Servicio de Cirugía Ortopédica y Traumatología, Hospital Hospiten, Estepona, España; Servicio de Cirugía Ortopédica y Traumatología, Hospital Universitario Virgen Macarena, Sevilla, España.
Servicio de Cirugía Ortopédica y Traumatología, Hospital Universitario Virgen Macarena, Sevilla, España; Servicio de Farmacia Hospitalaria, Hospital Universitario San Cecilio, Granada, España.
Rev Esp Cir Ortop Traumatol (Engl Ed). 2020 Mar-Apr;64(2):134-142. doi: 10.1016/j.recot.2019.09.008. Epub 2020 Jan 2.
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.
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.
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).
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.
比较自制富血小板血浆（PRP）溶液与透明质酸治疗对保守治疗无效的髋骨关节炎患者的疗效和安全性，并将 PRP 的细胞成分与临床结果相关联。
这是一项 III 期临床试验，采用双盲、对照和随机分组的方法分为两组（PRP 和透明质酸）。患者接受一次髋关节超声引导下的注射。随访时间为 12 个月。疼痛采用 VAS 评分评估，HHS 和 WOMAC 作为功能评分，记录镇痛、不良事件、外周血和 PRP 中的细胞成分（PRP 组）。采用 OARSI 标准评估临床反应。
共纳入 74 例患者。两组患者在 VAS、WOMAC 和 HHS 评分方面均有所改善，镇痛用量减少（p<.05）。治疗后 1 年，HHS 评分差异显著（PRP 组 70.9[3.7-58]，透明质酸组 60.2[43-74.2]，p<.05）。两组均未观察到不良事件。反应者和非反应者的血小板浓度不同（1 个月时，非反应者 449[438-578]×103 个/μl 与反应者 565[481-666]×103 个/μl，p<.044）。白细胞浓度与临床评分呈正相关（6 个月时 VAS，r=0.748，p<.013；6 个月时 WOMAC，r=0.748，p<.013）。早期髋骨关节炎患者对 PRP 的反应率高于晚期（11.51 OR，95%CI 2.34-50.65，p<.03）。
PRP 注射可改善髋关节功能，减轻疼痛，减少镇痛药物的使用。为了获得更好的临床反应，重要的是要注意细胞成分。
