐、腹痛的发生率为10%、6.7%、6.7%、3.3%和3.3%。
表6 肠胃症状发生率
症状 | 恶心 | 呕吐 | 腹胀 | 腹泻 | 腹痛 |
n(%) | 3(10%) | 1(3.3%) | 2(6.7%) | 2(6.7%) | 1(3.3%) |
5、口味评价
放疗过程中,询问患者在食用本发明所述营养剂(实施例1)的口味接受程度。口味的程度分为很好、好、一般、难吃四档。分别在第一天、第10天和第20天进行询问调查。结果如表7所示。很好和好的比例之和在80%以上,20天以后仍然保持在60%以上。可见,该营养品的口味是肿瘤患者可以接受的,长期使用并没有产生腻烦效应。
表7 口味评价
天数 | 很好(人数) | 好(人数) | 一般(人数) | 难吃(人数) |
1 | 18 | 6 | 5 | 1 |
10 | 14 | 7 | 7 | 2 |
20 | 11 | 8 | 9 | 2 |
一般来说,胃癌患者在肠胃吸收方面一般存在障碍。通过实验发现,使用本发明提供的全营养配方粉(实施例1),在放疗期间,患者的生化检验没有发生明显变化。可见,采用本发明的全营养配方粉,可维持患者营养状态,且肝功能、肾功能无恶化现象,取得了优异的技术效果。同时,患者的不良反应较少,恶心的比例为10%,其余症状的比例在10%以下。相比于正常进食,全营养配方粉还可以提供更全面的营养,具有消炎、抗凝的作用,具有一定的改善肝功能、肾功能的作用。
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 (10)
1.一种适用于肿瘤患者的全营养配方粉,以总重量100g计,组分包括:5g~30g蛋白质、4g~26g脂肪、30g~80g碳水化合物、1g~10g膳食纤维、190mg~970mg维生素、1.30g~5.65g矿物质、1g~10g调味剂和0.1g~0.5g特异性营养补充剂,其中脂肪包含0.1g~2.5g鱼油,所述特异性营养补充剂为大豆卵磷质、酵母提取物、牛磺酸和左旋肉碱的混合物。
2.如权利要求1所述的全营养配方粉,所述的肿瘤患者为胃癌患者。
3.如权利要求1所述的全营养配方粉,所述鱼油为0.6g。
4.如权利要求1所述的全营养配方粉,所述蛋白质为大豆蛋白和乳清蛋白的混合物,所述脂肪为菜籽油粉、葵花籽油粉、中链甘油三酸酯、鱼油和亚麻仁油粉混合物,所述碳水化合物为麦芽糊精和赤藻糖醇混合物,所述膳食纤维为抗性糊精、低聚果糖和菊粉混合物,所述维生素为重酒石酸胆碱、维生素C(L-抗坏血酸)、维生素E(dl-α-醋酸生育酚)、维生素A(醋酸维生素A)、烟酸、D-泛酸钙、维生素B12(氰钴胺)、维生素B6(盐酸吡哆醇)、维生素B2(核黄素)、维生素B1(盐酸硫胺素)、维生素D3(胆钙化醇)、维生素K(植物甲萘醌)、叶酸、生物素和肌醇混合物,所述矿物质为氯化钾、柠檬酸钠、碳酸钙、磷酸三钙、氯化镁、磷酸氢二钾、焦磷酸铁、氧化镁、柠檬酸钾、氯化钠、硫酸锌、硫酸锰、硫酸铜、三氯化铬、钼酸钠、碘化钾和硒酸钠混合物,所述调味剂为食用香料和三氯蔗糖混合物。
5.如权利要求1-4任一项所述的全营养配方粉,其中所述的各组分优选为蛋白质18~27g(优选为26.8g)、脂肪18~24g(优选为23g)、碳水化合物38~50g(优选为41g)、膳食纤维3.4~4.5g(优选为3.5g)、维生素718~850mg(优选827mg)、无机盐2.00~4.00(优选为2.05g)、调味剂2.2~5.0g(优选为2.6g)和特异性营养补充剂0.1g~0.3g(优选0.2mg)。
6.如权利要求4所述的全营养配方粉,其中所述的组分优选为大豆蛋白13~22g(优选为22.0g)、乳清蛋白1~5g(优选为4.8g)、菜籽油粉1.0g~12.0g(优选为10.0g)、葵花籽油粉2.1g~12.6g(优选为9.6g)、中链甘油三酸酯0.5~1.5g(优选为0.7g)、鱼油粉0.1g~2.5g(优选为0.6g)、亚麻仁油粉1.0g~8.0g(优选为2.1g)、麦芽糊精30g~50g(优选为30g)、赤藻糖醇10g~20g(优选为11g)、抗性糊精0.68~2.04g(优选为1.5g)、菊粉0.68~2.04g(优选为1.5g)和低聚果糖0.64~1.92g(优选为0.5g)。
7.如权利要求4所述的全营养配方粉,其中所述的组分优选为重酒石酸胆碱100~200mg(优选为183mg)、维生素C(L-抗坏血酸)42.5~182.5mg(优选为154.3mg)、维生素E(dl-α-醋酸生育酚)3~23mgα-TE(优选为17.1mgα-TE)、维生素A(醋酸维生素A)0.1~1mgRE(优选为0.732mgRE)、烟酸3~13mg(优选为9mg)、D-泛酸钙2~6mg(优选为4mg)、维生素B12(氰钴胺)1~2μg(优选为1.9μg)、维生素B6(盐酸吡哆醇)0.5~1.5mg(优选为1.21mg)、维生素B2(核黄素)0.5~1.5mg(优选为1.04mg)、维生素B1(盐酸硫胺素)0.5~1.5mg(优选为0.89mg)、维生素D3(胆钙化醇)1~10μg(优选为6.1μg)、维生素K(植物甲萘醌)28~48μg(优选为36μg)、叶酸100~150μg(优选为140μg)、生物素8~28μg(优选为18.6μg)、肌醇200~550mg(优选为455mg)、氯化钾0.5~1.5g、磷酸氢二钾、柠檬酸钾0.1~0.4g(含钾量优选为0.714mg)、氯化钠0.01~0.1g、柠檬酸钠0.2~1.2g(含钠量优选为0.464g)、碳酸钙0.5~1.5g、磷酸三钙磷酸钙0.1~0.5g(含钙量优选为528mg)、氯化镁、氧化镁0.1~0.2g(含镁量优选为150mg)、焦磷酸铁0.01~0.02g(含铁量优选为6.1mg)、硫酸锌0.01~0.02g(含锌量优选为8.92mg)、硫酸锰0.01~0.03g(含锰量优选为1.57mg)、硫酸铜0.5~1.5mg(含铜量优选为0.82mg)、三氯化铬0.05~0.15mg(含铬量优选为35.7μg)、钼酸钠0.05~0.15mg(含钼量优选为0.05mg)、碘化钾0.05~0.15mg(含碘量优选为0.057mg)、硒酸钠20~100μg(含硒量优选为29μg)、食用香料1~5g(优选为1g)和三氯蔗糖1~5g(优选为1.6g)。
8.如权利要求1-4任一项所述的适用于肿瘤患者的全营养配方粉的制备方法,其包括下述步骤:
(1)称量:将所有原料辅料进行称量;
(2)预混:先将各维生素、各矿物质进行预混,预混约15~40min,直至均匀;
(3)过筛:将蛋白质、脂肪、碳水化合物、膳食纤维、调味剂和特异性营养补充剂和上述步骤(2)中得到的预混料各自过10目筛,过筛的条件为温度不大于30℃且湿度不大于50%;
(4)总混:将步骤(2)中过筛得到的组分混合15~45min,直至均匀,混合的条件为不大于30℃且湿度不大于50%;
(5)填充、包装:将得到的总混合粉以需要的规格进行填充罐装。
9.如权利要求7所述的全营养配方粉的制备方法,步骤(2)中预混时间为25min。
10.如权利要求7所述的全营养配方粉的制备方法,步骤(4)中预混时间为30min。
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