医用壳聚糖与透明质酸钠关节腔内注射治疗膝骨关节炎的疗效比较

Comparison of therapeutic effect of chitosan and sodium hyaluronate intra-articular injection in the treatment of knee osteoarthritis

目的研究医用壳聚糖对比透明质酸钠关节腔注射治疗膝骨关节炎病人的疗效和安全性。方法选择2015年1月至2015年4月,在上海交通大学附属第六人民医院骨科门诊就诊的34例膝骨关节炎患者,其中男11例,女23例,侧别:单侧8例,双侧26例。平均年龄60岁。根据随机、双盲、平行对照、非劣性比较临床试验的原则,受试患者分别随机分入壳聚糖注射组和透明质酸钠注射组。在治疗结束后6周,及治疗结束后12周基于VAS评分;WOMAC评分:包括WOMAC疼痛、关节僵硬、关节生理功能评分;受试者总体评分来评估对于研究侧膝关节疗效,以及壳聚糖和透明质酸钠注射液的安全性。观察治疗后关节疼痛、关节腔积液及肿胀与关节功能改善程度。结果患者膝关节腔注射壳聚糖或透明质酸钠后,在访视时研究侧膝关节在平地行走时的疼痛程度减轻,上述相关评分均升高,壳聚糖注射组疗效相比透明质酸注射组无明显差异。结论关节内注射壳聚糖对膝骨关节炎有良好疗效,与透明质酸对比无明显差异,但是注射次数减少,安全性增高。

Objective To study the clinical efficacy and safety in the treatment of knee osteoarthritis by comparing the therapeutic effect and safety of the treatment of patients with knee osteoarthritis by chitosan with that by sodium hyaluronate injection. Methods 34 patients with knee osteoarthritis were selected the Sixth People＇s Hospital Affiliated to Shanghai Jiao Tong University in January 2015,April,and 11 patients were male,23 patients were female,8 cases,unilateral,26 cases,bilateral,average age of 60 years. According to the principle of randomized,double blind,parallel controlled,non inferiority trial,patients were randomly divided into several groups,respectively,chitosan groups and sodium hyaluronate injection group. 6 weeks after the end of treatment,and 12 weeks after the treatment,the VAS score：WOMAC score：WOMAC pain,joint stiffness,knee physiological function score,the overall score of subjects to assess the efficacy of the study side of the knee,as well as the safety of several chitosan and sodium hyaluronate injection. Joint pain,joint effusion and swelling and joint function improvement were observed. Results The pain of knee joint in patients with knee joint cavity was reduced,and the correlation score was higher than that in the treatment group.Conclusion There is a good effect of intra- articular injection of chitosan in the knee osteoarthritis with no significant difference in comparison with SHI Groups,but the number of injections decreases and the safety increases.