目的 评估安陆德免荷一号矫形器对内侧膝骨关节炎患者活动、疼痛、膝关节功能、日常生活以及生活质量的影响.方法 36例骨关节炎患者.按平均、计算机随机、双盲方法将患者分为A、B、C三组.A组以安陆德免荷一号矫形器加非甾体抗炎药(non-steroidal antiinflammatory drugs,NSAIDs)美洛昔康联合治疗,B组单用安陆德免荷一号矫形器治疗,C组单用美洛昔康治疗,每组12例.从入组起,每3周门诊随访,通过Lysholm膝关节评分表、KOOS评分表、SF-12生活质量评价量表、过去24 h VAS疼痛评分表以及Tegner活动积分表对患者进行评估,总疗程为12周.结果 (1)治疗后12周,A组患者Lysholm膝关节评分:85.64±4.74,KOOS评分症状:73.17±8.29、疼痛:70.33±5.96、日常生活:77.08±4.32、体育及娱乐:81.67±5.77、生活质量:80.58±5.76,SF-12生活质量评分:19.08±1.88,过去24 h VAS疼痛评分1.25±0.754,Tegner活动积分:7.45±1.08,各项评分较开始改善显著,差异有统计学意义(P<0.05).B组患者Lysholm膝关节评分:85.33±4.68,KOOS评分症状:71.33±10.63、疼痛:68.83±5.01、日常生活:75.92±5.18、体育及娱乐:80.00±7.07、生活质量:78.17±6.63,SF-12生活质量评分:18.83±2.52,过去24 h VAS疼痛评分1.4±0.809,Tegner活动积分7.55±1.31,各项评分较开始改善显著,差异有统计学意义(P<0.05).C组患者Lysholm膝关节评分:76.17±5.557,KOOS评分症状:60.92±7.75、疼痛:57.67±8.69、日常生活:68.17±4.61、体育及娱乐:70.00±8.53、生活质量:69.33±8.24,SF-12生活质量评分:14.18±1.81,过去24 h VAS疼痛评分2.2±0.669,Tegner活动积分:4.36±0.91,各项评分较开始改善显著,差异有统计学意义(P<0.05).B组评分与A组差异无统计学意义(P≥0.05),疗效较C组显著,差异有统计学意义(P<0.05).(2)从整体趋势而言:C组患者症状好转快,最终疗效不如A、B组.B组起效慢,最终疗效比C组好.A组起效快,最终疗效较C组好,但与B组差异无统计学意义(P≥0.05).(3)使用后3周,C组患者Lysholm膝关节评分:71.08±7.63,KOOS评分症状:56.25±12.22、疼痛:41±10.24、日常生活:55.5±10.7、体育及娱乐:57.08±14.22、生活质量:55.5±10.7,SF-12生活质量评分:10.92±2.11,过去24 h VAS疼痛评分2.08±1.08,Tegner活动积分:3.67±1.23,较疗效较B组显著,差异有统计学意义(P<0.05),C组与A之间差异无统计学意义(P≥0.05).(4)使用后6周,A组Lysholm膝关节评分:81.25±8.95,KOOS评分症状:69.5±11.33、疼痛:62.5±9.8、日常生活:69.5±9.35、体育及娱乐:72.92±10.97、生活质量:69.5±9.35,SF-12生活质量评分:16.58±2.84,过去24 h VAS疼痛评分1.58±0.79,Tegner活动积分:6.58±1.56,疗效明显优于C组,差异有统计学意义(P<0.05),C组疗效较3周前差异无统计学意义(P≥0.05),但与B组相比疗效差异有统计学意义(P<0.05).(5)在第9周时,A组Lysholm膝关节评分:85.08±4.91,KOOS评分症状:71.17±10.53、疼痛:65.67±7.33、日常生活:72.42±6.1、体育及娱乐:77.5±7.54、生活质量:72.42±6.1,SF-12生活质量评分:18.92±2.07,过去24 h VAS疼痛评分1.46±0.54,Tegner活动积分:7.42±0.9,疗效明显优于C组,差异有统计学意义(P<0.05);C组疗效较第6周差异无统计学意义(P≥0.05),且与B组疗效差异无统计学意义(P≥0.05).结论 (1)安陆德免荷一号骨关节炎矫形器治疗内侧膝骨关节炎具有较好的疗效.(2)单独使用安陆德一号骨关节炎矫形器起效较NSAIDs缓慢,但最终能全面改善患者症状、膝关节功能、日常生活以及生活质量.(3)矫形器联合使用NSAIDs在短期内可以缓解疼痛症状,且最终治疗效果良好,但最终疗效与单用矫形器差异无统计学意义.“,”Objective To evaluate the influence of Unloader? One knee brace on the range of motion, pain, function, quality of daily life in the patients with medial knee osteoarthritis ( OA ). Methods A prospective, randomized and double-blind trial was performed on 36 patients with OA, who were divided into 3 groups, with 12 patients in each group. In group A, the patients were treated with the combination of Unloader? One knee brace and nonsteroidal anti-inflammatory drugs ( NSAIDs ) ( meloxicam ). In group B, the patients were treated with Unloader? One knee brace alone. In group C, the patients was treated with NSAIDs ( meloxicam ) alone. All the patients visited the outpatient department every 3 weeks. The therapeutic effects were evaluated by means of the Lysholm knee scoring scale ( LKSS ), knee injury and osteoarthritis outcome score ( KOOS ), SF-12 physical component score, visual analogue scale ( VAS ) and Tegner activity level scale. The overall treatment time was 12 weeks. Results ( 1 ) At 12 weeks after the treatment, Lysholm score: 85.64 ± 4.74; KOOS score: 73.17 ± 8.29; pain: 70.33 ± 5.96;daily life: 77.08 ± 4.32; sports and entertainment: 81.67 ± 5.77; quality of life: 80.58 ± 5.76; SF-12 score: 19.08 ± 1.88;VAS pain score in the past 24 hours: 1.25 ± 0.754; Tegner active score: 7.45 ± 1.08 in group A, and all of the indexes got improved significantly ( P < 0.05 ). Lysholm score: 85.33 ± 4.68; KOOS score: 71.33 ± 10.63; pain: 68.83 ± 5.01; daily life: 75.92 ± 5.18; sports and entertainment: 80.00 ± 7.07; quality of life: 78.17 ± 6.63; SF-12 score: 18.83 ± 2.52; VAS pain score in the past 24 hours: 1.4 ± 0.809; Tegner active score: 7.55 ± 1.31 in group B, and all of the indexes got improved significantly ( P < 0.05 ). Lysholm score: 76.17 ± 5.557; KOOS score: 60.92 ± 7.75; pain: 57.67 ± 8.69; daily life: 68.17 ± 4.61; sports and entertainment: 70.00 ± 8.53; quality of life: 69.33 ± 8.24; SF-12 score: 14.18 ± 1.81; VAS pain score in the past 24 hours: 2.2 ± 0.669; Tegner active score: 4.36 ± 0.91 in group C, and all of the indexes got improved significantly ( P < 0.05 ). No significant differences were noticed between group B and group A ( P ≥ 0.05 ), while the therapeutic effects were much better than that in group C ( P < 0.05 ). ( 2 ) From the overall trend, the improvement of symptoms was achieved quickly in group C, but the final effects were worse than those in group A and B. The improvement of symptoms was achieved slowly in group B, but the final effects were better than those in group C. The improvement of symptoms was achieved quickly in group A. There were no significant differences between group A and group B ( P ≥ 0.05 ), while the final effects in group A were much better than those in group C. ( 3 ) Three weeks later, Lysholm score: 71.08 ± 7.63; KOOS score: 56.25 ± 12.22; pain: 41 ± 10.24; daily life: 55.5 ± 10.7; sports and entertainment: 57.08 ± 14.22; quality of life: 55.5 ± 10.7; SF-12 score: 10.92 ± 2.11, VAS pain score in the past 24 hours: 2.08 ± 1.08; Tegner active score: 3.67 ± 1.23 in group C, and the therapeutic effects were much better than those in group B ( P < 0.05 ), while no significant differences existed between group C and group A ( P ≥0.05 ). ( 4 ) Six weeks later, Lysholm score: 81.25 ± 8.95; KOOS score: 69.5 ± 11.33; pain: 62.5 ± 9.8; daily life: 69.5 ± 9.35; sports and entertainment: 72.92 ± 10.97; quality of life: 69.5 ± 9.35; SF-12 score: 16.58 ± 2.84; VAS pain score in the past 24 hours: 1.58 ± 0.79; Tegner active score: 6.58 ± 1.56 in group A, and the therapeutic effects were much better than those in group C ( P < 0.05 ). No significant differences were noticed when compared with group C 3 weeks earlier ( P ≥ 0.05 ), while there were significant differences when compared with group B ( P < 0.05 ). ( 5 ) Nine weeks later, Lysholm score: 85.08 ± 4.91; KOOS score: 71.17 ± 10.53; pain: 65.67 ± 7.33; daily life: 72.42 ± 6.1;sports and entertainment: 77.5 ± 7.54; quality of life: 72.42 ± 6.1; SF-12 score: 18.92 ± 2.07; VAS pain score in the past 24 hours: 1.46 ± 0.54; Tegner active score: 7.42 ± 0.9 in group A, and the therapeutic effects were much better than those in group C ( P < 0.05 ). No significant differences were noticed when compared with those at the 6th weeks in group C ( P ≥ 0.05 ), while there were no significant differences when compared with group B ( P ≥ 0.05 ). Conclusions ( 1 ) Better therapeutic effects can be achieved using Unloader? One knee brace in the treatment of medial knee OA. ( 2 ) The symptoms, pain, function and quality of daily life can be effectively improved by using the brace alone even though it takes a longer time relatively. ( 3 ) Pain can be relieved in a shorter time and the final effects are better by the combination of Unloader? One knee brace and NSAIDs, but no significant differences are found in the final effects when compared with that using the brace alone.