CN110383388B - 药物监测工具 - Google Patents
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Abstract
本发明的实施例涉及一种药物监测工具。所述药物监测工具包括数据接收器及交互式用户接口。所述数据接收器经配置以接收患者的药代动力学PK概况。所述交互式用户接口经配置以向所述患者显示所述患者的时变治疗性血浆蛋白水平。所述时变治疗性血浆蛋白水平基于凝血因子VIII的施用剂量及所述患者的所述PK概况。
Description
相关申请案
本申请案主张2017年1月27日申请的第62/451,391号美国临时申请的权益。上述申请案的全部教示通过引用的方式并入本文中。
背景技术
凝血因子VIII是一种血液凝固蛋白,其响应于受伤或出血而被激活。凝血因子VIII水平相对较低的个体易受内部或外部的长期出血事件的影响,这些事件是由没有原因的损伤及/或自发性出血引起的。虽然皮肤出血不严重,但关节、肌肉及器官的内部出血可能导致永久性损伤、毁容甚至死亡。
具有甲型血友病的患者具有导致凝血因子VIII水平低的遗传缺陷。患者中凝血因子VIII的量表示为相对于正常水平的百分比。凝血因子VIII为5到40%的患者被认为患有轻度甲型血友病,而凝血因子VIII为1到5%的患者被认为患有中度甲型血友病。凝血因子VIII不到1%的患者被认为患有严重甲型血友病。
甲型血友病患者(或以其它方式具有低水平凝血因子VIII的患者)的治疗包含为这些患者提供凝血因子浓缩物(例如,治疗性血浆蛋白)的定期输注。凝血因子浓缩物充当患者天然凝血因子VIII的替代或补充。此治疗性血浆蛋白的一个实例是夏尔(Shire)的ADVATE药物。在一些情况下,患者响应于具有不受控制的内部出血而接受治疗性血浆蛋白。替代地,可给患者开处治疗性血浆蛋白的预防性治疗方案,以减少未来出血的可能性。为避免患者跌入预定阈值以下的任何可能性,许多医疗服务提供者设计需要患者每隔一天、两天、三天或更多天接受治疗性血浆蛋白输注的治疗方案。目前,向患者提供电子日记以记录输注事件。不幸的是,此类日记不提供患者能够用来计划活动水平的可操作数据。举例来说,对于当前系统,如果患者在输注事件之后的任何时间点参与例如踢足球之类的活动,那么患者不能够确定出血风险。特定来说,对于当前的电子日记,患者无法在预防性输注事件之后的任何给定时间点确定其因子水平,这显著限制由此类来源提供的信息的有用性。
发明内容
本发明的实施例提供一种药物监测工具,其使患者能够在预防性输注事件之后查看凝血因子VIII水平的个性化实时指示。有利地,所揭示药物监测工具允许患者显著减少出血事件。举例来说,由药物监测工具提供的凝血因子VIII的实时指示使患者能够在任何给定时间点做出与体育活动的量及/或强度相关的知情决定。在药物监测工具提供低水平凝血因子VIII的指示的实例中,患者可避免参与体力要求严格的活动,例如运动,决定自我施用非预防性剂量的凝血因子VIII以便参与体力要求严格的活动,或选择低出血风险活动(例如,例如阅读书籍的静止活动)直到下一次预防性输注。因此,药物监测工具有利地消除由于缺乏可操作信息而导致的患者出血事件。
在一个实施例中,一种药物监测工具包括数据接收器,其经配置以接收患者的药代动力学(PK)概况。所述工具还包括交互式用户接口,其经配置以向患者呈现所述患者中的时变药物浓度水平。所述时变药物浓度水平基于受试药物的施用剂量及所述患者的所述PK概况。
在另一实施例中,揭示一种药物监测工具。所述工具包括数据接收器,其经配置以接收患者的药代动力学(PK)概况。另外,所述工具包括交互式用户接口,其经配置以向所述患者显示所述患者的时变治疗性血浆蛋白水平。所述时变治疗性血浆蛋白水平基于凝血因子VIII的施用剂量及所述患者的所述PK概况。
在实施例的一个方面,所述患者的所述PK概况可基于采样患者的PK概况的贝叶斯模型并且基于所述患者的体重、冯维勒布兰德因子("vWF")水平及/或年龄中的至少一者。
另一方面,所述数据接收器可为经配置以经配置以扫描存储包含至少PK概况信息的患者信息的快速响应(QR)码的相机。另外,所述药物监测工具可进一步包括QR码处理器,其经配置以提取及处理存储在所述QR码内的所述患者信息。
在一些方面中,所述数据接收器可为经配置以从安全服务器接收所述PK概况的通信接口。在此方面中,所述所接收PK概况可经加密且所述通信接口进一步可经配置以解密所述经加密PK概况。
在其它实例实施例中,所述药物监测工具可进一步包括QR码产生器,其经配置以产生所述QR码,所述QR码具有使用AES-256加密来加密的患者信息,所述AES-256加密采用密码块链接(CBC)及公钥加密标准(PKCS)填充方式。所述QR码产生器可位于远离所述药物监测工具的安全服务器处。
所述QR码可包含以下中的至少一者或任何组合:所述患者的患者识别信息、患者生理数据、患者给药信息及/或PK概况信息。所述患者给药信息可包含针对特定凝血因子VIII药物的预防性给药方案。
另一方面,所述药物监测工具可进一步包括激活工具包,其经配置以至少响应于以下情况而使得能够访问所述药物监测工具的功能性:接收所述患者的所述PK概况及/或接收所述凝血因子VIII的第一预防性输注的日志。
在其它方面,所述交互式用户接口可经配置以在任何给定时间显示所述患者内的时变量的所述治疗性血浆蛋白的图形表示。所述图形表示可勾画与所述时变量的所述治疗性血浆蛋白相关联的区。每一区可与所述患者内的所述时变量的所述治疗性血浆蛋白的特定浓度范围相关联。
所述交互式用户接口还可包含图形控制元件,其经配置以接收患者输入,所述患者输入对应于在特定时间对所述患者内的所述时变量的所述治疗性血浆蛋白的请求。所述交互式用户接口可进一步经配置以在所述特定时间显示所述患者内的所述时变量的所述治疗性血浆蛋白的所述图形表示。
另一实施例包含一种用于由药物监测工具执行的药物监测的方法。所述方法包含接收患者的药代动力学(PK)概况。另外,所述方法包含使交互式用户接口能够向患者显示所述患者的时变治疗性血浆蛋白水平。所述时变治疗性血浆蛋白水平基于凝血因子VIII的施用剂量及所述患者的所述PK概况。
在实施例的一个方面,所述患者的所述PK概况可基于采样患者的PK概况的贝叶斯模型并且基于所述患者的体重、冯维勒布兰德因子("vWF")水平及/或年龄中的至少一者。
在另一方面,所述方法可包含扫描存储包含至少PK概况信息的患者信息的快速响应(QR)码。另外,所述方法可包含提取及处理存储在所述QR码内的所述患者信息。
在其它方面,所述方法可包含从安全服务器接收所述PK概况。所述所接收PK概况可经加密。因此,所述方法还可包含解密所述经加密PK概况。
在额外方面,所述方法可包含产生所述QR码以具有使用AES-256加密来加密的患者信息,所述AES-256加密采用密码块链接(CBC)及公钥加密标准(PKCS)填充方式。
在某些方面,所述QR码包含以下中的至少一者或任何组合:所述患者的患者识别信息、患者生理数据、患者给药信息及/或PK概况信息。所述患者给药信息可包含针对特定凝血因子VIII药物的预防性给药方案。
此外,所述方法可包含至少响应于以下情况而使患者能够访问所述药物监测工具的功能性:接收所述患者的所述PK概况及/或接收第一预防性输注的日志。
在另一方面,所述方法可包含在任何给定时间显示所述患者内的时变量的所述治疗性血浆蛋白的图形表示。所述图形表示勾画与所述时变量的所述治疗性血浆蛋白相关联的区。每一区与所述患者内的所述时变量的所述治疗性血浆蛋白的特定浓度范围相关联。
本发明的另一实施例包含药物监测系统。所述药物监测系统包括治疗性血浆蛋白给药方案设备及药物监测工具。
所述治疗性血浆蛋白给药方案设备包括模型产生器,其经配置以创建采样患者的药代动力学(PK)概况的贝叶斯模型。所述贝叶斯模型包含(i)治疗性血浆蛋白清除率及(ii)基于患者年龄或体重中的至少一者的治疗性血浆蛋白的分布关系的体积。所述治疗性血浆蛋白给药方案设备还包括PK服务器。所述PK服务器经配置以基于所述贝叶斯模型、所述患者内的所述治疗性血浆蛋白的半衰期及所述患者的年龄或所述患者的重量中的至少一者来确定患者的近似PK概况。所述PK服务器还经配置以基于所述患者的所述近似PK概况确定包含剂量及时间周期内的治疗性血浆蛋白水平的所述治疗性血浆蛋白给药方案,响应于接收用于给所述患者施用剂量的给药间隔,修改所述治疗性血浆蛋白给药方案,以及所述经修改治疗性血浆蛋白给药方案传输到客户端装置。
所述药物监测工具包括数据接收器,其经配置以接收患者的所述药代动力学(PK)概况;另外,所述药物监测工具包括交互式用户接口,其经配置以向所述患者显示所述患者的时变治疗性血浆蛋白水平。所述时变治疗性血浆蛋白水平是基于凝血因子VIII的施用剂量及所述患者的所述PK概况。
附图说明
通过以下对本发明的实例实施例的更特定描述,前述内容将是显而易见的,如附图中所说明,其中相似参考字符贯穿不同视图中指代相同部分。图式不一定按比例绘制,而是将重点放在说明本发明的实施例上。
图1说明根据本发明的实例实施方案的药物监测工具在其中操作的实例药代动力学(PK)环境。
图2是根据本发明的实例实施例的用于产生特定患者的PK概况的方法的流程图。
图3是根据本发明的实例实施例的用于将PK概况转换为QR码的方法的流程图。
图4说明根据本发明的实例实施例的药物监测工具的交互式用户接口。
图5是根据本发明的实例实施例的实例远程服务器、药物监测工具及生态系统监测系统的详细框图。
具体实施方式
下文是对本发明的实例实施例的描述。
本发明涉及一种药物监测工具,其使患者能够在预防性输注事件之后查看凝血因子VIII水平的个性化实时指示。举例来说,药物监测工具包含因子计,其使用户能够确定凝血因子VIII的实时水平。有了此类信息,患者可以有更好的装备,例如决定其是否应参与体力要求严格的活动(例如,例如足球的运动)。因此,药物监测工具使患者能够基于其凝血因子VIII水平的准确信息就其活动水平做出知情决定。此外,由药物监测工具提供的因子计使患者能够在预防性输注事件后的任何给定时间确定其系统中的时变量的凝血因子VIII。有利地,患者然后能够基于预测凝血因子VIII水平来计划未来的活动水平。
如本文所用,术语“凝血因子VIII”、“FVIII”或“rAHF”是指任何FVIII分子,其具有至少一部分完整的B结构域,并且表现出与天然FVIII相关联的生物活性。在本发明的一个实施例中,FVIII分子是全长FVIII。FVIII分子是由能够与编码FVIII:C的DNA杂交的DNA序列编码的蛋白。此蛋白可在结构域A1-A2-B-A3-C1-C2之间或之内的各个位点处含有氨基酸缺失。FVIII分子也可为天然凝血因子FVIII的类似物,其中一或多个氨基酸残基已被定点诱变取代。
术语“重组因子VIII”(rFVIII)可包含经由重组DNA技术获得的任何异源或天然存在的rFVIII,或其生物活性衍生物。如本文所使用,“内源性FVIII”包含源自希望接受治疗的哺乳动物的FVIII。术语还包含由转基因或哺乳动物中存在的任何其它外源DNA转录的FVIII。如本文所使用,“外源性FVIII”或治疗性血浆蛋白包含不源自哺乳动物的凝血因子FVIII。
FVIII分子天然存在于治疗制剂中,作为由单一基因产物产生的多肽的异质分布。如本文所使用的术语“凝血因子VIII”是指所有此类多肽,无论是源自血浆还是通过使用重组DNA技术产生,并且包含(但不限于)FVIII模拟物、fc-FVIII缀合物、用水溶性聚合物化学修饰的FVIII,以及FVIII的其它形式或衍生物。含有FVIII的市售治疗制剂的实例包含以商品名ADVATE,HEMOFILM及RECOMBINATE(可从美国班诺克本III的夏尔(Shire,Bannockburn,III.,U.S.A)获得)销售的那些。其它制剂主要包括FVIII分子的单个亚群,其缺少分子的B结构域部分。
可用于本发明的FVIII分子包含全长蛋白、蛋白的前体、蛋白的生物活性或功能性亚基或片段及/或其功能性衍生物,以及如下文所描述的其变体。对凝血因子FVIII的参考意在包含此类蛋白的所有潜在形式,并且其中每种形式的FVIII具有完整的天然B结构域序列的至少一部分或全部。
如本文所使用,“给药间隔”意指在施用于患者的多个剂量之间经过的时间量。施用包含凝血因子VIII的治疗性血浆蛋白的给药间隔可为至少大约每一天、两天、三天、四天、五天、六天、七天、八天、九天、十天、十一天、十二天,十三天或十四天或更长。给药间隔可基于患者的变化的条件/特性、患者内治疗性血浆蛋白的最低可接受(例如,目标谷)浓度的变化及/或剂量的变化而改变。
图1说明根据本发明的实例实施例的药物监测工具150在其中操作的实例药代动力学(PK)环境100。环境100包含远程服务器120,其包含模型产生器125、QR产生器132及PK服务器130。远程服务器120通信地耦合到存储患者医疗样本110的数据存储器件115。
模型产生器125经配置以基于采样患者数据110产生一或多个患者药代动力学(PK)模型。环境100还包含药代动力学(“PK”)服务器130,其经配置以基于一或多个药代动力学模型向患者、医疗保健提供者及/或销售代表提供图形药代动力学药物给药工具150。在所说明实施例中,PK服务器130经由网络114(例如,因特网)将患者PK模型传输到药物监测工具150。在其它实施例中,PK服务器130托管PK概况,其可由药物监测工具150访问。在这些其它实施例中,PK服务器130可包含单个服务器,或者替代地,可分布在云计算框架内。
实例PK服务器130及/或模型产生器125可通信地耦合到数据库115,数据库115经配置以存储患者药代动力学(PK)模型。数据库115可包含任何类型的计算机可读媒体,包含RAM、ROM、闪存、磁盘或光盘、光存储器或其它存储媒体。实例数据库115还可存储响应于用户使用工具150而产生的信息,其包含例如患者信息、给药方案等。在一些情况下,数据库115可由单独第三方存储提供者管理。
在一些情况下,PK服务器130及/或模型产生器125可由同一服务器(例如,远程服务器120)及/或处理器提供及/或由同一实体操作。在这些情况下,模型产生器125的功能性可结合PK服务器130的功能性来操作。例如,模型产生器125可借助于经由工具150在PK服务器130中接收的治疗性血浆蛋白给药信息及/或患者信息来周期性地更新药物动力学模型。
在一些实例实施例中,药代动力学(PK)模型用于近似患者的药代动力学(PK)概况。例如,确定针对甲型血友病的患者特定药代动力学概况的当前方法包含执行多次血液测试。这些血液测试包含执行初始抽血以确定患者中的凝血因子VIII基线。然后,在施用治疗性血浆蛋白后,在输注后48小时内执行五次或更多次抽血。可了解,由于众多单独的抽血,此程序对患者、医疗保健提供者及实验室而言尤为繁重。因此,实例模型产生器125经配置以基于具有不同年龄、体重、性别及活动水平的患者样本来产生相对准确的药代动力学模型。这些模型接着用于确定或近似患者的药代动力学概况,而不必让患者接受所有抽血及随后的分析。
在实施例中,使用从一或多组患者数据选择的患者样本110来确定PK模型。举例来说,患者样品110可选自已经使用上文描述的抽血程序订购治疗剂量给药方案的患者。患者样本110还可包含出于创建模型的目的而专门选择经受抽血程序的患者。患者样本110可包含来自一个医院或医疗系统的患者及/或来自多个医院、医疗系统、地理区等的患者。
患者样本110包含不同年龄、体重(或身体质量指数(“BMI”))、医学状况、临床实验室数据、性别及/或活动水平的患者的数据。在本文描述的实例中,样本患者年龄在2岁与100岁之间变化。在一些实施例中,可将患者的数据分成儿童及成人年龄段,使得针对每一段产生单独模型。患者数据可额外地或替代地基于重量、性别及/或活动水平来划分。
如所提及,实例患者样本110包含在将治疗性血浆蛋白输注到患者中之前确定凝血因子VIII。然后,在一段持续时间之后从每一患者收集输注后血液样本。应了解,在其它实例中,可在不同时间收集血液样本及/或收集的血液样本的数目可更少或更多。例如,可从儿童收集更少血液样本。
实例模型产生器125通过执行贝叶斯分析来创建PK患者模型,贝叶斯分析在输注治疗性血浆蛋白后随时间使用采样患者中的凝血因子VIII的先前知识。在一些情况下,模型产生器125经配置以结合输注前凝血因子VIII水平分析每一患者的采样给药历史,使得不需要冲刷数据来构建PK模型。在其它实施例中,模型产生器125可结合输注后凝血因子VIII水平使用患者冲刷数据以创建一或多个药代动力学模型。患者冲刷数据对应于患者在其系统中不包含治疗性血浆蛋白的基线。
实例模型产生器125使用例如患者样本数据来创建一或多个PK模型。模型产生器125可将个别患者样本110组合成一或多个群体概况(例如,年龄组、重量组、活动水平组、内源性凝血因子VIII水平等),然后将其用作相应药代动力学模型的基础。例如,模型产生器125可将患者样本110针对不同年龄、重量及/或活动水平分组到不同的组中。然后,模型产生器125对每一组的经分组患者样本110执行协变量及统计建模,以创建所述组的群体药代动力学模型,如由贝克曼等人的标题为“重组因子VIII的群体药代动力学-药代动力学与年龄及体重的关系(Population pharmacokinetics of recombinant factorVIII-the relationships of pharmacokinetics to age and body weight)”的白皮书中所描述,所述文献的全部内容以引用的方式并入本文中。然而,应了解,模型产生器125可使用其它贝叶斯分析技术(例如,朴素贝叶斯分类器)对采样数据110建模。
在所说明实例中,由模型产生器125使用的协变量模型确定药代动力学参数(例如,治疗性血浆蛋白代谢的速度、内源性凝血因子VIII水平等)与患者特性(例如,年龄、体重、临床实验室数据、性别、活动水平等)之间的关系。模型产生器125使用统计模型来确定采样患者当中的药代动力学参数的变化,以及由于患者之间的生物学可变性、测量误差以及采样数据110与药代动力学模型的拟合内的误差导致的残差变化。
实例模型产生器125经配置以使用具有一阶积分近似方法的非线性混合效应建模来执行协变量及统计建模,如在软件(NLMIXED程序)中所提供。在所说明实例中,模型产生器125使用两隔室模型。在其它实例中,模型产生器125可使用单个隔室模型或三个或更多个隔室模型。在所说明两隔室实例中,第一隔室包含清除率(“CL”)的药代动力学参数及分布体积(VI)。CL是指患者以每小时每千克(“kg”)的毫升(“mL”)代谢治疗性血浆蛋白的时间量。换句话说,清除率是从患者去除或消除治疗性血浆蛋白的效率及速率的量度。
响应于创建一或多个药代动力学模型,模型产生器125将药代动力学模型提供给PK服务器130。传输可通过专用网络(例如局域网)或通过公共网络(例如,因特网)进行。模型产生器125还可将模型存储到数据库115,数据库115也可由PK服务器130经由一或多个接口访问。在其它情况下,模型产生器125可与PK服务器130集成。
实例模型产生器125可针对每一患者细化模型。例如,PK服务器130可接收患者特定信息,包含重量、年龄、性别、内源性凝血因子VIII水平及先前治疗的给药水平。模型产生器125使用先前治疗信息(例如,给药量、间隔等)来细化或调整模型,使得给药推荐及药代动力学概况更加符合特定患者但仍然考虑潜在患者变化。模型产生器125将患者特定模型传输到PK服务器130。
替代地,PK服务器130可经配置以使用由模型产生器125提供的药代动力学模型来创建患者特定模型,以考虑患者特定药代动力学方差。以此方式,响应于接收针对特定患者的先前治疗信息,由PK服务器130对一或多个基础模型进行细化或调整。PK服务器130可经配置以将患者特定模型存储到数据库115,以供同一医疗保健提供者或其它医疗保健提供者后续使用。
一旦产生针对患者的PK概况,PK服务器经配置以将PK概况传输到药物监测工具150。在一些实施例中,PK服务器130可在传输之前加密数据文件。加密可特定于特定患者,使得如果工具150具有患者特定认证密钥,那么药物监测工具150仅可打开并处理所接收PK概况。
在其它实施例中,PK服务器130可将PK概况提供到QR产生器132。QR产生器132可产生快速响应(QR)码,其可由药物监测工具150经由扫描仪160扫描。QR码也可使用加密QR码的已知或尚未知的方法加密。在一些实例中,QR码加密对于产生PK概况的患者是特定的。因此,如果药物监测工具150包含适当安全密钥及解密逻辑,那么药物监测工具150只能扫描及处理QR码。特定来说,QR码可呈现给药物监测工具150的用户。然后用户使用扫描仪160扫描QR码。在一些实施例中,药物监测工具包含激活工具包155。激活工具包155经配置以响应于至少以下各者而能够访问药物监测工具150的功能性:接收患者的PK概况及/或接收第一次预防性输注的日志。
一旦药物监测工具150被激活,工具150经由处理器165产生用于在工具150上显示的交互式用户接口175。本文参考例如图5进一步描述用户接口175的实例。用户接口175经配置以在任何给定时间显示患者内的时变量的治疗性血浆蛋白的图形表示。图形表示勾画与时变量的治疗性血浆蛋白相关联的区。每一区与患者内的时变量的治疗性血浆蛋白的特定浓度范围相关联。
药物监测工具150可通信地耦合到输注泵140及生物收集器135。输注泵140可经配置以基于给药方案/治疗方案自动施用特定凝血因子VIII药物。在一些实施例中,输注泵140可经配置以响应于由生物收集器135收集的生物样品的结果而施用一定剂量的特定凝结因子VIII药物。举例来说,收集器135可收集血液样品并确定患者的因子VIII水平。响应于量,输注泵140可施用一定剂量的特定凝血因子VIII药物。
另外,环境100可包含生态系统监测系统180,其耦合到网络105并且与远程服务器120及药物监测工具两者通信。系统180可向药剂师提供通知以制备特定的凝血因子VIII药物以供患者购买。举例来说,系统180可确定患者具有阈值量的药物剩下,使得患者在不久的将来将需要药物。类似地,系统180可联系医生以确保医生具有与患者相关联的实时信息。因此,如果需要,医生可立即采取行动来照顾患者。
图2是根据本发明的实例实施例的用于产生特定患者的PK概况的方法200的流程图。方法200在205处包含收集患者信息(例如,患者样本110、病史等)。在210处,方法200包含产生针对患者的PK概况210。可如2014年6月20日申请的第14/311,133号美国专利申请案(现在作为第2014/0379629号美国专利申请案于2014年12月25日发布)中描述那样产生PK概况。所述申请案的全部教示以引用的方式并入本文中。在215处,方法200包含编码PK概况。在一些实例中,PK概况可由PK服务器130使用已知或尚未知的电子数据编码技术来编码。在220处,方法200包含将PK概况传输到药物监测工具150。
图3是根据本发明的实例实施例的用于将PK概况转换为QR码的方法300的流程图。在310处,方法300包含从PK概况提取基本数据点。举例来说,下面的表1标识编码到针对实例患者的QR码中的信息:
表1
在320处,方法300然后使用来自上面的表1的信息产生QR码。方法300可产生QR码以使用AES-256加密来加密患者信息,所述AES-256加密采用密码块链接(CBC)及公钥加密标准(PKCS)填充方式。
图4说明根据本发明的实例实施例的药物监测工具(例如,图1的工具150)的交互式用户接口400。交互式用户接口经配置以在任何给定时间在患者内显示时变量的治疗性血浆蛋白的图形表示405。在此实例中,表示是电池的表示。所属领域的技术人员将理解,任何表示都可用于传达药物水平的时变性质。图形表示405勾画与时变量的治疗性血浆蛋白相关联的区415a到c。举例来说,安全区415a表明凝血因子VIII的水平被认为对许多预期活动水平是安全的。警告区415b向患者提供其应仔细选择活动水平以便防止出血事件的指示。危险区415c表明患者应在不久的将来施用另一剂量的特定凝血因子VIII药物。危险区415c还向患者提供应将活动水平保持为最小的指示。
接口400还包含药物(例如,特定凝血因子VIII药物)的当前药物水平(例如,因子水平)的表示。接口400进一步包含图形控制元件410,其经配置以接收患者输入,所述患者输入对应于在特定时间对患者内的时变量的治疗性血浆蛋白的请求。响应于患者滑动图形控制元件410,交互式用户接口400经配置以在对应于图形控制元件410的位置的特定时间在患者内显示时变量的治疗性血浆蛋白。
图5是实例计算装置3000的详细框图。计算装置3000可为任何通信装置,例如桌上型计算机、膝上型计算机、服务器系统,基于云的计算系统、无线传输/接收单元(WTRU)(例如,智能手机、平板计算机、手机、个人数字助理(PDA)等)。因此,计算装置3000可为例如远程服务器120、药物监测工具150及/或生态系统监测系统180。
在此实例中,装置3000包含主单元3102。主单元3102优选地包含通过地址/数据总线3106通信地耦合到一或多个存储器装置3108、其它计算机电路3110以及一或多个接口电路3112的一或多个处理器3104。处理器3104可为任何合适处理器,例如来自INTEL 或CORETM系列微处理器的微处理器。存储器3108优选地包含易失性存储器及非易失性存储器。优选地,存储器3108存储与环境100中的其它装置交互的软件程序,如上文描述。此程序可由处理器3104以任何合适方式执行。在实例实施例中,存储器3108可为“云”的部分,使得可由装置3000利用云计算。存储器3108还可存储从装置3000检索(或经由其加载)的指示文档、文件、程序、网页、患者样本、药代动力学模型、患者药代动力学概况等的数字数据。
实例存储器装置3108存储软件指令3123、患者样本/药代动力学模型3124、应用程序接口3126、用户接口特征、许可、协议、识别码、内容信息、注册信息、事件信息及/或配置。存储器装置3108还可存储供装置3000使用的网络或系统接口特征、许可、协议、配置及/或偏好信息3128。将了解,许多其它数据字段及记录可存储在存储器装置3108中以促进实施本文揭示的方法及设备。另外,将了解,可使用任何类型的合适数据结构(例如,平面文件数据结构、关系数据库、树数据结构等)来促进本文揭示的方法及设备的实施。
接口电路3112可使用任何合适接口标准来实施,例如以太网接口及/或通用串行总线(USB)接口。一或多个输入装置3114可连接到接口电路3112,用于将数据及命令输入主单元3102。举例来说,输入装置3114可为键盘、鼠标、触摸屏、跟踪板、跟踪球、等点、图像传感器、字符辨识、条形码扫描仪、麦克风及/或语音或声音辨识系统。
一或多个显示器、打印机、扬声器及/或其它输出装置3116也可经由接口电路3112连接到主单元3102。显示器可为阴极射线管(CRT)、液晶显示器(LCD)或任何其它类型的显示器。显示器产生在装置3000的操作期间产生的视觉显示。举例来说,显示器可提供用户接口并且可显示从装置3000接收的一或多个网页。用户接口可包含来自装置3000的用户的人类输入的提示,其包含链路、按钮、标签、复选框、缩略图、文本字段、下拉框等,并且可响应于用户输入提供各种输出,例如文本、静止图像、视频、音频及动画。
一或多个存储装置3118还可经由接口电路3112连接到主单元3102。举例来说,硬盘驱动器、CD驱动器、DVD驱动器及/或其它存储装置可连接到主单元3102。存储装置3118可存储可由装置3000使用的任何类型的数据,例如标识符、识别码、注册信息、患者样本、患者信息、药代动力学模型、患者药代动力学概况、治疗方案、统计数据、安全数据等。
计算装置3000还可经由到网络3121(例如,因特网)的连接或连接到网络3121的无线收发器3122与其它网络装置3120交换数据。网络装置3120可包含一或多个服务器,其可用于存储某些类型的数据,特别是可存储在一或多个数据存储库中的大量数据。服务器可处理或管理任何种类的数据,其包含数据库、程序、文件、库、标识符、识别码、注册信息、内容信息、患者样本、患者信息,药代动力学模型、患者药代动力学概况、治疗方案、统计数据、安全性数据等。服务器可存储及操作与接收、传输、处理及存储大量数据有关的各种应用程序。应了解,一或多个服务器的各种配置可用于支持、维护或实施环境100的装置3000。举例来说,服务器可由各种不同的实体操作,包含PK服务器108的操作员、医院系统、患者、药物制造商、服务提供者等。此外,某些数据可存储在装置3000中,装置3000也可临时或永久地存储在服务器上,例如存储在存储器3108或存储装置3118中。网络连接可为任何类型的网络连接,例如以太网连接、数字用户线(DSL)、电话线、同轴缆线、无线连接等。
可通过适当安全性软件或安全性措施来控制对装置3000的访问。个别第三方客户端或消费者的访问可由装置3000定义,并且限于某些数据及/或动作。因此,可能需要环境100的用户向计算装置3000注册。
虽然已经参考其实例实施例特定展示及描述本发明,但所属领域的技术人员将理解,在不脱离所附权利要求书所涵盖的本发明的范围的情况下,可在形式及细节上进行各种改变。
Claims (20)
1.一种药物监测工具,所述工具包括:
数据接收器,其经配置以从安全服务器接收患者的患者药代动力学PK概况,其中所述安全服务器包括:(I)采样患者的PK概况的贝叶斯模型,所述贝叶斯模型包含(i)治疗性血浆蛋白清除率及(ii)基于患者年龄或体重中的至少一者的治疗性血浆蛋白的分布关系的体积,以及(II)PK服务器,其经配置以传送基于所述贝叶斯模型和所述患者的体重、冯维勒布兰德因子水平及年龄中的至少一者而产生的所述患者PK概况;及
交互式用户接口,其经配置以:
向所述患者显示预测所述患者的时变治疗性血浆蛋白水平的图形表示,所述时变治疗性血浆蛋白水平由所述药物监测工具基于给予所述患者的凝血因子VIII的施用剂量的时间和量及所述患者PK概况而确定;以及
勾画所述图形表示内的与所述时变治疗性血浆蛋白水平相关联的多个区,所述多个区至少包括:
安全区,其向所述患者指示所述时变治疗性血浆蛋白水平在被认为针对活动水平是安全的第一浓度范围内;以及
危险区,其向所述患者指示所述时变治疗性血浆蛋白水平在第二浓度范围内,且体育活动应被限制。
2.根据权利要求1所述的药物监测工具,其中:
所述数据接收器是经配置以扫描存储包含至少PK概况信息的患者信息的快速响应QR码的相机;且
所述药物监测工具进一步包括QR码处理器,其经配置以提取及处理所述患者PK概况。
3.根据权利要求2所述的药物监测工具,其进一步包括QR码产生器,所述QR码产生器经配置以产生所述QR码,所述QR码具有使用AES-256加密来加密的患者信息,所述AES-256加密采用密码块链接CBC及公钥加密标准PKCS填充方式。
4.根据权利要求3所述的药物监测工具,其中所述QR码产生器位于远离所述药物监测工具的所述安全服务器处。
5.根据权利要求1所述的药物监测工具,其进一步包括激活工具包,所述激活工具包允许所述药物监测工具仅在接收所述患者PK概况及接收第一预防性输注的日志之后提供预测所述患者的时变治疗性血浆蛋白水平的所述图形表示。
6.根据权利要求1所述的药物监测工具,其中所述交互式用户接口包含图形控制元件,其经配置以接收患者输入,所述患者输入对应于在特定时间对所述患者内的所述时变治疗性血浆蛋白水平的请求;且其中所述交互式用户接口经配置以在所述特定时间显示所述患者内的所述时变治疗性血浆蛋白请求的所述图形表示。
7.根据权利要求6所述的药物监测工具,其中所述图形控制元件能够在所述多个区之间滑动。
8.根据权利要求1所述的药物监测工具,其中所述图形表示提供估计的时间量直到所述时变治疗性血浆蛋白水平达到所述危险区。
9.一种药物监测系统,所述系统包括:
远程服务器系统,其包括:
采样患者的药代动力学PK概况的贝叶斯模型,所述贝叶斯模型包含(i)治疗性血浆蛋白清除率及(ii)基于患者年龄或体重中的至少一者的治疗性血浆蛋白的分布关系的体积,
PK服务器,其传送基于所述贝叶斯模型和患者的体重、冯维勒布兰德因子水平及年龄中的至少一者而产生的患者PK概况,及
快速响应QR码产生器,所述QR码产生器产生存储所述患者PK概况的QR码;及
药物监测工具,其包括:
相机,其读取所述QR码,
码处理器,其从所述QR码中提取所述患者PK概况;及
交互式用户接口,其显示由所述药物监测系统基于给予所述患者的凝血因子VIII的施用剂量的时间和量及所述患者PK概况而确定的所述患者的时变治疗性血浆蛋白水平的图形表示,所述图形表示勾画所述图形表示内的与所述时变治疗性血浆蛋白水平相关联的多个区,所述多个区至少包括:
安全区,其向所述患者指示所述时变治疗性血浆蛋白水平在被认为针对活动水平是安全的第一浓度范围内;以及
危险区,其向所述患者指示所述时变治疗性血浆蛋白水平在第二浓度范围内,且体育活动应被限制。
10.根据权利要求9所述的药物监测系统,其中所述快速响应QR码产生器使用多个字段生成所述QR码,所述多个字段中的每一者独立地选择以下组:方案版本、门诊患者ID、重量、阿尔法、贝塔、K21、V1、持续时间、给药间隔、FIII基线、目标谷、时间之上、时间之下和时间戳。
11.根据权利要求9所述的药物监测系统,其中所述快速响应QR码产生器使用多个字段生成所述QR码,每个字段使用UTF8进行编码。
12.根据权利要求9所述的药物监测系统,其中所述图形表示提供估计的时间量直到所述时变治疗性血浆蛋白水平达到所述危险区。
13.一种使用患者药代动力学PK概况预测药物水平的方法,所述方法包括:
在用户装置处从服务器系统接收凝血因子的患者PK概况,所述患者PK概况基于采样患者的贝叶斯模型和患者的体重、冯维勒布兰德因子水平及年龄中的至少一者而确定;
通过所述用户装置确定使用所述患者PK概况预测的所述凝血因子的时变水平,以从所述凝血因子给药的时间和量对所述患者产生影响;及
经由所述用户装置的交互式用户接口显示多个区内的对所述患者预测的凝血因子的所述时变水平,所述凝血因子的所述时变水平定位与以下中的一者:
安全区,其向所述患者指示所述时变治疗性血浆蛋白水平在被认为针对活动水平是安全的第一浓度范围内;以及
危险区,其向所述患者指示所述时变治疗性血浆蛋白水平在第二浓度范围内,且体育活动应被限制。
14.根据权利要求13所述的方法,其进一步包括:
提供图形控制元件,用户可通过所述图形控制元件在有所述用户选择的特定时间请求所述凝血因子的所述时变水平;及
显示使用在所述特定时间的所述患者内的所述患者PK概况预测的所述凝血因子的第一估计水平。
15.根据权利要求14所述的方法,其中所述图形控制元件能够在所述多个区之间滑动。
16.根据权利要求13所述的方法,其中所述贝叶斯模型包含(i)治疗性血浆蛋白清除率及(ii)基于所述采样患者的年龄或体重的所述凝血因子的分布关系的体积。
17.根据权利要求13所述的方法,其中:
接收所述患者PK概况包含使用所述用户装置:
扫描存储患者信息的快速响应QR码,所述患者信息包含至少PK概况信息;及
提取和处理存储在所述QR码内的所述患者信息。
18.根据权利要求17所述的方法,其中所述服务器系统产生所述QR码,所述QR码具有使用AES-256加密来加密的患者信息,所述AES-256加密采用密码块链接CBC及公钥加密标准PKCS填充方式。
19.根据权利要求17所述的方法,其中所述QR码包含以下至少一者或其组合:所述患者的患者识别信息、患者生理数据、患者给药信息及/或PK概况信息,其中所述患者给药信息包含针对特定凝血因子VIII药物的预防性给药方案。
20.根据权利要求13所述的方法,其进一步包括响应于接收所述PK概况和第一预防性输注的日志对患者执行所述确定步骤和所述显示步骤。
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