Lussier A, Cividino A A, McFarlane C A, Olszynski W P, Potashner W J, De Médicis R
Rheumatic Disease Unit, Faculty of Medicine, Université de Sherbrooke, Québec, Canada.
J Rheumatol. 1996 Sep;23(9):1579-85.
To evaluate viscosupplementation with intraarticular hylan G-F 20 in current clinical practice.
A retrospective study of all patients with osteoarthritis of the knee treated with hylan by 5 Canadian clinicians over a period of 2.5 years.
A total of 1537 injections were performed in 336 patients involving 458 knees. The overall response and the change of activity level were judged better or much better for 77 and 76% of the treated knees after the first course of treatment (3 weekly injections), and 87 and 84% after a 2nd course. The mean time elapsing between the first and 2nd course, 8.2 +/- 0.5 months, is an evaluation of the duration of benefits. Local adverse events were observed in 28 patients (32 knees), with an overall rate of 2.7% adverse events per injection, 7.0% per joint, and 8.3% per patient. No systemic adverse events were noted in any patient. The adverse events were characterized by pain and/or transient swelling of the injected joint, mostly mild or moderate in intensity, and 72% of the adverse events were considered to be possibly or probably related to the injection. The incidence of adverse events is significantly influenced by the injection technique: 5.2% adverse events per injection with a medial approach to a partially bent knee, and 2.4% (straight medial) and 1.5% (straight lateral). After an adverse event, clinical improvement still occurred in 69% of the affected knees.
Hylan G-F 20 provided good clinical benefits and an acceptable safety profile in current clinical practice. The occurrence of adverse events after an intraarticular hylan injection is infrequent and unpredictable and is not necessarily hylan related, although injection related.
在当前临床实践中评估关节腔内注射透明质酸钠凝胶(hylan G-F 20)进行粘弹性补充治疗的效果。
对5位加拿大临床医生在2.5年期间用透明质酸钠治疗的所有膝骨关节炎患者进行回顾性研究。
共对336例患者的458个膝关节进行了1537次注射。在第一个疗程(每周注射3次)后,77%和76%的治疗膝关节的总体反应及活动水平变化被判定为良好或非常好;在第二个疗程后,这两个比例分别为87%和84%。第一个疗程和第二个疗程之间的平均间隔时间为8.2±0.5个月,这是对疗效持续时间的一种评估。28例患者(32个膝关节)出现局部不良事件,每次注射的总体不良事件发生率为2.7%,每个关节为7.0%,每位患者为8.3%。未观察到任何患者出现全身不良事件。不良事件的特征为注射关节疼痛和/或短暂肿胀,大多为轻度或中度,72%的不良事件被认为可能或很可能与注射有关。注射技术对不良事件的发生率有显著影响:膝关节部分弯曲时采用内侧入路注射,每次注射的不良事件发生率为5.2%;而采用直内侧入路为2.4%,直外侧入路为1.5%。出现不良事件后,69%的患膝仍有临床改善。
在当前临床实践中,透明质酸钠凝胶(hylan G-F 20)提供了良好的临床疗效和可接受的安全性。关节腔内注射透明质酸钠后不良事件的发生不常见且不可预测,虽然与注射有关,但不一定与透明质酸钠相关。