安慰剂对照观察重复关节内注射透明质酸钠的远期效果

Long-term effect of repeated intra-articular injections of hyalurinic acid:a randomised placebo-controlled study

[目的]应用安慰剂对照，观察关节内注射透明质酸钠的有效性、安全性和远期效果。[方法]56名膝关节骨性关节炎患者随机分为安慰剂组和透明质酸组，每组28名，分别接受关节内注射安慰剂或透明质酸钠3个疗程，每个疗程注射5次。前两个疗程每个疗程结束后观察6个月，第三个疗程结束后观察12个月。记录患者观察期间的疗效和不良反应。[结果]研究结果显示，透明质酸组治疗有效率明显高于安慰剂组（P〈0．05）。每次治疗后，透明质酸组治疗有效率均有升高（72．1％～82．1％），而安慰剂组则无明显变化（64．2％-67．8％）。透明质酸组患者在疼痛、关节功能、总体评价等方面改善情况均明显优于安慰剂组，差异均有统计学意义（19〈0．05）。两组均无严重不良事件发生。[结论]透明质酸钠关节内重复注射可明显改善患者的症状，其疗效可在注射结束后维持至少12个月，且无任何不良反应。

[ Objective ] To study the efficacy and safety of repeated injections of hyalurinic acid （HA） and its longterm effect. [ Methods] Fifty- six patients with knee osteoarthritis were randomly assigned to two groups： the placebo group （n = 28） and hyalurinic acid group （n = 28） . Patients received three cycles of five intra - articular placebo or HA injections with a follow - up of six months after the first two cycles, and the third cycle with another follow - up of tweleve months. Adverse events were recorded for safety purposes. [ Results ] The number of effective patients in HA group were significantly more than in placebo group at all the time points （P 〈0. 05） . [ Conclusion] The repeated intra - articular injections of HA not only improve knee osteoarthritis sympoms during the course of treatment but also have singnificant long - term effect after the last cycle for at least 12 months.