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WO2009037305A1 - Procédé permettant de déterminer un échec thérapeutique secondaire - Google Patents

Procédé permettant de déterminer un échec thérapeutique secondaire Download PDF

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Publication number
WO2009037305A1
WO2009037305A1 PCT/EP2008/062430 EP2008062430W WO2009037305A1 WO 2009037305 A1 WO2009037305 A1 WO 2009037305A1 EP 2008062430 W EP2008062430 W EP 2008062430W WO 2009037305 A1 WO2009037305 A1 WO 2009037305A1
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WO
WIPO (PCT)
Prior art keywords
values
months
severity
days
neurotoxins
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2008/062430
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German (de)
English (en)
Inventor
Harald Hefter
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of WO2009037305A1 publication Critical patent/WO2009037305A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271—Specific aspects of physiological measurement analysis
    • A61B5/7275—Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
    • 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
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients

Definitions

  • the present invention relates to a novel method for the determination of secondary treatment failure in the treatment with neurotoxins.
  • the object of the present invention is to provide a simple yet sensitive and reliable assay for the determination of secondary treatment failure without the in vitro detection of neutralizing antibodies.
  • This object is achieved by a method for determining a secondary treatment failure with continuous treatment with Neurotoxi- NEN, where a) over a period of more than 12 months at intervals between 2 and 4 months, the severity of the disease via standardized parameters is collected; b) the measured values from a) are compared with values from a standard patient collective; and c) where a systematic trend towards higher percentiles and / or an increase in the systematic trend by more than one and a half times the standard deviation indicates a secondary treatment failure.
  • the method according to the invention for the first time offers a simple routine control which significantly increases the safety of the determination of secondary therapy failures compared with the known and expensive procedures.
  • continuous treatment with neurotoxins is understood here and in the following to mean that the patients who are examined with the method according to the invention are already undergoing parallel medical treatment.
  • the method according to the invention dispenses with medical measures and is based only on the standardized method Measurement of Biophysical Parameters and Their Computational Evaluation The method according to the invention is therefore not a therapeutic method.
  • the term "ascertaining the severity of the disease via standardized parameters” is understood here and below to mean that the severity of the disease is determined by biophysical parameters which have proved to be characteristic for the clinical picture.
  • values of a standard patient collective is understood here and below to mean that the values of at least 30 unselected patients have been recorded.
  • the period is between 12 and 36 months.
  • the values are taken when the treatment with neurotoxins begins. It has proven to be particularly favorable if the intervals between the neurotoxin treatments and the determination of the degree of severity according to a) do not differ by more than 7 days, in particular by not more than 4 days. In this way, very reliable values can be obtained very early.
  • the standardized values are scores validated according to the invention (score values), electrophysiological measurements (e.g., joint angles or positions in space) or videographies determined under standard conditions.
  • scores validated according to the invention are scores validated according to the invention (score values), electrophysiological measurements (e.g., joint angles or positions in space) or videographies determined under standard conditions.
  • electrophysiological measurements e.g., joint angles or positions in space
  • videographys determined under standard conditions.
  • TSU I values are the so-called "TSU I values”.
  • the intervals between the individual intervals do not differ by more than 7 days.
  • the determination of the degree of severity is independent of the time of treatment (injection). Decisive is the regular determination of the severity. The lower the deviation in the interval of determination of the severity, the higher the significance of the presence of secondary treatment failure.
  • steps b) and c) are carried out according to the invention with a computer-assisted system.
  • the TSUI scores were determined on the day of injection prior to this. The injections were made every three months. The treatment period is 30 months.
  • the temporal evolution of the TSU I mean values with standard deviations of a standard patient collective is shown (vertical lines).
  • the regression lines of four consecutive TSU I values are additionally shown here.
  • the first regression line already covers a percentile range of more than one-and-a-half times the standard deviation.
  • the second regression line also covers a percentile range of more than one and a half times the standard deviation.
  • the third regression line even covers a range of more than two standard deviations.
  • the temporal evolution of the severity of cervical dystonia is shown as a percentage of the baseline for a standard population, i. the TSUI values are calculated as a percentage of the output TS U I value.
  • the mean value of the initial situation is 100 percent and the dispersion is zero. Only for the other values are relative mean values and standard deviations (vertical lines) and percentiles shown (the 2nd and 98th percentiles are shown in broken lines, the 33rd and 66th percentiles are shown in solid lines, and the 50th percentile is shown in bold).
  • the temporal development of the relative TSUI values of a patient with secondary treatment failure is shown by dashed lines, ie by a patient who after seven treatments no longer shows any clinical effect despite increasing the dose.
  • the relative TSUI value is permanently outside the normal range (2-fold standard deviation).
  • the regression lines of four consecutive relative TSU I values are also shown here.
  • the first regression straight covers a percentile range of more than one and a half times the standard deviation.
  • the second regression line also clearly outshines a percentile range of more than one-and-a-half times the standard deviation.
  • the third regression line clearly covers a range of more than two standard deviations.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Primary Health Care (AREA)
  • Artificial Intelligence (AREA)
  • Computer Vision & Pattern Recognition (AREA)
  • Physiology (AREA)
  • Psychiatry (AREA)
  • Signal Processing (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

L'invention concerne un procédé permettant de déterminer un échec thérapeutique secondaire au cours d'un traitement continu par neurotoxines. Selon le procédé, le degré de gravité de la maladie est relevé au moyen de paramètres type, tous les 2, 3 ou 4 mois, pendant une période de plus de 12 mois; les valeurs mesurées sont comparées à des valeurs d'un groupe de patients type et une tendance systématique à des percentiles supérieurs et/ou une augmentation de la tendance systématique de plus d'une fois et demi l'écart type indique un échec thérapeutique secondaire.
PCT/EP2008/062430 2007-09-19 2008-09-18 Procédé permettant de déterminer un échec thérapeutique secondaire Ceased WO2009037305A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102007044919.6 2007-09-19
DE102007044919A DE102007044919A1 (de) 2007-09-19 2007-09-19 Verfahren zur Bestimmung von sekundärem Therapieversagen

Publications (1)

Publication Number Publication Date
WO2009037305A1 true WO2009037305A1 (fr) 2009-03-26

Family

ID=40328413

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2008/062430 Ceased WO2009037305A1 (fr) 2007-09-19 2008-09-18 Procédé permettant de déterminer un échec thérapeutique secondaire

Country Status (2)

Country Link
DE (1) DE102007044919A1 (fr)
WO (1) WO2009037305A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998032088A1 (fr) * 1997-01-15 1998-07-23 Chiron Corporation Procede et dispositif pour prevoir des resultats therapeutiques
WO2003079137A2 (fr) * 2001-12-28 2003-09-25 Modrovich Ivan Endre Systemes d'informations de diagnostic

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1384199A2 (fr) * 2000-12-07 2004-01-28 Ronald E. Kates Procede de determination de risques concomitants
EP1352607A1 (fr) * 2002-04-10 2003-10-15 Siemens Aktiengesellschaft Méthode et système de surveillance de la progression thérapeutique d'un traitement médical
WO2005081161A2 (fr) * 2004-02-18 2005-09-01 Siemens Aktiengesellschaft Procede de controle de la qualite de jeux de donnees medicales recueillies dans le cadre d'un protocole medical et concernant dans chaque cas des collectifs de patients differents, mais comparables
WO2006042149A2 (fr) * 2004-10-06 2006-04-20 Allergan, Inc. Determination et reduction de l'immunoresistance a la therapie de la toxine botulinique a l'aide de peptides de la toxine botulinique de type a
WO2006110264A2 (fr) * 2005-03-16 2006-10-19 Sidney Kimmel Cancer Center Procedes et compositions permettant de predire le deces du au cancer et la survie au cancer de la prostate a l'aide de signatures d'expression genique

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998032088A1 (fr) * 1997-01-15 1998-07-23 Chiron Corporation Procede et dispositif pour prevoir des resultats therapeutiques
WO2003079137A2 (fr) * 2001-12-28 2003-09-25 Modrovich Ivan Endre Systemes d'informations de diagnostic

Also Published As

Publication number Publication date
DE102007044919A1 (de) 2009-04-02

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