Studie vlivu podávaného transfer-faktoru (IMUNOR) na změny subjektivních potíží u žen s chronickým vulvovaginálním diskomfortem nejasné etiologie. Subjektivní potíže hodnotily pacientky samy dle jejich intenzity číselným skórovacím systémem v rozsahu 0–10. Zařazeno bylo 28 žen fertilního věku. Po nárazové dávce byl IMUNOR 10 mg užíván na lačno 1krát týdně po dobu 3 měsíců. Výsledky: 46 % žen uvedlo výrazné zlepšení až vymizení potíží (skóre na konci studie nižší o více než 71 %), 33 % žen udalo zlepšení (závěrečné skóre nižší o 31–70 %) a jenom 21 % žen udalo zlepšení malé nebo žádné. Závěr: podávání transfer-faktoru IMUNOR 10mg vedlo u téměř 80 % žen ke zlepšení chronického vulvovaginálního diskomfortu.
A study on the effect of administration of the transfer-factor (IMUNOR) on the changes in subjective complaints in women suffering from chronic vulvovaginal discomfort of unclear etiology. The patients themselves assessed their subjective complaints based on their intensity using a 0–10 scale rating system. 28 women at fertile age were included in the study. After the loading dose was administered, IMUNOR 10mg was taken on an empty stomach once a week for a period of 3 months. Results: 46 % of the patients reported a significant improvement or even passing of their complaints (the score at the end of the study was lower by over 71 %), 33 % reported improvement (the final score decreased by 31–70 %) and only 21 % of the participants stated just a small or no improvement at all of their condition. Conclusion: the administration of the IMUNOR 10mg transfer-factor led to the improvement in the chronic vulvovaginal discomfort in almost 80 % of the study participants.
- MeSH
- Adjuvants, Immunologic therapeutic use MeSH
- Immunity, Cellular drug effects MeSH
- Adult MeSH
- Drug Evaluation MeSH
- Immunologic Factors therapeutic use MeSH
- Communicable Diseases drug therapy MeSH
- Clinical Trials as Topic MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Vagina immunology microbiology MeSH
- Vulva immunology microbiology MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Female MeSH
- Keywords
- Imunor,
- MeSH
- Chronic Disease drug therapy MeSH
- Drug Evaluation MeSH
- Immunomodulation * drug effects MeSH
- Communicable Diseases drug therapy MeSH
- Clinical Studies as Topic MeSH
- Humans MeSH
- Immune System Diseases drug therapy MeSH
- Surveys and Questionnaires MeSH
- Transfer Factor * pharmacology therapeutic use MeSH
- Check Tag
- Humans MeSH
- Keywords
- Imunor,
- MeSH
- Immunity, Cellular MeSH
- Chronic Disease MeSH
- Immunomodulation drug effects MeSH
- Communicable Diseases therapy MeSH
- Leukocytes MeSH
- Humans MeSH
- Immune System Diseases * drug therapy MeSH
- Observational Studies as Topic MeSH
- Cross-Sectional Studies MeSH
- Surveys and Questionnaires MeSH
- Recurrence MeSH
- Tissue Extracts therapeutic use MeSH
- Transfer Factor therapeutic use MeSH
- Check Tag
- Humans MeSH
V multicentrické studii byl vyhodnocen na 35 pacientech s recidivujícími či chronickými infekcemi s přetrvávajícími klinickými potížemi vliv imunostimulačního přípravku IMUNOR na klinický stav a základní parametry humorální a buněčné imunity. Byl ověřován efekt krátko dobé 4denní intenzivní terapie a dlouhodobé 9týdenní léčby. Po in tenzivní 4denní léčbě IMUNOREM došlo ke snížení symptomového skóre o 28 %. Ve skupině, kde imunostimulační léčba pokračovala udržovacími dávkami po dobu 9 týdnů, došlo k poklesu symptomového skóre na ko nci 3měsíčního sledovaného období o 42 %. Ve skupině bez pokračování imunostimulační léčby přetrvávalo zlepšení jen o 25 %. Sledová ní labora- torních hodnot prokázalo pozitivní vliv imunostimulační léčb y na hodnoty celkového počtu lymfocytů a subpopulací CD4+ a CD8+ ly mfocytů, které bylo statisticky významné již po 4denní intenzivní léčbě a př etrvávalo i po 3 měsících od za hájení studie. Mezi podsoubor y s udržovací imunostimulační léčbou a bez ní byl statisticky významný rozdíl jen v celkovém počtu lymfocytů, který byl ve skupině s udržovac í imunosti- mulační léčbou vyšší. Hodnoty humorální imuni ty prokazovaly statisticky významný pokles známek zánětu (pokles IgG, komplementu C3,C4). Léčba byla pacienty velmi dobře tolerována (jen u 1 pacienta ne byla dokončena pro zažívací potíže). Celkové subjektivní hodnoce ní pacienty vyznívalo na úrovni mírného zlepšení.
The effects of the immunostimulating product IMUNOR on clinical condition and basic parameters of humoral and cellular immunity were monitored in 35 patients with recurring or chronic infections with persistent clinical disorders. The effects of a short-term, four-day intensive therapy and a long-term, nine-week treatment were verified. After the four-day intensive IMUNOR treatment the symptom score was reduced by 28%. In the group with a long-term immunostimulating treatment ba sed on maintenance doses for 9 weeks the symptom score decreas ed by 42% at the end of the three-month period. In the group without the continued immunostimulating treatment the improvement reached on ly 25%. The monitoring of the laboratory values confirmed a positive effect of the immunostimulating treatment on the total number of lymph ocytes and the subpopulations of CD4+ and CD8+ lymphocytes, which was statistically significant after merely four days of intensive therapy an d persisted even after three months from study commencement. There was a statis tically significant difference between the subsets with and witho ut maintenance immunostimulating treatment only in the total number of lymphocy tes, which was higher in the group with this type of treatment. The values of humoral activity showed a statistically significant decrease of inflammation symptoms (decrease in IgG, C3, C4 complement an d CRP). The treatment was well tolerated by the patients (was not finished in only 1 patient for digestive disorders). The overall subjecti ve evaluation by the patients was at the level of a mild improvement.
- Keywords
- Imunor,
- MeSH
- Adjuvants, Immunologic administration & dosage therapeutic use MeSH
- Drug Evaluation MeSH
- Leukocytes drug effects MeSH
- Humans MeSH
- Lymphocytes radiation effects MeSH
- Immune System Diseases drug therapy MeSH
- Sus scrofa immunology MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Multicenter Study MeSH
In 35 patients with clinical complain caused by recurrent or chronic infections, the effectiveness of immunostimulatory preparation IMUNOR was monitored. The effect of short-term intensive treatment was studied on symptomatic score and some laboratory indicators of cellural and humoral immunity. According to patient subjective evaluation the treatment was reflected in a mild improvement.
- Keywords
- Imunor,
- MeSH
- Adjuvants, Immunologic administration & dosage therapeutic use MeSH
- Immunity, Cellular MeSH
- Chronic Disease MeSH
- Adult MeSH
- Drug Evaluation MeSH
- Immunity, Humoral MeSH
- Immunomodulation drug effects MeSH
- Communicable Diseases therapy MeSH
- Middle Aged MeSH
- Humans MeSH
- Lymphocytes drug effects MeSH
- Immune System Diseases drug therapy MeSH
- Recurrence MeSH
- Aged MeSH
- Tissue Extracts therapeutic use MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Keywords
- Imunor,
- MeSH
- Anti-Bacterial Agents therapeutic use MeSH
- Biomarkers MeSH
- Chronic Disease MeSH
- Child MeSH
- Adult MeSH
- Respiratory Tract Infections epidemiology prevention & control MeSH
- Infections epidemiology MeSH
- Communicable Disease Control MeSH
- Quality of Life MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Child, Preschool MeSH
- Aged MeSH
- Immunologic Deficiency Syndromes drug therapy prevention & control MeSH
- Tissue Extracts * administration & dosage adverse effects therapeutic use MeSH
- Transfer Factor MeSH
- Treatment Outcome MeSH
- Check Tag
- Child MeSH
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Male MeSH
- Child, Preschool MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Multicenter Study MeSH
- Observational Study MeSH
- Research Support, Non-U.S. Gov't MeSH
IMUNOR is an oral biotherapeutic drug that had been developed, registered, and approved in 1997 in the Czech Republic and Slovakia. IMUNOR is a dialyzable leukocyte extract (DLE) prepared from swine leukocytes. It is characterized as a mixture of small peptides with molecular weights smaller than 12 kDa and a specific portion of nucleotides. The medical uses of IMUNOR include therapeutic applications within its registered range of indications, primarily for the treatment of immunodeficiencies, allergies, and certain acute or relapsing bacterial infections in adults and children. Despite the long-term clinical application of DLE, with strong evidence of positive therapeutic effects and no serious side effects, a detailed physicochemical specification of this mixture was lacking. We developed several methods for more in-depth physicochemical characterization of IMUNOR, including a spectrophotometric method for quantification of the total protein concentration and total DNA concentration in a mixture, several chromatographic methods for identification of individual components present in significant concentrations in IMUNOR, such as HPLC methods and the Sodium Dodecyl Sulphate Polyacrylamide Gel Electrophoresis method, and characterization of amino acid composition of this mixture. For the investigation of the variability among different batches of IMUNOR, five to nine representative batches from a standard manufacturing process on an industrial scale were utilized. Using the analytical methods, we verified and confirmed the batch-to-batch reproducibility of the biological product IMUNOR.
- Publication type
- Journal Article MeSH
A low-molecular-weight (<12 kDa) ultrafiltered pig leukocyte extract, IMUNOR, was tested in experiments in vitro on non-stimulated and lipopolysaccharide (LPS)-stimulated murine RAW 264.7 macrophages in order to assess modulation of nitric oxide (NO) production (measured indirectly as the concentration of nitrites), hematopoiesis-stimulating activity of the supernatant of the macrophage cells (ascertained by counting cell colonies growing from progenitor cells for granulocytes and macrophages (GM-CFC) in vitro), and the release of hematopoiesis-stimulating cytokines. No hematopoiesis-stimulating activity and cytokine or NO production were found in the supernatant of non-stimulated macrophages. It was found that IMUNOR does not influence this status. Supernatant of LPS-stimulated macrophages was characterized by hematopoiesis-stimulating activity, as well as by the presence of nitrites, interleukin-6 (IL-6), and granulocyte colony-stimulating factor (G-CSF). A key role in the hematopoiesis-stimulating activity of the supernatant of LPS-stimulated macrophages could be ascribed to G-CSF since the formation of the colonies could be abrogated nearly completely by monoclonal antibodies against G-CSF. IMUNOR was found to suppress all the mentioned manifestations of the LPS-activated macrophages. When considering these results together with those from our previous in vivo study revealing stimulatory effects of IMUNOR on radiation-suppressed hematopoiesis, a hypothesis may be formulated which postulates a homeostatic role of IMUNOR, consisting in stimulation of impaired immune and hematopoietic systems but also in cutting back the production of proinflammatory mediators in cases of overstimulation which threats with undesirable consequences.
- MeSH
- Cell Line MeSH
- Bone Marrow Cells cytology drug effects MeSH
- Cytokines metabolism MeSH
- Granulocyte Colony-Stimulating Factor pharmacology metabolism MeSH
- Financing, Organized MeSH
- Hematopoiesis drug effects MeSH
- Immunologic Factors pharmacology MeSH
- Mice, Inbred Strains MeSH
- Cells, Cultured MeSH
- Lipopolysaccharides MeSH
- Macrophages metabolism drug effects MeSH
- Mice MeSH
- Nitric Oxide metabolism MeSH
- Swine MeSH
- Tissue Extracts MeSH
- Animals MeSH
- Check Tag
- Mice MeSH
- Female MeSH
- Animals MeSH
A single dose of IMUNOR, a low-molecular-weight immunodulator prepared from disintegrated and ultrafiltered pig leukocytes, was found to enhance recovery of murine pool of hemopoietic progenitor cells for granulocytes and macrophages damaged by a single injection of cytotoxic drugs 5-fluorouracil or cisplatin. The best results were obtained after the treatment with IMUNOR on days 3 or 4 after the injection of 5-fluorouracil or cisplatin. These results together with previous findings obtained in our laboratory suggest that IMUNOR has the potential to become a part of treatment schemes in oncological practice aimed at alleviation of myelosuppression evoked by cytotoxic anti-tumor therapy.
- MeSH
- Bone Marrow Cells immunology drug effects MeSH
- Cisplatin MeSH
- Financing, Organized MeSH
- Fluorouracil MeSH
- Granulocytes immunology drug effects MeSH
- Hematopoiesis drug effects MeSH
- Immunologic Factors pharmacology chemistry MeSH
- Stem Cells drug effects MeSH
- Leukocytes chemistry immunology MeSH
- Mice, Inbred ICR MeSH
- Mice MeSH
- Bone Marrow Diseases drug therapy chemically induced MeSH
- Swine MeSH
- Antimetabolites, Antineoplastic MeSH
- Antineoplastic Agents MeSH
- Ultrafiltration MeSH
- Animals MeSH
- Check Tag
- Mice MeSH
- Female MeSH
- Animals MeSH
