Long-term effects of intra-articular oxygen-ozone therapy versus hyaluronic acid in older people affected by knee osteoarthritis: A randomized single-blind extension study
Long-term effects of intra-articular oxygen-ozone therapy versus hyaluronic acid in older people affected by knee osteoarthritis: A randomized single-blind extension study
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DOI：
10.3233/bmr-181294
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发表时间：
2020-01-01
影响因子：
1.6
通讯作者：
Invernizzi, Marco
中科院分区：
文献类型：
--
作者：
de Sire, Alessandro;Stagno, Davide;Invernizzi, Marco
背景技术背景：膝关节骨关节炎（KOA）关节内（IA）治疗的证据很少，也缺乏长期随访研究。目的：评估IA氧-臭氧（O2 O3）和透明质酸（HA）在KOA患者31周内的功能方面的长期有效性和安全性。年龄> 60岁的KOA患者被随机分配接受4次O2 O3或HA IA膝关节注射（1次/周）（T0-T3），并在第4次注射后4周进行随访（T4）。在这项扩展研究中，我们评估了6个月随访访视（T5）、第二个治疗周期（T5-T8）和1个月随访访视（T9）时视觉疼痛评分（VAS）> 4的患者的VAS和安全性。42例患者（年龄70.5 ± 5.8岁）被随机分配至O2 O3组（n = 22）或HA组（n = 20）。23例患者接受了另一个IA周期：O2 O3组12例（54.6%），HA组11例（55.0%）。在两个周期内，与基线相比，两组的VAS均显著降低（p < 0.013）。在随访访视（T4和T9）时，HA组的VAS显著较低（p < 0.013）。有组之间的不良事件发生率没有差异。结论：IA O2 O3可能是可比的HA在有效性和安全性方面，减少疼痛KOA患者，虽然在两个后续访问（T4和T9）VAS显着降低HA组。
BACKGROUND: There is little evidence on intra-articular (IA) treatment in knee osteoarthritis (KOA) and there is a lack of long-term follow-up studies.OBJECTIVE: To assess the long-term effectiveness and safety of IA oxygen-ozone (O2O3) and hyaluronic acid (HA) in terms of functioning in KOA patients over a 31-week period.METHODS: Patients aged > 60 years with KOA were randomly allocated to receive 4 IA knee injections (1/week) of O2O3 or HA (T0-T3) and a follow-up visit 4 weeks after the fourth injection (T4). In this extension study we assessed VAS and safety in patients with Visual Analogue Scale (VAS) > 4 at the at 6-month follow-up visit (T5), undergoing a second treatment cycle (T5-T8) and 1-month follow-up visit (T9).RESULTS: Forty-two patients (aged 70.5 +/- 5.8 years) were randomly allocated to O2O3 ( n = 22) or HA group ( n = 20). Twenty-three underwent another IA cycle: 12 (54.6%) in the O2O3 group and 11 (55.0%) in the HA group. Both groups showed significant reduction in VAS (p < 0.013) compared to baseline during both cycles. At follow-up visits (T4 and T9), VAS was significantly lower in the HA group (p < 0.013). There were no differences in adverse events occurrence between groups.CONCLUSIONS: IA O2O3 might be comparable to HA in terms of effectiveness and safety in reducing pain in KOA patients, although at both follow-up visits (T4 and T9) VAS was significantly lower in the HA group.