MD27Y - Method for treating disorders of cellular immunity caused by the ionizing radiation - Google Patents
Method for treating disorders of cellular immunity caused by the ionizing radiation Download PDFInfo
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- MD27Y MD27Y MDS20080007A MDS20080007A MD27Y MD 27 Y MD27 Y MD 27Y MD S20080007 A MDS20080007 A MD S20080007A MD S20080007 A MDS20080007 A MD S20080007A MD 27 Y MD27 Y MD 27Y
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Abstract
Inventia se refera la medicina, in special la medicina preventiva. Metoda de tratament al dereglarii imunitatii celulare provocate de radiatia ionizanta consta in aceea ca se administreaza intramuscular sol. de Piridoxina de 5%, cate 1 ml, o data in zi, per os Essentiale cate 2 capsule de 3 ori pe zi si Pacovirin-plus, cate 1 pastila pe zi. Cura de tratament constituie 90 de zile.Invention refers to medicine, especially preventive medicine. The treatment method of the cellular immunity disorder caused by ionizing radiation consists in the fact that it is administered intramuscularly to the ground. of 5% pyridoxine, 1 ml, once daily, per Essential bone each 2 capsules 3 times daily and Pacovirin-plus, 1 pill daily. Treatment treatment is 90 days.
Description
Invenţia se referă la medicină, în special la medicina preventivă. The invention relates to medicine, in particular to preventive medicine.
În celulele persoanelor expuse acţiunii radiaţiilor ionizante are loc formarea radicalilor liberi, care condiţionează modificarea indicilor verigilor imunităţii T-celulare, ceea ce mărturiseşte despre dereglări imunologice celulare şi diminuarea rezistenţei organismului. Dereglarea componentului subpopulaţional al limfocitelor, imunodeficienţa-T pronunţată, este caracterizată prin scăderea conţinutului în sânge a limfocitelor-T, îndeosebi, a helperilor (CD4+). Aceasta impune necesitatea elaborării metodelor de reglare a reacţiilor imune, în vederea prevenirii maladiilor canceroase, care de obicei se declanşează pe fonul dereglărilor imunităţii. In the cells of people exposed to ionizing radiation, free radicals are formed, which cause changes in the indices of T-cell immunity, which indicates cellular immunological disorders and a decrease in the body's resistance. Dysregulation of the subpopulation component of lymphocytes, pronounced T-immunodeficiency, is characterized by a decrease in the content of T-lymphocytes in the blood, especially helpers (CD4+). This requires the development of methods for regulating immune reactions in order to prevent cancer, which usually occurs against the background of immune disorders.
Este cunoscută utilizarea pacovirinului cu acţiune imunomodulatoare [1]. The use of pacovirin with immunomodulatory action is known [1].
În calitate de cea mai apropiată soluţie serveşte metoda de tratament al dereglărilor imunităţii celulare, care constă în aceea că se administrează intramuscular sol. de Piridoxină de 5%, câte 1 ml o dată în zi şi per os Essentiale, câte 2 capsule de 3 ori pe zi [2]. The closest solution is the method of treating cellular immunity disorders, which consists of administering 5% Pyridoxine solution intramuscularly, 1 ml once a day, and Essentiale orally, 2 capsules 3 times a day [2].
Dezavantajele acestor metode constau în aceea că în cazul tratamentului tradiţional, dereglările imunităţii celulare nu se normalizează complet şi pot fi cauza recidivelor frecvente la persoanele expuse la radiaţii ionizante a diferitor maladii, pot contribui la declanşarea maladiilor oncologice. The disadvantages of these methods are that in the case of traditional treatment, cellular immunity disorders are not completely normalized and can be the cause of frequent relapses in people exposed to ionizing radiation of various diseases, and can contribute to the onset of oncological diseases.
Problema pe care o soluţionează invenţia constă în tratamentul dereglărilor imunităţii celulare la persoane expuse la radiaţii ionizante prin utilizarea preparatului Pacovirin-plus administrat concomitent cu Piridoxină şi Esenţiale. The problem solved by the invention consists in the treatment of cellular immunity disorders in people exposed to ionizing radiation by using the Pacovirin-plus preparation administered concomitantly with Pyridoxine and Essentials.
Metoda de tratament al dereglării imunităţii celulare provocate de radiaţia ionizantă constă în aceea că se administrează intramuscular sol. de Piridoxină de 5%, câte 1 ml o dată în zi, per os Essentiale, câte 2 capsule de 3 ori pe zi, şi Pacovirin-plus, câte 1 pastilă pe zi. Cura de tratament constituie 90 de zile. The treatment method for cellular immunity disorders caused by ionizing radiation consists of administering intramuscularly 5% Pyridoxine solution, 1 ml once a day, orally Essentiale, 2 capsules 3 times a day, and Pacovirin-plus, 1 pill a day. The treatment course is 90 days.
Pacovirin-plus este un produs de origine vegetală din grupul adaptogenilor, obţinut printr-un procedeu original de extracţie, în care substanţa biologic activă atinge valoarea de 92,8%. Pacovirin-plus is a product of plant origin from the adaptogen group, obtained through an original extraction process, in which the biologically active substance reaches 92.8%.
Pentru cercetare au fost selectate persoane participante la lichidarea consecinţelor accidentului nuclear de la Cernobâl în număr de 69, (mediu urban - 18 (26,1%), mediu rural - 51 (79,9%), dintre care sunt 68 de bărbaţi şi o femeie, cu vârsta medie de 48,6±8,0 ani. Prin metodă randomizată, pacienţii au fost divizaţi în două grupuri: experimental (33 pacienţi) şi martor (36 pacienţi). For the research, 69 people participating in the liquidation of the consequences of the Chernobyl nuclear accident were selected (urban environment - 18 (26.1%), rural environment - 51 (79.9%), of whom 68 were men and one woman, with an average age of 48.6±8.0 years. By randomized method, the patients were divided into two groups: experimental (33 patients) and control (36 patients).
În lotul martor tratamentul s-a efectuat tradiţional, cu vitaminoterapie grupa B, Essenţiale forte, iar în unele cazuri, după necesitate, spasmolitice, sedative şi analgetice. In the control group, treatment was carried out traditionally, with vitamin therapy group B, Essentiale forte, and in some cases, as needed, spasmolytics, sedatives and analgesics.
Studierea eficacităţii preparatului Pacovirin-plus, utilizat în procesul de recuperare a persoanelor participante la lichidarea consecinţelor accidentului nuclear de la Cernobâl s-a efectuat în baza supravegherii clinice şi paraclinice a acestei categorii de pacienţi. Investigaţiile clinice au inclus: starea de gravitate, statutul neurologic (acuzele, starea pielii şi a mucoaselor, ganglionii limfatici, starea sistemelor respirator, cardiovascular, digestiv, urinar la începutul şi sfârşitul tratamentului. Investigaţiile paraclinice au inclus: investigaţiile ALAT, ASAT, bilirubina, proteina totală, echilibrul acido-bazic, glucoza, timolul, ECG, USG, hemoleucogramele, analizele de urină, examenele virusologice (HSV, CMV, EBV), investigaţiile imunologice: CD4 + (T-helper), CD8+ (T-supresor), CD3+ (T-celule). Tratamentul la pacienţii din lotul experimental a fost suplinit cu fitoremediul autohton cu acţiune antivirală, imunomodulatoare, interferonogenă şi antioxidantă: 5α-furostan-3β.22.26-triol-3-[O-β-D-glucopiranozil(1→2)-β-D-glucopiranozil(1→4)-β-D-galactopiranozil]-26-O-β-D-glucopiranozil (pacovirin), 50 mg (o pastilă) o dată pe zi timp de 90 zile, concomitent cu produsele medicamentoase Piridoxină şi Essenţiale, iar celor din lotul martor li s-a administrat numai Piridoxină şi Esenţiale conform tratamentului standard. Pentru aprobarea metodei de tratament a persoanelor participante la lichidarea consecinţelor accidentului nuclear de la Cernobâl s-au efectuat investigaţii clinice şi paraclinice prin metoda randomizată pentru aprecierea eficacităţii variantei noi de tratament în condiţii de policlinică. The study of the efficacy of the Pacovirin-plus preparation, used in the recovery process of persons participating in the liquidation of the consequences of the Chernobyl nuclear accident, was carried out based on clinical and paraclinical surveillance of this category of patients. Clinical investigations included: severity, neurological status (accusations, condition of the skin and mucous membranes, lymph nodes, condition of the respiratory, cardiovascular, digestive, urinary systems at the beginning and end of treatment. Paraclinical investigations included: ALAT, ASAT, bilirubin, total protein, acid-base balance, glucose, thymol, ECG, USG, hemoleukograms, urine tests, virological examinations (HSV, CMV, EBV), immunological investigations: CD4 + (T-helper), CD8+ (T-suppressor), CD3+ (T-cells). Treatment of patients in the experimental group was supplemented with the local phytoremedie with antiviral, immunomodulatory, interferonogenic and antioxidant action: 5α-furostane-3β.22.26-triol-3-[O-β-D-glucopyranosyl(1→2)-β-D-glucopyranosyl(1→4)-β-D-galactopyranosyl]-26-O-β-D-glucopyranosyl (pacovirin), 50 mg (one tablet) once a day for 90 days, simultaneously with the medicinal products Pyridoxine and Essentials, and those in the control group were administered only Pyridoxine and Essentials according to the standard treatment. In order to approve the treatment method of the persons participating in the liquidation of the consequences of the Chernobyl nuclear accident, clinical and paraclinical investigations were carried out by the randomized method to assess the effectiveness of the new treatment variant in polyclinic conditions.
Mostrele de sânge, în volum de 5 ml, pentru investigaţii imunologice au fost recoltate individual cu 5 zile înainte de iniţierea tratamentului şi la 5 zile după finalizarea lui. Au fost examinaţi următorii markeri ai T-limfocitelor: CD4+, CD8+, CD3+, utilizând metoda de fenotipare a limfocitelor la flowcitometru, FACS count system. Blood samples, in a volume of 5 ml, for immunological investigations were collected individually 5 days before the initiation of treatment and 5 days after its completion. The following T-lymphocyte markers were examined: CD4+, CD8+, CD3+, using the lymphocyte phenotyping method on the flow cytometer, FACS count system.
Rezultatele sunt prezentate în tabelul 1. The results are presented in Table 1.
La studierea datelor iniţiale ce ţin de starea statusului imun la pacienţii expuşi la radiaţii ionizante s-a stabilit că practic toţi pacienţii au prezentat semne de proces imun cronic. When studying the initial data related to the immune status of patients exposed to ionizing radiation, it was established that practically all patients showed signs of a chronic immune process.
Din datele prezentate în tabel se evidenţiază că preparatul Pacovirin-plus administrat concomitent cu Piridoxină şi Essenţiale influenţează pozitiv asupra sistemului imun şi duce la normalizarea coraportului CD4/CD8. La pacienţii lotului martor terapia tradiţională nu a avut influenţă esenţială asupra acestor indici. The data presented in the table show that the Pacovirin-plus preparation administered concomitantly with Pyridoxine and Essentials has a positive influence on the immune system and leads to the normalization of the CD4/CD8 ratio. In the control group patients, traditional therapy had no essential influence on these indices.
Acest fapt se explică prin manifestarea proprietăţilor antioxidante ale preparatului Pacovirin-plus, capabile de a reduce radicalii liberi formaţi în procesul de radioliză, care are loc în celulă sub acţiunea radiaţiilor ionizante. În acest caz administrarea preparatului Pacovirin-plus concomitent cu Piridoxină şi Essenţiale favorizează substanţial efectul sinergetic, ce contribuie la sporirea indicelui imunoregulator. This is explained by the manifestation of the antioxidant properties of the Pacovirin-plus preparation, capable of reducing free radicals formed in the process of radiolysis, which occurs in the cell under the action of ionizing radiation. In this case, the administration of the Pacovirin-plus preparation simultaneously with Pyridoxine and Essentials substantially favors the synergistic effect, which contributes to the increase of the immunoregulatory index.
În tabelul 2 sunt prezentate rezultatele influenţei preparatului Pacovirin-plus asupra unor parametri biochimici la persoanele examinate. S-a observat o tendinţă de normalizare a parametrilor în cauză cu revenirea lor în limitele normei. O evoluţie pozitivă ca consecinţă a diminuării activităţii procesului patologic hepatic şi activităţii antioxidante a preparatului a avut activitatea ALAT în ser, valorile căreia la finele tratamentului cu Pacovirin s-au stabilit în limitele normei la 81,8%±6,7 pacienţi în lotul experimental comparativ cu 69,4%±7,7 din lotul martor (P<0,05). Merită atenţie şi dinamica pozitivă a unui indice important ce reflectă activitatea patologică hepatică - oxidarea peroxidică a lipidelor, care s-a diminuat de la 6,89±0,11 până la 5,9±0,09 (P<0,01). Table 2 presents the results of the influence of the Pacovirin-plus preparation on some biochemical parameters in the examined persons. A tendency of normalization of the parameters in question with their return to the normal limits was observed. A positive evolution as a consequence of the decrease in the activity of the hepatic pathological process and the antioxidant activity of the preparation had the ALAT activity in serum, the values of which at the end of the treatment with Pacovirin were established within the normal limits in 81.8%±6.7 patients in the experimental group compared to 69.4%±7.7 in the control group (P<0.05). Attention is also drawn to the positive dynamics of an important index reflecting the hepatic pathological activity - lipid peroxidation, which decreased from 6.89±0.11 to 5.9±0.09 (P<0.01).
Tabelul 1 Table 1
Caracteristica indicilor statusului imun CD4/CD8 Characteristics of CD4/CD8 immune status indices
la persoanele participante la lichidarea consecinţelor accidentului nuclear de la Cernobâl to persons participating in the liquidation of the consequences of the Chernobyl nuclear accident
Indicele Lotul experimental n=33 Lotul martor n=36 norma patologie P norma patologie P Nr.de pacienţi (valoarea medie) M±m Nr.de pacienţi (valoarea medie) M±m Nr.de pacienţi (valoarea medie) M±m Nr.de pacienţi (valoarea medie) M±m CD4 400…1100 cel/-L Până la tratament 12 (650) 34,6± 8,4 21 (360) 63,6± 8,4 <0,01 11(530) 30,5± 7,7 25 (340) 69,5± 7,7 >0,05 După tratament 30 (800) 90,1± 5,2 3 (390) 9,9± 5,2 13 (580) 36,1± 8,0 23 (360) 63,9± 8,0 CD8 300…700 cel/-L Până la tratament 12 (400) 36,4± 8,4 21 (750) 63,6± 8,4 <0,01 11 (350) 30,5± 7,7 25 (370) 69,5± 7,7 >0,05 După tratament 30 (350) 90,1± 5,2 3 (740) 9,9± 5,2 13 (370) 36,1± 8,0 23 (400) 63,9± 8,0 CD3 1100…1700 cel/-L Până la tratament 31 (1200) 93,9± 4,2 2 (900) 6,1± 4,2 <0,01 33 (1300) 91,6± 4,6 3 (850) 8,4± 4,6 <0,05 După tratament 33 (1500) 100 - - 33 (1350) 91,6± 4,6 3 (900) 8,4± 4,6 CD 4/CD8 1,5…2,5 unităţi Până la tratament 12 (1,6) 38,6± 8,4 21 (0,5) 63,6± 8,4 <0,01 11 (1,5) 30,5± 7,7 25 (0,9) 69,5± 7,7 >0,05 După tratament 30 (2,3) 90,1± 5,2 3 (0,5) 9,9± 5,2 13 (1,6) 36,1± 8,0 23 (0,9) 63,9± 8,0Index Experimental group n=33 Control group n=36 pathological norm P pathological norm P No. of patients (mean value) M±m No. of patients (mean value) M±m No. of patients (mean value) M±m No. of patients (mean value) M±m CD4 400…1100 cel/-L Before treatment 12 (650) 34.6± 8.4 21 (360) 63.6± 8.4 <0.01 11 (530) 30.5± 7.7 25 (340) 69.5± 7.7 >0.05 After treatment 30 (800) 90.1± 5.2 3 (390) 9.9± 5.2 13 (580) 36.1± 8.0 23 (360) 63.9± 8.0 CD8 300…700 cells/-L Before treatment 12 (400) 36.4± 8.4 21 (750) 63.6± 8.4 <0.01 11 (350) 30.5± 7.7 25 (370) 69.5± 7.7 >0.05 After treatment 30 (350) 90.1± 5.2 3 (740) 9.9± 5.2 13 (370) 36.1± 8.0 23 (400) 63.9± 8.0 CD3 1100…1700 cells/-L Before treatment 31 (1200) 93.9± 4.2 2 (900) 6.1± 4.2 <0.01 33 (1300) 91.6± 4.6 3 (850) 8.4± 4.6 <0.05 After treatment 33 (1500) 100 - - 33 (1350) 91.6± 4.6 3 (900) 8.4± 4.6 CD 4/CD8 1.5…2.5 units Before treatment 12 (1.6) 38.6± 8.4 21 (0.5) 63.6± 8.4 <0.01 11 (1.5) 30.5± 7.7 25 (0.9) 69.5± 7.7 >0.05 After treatment 30 (2.3) 90.1± 5.2 3 (0.5) 9.9± 5.2 13 (1.6) 36.1± 8.0 23 (0.9) 63.9± 8.0
Pacovirin s-a stabilit în limitele normei la 81,8%±6,7 pacienţi în lotul experimental comparativ cu 69,4%±7,7 din lotul martor (P<0,05). Merită atenţie şi dinamica pozitivă a unui indice important ce reflectă activitatea patologică hepatică - oxidarea peroxidică a lipidelor, care s-a diminuat de la 6,89±0,11 până la 5,9±0,09 (P<0,01). Pacovirin was established within the normal limits in 81.8%±6.7 patients in the experimental group compared to 69.4%±7.7 in the control group (P<0.05). It is also worth noting the positive dynamics of an important index reflecting the pathological liver activity - lipid peroxidation, which decreased from 6.89±0.11 to 5.9±0.09 (P<0.01).
Tabelul 2 Table 2
Influenţa preparatului Pacovirin-plus asupra unor parametri biochimici Influence of Pacovirin-plus preparation on some biochemical parameters
Nr Indici X±mx Norma 1 ALAT1 47,9±21,6 0 … 41,0 un/l ALAT2 41,1±17,4 2 ASAT1 58,3±28,9 0 … 37,0 un/l ASAT2 36,8±19,1 3 Bilirubina1 10,6±3,0 8,0 … 23,0 Bilirubina2 12,3±3,3 4 Glucoza1 4,9±0,6 3,3 … 6,5 mmol/l Glucoza2 4,7±1,2 5 Proba cu Timol1 1,7±0,7 1,5 … 5,0 mmol/l Proba cu Timol2 1,7±0,7 No. Indices X±mx Norm 1 ALAT1 47.9±21.6 0 … 41.0 un/l ALAT2 41.1±17.4 2 ASAT1 58.3±28.9 0 … 37.0 un/l ASAT2 36.8±19.1 3 Bilirubin1 10.6±3.0 8.0 … 23.0 Bilirubin2 12.3±3.3 4 Glucose1 4.9±0.6 3.3 … 6.5 mmol/l Glucose2 4.7±1.2 5 Sample with Thymol1 1.7±0.7 1.5 … 5.0 mmol/l Sample with Thymol2 1.7±0.7
Notă: 1 - rezultatele până la administrarea preparatului Pacovirin-plus, 2 - rezultatele după administrarea preparatului Pacovirin-plus. Note: 1 - results before administration of Pacovirin-plus, 2 - results after administration of Pacovirin-plus.
Investigarea pacienţilor a demonstrat o frecvenţă înaltă în ambele grupuri a dereglărilor de tip neurotic, tulburărilor digestive şi a hepatomegaliei (tab. 3), datele obţinute fiind comparabile. Investigation of the patients demonstrated a high frequency in both groups of neurotic disorders, digestive disorders and hepatomegaly (tab. 3), the data obtained being comparable.
Monitorizarea clinico-paraclinică efectuată până şi la sfârşitul tratamentului şi pe parcursul a 3 luni demonstrează că la bolnavii din lotul experimental s-a redus semnificativ frecvenţa de manifestare a dereglărilor de tip neurotic: sindroamele astenodepresiv, astenoneurotic, anxietofobic şi ipocondric, dereglările digestive, substanţial s-a redus hepatomegalia faţă de cei din lotul martor (tab. 3). Clinical and paraclinical monitoring carried out until the end of treatment and over 3 months demonstrates that in patients in the experimental group, the frequency of manifestation of neurotic disorders was significantly reduced: astheno-depressive, asthenoneurotic, anxiety-phobic and hypochondriacal syndromes, digestive disorders, and hepatomegaly was substantially reduced compared to those in the control group (Table 3).
Tabelul 3 Table 3
Caracteristica indicilor clinici până şi după tratament Characteristics of clinical indices before and after treatment
Nr Indici Lotul experimental (n=33) Lotul martor (n=36) Până la tratament După tratament Până la tratament După tratament p Nr.de pacienţi M±m Nr.de pacienţi M±m Nr.de pacienţi M±m Nr.de pacienţi M±m 1 Sindrom astenic, iritabilitate crescută, irascibilitate, labilitate emoţională, fatigabilitate fizică şi psihică, epuizare, dereglări vegetative 31 93,9±4,5 26 78,8±7,1 33 91,7±4,6 29 80,6±6,6 >0,05 2 Sindrom depresiv, dereglarea somnului şi a poftei de mâncare, absenţa bucuriei şi a plăcerii 32 96,9±3,0 18 54,5±8,6 33 91,7±4,6 33 91,7±4,6 <0,05 4 Dereglări digestive - senzaţie de greutate, dureri sub rebordul costal drept 24 72,7±7,7 12 36,4±8,4 25 69,4±7,9 21 58,3±8,2 <0,05 5 Hepatomegalie 16 48,5±8,7 7 1,2±7,1 17 7,2±8,3 15 41,7±8,2 <0,05No. Indices Experimental group (n=33) Control group (n=36) Before treatment After treatment Before treatment After treatment p No. of patients M±m No. of patients M±m No. of patients M±m No. of patients M±m 1 Asthenic syndrome, increased irritability, irascibility, emotional lability, physical and mental fatigue, exhaustion, vegetative disorders 31 93.9±4.5 26 78.8±7.1 33 91.7±4.6 29 80.6±6.6 >0.05 2 Depressive syndrome, sleep and appetite disorders, absence of joy and pleasure 32 96.9±3.0 18 54.5±8.6 33 91.7±4.6 33 91.7±4.6 <0.05 4 Digestive disorders - sensation weight, pain under the right costal margin 24 72.7±7.7 12 36.4±8.4 25 69.4±7.9 21 58.3±8.2 <0.05 5 Hepatomegaly 16 48.5±8.7 7 1.2±7.1 17 7.2±8.3 15 41.7±8.2 <0.05
Analizarea datelor prezentate în tabelul 3 demonstrează că administrarea preparatului Pacovirin a avut o acţiune benefică asupra evoluţiei principalelor semne clinice după trei luni de tratament. În special, merită atenţie evoluţia sindromului depresiv cu dereglarea somnului şi a poftei de mâncare, care a dispărut la 14 bolnavi din 32, precum şi a durerilor şi senzaţiei de greutate sub rebordul costal drept, care au rămas să persiste după prima lună de tratament doar la 12 din 24 bolnavi. Evoluţie favorabilă au înregistrat şi astfel de semne clinice ca greţurile, inapetenţa, cefaleea, concomitent s-au micşorat şi dimensiunile ficatului la 8 bolnavi. Datele obţinute în grupul martor sunt mult mai modeste, apreciindu-se o diferenţă statistic veridică conform tuturor criteriilor clinice monitorizate. The analysis of the data presented in Table 3 demonstrates that the administration of the Pacovirin preparation had a beneficial effect on the evolution of the main clinical signs after three months of treatment. In particular, it is worth paying attention to the evolution of the depressive syndrome with sleep and appetite disorders, which disappeared in 14 patients out of 32, as well as the pain and feeling of heaviness under the right costal margin, which remained after the first month of treatment only in 12 out of 24 patients. Favorable evolution was also recorded in such clinical signs as nausea, loss of appetite, headache, and at the same time the size of the liver decreased in 8 patients. The data obtained in the control group are much more modest, a statistically significant difference being assessed according to all monitored clinical criteria.
Evoluţia comparativă a indicilor de laborator de bază la persoanele supuse tratamentului (lotul martor şi experimental) până şi după tratament este prezentată în tabelul 4. The comparative evolution of basic laboratory indices in people undergoing treatment (control and experimental groups) until and after treatment is presented in Table 4.
Tabelul 4 Table 4
Evoluţia comparativă a indicilor de laborator de bază până şi după tratament Comparative evolution of basic laboratory indices before and after treatment
Indice Lotul experimental, n=33 Lotul martor, n=36 norma patologie P norma patologie P Nr.de pacienţi (valoarea medie) M±m Nr.de pacienţi (valoarea medie) M±m Nr.de pacienţi (valoarea medie) M±m Nr.de pacienţi (valoarea medie) M±m Hb 130…175 g/l Până la tratament 16 (145) 48,4±8,7 17 (120) 51,6±8,7 <0,05 18 (140) 50,0±8,3 18 (123) 50,0±8,3 >0,05 După tratament 26 (150) 78,7±7,1 7 (125) 21,3±7,1 19 (139) 52,8±8,3 17 (121) 47,2±8,3 Eritrocite 4…5,6 x 1012/L Până la tratament 20 (4,5) 60,6±8,5 13 (3,0) 39,4±8,5 <0,05 19 (4,3) 53,0±8,3 17 (3,2) 47,0±8,3 >0,05 După tratament 27 (5,0) 81,8±6,7 6 (3,2) 18,2±6,7 17 (4,0) 47,2±8,3 19 (3,1) 52,8±8,3 Leucocite 4…5,6 x 10/L Până la tratament 32 (5,0) 96,9±3,0 1 (3,5) 3,1±2,9 <0,05 17 (4,0) 47,2±8,3 19 (3,1) 52,8±8,3 După tratament 33 (5,2) 100 - - 36 (5,0) 100 - - Limfocite 19…37% Până la tratament 33 (30) 100 - - 36 (5,0) 100 - - După tratament 33 (35) 100 - - 36 (37) 100 - - VSH 1�14 mm/oră Până la tratament 33 (6) 100 - - 36 (7) 100 - - După tratament 33 (5) 100 - - 36 (6) 100 - - Index Experimental group, n=33 Control group, n=36 pathological norm P pathological norm P No. of patients (mean value) M±m No. of patients (mean value) M±m No. of patients (mean value) M±m No. of patients (mean value) M±m Hb 130…175 g/l Before treatment 16 (145) 48.4±8.7 17 (120) 51.6±8.7 <0.05 18 (140) 50.0±8.3 18 (123) 50.0±8.3 >0.05 After treatment 26 (150) 78.7±7.1 7 (125) 21.3±7.1 19 (139) 52.8±8.3 17 (121) 47.2±8.3 Erythrocytes 4…5.6 x 1012/L Before treatment 20 (4.5) 60.6±8.5 13 (3.0) 39.4±8.5 <0.05 19 (4.3) 53.0±8.3 17 (3.2) 47.0±8.3 >0.05 After treatment 27 (5.0) 81.8±6.7 6 (3.2) 18.2±6.7 17 (4.0) 47.2±8.3 19 (3.1) 52.8±8.3 Leukocytes 4…5.6 x 1012/L Before treatment 32 (5.0) 96.9±3.0 1 (3.5) 3.1±2.9 <0.05 17 (4.0) 47.2±8.3 19 (3.1) 52.8±8.3 After treatment 33 (5.2) 100 - - 36 (5.0) 100 - - Lymphocytes 19…37% Until treatment 33 (30) 100 - - 36 (5.0) 100 - - After treatment 33 (35) 100 - - 36 (37) 100 - - ESR 1�14 mm/hour Until treatment 33 (6) 100 - - 36 (7) 100 - - After treatment 33 (5) 100 - - 36 (6) 100 - -
Conform rezultatelor înregistrate, în lotul experimental s-a depistat o tendinţă clară spre creşterea numărului total de limfocite în sângele periferic, ceea ce denotă acţiunea imunomodulatoare a preparatului. According to the recorded results, in the experimental group a clear trend towards an increase in the total number of lymphocytes in the peripheral blood was detected, which denotes the immunomodulatory action of the preparation.
Exemplul 1 Example 1
Pacientul D., anul naşterii 1936, domiciliat în satul Jora de Mijloc, raionul Orhei. Diagnosticul clinic: Hepatită cronică de etiologie necunoscută. Bronşită cronică recidivată. Encefalopatie reziduală cu sindrom depresiv. Patient D., born in 1936, residing in the village of Jora de Mijloc, Orhei district. Clinical diagnosis: Chronic hepatitis of unknown etiology. Recurrent chronic bronchitis. Residual encephalopathy with depressive syndrome.
La prima vizită (27.02.2007) acuză dereglarea somnului şi a poftei de mâncare, fatigabilitate fizică şi psihică, epuizare, senzaţie de greutate, dureri sub rebordul costal drept, tusă seacă, mai mult noaptea. La examenul obiectiv s-a constatat: gravitate medie, conştiinţă clară, pasivă, fără dispoziţie, paliditate, limbă umedă cu depuneri, respiraţie pulmonară aspră, fără raluri. Zgomotele cardiace ritmice, sonore. Ficatul depăşea rebordul costal drept cu 2,5-2,5-1,5 cm, de consistenţă dur-elastică, sensibil la palpare. Micţiuni regulate, indolore. At the first visit (27.02.2007) he complained of sleep and appetite disorders, physical and mental fatigue, exhaustion, feeling of heaviness, pain under the right costal margin, dry cough, more at night. The objective examination revealed: medium severity, clear consciousness, passive, no mood, pallor, wet tongue with deposits, rough pulmonary breathing, no rales. Heart sounds rhythmic, sonorous. The liver exceeded the right costal margin by 2.5-2.5-1.5 cm, of hard-elastic consistency, sensitive to palpation. Regular, painless urination.
Investigat 27.02.2008 Hb. - 128 g/l, Er. - 4,4x1012/l, leuc. - 4,2x109/l, nes. - 1%, segm. - 70%, eoz. - 1%, limf. - 23%, mon. - 5%, VSH - 2 mm/oră, ALAT - 59,2 un/l, ASAT - 85,6 un/l, Bilirubina - 10,5 µmoli/l; directă - 4,2 µmol/l, indirectă - 6,3 µmoli/l; proteina totală - 65,2 g/l, proba cu timol - 1,8 U. ECG: ritm sinusal, frecvenţa contracţiilor cardiace 70 pe minut, tulburări de conducere pe ramura dreaptă, semne de hipertrofie a ventriculului stâng. USG: hepatomegalie, parenchimul hepatic de ecogenitare sporită, pancreasul mărit în dimensiuni, structura omogenă, de ecogenitare sporită. Analiza de urină - fără modificări patologice. Testarea indicilor imunităţii celulare: T-totale - limfocite - 1,1x109/l (62,0%), T-helper - 0,65x109/l (32%); T-supresor 0,50x109/l, T-helper/T-supresor-1,3. Examenele virusologice: AgHSV1/2 - negativ; Anti HSV1/2 IgM - negativ; Anti HSV IgG - pozitiv; CMV IgM - negativ; CMV IgG - pozitiv; EBV IgM - negativ; EBV VCA IgG - pozitiv; EBV EA IgG - pozitiv; EBV EBNA - pozitiv. Investigated 27.02.2008 Hb. - 128 g/l, Er. - 4.4x1012/l, leuc. - 4.2x109/l, nes. - 1%, segm. - 70%, eoz. - 1%, lymp. - 23%, mon. - 5%, ESR - 2 mm/hour, ALAT - 59.2 un/l, ASAT - 85.6 un/l, Bilirubin - 10.5 µmol/l; direct - 4.2 µmol/l, indirect - 6.3 µmol/l; total protein - 65.2 g/l, thymol test - 1.8 U. ECG: sinus rhythm, heart rate 70 per minute, conduction disorders on the right branch, signs of left ventricular hypertrophy. USG: hepatomegaly, liver parenchyma of increased echogenicity, enlarged pancreas, homogeneous structure, of increased echogenicity. Urinalysis - no pathological changes. Testing of cellular immunity indices: T-total - lymphocytes - 1.1x109/l (62.0%), T-helper - 0.65x109/l (32%); T-suppressor 0.50x109/l, T-helper/T-suppressor-1.3. Virological examinations: AgHSV1/2 - negative; Anti HSV1/2 IgM - negative; Anti HSV IgG - positive; CMV IgM - negative; CMV IgG - positive; EBV IgM - negative; EBV VCA IgG - positive; EBV EA IgG - positive; EBV EBNA - positive.
A fost indicat tratamentul: Pacovirin-Plus a câte 50 mg ( o pastilă) o dată pe zi timp de 90 zile; Vitamina B6 (Sol. Pyridoxini) 5%, câte 1 ml intramuscular o dată pe zi timp de 90 zile; Essentiale forte, câte 2 capsule de 3 ori pe zi timp de 90 zile. The treatment indicated was: Pacovirin-Plus 50 mg (one pill) once a day for 90 days; Vitamin B6 (Sol. Pyridoxine) 5%, 1 ml intramuscularly once a day for 90 days; Essentiale forte, 2 capsules 3 times a day for 90 days.
Peste 3 luni (05.06.2007) s-a ameliorat pofta de mâncare, somnul, au dispărut durerile în abdomen şi senzaţia de greutate sub rebordul costal drept. Examenul obiectiv a pus în evidenţă tegumente roz pale, micşorarea dimensiunilor ficatului până la 1,5 - 1,5 - 1,0 cm, marginea ficatului rotunjită, de consistenţă elastică, indoloră. After 3 months (05.06.2007) the appetite and sleep improved, the abdominal pain and the feeling of heaviness under the right costal margin disappeared. The objective examination revealed pale pink skin, a decrease in the size of the liver to 1.5 - 1.5 - 1.0 cm, the liver edge was rounded, elastic, painless.
Examenul biochimic: ALAT - 32,2 un/l, ASAT - 43,6 un/l, Bilirubina - 14,5 µmoli/l, directă - 2,2 µmoli/l, indirectă - 12,3 µmoli/l; proteina totală - 68,2 g/l, proba cu timol - 1,8 U. USG: hepatomegalie moderată. Hemoleucograma: leucocite - 7,5x109/l, limfocite (32%), T-totale -1,1x109/l (58%), T - helper - 0,75x109/l (36%), T - supresor - 0,26x109/l (17%), T - helper/T-supresor - 2,9. Examenele virusologice: AgHSV1/2 - negativ; Anti HSV1/2 IgM - negativ; Anti HSV IgG - pozitiv; CMV IgM - negativ; CMV IgG - pozitiv; EBV IgM - negativ; EBV VCA IgG - pozitiv; EBV EA IgG - negativ; EBV EBNA - pozitiv. Biochemical examination: ALAT - 32.2 u/l, ASAT - 43.6 u/l, Bilirubin - 14.5 µmol/l, direct - 2.2 µmol/l, indirect - 12.3 µmol/l; total protein - 68.2 g/l, thymol test - 1.8 U. USG: moderate hepatomegaly. Hemoleukogram: leukocytes - 7.5x109/l, lymphocytes (32%), T-total -1.1x109/l (58%), T - helper - 0.75x109/l (36%), T - suppressor - 0.26x109/l (17%), T - helper/T-suppressor - 2.9. Virological examinations: AgHSV1/2 - negative; Anti HSV1/2 IgM - negative; Anti HSV IgG - positive; CMV IgM - negative; CMV IgG - positive; EBV IgM - negative; EBV VCA IgG - positive; EBV EA IgG - negative; EBV EBNA - positive.
Reacţii adverse la administrarea preparatului nu au fost depistate. No adverse reactions to the administration of the preparation were detected.
Exemplul 2 Example 2
Pacientul P., anul naşterii 1948, domiciliat în satul Pelivan, raionul Orhei. Diagnosticul clinic: Encefalopatie reziduală cu sindrom astenic. Hepatită cronică de etiologie necunoscută. Colecistită cronică acalculoasă. Pancreatită cronică. Hipertensiune arterială. Patient P., born in 1948, residing in the village of Pelivan, Orhei district. Clinical diagnosis: Residual encephalopathy with asthenic syndrome. Chronic hepatitis of unknown etiology. Chronic acalculous cholecystitis. Chronic pancreatitis. Arterial hypertension.
La prima vizită (27.02.2007) acuză irascibilitate, labilitate emoţională, epuizare fizică şi psihică, insomnie, lipsa poftei de mâncare, senzaţie de greutate, dureri sub rebordul costal drept. La examenul obiectiv s-a constatat: gravitate medie, conştiinţă clară, iritată, paliditate, limbă umedă, saburată, respiraţie pulmonară veziculară. Zgomotele cardiace ritmice, atenuate, suflu sistolic la apex. Ficatul depăşea rebordul costal drept cu 3,0-2,5-1,5 cm, de consistenţă dur-elastică, sensibil la palpare. Micţiuni regulate, indolore. At the first visit (27.02.2007) he complained of irritability, emotional lability, physical and mental exhaustion, insomnia, lack of appetite, feeling of heaviness, pain under the right costal margin. The objective examination revealed: medium severity, clear consciousness, irritated, pallor, moist, greasy tongue, vesicular pulmonary breathing. Rhythmic, attenuated heart sounds, systolic murmur at the apex. The liver exceeded the right costal margin by 3.0-2.5-1.5 cm, of hard-elastic consistency, sensitive to palpation. Regular, painless urination.
Investigat 27.02.2008 Hb. - 108 g/l, Er. - 3,4x1012/l, leuc. - 4,2x109/l, nes. - 1%, segm.-63%, eoz. - 2%, limf. - 33%, mon. - 1%, VSH - 9 mm/oră. ALAT - 62,2 un/l, ASAT - 72,3 un/l, Bilirubina - 12,7 µmoli/l; directă - 1,2 µmoli/l, indirectă - 11,5 µmoli/l; proteină totală - 78,2 g/l, proba cu timol - 2,0 U. ECG: ritm sinusal, frecvenţa contracţiilor cardiace 84 pe minut, tulburări de conducere pe ramura dreaptă, semne de hipertrofie a ventriculului stâng. USG: parenchimul hepatic de ecogenitare sporită, omogen, vezica biliară cu pereţii îngroşaţi, calculi absenţi, pancreasul mărit în dimensiuni, structura omogenă, de ecogenitate sporită. Analiza de urină - fără modificări patologice. Examenele virusologice: AgHSV1/2 - negativ; Anti HSV1/2 IgM - negativ; Anti HSV IgG - pozitiv; CMV IgM - negativ; CMV IgG - pozitiv; EBV IgM - negativ; EBV VCA IgG - pozitiv; EBV EA IgG - negativ; EBV EBNA - pozitiv. Investigated 27.02.2008 Hb. - 108 g/l, Er. - 3.4x1012/l, leuc. - 4.2x109/l, nes. - 1%, segm.-63%, eoz. - 2%, lymp. - 33%, mon. - 1%, ESR - 9 mm/hour. ALAT - 62.2 un/l, ASAT - 72.3 un/l, Bilirubin - 12.7 µmol/l; direct - 1.2 µmol/l, indirect - 11.5 µmol/l; total protein - 78.2 g/l, thymol test - 2.0 U. ECG: sinus rhythm, heart rate 84 per minute, conduction disorders on the right branch, signs of left ventricular hypertrophy. USG: liver parenchyma of increased echogenicity, homogeneous, gallbladder with thickened walls, absent stones, pancreas enlarged in size, homogeneous structure, of increased echogenicity. Urinalysis - no pathological changes. Virological examinations: AgHSV1/2 - negative; Anti HSV1/2 IgM - negative; Anti HSV IgG - positive; CMV IgM - negative; CMV IgG - positive; EBV IgM - negative; EBV VCA IgG - positive; EBV EA IgG - negative; EBV EBNA - positive.
Testarea indicilor imunităţii celulare: T-totale - limfocite 0,6x109l (62,0%), T-active - 0,17x109/l (17%); T-termo - 0,1x109/l (1%); T - helper - 0,3x109/l(32%); T - supresor - 0,3x109/l, T-helper/T-supresor - 1,0. Testing of cellular immunity indices: T-total - lymphocytes 0.6x109l (62.0%), T-active - 0.17x109/l (17%); T-thermo - 0.1x109/l (1%); T - helper - 0.3x109/l (32%); T - suppressor - 0.3x109/l, T-helper/T-suppressor - 1.0.
Peste 3 luni (06.06.2007) starea cu ameliorare, este activ, bine dispus, doarme bine noaptea, durerile în abdomen au dispărut, pofta de mâncare s-a normalizat. Examenul obiectiv a pus în evidenţă micşorarea dimensiunilor ficatului până la 2,5-0,5-1,0 cm, marginea ficatului rotunjită, de consistenţă dur-elastică, indolară. After 3 months (06.06.2007) the condition improved, he is active, in a good mood, sleeps well at night, the pain in the abdomen has disappeared, the appetite has normalized. The objective examination revealed a decrease in the size of the liver to 2.5-0.5-1.0 cm, the liver edge is rounded, of a hard-elastic consistency, painless.
Examenul biochimic: ALAT - 36,2 un/l, ASAT - 39,6 un/l, Bilirubina - 10,5 µmoli/l directă - 1,8 µmoli/l, indirectă - 8,7 µmoli/l, proteina totală - 62,2 g/l, proba cu timol 1,8 U. USG: hepatomegalie moderată, colecistită cronică acalculoasă. Hemoleucograma: leucocite -8,1x109/l, limfocite (32%), T-totale - 1,1x109/l (58%), T-helper - 0,75x109/l (36%), T-supresor -0,26x109/l (17%), T-helper/T-supresor - 2,9. Examenele virusologice: AgHSV1/2 - negativ; Anti HSV1/2 IgM - negativ; Anti HSV IgG - pozitiv; CMV IgM - negativ; CMV IgG - pozitiv; EBV IgM - negativ; EBV VCA IgG - pozitiv; EBV EA IgG - negativ; EBV EBNA - pozitiv. Biochemical examination: ALAT - 36.2 u/l, ASAT - 39.6 u/l, Bilirubin - 10.5 µmol/l direct - 1.8 µmol/l, indirect - 8.7 µmol/l, total protein - 62.2 g/l, thymol test 1.8 U. USG: moderate hepatomegaly, chronic acalculous cholecystitis. Hemoleucogram: leukocytes -8.1x109/l, lymphocytes (32%), T-total - 1.1x109/l (58%), T-helper - 0.75x109/l (36%), T-suppressor -0.26x109/l (17%), T-helper/T-suppressor - 2.9. Virological examinations: AgHSV1/2 - negative; Anti HSV1/2 IgM - negative; Anti HSV IgG - positive; CMV IgM - negative; CMV IgG - positive; EBV IgM - negative; EBV VCA IgG - positive; EBV EA IgG - negative; EBV EBNA - positive.
Reacţii adverse la administrarea preparatului nu au fost depistate. No adverse reactions to the administration of the preparation were detected.
1. MD 670 G2 1997.08.31 1. MD 670 G2 1997.08.31
2. Moldovan M. Polimorfismul clinic al maladiilor şi particularităţile imunogenetice la participanţii lichidării consecinţelor accidentului de la Cernobâl. Autoreferat, Chişinău, 2001 2. Moldovan M. Clinical polymorphism of diseases and immunogenetic peculiarities in participants in the liquidation of the consequences of the Chernobyl accident. Self-referent, Chisinau, 2001
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