Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2000-09-21
2001-07-31
Henley, III, Raymond (Department: 1614)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C514S464000
Reexamination Certificate
active
06267992
ABSTRACT:
BACKGROUND OF THE INVENTION
Diabetic nephropathy accounts for approximately half of the patients receiving long-term renal dialysis and end-stage renal disease (Robbins, S. L., et al., “Basic Pathology”, 2nd ed., Ch. 13, W. B. Saunders, Philadelphia, Pa. (1976)). Microalbuminuria is a predictor of diabetic nephropathy (Abbott, K. C. et al.,
Arch. Intern. Med
. 154:146-153 (1994); Neil, A. et al.,
Diabetes Care
16:996-1003 (1993); Mattock, M. B. et al.,
Diabetes
41:736-741 (1992)). Clinical management strategies, such as aggressive glycemia treatments, anti-hypertensive therapies and low-protein diets, can moderate symptoms of diabetic nephropathy and microalbuminuria. However, such treatments must be meticulously monitored in patients, can be costly, are frequently associated with adverse side effects, and are typically less effective in patients where the diabetic nephropathy condition or microalbuminuria has been present for some time and where protein intake is difficult to control. Thus, there is a need to develop new, improved, and effective methods of treatment for diabetic nephropathy and microalbuminuria.
SUMMARY OF THE INVENTION
The present invention relates to a method of treating diabetic nephropathy or microalbuminuria in an individual.
In one embodiment, the method includes administering a Salviae Miltiorrhizae Radix herb, a Salviae Miltiorrhizae Radix mimic, or component thereof, to a diabetic individual exhibiting diabetic nephropathy.
In another embodiment, the method further includes the step of forming an extract of the Salviac Miltiorrhizae Radix herb or the Salviac Miltiorrhizae Radix mimic. The extract is administered to the diabetic individual exhibiting diabetic nephropathy. In a preferred embodiment, the extract is formed by boiling the Salviae Miltiorrhizae Radix or Salviae Miltiorrhizae Radix mimic.
In still another embodiment, the method includes determining the level of protein in urine of a diabetic individual, comparing the level of protein in urine of the diabetic individual with a control level, and administering a Salviae Miltiorrhizae Radix herb, a Salviae Miltiorrhizae Radix mimic or component thereof to lower the level of protein in urine of the diabetic individual to about that of the control level. In a preferred embodiment, an extract of the Salviae Miltiorrhizae Radix herb or Salviac Miltiorrhizae Radix mimic is administered to the diabetic individual.
Another embodiment includes administering a salt of lithospermic acid to the diabetic individual exhibiting diabetic nephropathy.
In yet another embodiment, the invention includes determining the level of protein in urine of a diabetic individual, comparing the level of protein in urine with a control level, and administering a salt of lithospennic acid to lower the level of protein in urine of the diabetic individual to about that of the control level. In a preferred embodiment, the salt of lithospermic acid used in the method of the invention is magnesium lithospermate B or magnesium lithospermate B mimic.
The methods of the invention can be used to treat diabetic nephropathy in a noninsulin-dependent diabetic individual and an insulin-dependent diabetic individual.
The invention also relates to treating microalbuminuria in an individual by administering a Salviae Miltiorrhizae Radix herb, a Salviae Miltiorrhizae Radix mimic, or component thereof, to the individual.
In another embodiment, the method includes forming an extract of a Salviae Miltiorrhizae Radix herb or a Salviae Miltiorrhizae Radix mimic and administering the extract to an individual exhibiting microalbuminuria. In a preferred embodiment, the extract is formed by boiling the Silviae Miltiorrhizae Radix herb or Salviae Miltiorrhizae Radix mimic.
In an additional embodiment of the invention, the level of albumin in urine of the individual exhibiting microalbuminuria is determined and compared to the level of albumin in urine with a control level. A Salviae Miltiorrhizae Radix herb or a Salviae Miltiorrhizae Radix mimic or component thereof is administered to the individual to restore the level of albumin in urine in the individual exhibiting microalbuminuria to about that of the control level. In another embodiment, the method further includes the step of forming an extract of the Salviac Miltiorrhizae Radix herb or Salviae Miltiorrhizae Radix mimic. In a preferred embodiment, the extract is formed by boiling the Salviae Miltiorrhizae Radix herb or the Salviae Miltiorrhizae Radix mimic.
Another embodiment includes treating microalbuminuria by administering a salt of lithospermic acid to an individual exhibiting microalbuminuria.
In yet another embodiment, the method of treating microalbuminuria in an individual includes determining the level of albumin in urine of the individual, comparing the level of albumin in urine with a control level, and administering a salt of lithospermic acid to the individual to restore the level of albumin in urine in the individual exhibiting microalbuminuria to about that of a control level.
In an additional embodiment of the invention diabetic nephropathy in a diabetic individual is treated by administering a metabolite of a Salviae Miltiorrhizae Radix herb to the diabetic individual.
In yet another embodiment, the invention relates to a method of treating diabetic nephropathy in a diabetic individual by determining the level of protein in urine of the diabetic individual and comparing the level of protein in urine with a control level. A metabolite of a Salviae Miltiorrhizae Radix herb is administered to the diabetic individual to lower the level of protein in urine of the diabetic individual to about that of the control level.
In still another embodiment, the invention relates to a method of treating microalbuminuria in an individual by administering a metabolite of a Salviae Miltiorrhizae Radix herb to the individual.
The invention also relates to a method of treating microalbuminuria in an individual by forming a metabolite to a Salviae Miltiorrhizae Radix herb and administering the metabolite to the individual.
In yet another embodiment, the invention relates to a method of treating microalbuminuria in an individual by determining the level of albumin in urine of the individual and comparing the level of albumin in urine with a control level. A metabolite of a Salviae Miltiorrhizae Radix herb is administered to the individual to restore the level of albumin in urine in the individual to about that of the control level.
The invention described herein provides a method for treating diabetic nephropathy and microalbuminuria. Advantages of the claimed invention include, for example, the treatment of diabetic nephropathy or microalbuminuria in an individual in a cost effective manner and without significant adverse side-effects, especially in individuals who have had the condition for an extended time and where clinical management strategies are difficult to implement. The claimed methods provide an efficient way to treat and reduce the severity of kidney disease and, ultimately, renal failure in diabetic patients.
Thus, treatment with the Salviae Miltiorrhizae Radix herb can potentially halt, reverse or diminish the progression of diabetic nephropathy or microalbuminuria, thereby increasing quality of life and life expectancy, without invasive medical interventions such as renal dialysis and kidney transplants.
REFERENCES:
patent: 6149915 (2000-11-01), Li et al.
patent: 01268682 (1989-10-01), None
patent: 07048265 (1995-02-01), None
http://rich.chonnam.ac.kr/HRIC/research/resear13.htm Aug. 9, 1999.
Yokozawa, T., et al., “Isolation of a renal function-facilitating constituent from the Oreintal drug, Salviae Miltiorrhizae Radix”,Japanese Journal of Nephrology, 31(10):91-98 (1989).
Yokozawa, T., et al., “Effects of a Dan Shen component, magnesium lithospermate B, in nephrectomized rats”,Japanese Journal of Nephrology, 37:105-111 (1995).
Baohua, S., et al., “Effects of Hypoxic Endothelial Cell Conditioned Medium on Proliferation and Collagen Synthesis of Smooth Muscle Cells and Inhibitory
Jung Mankil
Lee Hyun Chul
Li Hai-Ri
Shah Sudhir V.
Hamilton Brook Smith & Reynolds P.C.
Henley III Raymond
Shiva Biomedical LLC
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