Objective To investigate the effectiveness of flexible nanoliposomes of diclofen for external application in the treatment of knee osteoarthritis and the situation of local skin irritation. Methods Totally 60 patients with knee osteoarthritis who meet the requirements of clinical observation of indicators randomly divided into 3 groups: treatment group with flexible nanoliposomes of diclofen (nano-liposome group) (n =20); diclofenac sodium gel group(n=20); placebo group topical therapy of paraffin oil(n=20) . Before treatment and after 3 days, 7 days and 14 days treatment, the efficacy was observed. Effectiveness evaluations included Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index subscales, and subject global assessment (SGA) of response to therapy and Berger and Bowman Scoring System. Results WOMAC pain score: Before treatment, there was no significant difference between the three groups. After 14 days therapy, the difference value of WOMAC pain scores before and after treatment in the nano-liposome group was obviously greater than that of the diclofenac sodium gel group and placebo group (P<0.05).Subject global assessment (SGA) of OA status: Before treatment, there were no statistic significant in differences between the three groups. After 14 days therapy, the difference value of the SGA of OA status before and after treatment in the nano-liposome group was obviously greater than that of the diclofenac sodium gel group and placebo group (P<0.05).Total effective rate: After 14 days therapy, comparison of the total effective rate in the three groups according to WOMAC pain score and SGA of OA, the total effective rate of nano-liposome group was higher than diclofenac that of potassium gel group and placebo group (P<0.05).Local skin irritation: There were individual patients occurred application site reactions in three groups, but no statistical significance (P>0.05). Conclusions The total effective rate of Flexible nanoliposomes of diclofen for external application in the treatment of patients with knee osteoarthritis on the 14th day was higher than diclofenac potassium gel group, and no obvious skin irritation.%目的:探讨双氯芬酸柔性纳米脂质体局部外用治疗膝关节骨关节炎(OA)的疗效和局部皮肤刺激情况.方法:收集符合本实验临床观察指标的60例膝关节OA患者随机分为外用双氯芬酸柔性纳米脂质体组(简称纳米组)20例、外用双氯芬酸钠乳胶剂组(简称乳胶剂组)20例、外用石蜡油组(简称安慰剂组)20例.分别记录治疗前(即第0天)及治疗后的第3天、第7天和第14天的WOMAC疼痛评分、OA状况总体评分(SGA)、局部皮肤刺激评分.结果:①WOMAC疼痛评分:治疗前三组比较差异无统计学意义；治疗后第14天,三组患者WOMAC疼痛评分治疗前后的差值比较,纳米组与乳胶剂组和安慰剂组比较,差异均有统计学意义(P＜0.05)；②OA状况总体评估:治疗前三组比较差异无统计学意义；治疗第14天,三组患者OA状况总体评分治疗前后的差值比较,纳米组与乳胶剂组和安慰剂组比较,差异均有统计学意义(P＜0.05).③总有效率:治疗第14天,根据患者WOMAC及OA状况总体评估比较三组总有效率,纳米组的总有效率与乳胶剂组和安慰剂组比较,差异均有统计学意义(P＜0.05).4.局部皮肤刺激:三组均有个别患者发生局部皮肤反应,但无统计学意义.结论:外用双氯芬酸柔性纳米脂质体治疗膝关节骨关节炎第14天总有效率优于扶他林乳胶剂,且无明显皮肤刺激反应.
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