Evaluación de fugas extrarticulares del Fosfato crómico marcado con Fósforo-32 de producción nacional en pacientes hemofílicos / Evaluation of joint leakage of national Chromic Phosphate labeled with Phosphorus-32 in hemophilic patients

La radiosinoviortesis como tratamiento de la artropatía hemofílica, frecuentemente, ofrece excelentes resultados, al reducir grandemente el número de episodios de sangramiento y evitar daños ulteriores a las articulaciones. El Centro de Isótopos desarrolló el fosfato crómico coloidal marcado con Fósforo-32, producto listo para su empleo en pacientes hemofílicos. El objetivo de este trabajo fue evaluar la fuga extrarticular de este radiofármaco utilizado en la radiosinoviortesis en pacientes hemofílicos. Se determinó el porcentaje de fuga extrarticular del radiofármaco en 9 pacientes hemofílicos con sinovitis crónica, a los que se les realizó la radiosinoviortesis en la articulación de la rodilla. La radiactividad se midió, con un contador Geiger-Muller, sobre la rodilla tratada, en sus aspectos lateral, encima y medial; la rodilla contralateral; las cadenas linfáticas inguinales, de ambos lados, y el hígado. Los valores de fuga encontrados posteriormente a la inyección fueron 0,0046 por ciento a los 10 min; 0,0023 por ciento a las 24 horas; 0,1332 por ciento el día 7 y 4,0213 por ciento el día 30. Estos resultados coinciden con los valores comunicados por otros autores y con lo esperado de acuerdo a las características del producto, indican que se ejecutó el proceder adecuadamente y que los pacientes fueron seleccionados correctamente(AU)

Radiosynoviorthesis as a treatment for hemophilic arthropathy often offers excellent results, greatly reducing the number of bleeding episodes and avoiding further damage to the joints. The Isotope Center developed a product, Colloidal Chromic Phosphate labeled with Phosphorus-32, ready for use in hemophiliac patients. Our objective was to evaluate the joint leakage of this radiopharmaceutical use in radiosynoviorthesis in hemophilic patients. The percentage of radiopharmaceutical joint leakage was evaluated in 9 hemophilic patients with chronic synovitis, who underwent radiosynoviorthesis in the knee joint. The radioactivity was measured on the treated knee, in its lateral, above and medial aspects, the contralateral knee, the inguinal lymphatic chains of both sides and the liver, with a Geiger-Muller detector. The leakage values 8203;​found after the injection were 0.0046 percent at 10 minutes, 0.0023 percent at 24 hours, 0.1332 percent on day 7 and 4.0213 percent on day 30. These results are agreed with the values reported by other authors and with was expected according to the characteristics of the product, indicatate that the procedure was executed properly and that the patients were correctly selected(AU)

Radiosinoviortesis con suspensión de fosfato crómico [32p] en pacientes hemofílicos / Synoviorthèse radio-isotopique à phosphate chromique chez les patients atteints d'hémophilie / Use of radiosynoviorthesis with chromic phospate suspensión in hemophilic patients

Introducción: la hemofilia se define como una anomalía congénita, ligada al cromosoma X. Este hecho determina que se manifieste en varones, mientras que las mujeres son solo portadoras de la enfermedad. Objetivo: evaluar la seguridad y efectividad de la radiosinoviortesis con fosfato crómico marcado con [32P] producido por el Centro de Isótopos, en la sinovitis crónica del paciente hemofílico. Métodos: se incluyeron aquellos pacientes que presentaban más de tres hemartrosis en un mes. Previo consentimiento de los pacientes, se les inyectó 1 mCi del isótopo en la articulación afectada. Fue monitoreada la migración del radiofármaco 10 min después del proceder y en los días 1, 7 y 30 posteriores al tratamiento. También se realizaron estudios hematológicos y citogenéticos antes del tratamiento y un año después de este. Se determinó la frecuencia de sangrado, el dolor y el consumo de factor antihemofílico. Fueron tratadas 10 rodillas en 9 pacientes (hemofilia A, 88,9 por ciento y hemofilia B, 11,1 por ciento). La edad media de los enfermos fue de 36,3 años con un rango entre 23-59 años. Resultados: no se observó fuga articular significativa, ni cambios hematológicos. El estudio cromosómico fue normal en los pacientes estudiados. Antes de la radiosinoviortesis con 32P, los pacientes presentaron una tasa de sangrado de 10,3 veces por mes (rango 7-13, SD ± 2,2). La frecuencia de sangrado después de realizado el proceder disminuyó a 0,8 (P< 0,0001) en los 12 meses posteriores a la radiosinoviortesis (rango 0-4, SD ± 1,23). Conclusiones: la radiosinoviortesis con fosfato crómico es un procedimiento seguro y efectivo en la sinovitis crónica del paciente hemofílico(AU)

Introduction: hemophilia is defined as an X chromosome-linked congenital anomaly that mainly occurs in males whereas females just carry the disease. Objective: to evaluate the safety and the effectiveness of radiosynoviorthesis using 32P chromic phosphate manufactured by CENTIS to treat the chronic synovitis in hemophilic patients. Methods: the patients who presented with more than three hemarthoses in a month were included in the study. After the patients' consent, they were injected 1 mCi of the radionuclide in the affected joint. The migration of the radiopharmaceutical was then monitored 10 minutes after the procedure as well as 1, 7 and 30 days following the treatment. Hematological and cytogenetic studies were also performed before and one year after the treatment. The bleeding frequency rate, pain and the consumption of anti-hemophilic factor were determined. Ten knees from 9 patients received this therapy (hemophilia A in 88.9 pecent and hemophilia B in 11.1 percent). The average age of patients was 36.3 years, with a range of 23 to 59 years. Results: there was neither significant joint leakage nor hematological change. The chromosomal study yielded normal values. Before the radiosynoviothesis with 32P, the patients exhibited a bleeding frequency rate of 10.3 times a month (range 7-13, SD ± 2.2), but this rate lowered to 0.8 (P< 0.0001) within the 12 months after the procedure (range 0-4, SD ± 1.23). Conclusions: radiosynoviorthesis with chromic phosphate is a safe effective procedure to treat chronic synovitis in the hemophilic patient(AU)

Introduction: l'hémophilie est définie comme une anomalie congénitale associée au chromosome X. Ce sont donc les hommes qui se rendent malades, tandis que les femmes ne sont que porteuses de la maladie. Objectif: le but de ce travail est d'évaluer la sécurité et l'efficacité de la synoviorthèse radio-isotopique (SRI) à phosphate ( 32P) chromique (produit par le CENTIS, La Havane, Cuba) chez les patients hémophiliques atteints de synovite chronique. Méthodes: les patients ayant plus de trois hémarthroses en un seul mois ont été inclus dans cette étude. Avec le consentement préalable de chaque patient, 1 mCi de cet isotope a été injecté dans l'articulation affectée. On a commencé à surveiller le trajet du radio-isotope 10 min après le procédé, ainsi qu'aux 1e, 7e, et 30e jours. On a également réalisé des tests hématologiques et cytogénétiques avant et après un an de traitement. Les fréquences de l'hémorragie, de la douleur et de l'administration du facteur anti-hémophilique ont été déterminées. Neuf patients (10 genoux) ont été traités (hémophilie A, 88.9 pourcent et hémophilie B, 11.1 pourcent). L'âge moyen des malades a été 36.3 ans avec un rang de 23-59 ans. Résultats: on n'a observé ni fuite articulaire significative ni changements hématologiques; le test chromosomique des patients étudiés a été normal. Avant la SRI à 32P, les patients ont présenté un taux d'hémorragie de 10.3 fois par mois (rang de 7-13, DS ± 2.2). La fréquence de l'hémorragie après le procédé a diminué à 0.8 (P< 0.0001) en 12 mois (rang de 0-4, DS ± 1.23). Conclusions: la SRI à phosphate chromique est une technique sure et effective pour le traitement de la synovite chronique du patient atteint d'hémophilie(AU)

Fosfato de cromo (III) marcado con diferentes radionúclidos para uso en radiosinoviortesis / Chromium (III) labelled with several radionuclidesphosphate for use in radiosynoviothersis

Introducción: la radiosinoviortesis se utiliza en el tratamiento de la sinovitis crónica, complicación frecuente en enfermedades sistémicas como artritis reumatoide y hemofilia. En la práctica clínica internacional se emplean diferentes coloides y suspensiones radiactivas, pero su número es reducido y su disponibilidad limitada. Objetivo: obtención y caracterización físico-química de suspensiones de fosfato de cromo (III) marcadas con radionúclidos como potenciales radiofármacos para uso en radiosinoviortesis. Métodos: las suspensiones se obtuvieron por síntesis química, los radionúclidos se añadieron al inicio de la reacción o después de finalizada esta. El tamaño de partículas se estimó mediante microscopia óptica y filtración por membranas. Asimismo se evaluó por espectrofotometría la estabilidad de la suspensión al ser resuspendida en distintos medios. La pureza radioquímica se determinó por cromatografía de papel. Resultados: se obtuvo y caracterizó una suspensión de fosfato de cromo (III). El producto obtenido presentó un tamaño de partículas predominante entre 0,8-5 µm y que al ser suspendidas en solución de gelatina al 2 por ciento en tampón acetato 1 mg/mL no sedimentó en menos de 3 h. Se estableció la tecnología para la obtención de formulaciones de fosfato de cromo (III) marcado con 32P e 90Y y se demostró la factibilidad de marcar la suspensión obtenida con otros radionúclidos trivalentes como 177Lu y 68Ga. Conclusiones: los resultados permiten considerar al fosfato de cromo (III) una suspensión base para la obtención de radiofármacos para uso en radiosinoviortesis en diferentes articulaciones, en función de las características físico-nucleares de los radionúclidos que se empleen

Introduction: radiosynoviorthesis is used in treating chronic synovitis, a frequent complication of some systemic diseases as rheumatoid arthritis and hemophilia. There are different colloids and radioactive suspensions recommended in the international clinical practice, but the number is reduced and the availability limited. Objective: obtaining and physical-chemical characterization of suspensions of chromium phosphate (III) labeled with several radionuclides as potential radiopharmaceuticals for using in radiosynoviorthesis. Methods: the suspensions were obtained by chemical synthesis. Radionuclides were added at the beginning or after concluding the reaction. The particle size was estimated by means of optic microscopy and membrane filtration. Similarly, the stability of suspension when re-suspended in several media was evaluated by spectrophotometry. The radiochemical purity was determined by paper chromatography. Results: a suspension of chromium (III) phosphate was obtained and characterized. It was found that the obtained product had a predominant particle size range of 0,8 to 5 µm and that when suspended in 2 percent gelatin solution in 1mg/ml acetate buffer, it settled in no less than 3 hours. Technologies for the preparation of radiopharmaceuticals of Chromium (III) Phosphate labeled with 32P and 90Y were described. There was demonstrated the feasibility of labeling the obtained suspension with other trivalent radionuclides such as 177Lu and 68Ga. Conclusions: the results allow considering the obtained Chromium (III) Phosphate suspension as a matrix for the preparation of radiopharmaceuticals to be used in radiosinoviorthesis aimed at various joints, depending on the physical and nuclear characteristics of the radionuclides

Effectiveness of radiation synovectomy with samarium-153 particulate hydroxyapatite in rheumatoid arthritis patients with knee synovitis: a controlled randomized double-blind trial

OBJECTIVES: The aim of the present study was to investigate the effectiveness of Samarium153-particulate hydroxyapatite radiation synovectomy in rheumatoid arthritis patients with chronic knee synovitis. METHODS: Fifty-eight rheumatoid arthritis patients (60 knees) with chronic knee synovitis participated in a controlled double-blinded trial. Patients were randomized to receive either an intra-articular injection with 40 mg triamcinolone hexacetonide alone (TH group) or 40 mg triamcinolone hexacetonide combined with 15 mCi Samarium153-particulate hydroxyapatite (Sm/TH group). Blinded examination at baseline (T0) and at 1 (T1), 4 (T4), 12 (T12), 32 (T32), and 48 (T48) weeks post-intervention were performed on all patients and included a visual analog scale for joint pain and swelling as well as data on morning stiffness, flexion, extension, knee circumference, Likert scale of improvement, percentage of improvement, SF-36 generic quality of life questionnaire, Stanford Health Assessment Questionnaire (HAQ), Lequesne index, use of non-steroidal anti-inflammatory drugs or oral corticosteroids, events and adverse effects, calls to the physician, and hospital visits. RESULTS: The sample was homogeneous at baseline, and there were no withdrawals. Improvement was observed in both groups in relation to T0, but no statistically significant differences between groups were observed regarding all variables at the time points studied. The Sm/TH group exhibited more adverse effects at T1 (p<0.05), but these were mild and transitory. No severe adverse effects were reported during follow-up. CONCLUSION: Intra-articular injection of Samarium153-particulate hydroxyapatite (15 mCi) with 40 mg of triamcinolone hexacetonide is not superior to triamcinolone hexacetonide alone for the treatment of knee synovitis in patients with rheumatoid arthritis at 1 y of follow-up.

Efficacy of synovectomy in haemophilic patients with 153Sm-hydroxyapatite

Introduction - We preconized the use of 153Sm-Hydroxyapatite (HYP) in the synoviorthesis of haemophilic patients (pts) by physical, chemical and biological characteristics. The real efficacy is beeing confirmed by the actual experience over the previous results. These are the first results with 153Sm-HYP in our literature review. Material and Methods - Fiftheen pts. were treated, all males, with ages between 15 and 31 years (average = 22,8 years old), with an intraarticular injection of 185MBq (5mCi) of 153Sm-HYP, totalizing 29 joints: 12 knees, 11 elbows, 4 ankles and 2 shoulders. The 153Sm, produced by IPEN/CNEN - São Paulo, targeted hydroxyapatite particles with a diameter between 1-10µm, radiochemical purity superior to 95 percent and stability of 96,6 percent 1440min after the labeling process. The intraarticular punction was made after local antiseptic, aspirating synovial fluid, injecting 0,5 ml of radioactive solution and flushing the tract with a saline with a total volume no greater than 1,5 ml. The images were obtained 2 and 24h after injection in all pts in a large field of view gamma-camera. The clinical evaluation was made before and one year after it, using objective (range of motion, joint tenderness, degree of joint effusion) and subjective criteria (joint pain by visual scale and joint aspect). The response were graded: 1 - Excellent (E); 2 - Good (G); 3 - Mild (M); 4 - Bad (B); 5 - Worse (W). The reduction in clotting factor use and heamarthroses were others aspects evaluated. Results - The scintigrafies showed homogeneous distribution of the material in joints (2h) and no articular scape (24h). The was a reduction of 34 percent in the clotting factor use and of 51,4 percent in haemarthroses including the poor responses in knees. The results by patients were: 53,3 percent E, 20 percent G, 13,3 percent M, 13,3 percent B, 0 percent W and by joints were 47,75 with excellent and good responses and 84,75 percent when included the mild group. The...