CN114129722A - Use of human immunoglobulin for injection in preparing medicine for preventing or treating radiation injury - Google Patents
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Abstract
本发明公开了注射用人免疫球蛋白在制备预防或治疗辐照损伤的药物中的用途，属于生物制品领域。本发明的用途是静注人免疫球蛋白的全新用途，在人体或动物体经受辐照前或辐照后，注射静注人免疫球蛋白，可以预防或治疗射线引起的机体损伤，在肿瘤放疗和核泄漏致伤抢救中具有重要应用价值。
The invention discloses the use of human immunoglobulin for injection in preparing a medicine for preventing or treating radiation damage, and belongs to the field of biological products. The application of the invention is a brand-new application of intravenous injection of human immunoglobulin. Before or after irradiation of human or animal body, intravenous injection of human immune globulin can prevent or treat the body damage caused by radiation. It has important application value in the rescue of injuries caused by nuclear leakage.
Description
Technical Field
The invention belongs to the field of biological products.
Background
Worldwide, cancer is the second leading cause of death in humans. Radiotherapy (abbreviated as "radiotherapy") is widely used for treating tumors as an effective treatment means. Radiation therapy relies primarily on high-energy rays or particle beams for the treatment of almost all types of tumors. For some tumors (e.g., nasopharyngeal carcinoma), radiation therapy is the preferred treatment. Globally, about 70% of patients with tumors need to receive radiation therapy as a primary or secondary treatment during their course of treatment, and about 40% can be treated radically with radiation therapy. The contribution rate of radiotherapy to tumor treatment is as high as 18%, which is obviously higher than chemotherapy and biological treatment next to surgical treatment, so that radiotherapy is very important in the treatment process of tumor patients.
Irremediably, radiation therapy inflicts radiation damage to the body to varying degrees, primarily manifested as acute injury, represented by inflammation, and chronic organ injury, represented by fibrosis. In particular, radiation therapy of head and neck tumors often results in oral mucositis; radiation therapy of breast tumors often leads to chronic pneumonia; radiation therapy for pelvic and abdominal tumors often causes diarrhea, chronic enteritis, intestinal obstruction, and the like. Hematopoietic disorders such as leukopenia and myelogenous deviation, and digestive tract disorders such as enteritis and intestinal obstruction are common in many areas. These side effects can lead to premature termination of radiation therapy, severely reducing the quality of life of the patient and even causing death to the patient. Acute and chronic injuries show a progressive relationship, i.e. organ as well as systemic chronic inflammation will lead to the development of organ fibrosis. Increasing the dose of radiation therapy will also inevitably increase the risk of acute and chronic radiation damage to healthy organs. Therefore, the acute and chronic radiation damage accompanying the radiation therapy is reduced, the clinical application of the radiation therapy is promoted to a greater extent, and the life quality of the prognosis of the tumor patient is improved.
The rapid development of nuclear technology and nuclear industry makes the application of nuclear energy in industrial and agricultural production, scientific and technical research and national defense and civil life increasingly wide. Peaceful use of the "kernel" has become an irreducible driving force for development in countries around the world. A condition deviating from the operating conditions in a nuclear facility or activity, i.e., a nuclear accident (e.g., chernobel and fukushima events), will produce unexpected and involuntary radiation to radioactive workers and people around the site, resulting in radiation damage. The harm has long duration and wide spread range, and can cause great psychological panic and social and economic order disorder of people. How to rapidly cure people suffering from radiation injury is not only related to personal health, but also related to social stability and national strategy.
The human immunoglobulin for injection is prepared with blood plasma of healthy human, and through separation, purification, elimination of anticomplementary activity, virus inactivation and freeze drying, and has the main active component of polyclonal immunoglobulin composition for various exogenous antigens and autoantigens. The administration of human immunoglobulin for injection can be divided into: intravenous (IVIg) and intramuscular (IMIg) and subcutaneous (SCIg) injections of human immunoglobulin. The human immunoglobulin for injection is an effective medicine for treating primary immunodeficiency, secondary immunodeficiency diseases and autoimmune diseases (Kawasaki disease and idiopathic thrombocytopenic purple paralysis), and is widely used clinically.
At present, no report of the injection of human immunoglobulin for treating radiation injury is found.
Disclosure of Invention
The invention aims to solve the problems that: provides the application of IVIg in the preparation of medicines for preventing or treating radiation injury.
The technical scheme of the invention is as follows:
the use of human immunoglobulin for injection in the preparation of a medicament for the prevention or treatment of radiation damage.
The injection of human immunoglobulin is intravenous injection of human immunoglobulin, intramuscular injection of human immunoglobulin or subcutaneous injection of human immunoglobulin for the aforementioned use.
The use as described above, said injection of human immunoglobulin is an intravenous injection of human immunoglobulin.
For the aforementioned use, the IgG content of the human immunoglobulin for intravenous injection accounts for more than 95% of the protein content.
The use as described above, said radiation injury is radiation induced thymus atrophy, spleen atrophy, infection, inflammation, tissue damage or a decrease in intestinal length. The use as aforesaid, said medicament being a medicament for females or a medicament for females.
A combination for the treatment of tumors, said combination comprising a radiotherapeutic agent and human immunoglobulin for injection.
The combination as described above, wherein the human immunoglobulin for injection is human immunoglobulin for intravenous injection, human immunoglobulin for intramuscular injection or human immunoglobulin for subcutaneous injection.
The combination as described above, wherein the human immunoglobulin for injection is human immunoglobulin for intravenous injection; preferably, the IgG content of the immunoglobulin is more than 95% of the protein content.
A combination as hereinbefore described, which is a female medicament or a medicament for a female animal.
The invention has the following beneficial effects:
the human immunoglobulin can relieve the damage of irradiation to thymus and spleen, help to maintain the hematopoietic function, maintain the number of lymphocytes, reduce infection, inflammation or tissue damage in vivo, relieve or reverse the symptoms of large intestine shortening (the large intestine shortening is a manifestation of enteritis) and the like caused by irradiation, further prevent or treat the damage caused by irradiation, promote the recovery of an organism and obviously improve the survival rate of the organism after the irradiation of lethal dose.
The human immunoglobulin for injection is used for preparing the medicine for preventing or treating radiation injury, and has important significance for tumor patients receiving radiotherapy and the injured people suffering radiation.
Obviously, many modifications, substitutions, and variations are possible in light of the above teachings of the invention, without departing from the basic technical spirit of the invention, as defined by the following claims.
The present invention will be described in further detail with reference to the following examples. This should not be understood as limiting the scope of the above-described subject matter of the present invention to the following examples. All the technologies realized based on the above contents of the present invention belong to the scope of the present invention.
Drawings
FIG. 1: effect of IVIg intervention on survival of lethal dose irradiated mice for 30 days.
FIG. 2: effect of IVIg intervention on 30-day survival of lethal irradiated male and female mice; a, male; b, female.
FIG. 3: effect of IVIg on thymus after mouse irradiation; a, male; b, female.
FIG. 4: effect of IVIg on spleen after mouse irradiation; a, totality; b, female; c, male.
FIG. 5: the effect of IVIg on post-irradiation lymphocytes; group A, Pre; b, Post group.
FIG. 6: the effect of IVIg on irradiated neutrophils; a, pre group; b, post group.
FIG. 7: the effect of IVIg treatment on the intestinal tract of radiation-damaged mice; a, female; b, male.
Detailed Description
IVIg used in the examples was presented by Shandong Taibang biologicals Co., Ltd and had an IgG content of more than 98% of the total protein content.
Example 1IVIg intervention significantly increased 30-day survival of lethally irradiated mice (simulated accidental irradiation)
1. Method of producing a composite material
The 72 mice were divided into TBI, Pre and Post groups of 24 mice each (of which female mice 12 and male mice 12). Lethal dose systemic irradiation was performed at a dose of 7.2Gy for all three groups except:
TBI group was irradiated only, without IVIg injection;
pre group (prophylaxis group) was injected with IVIg 1 time 30min before irradiation, followed by 2 weekly administrations;
the Post group (treatment group) was administered 1 time within 30min after irradiation, followed by 2 times per week.
The administration is as follows: for injection, the dose of IVIg is 0.3g/Kg body weight.
2. Results
(1) IVIg intervention significantly improves 30-day survival rate of lethal dose irradiated mice
As shown in fig. 1, after systemic irradiation with lethal dose, 24 mice in TBI group survived 2 mice after 30 days, and survival rate was 8.33%; pre group 24 mice survived 4 mice with survival rate of 16.67%; in Post group, 17 mice survived, with a survival rate of 70.83%. The 30-day survival rate was significantly higher than that of TBI group, both Pre (prevention) and Post (treatment) groups.
(2) The effect of IVIg intervention on female mice is better than that of male mice
After the male mice were irradiated with lethal dose (fig. 2A), 12 mice in each of TBI group and Pre group survived 0 mice after 30 days, and the survival rate was 0; the Post group 12 mice survived 5 mice with a survival rate of 41.67%. The IVIg prophylactic (Pre group) had no effect on male mice, but the therapeutic (Post group) significantly improved survival for 30 days.
After the female mice were irradiated with lethal dose (fig. 2B), the TBI group of 12 mice survived 2 mice after 30 days, and the survival rate was 16.67%; pre group 12 mice survived 4 mice with survival rate of 33.33%; 12 mice survived in Post group 12, survival rate 100%. Both prophylactic (injection before irradiation) and therapeutic (injection after irradiation) IVIg can improve the 30-day survival rate of female mice, especially the therapeutic (Post group) has excellent effect on female mice.
The results of this example show that: the survival rate of the organism can be improved by injecting IVIg before and after the lethal dose irradiation, which indicates that the IVIg can effectively prevent or treat the irradiation injury and can be sufficiently used for the emergency treatment after the lethal dose irradiation. In addition, IVIg is more effective in female mice than male mice, and it is presumed that when it is used in humans, it is more effective in females than in males.
Example 2 treatment of irradiation damaged mice with IVIg (simulated accidental irradiation)
1. Method of producing a composite material
The 52 mice were divided into Con (control, no irradiation, no dosing), TBI, Pre and Post groups of 13 mice each (7 female mice, 6 male mice). All three groups were irradiated systemically at a dose of 4Gy, and hemograms were analyzed 15 days later, and thymus and spleen were analyzed after sacrifice and dissection. The difference is that:
con group did not irradiate, injected IVIg;
TBI group was irradiated only, without IVIg injection;
pre group (prophylaxis group) was injected with IVIg 1 time 30min before irradiation, followed by 2 weekly administrations;
the Post group (treatment group) was administered 1 time within 30min after irradiation, followed by 2 times per week.
The administration is as follows: for injection, the dose of IVIg is 0.3g/Kg body weight.
2. Results
(1) Thymus observation
After 15 days of systemic irradiation with 4Gy dose, compared to Con group, thymus was significantly atrophied in TBI group and in Pre and Post groups (FIG. 3B), regardless of male mice (FIG. 3A) or female mice.
(2) Observation of spleen
Spleen weight was significantly reduced in TBI group 15 days after systemic irradiation at 4Gy dose compared to Con group (fig. 4A). Spleen weight was increased in both Pre and Post groups compared to TBI group.
In female mice (fig. 4B), spleen weight was significantly increased in both Pre and Post groups compared to TBI group. In male mice (fig. 4C), spleen weights tended to increase in both Pre and Post groups compared to TBI group, but there was no statistical difference.
(3) Lymphocyte visualization
The number of lymphocytes in the TBI group was significantly reduced after 15 days of systemic irradiation at a dose of 4Gy compared to the Con group (fig. 5). The lymphocyte numbers were significantly increased in both the Pre (fig. 5A) and Post (fig. 5B) groups compared to the TBI group.
Thymus and spleen are important immune organs and hematopoietic organs of human body, the initial source of lymphocytes is hematopoietic organs, and the more number of lymphocytes indicates the stronger hematopoietic function.
The results of the above sections (1) to (3) show that:
IVIg can prevent and treat thymus and spleen injury (atrophy of appearance and impaired hematopoietic function) caused by irradiation.
(4) Neutrophil observation
The number of neutrophils in the TBI group was significantly increased after 15 days of systemic irradiation at 4Gy dose compared to the Con group (fig. 6). The numbers of neutrophils were significantly decreased in both Pre (fig. 6A) and Post (fig. 6B) groups compared to TBI group, especially Post group, almost to normal level.
Neutrophils are chemotactic, phagocytic, and bactericidal, and their increased numbers often indicate the presence of infection, inflammation, or tissue damage.
The results of the above section (4) show that: the prevention or treatment by administration of IVIg can significantly ameliorate the symptoms of infection, inflammation or tissue damage caused by irradiation to mice, particularly female mice.
The results of this example show that: after irradiation damage, IVIg administration can remarkably improve the immune and hematopoietic organs of mice (especially female mice) such as thymus, spleen and the like, protect hematopoietic function and reduce infection, inflammation and tissue damage related to irradiation.
EXAMPLE 3IVIg treatment of Abdominal radiation injured mice (simulated radiation therapy)
1. Method of producing a composite material
30 mice were divided into Con group (control, no irradiation, no dosing), TBI group, IVIg group (treatment), 10 per group (of which 5 female mice and 5 male mice). Three groups were irradiated locally on the abdomen at a total dose of 12Gy, sacrificed 21 days later, and analyzed for intestinal length changes by dissection. The difference is that:
con group did not irradiate, injected IVIg;
TBI group was irradiated only, without IVIg injection;
the IVIg group (treatment group) was administered 1 time within 30min after irradiation, followed by 2 times weekly administration.
The administration is as follows: for injection, the dose of IVIg is 0.3g/Kg body weight.
2. Results
The intestinal length was significantly shortened following topical abdominal irradiation with a total dose of 12Gy in both female and male mice, and this condition was significantly improved following IVIg treatment (fig. 6).
The results of this example show that IVIg can alleviate the symptoms of radiation-induced shortening of the large intestine length.
In conclusion, IVIg can reduce the damage of spleen and thymus caused by irradiation, ensure the hematopoietic function, maintain the number of lymphocytes, reduce infection, inflammation and tissue damage caused by irradiation, relieve the symptom of the shortening of the large intestine length caused by irradiation, and can be used for preventing or treating irradiation damage and improving the survival rate under the irradiation of lethal dose. Other human immunoglobulin for injection, such as intramuscular injection and subcutaneous injection, have the same basic components as IVIg and are human immunoglobulin, so that the human immunoglobulin for injection has similar functions of preventing and treating radiation damage to IVIg.
Claims (10)
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5562902A (en) * | 1994-03-14 | 1996-10-08 | Arp Biomed, Inc. | Immunotherapeutic method of treating cancerous diseases by administration of intravenous immunoglobulin |
| RU2011150766A (en) * | 2011-12-13 | 2013-06-20 | Федеральное государственное бюджетное учреждение "Федеральный Центр токсикологической, радиационной и биологической безопасности" (ФГБУ "ФЦТРБ-ВНИВИ") | METHOD FOR TREATING RADIATION-CHEMICAL-BIOLOGICAL DAMAGE OF THE ORGANISM AND METHOD FOR PRODUCING GLOBULINS FOR TREATMENT OF RADIATION-CHEMICAL-BIOLOGICAL DAMAGE OF THE ORGANISM |
-
2020
- 2020-09-04 CN CN202010925913.XA patent/CN114129722B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5562902A (en) * | 1994-03-14 | 1996-10-08 | Arp Biomed, Inc. | Immunotherapeutic method of treating cancerous diseases by administration of intravenous immunoglobulin |
| RU2011150766A (en) * | 2011-12-13 | 2013-06-20 | Федеральное государственное бюджетное учреждение "Федеральный Центр токсикологической, радиационной и биологической безопасности" (ФГБУ "ФЦТРБ-ВНИВИ") | METHOD FOR TREATING RADIATION-CHEMICAL-BIOLOGICAL DAMAGE OF THE ORGANISM AND METHOD FOR PRODUCING GLOBULINS FOR TREATMENT OF RADIATION-CHEMICAL-BIOLOGICAL DAMAGE OF THE ORGANISM |
Non-Patent Citations (1)
| Title |
|---|
| 孙琪云 等: "静脉注射免疫球蛋白在急性放射病人救治中的应用", 《解放军医学杂志》, vol. 32, no. 04, pages 408 * |
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| CN114129722B (en) | 2024-04-05 |
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