CN114028424A - 一种低出生体重新生儿标准化静脉营养液配方及配置装置 - Google Patents
一种低出生体重新生儿标准化静脉营养液配方及配置装置 Download PDFInfo
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Abstract
本发明涉及一种低出生体重新生儿标准化静脉营养液配方及配置装置,所述营养液包括如下组分:维生素、电解质、甘油磷酸钠、脂肪乳剂、氨基酸、葡萄糖、复合微量元素、钙盐、左卡尼汀;所述维生素包括水溶性维生素和脂溶性维生素,所述电解质为氯化钠、氯化钾、硫酸镁中的任意一种或几种,所述复合微量元素包括锌、铜、锰、硒以及碘。本发明营养液为低出生体重新生儿提供个体代谢和生长发育所需的液体、热卡、矿物质和维生素,促进其体质量增长,减少电解质、血糖、血脂、血清白蛋白异常情况,减少胆汁淤滞、支气管肺发育不良、颅内出血、早产儿视网膜病等异常情况,且见效快、无毒副作用;所述配置装置易于操作,配制简单快速、可实现无菌操作。
Description
技术领域
本发明属于静脉营养液技术领域,具体涉及一种低出生体重新生儿标准化静脉营养液配方及配置装置。
背景技术
静脉营养也叫肠外营养,是对于长时间不能经口喂养的新生儿提供营养的重要方法,当新生儿患有严重的先天性胃肠道畸形时应用静脉营养,其死亡率可由最高80%降至10%以下;对低出生体重的早产儿经口喂养同时应用静脉营养可以较快恢复初生体重,而且体重增长曲线与宫内生长曲线(Fenton曲线)接近。
在长期的临床实践中,目前国内尚无早产儿及低出生体重儿标准化静脉营养配方制剂,临床更多依赖病患一天一个处方的模式进行。由于组方复杂,不同的医师意见也不一致,每天每个处方需要单独计算,配制流程也要求较高,存在计算和配制时间长,容易发生污染引起新生儿病房感染等问题,配方质量也难以控制,这些情况步骤导致了一定的出错概率,并导致大量的人力资源和药品的浪费。研制早产儿及低出生体重儿标准化静脉营养配方并优化配置流程势在必行。
发明内容
本发明的目的在于提供一种低出生体重新生儿标准化静脉营养液及配制装置,经过大量的临床验证,已经证实安全有效,具有配制简便,操作流程省时、减少污染的特点,避免了儿科医生在繁重的工作中还要进行反复计算,减轻了儿科医护人员的工作强度。
为实现本发明的上述目的,本发明采用以下技术方案:
本发明提供一种低出生体重新生儿标准化静脉营养液,包括如下组分:维生素、电解质、甘油磷酸钠、脂肪乳剂、氨基酸、葡萄糖、复合微量元素、钙盐、左卡尼汀;所述维生素包括水溶性维生素和脂溶性维生素,所述电解质为氯化钠、氯化钾、硫酸镁中的任意一种或几种,所述复合微量元素包括锌、铜、锰、硒以及碘。
优选的,所述水溶性维生素为水乐维他,所述脂溶性维生素为维他利匹特;所述电解质为10%氯化钠、15%氯化钾、25%硫酸镁中的任意一种或几种,所述甘油磷酸钠为格利福斯,所述脂肪乳剂为20%脂肪乳剂,所述氨基酸为6%小儿复方氨基酸注射液19AA,所述葡萄糖为10%葡萄糖和/或50%葡萄糖,所述复合微量元素为多种微量元素注射液I,所述钙盐为10%葡萄糖酸钙注射液。
优选的,以200mL计,其组分组成如下:水乐维他0.15-0.3支、10%氯化钠2-3mL、15%氯化钾1.5-3mL、格利福斯2-5mL、20%脂肪乳剂20-30mL、6%小儿复方氨基酸注射液19AA 75-130mL、50%葡萄糖10-60mL、维他利匹特 1.5-2.5mL、多种微量元素注射液I1.5-2.5mL、10%葡萄糖酸钙注射液5-15mL、左卡尼汀1-2mL。进一步优选的,以200mL计,其组分组成如下:水乐维他0.2 支、10%氯化钠2.5mL、15%氯化钾2mL、格利福斯2.5mL、20%脂肪乳剂26mL、 6%小儿复方氨基酸注射液19AA 100mL、50%葡萄糖51.5mL、维他利匹特2mL、多种微量元素注射液I 2mL、10%葡萄糖酸钙注射液10mL、左卡尼汀1.5mL。从热量和营养角度看,优选配方营养密度为91.1Kcal/dL,渗透压1150msol/L,液体速度(3-4.5ml/Kg/h,标准4.2ml/Kg/h),糖浓度12.88%,氨基酸3%,脂肪乳2.6%,糖速5.4-11.6mmol/Kg/min,标准糖速9.0mmol/Kg/h。
水乐维他为复方制剂,主要成份是维生素C和多种B族水溶性维生素,其组份为(每瓶):硝酸硫胺(维生素B1)3.1mg,核黄素磷酸钠(维生素B2)4.9 mg,烟酰胺(俗名维生素B3)40mg,泛酸钠(维生素B5)16.5mg,盐酸吡多辛(维生素B6)4.9mg,维生素C钠113mg,生物素(俗名维生素B7或者H) 60μg,叶酸(俗名维生素B9或者M)0.4mg,维生素B12 5.0μg,辅料为:甘氨酸,乙二胺四乙酸二钠。水乐维他可用以满足成人和儿童每日对水溶性维生素的生理需要。本配方按照0.1支/dL浓度配制,渗透压和钠离子浓度极低,可以忽略不计。
10%氯化钠和15%氯化钾溶液能迅速提高细胞外液的渗透压,从而使细胞内液的水分移向细胞外。在增加细胞外液容量的同时,可提高细胞内液的渗透压。本配方经过大量临床实验,采用200mL营养液加入2.5mL的10%氯化钠和2mL 的15%氯化钾,钠离子浓度为2.13mmol/dL,钾离子浓度为2.02mmol/dL,氯离子浓度为4.15mmol/dL,这样的浓度和相关液体速度,可以长期保持患儿的血清[Na+][K+][Cl-]的浓度水平,有效防止高氯血症、低氯血症、高钾血症、低钾血症、高钠血症、低钠血症等离子水平的异常,保持生命活动兴奋性的稳定。新生儿生后3天内给液剂量约60-90mL/Kg/d,3天后液体总量逐渐增加至 140-160mL/Kg/d。
格利福斯主要成份为甘油磷酸钠,为α-甘油磷酸钠与β-甘油磷酸钠的混合物,每支(10mL)含无水甘油磷酸钠2.16g(相当于磷10mmol,钠20mmol)。本配方采用200mL营养液加入2.5mL格利福斯,磷浓度为1.25mmol/dL,钠离子浓度为2.5mmol/dL;这样的浓度和相关液体速度,经过大量临床试验,可以有效维持患儿的血清磷水平,防止低磷血症,满足早产儿对磷的生长需要,发育中的早产儿磷需求较多,可达1.6~3.5mmol/Kg/d,可以通过母乳或者药物进一步补充。防止出现患儿出现骨质矿化异常,同时补充营养液总钠离子至4.63mmol/dL。
10%葡萄糖酸钙注射液为钙补充剂,每支10mL制剂含有1g,(其中含有钙 89mg,2.23mmol)葡萄糖酸钙分子量为448.4,辅料为水,氢氧化钙、乳酸、药用炭等;主要用于治疗钙缺乏。本配方采用200mL营养液加入10mL的l0%葡萄糖酸钙注射液,钙浓度为1.11mmol/dL;实际钙磷比例为0.89:1。经过大量临床实验,可以有效维持患儿的血清钙磷水平,防止低钙、低磷血症,防止出现患儿出现低钙血症及骨质矿化异常。满足早产儿生长对钙的生长需要。发育中的早产儿钙需求较多,可以通过母乳或者药物进一步口服补充。
20%脂肪乳剂为白色乳状液体,是能量补充药,是静脉营养的组成部分之一,脂肪乳机体提供能量和必需脂肪酸,用于胃肠外营养补充能量及必需脂肪酸,预防和治疗人体必需脂肪酸缺乏症,也为经口服途径不能维持和恢复正常必需脂肪酸水平的病人提供必需脂肪酸。本配方采用200mL营养液加入26mL的20%脂肪乳剂,脂肪乳剂浓度为2.6g/dL,热卡为26.0Kcal/dL。这样的浓度和相关液体速度,可满足早产儿生长对脂质的需要,也能相对减少胆汁淤积的并发症。
6%小儿复方氨基酸是一种肠外营养氨基酸制剂,适用于小儿因消化系统疾病,不能经胃肠摄取食物者和早产儿、低体重儿的肠外营养。本配方采用200mL 营养液加入100mL的6%小儿复方氨基酸,浓度为3.0g/dL,热卡为12.3Kcal/dL。这样的浓度和相关液体速度,可满足早产儿生长对氨基酸左右的需要。
10%葡萄糖和50%葡萄糖,用于补充能量和体液,全静脉内营养,饥饿性酮症等,是维持和调节腹膜透析液渗透压的主要物质。本优化配方采用200mL营养液加入50%葡萄糖51.5mL,糖浓度为12.88g/dL,24h液体总量 80-120mL/Kg/d,糖速为5.4~11.6mmol/Kg/h,标准液量为100mL/Kg/d,标准糖速为9.0mmol/Kg/h,能够满足超低出生体重早产儿的生长要求。
维他利匹特可用以满足成人每日对脂溶性维生素A、维生素D、维生素E、维生素K1的基础需要。本配方加入的维生素K1能够满足超低出生体重早产儿对以上维生素的生长要求,为了增强效果,还可以另外补充维生素A、D和E 口服制剂。
多种微量元素注射液I,为复方制剂,其组分为:氯化锌(ZnCl2)5.21mg,氯化铜(CuCl2·2H2O)537μg,氯化锰(MnCl2·4H2O)36μg,亚硒酸钠 (Na2SeO3·5H2O)66.6μg,氟化钠(NaF)1.26mg,碘化钾(KI)13.1μg,辅料为注射用水。本配方200mL静脉营养加入2mL,基本能满足超低出生体重早产儿每天对锌、铜、锰、硒以及碘的基本需要,铬不作要求;由于铁制剂需求较多,还缺乏足够证据通过合适静脉制剂补充,尚需要通过口服制剂补充。
左卡尼汀,一般适应症为慢性肾衰,因继发性肉碱缺乏产生的一系列并发症状,临床表现如心肌病、骨骼肌病、心律失常、高脂血症,以及低血压和透析中肌痉挛等。本配方在早产儿实际应用中,发现早产儿及婴幼儿使用28天以上出现直接胆红素及总胆汁酸增高,加入左卡尼汀后直接胆红素及总胆汁酸增高较未加入左卡尼汀组增高幅度明显降低,采用200mL营养液加入 1.5mL(0.3g),符合药理剂量和相关要求,且使用当中未发现毒副作用。
本发明前述低出生体重新生儿标准化静脉营养液,根据需要可以另外考虑加入25%硫酸镁0.2-0.6ml补充镁离子。国内除了25%硫酸镁制剂外,尚无单独的镁制剂,考虑到与钙离子等制剂的药理拮抗,可以考虑单独静脉使用,但是因为剂量较小,输入时间较长,与静脉营养液混合后未发现有微量沉淀,也可以考虑使用25%硫酸镁(每毫升含有1mmol镁离子)加入静脉营养混合液体使用,最优方案为200mL加入25%硫酸镁0.3mL,折合浓度为0.15mmol/dL。按照本发明设计的预充式配制方法,镁离子可先加入氨基酸液体成分稀释,然后与其他溶液混合,远低于钙离子1.11mmol/dL,尚不足引起对钙离子拮抗的生理作用,同时能够满足早产儿生长对镁离子的营养需要。另外,本发明还可以根据调整液体浓度的需要添加80mL以内的10%葡萄糖。
本发明还提供一种用于配制前述低出生体重新生儿标准化静脉营养液的配制装置,包括塑料膜和所述塑料膜内部多个独立的中空储液腔,每一个所述中空储液腔用于填充一种营养液组分;所述中空储液腔均设有由所述中空储液腔延伸至塑料膜边缘,用于向所述中空储液腔填充营养液组分的加液管,所述加液管的入口处设有密封盖;所述中空储液腔之间设有导液管,所述中空储液腔通过一个或多个导液管相连通;所述导液管上均设有控制营养液组分通过所述导液管的通断阀,通过控制所述通断阀的通断完成营养液组分的混合。
优选的,所述塑料膜的中部设有主储液腔,所述主储液腔的左右两侧各设有一个通过导液管与主储液腔相连通的辅储液腔,所述主储液腔的上端和下端各设有两个通过导液管与主储液腔相连通的子储液腔,所述辅储液腔的上端和下端各设有一个通过导液管与辅储液腔相连通的子储液腔;所述主储液腔的加液管设于主储液腔的底部,所述辅储液腔的加液管设于辅储液腔的侧部且远离主储液腔一侧,所述主储液腔、辅储液腔上端的子储液腔的加液管设于所述子储液腔的顶部,所述主储液腔、辅储液腔下端的子储液腔的加液管设于所述子储液腔的底部。
进一步优选的,所述主储液腔用于填充6%小儿复方氨基酸注射液19AA,所述辅储液腔分别用于填充20%脂肪乳剂和50%葡萄糖,所述主储液腔的四个子储液腔分别用于填充10%氯化钠、15%氯化钾、左卡尼汀以及格利福斯,所述填充 20%脂肪乳剂的辅储液腔的两个子储液腔分别用于填充水乐维他和维他利匹特,所述填充50%葡萄糖的辅储液腔的两个子储液腔分别用于填充10%葡萄糖酸钙注射液和多种微量元素注射液I。
根据本发明所述的低出生体重新生儿标准化静脉营养液的配制装置,所述塑料膜为医用塑料膜,所述塑料膜的顶部还设有悬挂扣。
本发明全部营养液组分液体采用上述装置预充式设计,即配即用临时一次性配制,缩短了配制时间,可实现无菌操作。在临床实施中,通过静脉泵24h 匀速输入,调整液速范围2.0-5.5mL/Kg/h,即可达到婴儿每日所需的营养素和生长需要。
本发明的有益效果为:
本发明通过精确构建低出生体重新生儿静脉营养的标准化剂量,并进一步设计化配制装置组合,完成了标准化静脉营养组方和配置流程的一体式优化。一方面,大量临床证实,本发明营养液可以为不能接受经口喂养或部分经口喂养不足的新生儿,尤其是早产儿、低出生体重儿以及部分外科手术的新生儿经静脉途径提供个体代谢和生长发育所需的液体、热卡、矿物质和维生素,促进其体质量增长,减少电解质、血糖、血脂、血清白蛋白异常情况,减少胆汁淤滞、支气管肺发育不良、颅内出血、早产儿视网膜病等异常情况,且见效快、无毒副作用;另一方面,本发明配制装置为预充式设计,全部液体采用即配即用组合配制板装置临时一次性配制,极大地缩短了配制时间,同时可实现无菌操作,流程简洁,易操作。通过以上两个方面,本发明能够实现新生儿静脉营养实施过程中的医疗管理效率和质量的显著提升。
附图说明
图1:本发明营养液配制装置图;
其中:1-主储液腔;2-辅储液腔;3-子储液腔;4-导液管;5-通断阀;6- 加液管;7-密封盖;8-悬挂扣;9-塑料膜。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚,下面将对本发明的技术方案进行详细的描述。显然,所描述的实施例仅仅是本发明的一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动的前提下所得到的所有其它实施方式,都属于本发明所保护的范围。另外,本发明营养液涉及的各组分均为取得药品批准文号的上市药物,上市之前已有充分的动物实验证据,组分剂量均在法规推荐的范围内,组分所涉及的配方的药理毒理参数,在临床上业已使用多年,无需动物实验证明组分和配方的安全性和毒性等试验。
如图1所示,本发明提供一种用于配制以下各实施例低出生体重新生儿标准化静脉营养液的配制装置,包括医用塑料膜9和所述医用塑料膜9内部11 个独立的中空储液腔,每一个所述中空储液腔用于填充一种营养液组分;所述中空储液腔均设有由所述中空储液腔延伸至塑料膜边缘,用于向所述中空储液腔填充营养液组分的加液管6,所述加液管的入口处设有密封盖7;所述中空储液腔之间设有10个导液管,所述中空储液腔通过一个或多个导液管相连通;所述导液管上均设有控制营养液组分通过所述导液管的通断阀5,通过控制所述通断阀的通断完成营养液组分的混合。所述医用塑料膜的顶部还设有悬挂扣8 用于悬挂,方便使用。11个独立的中空储液腔设置如下:所述医用塑料膜的中部设有主储液腔1,所述主储液腔的左右两侧各设有一个通过导液管与主储液腔相连通的辅储液腔2,所述主储液腔1的上端和下端各设有两个通过导液管与主储液腔相连通的子储液腔,所述辅储液腔的上端和下端各设有一个通过导液管与辅储液腔相连通的子储液腔。加液管的设置如下:所述主储液腔的加液管设于主储液腔的底部,所述辅储液腔的加液管设于辅储液腔的侧部且远离主储液腔一侧,所述主储液腔、辅储液腔上端的子储液腔的加液管设于所述子储液腔的顶部,所述主储液腔、辅储液腔下端的子储液腔的加液管设于所述子储液腔的底部。液体填充方式如下:主储液腔1用于填充6%小儿复方氨基酸注射液19AA,辅储液腔2自左向右分别用于填充20%脂肪乳剂、50%葡萄糖,主储液腔1上端自左向右的两个子储液腔3分别用于填充10%氯化钠、15%氯化钾,主储液腔1下端自左向右的两个子储液腔3分别用于填充左卡尼汀、格利福斯,填充20%脂肪乳剂的辅储液腔2的上下两个子储液腔3分别用于填充水乐维他、维他利匹特,填充50%葡萄糖的辅储液腔2的上下两个子储液腔分别用于填充10%葡萄糖酸钙注射液、多种微量元素注射液I,各储液腔中的填充量按照表1 中比例进行。按上述填充方法和填充量标准,通过加液管,分别向各储液腔中预充相应液体,并避光保存于2~8℃。
配制时,按如下步骤操作:
(1)依次打开主储液腔上下端与之连通的4个子储液腔的通断阀,将子储液腔中的液体挤入主储液腔使混合均匀,关闭各通断阀;(当配方中含有硫酸镁时,先将硫酸镁通过主储液腔底部的加液管加入至主储液腔使与主储液腔中的液体混合均匀后,再进行前述操作,另外,10%的葡萄糖是在所有其余组分混合以后,通过主储液腔底部的加液管加入)
(2)依次打开位于主储液腔右侧的辅储液腔与其上下端的2个子储液腔之间的通断阀,将子储液腔中的液体挤入该辅储液腔使混合均匀,关闭各通断阀;
(3)打开主储液腔与其右侧的辅储液腔之间的通断阀,将该辅储液腔中的液体挤入主储液腔使混合均匀,关闭通断阀;
(4)依次打开位于主储液腔左侧的辅储液腔与其上下端的2个子储液腔之间的通断阀,将子储液腔中的液体挤入该辅储液腔使混合均匀,关闭各通断阀;
(5)打开主储液腔与其左侧的辅储液腔之间的通断阀,将该辅储液腔中的液体挤入主储液腔使混合均匀,关闭通断阀,即完成液体配制;
(6)主储液腔底部的加液管入口连接输液管,贴上输液标签(病区、床号、姓名、处方组分)。
实施例1
一种低出生体重新生儿标准化静脉营养液,以200mL计,其组分组成如下:
水乐维他0.15支、10%氯化钠2mL、15%氯化钾1.5mL、格利福斯2mL、20%脂肪乳剂20mL、6%小儿复方氨基酸注射液19AA 75mL、50%葡萄糖10.5mL、10%葡萄糖80mL、维他利匹特1.5mL、多种微量元素注射液I1.5mL、10%葡萄糖酸钙注射液5mL、左卡尼汀1mL。
实施例2
一种低出生体重新生儿标准化静脉营养液,以200mL计,其组分组成如下:
水乐维他0.2支、10%氯化钠3mL、15%氯化钾3mL、格利福斯5mL、20%脂肪乳剂24mL、6%小儿复方氨基酸注射液19AA 90mL、50%葡萄糖30.5mL、10%葡萄糖24mL、维他利匹特2mL、多种微量元素注射液I 2mL、10%葡萄糖酸钙注射液15mL、左卡尼汀1.5mL。
实施例3
一种低出生体重新生儿标准化静脉营养液,以200mL计,其组分组成如下:
水乐维他0.2支、10%氯化钠2.5mL、15%氯化钾2mL、格利福斯2.5mL、 20%脂肪乳剂26mL、6%小儿复方氨基酸注射液19AA 100mL、50%葡萄糖51.5mL、维他利匹特2mL、多种微量元素注射液I 2mL、左卡尼汀1.5mL、10%葡萄糖酸钙注射液10mL。
实施例4
一种低出生体重新生儿标准化静脉营养液,以200mL计,其组分组成如下:
水乐维他0.3支、10%氯化钠2.0mL、15%氯化钾2mL、格利福斯2mL、20%脂肪乳剂25mL、6%小儿复方氨基酸注射液19AA 130mL、50%葡萄糖27mL、维他利匹特2.5mL、多种微量元素注射液I 2.5mL、10%葡萄糖酸钙注射液5mL、左卡尼汀2.0mL。
对比例
一种低出生体重新生儿标准化静脉营养液,以200mL计,其组分组成如下:
水乐维他0.2支、10%氯化钠2.5mL、15%氯化钾2mL、格利福斯2.5mL、 20%脂肪乳剂26mL、6%小儿复方氨基酸注射液19AA 100mL、50%葡萄糖40mL、 10%葡萄糖15mL、维他利匹特2mL、10%葡萄糖酸钙注射液10mL。
本发明临床疗效观察试验
1.资料与方法
1.1一般资料
1.1.1研究人群及分组:研究人群包括筛选期间由于无法维持充分经口/肠内食物摄入营养,预期至少连续5天以上需要肠外营养(PN)的早产儿(出生时妊娠期<37周)。
1.1.2入组标准:1.早产出生(妊娠<37周);2.产后日龄<24小时即开始; 3.新生儿需要PN治疗,预期PN持续时间至少为28天;4.入组时(PN开始) 要求从PN中摄取的能量≥80%;(4)家属签署知情同意。
1.1.3排除标准:将从研究中排除符合以下任一标准的患者:(1)预期寿命 <1周的新生儿,这意味着患有非常严重的危重疾病,可能导致诱发可预见的危及受试者主要结局评估的并发事件;(2)需要或预期接受体外膜氧合(ECMO)治疗的新生儿;(3)先天性代谢紊乱,包括先天性氨基酸代谢异常;(4)已知Na、 K、Mg、Ca和/或P浓度的病理性升高;(5)显示重度高血糖>15mmol/L(270mg/dL); (6)表现出重度高脂血症或重度脂质代谢障碍,特征为高甘油三酯血症>4.5 mmol/L(400mg/dL);(7)重度肝脏疾病;(8)重度凝血功能障碍;(9)新生儿接受头孢曲松钠伴随治疗,即使用单独输注管路也排除。
1.1.4早产儿出院标准:体重2kg以上、不需呼吸机支持、合适口服热卡摄入、体重匀速增长(15-20g/Kg/d);早产儿出院肠内营养目标:口服母乳或者早产儿配方奶目标热卡值≥105-110kal/kg/d;以105kal/kg/d进行计算;早产儿停静脉营养标准:口服热卡≥目标热卡80%,即84kal/kg/d。
1.1.5分层与分组:全部病例来自我院产科,实际入选2015年7月至2020 年3月我院入住的162例早产新生儿参与本研究。其中对照组82例,干预组 80例。按照胎龄分层随机分组,其中极早产儿(28-31+6周)32例,超早产儿 (<28周)6例;小早产儿(32-33+6周)52例;大早产儿(34-36+6周)72 例,患者1:1的比例随机分配,(接受标准化静脉营养配方治疗或者个体化静脉营养配方)。其中包含男性婴儿78例,女性婴儿84例。各组治疗前性别、胎龄、早产发生率、窒息发生率比较明显无统计学差异。
1.2诊断标准
药物成分参照药物说明书,营养成分与功效参照化学工业出版社出版的由马越主编的《食品营养与卫生》;人民卫生出版社出版的倪鑫申昆玲沈颖主编的第八版的《诸福棠实用儿科学》;人民卫生出版社出版的邵肖梅叶鸿瑁丘肖汕主编的第5版《实用新生儿学》。
2.方法
产前通知新生儿儿科医师与家属沟通,分娩前提前至产房及手术室参加复苏,予以气管插管下SIMV辅助通气或者NCPAP辅助通气,复苏后使用转运暖箱转运至新生儿科NICU,转入后立即予以Graff暖箱复温,中性温度保暖,全天候监护生命体征,并予以珂立苏70mg/dl替代治疗;生后72h内完成PICC。予以青霉素及舒普深或特治星抗感染,大扶康预防真菌感染,维生素K1 2mg qw 等处理,针对新生儿呼吸窘迫综合征、支气管肺发育不良、颅内出血、早产儿脑白质软化及早产儿视网膜病等并发症,按照相关指南予以处理。
由于大部分早产儿刚出生糖利用能力不足,为了保持良好的血糖水平,所有早产儿生后第1-2天分别给予较低葡萄糖浓度全静脉营养(配好后葡萄糖浓度5-10%),3天内完成PICC置管后,对照组、治疗组确定无明显消化道出血等不适,即予以开始非营养性喂养(微量母乳喂养)。对照组早产儿生后3天内即予以常规肠外营养配方(对比例)治疗,医师开处并实施。每日一次配制给药,治疗最长可持续28天以上。干预组早产儿生后3天内给予本发明标准化肠外营养配方(实施例3),根据本发明处方及装置每日一次配制给药,治疗最长可持续28天以上。全部随访至出院后至少24月。
全部早产儿每日接受体格检查、体质量称重,按照病情需要接受血气分析、胸片、头颅及胸部CT、头颅MRI、腹部心脏及头颅B超检查,生后7天、14天、 28天、42天、56天及出院前,接受生化全项(包括宏量电解质、肝肾功能、甘油三酯、胆固醇、胆汁酸、总胆红素、直接胆红素、总蛋白及白蛋白等)、血常规、凝血四项等检查。
根据临床指标收集早产及低体重儿相关新生儿临床特征,主要指标包括体质量生长指标、血糖、血清白蛋白水平,[Na+]、[K+]、[Cl-]、[Ca2+]、[P]等水平,骨质矿化程度等指标,次要指标包括支气管肺发育不良、颅内出血、脑白质软化、早产儿视网膜病和胆汁淤积、院内死亡、机械通气持续时间、肠外营养持续时间、抗生素使用持续时间和住院时间等不良事件发生情况。
医生开处方到护理配置药品的流程比较方法:(1)干预组:本标准化处方录入临床路径,在计算总量是考虑到输液器内每日含有25ml左右不能泵入,根据处方药物成分比例,由病房主治医生根据患儿每日需要的静脉营养总量,通过调节液体输入速度,达到患儿每日需要的各种营养素的量,本研究仍然未将镁剂加入静脉营养而采用每周二及周五分2次补足一周镁剂的需要量。(2)对照组:由病房主治医生开出患儿每日的静脉营养处方后由护士确认执行。我院新生儿静脉营养配制,全部在我科治疗室完成。计算开出医嘱的到护理执行的时间,计算每个标准化静脉营养处方及常规静脉营养处方从摆药到配制完成的时间,护士配药过程中出错的概率等。
3.结果
3.1医生开处方到护理配置药品的流程结果。
3.1.1.医生开处方到护士确认医嘱时间的结果比较
表1早产儿生后数日内标准化静脉营养液应用参数
注:患儿接受全肠外营养时,出生后0天(第一天)用药时间预计<16~20h,患儿即开始使用本配方,优选液体速度2.5mL/kg/h左右,液体总量60mL/Kg/左右,以提供≥1.5g/kg/d的氨基酸摄入量和≤55kcal/kg/d的能量摄入;生后 0-3天,本配方建议目标摄入量介于60-90mL/Kg/d之间,以提供≥1.5g/kg/d 的氨基酸摄入量和≤84kcal/kg/d的能量摄入。
表2早产儿生后数日后标准化静脉营养液应用参数
注:出生后3天以上早产儿及低出生体重儿接受全肠外营养时,本配方建议目标摄入量介于90-110mL/Kg/d之间,标准液速度(3.8~4.6mL/kg/h),提供≥84kcal/Kg/d的能量摄入和≤3.5g/Kg/d的氨基酸摄入量。
表3医生开处方到护士确认医嘱时间的结果
3.1.2护士摆药到配制完成时间的结果比较
表4护士摆药到配制完成时间的结果比较
3.2出生后2周、4周、6周患儿体质量增长情况结果比较。
表5出生后2周患儿体质量增长情况结果比较
表6出生后4周患儿体质量增长情况结果比较
表7出生后6周患儿体质量增长情况结果比较
3.3出生后4周患儿电解质异常、血糖异常、血脂异常、血清蛋白异常等情况结果比较
表8出生后4周患儿电解质、血糖、血脂、血清白蛋白异常等情况结果比较
3.4出生后6周患儿直接胆红素、胆汁酸等情况结果比较。
表9出生后6周患儿直接胆红素、胆汁酸等情况结果比较
3.5孕周36周时,患儿存在支气管肺发育不良、颅内出血、早产儿视网膜病发生情况。
表10出生至孕周36周患儿支气管肺发育不良、颅内出血、早产儿视网膜病的发生情况
4.安全性分析
新生儿在试验观察过程中未发现明显毒副作用和不良反应,治疗前后两组患儿均作了血、尿、粪常规和肝、肾功能检查以及心电监护及心脏彩超检查,检查结果均无明显异常,与对照组相比,标准组与对照组均未患儿未出现毒副作用和不良反应表明使用该制剂安全,且无明显毒副作用。
5.统计学处理
本研究所有资料均采用SPSS23.0处理,计数资料采用卡方检验,计量资料采用μ检验。
6.结论
综上,在使用本发明治疗过程中,共治疗标准组新生儿82例,对照组新生儿80例,医生选用本发明标准化静脉营养配方作为干预组开出处方到护士确认所化费的时间优于选用常规静脉营养配方的对照组。护士选用本发明标准化静脉营养配方作为干预组,从摆药到配置完成所化费的时间优于选用常规静脉营养配方的对照组。早产儿生后2周、4周及6周内选用本发明标准化静脉营养配方作为干预组,体质量的增长优于选用常规静脉营养配方的对照组;早产儿生后4周内选用本发明标准化静脉营养配方作为干预组,出现电解质、血糖、血脂、血清白蛋白异常情况明显少于选用常规静脉营养配方的对照组。早产儿生后6周内选用本发明标准化静脉营养配方作为干预组,出现胆汁淤滞的异常情况明显少于选用常规静脉营养配方的对照组。早产儿从出生到生后36周时,选用标准化静脉营养配方作为干预组,出现在支气管肺发育不良、颅内出血、早产儿视网膜病等异常情况明显少于选用常规静脉营养配方的对照组。
两组均符合早产儿Fenton生长曲线,体重、身长、头围达标,在两组治疗过程中,新生儿患者未出现毒副作用和不良反应,表明本发明所涉及的标准化静脉营养配方安全有效。
典型病例
以下均为我院分娩住院治疗的早产儿
病例一:王××,男,孕34周早产,出生时体重为2000g,经肠道喂养困难、腹胀、胃出血;采用本发明静脉营养(实施例3)10天后体重增长了300g, 住院17天出院,且肠道功能有明显改善,查头颅B超、腹部B超正常,心脏彩超提示卵圆孔未闭。门诊回访,目前出生后15个月,矫正胎龄13+月,体重9.5Kg,身高75cm,智能发育可,已能独立行走。
病例二:戚××,女,孕33周早产儿,出生时体重为2400g,经过十天的母乳喂养,体重未有变化,伴有消化不良的症状,收住入院治疗,采用本发明静脉营养(实施例3)1周后,体重增长了300g,且肠道功能有明显改善,改为部分静脉营养,2周体重增长了600g,吃奶好,症状消失出院。门诊回访,目前出生后30个月,矫正胎龄28月,体重15Kg,身高84cm,智能发育可,能独立行走,跑跳攀登无异常。
病例三:严×之男,男,孕29周早产儿,出生时体重为1030g,呼吸机NCPAP 支持6周。采用本发明静脉营养(实施例3)两周后,体重增长400g,静脉营养四周后,体重为1700g,婴儿各项指标正常。7周后体重2100g,查头颅B超、腹部B超正常,心脏彩超提示卵圆孔未闭。头颅MRI提示发育可,吃奶好,大小便正常,无呼吸暂停,予以出院。门诊回访,目前出生后40个月,矫正胎龄 37+月,体重16Kg,身高90cm,智能发育可,上幼儿园小班。
病例四:张×之女,女,孕31周早产,出生时体重为1400g,呼吸机NCPAP 支持3周。采用本发明静脉营养(实施例3)两周后,体重增长了400g,且肠道功能有明显改善,改为部分静脉营养,3周体重增长600g,查头颅B超、腹部 B超正常,心脏彩超提示卵圆孔未闭。住院25天出院。门诊回访,目前出生后 30个月,矫正胎龄28月,体重14Kg,身高85cm。
病例五:宋××之男,孕33周早产,出生时体重为1800g,胃食道返流、反复呕吐,采用本发明静脉营养(实施例3)和治疗两周后,体重增长了500g,查头颅B超、腹部B超正常,心脏彩超提示卵圆孔未闭。予以出院。门诊回访,目前出生后26个月,矫正胎龄24月,体重13Kg,身高82cm。发育良好。
病例六:杨×之男,孕26周早产,出生时体重为800g,呼吸机NCPAP支持12周。出生第2天接受采用本发明全静脉营养(实施例1)两周后,5天开始微量母乳喂养,生后14天恢复到出生体重,肠道功能有明显改善,改为部分静脉营养加上经口营养性母乳喂养,生后3周,体重增长了200g,体重增长尚可,住院一共96天,体重增长至2600g,脱离呼吸机,查肺部CT仍有支气管肺发育不良,查头颅B超、腹部B超正常,心脏彩超提示卵圆孔未闭。头颅MRI 提示发育可,带制氧机吸氧监测经皮测氧饱和度条件下出院。门诊回访,目前出生后18个月,矫正胎龄15月,体重9Kg,身高74cm,智能发育可,已能独立行走。
病例七:靳××之男,孕26周早产,出生时体重为1030g,呼吸机NCPAP 支持15周。采用本发明全静脉营养(实施例2)两周后,体重增长了200g,开始微量母乳喂养,肠道功能有明显改善,改为部分静脉营养,体重增长尚可,住院一共112天,体重增长至2800g,脱离呼吸机,查肺部CT仍提示支气管肺发育不良,查头颅B超、腹部B超正常,心脏彩超提示卵圆孔未闭。头颅MRI 提示发育可,带制氧机吸氧监测经皮测氧饱和度条件下出院。门诊回访,目前出生后16个月,矫正胎龄13月,体重11Kg,身高75cm,智能发育可,已能独立行走。
以上所述,仅为本发明的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,可轻易想到变化或替换,都应涵盖在本发明的保护范围之内。因此,本发明的保护范围应以所述权利要求的保护范围为准。
Claims (10)
1.一种低出生体重新生儿标准化静脉营养液,其特征在于,包括如下组分:
维生素、电解质、甘油磷酸钠、脂肪乳剂、氨基酸、葡萄糖、复合微量元素、钙盐、左卡尼汀;所述维生素包括水溶性维生素和脂溶性维生素,所述电解质为氯化钠、氯化钾、硫酸镁中的任意一种或几种,所述复合微量元素包括锌、铜、锰、硒以及碘。
2.根据权利要求1所述的低出生体重新生儿标准化静脉营养液,其特征在于,所述水溶性维生素为水乐维他,所述脂溶性维生素为维他利匹特;所述电解质为10%氯化钠、15%氯化钾、25%硫酸镁中的任意一种或几种,所述甘油磷酸钠为格利福斯,所述脂肪乳剂为20%脂肪乳剂,所述氨基酸为6%小儿复方氨基酸注射液19AA,所述葡萄糖为10%葡萄糖和/或50%葡萄糖,所述复合微量元素为多种微量元素注射液I,所述钙盐为10%葡萄糖酸钙注射液。
3.根据权利要求2所述的低出生体重新生儿标准化静脉营养液,其特征在于,以200mL计,其组分组成如下:
水乐维他0.15-0.3支、10%氯化钠2-3mL、15%氯化钾1.5-3mL、格利福斯2-5mL、20%脂肪乳剂20-30mL、6%小儿复方氨基酸注射液19AA 75-130mL、50%葡萄糖10-60mL、维他利匹特1.5-2.5mL、多种微量元素注射液I1.5-2.5mL、10%葡萄糖酸钙注射液5-15mL、左卡尼汀1-2mL。
4.根据权利要求3所述的低出生体重新生儿标准化静脉营养液,其特征在于,以200mL计,其组分组成如下:
水乐维他0.2支、10%氯化钠2.5mL、15%氯化钾2mL、格利福斯2.5mL、20%脂肪乳剂26mL、6%小儿复方氨基酸注射液19AA 100mL、50%葡萄糖51.5mL、维他利匹特2mL、多种微量元素注射液I 2mL、10%葡萄糖酸钙注射液10mL、左卡尼汀1.5mL。
5.根据权利要求3所述的低出生体重新生儿标准化静脉营养液,其特征在于,还包括添加量在80mL以内的10%葡萄糖。
6.根据权利要求3所述的低出生体重新生儿标准化静脉营养液,其特征在于,还包括25%硫酸镁0.2-0.6ml。
7.一种用于配制权利要求1-6任一项所述的低出生体重新生儿标准化静脉营养液的配制装置,其特征在于:包括塑料膜和所述塑料膜内部多个独立的中空储液腔,每一个所述中空储液腔用于填充一种营养液组分;所述中空储液腔均设有由所述中空储液腔延伸至塑料膜边缘,用于向所述中空储液腔填充营养液组分的加液管,所述加液管的入口处设有密封盖;所述中空储液腔之间设有导液管,所述中空储液腔通过一个或多个导液管相连通;所述导液管上均设有控制营养液组分通过所述导液管的通断阀,通过控制所述通断阀的通断完成营养液组分的混合。
8.根据权利要求7所述的低出生体重新生儿标准化静脉营养液的配制装置,其特征在于:所述塑料膜的中部设有主储液腔,所述主储液腔的左右两侧各设有一个通过导液管与主储液腔相连通的辅储液腔,所述主储液腔的上端和下端各设有两个通过导液管与主储液腔相连通的子储液腔,所述辅储液腔的上端和下端各设有一个通过导液管与辅储液腔相连通的子储液腔;所述主储液腔的加液管设于主储液腔的底部,所述辅储液腔的加液管设于辅储液腔的侧部且远离主储液腔一侧,所述主储液腔、辅储液腔上端的子储液腔的加液管设于所述子储液腔的顶部,所述主储液腔、辅储液腔下端的子储液腔的加液管设于所述子储液腔的底部。
9.根据权利要求8所述的低出生体重新生儿标准化静脉营养液的配制装置,其特征在于:所述主储液腔用于填充6%小儿复方氨基酸注射液19AA,所述辅储液腔分别用于填充20%脂肪乳剂和50%葡萄糖,所述主储液腔的四个子储液腔分别用于填充10%氯化钠、15%氯化钾、左卡尼汀以及格利福斯,所述填充20%脂肪乳剂的辅储液腔的两个子储液腔分别用于填充水乐维他和维他利匹特,所述填充50%葡萄糖的辅储液腔的两个子储液腔分别用于填充10%葡萄糖酸钙注射液和多种微量元素注射液I。
10.根据权利要求7所述的低出生体重新生儿标准化静脉营养液的配制装置,其特征在于:所述塑料膜为医用塑料膜,所述塑料膜的顶部还设有悬挂扣。
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