Method for evaluating and method for monitoring therapeutic effect in critical limb ischemia patient who has undergone angiogenic therapy, reagent for evaluating therapeutic effect, and device and computer program for evaluating therapeutic effect

Patent metadata

Field	Value
Publication number	US-2020326351-A1
Application number	US-201716304681-A
Country	US
Kind code	A1
Filing date	May 24, 2017
Priority date	May 26, 2016
Publication date	Oct 15, 2020
Grant date	—

Abstract

Provided is a method whereby therapeutic effect in a critical limb ischemia patient after angiogenic therapy can be objectively evaluated with minimal patient burden. The problem addressed by the present invention is solved by a method for evaluating a therapeutic effect in a critical limb ischemia patient who has undergone angiogenic therapy. The evaluation method includes, a measurement step for measuring a VEGF-A 165 b concentration in a blood of the critical limb ischemia patient and an evaluation step for evaluating the therapeutic effect taking changes over time in the measured VEGF-A 165 b concentration as an indicator.

First claim

1 - 15 . (canceled)

16 . A method for evaluating a therapeutic effect in a critical limb ischemia patient who has undergone angiogenic therapy wherein the evaluation method includes:
a measurement step for measuring a VEGF-A 165 b concentration in a blood of the critical limb ischemia patient, and an evaluation step for evaluating the therapeutic effect taking changes over time in the measured VEGF-A 165 b concentration as an indicator.

17 . The evaluation method according to claim 16 , wherein:
the evaluation step evaluates the therapeutic effect to be present when the VEGF-A 165 b concentration rises temporarily after angiogenic therapy above that before angiogenic therapy, then decreases below that before angiogenic therapy.

18 . The evaluation method according to claim 16 , wherein:
the measurement step measures the VEGF-A 165 b concentration and the total VEGF-A concentration in the blood of the critical limb ischemia patient, and the evaluation step uses the changes over time in the VEGF-A 165 b concentration/total VEGF-A concentration ratio measured as the indicator.

19 . The evaluation method according to claim 16 , wherein:
the greater the percentage decrease in the VEGF-A 165 b concentration a predetermined time after angiogenic therapy in comparison to the VEGF-A 165 b concentration before angiogenic therapy, the higher the evaluation step evaluates the therapeutic effect to be.

20 . The evaluation method according to claim 17 , wherein:
the greater the percentage decrease in the VEGF-A 165 b concentration a predetermined time after angiogenic therapy in comparison to the VEGF-A 165 b concentration before angiogenic therapy, the higher the evaluation step evaluates the therapeutic effect to be.

21 . The evaluation method according to claim 18 , wherein:
the greater the percentage decrease in the VEGF-A 165 b concentration/total VEGF-A concentration ratio a predetermined time after angiogenic therapy in comparison to the VEGF-A 165 b concentration/total VEGF-A concentration before angiogenic therapy, the higher the evaluation step evaluates the therapeutic effect to be.

22 . The evaluation method according to claim 19 , wherein:
the evaluation step evaluates a therapeutic effect to be present when the percentage decrease is greater than a predetermined standard value.

23 . The evaluation method according to claim 20 , wherein:
the evaluation step evaluates a therapeutic effect to be present when the percentage decrease is greater than a predetermined standard value.

24 . The evaluation method according to claim 21 , wherein:
the evaluation step evaluates a therapeutic effect to be present when the percentage decrease is greater than a predetermined standard value.

25 . A method for monitoring a therapeutic effect in a critical limb ischemia patient who has undergone angiogenic therapy wherein the monitoring method includes:
a first measurement step to measure a VEGF-A 165 b concentration in a blood of the patient before angiogenic therapy, a second measurement step to measure the VEGF-A 165 b concentration in the blood of the patient after angiogenic therapy, and a step to evaluate the therapeutic effect of angiogenic therapy in the patient based on the results of the first measurement step and the second measurement step.

26 . The monitoring method according to claim 25 , wherein:
a therapeutic effect of angiogenic therapy is evaluated to be present in the patient when the VEGF-A 165 b concentration measured in the second measurement step is lower than the VEGF-A 165 b concentration measured in the first measurement step.

27 . The monitoring method according to claim 25 , wherein:
VEGF-A 165 a is also measured in the first measurement step, VEGF-A 165 a is also measured in the second measurement step, a first ratio=(VEGF-A 165 b concentration measured in first measurement step)/(total of VEGF-A 165 a concentration and VEGF-A 165 b concentration measured in first measurement step) is calculated prior to the evaluation step, a second ratio=(VEGF-A 165 b concentration measured in second measurement step)/(total of VEGF-A 165 a concentration and VEGF-A 165 b concentration measured in second measurement step) is calculated prior to the evaluation step, and a therapeutic effect of angiogenic therapy is evaluated to be present in the patient when a value of the second ratio is lower than the value of the first ratio in the evaluation step.

28 . The monitoring method according to claim 25 , wherein:
total VEGF-A concentration is also measured in the first measurement step, total VEGF-A concentration is also measured in the second measurement step, a first ratio=(VEGF-A 165 b concentration measured in first measurement step)/(total VEGF-A concentration measured in first measurement step) is calculated prior to the evaluation step, a second ratio=(VEGF-A 165 b concentration measured in second measurement step)/(total VEGF-A concentration measured in second measurement step) is calculated prior to the evaluation step, and a therapeutic effect of angiogenic therapy is evaluated to be present in the patient when the value of the second ratio is lower than the value of the first ratio.

29 . The monitoring method according to any of claim 25 , wherein:
the second measurement step is performed approximately one month after angiogenic therapy.

30 . The monitoring method according to any of claim 26 , wherein:
the second measurement step is performed approximately one month after angiogenic therapy.

31 . The monitoring method according to any of claim 27 , wherein:
the second measurement step is performed approximately one month after angiogenic therapy.

32 . The monitoring method according to any of claim 28 , wherein:
the second measurement step is performed approximately one month after angiogenic therapy.

Assignees

• Univ Nagoya Nat Univ Corp

Inventors

• Kikuchi Ryosuke
• Kondo Kazuhisa
• Murohara Toyoaki

Classifications

• G01N33/5008 Primary

  for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics · CPC title

• G01N2333/515

  Angiogenesic factors; Angiogenin · CPC title

• G01N2800/32

  Cardiovascular disorders · CPC title

• G01N33/68 Primary

  involving proteins, peptides or amino acids {(involving lipoproteins G01N33/92)} · CPC title

• G01N2800/52

  Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis · CPC title