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    Home > Medical News > Medical World News > The development status and trend of immunoglobulin injection under the skin

    The development status and trend of immunoglobulin injection under the skin

    • Last Update: 2020-11-13
    • Source: Internet
    • Author: User
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    Author . . Small silt immunoglobulin injection drugs are immunoglobulin-like blood products prepared from a mixture of plasma from thousands of healthy blood donors, the main component of which is immunoglobulin G (IgG).
    depending on the injection method, immunoglobulin drugs can be divided into sub-cort injection immunoglobulin (SCIg), intra-intra-intra-intra-intra-intra-intra-intra-intra-intra-intra-intra-immune globulin (IVIg).
    Immunoglobulin (SCIg) began in 1952, and in the 1980s, with the improvement of immunoglobulin drug production processes and the development of IgG stabilization technology, IVIg became widely used in the treatment of a variety of immunologic diseases and became the preferred treatment for primary immunodeficiency diseases.
    the 1990s, with the use of portable syringes and the development of drug propulsion accuracy technology, the use of SCIg became more and more extensive.
    In December 2002, CSL's Vivaglobin® was first approved in Germany as the first immunoglobulin specifically for subsethic injections and certified by the Food and Drug Administration (FDA) in January 2006.
    since then, different concentrations, different specifications of SCIg, such as CSL's Hizentra ®, Shire's CuvitAK'ru and so on.
    , SCIg drugs, which add different auxiliary ingredients, have also grown rapidly, such as the promoted subsuplisive injection immunoglobulin (fSCIg).
    fSCIg's main advantage is that the use of hyalurase can temporarily or locally break down the role of hyalurinoic acid, accelerate the drug through the skin extracellular substitin, and help the drug into the lymphatic tube, is conducive to the absorption of large molecular substances, mainly immunoglobulin, can extend the infusion interval of immunoglobulin and improve tolerance, for immunoglobulin treatment program to provide a wider range of options.
    addition, the high-purity recombinant human hyalurase fSCIg, which has appeared in recent years, has the advantages of good long-term tolerance, high bio-utilization and low systemic adverse reactions, and can also be used for immunoglobulin replacement therapy during pregnancy.
    SCIg mechanism SCIg's main component is IgG, IgG can be divided into antigen binding fragments (Fab) and crystallization fragments (Fc), can act on dexterity cells, monocytes / macrophages, natural killer (NK) cells, neutral granulocytes and other immune cells, play Fab and Fc anti-inflammatory and immunomodulation role.
    among them, the Fc action mechanism includes activating the Fc gamma subject (Fc-Rs), promoting the activation and proliferation of T cells, inhibiting FcRII.b assotrophy, promoting the proliferation of regulatory T-cells (Treg), etc., and the Fab action mechanism including neutralizing the action and inhibiting the differentiation of Th17.
    addition, IgG's glycosylation and djubialization are also associated with anti-inflammatory effects, in particular IgG's Fc saliva acidification.
    Such as saliva acidified IgG Fc can induce the expression of inhibitory Fc-RII.b, thus playing the role of immunomodulation, the diglymer can be preferred to bind to Fc-Rs, thereby enhancing the role of Fc-Rs in the treatment of immunologic diseases.
    SCIg's clinical application SCIg can be used to treat autoimmune neuromuscular diseases, primary immunodeficiency diseases, secondary immunodeficiency syndrome (SID), and immunoploid reduction cyanosis (ITP), Kawasaki disease, etc. in adults and children, and has the same or better efficacy as intravenous immunoglobulin (IVIg).
    1. The treatment of autoimmune neuromuscular disease chronic inflammatory demyelinative multiple neuropathy (CIDP) is an autoimmune-mediated peripheral neuropathy that often requires long-term treatment with intravenous immunoglobulin (IVIg), but IVIg has many systemic adverse reactions, requires long-term infusions and complete intravenous angiopathy, so patients who cannot or do not tolerate long-term IVIg treatment can choose SCIg.
    SCIg is a drug approved by the FDA and the European Drug Review Agency for CIDP patient maintenance treatment as an effective alternative to IVIg treatment CIDP.
    SCIg is a flexible and effective maintenance treatment for CIDP patients, with good patient tolerance and greater convenience and safety, and is the preferred route for IgG dosing.
    , the study found that SCIg can be used not only for the treatment of CIDP adult patients, but also for the treatment of CIDP infants and young children.
    2, the treatment of polymyositis, dermatitis and inclusive myositis SCIg in the treatment of polymyositis, dermatitis and inclusive myositis was significant.
    -related studies found that during the 72-month treatment period, all patients showed good therapeutic results and tolerance, the quality of life was significantly improved, some patients could deactivate immunosuppressants, and all patients were able to reduce the daily maintenance dose of pernisone, confirming the effectiveness and safety of SCIg for active and incurable inflammatory myositis.
    Some scholars have confirmed the effectiveness and safety of treating 8 patients with dermatitis and polymyositis with a combined SCIg, glucosticoids, immunosuppressants, and found that combined SCIg reduced the use of glucosticoids and immunosuppressants.
    3, the treatment of primary immunodeficiency pathogenic immunodeficiency disease is due to genetic defects of the immune system or congenital development and susceptible to infection, malignant tumors and autoimmune diseases of immunodeficiency diseases, a wide variety of which have been found, a total of more than 200 clear pathogenic genes have been found common primary immunodeficiency disease.
    to reduce the risk of infection in patients with primary immunodeficiency, immunoglobulin replacement therapy is needed in a timely manner.
    because immunoglobulin replacement therapy for patients with primary immunodeficiency is lifelong, the acceptability and ease of operation of the drug is essential for patients to adhere to treatment for a long time.
    IVIg has become the preferred treatment for primary immunodeficiency disease in the United States and has been widely used in Europe for many years, SCIg has been recognized by more and more patients and physicians in recent years.
    , there are literatures that have reported that SCIg can be used as an immunoglobulin replacement therapy for secondary hypoproproteinemia.
    In patients treated with chronic lymphoblastic leukemia (CLL) with secondary hypoproglobulinemia, SCIg is as effective as IVIg, and SCIg is well-to-resistant, maintains higher levels of IgG concentration, and reduces the incidence of serious infections.
    In the treatment of patients with common mutated immunodeficiency (CVID) associated with autoimmune plateroid reduction (AITP), it has been confirmed that treatment with SCIg is not only as safe as IVIg, but also reduces plate plate plate reduction events to some extent.
    although a large number of clinical trials have confirmed that SCIg is effective, well-to-do, and that high concentrations of SCIg reduce infusion time and the number of injection sites, adverse reactions to SCIg cannot be ignored.
    common immunoglobulin replacement therapy have skin redness, headache, fever, chills, fatigue, drowsiness.
    Although adverse reactions are generally temporary and mild, there are sometimes some rare and serious adverse reactions, such as kidney damage, thrombosis, arrhythmic disorders, aseptic meningitis, hemolytic anemia and acute lung injury (TRALI) associated with blood transfusions.
    SCIg appeared earlier than IVIg, IVIg was the first to be widely used in immunoglobulin replacement therapy.
    with the advent of portable syringes and the development of drug propulsion accuracy technology, SCIg was widely produced and used.
    At present, the clinical application of SCIg abroad has become more and more mature, SCIg is widely used in primary immunodeficiency patients, autoimmune disease patients, inflammatory patients, infected patients and tumor patients treatment, and shows a series of IVIg does not have the advantages, such as can be used at home, self-management, low side effects, can more stable maintenance of physiological levels of IgG concentration.
    but there are no reports of SCIg in China, nor is there research and development and production of SCIg.
    SCIg's research and development and production can enrich the types of immunoglobulin drugs, provide more drug options for immunoglobulin replacement therapy, and facilitate the formulation of personalized treatment options, improvement of clinical efficacy and rational use of blood resources.
    : Zhang Wei, Xu Jixuan, Ye Shengliang, Liu Fengxuan, Mary, Li Changqing. The Development and Clinical Application of Subderpose Injection Immunoglobulins, China Pharmacy, 2020, 31 (03): 378-384. Peng Xia, YuWen. The role of subsocial injection immunoglobulin in the treatment of severe muscle weakness deterioration: a forward-looking open clinical trial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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