Indications and efficacy of recombinant human growth hormone

Growth hormone (GH) is a protein hormone produced by growth hormone cells in the anterior lobe of the pituitary gland.GH is necessary for normal growth, in addition to the effect of increasing height, the function of the heart, kidneys, etc., and skin, internal organs, bones, muscles, gonads, etc., play an important role in the development of growth; on the human body’s three major metabolisms: sugar, fat, and protein have a greater impact. Although growth hormone deficiency, not like insulin deficiency caused by diabetes, without insulin will immediately appear life-threatening, but will also cause shortness, osteoporosis, muscle dysplasia, susceptible to cardiovascular disease, sexual dysplasia, easy to aging, and a series of abnormal performance. In 1958, the clinical application of GH extracted from the pituitary gland of newly dead people began to treat patients with growth hormone deficiency (GHD), although the efficacy of the treatment is remarkable, but it is not easy to obtain, the yield is very small, and the cause of death of different people is not the same, and there is a possibility of infection with serious infectious diseases, which can not satisfy the needs of patients for treatment. Until 1985, human growth hormone (rhGH) made by genetic recombination technology was formally marketed and better applied to the clinic. Recombinant human growth hormone (rhGH) has been widely used in the treatment of pituitary GHD, and achieved better efficacy and experience. With the continuous research on the etiology of short stature, the application of rhGH has been extended to the treatment of non-GHD short stature, such as congenital ovarian hypoplasia (Turner syndrome), less-than-foetal-age babies, Prader-Willi syndrome, chronic renal failure, and precocious puberty adjuvant therapy. The U.S. Food and Drug Administration (FDA), the world’s most rigorous drug review agency, approved growth hormone for the following indications: 1985 Growth hormone deficiency (GHD) in children; 1993 Chronic renal insufficiency prior to renal transplantation; 1996 HIV infection-associated failure syndrome; 1996 Turner syndrome Short stature; 1997 GHD replacement therapy for adults; 2000 Prader-Willi syndrome; 2001 Small for gestational age (SGA); 2003 Idiopathic short stature (ISS); 2003 Short bowel syndrome; 2006 SHOX gene deficiency in children without GHD; In recent years, it has also been found that rhGH has achieved outstanding efficacy in the treatment of anti-aging and weight loss. GH is a molecular weight of about 22 Kilograms (Kg). Since GH is a protein with a molecular weight of about 22KD, it will be broken down if taken orally. After decomposition, it is no longer GH, and even if it is taken orally without being decomposed through certain methods, the large molecule cannot be absorbed through the gastrointestinal tract. Similar to insulin used by diabetics, it is difficult to realize in the near future, although it is a dream of mankind to be able to make an oral preparation. Currently rhGH is used in a similar way to insulin, the lyophilized powder should be dissolved in water for injection delivered by the manufacturer and then injected with insulin needles (BD needles), once a night about 1 hour before bedtime. The aqueous dose can also be injected directly with a regular BD needle, or possibly with a “Novo pen”. Since BD needles are very thin, thinner than acupuncture needles used in traditional Chinese medicine, the pain is not obvious to a certain extent. Normal people GH usually in the blood content is very small, only at night in deep sleep will appear several peaks, to determine the lack of GH, only check the usual value can not respond to the level of GH, must be through the drug stimulation test (stimulation test), and constantly small amount of blood (usually used in common venous needle, which reduces the pain of multiple venepuncture), in order to measure the secretion of the peak value of the growth hormone. It is the level of the peak that determines whether GH is deficient or not. The usual value of GH is very low, while the peak value can be more than 50 times greater than the usual value, and the half-life (the time required for the concentration in the blood to fall by half) is very short, usually only about 20 minutes, thus, after the application of therapeutic dose of GH deficiency, it will not cause too much GH or affect their own secretion of GH. GH secretion peaks and secretion amounts also vary greatly at different ages, and the peak in mid-puberty is 22.4 ng/ml, which is the highest in the world, and the peak in mid-puberty is 22.4 ng/ml, which is the highest in the world. 22.4ng/ml in mid-puberty, which is more than twice the adult value. In the middle of puberty, the total amount of secretion in a day can be up to 60ug/kg/day, which is more than three times of the adult. Normal therapeutic amount, and the total daily secretion of normal people still have a certain gap, but in the appropriate time application, and their own secretion peak overlap, can reach a more normal secretion peak, and play an effective role in improving the lifelong high role and normal metabolism required for the GH peak. In 2003, the FDA formally approved the use of rhGH for the treatment of non-GH-deficient idiopathic short stature (ISS). Since it is officially approved for use in non-GH-deficient individuals, it must at least have a good safety and efficacy profile, both of which are essential. The etiology of ISS is not well defined and may be due to a combination of underlying factors. There may be insufficient or disturbed total GH secretion and poor GH activity; there may also be GH receptor abnormalities, mutations, or receptor insensitivity; and there may be a relative deficiency of insulin-like growth factor-1 (IGF-1). With the improvement of biochemical and genetic testing technology, the etiology of ISS may be gradually found in the future. Other indications: ① Chronic renal failure; ② Liver failure; ③ Dilated cardiomyopathy; ④ Surgical field: burns, severe trauma, post-surgery, total venous nutrition, etc.; ⑤ Improvement of immune function; ⑥ Other: anti-aging, certain infertility. Dosage and course of treatment: The dosage and course of treatment vary according to the type of disease, age and bone age at the time of treatment. Compared with foreign countries, the general situation in China is that the dosage is relatively small and the course of treatment is short. Diseases for which GH should be contraindicated or used with caution: active tumors, diabetes mellitus with severe complications, Down syndrome, Bloom syndrome, megaloblastic anemia, and so on.