利多分注射剂治疗膝关节骨性关节炎的疗效与安全性(英文)

Efficacy and safety of liduofen in treatment of patients with osteoarthritis of knee joint

目的 :评价利多分治疗膝关节骨性关节炎的临床疗效和安全性。方法 :采用随机、双盲、平行对照方法 ,研究 2 0 0 2年 1月～ 2 0 0 3年 12月间 ,136例病人使用利多分与奥尔芬 75的疗效与安全性。病人随机分为 2组 ,给以 75mg(以双氯芬酸计 )利多分或 75mg(以双氯芬酸计 )奥尔芬 75 ,每日 1次 ,7天 1个疗程。结果 :治疗后 ,对于休息痛、运动性疼痛、关节肿胀、关节压痛、关节屈伸功能 ,采用 10cm目视模拟标尺法 ,利多分与奥尔芬 75疗效相当 :利多分组疼痛改善率治疗d 3为 5 7.97% ,d 5为93.8 7% ,d 7为 96 .94 % ;奥尔芬 75组疼痛改善率治疗d 3为 6 2 .6 9% ,d 5为 95 .76 % ,d 7为97.88% ;利多分与奥尔芬 75的有效率分别为5 6 .72 %和 5 5 .0 7% ,总改善率分别为 89.85 %和92 .5 4% (P >0 .0 5 ) ;利多分无不良反应发生 ,奥尔芬 75不良反应发生率为 1.4 9% (P >0 .0 5 )。结论 :利多分注射剂治疗膝关节骨性关节炎安全有效 ,与奥尔芬 75相比无显著性差别。

AIM: To investigate the efficacy and safety of liduofen in the treatment of patients with osteoarthritis of the knee joint. METHODS: A randomized, double blind, parallel controlled, multi centre study was adapted to compare the efficacy and safety between liduofen and Olfen 75 in 136 patients. Patients were randomly assigned into two groups: liduofen group which was received 75 mg (diclofenac) Liduofen injection (n=69) once a day for seven days and Olfen group which was received 75 mg (diclofenac) Olfen 75 injection (n=67) once a day for seven days. RESULTS: After the treatment, similar improvements for rest pain, pain on exercise, swelling of joint, pressing pain of joint, knee joint bend extend function measured using a 10 cm visual analogue scale was performed in two groups. In Olfen 75 group, the rate of efficacy was 62.69 % in the 3rd day, 95.76 % in the 5th day and 97.88 % in the 7th day. While in liduofen group, the rate of efficacy was 57.97 % in the 3rd day, 93.87 % in the 5th day and 96.94 % in the 7th day. In liduofen and Olfen 75 groups, the progressive rates were 56.72 % and 55.07 %, respectively. The total improvement rates were 89.85 % and 92.54 % respectively (P> 0.05 ), and the rates of side effects were 0% and 1.49 %, respectively (P> 0.05 ). CONCLUSION: Liduofen is an effective and safty drug inthe treatment of patients with osteoarthritis of the knee joint. There is no significant difference on efficacy and safety between the two groups using liduofen and Olfen 75.