透明质酸钠治疗颞颌关节退行性关节病临床随机对照研究

RANDOMIZED CONTROLLED TRIAL OF SODIUM HYALURONATE FOR DEGENERATIVE DISORDERS OF THE TEMPOROMANDIBULAR JOINT

目的 通过临床随机对照研究检验透明质酸钠治疗颞颌关节退行性关节病的效果及不良反应 ,为该病治疗寻找新的手段。方法 应用临床随机对照方法将患者分成治疗组与对照组 ,治疗组应用透明质酸钠 ,对照组应用醋酸强的松龙 ,均行颞颌关节上腔注射 ,每周 1次 ,每次剂量分别为 6 m g和 12 .5 mg,3～ 4次为一个疗程 ,治疗前、后观察临床症状及监测关节滑液中白细胞介素 - 6 (IL- 6 )水平及蛋白总量的变化。共纳入患者 6 7例 ,失访 4例 ;6 3例中 ,男 12例 ,女 5 1例。滑膜炎 14例 ,不可复性盘前移位 2 1例 ,骨关节炎 2 8例 ;治疗组 35例 ,对照组2 8例。结果 两种药物均可有效缓解颞颌关节退行性关节病的临床症状 ,治疗组显效率 5 1.43% ,有效率 45 .71% ,无效率 2 .86 % ;对照组显效率 39.2 9% ,有效率 42 .86 % ,无效率 17.86 %。两种药物均可显著降低关节滑液内 IL- 6的含量 ,但治疗组降低幅度更大。透明质酸钠注射后疼痛发生率 37.1% ,一过性患侧开牙合及咀嚼无力发生率8.6 % ;强的松龙注射后疼痛发生率 5 0 %。结论 应用透明质酸钠治疗颞颌关节退行性关节病疗效明显 ,无严重不良反应 ,有效率及 IL- 6减少幅度优于强的松龙 ,可作为皮质激素的替代用药在临床推广使用。

Objective To assess the effect of sodium hyaluronate(HA) for degenerative disorders of the temporomandibular joint (TMJ). Methods A prospective randomized controlled clinical trial was conducted. The experimental group received injections in the upper compartments of the involved TMJs with 1% HA 6mg, whereas the control group received prednisolone (PS) 12.5 mg once a week. Three to four injections were as one course. Before and one week after the treatment courses, clinical symptoms, amount of interleukin 6 (IL 6) and total protein of synovial fluid were measured and compared. Results Sixty seven patients were included and 4 out of them were dropped out. There were 12 males and 51 females, among them, 14 cases with synovitis, 21 with anterior disc displacement without reduction and 28 with osteoarthritis of the TMJ. Thirty five patients allocated in HA group and 28 in PS group. Both drugs could relieve the clinical symptoms of TMJ degenerative disorders. In HA group, marked improvement rate was 51.43% and failure rate was 2.86%, whereas marked improvement rate 39 29% and failure rate 17.86% in PS group. The declined levels of IL 6 in synovial fluid was notably greater in HA group than those in PS group. Conclusion Intra articular injection of HA is effective and safe to treat TMJ degenerative disorders with mild adverse reactions, better in terms of effective rate and declined level of IL 6 than PS.