Ensayo clínico fase III para evaluar la eficacia y seguridad del uso de plasma rico en plaquetas frente a ácido hialurónico en coxartrosis / Randomized, double-blind, controlled trial, phase III, to evaluate the use of platelet-rich plasma versus hyaluronic acid in hip coxarthrosis

OBJETIVOS: Comparar la eficacia y seguridad de la infiltración de plasma rico en plaquetas preparado respecto a ácido hialurónico en pacientes con coxartrosis refractaria a tratamiento conservador. Así como correlacionar el impacto clínico entre las diferentes concentraciones celulares. MATERIALES Y MÉTODOS: Ensayo clínico fase III, doble-ciego, controlado, en el que se aleatorizaron a los pacientes en dos grupos de tratamiento (PRP o AH) con una única infiltración de cadera ecoguiada. El seguimiento fue de 12 meses, registrando escala de dolor (EVA) y escalas funcionales (HHS y WOMAC), analgesia consumida, respondedores (criterios OARSI) y efectos adversos. Se analizaron, en el grupo experimental, las concentraciones celulares en sangre periférica y en el PRP infiltrado. RESULTADOS: Se incluyeron un total de 74 pacientes. Ambos grupos de tratamiento presentaron mejoría en las escalas EVA, WOMAC, HHS y reducción del consumo de analgesia en el tiempo (p < 0,05). Únicamente encontramos diferencias significativas entre grupos al año de tratamiento en los valores de HHS (Grupo PRP 70,9 [3,7-58] grupo AH 60,2[43-74,2] p < 0,05). No se registraton efectos adversos en ninguno de los grupos. Encontramos correlación entre la concentración de plaquetas en pacientes respondedores (un mes postratamiento; no respondedores 449[438-578] x103 plaquetas/μl, respondedores 565 [481-666] x103 plaquetas/μl, p < 0,044). Se correlaciona la concentración de leucocitos con las escalas clínico-funcionales (EVA 6 meses, r=0,748, p < 0,013, subescala rigidez WOMAC 6 meses, r=0,748, p < 0,013). Los pacientes con estadios de coxartrosis iniciales (KL 1 y 2) tienen mayor probabilidad de responder al tratamiento con plasma rico en plaquetas (11,51 OR, IC 95% 2,34-50,65, p < 0,03). CONCLUSIONES: La infiltración única de PRP es eficaz en términos de mejoría funcional, reducción del dolor y disminución del consumo de analgesia en coxartrosis. Los sistemas de preparación abiertos, son un procedimiento seguro para la obtención de PRP. Se deben indicar las infiltraciones de cadera en estadios evolutivos iniciales. Se debe tener en cuenta la composición celular para garantizar una repuesta clínica positiva

AIMS OF THE STUDY: To compare efficacy and safety of a home-made platelet-rich plasma (PRP) solution versus hyaluronic acid in patients with hip osteoarthritis not responding to conservative treatment and to correlate cellular composition of PRP to clinical outcomes. MATERIAL AND METHODS: This is a phase III clinical trial, double-blinded, controlled and randomised into two treatment groups (PRP and hyaluronic acid). Patients received one hip ultrasound-guided injection. Follow up was 12 months. Pain was assessed using VAS score, HHS and WOMAC were used as functional scores, analgesia, adverse events, cellular components (PRP group) in peripheral blood and in PRP were recorded. Clinical response was assessed using OARSI criteria. RESULTS: Seventy-four patients were included. Both groups improved in VAS, WOMAC and HHS score and reduced the amount of analgesia (p<.05). Significant differences were seen at 1 year post-treatment in HHS score (PRP 70.9 [3.7-58], hyaluronic acid 60.2[43-74.2] p<.05). No adverse events were observed in none of the groups. Platelet concentration was different between responders and non-responders (at 1 month, non-responders 449[438-578] x103 platelets/μl versus responders 565 [481-666] x103 platelets/μl, p<.044). There was a correlation between leukocytes concentration and clinical scores (VAS at six months, r=0.748, p<.013, WOMAC at 6 months r=0.748, p <.013). Patients with early stage hip OA showed higher response rate to PRP compared with late stage (11.51 OR, 95%CI 2.34-50.65, p<.03). CONCLUSIONS: Platelet-rich plasma injection improved hip function, reduced pain and the use of analgesia. It is important to bear in mind the cellular composition in order to achieve a better clinical response

Randomized, double-blind, controlled trial, phase III, to evaluate the use of platelet-rich plasma versus hyaluronic acid in hip coxarthrosis. / Ensayo clínico fase III para evaluar la eficacia y seguridad del uso de plasma rico en plaquetas frente a ácido hialurónico en coxartrosis.

AIMS OF THE STUDY: To compare efficacy and safety of a home-made platelet-rich plasma (PRP) solution versus hyaluronic acid in patients with hip osteoarthritis not responding to conservative treatment and to correlate cellular composition of PRP to clinical outcomes. MATERIAL AND METHODS: This is a phase III clinical trial, double-blinded, controlled and randomised into two treatment groups (PRP and hyaluronic acid). Patients received one hip ultrasound-guided injection. Follow up was 12 months. Pain was assessed using VAS score, HHS and WOMAC were used as functional scores, analgesia, adverse events, cellular components (PRP group) in peripheral blood and in PRP were recorded. Clinical response was assessed using OARSI criteria. RESULTS: Seventy-four patients were included. Both groups improved in VAS, WOMAC and HHS score and reduced the amount of analgesia (p<.05). Significant differences were seen at 1 year post-treatment in HHS score (PRP 70.9 [3.7-58], hyaluronic acid 60.2[43-74.2] p<.05). No adverse events were observed in none of the groups. Platelet concentration was different between responders and non-responders (at 1 month, non-responders 449[438-578] x103 platelets/µl versus responders 565 [481-666] x103 platelets/µl, p<.044). There was a correlation between leukocytes concentration and clinical scores (VAS at six months, r=0.748, p<.013, WOMAC at 6 months r=0.748, p <.013). Patients with early stage hip OA showed higher response rate to PRP compared with late stage (11.51 OR, 95%CI 2.34-50.65, p<.03). CONCLUSIONS: Platelet-rich plasma injection improved hip function, reduced pain and the use of analgesia. It is important to bear in mind the cellular composition in order to achieve a better clinical response.

Simultaneous determination of quinoline yellow and brilliant blue FCF in cosmetics by solid-phase spectrophotometry.

A method for the simultaneous determination of quinoline yellow (QY) and brilliant blue FCF (BB) in mixtures by solid-phase spectrophotometry has been developed. Both colorants were isolated in Sephadex DEAE A-25 gel showing maximum absorbances at 632 nm and 415 nm for BB and QY respectively. The applicable concentration ranges were between 25.0 and 500.0 mug 1(-1) for BB and between 50.0 and 750.0 mug 1(-1) for QY. The detection limits were 6.1 and 13.4 mug (-1) for BB and QY respectively. Application of the method to real samples (colognes, after shave lotions and shampoo gels) involves a previous extraction process of the colorants before their isolation on the gel.