Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Patent
1995-11-27
1998-07-21
Tsang, Cecilia J.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
530399, A61K 3800, A61K 31195, A61K 3170, A61K 31715
Patent
active
057835608
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to the use of growth hormone (GH) or effective analogues thereof for the manufacture of a medicament intended for preoperative administration in order to reduce protein loss and for the preparation of patients for surgery so as to achieve an improved outcome.
INTRODUCTION
Growth hormone (GH) is a peptide present in plasma. It is a 191 amino acid peptide secreted into the blood stream. It acts on receptors in the liver, muscle, fat, growth plate and in other tissues. Its actions on skeletal growth and on protein anabolism are mediated at least in large part by insulin-like growth factor-1 (IGF-1). IGF-1 is released by the liver into the blood stream in response to stimulation by GH. It is also produced in tissues including muscle in response to the action of GH. Human GH has been purified from human tissues and the complete amino acid sequences established. GH is found in other species including ruminants with extensive homologies to those in humans. Because GH can only be purified from the human pituitary gland it is scarce: further purified GH is considered unsafe because of the risk of contamination by prions.
Nowadays large scale production for both hormones is readily achieved using recombinant DNA techniques. It has been demonstrated that recombinant GH (rGH) stimulates skeletal growth in GH deficiency and that it reduces protein catabolism in patients with severe catabolic illness consequence on surgery or burns. These effects of GH are due to a reduction in protein breakdown and possibly an increase in protein synthesis. Moreover these actions of GH are associated with a rise in serum IGF-1 levels.
In EP 288 478, Brigham and Women's hospital, the use of growth hormone together with a hypocaloric dietary component is disclosed for producing or maintaning a positive nitrogen balance. The protein builtup is thereby maintained.
WO 91/11195, Novo Nordisk, discloses the use of growth hormone for reducing the incidence of post-surgical problems, wherein the hormone is administered for a period starting at the time of an operation.
However, all consideration of the use of GH to ameliorate a catabolic state has been restricted to its use after a state of catabolism exists. Prior art does not exist to suggest an alternate use or approach or that the use of GH prior to an insult would be of therapeutic value.
THE INVENTION
We have found that a specific biological action of GH and its analogues, when administered to mammals including man for a period prior to the induction of a catabolic state reduces the severity of the catabolic state.
We have also found that prophylactic use of GH or effective analogues acts to allow parenteral nutritional therapy to be effective in a catabolic state in a manner not seen if GH is administered solely after the catabolism has been established. Thus GH or affective analogues are, according to the present invention, suitable preparative therapies for human subjects facing elective surgery or other comparable catabolic stresses.
The use is especially of interest for the preparation of a patient for major surgery of an elective nature including major cardiac surgery, major abdominal surgery, orthopaedic surgery, neurosurgery, or any other surgical procedure of an elective nature. A universal problem of major surgery is that catabolic states develop after surgery which prolong the patients convalescence and increase the risk of death or morbidity from cardiac, respiratory or infective complication and slow the rate of wound healing. The invention discloses the considerable advantage to the patient placed electively in that position if prepared for a period prior to the surgery with GH or its effective analogue to both reduce the severity of the catabolic state and/or improve the capacity of the patient to respond to current therapeutic modalities which are nutritional support and/or GH administration.
The invention thus relates to the use of growth hormone (GH) or effective analogues thereof for the manufacture of a medicament intended for preope
REFERENCES:
patent: 5179080 (1993-01-01), Rothkopf
Hollander et al., Increased Wound Breaking Strength in Rats Following Treatment with Synthetic Human Growth Hormone, Surgical Forum, vol. 35 (1984), pp. 612-614.
Zaizen et al., The Effect of Perioperative Exogenous Growth Hormone on Wound Bursting Strength in Normal and Malnourished Rats, Journal of Pediatric Surgery, vol. 25, No. 1 (1990), pp. 70-74.
Jiang et al., Low-Dose Growth Hormone and Hypocaloric Nutrition Attenuate the Protein-Catabolic Response After Major Operation, Ann Surg. vol. 210, No. 4 (1989), pp. 513-525.
Gustafsson, Possible Metabolic Side Effects of High Dose Growth Hormone Treatment, Acta Pediatr. Suppl., vol. 362 (1989), pp. 50-55.
Pharmacia & Upjohn Aktiebolag
Touzeau P. Lynn
Tsang Cecilia J.
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