What Are Therapeutic Peptides?

Thymosin (also known as thymosin, Thymosin) is a group of polypeptides with physiological activity secreted by thymus tissue. Thymosin commonly used in clinical practice is a small molecule peptide with non-specific immune effects found and purified from calf thymus.

Chinese name: Thymosin
Foreign name: Thymosin

Aka: Thymosin
Nature: A group of polypeptides

Thymosin physiological function

1. Continuously induce T cell differentiation and development at various stages 2. Maintain the body's immune balance and enhance T cell response to antigens

3. Improve the body's ability to resist disease

The thymus contains a variety of hormones, which belong to the three types of , , and , and together induce the maturation and differentiation of T cells. Thymosin has been used clinically in China for more than 20 years. In the past, due to inconsistent preparation methods and quality control of various preparations, clinical observation was not standardized, and the efficacy was difficult to be sure. The main active ingredient of thymosin is thymosin 1 (T1), which is composed of 28 amino acids. Chemically synthesized products are available now.

Thymosin treatment mechanism

Thymopeptides with various biological activities mainly induce the differentiation and maturation of T cells, enhance the production of cytokines, and enhance the antibody response of B cells.

Thymosin clinical trial

The early results used to treat a small number of cases showed that the condition improved and the HBeAg negative conversion was higher than the control group. Patients were tolerated in each clinical trial, and no significant adverse reactions were found.

Thymosin dosage and efficacy

It is recommended to use T1, 1.6mg or 900g / m², 2 times / week for 6 months.

(1) Delayed effect: The rate of response to T1 at the end of treatment is very low, not exceeding that of the control group. However, the number of cases with complete effects in follow-up observations gradually increased. It is suggested that T1 directly inhibits the virus, and the decrease of serum virus level is the result of its immune regulation. T1 may activate virus-specific Th cell functions and induce CTL by secreting IFN, IL-2 and TNF. The delayed effect is shown in most effector cases without elevated ALT before the virus is cleared (the virus is eliminated by cytokines without damaging the cells); a few cases may be the killing effect of CTL.

(2) Complete response rate: T1 for chronic hepatitis B alone may not have a high response rate, which is about 15% higher than that of the control group. Clinical trials in combination with antiviral drugs are ongoing.

(3) Liver histology: Paired examinations of liver biopsy before and after treatment in the sustained-effect group showed significant progress.

Thymosin pharmacology and toxicology

This product is an immunomodulatory drug. It has the function of regulating and enhancing the immune function of human cells, can promote the maturation of T lymphocytes in peripheral blood after mitogen activation, and increase T lymphocyte factors (such as: Interferon, interleukin 2 and interleukin 3) secretion, increase the level of lymphokine receptors on T cells. It also enhances lymphocyte response by activating T4 helper cells. In addition, this product may affect the chemotaxis of NK precursor cells, which become more cytotoxic after exposure to interferon. Therefore, this product has the effect of regulating and enhancing the immune function of human cells.

Thymosin indications

It is used for the treatment of various primary or secondary T cell deficiency diseases, certain autoimmune diseases, various diseases with low cellular immune function and adjuvant treatment of tumors.

Including: 1. Various types of severe hepatitis, chronic active hepatitis, chronic persistent hepatitis, and cirrhosis;

2. Herpes zoster, genital herpes, genital warts, etc .;

3. Bronchitis, bronchial asthma, tuberculosis, prevention of upper respiratory infections, etc .;

4. Combination of pre-malignant tumors, chemotherapy and radiotherapy;

5. Lupus erythematosus, rheumatic and rheumatoid diseases, ankylosing spondylitis, Guillain-Barre syndrome, etc .;

6. Aplastic anemia, leukemia, thrombocytopenia, etc .;

7. Viral keratitis, viral conjunctivitis, allergic rhinitis, etc .;

8. Premature senile aging, women's menopause syndrome, etc .;

9. Multiple bloated and facial skin acne, etc., psoriasis, lichen planus, squamous cell carcinoma, and epithelial keratosis;

10. Children with congenital immunodeficiency, etc.

[Usage and Dosage] Subcutaneous or intramuscular injection: 10 to 20 mg once, once a day or as directed by your doctor. Dissolved in 2ml of sterile water for injection or 0.9% sodium chloride injection. Intravenous infusion: 20 to 80 mg once, once a day or as directed by your doctor. Dissolved in 500ml 0.9% sodium chloride injection or 5% glucose injection.

[Adverse reactions] Well tolerated, some adverse reactions such as nausea, fever, dizziness, chest tightness, and weakness can be seen. A few patients occasionally have drowsiness. Chronic hepatitis B patients may have a transient rise in ALT levels when used. If there are no signs of liver failure, continue to use this product.

The State Food and Drug Administration reminded to pay attention to the severe allergic reaction of thymosin injection:

From 2003 to April 30, 2011, the National Center received a total of 5,459 reports of adverse reactions / incidents of suspected drugs as thymosin injections, of which 1326 were severe cases, accounting for 24.29%. Serious adverse reactions mainly involved systemic damage (93.74%), including allergic reactions, anaphylactic shock, high fever, etc .; followed by respiratory damage (5.13%), including dyspnea, throat edema, asthma, chest tightness, and asphyxia; The damage to its attachments (0.45%) was mainly severe rash. The above serious adverse reactions are all related to allergic reactions.

Based on the information analysis of the case report database, the State Food and Drug Administration recommended:

1. Medical staff should inquire the patient's allergy history in detail before taking the medicine. Those who are allergic to the ingredients contained in this product should not use it, and those with allergies should use it with caution. Patients should be closely observed during the administration. Once allergic symptoms occur, the drug should be stopped and treated immediately.

2. Medical staff should strictly grasp the indications of thymosin injections, weigh the pros and cons of patients, and use them with caution; they should be administered strictly in accordance with the dosage and dosage prescribed in the drug instructions; they should be used alone to avoid unreasonable compatibility; children should be used with caution to reduce The occurrence of serious adverse reactions.

3. Manufacturers should revise the relevant contents of the manual to add descriptions of adverse reactions, especially severe allergic reactions; strengthen the promotion of clinically rational drug use, and ensure that the safety information of products is transmitted to patients and doctors in a timely manner; improve production processes and improve product quality standards And carry out corresponding security research.

4. At present, thymosin has been largely replaced by thymosin. Clinical application shows that thymosin has a clear molecular formula, more advanced technology and better curative effect, and good safety.

[Contraindications] Those who have an allergic reaction to this product or those who have an organ transplant are prohibited.

[Precautions] This product exerts its therapeutic effect by enhancing the immune function of patients, so it should not be used in patients who are receiving immunosuppressive therapy (such as organ transplant recipients), unless the benefits brought by the treatment are significantly greater than the danger Sex time. Liver function should be checked regularly during treatment. Use with caution in patients under 18 years of age.

[Medication for pregnant women and lactating women] Animal fertility studies have shown that there is no difference in heterogeneous effects on embryos in the control group and the treatment group. It is unknown at this time whether the drug is harmful to the embryo or whether it affects fertility. Therefore, this medicine can only be given to pregnant women when necessary. Although this product has not been confirmed to be excreted by human milk, it should be used with caution in lactating women.

[Children's medication] Intramuscular injection is commonly used, and the dosage depends on the age, weight and condition of the child. For children with thymic hypoplasia, 1 mg / kg per day. After the symptoms improve, the maintenance amount is changed to 1 mg / kg per week, which can be used as a long-term alternative treatment. Treatment of children with recurrent respiratory tract infections from 8 months to 12 years old, once every other day, 5 mg each time, after 1 month, changed to 2 times a week, 5 mg each time. In case of fever and respiratory infections during treatment, the course of treatment can be continued while antibacterial and antiviral treatment is taken, 3 months is a course of treatment, or as prescribed by your doctor.

[Medicine for the elderly] The thymus of the elderly has become fat, and the level of thymosin in the blood is low. It can be used according to the above provisions.

[Drug interactions] This product is used in combination with many commonly used drugs, including interferon, anti-inflammatory drugs, antibiotics, hormones, analgesics, antihypertensive drugs, diuretics, drugs for treating cardiovascular diseases, central nervous system drugs, Birth control pills without any interference. The combination of this product and interferon has a synergistic effect on improving immune function.

[Drug Overdose] There are no reports of human overdose (treatment or accident). Animal toxicity tests showed no side effects below the 10 mg / kg dose (the highest amount currently used in the study). ^[1]

Thymosin treatment

Thymosin alpha 1 alone in chronic hepatitis B has been studied in and outside of China. Studies have shown that thymosin alpha 1 alone in chronic hepatitis B has a continuous response rate (ALT normal + DNA to negative + HBeAg to negative) of about 37%, which is similar to interferon alone, but No toxic side effects of interferon.

Clinical studies on the use of thymosin 1 in the treatment of chronic hepatitis B in Taiwan, China have shown that thymosin 1 has a delayed therapeutic effect. After thymosin 1 treatment was completed, ALT increased transiently, accompanied by seroconversion of HBeAg, and HBV DNA disappeared.

The results of HBV DNA negative conversion rate and superiority of seroconversion showed that thymosin 1 alone has a long-term effect on chronic hepatitis B without significant adverse reactions. For patients with advanced liver fibrosis, high-dose thymosin alpha 1 is effective.

Thymosin price reference

Specification: 20mg * 10 tablets, 55.00 yuan / box

[Indications]

For patients with chronic hepatitis B.

Various primary or secondary t-cell defects. (Eg children with congenital immunodeficiency disease).

Certain autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, bronchial asthma and asthmatic bronchitis in children, etc.).

Various diseases with low cellular immune function (such as viral hepatitis, prevention of respiratory infections, refractory oral ulcers, etc.).

Adjuvant treatment of tumor.

[Usage and Dosage] Oral. 20mg (1 tablet) each time, 1-3 times a day or as directed by your doctor.