Raeissadat Seyed Ahmad, Tabibian Elnaz, Rayegani Seyed Mansoor, Rahimi-Dehgolan Shahram, Babaei-Ghazani Arash
Clinical Development Research Center of Shahid Modarres Hospital, Physical Medicine and Rehabilitation Department and Research Center, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Radiology Department, Medical Imaging Center, Advanced Diagnostic and Interventional Radiology Research Center (ADIR), Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
J Pain Res. 2018 Oct 25;11:2537-2550. doi: 10.2147/JPR.S175441. eCollection 2018.
This study aimed to review and pool the current literature on intra-articular ozone injection in knee osteoarthritis (OA) patients.
A systematic review of three big databases was performed to identify all English-language randomized clinical trials (RCTs) that evaluated the efficacy of intra-articular ozone injection vs a control injection for knee OA sufferers, using the following two measuring tools: pain VAS and Western Ontario and McMaster Universities Arthritis Index (WOMAC).
A total of 428 patients in five RCTs were included, from which 53% (n=225) were in the ozone group and 47% in the control (hyaluronic acid [HA], dextrose, and air injection) group (n=203). The mean age of the patients in both groups was 64 years. Females were the majority. All studies had at least 2 months of follow-up (F/U). Mean difference (MD) between the groups for VAS in the first month was -0.23 with a -value of 0.71 (negative value was in favor of ozone), whereas this difference in the third and sixth months reached 1.04 and 1.31, respectively, favoring the control group. These data demonstrated that control injection had a more prolonged pain relief period. A similar trend was seen regarding WOMAC scores; pooled results showed that ozone was slightly better than the control injections during the first month (MD =-7.84 [=0.15]), but it declined to MD=2.55 and 8.23 at 2- to 3- and 4- to 6-month F/U, respectively, again in favor of control injections. Also, adverse events occurred homogeneously in both ozone (6/150 cases, 4%) and control groups (7/129 cases, 5.4%; -value=0.31).
Based on the current meta-analysis, intra-articular ozone injection efficacy was significantly superior to placebo and slightly lower to other control injections with non-significant difference. Therefore, ozone could be recommended as an efficient non-surgical treatment, durable for at least 3-6 months, in mild or moderate knee OA management.
本研究旨在回顾和汇总目前关于膝关节骨关节炎（OA）患者关节腔内注射臭氧的文献。
对三个大型数据库进行系统回顾，以确定所有评估关节腔内注射臭氧与对照注射对膝关节OA患者疗效的英文随机临床试验（RCT），使用以下两种测量工具：疼痛视觉模拟评分（VAS）和西安大略和麦克马斯特大学骨关节炎指数（WOMAC）。
五项RCT共纳入428例患者，其中臭氧组占53%（n = 225），对照组（透明质酸[HA]、葡萄糖和空气注射）占47%（n = 203）。两组患者的平均年龄均为64岁。女性占多数。所有研究的随访时间至少为2个月（F/U）。第一个月两组VAS的平均差值（MD）为-0.23，P值为0.71（负值有利于臭氧组），而在第三个月和第六个月，该差值分别达到1.04和1.31，有利于对照组。这些数据表明对照注射的疼痛缓解期更长。WOMAC评分也呈现类似趋势；汇总结果显示，臭氧在第一个月略优于对照注射（MD = -7.84 [P = 0.15]），但在2至3个月和4至6个月的随访中分别降至MD = 2.55和8.23，同样有利于对照注射。此外，臭氧组（6/150例，4%）和对照组（7/129例，5.4%；P值 = 0.31）的不良事件发生率相近。
基于当前的荟萃分析，关节腔内注射臭氧的疗效显著优于安慰剂，略低于其他对照注射，差异无统计学意义。因此，对于轻度或中度膝关节OA的治疗，臭氧可作为一种有效的非手术治疗方法推荐使用，其疗效可持续至少3至6个月。
