Kotz R, Kolarz G
Orthopedic Department, University of Vienna, Austria.
Am J Orthop (Belle Mead NJ). 1999 Nov;28(11 Suppl):5-7.
An open-label, multicenter study was designed to evaluate the effects of intra-articular (IA) hyaluronic acid in patients given a diagnosis of osteoarthritis of the knee. Patients (n = 108) received five weekly IA injections of hyaluronic acid 20 mg (Hyalgan) under sterile conditions, and were observed for up to 12 months after the last injection. Some patients received a second series of injections after 4 to 8 months. For the 59 patients who were observed for 12 months after the first treatment cycle, evaluation of pain according to a visual analog scale showed significant improvements lasting 12 months, with pain during load, pain at rest, and duration of walking ability compared with a baseline evaluation. Patients who required a second treatment cycle showed a further amelioration. Significant improvements were also seen in knee function and in global evaluations by both patient and investigators. Relief of symptoms of osteoarthritis of the knee was seen as early as 4 weeks after treatment in 68% of patients receiving IA hyaluronic acid. In 55% of these patients, relief was maintained until the end of the 12-month follow-up.
一项开放标签、多中心研究旨在评估关节内（IA）注射透明质酸对诊断为膝关节骨关节炎患者的影响。108例患者在无菌条件下每周接受5次IA注射20mg透明质酸（海乐妙），并在最后一次注射后观察长达12个月。部分患者在4至8个月后接受了第二轮注射。对于在第一个治疗周期后观察12个月的59例患者，根据视觉模拟量表进行的疼痛评估显示，与基线评估相比，疼痛在12个月内有显著改善，包括负重时疼痛、静息时疼痛以及行走能力持续时间。需要第二个治疗周期的患者症状进一步改善。患者和研究者对膝关节功能及整体评估也有显著改善。接受IA透明质酸治疗的患者中，68%在治疗后4周即出现膝关节骨关节炎症状缓解。其中55%的患者症状缓解持续至12个月随访结束。
