CN106053379A - 一种IgA肾病(IgAN)治疗方案综合评估装置 - Google Patents
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Abstract
本发明涉及医疗器械技术领域,具体涉及一种IgA肾病(IgAN)治疗方案综合评估装置,它包括机体、显示屏、菜单键、调节键、收集标本控制键、收集凹槽、收集吸管、电源接头、检测仪器、软件操作管理系统;机体正面设有显示屏;显示屏下方设有菜单键;调节键以菜单键中心部分为圆心呈圆形阵列分布;菜单键右侧设有收集标本控制键;机体背面设有收集凹槽;收集凹槽中心设有收集吸管;电源接头位于机体底部;本发明为一种IgA肾病(IgAN)治疗方案综合评估装置,它是以无创、实时、便捷测定IgAN患者临床指标(蛋白尿和肾功能)及病理评分积分为切入点,在综合考虑临床类型和病理表现,以及既往循证医学证据的基础上发明的,对IgAN患者无创、快捷、实时的临床治疗方案的综合评估装置,为广大医生和IgAN患者提供科学合理的综合治疗评估。
Description
技术领域
本发明涉及医疗器械技术领域,具体涉及一种IgA肾病(IgAN)治疗方案综合评估装置。
背景技术
IgAN是指肾小球系膜区以IgA或IgA沉积为主等原发性肾小球疾病,是肾小球源性血尿最常见的病因。为目前世界范围内最常见的原发性肾小球疾病,约占全部肾活检病例的10%~40%,占原发性肾小球疾病的20%~50%。亚洲地区最高,占肾活检病例的30%~40%,也是我国最常见的肾小球疾病,患病人群数量大、分布广、异质性强,已成为终末期肾病的主要原因之一。
IgAN常见于青壮年,临床表现轻重不一,治疗方案与预后也各不相同。大量的临床及实验研究证明,IgAN各种临床症候群之间有着很大的差别。IgAN治疗方案的选择主要根据其临床类型的不同,有针对性地采取措施分型治疗。IgAN临床表现多种多样,从孤立性血尿到快速进展的肾小球肾炎;其进展至肾衰竭的速率也各不相同。因此,确定规范、全面的治疗方案十分重要。遗憾的是,迄今为止还没有一套针对IgAN综合治疗统一、规范的评估装置。
IgAN的临床症状与病理表现存在紧密的联系。对IgAN病理分级,目前已从单一分级发展到半定量评分,病理分类的多样性包括最初的WHO分级、Lee氏分级到后来的Haas氏分级,主要根据肾小球病变及小管间质病变的严重程度分级,但如用其指导临床治疗仍存在诸多局限性。2009年发表的牛津IgAN分型,重点关注系膜细胞增殖(M)、毛细血管内细胞增生(E)、节段性肾小球硬化(S)、小管萎缩/间质纤维化(T)的程度,虽然给出了IgAN的病理定量评分方法,但没有考虑到肾小管间质炎症、水肿,以及快速进展型肾病病理表现(如新月体),因而并不能完全指导临床。
虽然IgAN临床症状和病理表现之间存在广泛联系,但常常出现临床症状与病理表现不一致的情况。比如,大量蛋白尿(24小时尿蛋白定量大于3.0g)的患者可能只是病理表现为轻微病变(微小病变型)。因此,若制定统一、规范的治疗方案不应该只考虑患者的临床症状(蛋白尿的多少)或病理表现(如病理类型与评分积分),而是将它们结合起来考虑。本发明专利创造性地将临床症状(蛋白尿的具体定量)与病理表现(病理评分积分)结合起来,用于指导IgAN患者的临床治疗方案。
目前国内外对IgAN的治疗比较混乱,特别是是否使用糖皮质激素以及具体使用的剂量。一方面由于现有的激素治疗方案都源于碎片化的循证医学证据,很多临床类型的患者还缺乏大样本、多中心的循证医学结论;另一方面具体激素使用的剂量也没有充分考虑IgAN患者的临床类型和病理评分积分。虽然2012年改善全球肾脏疾病预后组织(KDIGO)提出激素使用的推荐,但仍存在很大问题,只适用部分人群,覆盖面窄。这就造成了目前虽有指南,但临床治疗仍很混乱的局面。因此迫切需要建立一套具有广泛代表性和可操作性的具体激素用量的评价体系。
目前医院对IgAN患者蛋白尿的测定都在检验科或实验室完成,数据传送到临床医师手上需要一定的时间,并不能做到实时、快速和便捷。
发明内容
本发明的目的在于针对现有技术的缺陷和不足,提供一种结构简单,设计合理、使用方便的一种IgA肾病(IgAN)治疗方案综合评估装置,它包括机体、显示屏、菜单键、调节键、收集标本控制键、收集凹槽、收集吸管、电源接头、检测仪器、软件操作管理系统;机体正面设有显示屏;显示屏下方设有菜单键;调节键以菜单键中心部分为圆心呈圆形阵列分布;菜单键右侧设有收集标本控制键;机体背面设有收集凹槽;收集凹槽中心设有收集吸管;电源接头位于机体底部;检测仪器和软件操作管理系统均位于机体内部。
采用上述结构后,本发明有益效果为:本发明所述的一种IgA肾病(IgAN)治疗方案综合评估装置,它是以无创、实时、便捷测定IgAN患者临床指标(蛋白尿和肾功能)及病理评分积分为切入点,在综合考虑临床类型和病理表现,以及既往循证医学证据的基础上发明的,对IgAN患者无创、快捷、实时的临床治疗方案的综合评估装置,为广大医生和IgAN患者提供科学合理的综合治疗评估。
附图说明
此处所说明的附图是用来提供对本发明的进一步理解,构成本申请的一部分,但并不构成对本发明的不当限定,在附图中:
图1是本发明结构示意图;
图2是图1背部示意图;
图3是具体实施方式中软件运行流程图;
附图标记说明:
1-机体、2-显示屏、3-菜单键、4-调节键、5-收集标本控制键、6-收集凹槽、7-收集吸管、8-电源接头、9-检测仪器、10-软件操作管理系统。
具体实施方式
下面将结合附图以及具体实施例来详细说明本发明,其中的示意性实施例以及说明仅用来解释本发明,但并不作为对本发明的限定。
如图1和图2所示,本具体实施方式所述的一种IgA肾病(IgAN)治疗方案综合评估装置,它包括机体1、显示屏2、菜单键3、调节键4、收集标本控制键5、收集凹槽6、收集吸管7、电源接头8、检测仪器9、软件操作管理系统10;机体1正面设有显示屏2;显示屏2下方设有菜单键3;调节键4以菜单键3中心部分为圆心呈圆形阵列分布;菜单键3右侧设有收集标本控制键5;机体1背面设收集凹槽6;收集凹槽6中心设有收集吸管7;电源接头8位于机体1底部;检测仪器9和软件操作管理系统10均位于机体1内部。
本发明所述的一种IgA肾病(IgAN)治疗方案综合评估装置,它采用如下技术方案:它包含尿蛋白定量、肾小球滤过率(GFR)的检测仪器9和软件操作管理系统10。检测仪器9包含唾液和尿液标本的收集、检测分析,系统自动计算出GFR和24小时尿蛋白定量的结果,并输入IgAN的病理评分积分,通过预先设计的软件程序,得出综合的最终治疗方案。
本发明的基本思路是:采用近红外光谱测定法实时、便捷检测IgAN患者尿蛋白定量,无创测定其唾液中胱抑素C得到GFR数值,将IgAN患者的临床类型与病理表现评分积分结合起来,结合现有的循证医学治疗证据,编制一个科学、完整的软件系统,并通过软件系统,根据IgAN患者尿蛋白定量结果、GFR数值及病理类型评分积分,最终得出完整、科学的治疗方案。
本发明首次创造性提出了将早期的Lee氏分级和最新的牛津分型两种病理评分系统结合起来,充分吸收两种评分系统的优点,最大限度地全面评估IgAN各种病理类型,并将它充分量化,以利于开发本专利的治疗方案,特别是对使用糖皮质激素剂量的计算。
本发明采用的计算公式为:
公式1:24小时尿蛋白定量(g/d)= 24小时尿量(ml/d)× 尿蛋白浓度(g/ml)
公式2:估计GFR的公式
性别 | 血清胱抑素C (mg/L) | GFR公式(≥18y) |
男或女 | ≤0.8 | GFR=133×(SCysC/0.8)-0.499×0.996Age[×0.932 if female] |
男或女 | >0.8 | GFR=133×(SCysC/0.8)-1.328×0.996Age[×0.932 if female] |
公式3:24小时尿蛋白定量位于1~3g/d且GFR>30ml/(min·1.73m2)的初始激素用量。初始激素用量(mg/kg·d) = 0.4 + 0.1×尿蛋白定量数值(g/d) + 0.1×肾脏病理MET评分积分。
本发明软件运行流程图为图3。
本发明所述的一种IgA肾病(IgAN)治疗方案综合评估装置,它是以无创、实时、便捷测定IgAN患者临床指标(蛋白尿和肾功能)及病理评分积分为切入点,在综合考虑临床类型和病理表现,以及既往循证医学证据的基础上发明的,对IgAN患者无创、快捷、实时的临床治疗方案的综合评估装置,为广大医生和IgAN患者提供科学合理的综合治疗评估。
以上所述仅是本发明的较佳实施方式,故凡依本发明专利申请范围所述的构造、特征及原理所做的等效变化或修饰,均包括于本发明专利申请范围内。
Claims (1)
1.一种IgA肾病(IgAN)治疗方案综合评估装置,其特征在于:它包括机体(1)、显示屏(2)、菜单键(3)、调节键(4)、收集标本控制键(5)、收集凹槽(6)、收集吸管(7)、电源接头(8)、检测仪器(9)、软件操作管理系统(10);机体(1)正面设有显示屏(2);显示屏(2)下方设有菜单键(3);调节键(4)以菜单键(3)中心部分为圆心呈圆形阵列分布;菜单键(3)右侧设有收集标本控制键(5);机体(1)背面设收集凹槽(6);收集凹槽(6)中心设有收集吸管(7);电源接头(8)位于机体(1)底部;检测仪器(9)和软件操作管理系统(10)均位于机体(1)内部。
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