CN101496042A - 患者定制的治疗方案 - Google Patents

患者定制的治疗方案 Download PDF

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CN101496042A
CN101496042A CNA2007800244235A CN200780024423A CN101496042A CN 101496042 A CN101496042 A CN 101496042A CN A2007800244235 A CNA2007800244235 A CN A2007800244235A CN 200780024423 A CN200780024423 A CN 200780024423A CN 101496042 A CN101496042 A CN 101496042A
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patient
data
therapeutic scheme
deterministic data
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M·兹德布利克
A·汤普森
G·萨瓦奇
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Proteus Digital Health Inc
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Proteus Biomedical Inc
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0026—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the transmission medium
    • A61B5/0028—Body tissue as transmission medium, i.e. transmission systems where the medium is the human body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4848—Monitoring or testing the effects of treatment, e.g. of medication
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    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
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    • G—PHYSICS
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    • H04B13/00—Transmission systems characterised by the medium used for transmission, not provided for in groups H04B3/00 - H04B11/00
    • H04B13/005—Transmission systems in which the medium consists of the human body
    • H—ELECTRICITY
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    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00—Surgery
    • Y10S128/92—Computer assisted medical diagnostics

Abstract

提供允许根据患者定制的治疗方案治疗患者的方法、系统和成分。本发明的实施例包括从患者获得剂量施用信息，并使用该信息针对患者制作治疗方案。本发明的实施例还包括制备并向患者转达基于定制的治疗方案的物理药物剂量。

Description

患者定制的治疗方案
相关申请交叉引用
根据35U.S.C.§119(e)，本申请要求2006年5月2日提交的申请号为60/746250的美国临时专利申请的优选权，该申请的公开内容通过引用结合于本文中。
简介
技术领域
本发明概要地涉及保保健，并且具体而言，涉及治疗方案。更具体地说，本发明涉及关于根据能随着治疗计划进展而调整的患者特定的定制治疗方案来治疗患者的方法和系统。
背景技术
处方药对于例如根据指示正确服用的许多患者而言是有效的治疗法。然而，处方药的服用一般是根据使用从大量患者获得的临床数据而形成的预定剂量给药安排。如此，在保健人员确定患者将受益于给定处方药时，保健人员一般向患者指定标准剂量计划，例如，每天服用一次，每天每隔12小时服用两次等。
虽然标准剂量给药方案是基于从大量患者得到的临床信息，但此类方案未考虑对于给定患者独特的且可影响给定的药物药剂如何影响特定患者的任何生理因素。例如，此类标准剂量给药安排未考虑患者可能正在服用的任何其它药剂可能对处方药的活动的影响。此外，标准剂量给药安排未考虑可能在患者上存在并工作的植入式医疗装置(例如，起博器)的任何活动。另外，标准剂量给药安排未考虑不依从剂量给药安排可能具有的任何影响。标准剂量给药安排中未计及的其它变数包括患者的日常预期活动、患者主观上的感觉如何等。
因此，用于治疗某种病症的处方药的标准剂量给药方案对于至少一些患者不是最优剂量给药方案。根据次优的剂量给药方案服药会具有多个不良效应，包括次优治疗、次优依从性、毒性副作用以及甚至死亡。
因此，需要开发为患者确定治疗方案的更好方法。特别关注的将是开发用于确定患者定制的治疗方案的方法，其中为特定的患者特别制作这些方案。本发明满足了此需要和其它需要。
发明内容
本发明第一次允许开发患者特定的定制的治疗方案，在该方案中，为给定患者特别制作例如药物干预的治疗干预的剂量，其中，剂量能够基于诸如患者正在服用的其它药剂的影响、患者的预期日常活动及诸如此类等多个不同患者特定条件确定。本发明也考虑了随着时间的进展修改给定治疗方案的能力，例如，计及对给定患者独特的改变，如患者对以前治疗的反应如何，患者对以前的剂量给药安排的依从程度等。
本发明的实施例包括其中从患者获得的诸如依从性数据等剂量施用数据(特别是以关于药用成分的施用的确定性数据形式)的方法。随后，例如使用自动化决定工具评估此获得的确定性数据，以确定是否需要改变已向患者开出的治疗方案。基于此确定，决定工具提供建议。如果建议改变，则随后可以某种方式调整对于患者的治疗方案。在某些实施例中，该方法还包括例如以如下形式实现修订的治疗方案：根据修订的治疗方案制备定制的生理剂量并将该方案转达给患者。还提供有用于执行主题方法的各种步骤的系统和编程。
附图简述
图1显示根据本发明实施例的流程图，示出用于形成患者特定的治疗方案的过程。
图2显示根据本发明一个实施例的流程图，示出图1中所示的过程的变化，其中修改的治疗方案通过产生患者特定的物理药物剂量而实现。
图3提供本发明的特定实施例的示图。
图4示出用于执行本发明的方法的根据本发明实施例的系统。
定义
除非另有规定，否则，本文使用的所有技术和科学术语具有与本发明所属领域的技术人员通常理解的相同含意。为简明起见和便于参考，下面仍定义了某些元素。
“远程位置”指与参考的项目存在的位置不同的位置，例如，远离患者的位置，如同一城市中的另一物理位置(例如，办公室、实验室等)、不同城市中的另一位置、不同州中的另一位置、不同国家中的另一位置等。如此，在一个项目被指示为“远离”另一项目，这意味着两个项目至少在同一房间的不同区域，如在不同房间或不同建筑物中，并且可相隔至少一英里、十英里或至少一百英里。
“传递”信息指通过适合的通信信道(例如，专用或公共网络)，例如广域网(“WAN”)、电话网络、卫星网络或任何其它适合的通信信道，包括因特网、内联网等，发射将该信息表示为信号(例如，电的、光的、无线电的信号等)的数据。通信可使用适合所使用的通信信道类型的任何方便的通信模块进行，如计算机网络卡、计算机传真卡或传真机或电话或卫星调制解调器。
“转达”项目指从一个位置到下一位置获得该项目的任何方式，而无论是通过物理方式传输该项目或以其它方式(在可能的情况下)，并且至少对于数据的情况包括物理地传输携带数据的媒体或例如经上述的方式传递数据。
术语“系统”和“基于计算机的系统”指用于实践本发明方面的硬件部件、软件部件和数据存储部件(例如，存储器)。本发明的基于计算机的系统的最少硬件包括中央处理单元(CPU)、输入部件、输出部件和数据存储部件(例如，存储器)。技术人员能容易理解，可获得适合在本发明中使用的许多基于计算机的系统。数据存储部件可包括具有如上所述的现有信息的记录的任何制品，或能访问此类制品的存储器访问部件。
“处理器”指将执行需要它的功能的任何硬件和/或软件组合。例如，本文的任何处理器可以是可编程数字微处理器，如可以电子控制器、大型机、服务器或个人计算机(台式或便携式)形式提供。在处理器可编程的情况下，适合的编程能够从远程位置传递到处理器，或者能预先保存在计算机程序产品(如便携式或固定计算机可读存储媒体，无论是基于磁性、光学还是固态装置)中。例如，磁性媒体或光盘可携带编程，并且能够由与在其对应站点的每个处理器通信的适合阅读器读取。
“存储器”、“存储器元件”或“存储器单元”指能够存储信息以便随后由处理器检索的任何装置，并且可包括磁性或光学装置(如，硬盘、软盘、CD或DVD)或固态存储器装置(如易失性或非易失性RAM)。存储器或存储器单元可具有不止一个相同或不同类型的物理存储器装置(例如，存储器可具有多个存储器装置，如多个硬盘驱动器或多个固态存储器装置或硬盘驱动器与固态存储器装置的某些组合)。
在某些实施例中，系统包括采取一个或多个平台形式的硬件组件，例如以服务器的形式，使得通过在表示系统的所述一个或多个计算机平台上和跨这些平台执行软件应用，可实施系统的任何功能元件，即那些实施系统的特定任务(如管理信息的输入和输出，处理信息等)的系统元件。主题系统中存在的一个或多个平台可以是任何方便类型的计算机平台，例如，服务器、大型计算机、工作站等。在存在不止一个平台的情况下，平台可经联网的或其它方式的任何方便类型的连接而连接，例如电缆敷设或包括无线系统的其它通信系统。在不止一个平台存在的情况下，平台可处在相同的位置或者它们可在物理上分开。各种操作系统可在任何计算机平台上采用，其中，典型的操作系统包括Windows、Sun Solaris、Linux、OS/400、Compaq Tru64Unix、SGI IRIX、Siemens Reliant Unix和其它。正如本领域所熟知的一样，系统的功能元件也可根据多种多样的软件服务商(software facilitator)和平台而实现。
具体实施方式
本发明为临床医生在他们的治疗医疗设备中提供了重要的新工具，例如，以患者特定的方式定制治疗方案的能力。本发明允许基于实际剂量施用信息，即，对患者的药用成分的施用的确定性数据，形成和修改治疗方案，能够以附加的剂量相关信息补充该信息，如生活方式信息等。这样，临床医生可制定患者特定的定制的最优治疗方案。例如，基于包括实际的依从性数据等多个因素，心脏刺激药品能够滴定到最适当的剂量，从而将诸如心肌衰竭和反弹效应及其它的副作用降到最低，并为每个单独的患者优化剂量和时机。
通过本发明，备选药剂的范围的评定成为可能，而无需等待治疗的显性临床后遗症，这些后遗症大多数会有严重的不利后果。例如，积极效应将可快速断定而不会被更多随机因素所混淆。因为药品相关或独立于背景生理变化之上，诸如血压改变等负面反应将变得十分明显。在一个临床场所，本发明允许，结合例如本申请的受让人开发和拥有的装置等其它感测装置，测量和评定这些药剂的心脏反应。除其它装置外，这些共同采用的感测装置还能够是下面列举的那些装置。本发明一些发明人开发的其它感测技术允许测量心脏健康和心效率。通过将这些工具与本发明方法和系统结合使用，临床医生将能够比较心脏和身体对施用的药物的反应，并进行患者特定的定制的治疗方案修改以实现最优患者特定的治疗方案。
在对本发明的进一步更详细描述中，首先，更详细地评论方法。随后，描述用于实现该方法的系统。最后，评论其中使用该方法的代表性应用。
方法
一方面，本发明提供治疗患者某种病症的方法，其中，该病症可以是受益于某些种类型医学干预(如药物干预、营养/维生素干预、液体干预(例如，透析)等)的病症，其中一些形式的药用成分给患者施用。术语“药用成分”广泛用于指可给患者施用的各种不同类型成分，以实现以某种方式改进患者健康的最终目标，其中药用成分的示例包括但不限于：药物或药品(例如，可由处方或通过柜台得到的)、维生素和营养药、治疗液(如盐水、透析液等输液)、抗酸剂等。只为描述方便起见，现在主要根据药物的药用成分进一步描述本发明。然而，本发明并不限于此。
在实践本发明的方法中，第一步骤是从患者获得剂量施用数据(即，关于给患者的药用成分的施用的确定性数据)，其中，在某些实施例中，患者是在进行治疗方案。“进行治疗方案”指已向患者开出治疗计划，其中，患者由自行施用或通过保健人员或另一个体(或甚至患者本人)，根据剂量给药安排施用了药用成分，例如，每几个小时一次，一天一次，每两天一次，一周一次等。
在某些实施例中，患者包括在药用成分施用中涉及的可植入的医疗装置，如心血管装置，例如，糖尿病护理装置、给药装置等。
在方法的此步骤中获得的剂量施用数据是有关是否及何时患者已施用(通过自行施用或另一个人)给定治疗发明的信息，例如，可植入的装置的活动、药物剂量等。剂量施用数据是给患者的药用成分的施用的确定性数据。由于数据是确定性的，因此，它是告知特定成分确实已经对患者施用的数据。在某些实施例中，确定性数据是只在药用成分确实接触患者时才能够生成的数据，并因此它与可从使用用于此类接触的代理(proxy)的方法/系统生成的依从性数据区分开来，如依赖患者施用记录的方法或系统，依赖药用成分智能包装的方法或系统等。如此，在本发明的方法中采用的剂量施用或确定性数据可包括药物依从性数据，该依从性数据包括有关是否及何时患者接受特定药物剂量的信息。
在某些实施例中，确定性数据是由第一装置产生并发射到第二装置的数据，其中所述第一和第二装置均与所述患者的身体相关联。在这些情况下，在已给患者施用药用成分时，与身体相关联的第一装置生成或产生信号(其可以是例如比特的单个数据元素的集合)。信号随后发射到第二装置，第二装置接收并可记录信号。第二装置也与身体相关联。与身体相关联是指第一和第二装置与身体局部地或在身体内地接触，例如，食入、植入等，这取决于第一和第二装置的特定性质。
第一和第二装置与患者身体相关联的情况示例是第一和第二装置电耦合到患者身体的情况。在装置电耦合到患者身体时，通过在第一与第二装置之间建立电流，确定性数据可从第一装置发射到第二装置，其中，身体充当电流经过的导电媒体，并因此提供用于第一与第二装置之间的“库仑”通信。此类实施例不同于经射频(RF)相互通信的装置。
视第一与第二装置的性质而定，电流可以是限制在第一和第二装置及患者身体之间的电流。例如，在第一装置是药物信息机制(pharma-informatics)已启用的药物剂量(下面更详细描述)，并且第二装置是植入患者体内或在患者身上局部存在的个人健康伴侣(personal health companion)，可将在数据发射时建立的电流限制于第一与第二装置及患者。备选地，电流可以是限制在第一与第二装置之间电流，其中第一与第二装置电容性耦合到患者外部的导体或地。例如，在第一装置是例如如下所述的智能肠道外输送装置(parenteraldelivery device)，并且第二装置是在患者表面上存在的个人健康伴侣的情况下，第一与第二装置可电容性耦合到方便的患者体外的地，并且确定性数据使用在患者身体中建立的电流从第一装置发射到第二装置。
第一与第二装置的系统可视为通过以下方式生成确定性数据的系统：在例如从第一装置给患者施用药剂时，从第一装置广播电信号；将通过患者的确定性信号传导到与所述患者相关联的接收器，例如，植入患者中或局部应用到患者的个人健康伴侣装置；以及由第二装置记录确定性信号。
为提供更高的可靠性，但不一定实践本发明所有方面，确定性数据可通过使用自动生成、发射、接收和记录确定性数据的第一与第二装置的系统获得。词语“自动”指除初始设置外无需人为干预便可获得确定性数据的情况。
在某些实施例中，可单独检测的智能剂量可用作生成确定性数据的上述系统中所述的第一装置。此类智能剂量的示例包括但不限于以下专利中所述的那些剂量：美国专利5079006和公开的PCT公布WO2007/027660、WO 2007/021496、WO 2007/014084、WO 2007/013952、WO 2007/001742、WO 2007/001724、WO 2006/127355、WO2006/104843、WO 2006/055892、WO 2001/047466及WO 2005/020023，这些公布和其美国对应物(例如，优先权申请)的监视装置和方法的公开内容通过引用明确结合于本文中。
某些实施例中特别关注的是使用在与目标身体位置(例如，胃)接触时激活的“智能”剂量，其中，激活例如经电源接通(completion)而发生。此类剂量可包括与药物成分相关联的识别器，并(例如通过在接触例如胃的目标生理部位时发射信号)提供有关患者何时确实施用剂量的信息(即确定性数据)，使得获得的信息不是用于剂量施用的代理，而是实际上关于剂量的实际施用。这种类型的智能剂量包括在2006年4月28日提交，在2006年11月2日公布为WO 2006/116718的名称为“Pharma Informatics System”的PCT申请(申请号为PCT/US2006/016370)中描述的那些剂量，以及如美国临时申请60/866581、60/829832、60/887780、60/889868、60/889870、60/889871、60/894171及60/894167中所述的此类智能剂量的另外实施例，这些申请的公开内容通过引用结合于本文中。此类剂量可视为药物信息机制已启用的剂量。
剂量依从性数据也能通过使用智能治疗系统获得，例如，通过其它方法，例如，通过使用注射器、吸入器、输液机(infusion machine)、透析机或施用药的其它装置，提供摄入身体的有益制剂或有益制剂的特定识别和检测的系统。智能治疗系统能包括具有芯片的有益制剂。芯片能包含有关要给患者施用的有益制剂的类型的信息。在从例如瓶等保持容器提取有益制剂时，信号能从瓶发送到注射器内的芯片。所广播的信号能指示从瓶提取的有益制剂的类型。在注入患者时，信息能从注射器发送到在患者中，患者上或患者附近的信息管理数据库，例如，个人健康伴侣装置。系统也能通知接收器有关患者正在进行的任何治疗，如透析。这种情况下，透析机或添加到当前透析机的附加模块能用于收集和发射有关正在执行的透析的数据和透析期间进出患者的血液参数。在成功完成发射信号的检测和解码时，接收器能激活警报，让护士或其它护理人员和/或患者知道接收器已成功接收有关施用的药剂或治疗的信息。2006年7月7日提交的美国临时专利申请60/819750和2007年2月27日提交的60/891883中公开了此类系统；其公开内容通过引用结合于本文中。
如上所述，第二装置可以是配置为接收从第一装置通过身体发射的数据(并在需要的情况下记录和重新发射数据)的装置，其中，第二装置可以是配置为例如通过药物信息机制已启用的剂量配方的识别器发射的信号而检测剂量施用的个人健康伴侣装置，如名称为“Signal Receivers for Pharma-informatics Systems”的未决的临时申请60/887780中所述的，该申请的公开内容通过引用结合于本文中。如上所述，可为个人健康伴侣确定尺寸以便植入患者，和/或局部应用到患者，其中，确定装置的尺寸使得无论它与患者如何相关联，它能与患者相关联扩展的时间期，例如，数天、数周、数月、数年或更长，而不会给患者造成大的不适(如果有)。
在某些上述实施例中，第一装置与第二装置是不同类型的装置，例如，其中第一装置可与活性剂相关联，例如其中第一装置是智能剂量，并且第二装置不与活性剂相关联。
在某些实施例中，根据患者的特定方案，方法包括从患者获得给定时间期内两组或更多组确定性数据，例如，在1天、1周、1月、1年等时期内两组或更多组确定性数据。虽然两组或更多组确定性数据可从相同的第一装置生成，但在某些实施例中，例如，其中第一装置是药物信息机制已启用的剂量(例如，如上述的智能剂量)，第一与第二装置将是不同的剂量，例如，不同的药丸。如此，方法的实施例包括从至少第三装置(例如，与第一药物剂量分开的第二药物剂量)获得另一组确定性数据，其中采用了相同的第二装置而无论采用了多少个另外的第一、第三等装置。
除剂量施用数据外，可根据需要从患者获得另外的数据。可获得的另外的患者数据的类型包括但不限于：生理参数数据，例如，如可通过使用任何方便的感测装置获得的数据，感测装置包括由本申请的受让人的一些发明人开发的并在如下引用的共同拥有的申请和专利中所述的传感器和系统；生活方式数据，如有关患者的历史信息(例如，在给定日期的患者活动，患者感觉如何等)；患者的预期活动(例如，患者是否预期要运动，患者是否感觉良好等)及诸如此类。
在从患者获得剂量施用(即，确认性)数据后，例如，在患者可以在或不在远程位置，使得数据的获得包括从第一位置发射数据到第二位置(例如，通过因特网)的情况下，随后例如通过使用如下所述的系统来评估数据，以确定何时需要改变治疗方案并基于该确定提供建议。方法的此步骤可包括将数据输入(例如，适当系统的)决定支持工具，并基于关于改变治疗方案是否合乎需要的确定性数据，从决定支持工具获得建议。剂量施用数据经评定以便基于从患者接收的信息，如依从性数据、生理参数和生活方式数据，识别是否应对治疗方案进行任何修改以便以某种方式为患者优化治疗方案。数据可由保健人员例如通过手动或使用例如如下所述的系统等任何方便的决定工具进行评估，决定工具可包括数据库、算法、可操作的接口(例如，以图形用户接口(GUI)的形式)、结果测量等。
随后可例如由保健专业人员采用基于此评估步骤的结果建议，确定是否应以某种方式调整治疗方案。随后，例如通过保健人员将该确定传递给患者，其中，确定可以采用不应对治疗方案进行改变或者应对治疗方案进行改变的指示的形式。如此，保健人员可通知患者将不对治疗方案进行改变，并且患者应该继续遵循以前指定给患者的治疗方案。备选地，保健人员在遵循来自评估步骤的建议后，也可例如以有关如何改变以前指定给患者的方案的指导的形式，向患者转达修改的治疗方案。
治疗方案的调整在进行时可采用多种不同格式。例如，调整可采用改变药物剂量方案的形式，例如，在所服用的活性剂的量和/或所服用的活性剂的不同类型方面。调整也可采用改变植入式医疗装置的活动的形式。另外，修改可包括生活方式改变建议，例如，禁止运动的指导，参与运动的指导，调节饮食的指导等。
在某些实施例中，方法可还包括治疗方案的改变的实现。该实现可以多个不同方式表明。例如，该实现可以是将在所修改的治疗方案中使用的一个或多个实际的物理药物剂量的制备的形式。词语“物理药物剂量”指在任何给定时间施用的实际药物成分，例如，在给定施用事件施用的实际的一个或多个药丸。在一种形式的实现中，通过将活性剂的不同成分(例如药丸)收集成组并将该组转达到患者，实现了包括选择特定量的不同活性剂的修改的治疗方案。在另一种形式的实现中，由如上所述治疗方案指定数量的两种或多种活性剂的组合被组合成单个成分，并且该成分随后被转达到患者。例如，如上所述确定的给定修改的治疗方案可要求施用第一数量的药物X，第二数量的药物Y及第三数量的药物Z。如下面更详细所述一样，单个成分例如由药物成分制造商响应来自系统的指导而形成，其包括指定数量的所有三种不同的药物。三个不同数量可根据需要，位于惰性载体的不同室中、组合在胶囊中等。这些实施例的成分可沿给定供应链的任何点制造，例如，在药物制剂制造商层、在分销商层、在零售商(例如，药房)层或甚至在客户层，例如，通过使用从常备成分(stockcomponent)制备定制的配方的家用装置。当可能需要时，实现也可包括调整植入式装置的活动，如心脏装置、神经刺激装置等。
在某些实施例中，监视或跟踪单个剂量或剂量集合的另外的方法和系统可结合本发明的方法和系统使用。例如，可采用记录患者何时从包装获得剂量并由此为向患者施用剂量提供代理的“智能”包装装置(即，药物依从性包装)。此类“智能”包装装置和方法的示例可在以下专利中发现，但并不限于此：如在美国专利4360125、4768176、4768177、5200891、5,642731、5752235和5954641中所公开的智能发药机；这些专利的公开内容通过引用结合于本文中。备选地或附加地，RFID/条形码手段可用于在药物剂量源与患者之间提供额外的确认或跟踪信息。
其它剂量依从性数据源包括但不限于患者数据记录，例如，通过对依从性记录程序的输入等。剂量施用数据也能包括可植入的医疗装置活动数据，如起博器活动数据，其中，此类活动可通过使用任何方便的系统而受到监视，包括在名称为“Implantable Zero-WireCommunications System”的公开的PCT申请(公布号WO 2007/028035)中所述的系统，该申请的内容通过引用结合于本文中。
在需要的情况下，此类额外的信息源可结合本发明的方法使用。
图1和2提供上述方法的两个不同实施例的流程图。在图1中，如上所述，示范方法的第一步骤110是获得剂量施用数据，如药物依从性数据。接着，在步骤120，所获得的剂量施用数据输入到治疗方案评估器中，例如，如下面更详细所述一样。在步骤120之后，评估器在步骤130评定输入数据以确定是否需要改变治疗方案。在决定框140，如果建议不改变方案，则如在步骤150所示，将指导转达到患者以继续当前治疗方案。然而，如果在决定框140建议改变方案，则在步骤160形成修改的治疗方案，例如，以改变的药物剂量方案和/或植入式医疗装置活动方案的形式。在步骤170，所形成的调整药物剂量方案随后转达到患者。最后，如在步骤180所示，患者通过继续遵循以前的治疗方案或者采用修改的方案接着治疗。
图2提供图1所示计划的修改的版本，其中，方法包括修改的治疗方案的实现。在图2中，如上所述，示范方法的第一步骤210是获得剂量施用数据，如药物依从性数据。接着，在步骤220，将所获得的剂量施用数据输入到治疗方案评估器，例如，如下面更详细所述一样。在步骤220之后，评估器在步骤230评定输入数据以确定是否需要改变治疗方案。在决定框240，如果建议不改变方案，则如在步骤250所示，将指导转达到患者以继续当前治疗方案。在步骤250，指导也发送到患者以继续以前治疗方案的实现，例如，通过根据相同的剂量给药安排服用相同的药物成分等。然而，如果在决定框240建议改变方案，则在步骤260形成修改的治疗方案，例如，以改变的药物剂量方案和/或植入式医疗装置活动方案的形式。在步骤270，结果的修改的治疗方案例如通过制成物理药物剂量(如上所述)而根据需要实现。在步骤275，所形成的调整药物剂量方案及其实现随后转达到患者。最后，如在步骤280所示，患者通过继续依从以前的治疗方案或者采用修改的方案及其实现接着治疗。
系统
主题发明还提供的是可用于执行方法一个或多个方面(例如，如上所述的数据评估步骤)的系统。在某些实施例中，系统包括可采用数据评估模块形式的决定工具，例如以评定数据库和运行适当算法的处理器形式，它用作治疗方案评估器以评定输入数据并提供是否需要改变的建议。
在图1中以示意图方式所示的过程中，数据评估模块用作治疗方案评估器以评定输入数据和生成有关是否应该改变方案的建议。如此，数据评估模块执行接收输入信息并响应输入信息生成方案建议信息的功能。
在主题方法中采用的数据评估模块可包括集中剂量施用数据(例如，依从性数据)元素和在存储器(如数据库)中存储的方案建议链接数据元素。模块的数据元素可以任何方便的方式组织。数据评估模块的内容可使用任何方便的计划控制。在某些实施例中，内容可由单个实体维护，例如，在实体最初创建内容并随后定期更新内容的情况下。模块的实施例包括更新的模块，其中模块的内容已在其制造后更新一次或多次，例如，两次或更多次、5次或更多次、10次或更多次、50次或更多次、100次或更多次、1000次或更多次等，其中，更新的内容可以是任何多种不同类型的信息。
图3中示出了包括数据评估模块的系统的实施例。在图3中，系统300包括通信模块320和处理模块330，其中，正如本领域所熟知的一样，每个模块可存在于相同或不同的平台上，例如，服务器。通信模块包括输入管理器322和输出管理器324功能元件。输入管理器322从例如在本地或来自远程位置(如通过因特网)的用户接收信息，例如样本识别器信息。输入管理器322处理并转达此信息到处理模块330。输出管理器324向用户提供由处理模块330汇集的信息，例如，修改的治疗方案。通信模块320可通过通信元件315操作性连接到用户计算机310，而通信元件315为用户提供与系统300进行交互的媒介物。如图3所示的用户计算机310可以是特殊设计和配置成支持并执行任何多种不同应用的计算装置。计算机310也可以是任何多种类型的通用计算机，如个人计算机、网络服务器、工作站或现在或将来开发的其它计算机平台。
如上所述，系统包括在平台上实施特定任务以响应由一个或多个用户引入到系统中的信息的各种功能元件。在图3中，元件332、334和336表示处理模块330的三个不同功能元件。处理模块330的至少一个功能元件332是用于评定剂量施用数据并提供有关是否需要改变治疗剂量方案的功能，并且在本文中方便地称为治疗方案评估器。可存在的另外的功能元件包括但不限于用于确定修改的治疗方案的元件等。
在某些实施例中，系统包括可具有治疗的(如电刺激)和/或感觉的活动的一个或多个可植入装置。此类传感器和系统包括但不限于在受让给本申请受让人的各种申请中描述的那些传感器和系统，其中，这些申请包括但不限于：公布为20040193021，名称为“Method AndSystem For Monitoring And Treating Hemodynamic Parameters”的美国专利申请10/734490；公布为20060058588，名称为“Methods AndApparatus For Tissue Activation And Monitoring”的美国专利申请11/219305；名称为“Implantable Addressable Segmented Electrodes”的国际申请PCT/US2005/046815；名称为“ImplantableAccelerometer-Based Cardiac Wall Position Detector”的美国专利申请11/324196；名称为“Method and Apparatus for Enhancing CardiacPacing”的美国专利申请10/764429；名称为“Methods and Systems forMeasuring Cardiac Parameters”的美国专利申请10/764127；名称为“Method and System for Remote Hemodynamic Monitoring”的美国专利申请10/764125；名称为“Implantable Hermetically Sealed Structures”的国际申请PCT/US2005/046815；名称为“Fiberoptic Tissue MotionSensor”的美国申请11/368259；名称为“Implantable Pressure Sensors”的国际申请PCT/US2004/041430；名称为“Implantable DopplerTomography System”并要求具有美国临时专利申请60/617618的优先权的美国专利申请11/249152；名称为“Cardiac Motion Characterizationby Strain Gauge”的国际申请PCT/USUS05/39535。这些申请通过引用整体结合于本文中。
代表性实施例
在图4中示出了可在对特定疾病病症的特定患者的管理中采用的上述方法和系统的特定代表性实施例。患者410是可能遭受例如心力衰竭、高血压等多种心血管疾病病症的心脏管患者。患者410已植入心血管病医疗装置420，该装置可包括电治疗元件、包括但不限于下述传感器的传感器元件及监视元件中的一个或多个元件。在某些实施例中，监视元件配置成从识别器标记的药物成分获得、存储并转达实际剂量施用信息，例如，如2006年4月28日提交，并在2006年11月2日公布为WO 2006/116718的名称为“Pharma InformaticsSystem”的PCT申请PCT/US2006/016370中所述；以及如以下美国临时申请中所述的此类智能剂量的另外的实施例：60/866581、60/829832、60/887780、60/889868、60/889870、60/889871、60/894171及60/894167；这些申请的公开内容通过引用结合于本文中。另外，患者410根据开出的药物剂量方案，正在服用多个不同的药物430。药物430是识别器标记的药物，例如，其包括在与目标生理部位接触时发射信号的识别IC芯片，如在2006年4月28日提交并在2006年11月2日公布为WO 2006/116718的名称为“Pharma InformaticsSystem”的PCT申请PCT/US2006/016370中所述；以及如在美国临时申请60/866581、60/829832、60/887780、60/889868、60/889,870、60/889871、60/894171及60/894167中所述的此类智能剂量的另外的实施例，这些申请的公开内容通过引用结合于本文中。在图4中也示出了用于将所获得的剂量信息从患者410传播到例如医生办公室等远程位置的调制解调器440。调制解调器440可位于家中位置，例如，在床边，并且连接到因特网，例如，经无线连接，以便数据能在预定的每天时间自动通过调制解调器上载到因特网和其上的指定地址，例如，在预期患者接近调制解调器时，如预期患者在其床上睡觉的3AM。当然，调制解调器440可替换为任何方便的通信元件，如网络中继站等。受关注的是其中元件430、420和440经配置成例如通过药物信息机制已启用的剂量配方的识别器发射的信号而检测剂量施用的可植入的或局部信号接收器元件(例如个人健康伴侣装置)进行通信的实施例，例如在名称为“Signal Receivers for Pharma-lnformaticsSystems”的未决临时申请60/887780中所述；该申请的公开内容通过引用结合于本文中。
中央处理器450包括服务器，服务器包括或能够访问多个不同的信息源，例如，患者数据库、群体信息、亚群信息、患者特定信息等。过程450中存在的数据集或集合可以是原始数据集或以某种方式处理，例如以产生子集或群体(例如，数据类别)。例如，在一段时间期内来自单个患者的依从性数据能够与来自其它个体的数据组合在一起。组合的数据能够经处理以识别在类似的剂量依从性和/或例如健康、年龄、疾病阶段等其它参数下做出类似响应的个体的亚群或趋势。通过使用任何方便的计划，包括使用例如根据预定规则能够自动处理数据并识别趋势或亚群的数据处理算法，可从原始数据识别趋势或亚群。所识别的趋势/亚群随后能够在需要时以多种不同方式运用。例如，假定有患者个体依从性数据，有关给定群体或群体组的信息能由保健专业人员用于帮助通知保健人员以最佳方式治疗特定患者。诸如药物代表等保健专业人员通过帮助470和/或医生490解释从患者410获得的特定依从性数据，能够帮助护士470和/或医生490为患者410做出有见地的治疗方案决定(在该代表从数据集450识别和可获得患者的给定亚群的情况下)。这样，护士470和/或医生490积极地利用销售代表和从数据集450提供给销售代表的知识，为患者410做出单独治疗的治疗方案的决定。
膝上型电脑460是图3中所示的系统300的实施例，并包括决定支持工具，例如如上所述的治疗方案评估器。决定支持工具可访问多种不同类型的信息，如在示范为元件450的数据库中提供的信息、在医生办公室中存在的信息(例如，患者记录)。在某些实施例中，决定支持工具460能够基于数据完成处方和/或生成电子邮件警报。在某些实施例中，决定支持工具460链接到更广的健康或医院信息系统。
在图4中示出了护士450，护士能查看患者警报和个人网页，联系患者或其护理，基于由决定支持工具生成的建议，例如经电话480提供意见和/或安排出诊。
在图4中，医师490执行一个或多个以下任务，例如，查看患者日志，调整电疗，形成档案(profile)，选择药品代替品，调整剂量给药，确认当前方案可接受等。在图4所示实施例中，在医生调整剂量给药时，此信息转达到制造商500。虽然中央的工厂在图4中示出，但剂量给药调整指导能转达到任何方便的配方设计者，例如，医院或独立的药房，或甚至家庭配方装置。制造商500响应医生490提供的剂量给药信息，根据订单制造如医生490指定的对患者410特别制作的药品，例如，在48小时周期内。如元件510所示，制造的物理剂量随后例如通过快递直接转达给患者。
编程
本发明也提供用于实践方法的编程，例如，以计算机程序产品的形式。根据本发明的编程能记录在计算机可读媒体上，例如，能直接由计算机读取和访问的任何媒体。此类媒体包括但不限于：磁性存储媒体，如软盘、硬盘存储媒体和磁带；光学存储媒体，如CD-ROM；电存储媒体，如RAM、ROM、闪盘、微驱动器；以及这些类别的混合，如磁性/光学存储媒体。本领域的技术人员能够轻松理解任何目前已知的计算机可读媒体能如何用于创建包括用于实施上述方法的本编程/算法的记录的制品。
效用
本发明向临床医生在他们的治疗医疗设备中提供了重要的新工具，即，以患者特定的方式定制治疗方案的能力。本发明允许基于实际剂量施用信息形成和修改治疗方案，而实际剂量施用信息能以附加的剂量相关信息补充，如附加的生理参数、生活方式信息等。这样，临床医生可制定患者特定的定制的最优治疗方案。多个益处可由本发明的实现而产生，包括但不限于以下的一项或多项：降低医疗差错，例如，如能够在变化的依从性环境中使用标准化治疗方案产生的那些差错；由于差错将降低，因而减少了责任等。
主题成分和系统在其中使用的一种类型的应用是监视患者对开出的治疗方案的依从性。监视患者依从性是指跟踪患者是否确实在以向患者开出的方式服药。如此，本发明提供了何时已服用药丸和已服用哪种药丸的精确数据。这允许精确地确定在特定的时间点服用了哪种药丸。此类监视能力确保患者正在正确地服用处方药。此信息避免了过量开出实际上未服用的药剂的可能性。例如，如果预期要给患者施用止痛药，则通过本发明验证患者确实实际上在某个时间期内服用那些止痛药是可能的。此认识是限制向无意的一方不当地销售未消耗药品的重要工具。在使用心血管药丸的情况下，临床医生或护理能够验证服用的药品量已在大约正确的点和时间服用。因此，能够准确地评估药品的真实功效。正确的施用和患者依从性对阿尔茨海默氏病的、精神病的和戒酒的药品及其余家庭成员的治疗中特别重要。在出现意外或其它服药过量情况下，介入的临床医生将能够辨别食入已发生到什么程度，以及涉及的药丸是多少。
在本发明更复杂的实施例中，正确、及时食入药品将自动触发处方重填信号，该信号将转达到药房数据系统，并且在一些情况下重填将自动直接输送到患者家中，或者由患者家中的装置在一段时间期后发布。此特征对于具有脑力功能受损和/或身体移动受限的患者特别有价值。
本发明对于复杂的施用方案特别有用，如在服用多种药物并且更可能发生混淆时。发明性药丸能够具有多个外层，仅具有允许分解和吸收药物成分的正确剂量。例如响应药物的血液中的电解水平或心脏中的导电速度(electrical conduction velocity)等特定指标也能够滴定。
在某些实施例中，在患者以某些方式不依从给定治疗方案时，能警告患者。例如，通过声音、视觉或计算机提醒，如果未在准确地坚持药物方案，则提供提醒。如果该提醒未得到准确响应，则系统能向家庭成员、护理或临床医生提供警报以便补救服药过量或治疗中的差异。装置也可自动修改方案的剂量和时机以补偿以前的非标准剂量给药。
主题成分和系统在其中使用的一种类型的应用是基于患者依从性制作治疗方案。在此类应用中，获得的有关患者是否已服用特定剂量的数据用于确定将来的剂量和/或此类剂量的时机。在某些实施例中，有关患者依从性的数据与例如所感测的生理数据等另外的数据组合，以对给定治疗方案进行定制的改变或修改。例如，根据本发明获得的有关剂量依从性的数据与其它医疗感测装置结合使用时，药品输送、批量与剂量之间的关联可与生理反应相关。这样，临床医生可制定最优的药物治疗方案。例如，心脏刺激药品能够滴定到最适当的剂量，从而将诸如心肌衰竭和反弹效应及其它等副作用降到最低，并为每个单独的患者优化剂量和时机。
通过本发明，多个备选药剂的评定成为可能，而无需等待治疗的显性临床后遗症，这些后遗症大多数会有严重的不利后果。例如，积极效用将可快速断定而不会被更多随机因素所混淆。因为药品相关或独立于背景生理变化之上，诸如血压改变等负面反应将变得十分明显。
在一个临床场所，本发明允许结合本发明一些发明者开发的其它感测装置，测量和评估这些药剂的心脏反应。除其它装置外，这些共同采用的感测装置还能够是下面列举的那些装置。由本发明一些发明者开发的例如如上所述的其它感测技术允许测量心脏健康和心效率。通过将这些工具与本发明装置结合使用，临床医生将能够比较心脏和身体对施用的药物的反应。本发明提供的数据能够随时间选择性地记录。记录系统记录通过心脏组织的信号的同步或传导速度，以及如何通过某个药剂的存在而调和该速度。此独特的数据通过本发明而可能提供。
在更标准的临床环境中，此独特的数据允许仔细的选择和滴定药品施用，而无需更显性的身体症状来断定禁忌、功效和最优剂量水平。本发明在患者住院时为急诊室技师或医生提供记录，使得患者的状态能得到准确地断定。住院前最后时刻或最后一天内的剂量事件和最后药剂的标识将可立即得到。如此，将来的治疗方案能基于患者药品药剂历史的准确记录而做出。
外部报告设备的患者监视能力是本发明装置能够提供的重要功能。在结合内部或外部生理感测数据时，装置能读出患者对食入药剂的生理反应，并随后将此信息发射回临床医生。临床医生随后能如新数据所指示，将治疗修改为最优效果，以响应修改的治疗等等。
在本发明更精细的实施例中，某些参数内的剂量调整功能能由设备中的智能电路执行。例如，对于血压药剂，患者服用其血压药丸。20分钟后，可植入装置中的内部监视电路记录血压下降。电路将此下降量化，并将它发射到此床边的设备。设备随后能调整药丸的剂量以便以最优方式治疗患者。类似地，在患者连接到IV时，剂量能直接配给到IV液中。在某些实施例中，闭环系统作为完全可植入装置提供。
当前用于药品治疗优化的临床实践与使用本发明装置可获得的临床实践相比，受到了大得多的限制。目前，血压药剂治疗每天要服用太多的药丸。由于反馈环特别慢，因此，此类迟钝的剂量方案要很长时间才适当地优化。与此相反，通过本发明，对药物剂量的生理反应的反馈环特别快，且特别有效。最后，本发明允许逐日(或者更精细地)制作药品剂量，以计及活动改变、患者中的生理病症改变及其它剂量参数。
在本发明更精细的实施例中，也将继续监视对特定剂量和时间间隔的生理反应。在一些实施例中，监视血流中的药的水平，从而允许药品新陈代谢的单个和时间的日变化。
本方面的此方面有效地将受控物质的剂量不足或过量降到最低，一些情况下在它们产生对患者或临床医生明显的外部症状前解决了这些改变。药品剂量能自动滴定，以便例如将配给最小的适当的水平以抑制由于疼痛引起的焦虑、对疼痛的其它生理反应，或者提供稳定或逐渐消失的药品的血浓度。本发明的此特征提供了药品的自动的、适当的逐渐脱离，从而减少严重上瘾或严重的不利停药反应的可能性。
套件
还提供有用于实践主题方法的套件。套件可包括如上所述的一个或多个组件，例如，智能包装剂量、智能药物成分、接收器和调制解调器、计算机编程等。
主题套件也可包括关于使用套件的组件如何实践主题方法的指导。指导可记录在适合的记录媒体或基质上。例如，指导可印刷在诸如纸张或塑料等基质上。如此，指导可在套件中作为包装插入物存在于套件中，存在于套件或其组件的容器的标签中(即，与包装或分包装相关联)等。在其它实施例中，指导作为电子存储数据文件存在于例如CD-ROM、磁盘等适合的计算机可读存储媒体上。在仍有的其它实施例中，实际的指导在套件中不存在，而提供的是用于从远程源获得指导的方式，例如，经因特网。此实施例的示例是包括网址的套件，通过该网址能够查看指导和/或从其下载指导。与指导一样，用于获得指导的此方式记录在适合的基质上。
主题套件的一些或所有组件可包装在适合的包装中以保持无菌状态。在主题套件的许多实施例中，套件的组件包装在套件包容元件中以形成单个的，易于携带的单元，其中，例如盒或类似结构的套件包容元件可以是或不是气密容器(例如，用于进一步保持套件的一些或所有组件的无菌状态)。
应理解，本发明并不限于所述特定实施例，因为此类实施例可进行变化。也应理解，由于本发明的范围将只受所附权利要求的限制，因此，本文中使用的术语只是为了描述特定实施例，而无意于限制。
在提供值的范围的情况下，应理解，除非上下文另有明确说明，否则，在该范围上下界限之间到下界限单位十分之一的每个居中值和该所陈述范围中任何其它所陈述的或居中的值包含在本发明内。这些更小范围的上下界限可独立包括在更小范围中，并且也包含在本发明内，从属于所陈述的范围中任何明确排除的界限。在陈述的范围包括界限之一或两者的情况下，排除那些所包括的界限任意之一或两者的范围也包括在本发明中。
某些范围在本文中通过前面带有术语“大约”的数值表述。术语“大约”在本文中用于为它之后的确切数字以及接近或近似该术语之后的数字的数字提供字面支持。在确定数字是否接近或近似明确所记载的数字方面，接近或近似的未记载的数字可以是在其中陈述它的上下文中提供明确记载的数字的基本上的等同物的数字。
除非另有规定，否则，本文使用的所有技术和科学术语具有与本发明所属领域的技术人员通常理解的相同含意。虽然类似或等效于本文中所述的任何方法和材料也能够在本发明的实践或测试中使用，但代表性说明性方法和材料现在已描述。
此说明书中引用的所有公开和专利通过引用结合于本文中，就好象每个单独的公开或专利明确地并单独地指示为通过引用结合一样，并且通过引用结合于本文中以公开和描述引用这些公开结合的方法和/或材料。任何公开的引用是关于提交日前的其公开内容，并不应视为承认本发明由于以前的发明无权早于此类公开。此外，提供的公开的日期可能不同于实际的公开日期，这些日期可能需要独立确认。
注意，除非上下文明确指明，否则，在本文和所附权利要求中使用时，单数形式“一”包括复数对象。还要注意的是，权利要求可草拟为排除任何可选元件。如此，此声明旨在用作结合权利要求元素的记载而使用诸如“唯一”、“仅”及诸如此类的此类排斥性术语或使用“否定”限制的前置基础。
正如本领域的技术人员在阅读此公开时将明白的一样，在不脱离本发明范围或实质的情况下，本文所述和所示每个单独的实施例具有可轻松与任何其它几个实施例的特征分开或组合的特征和分离的组件。任何记载的方法能以所记载的事件的顺序或逻辑上可能的任何其它顺序实施。
虽然为便于清楚地理解而以一定的细节通过示图和示例的方式描述了上述发明，但本领域的技术人员将轻松地明白，根据本发明的教导，在不脱离所附权利要求实质或范围的情况下，可对其进行某些改变和修改。
因此，前述内容只是示出本发明的原理。将理解，本领域的技术人员将能够设计各种设置，这些设置虽然未在本文中明确描述或示出，但体现本发明的原理并且包括在其实质和范围内。此外，本文记载的所有示例和条件的语言原则上旨在帮助读者理解发明者贡献的概念和发明的原理以促进技术，并且要视为不限于这些明确记载的示例和条件。另外，本文中记载本发明的原理、方面和实施例的所有声明及其特定示例旨在涵盖其所有的结构的和功能的等同物。另外，此类等同物旨在包括当前已知等同物和将来开发的等同物，即，所开发的执行相同功能的任何元件，而无论结构如何。本发明的范围因此无意限于本文所示和所述的示范实施例。相反，本发明的范围和实质由所附权利要求体现。

Claims (32)

1.一种针对病症治疗患者的方法，所述方法包括：
(a)获得关于对所述患者的药用成分的施用的确定性数据，其中：
(i)所述患者在进行用于治疗所述病症的治疗方案；以及
(ii)所述确定性数据由第一装置产生并发射到第二装置，其中所述第一和第二装置均与所述患者的身体相关联；
(b)评估所述确定性数据以确定何时需要改变所述治疗方案；以及
(c)如果确定需要改变，则调整所述治疗方案。
2.如权利要求1所述的方法，其中所述确定性数据由所述第二装置记录。
3.如权利要求1所述的方法，其中所述第一和第二装置电耦合到所述身体。
4.如权利要求1所述的方法，其中通过建立所述第一与第二装置之间的电流，所述确定性数据从所述第一装置发射到所述第二装置。
5.如权利要求4所述的方法，其中所述电流被限制在所述第一和第二装置和所述身体之间。
6.如权利要求4所述的方法，其中所述电流被限制在所述第一与第二装置之间，并且其中所述第一与第二装置的每个电容性耦合到所述患者外部的导体或地。
7.如权利要求1所述的方法，其中所述确定性数据是自动获得。
8.如权利要求1所述的方法，其中所述第一和第二装置是不同类型的装置。
9.如权利要求8所述的方法，其中所述第一装置包括活性剂。
10.如权利要求9所述的方法，所述第二装置不包括活性剂。
11.如权利要求10所述的方法，其中所述方法还包括将第二组的确定性数据从第三装置发射到所述第二装置。
12.如权利要求11所述的方法，其中所述第三装置包括活性剂。
13.如权利要求1所述的方法，其中所述药用成分从由药品、维生素、盐水、输液、透析液和抗酸剂组成的组中选择。
14.如权利要求1所述的方法，其中所述第一装置包括与药物成本相关联的识别器，其中所述识别器在与所述患者的目标生理部位接触时，产生所述确定性数据。
15.如权利要求1所述的方法，其中所述评估包括将所述数据输入决定支持工具，并从所述决定支持工具获得基于所述确定性数据的有关所述治疗方案是否需要改变的建议。
16.如权利要求15所述的方法，其中所述评估还包括评定从所述患者获得的生理数据。
17.如权利要求15所述的方法，其中所述评估还包括评定从所述患者获得的生活方式信息。
18.如权利要求1所述的方法，其中所述方法还包括将所述确定性数据从所述患者转达到第二位置。
19.如权利要求18所述的方法，其中所述第二位置是远程位置。
20.如权利要求15所述的方法，其中所述方法还包括向保健人员提供建议，所述保健人员查看所述建议以确定是否要进行所述治疗方案的改变。
21.如权利要求20所述的方法，其中响应所述建议，所述保健人员调整所述治疗方案并向所述患者传递调整的治疗方案。
22.如权利要求21所述的方法，其中所述调整的治疗方案包括改变药物剂量方案。
23.如权利要求22所述的方法，其中所述药物剂量方案的所述改变包括药物制剂的量的改变。
24.如权利要求22所述的方法，其中所述药物剂量方案的所述改变包括对所述患者施用的至少一种类型的药物制剂的改变。
25.如权利要求20所述的方法，其中所述方法还包括制备包括一种或多种活性剂的物理药物剂量，并将所述物理药物剂量转达给所述患者。
26.如权利要求25所述的方法，其中所述物理药物剂量包括两种或更多种不同的成分。
27.如权利要求25所述的方法，其中所述物理药物剂量包括含有两种或更多种活性剂的成分。
28.如权利要求27所述的方法，其中所述成分响应所述治疗方案的所述调整而制造。
29.如权利要求25所述的方法，其中所述物理药物剂量的所述成分包括剂量施用依从性识别器。
30.一种用于针对病症治疗患者的系统，所述系统包括：
(a)输入管理器，用于接收关于对患者的药用成分的施用的确定性数据；
(b)处理模块，包括治疗方案评估器，配置成基于接收的确定性数据评定治疗方案以确定治疗方案的改变是否合乎需要，并基于所述确定提供建议；以及
(c)输出管理器，用于向用户提供所述建议。
31.一种针对病症治疗患者的方法，所述方法包括：
将从所述患者接收的确定性数据输入到如权利要求30所述的系统；以及
从所述系统获得建议并根据所述建议治疗所述患者。
32.一种计算机程序产品，包括其上存储有计算机程序的计算机可读存储媒体，其中所述计算机程序当加载到计算机上时，操作所述计算机以：
(a)接收关于对患者的药用成分的施用的确定性数据；
(b)考虑所述确定性数据评定所述患者的治疗方案以确定治疗方案中的改变是否合乎需要，并基于所述确定提供建议；以及
(c)向用户提供所述建议。
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