System for use in treating a patient with FK 506 to prevent an adverse immune response

• US 5,542,436 A
• Filed: 06/03/1994
• Issued: 08/06/1996
• Est. Priority Date: 08/21/1992
• Status: Expired due to Fees

• Current Assignee: John P. Mcmichael
• Original Assignee: John P. Mcmichael
• Inventors: McMichael, John P.
• Primary Examiner(s): Sykes, Angela D.
• Application Number:
  US08/253,661
• Time in Patent Office: 795 Days
• Field of Search: 128/897-8, 364/413.01-.02, 540/455
• US Class Current: 128/897
• CPC Class Codes: A61K 49/0004 Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions

Abstract

A method and system for use in treating a patient with FK 506 to prevent an adverse immune response, either a rejection of a transplanted organ or an attack on the patient'"'"'s body by its own immune system caused by an autoimmune disease, without unduly suppressing the ability of the patient'"'"'s immune system to combat infection. The method employs an expert system to provide non-numerical information concerning the course of action to be taken with respect to a patient'"'"'s FK 506 treatment, at a given time, including, in particular, an instruction on whether the FK 506 dosage being administered to the patient should be changed, and if so how. That instruction is determined by the expert system through analysis of standardized characterizations assigned to standardized patient examination criteria provided to the expert system. The method also determines the actual numerical FK 506 dosage the patient should receive at a given time.

Claims

1. An expert system for providing treatment information pertaining to a patient receiving FK 506 to prevent an adverse immune response by partially suppressing the patient'"'"'s immune system without unduly suppressing the ability of the immune system to combat infection, the system comprising:

(a) an input means;

(b) an output means;

(c) a storage means having a knowledge base comprising rules including one of a plurality of treatment instructions in response to at least one of various combinations of a plurality of characterizations which can be assigned to a plurality of patient examination criteria; and

an expert computer program including a first routine for prompting, through the output means, a user to enter, through the input means, the characterizations assigned to the patient examination criteria;

a second routine for selecting the treatment instruction by locating a rule which covers the characterizations assigned to the patient examination criteria; and

a third routine for communicating to the output means the treatment instruction; and

(d) a processor.

2. An expert system according to claim 1, wherein the patient examination criteria comprise a toxicity criterion, a rejection criterion and an FK 506 blood plasma level criterion.

3. An expert system according to claim 1, wherein the patient examination criteria comprise a toxicity criterion, a rejection criterion, an FK 506 blood plasma level criterion, a creatinine level criterion, a bilirubin level criterion, and a SGOT and SGPT levels criterion.

4. An expert system according to claim 1, wherein the patient examination criteria comprise a toxicity criterion, a desired effect criterion and an FK 506 level blood plasma criterion.

5. An expert system according to claim 1, further comprising a means for determining a next FK 506 dosage to be administered to the patient, when the treatment instruction requires that the FK 506 dosage be changed.

6. An expert system according to claim 5, wherein the means for determining a next FK 506 dosage comprises a knowledge base comprising rules including one of a finite number of values for a decreased next FK 506 dosage in response to at least one of various combinations of characterizations which can be assigned to an FK 506 blood plasma level criterion and values for the patient'"'"'s current FK 506 dosage;

and

additional expert computer program routines, including a first additional routine for prompting, through the output means, a user to enter, through the input means, the patient'"'"'s current FK 506 dosage;

a second additional routine for selecting the decreased next FK 506 dosage by locating a rule which covers the patient'"'"'s current FK 506 dosage and the characterization assigned to the FK 506 blood plasma level criterion; and

a third additional routine for communicating the next FK 506 dosage to the output means.

7. An expert system according to claim 5, wherein the means for determining a next FK 506 dosage comprises a knowledge base comprising rules including one of a finite number of values for the next FK 506 dosage in response to at least one of various combinations of values for the patient'"'"'s current FK 506 dosage, the patient'"'"'s current FK 506 blood plasma level and a desired FK 506 level for the patient;

and

additional expert computer program routines, including a first additional routine for prompting, through the output means, a user to enter, through the input means, the patient'"'"'s current FK 506 dosage, the patient'"'"'s current FK 506 blood plasma level and the desired FK 506 level for the patient;

a second additional routine for selecting the next FK 506 dosage by locating a rule which covers the patient'"'"'s current FK 506 dosage, the patient'"'"'s current FK 506 blood plasma level and the desired FK 506 level for the patient; and

a third additional routine for communicating the next FK 506 dosage to the output means.

8. An expert system according to claim 5, wherein the means for determining a the next FK 506 dosage means comprises a first additional expert computer program routine for prompting, through the output means, a user to enter, through the input means, the patient'"'"'s current FK 506 dosage, the patient'"'"'s current FK 506 blood plasma level, and a desired FK 506 level for the patient;

a second additional expert computer program routine for determining the next FK 506 dosage by employing the following relationship;

space="preserve" listing-type="equation">ND=CD-((((CL-DL)/CL)/(1+(CD/40)))CD),

wherein,

ND=the next FK 506 dosage,

CD=the patient'"'"'s current FK 506 dosage,

CL=the patient'"'"'s current FK 506 blood plasma level, and

DL=the desired FK 506 blood plasma level for the patient; and

a third additional expert computer program routine for communicating the next FK 506 dosage to the output means.

9. An expert system according to claim 5, wherein the means for determining a next FK 506 dosage comprises a first additional expert computer program routine for prompting, through the output means, a user to enter, through the input means, the patient'"'"'s current FK dosage, the patient'"'"'s current FK 506 blood plasma level, and a potential next FK 506 dosage;

a second additional expert computer program routine for determining a potential desired level by employing the following relationship;

space="preserve" listing-type="equation">PDL=(((PND-CD)/CD)(1+(CD/40)) (CL))+CL

wherein,

PND=the potential next FK 506 dosage,

CD=the patient'"'"'s current FK 506 dosage,

CL=the patient'"'"'s current FK 506 blood plasma level, and

PDL=the potential desired FK 506 level; and

a third additional expert computer program routine for communicating the potential desired FK 506 level to the output means.

10. An expert system according to claim 1, further comprising a means for determining and communicating to the output means comments concerning potential problems, and means for solving those problems which cannot be corrected by an FK 506 treatment.

11. An expert system according to claim 1, further comprising a means for determining and communicating to the output means a prednisone treatment instruction which comprises a prednisone treatment instruction knowledge base comprising prednisone treatment instruction rules including one of a plurality of prednisone treatment instructions in response to at least one of various combinations of characterizations which can be assigned to a prednisone dosage criterion and an efficacy criterion;

and

additional expert computer program routines including a first additional expert computer program routine for selecting the next prednisone dosage by locating a rule which covers the characterizations assigned to the prednisone dosage criterion and the efficacy criterion; and

a second additional expert computer program routine for communicating the prednisone treatment instruction to the output means.

12. An expert system according to claim 4, wherein the expert computer program is written for an organ transplant patient and the efficacy criterion is a rejection criterion.

13. An expert system according to claim 11, wherein the expert computer program is written for a patient who is afflicted with an autoimmune disease and the efficacy criterion is a desired effect criterion.

14. An expert system according to claim 11, further comprising a means for determining a next prednisone dosage, when a decrease in the prednisone dosage is required by the prednisone treatment instruction.

15. An expert system according to claim 1, further comprising a means for determining and communicating to the output means at least one characterization to be assigned to a toxicity criterion which comprises a toxicity determination knowledge base comprising toxicity determination rules including at least one of a plurality of characterizations which can be assigned to the toxicity criterion in response to at least one of various combinations of toxicity determination characterizations which can be assigned to a plurality of toxicity determination criteria;

and

additional expert computer program routines including a first additional expert computer program routine for prompting, through the output means, a user to enter, through the input means, the toxicity determination characterization assigned to each toxicity determination criteria;

a second additional expert computer program routine for selecting at least one characterization to be assigned to the toxicity criterion by locating a toxicity determination rule which covers the characterizations assigned to the toxicity determination criteria; and

a third additional expert computer program routine for communicating the characterization to be assigned to the toxicity criterion to the output means.

16. An expert system according to claim 15, wherein the toxicity determination criteria comprise a tingling/loss of sensation toxicity determination criterion, a tremor toxicity determination criterion, a trouble sleeping toxicity determination criterion, a diabetogenicity toxicity determination criterion and a change in creatinine level toxicity determination criterion.

17. An expert system for determining a decreased next FK 506 dosage to be administered to a patient being treated with FK 506 to prevent an adverse immune response by partially suppressing the patient'"'"'s immune system without unduly suppressing the ability of the immune system to combat infection, the system comprising:

(a) an input means;

(b) an output means;

(c) a storage means having a knowledge base comprising rules including one of a finite number of values for the decreased next FK 506 dosage in response to at least one of various combinations of characterizations which can be assigned to the patient'"'"'s FK 506 blood plasma level and values for the patient'"'"'s current FK 506 dosage; and

an expert computer program including a first routine for prompting, through the output means, a user to enter, through the input means, the patient'"'"'s current FK 506 dosage and the characterization assigned to the patient'"'"'s FK 506 blood plasma level;

a second routine for selecting a decreased next FK 506 dosage by locating a rule which covers the patient'"'"'s current FK 506 dosage and the characterization assigned to the patient'"'"'s current FK 506 blood plasma level; and

a third routine for communicating the decreased next FK 506 dosage to the output means; and

(d) a processor.

18. An expert system for determining and providing the next FK 506 dosage to be administered to a patient being treated with FK 506 to prevent an adverse immune response by partially suppressing the patient'"'"'s immune system without unduly suppressing the ability of the system to combat infection, the system comprising:

(a) an input means;

(b) an output means;

(c) a storage means having a knowledge base comprising rules including one of a finite number of values for the next FK 506 dosage in response to at least one of various combinations of values for the patent'"'"'s current FK 506 dosage, current FK 506 blood plasma level and desired FK 506 level; and

an expert computer program including a first routine for prompting, through an output means, a user to enter, through an input means, the patient'"'"'s current FK 506 dosage, the patient'"'"'s current FK 506 blood plasma level and the desired FK 506 level for the patient;

a second routine for selecting a next FK 506 dosage by locating a rule which covers the patient'"'"'s current FK 506 dosage, the patient'"'"'s current FK 506 blood plasma level and the desired FK 506 level for the patient; and

a third routine for communicating the next FK 506 dosage to the output means; and

(d) a processor.