CN111588835A - 用于治疗烧伤后创面的混合物 - Google Patents

用于治疗烧伤后创面的混合物 Download PDF

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CN111588835A
CN111588835A CN202010591188.7A CN202010591188A CN111588835A CN 111588835 A CN111588835 A CN 111588835A CN 202010591188 A CN202010591188 A CN 202010591188A CN 111588835 A CN111588835 A CN 111588835A
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mixture
burn wound
group
wound
burn
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谢岩
吴银生
关光玉
陈倩
赵丹
安晶晶
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Priority to CN202010591188.7A priority Critical patent/CN111588835A/zh
Publication of CN111588835A publication Critical patent/CN111588835A/zh
Priority to US17/180,965 priority patent/US11737998B2/en
Priority to AU2021101843A priority patent/AU2021101843A4/en
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Abstract

本发明提出的用于治疗烧伤后创面的混合物，包括脂肪类261mg‑639mg，有机物类3.5‑350mg，糖类0.02‑60mg，维生素类9‑13ug，微量元素3.04mg‑5.5mg，抗生素0.6‑70mg，氨基酸类105mg‑335mg多种成分，治疗效果显著，有效促进烧伤创面修复、抗感染、抑制瘢痕增生、无毒副作用、使用方便、容易吸收，经济实惠等，为患者提供了一种高效、经济、方便实用的烧伤创面疗法，大大减低了患者的负担，有效弥补目前现有烧伤创面疗法中的种种缺陷。

Description

用于治疗烧伤后创面的混合物
技术领域
本发明涉及医药技术领域，尤其涉及一种用于治疗烧伤后创面的混合物。
背景技术
烧伤是一种主要由高温引起，或由辐射、放射、电、摩擦或接触化学品而导致的皮肤或其它组织或器官的损伤。据世界卫生组织的实况报道，烧伤是一项全球性公共卫生问题，据统计，每年全世界约有1000万烧伤病人，导致约26.5万例死亡。其中大部分发生在低收入和中等收入国家。在印度，每年有100多万人遭受中度或严重烧伤。烧伤的后遗症之一瘢痕的发生率是91.4％，仅瘢痕每年所需治疗费用预计至少为40亿美元。烧伤不仅给国家和社会带来巨大的经济负担，非致命烧伤，例如难愈创面等给患者造成巨大的精神创伤、肉体痛苦及沉重的经济负担。
烧伤难愈创面频繁发作、经久不愈、愈后再发可能性大、并且有癌变的风险。烧伤难愈创面的治疗是临床上较棘手的问题，也是烧伤领域的研究重点和难点。本专利致力于有效解决烧伤难愈创面修复问题，发明一种新型经济、高效的加速创面愈合、抗感染及减少瘢痕的理想疗法，以有效解决烧伤难愈创面修复问题。
发明内容
有必要提出一种用于治疗烧伤后创面的混合物。
一种用于治疗烧伤后创面的混合物，包括以下质量含量的成分：脂肪类261mg-639mg，有机物类3.5-350mg，糖类0.02-60mg，维生素类9-13ug，微量元素3.04mg-5.5mg，抗生素0.6-70mg，氨基酸类105mg-335mg。优选的，所述脂肪类的具体成分如下所示：
Figure BDA0002555604330000021
优选的，所述有机物类的具体成分如下所示：
Figure BDA0002555604330000031
Figure BDA0002555604330000041
优选的，所述有糖类的具体成分如下所示：
名称 成分含量(mg/ml)
葡萄糖 0.01-30
果糖 0.01-30
优选的，所述有维生素的具体成分如下所示：
Figure BDA0002555604330000051
优选的，所述有微量元素的具体成分如下所示：
Figure BDA0002555604330000052
优选的，所述有抗生素的具体成分如下所示：
Figure BDA0002555604330000053
在制成所述混合物时，所述混合物中抗生素为莫匹罗星、新霉素、多粘菌素B、庆大霉素、两性霉素B、万古霉素中的一种或几种。
优选的，所述有氨基酸的具体成分如下所示：
Figure BDA0002555604330000054
Figure BDA0002555604330000061
本发明提供的本发明混合物治疗效果显著，有效促进烧伤难愈创面修复、抗感染、抑制瘢痕增生、无毒副作用、使用方便、容易吸收，经济实惠等，为患者提供了一种高效、经济、方便实用的烧伤难愈创面疗法，大大减低了患者的负担，有效弥补目前现有烧伤难愈创面疗法治疗烧伤难愈创面的种种缺陷。
附图说明
图1.猪全层烧伤创面造模。
(a)烧伤装置；(b)烧伤创面；(c)烧伤后24小时的烧伤创面组织形态(X40倍)；(d)此图是图1c中所示区域的高倍放大视图；(e)烧伤后3周形成痂；(f)烧伤后3周清除坏死焦痂形成猪全层烧伤创面；(g)本发明混合物；(h)自制松紧外套覆盖猪烧伤创面。比例尺＝200μm。
图2.创面在本发明混合物、重组人表皮生长因子及生理盐水治疗后第1、2、3、4周修复情况。
图3为不同处理组用药1、2、3、4周量化残余创面面积(注：*表示与生理盐水组相比P<0.05)。
图4为不同处理组用药1、2、3、4周量化创面愈合率(治疗前烧伤创面面积-治疗后烧伤创面面积/治疗前烧伤创面面积×100％)(注：*表示与生理盐水组相比P<0.05)。
图5.不同处理组量化创面愈合时间(注：*表示与生理盐水组相比P<0.05)。
图6.应用本发明混合物、生长因子及生理盐水治疗4周后烧伤创面组织形态和免疫组化染色(P63、CK10、Masson染色)(比例尺＝100μm)。
图7不同处理组用药1、2、3、4周量化表皮厚度(增殖层和分化层，单位：μm)。
图8为P63染色的定量。
图9为CK10染色的定量。
图10本发明混合物对人的难愈烧伤创面的疗效。
(a)超过1个月的儿童背部难愈创面。(a1)涂抹本发明混合物；(a2)治疗后4天。(b)超过1个月的成人肘部难愈创面。(b1)涂抹本发明混合物；(b2)治疗后1周；(b3)治疗后2周。(c)超过1个月的成人背部难愈创面。(c1)涂抹本发明混合物；(c2)治疗后3天；(c3)治疗后7天；(c4)治疗后10天。
具体实施方式
本发明实施例提供了的用于治疗烧伤后创面的混合物，包括以下质量份数的成分：
一种用于治疗烧伤后创面的混合物，包括以下质量含量的成分：脂肪类261mg-639mg，有机物类3.5-350mg，糖类0.02-60mg，维生素类9-13ug，微量元素3.04mg-5.5mg，抗生素0.6-70mg，氨基酸类105mg-335mg。
优选的，所述脂肪类的具体成分如下所示：
Figure BDA0002555604330000081
更为优选的，所述脂肪类的具体成分如下所示：
Figure BDA0002555604330000082
优选的，所述有机物类的具体成分如下所示：
Figure BDA0002555604330000091
Figure BDA0002555604330000101
更为优选的，所述有机物类的具体成分如下所示：
Figure BDA0002555604330000111
Figure BDA0002555604330000121
优选的，所述有糖类的具体成分如下所示：
名称 成分含量(mg/ml)
葡萄糖 0.01-30
果糖 0.01-30
更为优选的，所述有糖类的具体成分如下所示：
名称 成分含量(mg/ml)
葡萄糖 0.5
果糖 0.5
优选的，所述有维生素的具体成分如下所示：
Figure BDA0002555604330000122
更为优选的，所述有维生素的具体成分如下所示：
Figure BDA0002555604330000123
优选的，所述有微量元素的具体成分如下所示：
Figure BDA0002555604330000124
更为优选的，所述有微量元素的具体成分如下所示：
Figure BDA0002555604330000131
优选的，所述有抗生素的具体成分如下所示：
Figure BDA0002555604330000132
在制成所述混合物时，所述混合物中抗生素为莫匹罗星、新霉素、多粘菌素B、庆大霉素、两性霉素B、万古霉素中的一种或几种。
优选的，所述有氨基酸的具体成分如下所示：
Figure BDA0002555604330000133
Figure BDA0002555604330000141
更为优选的，所述有氨基酸的具体成分如下所示：
Figure BDA0002555604330000142
本发明的混合制备方法，可以先将每一类物质分别单独混合，再将混合后的物质二次混合。例如，先将脂肪类的各种物质混合，将有机物类的各种物质混合，将糖类的各种物质混合，将维生素类的各种物质混合，将微量元素的各种物质混合，将抗生素的各种物质混合，将氨基酸类的各种物质混合，然后将这些混合后的物质放入同一容器中二次混合，由于该物质制备后，各物质之间并不发生化学反应，为物理混合，所以制备方法可参见现有技术中的物理混合即可得到。
抗生素混合的方案有多种可选方案，如表1所示。
表1
Figure BDA0002555604330000151
以下通过动物实验和临床试验来验证本发明混合物的有益效果。
一、动物实验
(1)动物伦理：动物实验的伦理已通过。实验所用动物都将予以人道待遇，实验过程将遵守“动物保健和保护法”和“用于科研目的的动物护理和使用实践守则”的相关规定。
(2)实验动物：实验级广西巴马小型猪3只(天津市百农实验动物繁育科技有限公司提供)，体重19-21Kg，雌性。单笼饲养，笼具为钢制笼具，体积为80×100×110cm2。用消毒液及紫外灯对动物饲养室及笼具进行全面彻底的消毒后，动物入住。实验期间非实验人员严禁进入饲养室。动物的喂养饲料为150g/次，一天2次，水足量(用水为自来水的清洁标准)，自然光照射，室温控制在25℃左右。每周定期对饲养室及笼具进行消毒，每次喂料前清洗饲料槽及水槽。(3)猪难愈创面造模(图1)：小型猪常规饲养后，禁食水12小时，一侧卧位，臀部肌肉注射速眠新注射液，待麻醉起效。麻醉起效后，转移至操作台，口内放置通气管。耳背部消毒后留置耳廓静脉留置针，充分镇痛镇静，背部术区备皮，碘伏消毒，铺无菌单，标记预计烫伤的部位。加热铝块模具(铝块模具净重265g，加负重1kg，)至96℃10分钟。将模具与皮肤密切接触，烫伤时间45秒，每只小猪9个创面。3只小型猪背部操作保持一致。术毕，碘伏消毒，应用棉垫敷料及弹力套包扎固定。抗生素静脉注射预防感染，静脉注射促醒剂陆醒宁2ml，后转入笼具中，注意保暖。苏醒后1小时可进食，给予口服补液盐饮水。密切观察活动及体征。烧伤后对创面进行局部清创并进行不同治疗。
(4)本发明混合物促进难愈创面修复疗效评价(图2)
为了验证本发明的效果，设计了三组对照方案，即本发明混合物、重组人表皮生长因子及生理盐水。本发明混合物所采用的成分配方为更为优选的方案中的成分。抗生素选择的表1中的序号1的成分。
4、1创面愈合情况
创面在不同治疗方法后随时间变化后的创面愈合情况(图2)，由图可见创面新生肉芽组织新鲜红润、无渗液；创面愈合部分的皮肤形成瘢痕，颜色较深、质地较正常皮肤稍硬，略高出周围正常皮肤，创面愈合部分无毛发生长；创面周围局部皮肤无发红、水泡、破溃等反应，无进一步扩大、坏死等恶化情况。从第四周创面局部情况可见，本发明混合物组创面瘢痕形成面积较生长因子小，瘢痕颜色较浅，本发明混合物组和生长因子两组创面均较生理盐水组愈合早。
4.2残余创面、创面愈合率及创面愈合时间
在用药1周、2周、3周、4周后对创面进行摄片并测量。图3和图4显示，与生理盐水组相比，混合物在治疗后后第7、14、21、28天明显减少了伤口面积并提高了伤口愈合率(p<0.05)。混合物和阳性对照生长因子之间无显着差异(p＝0.946)(图3b，3c)。这些数据表明核桃软膏具有改善烧伤伤口的愈合率。
图5显示在混合物组中，完成伤口完全闭合所需的时间为18.44±3.09天，在生长因子组中为23.56±4.85天，在生理盐水组中为32.56±5.36天。见表2，这些数据表明，与用盐水处理的伤口相比，混合物明显缩短了伤口的愈合时间。有趣的是，我们观察到用核桃软膏治疗的伤口与用阳性对照组生长因子治疗的伤口没有差异(p＝0.063)。
表2.创面愈合时间比较
Figure BDA0002555604330000171
1P<0.05与生理盐水组相比；2P<0.05与生理盐水组相比；3P>0.05本发明混合物组与生长因子组相比。
4.3创面用药4周后免疫组化及Masson染色(图6)
通过免疫组织化学技术对创面修复后表皮增殖与分化表达蛋白进行定位并分析，其中P63主要在基底上层增殖的角质细胞中表达，角蛋白10(CK10)主要在分化的角质细胞中表达，P63及CK10蛋白表达的强弱能够显示创面在上皮化修复过程中角质细胞增殖与分化情况；创面修复后期因成纤维细胞分泌胶原纤维增多，大量胶原纤维增生明显，排列密集，应用Masson染色使皮下胶原纤维呈绿色。本发明混合物组表皮各层结构清晰，通过免疫组化染色可以看出增殖层与分化层明显，通过Image-Pro Plus 6.0进行阳性蛋白P63与CK10积分光密度的统计(表3)，可以看出P63蛋白表达弱于生长因子组但较生理盐水组强，差异有统计学意义，而与CK10蛋白表达亦较生长因子组弱；同时本发明混合物组表皮厚度及增殖层与分化层均明显薄于生长因子组，差异有统计学意义，如表4和图7、8、9所示。
表3.免疫组化积分光密度(IOD)
Figure BDA0002555604330000181
1P<0.05与生理盐水组相比；2P<0.05与生理盐水组相比；3P<0.05本发明混合物组与生长因子组相比。
表4.增殖层与分化层厚度比较
Figure BDA0002555604330000182
1P<0.05与生理盐水组相比；2P<0.05与生理盐水组相比；3P<0.05本发明混合物组与生长因子组相比。
二、临床研究
(1)一般资料
共收集患者430例，男368例，女62例，年龄1-70岁。致伤因素：热液烧伤150例，火焰烧伤167例，电弧烧伤84例，化学烧伤29例。430例患者中，Ⅲ度烧伤面积为0.2％-53.5％TBSA，随后形成的烧伤难愈创面面积为0.1％-7％TBSA。其中本发明混合物组患者为49例，手术组患者为197例，常规换药组患者为184例。三组患者的性别、年龄及烧伤难愈创面面积等方面基本相似，差异无统计学意义(P>0.05)，具有可比性(表5、6、7)。
表5.不同处理组性别情况比较
Figure BDA0002555604330000191
表6.不同处理组年龄情况比较
Figure BDA0002555604330000192
表7.不同处理组烧伤难愈创面面积比较
Figure BDA0002555604330000193
(2)创面愈合总有效率比较(表8)。本发明混合物组49例患者中，创面完全愈合有31例(占63.27％)，显效15例(占30.61％)，好转2例(4.08％)，无效1例(占2.04％)；手术组197例患者中，创面完全愈合有152例(占77.15％)，显效39例(占19.80％)，好转6例(占3.05％)，无效0例(占0％)；常规换药组184例患者中，创面完全愈合有96例(占52.17％)，显效56例(占30.43％)，好转24例(13.05％)，无效8例(占4.35％)。从以上数据可以得出，本发明混合物组创面痊愈例数百分比高于常规换药组而低于手术组，本发明混合物组创面显效例数百分比与常规换药组无明显差别但高于手术组，本发明混合物组创面好转例数百分比稍高于手术组并显著低于常规换药组，本发明混合物组无效例数百分比高于手术组而低于常规换药组。通过对不同处理组治疗后总有效率来分析本发明混合物组对创面愈合的作用，总有效率＝(痊愈例数+显效例数)/总例数。本发明混合物组与手术组治疗烧伤难愈创面的总有效率明显高于常规换药组，差异有统计学意义(P<0.05)，而本发明混合物组与手术组对于烧伤难愈创面的总有效率无明显差异(P>0.05)。
表8创面愈合情况(例数/百分比)
Figure BDA0002555604330000201
1P<0.05与常规换药组相比；2P<0.05与常规换药组相比；3P>0.05本发明混合物组与手术组相比。
(3)创面愈合时间比较(表9)：通过对不同处理组创面愈合时间的统计发现，本发明混合物组的创面愈合时间为19.87±9.10天，手术组的创面愈合时间为22.71±11.77天，常规换药组的创面愈合时间为36.71±10.60天。本发明混合物组及手术组与常规换药组相比均有统计学意义(P<0.05)，本发明混合物组与手术组对烧伤难愈创面的创面愈合时间尚无明显差异(P>0.05)。
表9创面愈合时间(天)
Figure BDA0002555604330000202
Figure BDA0002555604330000211
1P<0.05与常规换药组相比；2P<0.05与常规换药组相比；3P>0.05本发明混合物组与手术组相比。
(4)本发明混合物对人难愈烧伤创面的疗效(三例代表患者)(图10)。
超过1个月的儿童背部难愈创面，涂抹本发明混合物，治疗后4天，创面愈合(图10a)。超过1个月的成人肘部难愈创面，涂抹本发明混合物，治疗后2周后，创面愈合(图10b)。超过1个月的成人背部难愈创面,涂抹本发明混合物,治疗后10天,创面愈合(图10c)。
以下表10为本发明使用的各物质的来源厂家。
表10
Figure BDA0002555604330000212
Figure BDA0002555604330000221
Figure BDA0002555604330000231
以上所揭露的仅为本专利文件较佳实施例而已，当然不能以此来限定本发明之权利范围，而且在不背离本发明的精神或基本特征的情况下，能够以其他的具体形式实现本发明。本领域普通技术人员可以理解实现上述实施例的全部或部分流程，并依本发明权利要求所作的等同变化，仍属于发明所涵盖的范围。因此，无论从哪一点来看，均应将实施例看作是示范性的，而且是非限制性的，本发明的范围由所附权利要求而不是上述说明限定，因此旨在将落在权利要求的等同要件的含义和范围内的所有变化囊括在本发明内。不应将权利要求中的任何标记视为限制所涉及的权利要求。
此外，应当理解，虽然本说明书按照实施方式加以描述，但并非每个实施方式仅包含一个独立的技术方案，说明书的这种叙述方式仅仅是为清楚起见，本领域技术人员应当将说明书作为一个整体，各实施例中的技术方案也可以经适当组合，形成本领域技术人员可以理解的其他实施方式。

Claims (8)

1.一种用于治疗烧伤后创面的混合物，其特征在于包括以下质量含量的成分：脂肪类261mg-639mg，有机物类3.5-350mg，糖类0.02-60mg，维生素类9-13ug，微量元素3.04mg-5.5mg，抗生素0.6-70mg，氨基酸类105mg-335mg。
2.如权利要求1所述的用于治疗烧伤后创面的混合物，其特征在于所述脂肪类的具体成分如下所示：
Figure FDA0002555604320000011
3.如权利要求1所述的用于治疗烧伤后创面的混合物，其特征在于所述有机物类的具体成分如下所示：
Figure FDA0002555604320000021
Figure FDA0002555604320000031
4.如权利要求1所述的用于治疗烧伤后创面的混合物，其特征在于所述有糖类的具体成分如下所示：
名称 成分含量(mg/ml)
葡萄糖 0.01-30
果糖 0.01-30 。
5.如权利要求1所述的用于治疗烧伤后创面的混合物，其特征在于所述有维生素的具体成分如下所示：
Figure FDA0002555604320000032
6.如权利要求1所述的用于治疗烧伤后创面的混合物，其特征在于所述有微量元素的具体成分如下所示：
Figure FDA0002555604320000033
7.如权利要求1所述的用于治疗烧伤后创面的混合物，其特征在于所述有抗生素的具体成分如下所示：
Figure FDA0002555604320000034
Figure FDA0002555604320000041
在制成所述混合物时，所述混合物中抗生素为莫匹罗星、新霉素、多粘菌素B、庆大霉素、两性霉素B、万古霉素中的一种或几种。
8.如权利要求1所述的用于治疗烧伤后创面的混合物，其特征在于所述有氨基酸的具体成分如下所示：
Figure FDA0002555604320000042
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